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Cyberbullying triples suicide risk in teens
SAN FRANCISCO – Suicide attempts that required treatment were more than three times as likely in teenagers who reported being bullied online, compared with youths who were not bullied, an analysis of federal data on more than 15,000 adolescents found.
Girls faced twice as much electronic bullying as boys. Cyberbullying was reported by 22% of girls and 11% of boys, according to the study of data on teens aged 13-18 years from the Centers for Disease Control and Prevention’s 2011 Youth Risk Behavior Survey, the first of its kind to ask questions about cyberbullying.
Other data suggest that 80% of U.S. teens use social networking sites, Dr. Kristi M. Kindrick said at a press briefing at the annual meeting of the American Psychiatric Association.
Among 13- to 17-year-olds, an estimated 12% have suicidal ideation, 4% plan suicide, and another 4% attempt suicide, rates that now are similar to those in adults, she noted.
The effects of online harassment on suicidal risk may be one reason that suicide is now the third leading cause of death in adolescents, behind accidents and homicides.
Dr. Kindrick and her associates found that one in six teens reported being electronically bullied, compared with one in five who said they had been bullied on school grounds. Almost 6% of high school students said they had missed school because of fears for their safety. The rate of conventional off-line bullying, such as harassment in the schoolyard, was 22% for girls (the same rate as online bullying) and 18% for boys (higher than the 11% rate for cyberbullying), reported Dr. Kindrick, a fourth-year resident in psychiatry at the University of Arkansas for Medical Sciences, Little Rock, who was moved to do the study after a young patient killed herself following cyberbullying.
Offline bullying, however, only doubled the risk for suicide, compared with the tripling in risk seen with cyberbullying, she said. Rates for the most serious cases – suicide attempts that required treatment – were 1.5% for youths who had not been bullied, 2.3% for those who reported being bullied at school, 5.4% among those who had been cyberbullied, and 6% if they had been bullied both offline and online.
Dr. Kindrick said that she is a clinician more than a researcher, and her goal is to educate communities and schools about this problem. Clinicians need to ask about bullying, sometimes in more than one way, to identify youths who are being bullied and help them cope and get help.
"Why I really care about it is because I’m a mom. I have three young children," she added.
The fact that rates of suicidal ideation, suicide planning, and suicide attempts in teens now are nearly the same as in adults belies the notion that today’s children and adolescents live carefree lives. The highest rates of cyberbullying in the study targeted white girls, she said, so "the movie ‘Mean Girls’ kind of lives up to its reputation here."
Dr. Kindrick reported having no financial disclosures.
On Twitter @sherryboschert
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I think that the issue of cyberbullying for teenagers and preteenagers is important. The issue of bullying in general is important. Certainly for psychiatrists and other mental health professionals, parents, teachers, other people in school, and pediatricians, this should be in the back of our minds when interacting with a youngster, to see if this is an issue. Sometimes you need to ask them in more than one way.
We shouldn’t tolerate cyberbullying, and we should make sure that those who experience it know that the people who are doing it are the people who are wrong. We should make sure that the targets of cyberbullying know that they can seek help and support from adults and from friends who don’t engage in that, and that they’re not alone. That’s where the risk comes, when they feel alone.
Dr. Jeffrey Borenstein is president and chief executive officer of the Brain and Behavior Research Foundation in Great Neck, N.Y. He reported having no financial disclosures.
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I think that the issue of cyberbullying for teenagers and preteenagers is important. The issue of bullying in general is important. Certainly for psychiatrists and other mental health professionals, parents, teachers, other people in school, and pediatricians, this should be in the back of our minds when interacting with a youngster, to see if this is an issue. Sometimes you need to ask them in more than one way.
We shouldn’t tolerate cyberbullying, and we should make sure that those who experience it know that the people who are doing it are the people who are wrong. We should make sure that the targets of cyberbullying know that they can seek help and support from adults and from friends who don’t engage in that, and that they’re not alone. That’s where the risk comes, when they feel alone.
Dr. Jeffrey Borenstein is president and chief executive officer of the Brain and Behavior Research Foundation in Great Neck, N.Y. He reported having no financial disclosures.
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I think that the issue of cyberbullying for teenagers and preteenagers is important. The issue of bullying in general is important. Certainly for psychiatrists and other mental health professionals, parents, teachers, other people in school, and pediatricians, this should be in the back of our minds when interacting with a youngster, to see if this is an issue. Sometimes you need to ask them in more than one way.
We shouldn’t tolerate cyberbullying, and we should make sure that those who experience it know that the people who are doing it are the people who are wrong. We should make sure that the targets of cyberbullying know that they can seek help and support from adults and from friends who don’t engage in that, and that they’re not alone. That’s where the risk comes, when they feel alone.
Dr. Jeffrey Borenstein is president and chief executive officer of the Brain and Behavior Research Foundation in Great Neck, N.Y. He reported having no financial disclosures.
SAN FRANCISCO – Suicide attempts that required treatment were more than three times as likely in teenagers who reported being bullied online, compared with youths who were not bullied, an analysis of federal data on more than 15,000 adolescents found.
Girls faced twice as much electronic bullying as boys. Cyberbullying was reported by 22% of girls and 11% of boys, according to the study of data on teens aged 13-18 years from the Centers for Disease Control and Prevention’s 2011 Youth Risk Behavior Survey, the first of its kind to ask questions about cyberbullying.
Other data suggest that 80% of U.S. teens use social networking sites, Dr. Kristi M. Kindrick said at a press briefing at the annual meeting of the American Psychiatric Association.
Among 13- to 17-year-olds, an estimated 12% have suicidal ideation, 4% plan suicide, and another 4% attempt suicide, rates that now are similar to those in adults, she noted.
The effects of online harassment on suicidal risk may be one reason that suicide is now the third leading cause of death in adolescents, behind accidents and homicides.
Dr. Kindrick and her associates found that one in six teens reported being electronically bullied, compared with one in five who said they had been bullied on school grounds. Almost 6% of high school students said they had missed school because of fears for their safety. The rate of conventional off-line bullying, such as harassment in the schoolyard, was 22% for girls (the same rate as online bullying) and 18% for boys (higher than the 11% rate for cyberbullying), reported Dr. Kindrick, a fourth-year resident in psychiatry at the University of Arkansas for Medical Sciences, Little Rock, who was moved to do the study after a young patient killed herself following cyberbullying.
Offline bullying, however, only doubled the risk for suicide, compared with the tripling in risk seen with cyberbullying, she said. Rates for the most serious cases – suicide attempts that required treatment – were 1.5% for youths who had not been bullied, 2.3% for those who reported being bullied at school, 5.4% among those who had been cyberbullied, and 6% if they had been bullied both offline and online.
Dr. Kindrick said that she is a clinician more than a researcher, and her goal is to educate communities and schools about this problem. Clinicians need to ask about bullying, sometimes in more than one way, to identify youths who are being bullied and help them cope and get help.
"Why I really care about it is because I’m a mom. I have three young children," she added.
The fact that rates of suicidal ideation, suicide planning, and suicide attempts in teens now are nearly the same as in adults belies the notion that today’s children and adolescents live carefree lives. The highest rates of cyberbullying in the study targeted white girls, she said, so "the movie ‘Mean Girls’ kind of lives up to its reputation here."
Dr. Kindrick reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Suicide attempts that required treatment were more than three times as likely in teenagers who reported being bullied online, compared with youths who were not bullied, an analysis of federal data on more than 15,000 adolescents found.
Girls faced twice as much electronic bullying as boys. Cyberbullying was reported by 22% of girls and 11% of boys, according to the study of data on teens aged 13-18 years from the Centers for Disease Control and Prevention’s 2011 Youth Risk Behavior Survey, the first of its kind to ask questions about cyberbullying.
Other data suggest that 80% of U.S. teens use social networking sites, Dr. Kristi M. Kindrick said at a press briefing at the annual meeting of the American Psychiatric Association.
Among 13- to 17-year-olds, an estimated 12% have suicidal ideation, 4% plan suicide, and another 4% attempt suicide, rates that now are similar to those in adults, she noted.
The effects of online harassment on suicidal risk may be one reason that suicide is now the third leading cause of death in adolescents, behind accidents and homicides.
Dr. Kindrick and her associates found that one in six teens reported being electronically bullied, compared with one in five who said they had been bullied on school grounds. Almost 6% of high school students said they had missed school because of fears for their safety. The rate of conventional off-line bullying, such as harassment in the schoolyard, was 22% for girls (the same rate as online bullying) and 18% for boys (higher than the 11% rate for cyberbullying), reported Dr. Kindrick, a fourth-year resident in psychiatry at the University of Arkansas for Medical Sciences, Little Rock, who was moved to do the study after a young patient killed herself following cyberbullying.
Offline bullying, however, only doubled the risk for suicide, compared with the tripling in risk seen with cyberbullying, she said. Rates for the most serious cases – suicide attempts that required treatment – were 1.5% for youths who had not been bullied, 2.3% for those who reported being bullied at school, 5.4% among those who had been cyberbullied, and 6% if they had been bullied both offline and online.
Dr. Kindrick said that she is a clinician more than a researcher, and her goal is to educate communities and schools about this problem. Clinicians need to ask about bullying, sometimes in more than one way, to identify youths who are being bullied and help them cope and get help.
"Why I really care about it is because I’m a mom. I have three young children," she added.
The fact that rates of suicidal ideation, suicide planning, and suicide attempts in teens now are nearly the same as in adults belies the notion that today’s children and adolescents live carefree lives. The highest rates of cyberbullying in the study targeted white girls, she said, so "the movie ‘Mean Girls’ kind of lives up to its reputation here."
Dr. Kindrick reported having no financial disclosures.
On Twitter @sherryboschert
AT APA ANNUAL MEETING
Major finding: Rates of suicide attempts requiring treatment were 1.5% in teens who were not bullied, 2.3% if bullied on school grounds, 5.4% if cyberbullied, and 6% if bullied at school and online.
Data source: Retrospective study of data from more than 15,000 youths in the 2011 Youth Risk Behavior Survey.
Disclosures: Dr. Kindrick reported having no financial disclosures.
New approach tried for treatment-resistant depression
SAN FRANCISCO – A pilot randomized study of 30 patients with treatment-resistant depression suggests that helping them cope with their illness as a chronic disease might be more helpful than focusing exclusively on symptom remission.
Clinicians usually focus on trying to push symptoms of depression into remission using one medication or combination of therapies after another, Dr. Gabor I. Keitner said at the annual meeting of the American Psychiatric Association.
That does not work for many patients, leaving them and their clinicians feeling hopeless and disillusioned. Approximately 40%-60% of people with depression will have symptoms that do not remit, and perhaps 20%-30% of depressed patients might have treatment-resistant depression.
"In many ways, we’ve been looking at the wrong side of the equation," said Dr. Keitner, professor of psychiatry and human behavior at Brown University, Providence, R.I. Instead of throwing one drug or procedure after another at the symptoms, perhaps clinicians should interrupt this "endless, vicious cycle" and help patients with treatment-resistant depression reframe the approach, he said. Clinicians could teach ways to improve function while living with chronic depression, much as other clinicians employ blame-free approaches to helping patients manage diabetes or other chronic diseases.
Dr. Keitner and his associates created a management of depression program at his institution to do just that. Most patients who come to the program are on six, seven, even eight medications for depression when they arrive.
Among 30 adults with treatment-resistant depression who finished the 12-week pilot study, 17 were randomized to the management of depression program and 13 to treatment as usual, which involved continuing any medication or psychotherapy being used and monthly telephone contacts.
The intervention group also continued any therapies being used and added nine adjunctive management of depression sessions, which provided education about persistent depression, helped set realistic expectations, and focused on living fully in the context of persisting symptoms. Other topics included healthy living habits (diet, exercise, sleep, and relaxation techniques), the important of relationships, strategies for communication and emotional problem-solving, and a focus on meaning and purpose in life.
Patients had been depressed for 20 years, on average. Compared with the control group, the intervention group had more patients with severe depression and with borderline personality disorder, though the groups’ characteristics did not differ significantly, probably because of the small cohorts, Dr. Keitner said. The study defined treatment-resistant depression as failure to respond to at least two adequate courses of pharmacologic therapy for depression.
After 12 weeks, depressive symptoms improved significantly in both groups. Patients in both groups still had moderate depression, but the intervention group moved from more severe to moderate depression, Dr. Keitner reported. Patients in the management of depression group but not in the control group also showed significantly improved scores on measures of perceived social support and purpose in life.
Mean self-reported depression severity scores on the Beck Depression Inventory (BDI) improved from 32 at baseline to 22 at 12 weeks in the management of depression group and from 35 to 26 in the control group. Clinician-rated depression severity scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) improved from 33 at baseline to 26 at 12 weeks in the intervention group and from 31 to 23 in the control group.
Social support scores on the Mood and Physical Symptoms Scale (MPSS) improved from 4.2 at baseline to 3.4 at 12 weeks in the intervention group and from 4.1 to 3.6 in the control group. Scores for purpose in life, assessed on the Scales of Psychological Well-Being (SPWB), improved from 2.6 to 3.0 in the intervention group and from 2.9 to 3.2 in the control group. The changes in both these measures were significant for the intervention group but not the control group.
The increased attention provided to patients in the control group from being in the study might have led to improved symptoms, suggesting that all patients with treatment-resistant depression might benefit from ongoing involvement in treatment, Dr. Keitner said. Broadening the therapeutic focus beyond symptoms might have additional benefits, the findings suggest.
Of course, larger studies are needed to replicate the findings. Future iterations of the management of depression program will include modules on emotion regulation and distress tolerance to help patients with comorbid borderline personality disorder and treatment-resistant depression. Dr. Keitner also plans to increase the number of sessions from 9 to 16 in future studies and to incorporate telehealth strategies to improve adherence in patients who have difficulty coming for therapy.
"I think we’re moving toward a recognition that focusing on symptom reduction is illusory, and broadening our therapeutic options," he said. There’s been too great a focus on magic-bullet drugs, he believes. Approaches that combine medication, devices, and psychosocial interventions are important, and the treatment focus should broaden to include social and work functioning, treatment adherence, access to care, and reduced costs.
Dr. Keitner published a description of his program in 2012 (Psychiatr. Clin. North Am. 2012;35:249-65).
Some critics of this new approach fear it is nihilistic, and that telling patients there is no cure for their symptoms will lead to increased suicides, he added. That has not been the case, in his experience. "You’re not telling them anything they don’t know. They have an illness that’s not going to go away," he said. By definition, there are no effective treatments for treatment-resistant depression.
The study excluded patients with bipolar or psychotic disorders, acutely suicidal or substance-abusing patients, and patients currently receiving electroconvulsive therapy.
Dr. Keitner reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – A pilot randomized study of 30 patients with treatment-resistant depression suggests that helping them cope with their illness as a chronic disease might be more helpful than focusing exclusively on symptom remission.
Clinicians usually focus on trying to push symptoms of depression into remission using one medication or combination of therapies after another, Dr. Gabor I. Keitner said at the annual meeting of the American Psychiatric Association.
That does not work for many patients, leaving them and their clinicians feeling hopeless and disillusioned. Approximately 40%-60% of people with depression will have symptoms that do not remit, and perhaps 20%-30% of depressed patients might have treatment-resistant depression.
"In many ways, we’ve been looking at the wrong side of the equation," said Dr. Keitner, professor of psychiatry and human behavior at Brown University, Providence, R.I. Instead of throwing one drug or procedure after another at the symptoms, perhaps clinicians should interrupt this "endless, vicious cycle" and help patients with treatment-resistant depression reframe the approach, he said. Clinicians could teach ways to improve function while living with chronic depression, much as other clinicians employ blame-free approaches to helping patients manage diabetes or other chronic diseases.
Dr. Keitner and his associates created a management of depression program at his institution to do just that. Most patients who come to the program are on six, seven, even eight medications for depression when they arrive.
Among 30 adults with treatment-resistant depression who finished the 12-week pilot study, 17 were randomized to the management of depression program and 13 to treatment as usual, which involved continuing any medication or psychotherapy being used and monthly telephone contacts.
The intervention group also continued any therapies being used and added nine adjunctive management of depression sessions, which provided education about persistent depression, helped set realistic expectations, and focused on living fully in the context of persisting symptoms. Other topics included healthy living habits (diet, exercise, sleep, and relaxation techniques), the important of relationships, strategies for communication and emotional problem-solving, and a focus on meaning and purpose in life.
Patients had been depressed for 20 years, on average. Compared with the control group, the intervention group had more patients with severe depression and with borderline personality disorder, though the groups’ characteristics did not differ significantly, probably because of the small cohorts, Dr. Keitner said. The study defined treatment-resistant depression as failure to respond to at least two adequate courses of pharmacologic therapy for depression.
After 12 weeks, depressive symptoms improved significantly in both groups. Patients in both groups still had moderate depression, but the intervention group moved from more severe to moderate depression, Dr. Keitner reported. Patients in the management of depression group but not in the control group also showed significantly improved scores on measures of perceived social support and purpose in life.
Mean self-reported depression severity scores on the Beck Depression Inventory (BDI) improved from 32 at baseline to 22 at 12 weeks in the management of depression group and from 35 to 26 in the control group. Clinician-rated depression severity scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) improved from 33 at baseline to 26 at 12 weeks in the intervention group and from 31 to 23 in the control group.
Social support scores on the Mood and Physical Symptoms Scale (MPSS) improved from 4.2 at baseline to 3.4 at 12 weeks in the intervention group and from 4.1 to 3.6 in the control group. Scores for purpose in life, assessed on the Scales of Psychological Well-Being (SPWB), improved from 2.6 to 3.0 in the intervention group and from 2.9 to 3.2 in the control group. The changes in both these measures were significant for the intervention group but not the control group.
The increased attention provided to patients in the control group from being in the study might have led to improved symptoms, suggesting that all patients with treatment-resistant depression might benefit from ongoing involvement in treatment, Dr. Keitner said. Broadening the therapeutic focus beyond symptoms might have additional benefits, the findings suggest.
Of course, larger studies are needed to replicate the findings. Future iterations of the management of depression program will include modules on emotion regulation and distress tolerance to help patients with comorbid borderline personality disorder and treatment-resistant depression. Dr. Keitner also plans to increase the number of sessions from 9 to 16 in future studies and to incorporate telehealth strategies to improve adherence in patients who have difficulty coming for therapy.
"I think we’re moving toward a recognition that focusing on symptom reduction is illusory, and broadening our therapeutic options," he said. There’s been too great a focus on magic-bullet drugs, he believes. Approaches that combine medication, devices, and psychosocial interventions are important, and the treatment focus should broaden to include social and work functioning, treatment adherence, access to care, and reduced costs.
Dr. Keitner published a description of his program in 2012 (Psychiatr. Clin. North Am. 2012;35:249-65).
Some critics of this new approach fear it is nihilistic, and that telling patients there is no cure for their symptoms will lead to increased suicides, he added. That has not been the case, in his experience. "You’re not telling them anything they don’t know. They have an illness that’s not going to go away," he said. By definition, there are no effective treatments for treatment-resistant depression.
The study excluded patients with bipolar or psychotic disorders, acutely suicidal or substance-abusing patients, and patients currently receiving electroconvulsive therapy.
Dr. Keitner reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – A pilot randomized study of 30 patients with treatment-resistant depression suggests that helping them cope with their illness as a chronic disease might be more helpful than focusing exclusively on symptom remission.
Clinicians usually focus on trying to push symptoms of depression into remission using one medication or combination of therapies after another, Dr. Gabor I. Keitner said at the annual meeting of the American Psychiatric Association.
That does not work for many patients, leaving them and their clinicians feeling hopeless and disillusioned. Approximately 40%-60% of people with depression will have symptoms that do not remit, and perhaps 20%-30% of depressed patients might have treatment-resistant depression.
"In many ways, we’ve been looking at the wrong side of the equation," said Dr. Keitner, professor of psychiatry and human behavior at Brown University, Providence, R.I. Instead of throwing one drug or procedure after another at the symptoms, perhaps clinicians should interrupt this "endless, vicious cycle" and help patients with treatment-resistant depression reframe the approach, he said. Clinicians could teach ways to improve function while living with chronic depression, much as other clinicians employ blame-free approaches to helping patients manage diabetes or other chronic diseases.
Dr. Keitner and his associates created a management of depression program at his institution to do just that. Most patients who come to the program are on six, seven, even eight medications for depression when they arrive.
Among 30 adults with treatment-resistant depression who finished the 12-week pilot study, 17 were randomized to the management of depression program and 13 to treatment as usual, which involved continuing any medication or psychotherapy being used and monthly telephone contacts.
The intervention group also continued any therapies being used and added nine adjunctive management of depression sessions, which provided education about persistent depression, helped set realistic expectations, and focused on living fully in the context of persisting symptoms. Other topics included healthy living habits (diet, exercise, sleep, and relaxation techniques), the important of relationships, strategies for communication and emotional problem-solving, and a focus on meaning and purpose in life.
Patients had been depressed for 20 years, on average. Compared with the control group, the intervention group had more patients with severe depression and with borderline personality disorder, though the groups’ characteristics did not differ significantly, probably because of the small cohorts, Dr. Keitner said. The study defined treatment-resistant depression as failure to respond to at least two adequate courses of pharmacologic therapy for depression.
After 12 weeks, depressive symptoms improved significantly in both groups. Patients in both groups still had moderate depression, but the intervention group moved from more severe to moderate depression, Dr. Keitner reported. Patients in the management of depression group but not in the control group also showed significantly improved scores on measures of perceived social support and purpose in life.
Mean self-reported depression severity scores on the Beck Depression Inventory (BDI) improved from 32 at baseline to 22 at 12 weeks in the management of depression group and from 35 to 26 in the control group. Clinician-rated depression severity scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) improved from 33 at baseline to 26 at 12 weeks in the intervention group and from 31 to 23 in the control group.
Social support scores on the Mood and Physical Symptoms Scale (MPSS) improved from 4.2 at baseline to 3.4 at 12 weeks in the intervention group and from 4.1 to 3.6 in the control group. Scores for purpose in life, assessed on the Scales of Psychological Well-Being (SPWB), improved from 2.6 to 3.0 in the intervention group and from 2.9 to 3.2 in the control group. The changes in both these measures were significant for the intervention group but not the control group.
The increased attention provided to patients in the control group from being in the study might have led to improved symptoms, suggesting that all patients with treatment-resistant depression might benefit from ongoing involvement in treatment, Dr. Keitner said. Broadening the therapeutic focus beyond symptoms might have additional benefits, the findings suggest.
Of course, larger studies are needed to replicate the findings. Future iterations of the management of depression program will include modules on emotion regulation and distress tolerance to help patients with comorbid borderline personality disorder and treatment-resistant depression. Dr. Keitner also plans to increase the number of sessions from 9 to 16 in future studies and to incorporate telehealth strategies to improve adherence in patients who have difficulty coming for therapy.
"I think we’re moving toward a recognition that focusing on symptom reduction is illusory, and broadening our therapeutic options," he said. There’s been too great a focus on magic-bullet drugs, he believes. Approaches that combine medication, devices, and psychosocial interventions are important, and the treatment focus should broaden to include social and work functioning, treatment adherence, access to care, and reduced costs.
Dr. Keitner published a description of his program in 2012 (Psychiatr. Clin. North Am. 2012;35:249-65).
Some critics of this new approach fear it is nihilistic, and that telling patients there is no cure for their symptoms will lead to increased suicides, he added. That has not been the case, in his experience. "You’re not telling them anything they don’t know. They have an illness that’s not going to go away," he said. By definition, there are no effective treatments for treatment-resistant depression.
The study excluded patients with bipolar or psychotic disorders, acutely suicidal or substance-abusing patients, and patients currently receiving electroconvulsive therapy.
Dr. Keitner reported having no financial disclosures.
On Twitter @sherryboschert
AT APA ANNUAL MEETING
Major finding: Social support scores on the MPSS improved from 4.3 at baseline to 3.4 at 12 weeks and life purpose scores on the SPWB improved from 2.6 to 3.0 in the intervention group (both significant changes), compared with nonsignificant changes in the control group from 4.2 to 3.6 on the MPSS and from 2.9 to 3.2 on the SPWB.
Data source: Pilot study of 30 patients at one institution randomized to a management of depression program or treatment as usual.
Disclosures: Dr. Keitner reported having no financial disclosures.
Online cancer community colaunched by ex-Google executive
Two heavyweight leaders in the blend of online and medical worlds have colaunched a new online community for cancer patients and caregivers called Smart Patients that takes the goal of patient-centered services in several technological directions.
Dr. Roni Zeiger, former chief health strategist for Google, and Gilles Frydman, founder of the Association of Cancer Online Resources, introduced Smart Patients at the recent TEDMED conference in Washington. TEDMED is the medical version of the popular TED (Technology, Entertainment, and Design) conferences, where innovators and influential leaders give short talks on their activities and thoughts on the future.
Smart Patients is one of a number of online communities that connect cancer patients, helpers, and cancer survivors to share knowledge and support. What makes Smart Patients different is some of its additional features, such as a user-friendly way to search for clinical trials and the possibility of providing patient feedback on the design of future clinical trials.
The technological pedigrees of the cofounders already have brought considerable attention to Smart Patients in what might be considered a crowded field. A Google search for online cancer communities turned up the following on the first page of results alone. Frydman’s Association of Cancer Online Resources (ACOR), the granddaddy of the online sharing community when it comes to cancer, provides links to 142 online cancer communities. The American Cancer Society provides multiple online tools including a Cancer Survivors Network with chat rooms, discussion boards, private e-mail, and more. The Cancer Treatment Centers of America offers CancerCompass, where participants can share status updates, follow friends, and comment on their activities among other features. Another start-up, I Had Cancer, says it is beta testing a website that connects people battling cancer with cancer survivors.
Like some of these sites, Smart Patients lets users start and follow conversations and search for keywords to find the topics that interest them. Its clinical trials search function is based on the clinicaltrials.gov database. Smart Patients is intended to complement physician care, not replace it, according to its FAQ section, which also states that the site will include no advertising. Smart Patients plans to make money by selling anonymous data harvested from voluntary survey comments posted on the website. Potential customers include companies, researchers, and educators who want to better understand the experiences, insights, and needs of cancer patients and their caregivers. The site will follow guidelines from the Health Insurance Portability and Accountability Act (HIPAA) to ensure that individuals are not identified in these commercial transactions.
Smart Patients announced at TEDMED that it has inked partnerships with WorldOne Interactive (owner of the online physician networking site Sermo), The Bonnie J. Addario Lung Cancer Foundation, and Cancer Commons, according to news reports. Another partner is the biotechnology company Oncosec Medical, which aims to gather patient feedback before designing clinical trials of its skin cancer therapies.
Cancer was one of the first medical topics to gain traction in online sharing. With this latest entry from two power players in the field, online cancer communities may be moving to the next level.
On Twitter @sherryboschert
Smart Patients is one of a number of online communities that connect cancer patients, helpers, and cancer survivors to share knowledge and support. What makes Smart Patients different is some of its additional features, such as a user-friendly way to search for clinical trials and the possibility of providing patient feedback on the design of future clinical trials.
The technological pedigrees of the cofounders already have brought considerable attention to Smart Patients in what might be considered a crowded field. A Google search for online cancer communities turned up the following on the first page of results alone. Frydman’s Association of Cancer Online Resources (ACOR), the granddaddy of the online sharing community when it comes to cancer, provides links to 142 online cancer communities. The American Cancer Society provides multiple online tools including a Cancer Survivors Network with chat rooms, discussion boards, private e-mail, and more. The Cancer Treatment Centers of America offers CancerCompass, where participants can share status updates, follow friends, and comment on their activities among other features. Another start-up, I Had Cancer, says it is beta testing a website that connects people battling cancer with cancer survivors.
Like some of these sites, Smart Patients lets users start and follow conversations and search for keywords to find the topics that interest them. Its clinical trials search function is based on the clinicaltrials.gov database. Smart Patients is intended to complement physician care, not replace it, according to its FAQ section, which also states that the site will include no advertising. Smart Patients plans to make money by selling anonymous data harvested from voluntary survey comments posted on the website. Potential customers include companies, researchers, and educators who want to better understand the experiences, insights, and needs of cancer patients and their caregivers. The site will follow guidelines from the Health Insurance Portability and Accountability Act (HIPAA) to ensure that individuals are not identified in these commercial transactions.
Smart Patients announced at TEDMED that it has inked partnerships with WorldOne Interactive (owner of the online physician networking site Sermo), The Bonnie J. Addario Lung Cancer Foundation, and Cancer Commons, according to news reports. Another partner is the biotechnology company Oncosec Medical, which aims to gather patient feedback before designing clinical trials of its skin cancer therapies.
Cancer was one of the first medical topics to gain traction in online sharing. With this latest entry from two power players in the field, o
Two heavyweight leaders in the blend of online and medical worlds have colaunched a new online community for cancer patients and caregivers called Smart Patients that takes the goal of patient-centered services in several technological directions.
Dr. Roni Zeiger, former chief health strategist for Google, and Gilles Frydman, founder of the Association of Cancer Online Resources, introduced Smart Patients at the recent TEDMED conference in Washington. TEDMED is the medical version of the popular TED (Technology, Entertainment, and Design) conferences, where innovators and influential leaders give short talks on their activities and thoughts on the future.
Smart Patients is one of a number of online communities that connect cancer patients, helpers, and cancer survivors to share knowledge and support. What makes Smart Patients different is some of its additional features, such as a user-friendly way to search for clinical trials and the possibility of providing patient feedback on the design of future clinical trials.
The technological pedigrees of the cofounders already have brought considerable attention to Smart Patients in what might be considered a crowded field. A Google search for online cancer communities turned up the following on the first page of results alone. Frydman’s Association of Cancer Online Resources (ACOR), the granddaddy of the online sharing community when it comes to cancer, provides links to 142 online cancer communities. The American Cancer Society provides multiple online tools including a Cancer Survivors Network with chat rooms, discussion boards, private e-mail, and more. The Cancer Treatment Centers of America offers CancerCompass, where participants can share status updates, follow friends, and comment on their activities among other features. Another start-up, I Had Cancer, says it is beta testing a website that connects people battling cancer with cancer survivors.
Like some of these sites, Smart Patients lets users start and follow conversations and search for keywords to find the topics that interest them. Its clinical trials search function is based on the clinicaltrials.gov database. Smart Patients is intended to complement physician care, not replace it, according to its FAQ section, which also states that the site will include no advertising. Smart Patients plans to make money by selling anonymous data harvested from voluntary survey comments posted on the website. Potential customers include companies, researchers, and educators who want to better understand the experiences, insights, and needs of cancer patients and their caregivers. The site will follow guidelines from the Health Insurance Portability and Accountability Act (HIPAA) to ensure that individuals are not identified in these commercial transactions.
Smart Patients announced at TEDMED that it has inked partnerships with WorldOne Interactive (owner of the online physician networking site Sermo), The Bonnie J. Addario Lung Cancer Foundation, and Cancer Commons, according to news reports. Another partner is the biotechnology company Oncosec Medical, which aims to gather patient feedback before designing clinical trials of its skin cancer therapies.
Cancer was one of the first medical topics to gain traction in online sharing. With this latest entry from two power players in the field, online cancer communities may be moving to the next level.
On Twitter @sherryboschert
Two heavyweight leaders in the blend of online and medical worlds have colaunched a new online community for cancer patients and caregivers called Smart Patients that takes the goal of patient-centered services in several technological directions.
Dr. Roni Zeiger, former chief health strategist for Google, and Gilles Frydman, founder of the Association of Cancer Online Resources, introduced Smart Patients at the recent TEDMED conference in Washington. TEDMED is the medical version of the popular TED (Technology, Entertainment, and Design) conferences, where innovators and influential leaders give short talks on their activities and thoughts on the future.
Smart Patients is one of a number of online communities that connect cancer patients, helpers, and cancer survivors to share knowledge and support. What makes Smart Patients different is some of its additional features, such as a user-friendly way to search for clinical trials and the possibility of providing patient feedback on the design of future clinical trials.
The technological pedigrees of the cofounders already have brought considerable attention to Smart Patients in what might be considered a crowded field. A Google search for online cancer communities turned up the following on the first page of results alone. Frydman’s Association of Cancer Online Resources (ACOR), the granddaddy of the online sharing community when it comes to cancer, provides links to 142 online cancer communities. The American Cancer Society provides multiple online tools including a Cancer Survivors Network with chat rooms, discussion boards, private e-mail, and more. The Cancer Treatment Centers of America offers CancerCompass, where participants can share status updates, follow friends, and comment on their activities among other features. Another start-up, I Had Cancer, says it is beta testing a website that connects people battling cancer with cancer survivors.
Like some of these sites, Smart Patients lets users start and follow conversations and search for keywords to find the topics that interest them. Its clinical trials search function is based on the clinicaltrials.gov database. Smart Patients is intended to complement physician care, not replace it, according to its FAQ section, which also states that the site will include no advertising. Smart Patients plans to make money by selling anonymous data harvested from voluntary survey comments posted on the website. Potential customers include companies, researchers, and educators who want to better understand the experiences, insights, and needs of cancer patients and their caregivers. The site will follow guidelines from the Health Insurance Portability and Accountability Act (HIPAA) to ensure that individuals are not identified in these commercial transactions.
Smart Patients announced at TEDMED that it has inked partnerships with WorldOne Interactive (owner of the online physician networking site Sermo), The Bonnie J. Addario Lung Cancer Foundation, and Cancer Commons, according to news reports. Another partner is the biotechnology company Oncosec Medical, which aims to gather patient feedback before designing clinical trials of its skin cancer therapies.
Cancer was one of the first medical topics to gain traction in online sharing. With this latest entry from two power players in the field, online cancer communities may be moving to the next level.
On Twitter @sherryboschert
Smart Patients is one of a number of online communities that connect cancer patients, helpers, and cancer survivors to share knowledge and support. What makes Smart Patients different is some of its additional features, such as a user-friendly way to search for clinical trials and the possibility of providing patient feedback on the design of future clinical trials.
The technological pedigrees of the cofounders already have brought considerable attention to Smart Patients in what might be considered a crowded field. A Google search for online cancer communities turned up the following on the first page of results alone. Frydman’s Association of Cancer Online Resources (ACOR), the granddaddy of the online sharing community when it comes to cancer, provides links to 142 online cancer communities. The American Cancer Society provides multiple online tools including a Cancer Survivors Network with chat rooms, discussion boards, private e-mail, and more. The Cancer Treatment Centers of America offers CancerCompass, where participants can share status updates, follow friends, and comment on their activities among other features. Another start-up, I Had Cancer, says it is beta testing a website that connects people battling cancer with cancer survivors.
Like some of these sites, Smart Patients lets users start and follow conversations and search for keywords to find the topics that interest them. Its clinical trials search function is based on the clinicaltrials.gov database. Smart Patients is intended to complement physician care, not replace it, according to its FAQ section, which also states that the site will include no advertising. Smart Patients plans to make money by selling anonymous data harvested from voluntary survey comments posted on the website. Potential customers include companies, researchers, and educators who want to better understand the experiences, insights, and needs of cancer patients and their caregivers. The site will follow guidelines from the Health Insurance Portability and Accountability Act (HIPAA) to ensure that individuals are not identified in these commercial transactions.
Smart Patients announced at TEDMED that it has inked partnerships with WorldOne Interactive (owner of the online physician networking site Sermo), The Bonnie J. Addario Lung Cancer Foundation, and Cancer Commons, according to news reports. Another partner is the biotechnology company Oncosec Medical, which aims to gather patient feedback before designing clinical trials of its skin cancer therapies.
Cancer was one of the first medical topics to gain traction in online sharing. With this latest entry from two power players in the field, o
Smart Patients is one of a number of online communities that connect cancer patients, helpers, and cancer survivors to share knowledge and support. What makes Smart Patients different is some of its additional features, such as a user-friendly way to search for clinical trials and the possibility of providing patient feedback on the design of future clinical trials.
The technological pedigrees of the cofounders already have brought considerable attention to Smart Patients in what might be considered a crowded field. A Google search for online cancer communities turned up the following on the first page of results alone. Frydman’s Association of Cancer Online Resources (ACOR), the granddaddy of the online sharing community when it comes to cancer, provides links to 142 online cancer communities. The American Cancer Society provides multiple online tools including a Cancer Survivors Network with chat rooms, discussion boards, private e-mail, and more. The Cancer Treatment Centers of America offers CancerCompass, where participants can share status updates, follow friends, and comment on their activities among other features. Another start-up, I Had Cancer, says it is beta testing a website that connects people battling cancer with cancer survivors.
Like some of these sites, Smart Patients lets users start and follow conversations and search for keywords to find the topics that interest them. Its clinical trials search function is based on the clinicaltrials.gov database. Smart Patients is intended to complement physician care, not replace it, according to its FAQ section, which also states that the site will include no advertising. Smart Patients plans to make money by selling anonymous data harvested from voluntary survey comments posted on the website. Potential customers include companies, researchers, and educators who want to better understand the experiences, insights, and needs of cancer patients and their caregivers. The site will follow guidelines from the Health Insurance Portability and Accountability Act (HIPAA) to ensure that individuals are not identified in these commercial transactions.
Smart Patients announced at TEDMED that it has inked partnerships with WorldOne Interactive (owner of the online physician networking site Sermo), The Bonnie J. Addario Lung Cancer Foundation, and Cancer Commons, according to news reports. Another partner is the biotechnology company Oncosec Medical, which aims to gather patient feedback before designing clinical trials of its skin cancer therapies.
Cancer was one of the first medical topics to gain traction in online sharing. With this latest entry from two power players in the field, o
Titrate statin dose, try ubiquinone for myalgias
SAN FRANCISCO – When patients develop myalgia on statin therapy, consider lowering the statin dose and adding ubiquinone, or switching them from a statin to red yeast rice, Dr. Douglas S. Paauw said.
Statin-related myalgias are more common in patients with low body mass and, because of metabolic variations, in patients of Asian descent.
Training emphasized the potential for liver effects and rhabdomyolysis from statins, but 20 years of evidence now shows that statins do not cause chronic liver disease, rare patients get acute liver injury, and about 0.01% of patients develop rhabdomyolysis from drug interactions with statins.
Muscle pain is the most common statin side effect, he said. Studies suggest that 5%-18% of patients on the highest doses of statins will develop myalgia.
In one recent prospective, blinded study, 420 healthy, statin-naïve participants were randomized to 80 mg of atorvastatin or placebo for 6 months. Significantly more statin users (19) developed myalgia than did those on placebo (10). Creatine kinase levels increased significantly by an average of 21 U/L in atorvastatin users, suggesting that, even without symptoms, statins cause mild muscle injury (Circulation 2013;127:96-103).
Statin package inserts suggest that 1%-2% of patients will develop myalgia; however, early studies of statins did not look for myalgia, and the real-world rates of statin-related myalgia may be as high as 20%-30%, Dr. Paauw said at the annual meeting of the American College of Physicians.
The trick to avoiding this side effect is titrating the dose upward until you achieve lipid control. "Cardiologists often want to start people at high doses, and they have reasons for that. In general medicine, I certainly am a believer in getting patients started on a reasonable dose and then pushing up the dose. Once they get myalgias, patients are often reluctant to trust taking more statins. I like to prevent myalgias from happening in the first place," said Dr. Paauw, professor of medicine at the University of Washington, Seattle.
When a patient on a statin complains of muscle pain, check the creatine kinase level to see how big the problem is, and check the patient’s thyroid-stimulating hormone (TSH) level. Severe hypothyroidism can raise lipid levels and cause myalgia that looks just like statin-related myalgia. "When you treat the hypothyroidism, you may have much more success with a statin," he said.
The next step is to stop the statin to see if the myalgia goes away. "Patients should get better in a few weeks if it’s statin-related myalgia," he said. If symptoms disappear, restart the statin at a lower dose or switch to a different statin. One study found that myalgia rates on the highest dose of each respective drug ranged from a low of 5% with extended-release fluvastatin to 11% with pravastatin, 15% with atorvastatin, and 18% with simvastatin (Cardiovasc. Drugs Ther. 2005;19:403-14).
If myalgia recurs after switching, try switching again. Consider specific low dosages: extended-release fluvastatin 80 mg daily or every other day, or twice-weekly atorvastatin 10 mg, or low-dose rosuvastatin daily every other day or weekly, Dr. Paauw said.
But don’t completely sacrifice lipid control for side-effect management, he added. "The problem is that fluvastatin is about equal to giving jelly beans" for lipid control. "My view is that a little statin is probably better than no statin. Many of these patients have gotten to the point where we can’t use anything" at normal statin dosages, he said.
When switching statins doesn’t make a difference, it may simply mean that some patients are going to get myalgias with statins or they won’t, he added.
Discuss with the patient whether they want to consider adding ubiquinone (coenzyme Q10) to statin therapy. One positive study suggesting that coenzyme Q10 may reduce statin-related myalgia has been followed by several negative studies. One recent study randomized 76 statin users who developed myalgia in two or more extremities to statin treatment with twice-daily placebo or coenzyme Q10 at 60 mg. Visual analog pain scores did not differ significantly between groups after 1 month (Am. J. Cardiol. 2012;110:526-9).
"I think it’s still okay to try [coenzyme Q10]. It’s benign, and you may get a placebo effect," and there’s some scientific basis for why it might work, he said. Patients on statins have low ubiquinone levels, and coenzyme Q adds it back. "I think the jury is still out in this."
Another reasonable option to consider is to switch from a statin to red yeast rice, whose active ingredient is 4-5 mg of lovastatin, he said. One study randomized 62 patients who stopped statins due to myalgias to 24 weeks of twice-daily placebo or 1,800 mg of red yeast rice. The red yeast rice group had a significantly greater decrease in LDL cholesterol levels (35 mg/dL) than did the placebo group (15 mg/dL). Pain severity scores did not differ significantly between the two groups (Ann. Intern. Med. 2009;150:830-39).
"It may well be a positive placebo effect from getting a natural product. ... We’ll do whatever it takes to get our patients on therapy," he said.
Dr. Paauw reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – When patients develop myalgia on statin therapy, consider lowering the statin dose and adding ubiquinone, or switching them from a statin to red yeast rice, Dr. Douglas S. Paauw said.
Statin-related myalgias are more common in patients with low body mass and, because of metabolic variations, in patients of Asian descent.
Training emphasized the potential for liver effects and rhabdomyolysis from statins, but 20 years of evidence now shows that statins do not cause chronic liver disease, rare patients get acute liver injury, and about 0.01% of patients develop rhabdomyolysis from drug interactions with statins.
Muscle pain is the most common statin side effect, he said. Studies suggest that 5%-18% of patients on the highest doses of statins will develop myalgia.
In one recent prospective, blinded study, 420 healthy, statin-naïve participants were randomized to 80 mg of atorvastatin or placebo for 6 months. Significantly more statin users (19) developed myalgia than did those on placebo (10). Creatine kinase levels increased significantly by an average of 21 U/L in atorvastatin users, suggesting that, even without symptoms, statins cause mild muscle injury (Circulation 2013;127:96-103).
Statin package inserts suggest that 1%-2% of patients will develop myalgia; however, early studies of statins did not look for myalgia, and the real-world rates of statin-related myalgia may be as high as 20%-30%, Dr. Paauw said at the annual meeting of the American College of Physicians.
The trick to avoiding this side effect is titrating the dose upward until you achieve lipid control. "Cardiologists often want to start people at high doses, and they have reasons for that. In general medicine, I certainly am a believer in getting patients started on a reasonable dose and then pushing up the dose. Once they get myalgias, patients are often reluctant to trust taking more statins. I like to prevent myalgias from happening in the first place," said Dr. Paauw, professor of medicine at the University of Washington, Seattle.
When a patient on a statin complains of muscle pain, check the creatine kinase level to see how big the problem is, and check the patient’s thyroid-stimulating hormone (TSH) level. Severe hypothyroidism can raise lipid levels and cause myalgia that looks just like statin-related myalgia. "When you treat the hypothyroidism, you may have much more success with a statin," he said.
The next step is to stop the statin to see if the myalgia goes away. "Patients should get better in a few weeks if it’s statin-related myalgia," he said. If symptoms disappear, restart the statin at a lower dose or switch to a different statin. One study found that myalgia rates on the highest dose of each respective drug ranged from a low of 5% with extended-release fluvastatin to 11% with pravastatin, 15% with atorvastatin, and 18% with simvastatin (Cardiovasc. Drugs Ther. 2005;19:403-14).
If myalgia recurs after switching, try switching again. Consider specific low dosages: extended-release fluvastatin 80 mg daily or every other day, or twice-weekly atorvastatin 10 mg, or low-dose rosuvastatin daily every other day or weekly, Dr. Paauw said.
But don’t completely sacrifice lipid control for side-effect management, he added. "The problem is that fluvastatin is about equal to giving jelly beans" for lipid control. "My view is that a little statin is probably better than no statin. Many of these patients have gotten to the point where we can’t use anything" at normal statin dosages, he said.
When switching statins doesn’t make a difference, it may simply mean that some patients are going to get myalgias with statins or they won’t, he added.
Discuss with the patient whether they want to consider adding ubiquinone (coenzyme Q10) to statin therapy. One positive study suggesting that coenzyme Q10 may reduce statin-related myalgia has been followed by several negative studies. One recent study randomized 76 statin users who developed myalgia in two or more extremities to statin treatment with twice-daily placebo or coenzyme Q10 at 60 mg. Visual analog pain scores did not differ significantly between groups after 1 month (Am. J. Cardiol. 2012;110:526-9).
"I think it’s still okay to try [coenzyme Q10]. It’s benign, and you may get a placebo effect," and there’s some scientific basis for why it might work, he said. Patients on statins have low ubiquinone levels, and coenzyme Q adds it back. "I think the jury is still out in this."
Another reasonable option to consider is to switch from a statin to red yeast rice, whose active ingredient is 4-5 mg of lovastatin, he said. One study randomized 62 patients who stopped statins due to myalgias to 24 weeks of twice-daily placebo or 1,800 mg of red yeast rice. The red yeast rice group had a significantly greater decrease in LDL cholesterol levels (35 mg/dL) than did the placebo group (15 mg/dL). Pain severity scores did not differ significantly between the two groups (Ann. Intern. Med. 2009;150:830-39).
"It may well be a positive placebo effect from getting a natural product. ... We’ll do whatever it takes to get our patients on therapy," he said.
Dr. Paauw reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – When patients develop myalgia on statin therapy, consider lowering the statin dose and adding ubiquinone, or switching them from a statin to red yeast rice, Dr. Douglas S. Paauw said.
Statin-related myalgias are more common in patients with low body mass and, because of metabolic variations, in patients of Asian descent.
Training emphasized the potential for liver effects and rhabdomyolysis from statins, but 20 years of evidence now shows that statins do not cause chronic liver disease, rare patients get acute liver injury, and about 0.01% of patients develop rhabdomyolysis from drug interactions with statins.
Muscle pain is the most common statin side effect, he said. Studies suggest that 5%-18% of patients on the highest doses of statins will develop myalgia.
In one recent prospective, blinded study, 420 healthy, statin-naïve participants were randomized to 80 mg of atorvastatin or placebo for 6 months. Significantly more statin users (19) developed myalgia than did those on placebo (10). Creatine kinase levels increased significantly by an average of 21 U/L in atorvastatin users, suggesting that, even without symptoms, statins cause mild muscle injury (Circulation 2013;127:96-103).
Statin package inserts suggest that 1%-2% of patients will develop myalgia; however, early studies of statins did not look for myalgia, and the real-world rates of statin-related myalgia may be as high as 20%-30%, Dr. Paauw said at the annual meeting of the American College of Physicians.
The trick to avoiding this side effect is titrating the dose upward until you achieve lipid control. "Cardiologists often want to start people at high doses, and they have reasons for that. In general medicine, I certainly am a believer in getting patients started on a reasonable dose and then pushing up the dose. Once they get myalgias, patients are often reluctant to trust taking more statins. I like to prevent myalgias from happening in the first place," said Dr. Paauw, professor of medicine at the University of Washington, Seattle.
When a patient on a statin complains of muscle pain, check the creatine kinase level to see how big the problem is, and check the patient’s thyroid-stimulating hormone (TSH) level. Severe hypothyroidism can raise lipid levels and cause myalgia that looks just like statin-related myalgia. "When you treat the hypothyroidism, you may have much more success with a statin," he said.
The next step is to stop the statin to see if the myalgia goes away. "Patients should get better in a few weeks if it’s statin-related myalgia," he said. If symptoms disappear, restart the statin at a lower dose or switch to a different statin. One study found that myalgia rates on the highest dose of each respective drug ranged from a low of 5% with extended-release fluvastatin to 11% with pravastatin, 15% with atorvastatin, and 18% with simvastatin (Cardiovasc. Drugs Ther. 2005;19:403-14).
If myalgia recurs after switching, try switching again. Consider specific low dosages: extended-release fluvastatin 80 mg daily or every other day, or twice-weekly atorvastatin 10 mg, or low-dose rosuvastatin daily every other day or weekly, Dr. Paauw said.
But don’t completely sacrifice lipid control for side-effect management, he added. "The problem is that fluvastatin is about equal to giving jelly beans" for lipid control. "My view is that a little statin is probably better than no statin. Many of these patients have gotten to the point where we can’t use anything" at normal statin dosages, he said.
When switching statins doesn’t make a difference, it may simply mean that some patients are going to get myalgias with statins or they won’t, he added.
Discuss with the patient whether they want to consider adding ubiquinone (coenzyme Q10) to statin therapy. One positive study suggesting that coenzyme Q10 may reduce statin-related myalgia has been followed by several negative studies. One recent study randomized 76 statin users who developed myalgia in two or more extremities to statin treatment with twice-daily placebo or coenzyme Q10 at 60 mg. Visual analog pain scores did not differ significantly between groups after 1 month (Am. J. Cardiol. 2012;110:526-9).
"I think it’s still okay to try [coenzyme Q10]. It’s benign, and you may get a placebo effect," and there’s some scientific basis for why it might work, he said. Patients on statins have low ubiquinone levels, and coenzyme Q adds it back. "I think the jury is still out in this."
Another reasonable option to consider is to switch from a statin to red yeast rice, whose active ingredient is 4-5 mg of lovastatin, he said. One study randomized 62 patients who stopped statins due to myalgias to 24 weeks of twice-daily placebo or 1,800 mg of red yeast rice. The red yeast rice group had a significantly greater decrease in LDL cholesterol levels (35 mg/dL) than did the placebo group (15 mg/dL). Pain severity scores did not differ significantly between the two groups (Ann. Intern. Med. 2009;150:830-39).
"It may well be a positive placebo effect from getting a natural product. ... We’ll do whatever it takes to get our patients on therapy," he said.
Dr. Paauw reported having no financial disclosures.
On Twitter @sherryboschert
EXPERT ANALYSIS FROM ACP INTERNAL MEDICINE 2013
Meta-analysis backs same-day discharge after PCI
SAN FRANCISCO – Sending patients home the same day that they undergo percutaneous coronary intervention appears to be as safe as watching patients overnight in the hospital, based on a meta-analysis of 37 studies involving 12,803 patients.
Most patients underwent PCI for stable angina: 66% in the seven randomized, controlled trials and 98% in the 30 observational studies in the meta-analysis.
In a meta-analysis of results for 2,738 of the patients who were in seven randomized, controlled trials, rates for a composite of death, myocardial infarction (MI), and target lesion revascularization did not differ significantly between the same-day discharge group and the overnight observation group, Dr. Kimberly Brayton and her associates reported.
The two groups also did not differ significantly in the rate of another composite endpoint in the randomized trials: major bleeding or vascular complications, she said at the annual meeting of the American College of Cardiology.
Pooled results for 10,065 of the patients in 30 observational studies showed a 1% rate of the combined endpoint of death, MI, and target lesion revascularization and a 0.7% rate of major bleeding or vascular complications, said Dr. Brayton, of Stanford (Calif.) University.
Of the 15 deaths in the observational studies, 11 occurred more than 24 hours after PCI and "presumably were not modifiable by overnight observation," she added. Data on the remaining four deaths did not specify when they occurred and did not suggest the patients died between 6 and 24 hours following PCI.
The similarities of results between groups in the randomized controlled trials held steady in a secondary analysis that excluded three trials of patients with acute coronary syndrome, and in another secondary analysis that excluded studies conducted outside the United States.
Restricting the analysis to studies using only transfemoral access for PCI did not produce any significant differences between groups in major bleeding or vascular complications.
The findings support consideration of same-day discharge for carefully selected patients undergoing PCI, though larger studies are needed for more robust comparisons. "PCI is now much safer than it was in the past," she said.
Complications from PCI predominantly happen in the first 6 hours after the procedure, previous studies have shown. Outside the United States, patients commonly go home the day of PCI, but only approximately 1% of U.S. patients get same-day discharge after PCI, one study suggests (JAMA 2011;306:1461-1467).
Dr. Brayton and her associates developed a sample protocol for deciding which patients undergoing PCI to send home the same day and which to admit for observation, based on existing PCI guidelines and the protocols used in the studies in the meta-analyses.
Some preprocedure criteria would exclude patients from same-day discharge, including age older than 75 years, a glomerular filtration rate less than 60 mL/min per 1.73 m2, an ejection fraction less than 30%, the presence of acute coronary syndrome, allergy to contrast media, inadequate social support at home, or living more than 30-60 minutes away from the hospital.
If none of those factors are present, consider procedural factors that would exclude same-day discharge. These include significant left main disease, use of a glycoprotein IIb/IIIa inhibitor, performance of a complex PCI, or procedure-related complications.
Barring any of those, observe the patient for 6 hours and admit for overnight observation if there is any recurrent chest pain, hemodynamic instability, or bleeding or vascular complications. If not, the patient may go home the same day, but schedule a follow-up visit or phone call for 24 hours after PCI, Dr. Brayton suggested.
Patients had a mean age of 61 years in the randomized controlled trials and 62 years in the observational studies. Before PCI, 27% in the randomized studies and 29% in the observational studies had multivessel disease. As part of PCI, 39% in the randomized studies and 17% in the observational studies received glycoprotein inhibitors, and 29% in the observational studies received bivalirudin (with no data on bivalirudin for the randomized trials). A closure device was used in 4% of patients in the randomized trials and 54% in the observational studies.
The findings were limited by the heterogeneity of the studies in the meta-analysis, limited statistical power in the small numbers studied, the unavailability of patient-level data, and possible bias, especially in the observational studies, she said.
Dr. Brayton reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Sending patients home the same day that they undergo percutaneous coronary intervention appears to be as safe as watching patients overnight in the hospital, based on a meta-analysis of 37 studies involving 12,803 patients.
Most patients underwent PCI for stable angina: 66% in the seven randomized, controlled trials and 98% in the 30 observational studies in the meta-analysis.
In a meta-analysis of results for 2,738 of the patients who were in seven randomized, controlled trials, rates for a composite of death, myocardial infarction (MI), and target lesion revascularization did not differ significantly between the same-day discharge group and the overnight observation group, Dr. Kimberly Brayton and her associates reported.
The two groups also did not differ significantly in the rate of another composite endpoint in the randomized trials: major bleeding or vascular complications, she said at the annual meeting of the American College of Cardiology.
Pooled results for 10,065 of the patients in 30 observational studies showed a 1% rate of the combined endpoint of death, MI, and target lesion revascularization and a 0.7% rate of major bleeding or vascular complications, said Dr. Brayton, of Stanford (Calif.) University.
Of the 15 deaths in the observational studies, 11 occurred more than 24 hours after PCI and "presumably were not modifiable by overnight observation," she added. Data on the remaining four deaths did not specify when they occurred and did not suggest the patients died between 6 and 24 hours following PCI.
The similarities of results between groups in the randomized controlled trials held steady in a secondary analysis that excluded three trials of patients with acute coronary syndrome, and in another secondary analysis that excluded studies conducted outside the United States.
Restricting the analysis to studies using only transfemoral access for PCI did not produce any significant differences between groups in major bleeding or vascular complications.
The findings support consideration of same-day discharge for carefully selected patients undergoing PCI, though larger studies are needed for more robust comparisons. "PCI is now much safer than it was in the past," she said.
Complications from PCI predominantly happen in the first 6 hours after the procedure, previous studies have shown. Outside the United States, patients commonly go home the day of PCI, but only approximately 1% of U.S. patients get same-day discharge after PCI, one study suggests (JAMA 2011;306:1461-1467).
Dr. Brayton and her associates developed a sample protocol for deciding which patients undergoing PCI to send home the same day and which to admit for observation, based on existing PCI guidelines and the protocols used in the studies in the meta-analyses.
Some preprocedure criteria would exclude patients from same-day discharge, including age older than 75 years, a glomerular filtration rate less than 60 mL/min per 1.73 m2, an ejection fraction less than 30%, the presence of acute coronary syndrome, allergy to contrast media, inadequate social support at home, or living more than 30-60 minutes away from the hospital.
If none of those factors are present, consider procedural factors that would exclude same-day discharge. These include significant left main disease, use of a glycoprotein IIb/IIIa inhibitor, performance of a complex PCI, or procedure-related complications.
Barring any of those, observe the patient for 6 hours and admit for overnight observation if there is any recurrent chest pain, hemodynamic instability, or bleeding or vascular complications. If not, the patient may go home the same day, but schedule a follow-up visit or phone call for 24 hours after PCI, Dr. Brayton suggested.
Patients had a mean age of 61 years in the randomized controlled trials and 62 years in the observational studies. Before PCI, 27% in the randomized studies and 29% in the observational studies had multivessel disease. As part of PCI, 39% in the randomized studies and 17% in the observational studies received glycoprotein inhibitors, and 29% in the observational studies received bivalirudin (with no data on bivalirudin for the randomized trials). A closure device was used in 4% of patients in the randomized trials and 54% in the observational studies.
The findings were limited by the heterogeneity of the studies in the meta-analysis, limited statistical power in the small numbers studied, the unavailability of patient-level data, and possible bias, especially in the observational studies, she said.
Dr. Brayton reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Sending patients home the same day that they undergo percutaneous coronary intervention appears to be as safe as watching patients overnight in the hospital, based on a meta-analysis of 37 studies involving 12,803 patients.
Most patients underwent PCI for stable angina: 66% in the seven randomized, controlled trials and 98% in the 30 observational studies in the meta-analysis.
In a meta-analysis of results for 2,738 of the patients who were in seven randomized, controlled trials, rates for a composite of death, myocardial infarction (MI), and target lesion revascularization did not differ significantly between the same-day discharge group and the overnight observation group, Dr. Kimberly Brayton and her associates reported.
The two groups also did not differ significantly in the rate of another composite endpoint in the randomized trials: major bleeding or vascular complications, she said at the annual meeting of the American College of Cardiology.
Pooled results for 10,065 of the patients in 30 observational studies showed a 1% rate of the combined endpoint of death, MI, and target lesion revascularization and a 0.7% rate of major bleeding or vascular complications, said Dr. Brayton, of Stanford (Calif.) University.
Of the 15 deaths in the observational studies, 11 occurred more than 24 hours after PCI and "presumably were not modifiable by overnight observation," she added. Data on the remaining four deaths did not specify when they occurred and did not suggest the patients died between 6 and 24 hours following PCI.
The similarities of results between groups in the randomized controlled trials held steady in a secondary analysis that excluded three trials of patients with acute coronary syndrome, and in another secondary analysis that excluded studies conducted outside the United States.
Restricting the analysis to studies using only transfemoral access for PCI did not produce any significant differences between groups in major bleeding or vascular complications.
The findings support consideration of same-day discharge for carefully selected patients undergoing PCI, though larger studies are needed for more robust comparisons. "PCI is now much safer than it was in the past," she said.
Complications from PCI predominantly happen in the first 6 hours after the procedure, previous studies have shown. Outside the United States, patients commonly go home the day of PCI, but only approximately 1% of U.S. patients get same-day discharge after PCI, one study suggests (JAMA 2011;306:1461-1467).
Dr. Brayton and her associates developed a sample protocol for deciding which patients undergoing PCI to send home the same day and which to admit for observation, based on existing PCI guidelines and the protocols used in the studies in the meta-analyses.
Some preprocedure criteria would exclude patients from same-day discharge, including age older than 75 years, a glomerular filtration rate less than 60 mL/min per 1.73 m2, an ejection fraction less than 30%, the presence of acute coronary syndrome, allergy to contrast media, inadequate social support at home, or living more than 30-60 minutes away from the hospital.
If none of those factors are present, consider procedural factors that would exclude same-day discharge. These include significant left main disease, use of a glycoprotein IIb/IIIa inhibitor, performance of a complex PCI, or procedure-related complications.
Barring any of those, observe the patient for 6 hours and admit for overnight observation if there is any recurrent chest pain, hemodynamic instability, or bleeding or vascular complications. If not, the patient may go home the same day, but schedule a follow-up visit or phone call for 24 hours after PCI, Dr. Brayton suggested.
Patients had a mean age of 61 years in the randomized controlled trials and 62 years in the observational studies. Before PCI, 27% in the randomized studies and 29% in the observational studies had multivessel disease. As part of PCI, 39% in the randomized studies and 17% in the observational studies received glycoprotein inhibitors, and 29% in the observational studies received bivalirudin (with no data on bivalirudin for the randomized trials). A closure device was used in 4% of patients in the randomized trials and 54% in the observational studies.
The findings were limited by the heterogeneity of the studies in the meta-analysis, limited statistical power in the small numbers studied, the unavailability of patient-level data, and possible bias, especially in the observational studies, she said.
Dr. Brayton reported having no financial disclosures.
On Twitter @sherryboschert
AT ACC 13
Major finding: The rate of the combined endpoint of death, MI, and target lesion revascularization was 1% after PCI, and the rate for major bleeding or vascular complications was 0.7%. Rates were similar for patients discharged on the same day and those hospitalized overnight.
Data source: Meta-analysis of 37 studies involving 12,803 patients.
Disclosures: Dr. Brayton reported having no financial disclosures.
Beware warfarin interaction with antibiotics, acetaminophen, steroids
SAN FRANCISCO – The main reason older U.S. adults are hospitalized for drug interaction is an interaction with warfarin, so watch out for some of the main culprits: trimethoprim/sulfamethoxazole, acetaminophen, and oral steroids, advised Dr. Douglas S. Paauw.
"The biggest, most serious interaction we’re going to stumble into with warfarin" is with trimethoprim/sulfamethoxazole, he said at the annual meeting of the American College of Physicians.
Nearly 100,000 U.S. adults older than 65 years were hospitalized per year in 2007-2009 because of drug interactions, according to a study of data from the National Electronic Injury Surveillance System’s Cooperative Adverse Drug Event Surveillance Project. Warfarin led the four drug classes that caused 67% of "the mayhem," Dr. Paauw said, and was responsible for nearly three times the number of hospitalizations for drug interactions as any of the runner-ups – insulin, oral antiplatelet drugs, or oral hypoglycemics (N. Engl. J. Med. 2011;365:2002-12).
Trimethoprim/sulfamethoxazole can decrease metabolism and increase prothrombin times in patients on warfarin. So can erythromycin, which "we don’t use much any more," said Dr. Paauw, professor of medicine at the University of Washington, Seattle. "Trimethoprim/sulfamethoxazole has had a resurgence because of MRSA [methicillin-resistant Staphylococcus aureus]" infection.
Other drugs that can cause similar and clinically important interactions with warfarin are amiodarone, propafenone, and three antifungals that can be a problem at high doses but not with single doses – ketoconazole/fluconazole, itraconazole, or metronidazole.
Drugs that possibly can interact with warfarin, especially in elderly patients and those on multiple medications, include quinolones, omeprazole, clarithromycin, and azithromycin.
One retrospective study of 104 patients on stable warfarin therapy found mean increases in the international normalized ratio (INR) of 1.76 in patients who also took trimethoprim/sulfamethoxazole, 0.85 with levofloxacin, and 0.51 with azithromycin, compared with a decrease of 0.15 in patients on terazosin, who served as a control group.
Another way to look at it, Dr. Paauw said, is that the INR increased beyond therapeutic levels in 69% of patients on warfarin plus trimethoprim/sulfamethoxazole, 33% of patients on warfarin plus levofloxacin, 31% on warfarin and azithromycin, or 5% on warfarin and terazosin (J. Gen. Intern. Med. 2005;20:653-6).
To treat a urinary tract infection in an anticoagulated patient, try not to use trimethoprim/sulfamethoxazole, and be worried about using quinolones, Dr. Paauw advised. Penicillins/cephalosporins are acceptable, or use nitrofurantoin, he said.
As for acetaminophen, "we always think of acetaminophen as a safe drug, but if you take enough of it – like three extrastrength Tylenol a day it can affect the INR," he said. Be aware of this, and if a patient on warfarin is taking acetaminophen regularly, check the INR more often than you normally would, he added.
Findings from three studies suggest there are INR effects from interactions of warfarin and acetaminophen.
One study of patients on warfarin who received 2 g or 4 g of acetaminophen or placebo found that 54% of patients on acetaminophen overshot their INR goal, compared with 17% on placebo (Pharmacotherapy 2007;27:675-83). In another study, taking more than 9,100 mg/wk of acetaminophen increased the risk 10-fold for developing an INR above 6.0 (JAMA 1998;279:657-62).
In a separate double-blind crossover trial, patients on warfarin and 4 g/day of acetaminophen had prothrombin times 75% greater than a control group (Clin. Res. 1984;32:698a).
Oral corticosteroids significantly increased the INR by a mean of 1.24 in patients on warfarin, giving 62% of patients an INR above their targeted range, one retrospective study found. The INR became elevated a mean of 7 days after starting steroids (Ann. Pharmacother. 2006;40:2101-6).
When you recognize that this interaction is developing, reduce the steroids but don’t decrease the warfarin dose, Dr. Paauw advised, because the INR will normalize as the steroids disappear. If you simultaneously reduce the warfarin dose, the INR will not be where you want it post corticosteroids.
Dr. Paauw reported having no relevant financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – The main reason older U.S. adults are hospitalized for drug interaction is an interaction with warfarin, so watch out for some of the main culprits: trimethoprim/sulfamethoxazole, acetaminophen, and oral steroids, advised Dr. Douglas S. Paauw.
"The biggest, most serious interaction we’re going to stumble into with warfarin" is with trimethoprim/sulfamethoxazole, he said at the annual meeting of the American College of Physicians.
Nearly 100,000 U.S. adults older than 65 years were hospitalized per year in 2007-2009 because of drug interactions, according to a study of data from the National Electronic Injury Surveillance System’s Cooperative Adverse Drug Event Surveillance Project. Warfarin led the four drug classes that caused 67% of "the mayhem," Dr. Paauw said, and was responsible for nearly three times the number of hospitalizations for drug interactions as any of the runner-ups – insulin, oral antiplatelet drugs, or oral hypoglycemics (N. Engl. J. Med. 2011;365:2002-12).
Trimethoprim/sulfamethoxazole can decrease metabolism and increase prothrombin times in patients on warfarin. So can erythromycin, which "we don’t use much any more," said Dr. Paauw, professor of medicine at the University of Washington, Seattle. "Trimethoprim/sulfamethoxazole has had a resurgence because of MRSA [methicillin-resistant Staphylococcus aureus]" infection.
Other drugs that can cause similar and clinically important interactions with warfarin are amiodarone, propafenone, and three antifungals that can be a problem at high doses but not with single doses – ketoconazole/fluconazole, itraconazole, or metronidazole.
Drugs that possibly can interact with warfarin, especially in elderly patients and those on multiple medications, include quinolones, omeprazole, clarithromycin, and azithromycin.
One retrospective study of 104 patients on stable warfarin therapy found mean increases in the international normalized ratio (INR) of 1.76 in patients who also took trimethoprim/sulfamethoxazole, 0.85 with levofloxacin, and 0.51 with azithromycin, compared with a decrease of 0.15 in patients on terazosin, who served as a control group.
Another way to look at it, Dr. Paauw said, is that the INR increased beyond therapeutic levels in 69% of patients on warfarin plus trimethoprim/sulfamethoxazole, 33% of patients on warfarin plus levofloxacin, 31% on warfarin and azithromycin, or 5% on warfarin and terazosin (J. Gen. Intern. Med. 2005;20:653-6).
To treat a urinary tract infection in an anticoagulated patient, try not to use trimethoprim/sulfamethoxazole, and be worried about using quinolones, Dr. Paauw advised. Penicillins/cephalosporins are acceptable, or use nitrofurantoin, he said.
As for acetaminophen, "we always think of acetaminophen as a safe drug, but if you take enough of it – like three extrastrength Tylenol a day it can affect the INR," he said. Be aware of this, and if a patient on warfarin is taking acetaminophen regularly, check the INR more often than you normally would, he added.
Findings from three studies suggest there are INR effects from interactions of warfarin and acetaminophen.
One study of patients on warfarin who received 2 g or 4 g of acetaminophen or placebo found that 54% of patients on acetaminophen overshot their INR goal, compared with 17% on placebo (Pharmacotherapy 2007;27:675-83). In another study, taking more than 9,100 mg/wk of acetaminophen increased the risk 10-fold for developing an INR above 6.0 (JAMA 1998;279:657-62).
In a separate double-blind crossover trial, patients on warfarin and 4 g/day of acetaminophen had prothrombin times 75% greater than a control group (Clin. Res. 1984;32:698a).
Oral corticosteroids significantly increased the INR by a mean of 1.24 in patients on warfarin, giving 62% of patients an INR above their targeted range, one retrospective study found. The INR became elevated a mean of 7 days after starting steroids (Ann. Pharmacother. 2006;40:2101-6).
When you recognize that this interaction is developing, reduce the steroids but don’t decrease the warfarin dose, Dr. Paauw advised, because the INR will normalize as the steroids disappear. If you simultaneously reduce the warfarin dose, the INR will not be where you want it post corticosteroids.
Dr. Paauw reported having no relevant financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – The main reason older U.S. adults are hospitalized for drug interaction is an interaction with warfarin, so watch out for some of the main culprits: trimethoprim/sulfamethoxazole, acetaminophen, and oral steroids, advised Dr. Douglas S. Paauw.
"The biggest, most serious interaction we’re going to stumble into with warfarin" is with trimethoprim/sulfamethoxazole, he said at the annual meeting of the American College of Physicians.
Nearly 100,000 U.S. adults older than 65 years were hospitalized per year in 2007-2009 because of drug interactions, according to a study of data from the National Electronic Injury Surveillance System’s Cooperative Adverse Drug Event Surveillance Project. Warfarin led the four drug classes that caused 67% of "the mayhem," Dr. Paauw said, and was responsible for nearly three times the number of hospitalizations for drug interactions as any of the runner-ups – insulin, oral antiplatelet drugs, or oral hypoglycemics (N. Engl. J. Med. 2011;365:2002-12).
Trimethoprim/sulfamethoxazole can decrease metabolism and increase prothrombin times in patients on warfarin. So can erythromycin, which "we don’t use much any more," said Dr. Paauw, professor of medicine at the University of Washington, Seattle. "Trimethoprim/sulfamethoxazole has had a resurgence because of MRSA [methicillin-resistant Staphylococcus aureus]" infection.
Other drugs that can cause similar and clinically important interactions with warfarin are amiodarone, propafenone, and three antifungals that can be a problem at high doses but not with single doses – ketoconazole/fluconazole, itraconazole, or metronidazole.
Drugs that possibly can interact with warfarin, especially in elderly patients and those on multiple medications, include quinolones, omeprazole, clarithromycin, and azithromycin.
One retrospective study of 104 patients on stable warfarin therapy found mean increases in the international normalized ratio (INR) of 1.76 in patients who also took trimethoprim/sulfamethoxazole, 0.85 with levofloxacin, and 0.51 with azithromycin, compared with a decrease of 0.15 in patients on terazosin, who served as a control group.
Another way to look at it, Dr. Paauw said, is that the INR increased beyond therapeutic levels in 69% of patients on warfarin plus trimethoprim/sulfamethoxazole, 33% of patients on warfarin plus levofloxacin, 31% on warfarin and azithromycin, or 5% on warfarin and terazosin (J. Gen. Intern. Med. 2005;20:653-6).
To treat a urinary tract infection in an anticoagulated patient, try not to use trimethoprim/sulfamethoxazole, and be worried about using quinolones, Dr. Paauw advised. Penicillins/cephalosporins are acceptable, or use nitrofurantoin, he said.
As for acetaminophen, "we always think of acetaminophen as a safe drug, but if you take enough of it – like three extrastrength Tylenol a day it can affect the INR," he said. Be aware of this, and if a patient on warfarin is taking acetaminophen regularly, check the INR more often than you normally would, he added.
Findings from three studies suggest there are INR effects from interactions of warfarin and acetaminophen.
One study of patients on warfarin who received 2 g or 4 g of acetaminophen or placebo found that 54% of patients on acetaminophen overshot their INR goal, compared with 17% on placebo (Pharmacotherapy 2007;27:675-83). In another study, taking more than 9,100 mg/wk of acetaminophen increased the risk 10-fold for developing an INR above 6.0 (JAMA 1998;279:657-62).
In a separate double-blind crossover trial, patients on warfarin and 4 g/day of acetaminophen had prothrombin times 75% greater than a control group (Clin. Res. 1984;32:698a).
Oral corticosteroids significantly increased the INR by a mean of 1.24 in patients on warfarin, giving 62% of patients an INR above their targeted range, one retrospective study found. The INR became elevated a mean of 7 days after starting steroids (Ann. Pharmacother. 2006;40:2101-6).
When you recognize that this interaction is developing, reduce the steroids but don’t decrease the warfarin dose, Dr. Paauw advised, because the INR will normalize as the steroids disappear. If you simultaneously reduce the warfarin dose, the INR will not be where you want it post corticosteroids.
Dr. Paauw reported having no relevant financial disclosures.
On Twitter @sherryboschert
EXPERT ANALYSIS FROM ACP INTERNAL MEDICINE 2013
Azithromycin cardiovascular risk perhaps in subgroup only
A large study of Danish national data found no significantly increased cardiovascular risk from taking azithromycin, results that are different from, but perhaps not contradictory to, a recent report that prompted the Food and Drug Administration to beef up warnings about the antibiotic.
The discordance may be attributable to the different populations in the two studies. The earlier study found a doubled or tripled risk of cardiovascular-related death in a higher-risk U.S. cohort of Medicaid recipients while taking azithromycin, compared with no antibiotic or amoxicillin. The current study found a tripled risk of cardiovascular-related deaths in a lower-risk, young- to middle-age Danish cohort while on azithromycin, compared with no antibiotic use, but there was no increased risk from azithromycin use, compared with taking penicillin V, an antibiotic with similar indications.
Clinicians should find the Danish study "reassuring" because it appears that any cardiovascular risk from azithromycin is not generalizable to all patients seen in office practices, Henrik Svanström and his associates concluded.
They analyzed data from multiple Danish national databases from 1997 through 2010 to conduct two comparisons: one of 1,102,050 episodes of azithromycin use, compared with the same number of matched patients on no antibiotics; and a comparison of 1,102,419 episodes of azithromycin use and 7,364,292 episodes of penicillin V use.
There were 6 deaths from cardiovascular causes while on no antibiotics, 17 while on a 5-day course of azithromycin, and 146 while on penicillin V, which translated into cardiovascular death rates of 0.4/1,000 patient-years on no antibiotics, 1.1/1,000 patient-years on azithromycin, and 1.5/1,000 patient-years on penicillin V, reported Mr. Svanström, a statistician at the Statens Serum Institut, Copenhagen, Denmark.
The adjusted difference in absolute risk was one less cardiovascular death per 1 million treatment episodes of azithromycin, compared with penicillin V, the investigators calculated (N. Engl. J. Med. 2013;368:1704-12).
The lack of any significantly increased risk on azithromycin compared with penicillin V suggests that the increase in cardiovascular deaths on azithromycin, compared with no antibiotics, was not attributable to the drug but was entirely brought about by mortality risks from the acute infections or other health problems being treated, Mr. Svanström suggested.
A post hoc analysis also compared episodes of azithromycin use with matched patients given amoxicillin and found no significantly increased risk of cardiovascular death from azithromycin, he reported.
In subgroup analyses, the risk of cardiovascular death appeared to be increased in patients on azithromycin who’d had cardiovascular disease, compared with patients on the drug with no history of cardiovascular disease (rates of 10 and 1 cardiovascular death per 1,000 patient-years, respectively), but the difference did not reach statistical significance.
The FDA recently issued a warning of increased risk for fatal arrhythmia associated with azithromycin use and strengthened the existing warning on the drug’s label about the risk of QT interval prolongation and torsades de pointes. The people at greatest risk are those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower-than-normal heart rate, or use of certain drugs to treat abnormal heart rhythms or arrhythmias, the FDA said.
The FDA action followed a retrospective cohort study of Tennessee Medicaid patients from 1992 through 2006, including 347,795 episodes of azithromycin use, 1.4 million matched episodes with no antibiotics, and 1.3 million prescriptions for amoxicillin. That study found a small absolute increase in the risk of cardiovascular death while on azithromycin: 85.2 deaths per million courses of azithromycin, compared with 29.8 per million periods with no antibiotics and 31.5 per million with amoxicillin. The risk was most pronounced among the 10% of patients who already were at highest risk for cardiovascular disease (N. Engl. J. Med. 2012;366:1881-90).
Considering the "profound differences" between the two studies’ patient cohorts and their baseline risks of death, the Danish study should be considered "a clinically relevant complement to, rather than a contrast with," the U.S. study, Mr. Svanström suggested.
The Danish Medical Research Council funded the study.
Mr. Svanström and his associates reported having no financial disclosures.
On Twitter @sherryboschert
Pharmacologic and epidemiologic evidence that macrolide antibiotics, including azithromycin, and fluoroquinolones can prolong the QT interval and cause lethal arrhythmias should give clinicians pause before prescribing these drugs, especially if the treatment is expected to be of limited benefit or the patient has cardiovascular risk factors, FDA officials said in an editorial.
In the Danish study, the upper bound of the 95% confidence interval did not exclude an increased risk of cardiovascular death of as much as 55% from using azithromycin, compared with penicillin V, they noted. The Danish patients, in general, had better cardiovascular health than did the Tennessee Medicaid patients.
Any potential cardiovascular risk from azithromycin was associated with current use of the drug and did not affect cardiovascular risk afterward. Separate studies suggest that macrolides may improve survival from community-acquired pneumonia, compared with treatment using other antibacterial agents, an attribute that may not have been incorporated in the Tennessee study’s analysis. It’s possible that the drug may reduce longer-term death rates from pneumonia that outweigh any potential cardiovascular risk during its 5-day course, Dr. Andrew D. Mosholder and his FDA associates suggested (N. Engl. J. Med. 2013;368:1704-12).
Pneumonia was seldom the reason azithromycin was used in the Tennessee study, however. Physicians discuss azithromycin with patients most commonly for chronic sinusitis or bronchitis, according to a separate FDA analysis of data from a survey of about 3,200 office-based physicians conducted by Encuity Research in 2002 through 2011.
When considering prescribing an antibiotic, weigh the potential cardiovascular risks not only of azithromycin but of its alternatives, Dr. Mosholder and his associates advised. The FDA has warned that erythromycin, clarithromycin, and fluoroquinolones can prolong QT intervals, and the Tennessee study found a cardiac death risk from levofloxacin that was similar to that of azithromycin.
More than 40 million U.S. residents received prescriptions for azithromycin in 2011. The Tennessee study found an extra cardiovascular death for every 21,000 outpatient prescriptions of azithromycin, compared with amoxicillin prescriptions. Consider the potential benefits and risks of antibiotic options when prescribing, Dr. Mosholder said.
Dr. Mosholder is with the FDA’s Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research. He and his associates reported having no financial disclosures.
Henrik Svanström,
Pharmacologic and epidemiologic evidence that macrolide antibiotics, including azithromycin, and fluoroquinolones can prolong the QT interval and cause lethal arrhythmias should give clinicians pause before prescribing these drugs, especially if the treatment is expected to be of limited benefit or the patient has cardiovascular risk factors, FDA officials said in an editorial.
In the Danish study, the upper bound of the 95% confidence interval did not exclude an increased risk of cardiovascular death of as much as 55% from using azithromycin, compared with penicillin V, they noted. The Danish patients, in general, had better cardiovascular health than did the Tennessee Medicaid patients.
Any potential cardiovascular risk from azithromycin was associated with current use of the drug and did not affect cardiovascular risk afterward. Separate studies suggest that macrolides may improve survival from community-acquired pneumonia, compared with treatment using other antibacterial agents, an attribute that may not have been incorporated in the Tennessee study’s analysis. It’s possible that the drug may reduce longer-term death rates from pneumonia that outweigh any potential cardiovascular risk during its 5-day course, Dr. Andrew D. Mosholder and his FDA associates suggested (N. Engl. J. Med. 2013;368:1704-12).
Pneumonia was seldom the reason azithromycin was used in the Tennessee study, however. Physicians discuss azithromycin with patients most commonly for chronic sinusitis or bronchitis, according to a separate FDA analysis of data from a survey of about 3,200 office-based physicians conducted by Encuity Research in 2002 through 2011.
When considering prescribing an antibiotic, weigh the potential cardiovascular risks not only of azithromycin but of its alternatives, Dr. Mosholder and his associates advised. The FDA has warned that erythromycin, clarithromycin, and fluoroquinolones can prolong QT intervals, and the Tennessee study found a cardiac death risk from levofloxacin that was similar to that of azithromycin.
More than 40 million U.S. residents received prescriptions for azithromycin in 2011. The Tennessee study found an extra cardiovascular death for every 21,000 outpatient prescriptions of azithromycin, compared with amoxicillin prescriptions. Consider the potential benefits and risks of antibiotic options when prescribing, Dr. Mosholder said.
Dr. Mosholder is with the FDA’s Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research. He and his associates reported having no financial disclosures.
Pharmacologic and epidemiologic evidence that macrolide antibiotics, including azithromycin, and fluoroquinolones can prolong the QT interval and cause lethal arrhythmias should give clinicians pause before prescribing these drugs, especially if the treatment is expected to be of limited benefit or the patient has cardiovascular risk factors, FDA officials said in an editorial.
In the Danish study, the upper bound of the 95% confidence interval did not exclude an increased risk of cardiovascular death of as much as 55% from using azithromycin, compared with penicillin V, they noted. The Danish patients, in general, had better cardiovascular health than did the Tennessee Medicaid patients.
Any potential cardiovascular risk from azithromycin was associated with current use of the drug and did not affect cardiovascular risk afterward. Separate studies suggest that macrolides may improve survival from community-acquired pneumonia, compared with treatment using other antibacterial agents, an attribute that may not have been incorporated in the Tennessee study’s analysis. It’s possible that the drug may reduce longer-term death rates from pneumonia that outweigh any potential cardiovascular risk during its 5-day course, Dr. Andrew D. Mosholder and his FDA associates suggested (N. Engl. J. Med. 2013;368:1704-12).
Pneumonia was seldom the reason azithromycin was used in the Tennessee study, however. Physicians discuss azithromycin with patients most commonly for chronic sinusitis or bronchitis, according to a separate FDA analysis of data from a survey of about 3,200 office-based physicians conducted by Encuity Research in 2002 through 2011.
When considering prescribing an antibiotic, weigh the potential cardiovascular risks not only of azithromycin but of its alternatives, Dr. Mosholder and his associates advised. The FDA has warned that erythromycin, clarithromycin, and fluoroquinolones can prolong QT intervals, and the Tennessee study found a cardiac death risk from levofloxacin that was similar to that of azithromycin.
More than 40 million U.S. residents received prescriptions for azithromycin in 2011. The Tennessee study found an extra cardiovascular death for every 21,000 outpatient prescriptions of azithromycin, compared with amoxicillin prescriptions. Consider the potential benefits and risks of antibiotic options when prescribing, Dr. Mosholder said.
Dr. Mosholder is with the FDA’s Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research. He and his associates reported having no financial disclosures.
A large study of Danish national data found no significantly increased cardiovascular risk from taking azithromycin, results that are different from, but perhaps not contradictory to, a recent report that prompted the Food and Drug Administration to beef up warnings about the antibiotic.
The discordance may be attributable to the different populations in the two studies. The earlier study found a doubled or tripled risk of cardiovascular-related death in a higher-risk U.S. cohort of Medicaid recipients while taking azithromycin, compared with no antibiotic or amoxicillin. The current study found a tripled risk of cardiovascular-related deaths in a lower-risk, young- to middle-age Danish cohort while on azithromycin, compared with no antibiotic use, but there was no increased risk from azithromycin use, compared with taking penicillin V, an antibiotic with similar indications.
Clinicians should find the Danish study "reassuring" because it appears that any cardiovascular risk from azithromycin is not generalizable to all patients seen in office practices, Henrik Svanström and his associates concluded.
They analyzed data from multiple Danish national databases from 1997 through 2010 to conduct two comparisons: one of 1,102,050 episodes of azithromycin use, compared with the same number of matched patients on no antibiotics; and a comparison of 1,102,419 episodes of azithromycin use and 7,364,292 episodes of penicillin V use.
There were 6 deaths from cardiovascular causes while on no antibiotics, 17 while on a 5-day course of azithromycin, and 146 while on penicillin V, which translated into cardiovascular death rates of 0.4/1,000 patient-years on no antibiotics, 1.1/1,000 patient-years on azithromycin, and 1.5/1,000 patient-years on penicillin V, reported Mr. Svanström, a statistician at the Statens Serum Institut, Copenhagen, Denmark.
The adjusted difference in absolute risk was one less cardiovascular death per 1 million treatment episodes of azithromycin, compared with penicillin V, the investigators calculated (N. Engl. J. Med. 2013;368:1704-12).
The lack of any significantly increased risk on azithromycin compared with penicillin V suggests that the increase in cardiovascular deaths on azithromycin, compared with no antibiotics, was not attributable to the drug but was entirely brought about by mortality risks from the acute infections or other health problems being treated, Mr. Svanström suggested.
A post hoc analysis also compared episodes of azithromycin use with matched patients given amoxicillin and found no significantly increased risk of cardiovascular death from azithromycin, he reported.
In subgroup analyses, the risk of cardiovascular death appeared to be increased in patients on azithromycin who’d had cardiovascular disease, compared with patients on the drug with no history of cardiovascular disease (rates of 10 and 1 cardiovascular death per 1,000 patient-years, respectively), but the difference did not reach statistical significance.
The FDA recently issued a warning of increased risk for fatal arrhythmia associated with azithromycin use and strengthened the existing warning on the drug’s label about the risk of QT interval prolongation and torsades de pointes. The people at greatest risk are those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower-than-normal heart rate, or use of certain drugs to treat abnormal heart rhythms or arrhythmias, the FDA said.
The FDA action followed a retrospective cohort study of Tennessee Medicaid patients from 1992 through 2006, including 347,795 episodes of azithromycin use, 1.4 million matched episodes with no antibiotics, and 1.3 million prescriptions for amoxicillin. That study found a small absolute increase in the risk of cardiovascular death while on azithromycin: 85.2 deaths per million courses of azithromycin, compared with 29.8 per million periods with no antibiotics and 31.5 per million with amoxicillin. The risk was most pronounced among the 10% of patients who already were at highest risk for cardiovascular disease (N. Engl. J. Med. 2012;366:1881-90).
Considering the "profound differences" between the two studies’ patient cohorts and their baseline risks of death, the Danish study should be considered "a clinically relevant complement to, rather than a contrast with," the U.S. study, Mr. Svanström suggested.
The Danish Medical Research Council funded the study.
Mr. Svanström and his associates reported having no financial disclosures.
On Twitter @sherryboschert
A large study of Danish national data found no significantly increased cardiovascular risk from taking azithromycin, results that are different from, but perhaps not contradictory to, a recent report that prompted the Food and Drug Administration to beef up warnings about the antibiotic.
The discordance may be attributable to the different populations in the two studies. The earlier study found a doubled or tripled risk of cardiovascular-related death in a higher-risk U.S. cohort of Medicaid recipients while taking azithromycin, compared with no antibiotic or amoxicillin. The current study found a tripled risk of cardiovascular-related deaths in a lower-risk, young- to middle-age Danish cohort while on azithromycin, compared with no antibiotic use, but there was no increased risk from azithromycin use, compared with taking penicillin V, an antibiotic with similar indications.
Clinicians should find the Danish study "reassuring" because it appears that any cardiovascular risk from azithromycin is not generalizable to all patients seen in office practices, Henrik Svanström and his associates concluded.
They analyzed data from multiple Danish national databases from 1997 through 2010 to conduct two comparisons: one of 1,102,050 episodes of azithromycin use, compared with the same number of matched patients on no antibiotics; and a comparison of 1,102,419 episodes of azithromycin use and 7,364,292 episodes of penicillin V use.
There were 6 deaths from cardiovascular causes while on no antibiotics, 17 while on a 5-day course of azithromycin, and 146 while on penicillin V, which translated into cardiovascular death rates of 0.4/1,000 patient-years on no antibiotics, 1.1/1,000 patient-years on azithromycin, and 1.5/1,000 patient-years on penicillin V, reported Mr. Svanström, a statistician at the Statens Serum Institut, Copenhagen, Denmark.
The adjusted difference in absolute risk was one less cardiovascular death per 1 million treatment episodes of azithromycin, compared with penicillin V, the investigators calculated (N. Engl. J. Med. 2013;368:1704-12).
The lack of any significantly increased risk on azithromycin compared with penicillin V suggests that the increase in cardiovascular deaths on azithromycin, compared with no antibiotics, was not attributable to the drug but was entirely brought about by mortality risks from the acute infections or other health problems being treated, Mr. Svanström suggested.
A post hoc analysis also compared episodes of azithromycin use with matched patients given amoxicillin and found no significantly increased risk of cardiovascular death from azithromycin, he reported.
In subgroup analyses, the risk of cardiovascular death appeared to be increased in patients on azithromycin who’d had cardiovascular disease, compared with patients on the drug with no history of cardiovascular disease (rates of 10 and 1 cardiovascular death per 1,000 patient-years, respectively), but the difference did not reach statistical significance.
The FDA recently issued a warning of increased risk for fatal arrhythmia associated with azithromycin use and strengthened the existing warning on the drug’s label about the risk of QT interval prolongation and torsades de pointes. The people at greatest risk are those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower-than-normal heart rate, or use of certain drugs to treat abnormal heart rhythms or arrhythmias, the FDA said.
The FDA action followed a retrospective cohort study of Tennessee Medicaid patients from 1992 through 2006, including 347,795 episodes of azithromycin use, 1.4 million matched episodes with no antibiotics, and 1.3 million prescriptions for amoxicillin. That study found a small absolute increase in the risk of cardiovascular death while on azithromycin: 85.2 deaths per million courses of azithromycin, compared with 29.8 per million periods with no antibiotics and 31.5 per million with amoxicillin. The risk was most pronounced among the 10% of patients who already were at highest risk for cardiovascular disease (N. Engl. J. Med. 2012;366:1881-90).
Considering the "profound differences" between the two studies’ patient cohorts and their baseline risks of death, the Danish study should be considered "a clinically relevant complement to, rather than a contrast with," the U.S. study, Mr. Svanström suggested.
The Danish Medical Research Council funded the study.
Mr. Svanström and his associates reported having no financial disclosures.
On Twitter @sherryboschert
Henrik Svanström,
Henrik Svanström,
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major finding: Death rates from cardiovascular causes were 1.1/1,000 person-years with azithromycin and 1.5/1,000 person-years on penicillin V, a nonsignificant difference.
Data source: Analyses of Danish national records from 1997 through 2010 for 1,102,050 episodes of azithromycin use, compared with the same number of matched patients on no antibiotics; and 1,102,419 episodes of azithromycin use, compared with 7,364,292 episodes of penicillin V use.
Disclosures: Mr. Svanström and his associates reported having no financial disclosures.
Prescription refills may continue after discontinuation
SAN FRANCISCO – Pharmacies refilled prescriptions for 1.5% of electronically discontinued medications, risking potential harm in 12% of cases, a study of 30,406 patients showed.
A retrospective study of records on 83,902 medications that had been electronically discontinued by physicians showed that 1,218 medications continued to be dispensed for 1,128 patients an average of one time in the year after discontinuation, Dr. Adrienne S. Allen reported at the annual meeting of the American College of Physicians.
Dr. Allen and her colleagues manually reviewed 416 charts to look for high-risk events and found suggestions of potential harm in 50 patients, including clinical reactions in 18 patients, laboratory abnormalities in 17, medication duplication in 8, and documented allergy in 7, said Dr. Allen, an internist in group practice in Danvers, Mass.
The continued refilling of discontinued prescriptions was seen for all drug classes and was most likely to affect patients with multiple prescriptions, nonwhite patients, and patients on Medicare or Medicaid (Ann. Intern. Med. 2012;157:700-5). Dr. Allen received a Junior Investigator Recognition Award at the meeting for her study.
Clinicians need to realize that dispensing of discontinued medication "does occur," Dr. Allen said. "Systemic intervention is needed to ensure that patients receive the correct medication."
Electronic health records with direct links to pharmacies make it easier to prescribe electronically, but most electronic health records do not transmit discontinuation orders to pharmacies, she noted.
The investigators studied records from 1 year in an integrated group practice with a common electronic health record that was separate from the group pharmacy’s computer system. They looked at medications commonly used in primary care: statins, antihypertensive medications, oral hypoglycemics, antiplatelet medications, and anticoagulants.
Among the 10 most commonly discontinued medications, dispensing continued for 1.4% of patients who had been using lisinopril or simvastatin, 1.2% of patients on hydrochlorothiazide, 1% on atenolol, 2.1% on amlodipine, 2.5% on metoprolol, 0.9% on metformin, 1.1% on enalapril, 1.5% on irbesartan, and 1.6% on warfarin.
The main reason for discontinuing a prescription was a dose adjustment. Other reasons included a change to an alternative medication, clinical intolerance, no further need for the drug, patient preference, or a laboratory abnormality.
Compared with white patients, black patients were 50% more likely and patients of other races were 60% more likely to have a discontinued medication dispensed. Patients covered by Medicaid were 40% more likely, and patients covered by Medicare were 70% more likely, to have a discontinued medication dispensed, compared with patients who had commercial insurance.
Patients on 15 or more medications were twice as likely to continue receiving a discontinued medication, compared with patients with fewer prescriptions.
Clinical reactions that suggested potential harm from the continued dispensing included hypotension in six patients; bradycardia, cough, or light-headedness in three patients each; and atrial flutter, GI upset, or myalgia in one patient each.
Laboratory abnormalities that suggested potential harm from refilling discontinued prescriptions included elevated liver function tests in five patients, hyponatremia or hypokalemia in four patients each, hyperkalemia in two patients, and increased levels of creatinine or uric acid in one patient each.
Dispensing of duplicate medications involved two statins in three patients, one patient each who got two sulfonylureas, two angiotensin-converting enzyme inhibitors, or two angiotensin receptor blockers, and two patients who got duplicate angiotensin-converting enzyme inhibitor/angiotensin receptor blocker medications. Medications continued to be dispensed despite records of allergy in seven patients, with allergy documented by cough in five patients and by rash or elevated creatinine phosphokinase in one patient each.
The National Institutes of Health funded the study. Dr. Allen reported having no relevant financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Pharmacies refilled prescriptions for 1.5% of electronically discontinued medications, risking potential harm in 12% of cases, a study of 30,406 patients showed.
A retrospective study of records on 83,902 medications that had been electronically discontinued by physicians showed that 1,218 medications continued to be dispensed for 1,128 patients an average of one time in the year after discontinuation, Dr. Adrienne S. Allen reported at the annual meeting of the American College of Physicians.
Dr. Allen and her colleagues manually reviewed 416 charts to look for high-risk events and found suggestions of potential harm in 50 patients, including clinical reactions in 18 patients, laboratory abnormalities in 17, medication duplication in 8, and documented allergy in 7, said Dr. Allen, an internist in group practice in Danvers, Mass.
The continued refilling of discontinued prescriptions was seen for all drug classes and was most likely to affect patients with multiple prescriptions, nonwhite patients, and patients on Medicare or Medicaid (Ann. Intern. Med. 2012;157:700-5). Dr. Allen received a Junior Investigator Recognition Award at the meeting for her study.
Clinicians need to realize that dispensing of discontinued medication "does occur," Dr. Allen said. "Systemic intervention is needed to ensure that patients receive the correct medication."
Electronic health records with direct links to pharmacies make it easier to prescribe electronically, but most electronic health records do not transmit discontinuation orders to pharmacies, she noted.
The investigators studied records from 1 year in an integrated group practice with a common electronic health record that was separate from the group pharmacy’s computer system. They looked at medications commonly used in primary care: statins, antihypertensive medications, oral hypoglycemics, antiplatelet medications, and anticoagulants.
Among the 10 most commonly discontinued medications, dispensing continued for 1.4% of patients who had been using lisinopril or simvastatin, 1.2% of patients on hydrochlorothiazide, 1% on atenolol, 2.1% on amlodipine, 2.5% on metoprolol, 0.9% on metformin, 1.1% on enalapril, 1.5% on irbesartan, and 1.6% on warfarin.
The main reason for discontinuing a prescription was a dose adjustment. Other reasons included a change to an alternative medication, clinical intolerance, no further need for the drug, patient preference, or a laboratory abnormality.
Compared with white patients, black patients were 50% more likely and patients of other races were 60% more likely to have a discontinued medication dispensed. Patients covered by Medicaid were 40% more likely, and patients covered by Medicare were 70% more likely, to have a discontinued medication dispensed, compared with patients who had commercial insurance.
Patients on 15 or more medications were twice as likely to continue receiving a discontinued medication, compared with patients with fewer prescriptions.
Clinical reactions that suggested potential harm from the continued dispensing included hypotension in six patients; bradycardia, cough, or light-headedness in three patients each; and atrial flutter, GI upset, or myalgia in one patient each.
Laboratory abnormalities that suggested potential harm from refilling discontinued prescriptions included elevated liver function tests in five patients, hyponatremia or hypokalemia in four patients each, hyperkalemia in two patients, and increased levels of creatinine or uric acid in one patient each.
Dispensing of duplicate medications involved two statins in three patients, one patient each who got two sulfonylureas, two angiotensin-converting enzyme inhibitors, or two angiotensin receptor blockers, and two patients who got duplicate angiotensin-converting enzyme inhibitor/angiotensin receptor blocker medications. Medications continued to be dispensed despite records of allergy in seven patients, with allergy documented by cough in five patients and by rash or elevated creatinine phosphokinase in one patient each.
The National Institutes of Health funded the study. Dr. Allen reported having no relevant financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Pharmacies refilled prescriptions for 1.5% of electronically discontinued medications, risking potential harm in 12% of cases, a study of 30,406 patients showed.
A retrospective study of records on 83,902 medications that had been electronically discontinued by physicians showed that 1,218 medications continued to be dispensed for 1,128 patients an average of one time in the year after discontinuation, Dr. Adrienne S. Allen reported at the annual meeting of the American College of Physicians.
Dr. Allen and her colleagues manually reviewed 416 charts to look for high-risk events and found suggestions of potential harm in 50 patients, including clinical reactions in 18 patients, laboratory abnormalities in 17, medication duplication in 8, and documented allergy in 7, said Dr. Allen, an internist in group practice in Danvers, Mass.
The continued refilling of discontinued prescriptions was seen for all drug classes and was most likely to affect patients with multiple prescriptions, nonwhite patients, and patients on Medicare or Medicaid (Ann. Intern. Med. 2012;157:700-5). Dr. Allen received a Junior Investigator Recognition Award at the meeting for her study.
Clinicians need to realize that dispensing of discontinued medication "does occur," Dr. Allen said. "Systemic intervention is needed to ensure that patients receive the correct medication."
Electronic health records with direct links to pharmacies make it easier to prescribe electronically, but most electronic health records do not transmit discontinuation orders to pharmacies, she noted.
The investigators studied records from 1 year in an integrated group practice with a common electronic health record that was separate from the group pharmacy’s computer system. They looked at medications commonly used in primary care: statins, antihypertensive medications, oral hypoglycemics, antiplatelet medications, and anticoagulants.
Among the 10 most commonly discontinued medications, dispensing continued for 1.4% of patients who had been using lisinopril or simvastatin, 1.2% of patients on hydrochlorothiazide, 1% on atenolol, 2.1% on amlodipine, 2.5% on metoprolol, 0.9% on metformin, 1.1% on enalapril, 1.5% on irbesartan, and 1.6% on warfarin.
The main reason for discontinuing a prescription was a dose adjustment. Other reasons included a change to an alternative medication, clinical intolerance, no further need for the drug, patient preference, or a laboratory abnormality.
Compared with white patients, black patients were 50% more likely and patients of other races were 60% more likely to have a discontinued medication dispensed. Patients covered by Medicaid were 40% more likely, and patients covered by Medicare were 70% more likely, to have a discontinued medication dispensed, compared with patients who had commercial insurance.
Patients on 15 or more medications were twice as likely to continue receiving a discontinued medication, compared with patients with fewer prescriptions.
Clinical reactions that suggested potential harm from the continued dispensing included hypotension in six patients; bradycardia, cough, or light-headedness in three patients each; and atrial flutter, GI upset, or myalgia in one patient each.
Laboratory abnormalities that suggested potential harm from refilling discontinued prescriptions included elevated liver function tests in five patients, hyponatremia or hypokalemia in four patients each, hyperkalemia in two patients, and increased levels of creatinine or uric acid in one patient each.
Dispensing of duplicate medications involved two statins in three patients, one patient each who got two sulfonylureas, two angiotensin-converting enzyme inhibitors, or two angiotensin receptor blockers, and two patients who got duplicate angiotensin-converting enzyme inhibitor/angiotensin receptor blocker medications. Medications continued to be dispensed despite records of allergy in seven patients, with allergy documented by cough in five patients and by rash or elevated creatinine phosphokinase in one patient each.
The National Institutes of Health funded the study. Dr. Allen reported having no relevant financial disclosures.
On Twitter @sherryboschert
AT ACP INTERNAL MEDICINE 2013
Major finding: Prescriptions that had been electronically discontinued were refilled 1.5% of the time, with potential harm in 12% of cases.
Data source: Retrospective studies of 83,902 discontinued medications for 30,406 patients in an integrated group practice.
Disclosures: The National Institutes of Health funded the study. Dr. Allen reported having no relevant financial disclosures.
New ACP center will foster physician-patient collaboration
The American College of Physicians announced the creation of the Center for Patient Partnership in Health Care to foster closer collaboration between patients and physicians. Dr. Steven Weinberger outlines the goals of the new initiative, and explains how it it can support the patient-centered medical home model.
For complete coverage of ACP's annual meeting in San Francisco, visit our conference coverage page.
The American College of Physicians announced the creation of the Center for Patient Partnership in Health Care to foster closer collaboration between patients and physicians. Dr. Steven Weinberger outlines the goals of the new initiative, and explains how it it can support the patient-centered medical home model.
For complete coverage of ACP's annual meeting in San Francisco, visit our conference coverage page.
The American College of Physicians announced the creation of the Center for Patient Partnership in Health Care to foster closer collaboration between patients and physicians. Dr. Steven Weinberger outlines the goals of the new initiative, and explains how it it can support the patient-centered medical home model.
For complete coverage of ACP's annual meeting in San Francisco, visit our conference coverage page.
Cardiac medication errors common after hospitalization
SAN FRANCISCO – Clinically important medication errors occurred in 51% of patients within 3 months of discharge from hospitalization for acute coronary syndrome and/or decompensated heart failure, a study of 851 patients showed.
In addition, the randomized controlled trial found no benefit from a predischarge pharmacist intervention and counseling incorporating tools designed for patients with low health literacy levels, compared with usual care in which the treating health care provider reconciled medications with the help of support software before patient discharge.
Although the trial focused on comparing the pharmacist intervention with usual care, "the biggest take-home message is that medication errors are very common" in these patients after hospitalization, Dr. Cecelia N. Theobald said at the annual meeting of the American College of Physicians.
Patients came from Vanderbilt University Medical Center in Nashville, Tenn., and from Brigham and Women’s Hospital in Boston. The study randomized 423 patients to the intervention and 428 to usual care.
In the intervention group, pharmacists reconciled medications and provided in-depth patient counseling before discharge, including a review of potential drug side effects. The pharmacists had specialized aids to help low-literacy patients adhere to their medication regimens, and they provided tailored follow-up to patients via postdischarge phone calls. In the usual-care group, the treating provider reconciled medications and pharmacist consultation was available on request. The usual-care group did not use the low-literacy aids or phone follow-up.
To assess outcomes, two clinicians reviewed patient records and patients were interviewed by phone 30 days after discharge.
Thirty percent of patients had one or more adverse drug events that were considered to be preventable or ameliorable. Another 30% of patients had at least one potential adverse drug event, she said. Adverse drug events occurred in 47% of patients on cardiovascular agents other than diuretics, 21% of patients on diuretics, and 5% of patients on opioids. Potential adverse drug events were seen in 43% of patients on cardiovascular agents other than diuretics, and in 12% of patients on diuretics (Ann. Intern. Med. 2012;157:1-10).
On a per-patient basis, 0.87 clinically important medication errors occurred in the intervention group, compared with 0.95 events per patient in the usual-care group, a difference that was not statistically significant, reported Dr. Theobald of Vanderbilt University and her associates.
These events included adverse drug events (0.43 per patient in the intervention group and 0.40 per patient in the control group) and potential adverse drug events (0.44 per patient in the intervention group and 0.55 in the control group), rates of which did not differ significantly between groups.
"If we can’t figure out a way to talk to our patients immediately after discharge, these problems will continue," one physician in the audience said during the discussion session after the presentation.
Dr. Theobald noted that the Vanderbilt University system still has pharmacists available to counsel patients before discharge, but only at the request of clinicians, not routinely.
At the start of the study, 41% in the intervention group and 42% in the control group were female, and 61% in both groups had acute coronary syndrome. Congestive heart failure was diagnosed in 32% of the intervention group and 31% of the control group, and both diagnoses were present in 7% of the intervention group and 8% of the control group. Before admission, patients in the intervention group were on a median of eight medications, and those in the control group were taking a median of seven medications.
Health literacy levels were considered marginal in 9% of each group, and inadequate in 12% of the intervention group and 9% of the control group. Twelve percent of patients in the intervention group and 11% of patients in the control group had cognitive impairment.
There were suggestions of benefit from the intervention, compared with usual care, in three prespecified subgroups, but these did not reach statistical significance. With the intervention, clinically important medication errors were 32% less likely in patients with inadequate health literacy, 38% less likely in cognitively impaired patients, and 17% less likely in patients treated at Vanderbilt.
Further work would be needed to determine if high-risk subgroups should be targeted for this kind of intervention, Dr. Theobald said.
In general, 13%-17% of patients develop clinically important medication errors after hospitalization, according to previous studies. An estimated 50%-75% of those errors are preventable or ameliorable, other data suggest. Some studies report that postdischarge medication errors may be more common in patients who are older, are on complex regimens of multiple medications, are cognitively impaired, or have low health literacy. Previous trials of interventions to reduce posthospitalization medication errors have produced mixed results.
The National Heart, Lung, and Blood Institute and the Department of Veterans Affairs funded the study. Dr. Theobald reported having no financial disclosures.
On Twitter @sherryboschert
According to the Institute of Medicine,
gaps in medication information collected at interfaces in care may represent
the most common source of preventable health care error. Studies have shown
that unintentional prescribing discrepancies are common and occur in 60%-90% of
hospital admissions (Arch. Intern. Med.
 |
| Dr. Blake Lesselroth |
While systematized processes intended to reconcile
medications have been shown to reduce discrepancies by up to 70% and
potentially reduce downstream adverse drug events, most US hospitals
have not yet fully implemented standardized reconciliation practices (BMJ Qual. Saf.
Hospitalists have a particularly critical role to play
in the development and diffusion of reconciliation practices for multiple
reasons (J. Hosp. Med. 2010;5:477-85).
First, patients on hospitalist services tend to be
medically complex and have the most to gain from a structured medication
review. Second, hospitalists are well positioned to recognize problems across a
breadth of specialty domains and marshal resources to triage and manage
potential medication errors. Third, hospitalists have assumed a central role in
the quality improvement movement and possess the skills to lead multi-modal
interventions designed to detect and manage high risk discrepancies. Despite
these disciplinary strengths and opportunities, an alarmingly high proportion
of hospitalists are unconvinced that their time is well spent on reconciliation
efforts or that interventions can improve outcomes (J.
Hosp. Med. 2011;6:329-3; J. Hosp. Med. 2008;3:465-72).
Multidisciplinary approaches that are patient centered,
leverage the unique skills of nurses, pharmacists, and physicians, and
capitalize upon information technologies are most likely to be successful.
Dr. Blake J.
Lesselroth, is a hospitalist-informatician at the Portland Veterans Affairs
Medical Center
in Oregon.
According to the Institute of Medicine,
gaps in medication information collected at interfaces in care may represent
the most common source of preventable health care error. Studies have shown
that unintentional prescribing discrepancies are common and occur in 60%-90% of
hospital admissions (Arch. Intern. Med.
|
| Dr. Blake Lesselroth |
While systematized processes intended to reconcile
medications have been shown to reduce discrepancies by up to 70% and
potentially reduce downstream adverse drug events, most US hospitals
have not yet fully implemented standardized reconciliation practices (BMJ Qual. Saf.
Hospitalists have a particularly critical role to play
in the development and diffusion of reconciliation practices for multiple
reasons (J. Hosp. Med. 2010;5:477-85).
First, patients on hospitalist services tend to be
medically complex and have the most to gain from a structured medication
review. Second, hospitalists are well positioned to recognize problems across a
breadth of specialty domains and marshal resources to triage and manage
potential medication errors. Third, hospitalists have assumed a central role in
the quality improvement movement and possess the skills to lead multi-modal
interventions designed to detect and manage high risk discrepancies. Despite
these disciplinary strengths and opportunities, an alarmingly high proportion
of hospitalists are unconvinced that their time is well spent on reconciliation
efforts or that interventions can improve outcomes (J.
Hosp. Med. 2011;6:329-3; J. Hosp. Med. 2008;3:465-72).
Multidisciplinary approaches that are patient centered,
leverage the unique skills of nurses, pharmacists, and physicians, and
capitalize upon information technologies are most likely to be successful.
Dr. Blake J.
Lesselroth, is a hospitalist-informatician at the Portland Veterans Affairs
Medical Center
in Oregon.
According to the Institute of Medicine,
gaps in medication information collected at interfaces in care may represent
the most common source of preventable health care error. Studies have shown
that unintentional prescribing discrepancies are common and occur in 60%-90% of
hospital admissions (Arch. Intern. Med.
|
| Dr. Blake Lesselroth |
While systematized processes intended to reconcile
medications have been shown to reduce discrepancies by up to 70% and
potentially reduce downstream adverse drug events, most US hospitals
have not yet fully implemented standardized reconciliation practices (BMJ Qual. Saf.
Hospitalists have a particularly critical role to play
in the development and diffusion of reconciliation practices for multiple
reasons (J. Hosp. Med. 2010;5:477-85).
First, patients on hospitalist services tend to be
medically complex and have the most to gain from a structured medication
review. Second, hospitalists are well positioned to recognize problems across a
breadth of specialty domains and marshal resources to triage and manage
potential medication errors. Third, hospitalists have assumed a central role in
the quality improvement movement and possess the skills to lead multi-modal
interventions designed to detect and manage high risk discrepancies. Despite
these disciplinary strengths and opportunities, an alarmingly high proportion
of hospitalists are unconvinced that their time is well spent on reconciliation
efforts or that interventions can improve outcomes (J.
Hosp. Med. 2011;6:329-3; J. Hosp. Med. 2008;3:465-72).
Multidisciplinary approaches that are patient centered,
leverage the unique skills of nurses, pharmacists, and physicians, and
capitalize upon information technologies are most likely to be successful.
Dr. Blake J.
Lesselroth, is a hospitalist-informatician at the Portland Veterans Affairs
Medical Center
in Oregon.
SAN FRANCISCO – Clinically important medication errors occurred in 51% of patients within 3 months of discharge from hospitalization for acute coronary syndrome and/or decompensated heart failure, a study of 851 patients showed.
In addition, the randomized controlled trial found no benefit from a predischarge pharmacist intervention and counseling incorporating tools designed for patients with low health literacy levels, compared with usual care in which the treating health care provider reconciled medications with the help of support software before patient discharge.
Although the trial focused on comparing the pharmacist intervention with usual care, "the biggest take-home message is that medication errors are very common" in these patients after hospitalization, Dr. Cecelia N. Theobald said at the annual meeting of the American College of Physicians.
Patients came from Vanderbilt University Medical Center in Nashville, Tenn., and from Brigham and Women’s Hospital in Boston. The study randomized 423 patients to the intervention and 428 to usual care.
In the intervention group, pharmacists reconciled medications and provided in-depth patient counseling before discharge, including a review of potential drug side effects. The pharmacists had specialized aids to help low-literacy patients adhere to their medication regimens, and they provided tailored follow-up to patients via postdischarge phone calls. In the usual-care group, the treating provider reconciled medications and pharmacist consultation was available on request. The usual-care group did not use the low-literacy aids or phone follow-up.
To assess outcomes, two clinicians reviewed patient records and patients were interviewed by phone 30 days after discharge.
Thirty percent of patients had one or more adverse drug events that were considered to be preventable or ameliorable. Another 30% of patients had at least one potential adverse drug event, she said. Adverse drug events occurred in 47% of patients on cardiovascular agents other than diuretics, 21% of patients on diuretics, and 5% of patients on opioids. Potential adverse drug events were seen in 43% of patients on cardiovascular agents other than diuretics, and in 12% of patients on diuretics (Ann. Intern. Med. 2012;157:1-10).
On a per-patient basis, 0.87 clinically important medication errors occurred in the intervention group, compared with 0.95 events per patient in the usual-care group, a difference that was not statistically significant, reported Dr. Theobald of Vanderbilt University and her associates.
These events included adverse drug events (0.43 per patient in the intervention group and 0.40 per patient in the control group) and potential adverse drug events (0.44 per patient in the intervention group and 0.55 in the control group), rates of which did not differ significantly between groups.
"If we can’t figure out a way to talk to our patients immediately after discharge, these problems will continue," one physician in the audience said during the discussion session after the presentation.
Dr. Theobald noted that the Vanderbilt University system still has pharmacists available to counsel patients before discharge, but only at the request of clinicians, not routinely.
At the start of the study, 41% in the intervention group and 42% in the control group were female, and 61% in both groups had acute coronary syndrome. Congestive heart failure was diagnosed in 32% of the intervention group and 31% of the control group, and both diagnoses were present in 7% of the intervention group and 8% of the control group. Before admission, patients in the intervention group were on a median of eight medications, and those in the control group were taking a median of seven medications.
Health literacy levels were considered marginal in 9% of each group, and inadequate in 12% of the intervention group and 9% of the control group. Twelve percent of patients in the intervention group and 11% of patients in the control group had cognitive impairment.
There were suggestions of benefit from the intervention, compared with usual care, in three prespecified subgroups, but these did not reach statistical significance. With the intervention, clinically important medication errors were 32% less likely in patients with inadequate health literacy, 38% less likely in cognitively impaired patients, and 17% less likely in patients treated at Vanderbilt.
Further work would be needed to determine if high-risk subgroups should be targeted for this kind of intervention, Dr. Theobald said.
In general, 13%-17% of patients develop clinically important medication errors after hospitalization, according to previous studies. An estimated 50%-75% of those errors are preventable or ameliorable, other data suggest. Some studies report that postdischarge medication errors may be more common in patients who are older, are on complex regimens of multiple medications, are cognitively impaired, or have low health literacy. Previous trials of interventions to reduce posthospitalization medication errors have produced mixed results.
The National Heart, Lung, and Blood Institute and the Department of Veterans Affairs funded the study. Dr. Theobald reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Clinically important medication errors occurred in 51% of patients within 3 months of discharge from hospitalization for acute coronary syndrome and/or decompensated heart failure, a study of 851 patients showed.
In addition, the randomized controlled trial found no benefit from a predischarge pharmacist intervention and counseling incorporating tools designed for patients with low health literacy levels, compared with usual care in which the treating health care provider reconciled medications with the help of support software before patient discharge.
Although the trial focused on comparing the pharmacist intervention with usual care, "the biggest take-home message is that medication errors are very common" in these patients after hospitalization, Dr. Cecelia N. Theobald said at the annual meeting of the American College of Physicians.
Patients came from Vanderbilt University Medical Center in Nashville, Tenn., and from Brigham and Women’s Hospital in Boston. The study randomized 423 patients to the intervention and 428 to usual care.
In the intervention group, pharmacists reconciled medications and provided in-depth patient counseling before discharge, including a review of potential drug side effects. The pharmacists had specialized aids to help low-literacy patients adhere to their medication regimens, and they provided tailored follow-up to patients via postdischarge phone calls. In the usual-care group, the treating provider reconciled medications and pharmacist consultation was available on request. The usual-care group did not use the low-literacy aids or phone follow-up.
To assess outcomes, two clinicians reviewed patient records and patients were interviewed by phone 30 days after discharge.
Thirty percent of patients had one or more adverse drug events that were considered to be preventable or ameliorable. Another 30% of patients had at least one potential adverse drug event, she said. Adverse drug events occurred in 47% of patients on cardiovascular agents other than diuretics, 21% of patients on diuretics, and 5% of patients on opioids. Potential adverse drug events were seen in 43% of patients on cardiovascular agents other than diuretics, and in 12% of patients on diuretics (Ann. Intern. Med. 2012;157:1-10).
On a per-patient basis, 0.87 clinically important medication errors occurred in the intervention group, compared with 0.95 events per patient in the usual-care group, a difference that was not statistically significant, reported Dr. Theobald of Vanderbilt University and her associates.
These events included adverse drug events (0.43 per patient in the intervention group and 0.40 per patient in the control group) and potential adverse drug events (0.44 per patient in the intervention group and 0.55 in the control group), rates of which did not differ significantly between groups.
"If we can’t figure out a way to talk to our patients immediately after discharge, these problems will continue," one physician in the audience said during the discussion session after the presentation.
Dr. Theobald noted that the Vanderbilt University system still has pharmacists available to counsel patients before discharge, but only at the request of clinicians, not routinely.
At the start of the study, 41% in the intervention group and 42% in the control group were female, and 61% in both groups had acute coronary syndrome. Congestive heart failure was diagnosed in 32% of the intervention group and 31% of the control group, and both diagnoses were present in 7% of the intervention group and 8% of the control group. Before admission, patients in the intervention group were on a median of eight medications, and those in the control group were taking a median of seven medications.
Health literacy levels were considered marginal in 9% of each group, and inadequate in 12% of the intervention group and 9% of the control group. Twelve percent of patients in the intervention group and 11% of patients in the control group had cognitive impairment.
There were suggestions of benefit from the intervention, compared with usual care, in three prespecified subgroups, but these did not reach statistical significance. With the intervention, clinically important medication errors were 32% less likely in patients with inadequate health literacy, 38% less likely in cognitively impaired patients, and 17% less likely in patients treated at Vanderbilt.
Further work would be needed to determine if high-risk subgroups should be targeted for this kind of intervention, Dr. Theobald said.
In general, 13%-17% of patients develop clinically important medication errors after hospitalization, according to previous studies. An estimated 50%-75% of those errors are preventable or ameliorable, other data suggest. Some studies report that postdischarge medication errors may be more common in patients who are older, are on complex regimens of multiple medications, are cognitively impaired, or have low health literacy. Previous trials of interventions to reduce posthospitalization medication errors have produced mixed results.
The National Heart, Lung, and Blood Institute and the Department of Veterans Affairs funded the study. Dr. Theobald reported having no financial disclosures.
On Twitter @sherryboschert
AT ACP INTERNAL MEDICINE 2013
Major finding: After discharge, 0.87 clinically important medication errors occurred per patient in the intervention group, compared with 0.95 events per patient in the usual-care group.
Data source: Randomized controlled trial of a health literacy–sensitive pharmacist intervention in 851 patients at two institutions.
Disclosures: The National Heart, Lung, and Blood Institute and the Veterans Administration funded the study. Dr. Theobald reported having no financial disclosures.
