Sherry Boschert

SAN FRANCISCO – Taking 800 IU/day of vitamin D₃ supplements for 1 year pushed serum levels into acceptable ranges in 98% of postmenopausal white women with vitamin D insufficiency, and 600 IU/day may work just as well, a study of 163 patients found.

The study was the first long-term, randomized, double-blind placebo-controlled comparison of multiple dosages of vitamin D supplements, Dr. Adarsh J. Sai and his associates reported at the annual meeting of the American College of Physicians. Many trials of vitamin D supplementation in osteoporotic women studied mainly single dosages.

Participants started out with serum levels of 25 hydroxyvitamin D, or 25-(OH)D, greater than 5 ng/mL but less than 20 ng/mL. The World Health Organization and Institute of Medicine consider normal levels to be above 20 ng/mL(or greater than 50 nmol/L), although the 2011 Endocrine Society guidelines define normal as above 30 ng/mL, he said.

The study randomized participants to daily supplementation with placebo or one of seven doses of vitamin D₃: 400, 800, 1,600, 2,400, 3,200, 4,000, or 4,800 IU/day. They also received calcium citrate supplements based on a 7-day food diary to increase daily calcium intake to 1,200-1,400 mg/day (Ann. Intern. Med. 2012;156:425-37).

Serum 25-(OH)D levels increased to above 20 ng/mL in 98% of women on the 800-IU dose, which is the current recommended dietary allowance of vitamin D to maintain normal serum levels in at least 98% of people, he said. A 600-IU dose, however, could achieve the same blood levels, a modeling analysis predicted, though that dose was not provided to women in the study, said Dr. Sai of Loma Linda (Calif.) University.

Prospective trials are needed to confirm whether 600 IU/day would be sufficient supplementation, he said.

After a year of supplementation, serum 25-(OH)D levels were higher in the 31 women with a normal body mass index (BMI), compared with the 65 overweight women or 76 obese women. The normal-weight women’s serum 25-(OH)D levels were 5 ng/mL higher than those of the overweight women and 7 ng/mL higher than those of the obese women.

Serum parathyroid hormone levels decreased with increasing doses of vitamin D. Hypercalcemia occurred in 9% of patients, and hypercalciuria developed in 33%. No patients developed kidney stones.

"The long-term safety of vitamin D combined with calcium needs to be considered," Dr. Sai said at the meeting. "As a reminder, in the Women’s Health Initiative study of approximately 40,000 women on vitamin D 400 IU plus calcium 2,000 mg, the kidney stones incidence increased by about 20%."

At the start of the study, patients had a mean age of 67 years and a mean body mass index of 30 kg/m². The mean serum 25-(OH)D level was 15 ng/mL. During the study, a mean of 94% of patients adhered to vitamin D supplementation, and 91% adhered to calcium supplementation.

The study excluded women with significant comorbidities, active kidney stone disease, or a body mass index greater than 45 kg/m², and women taking any medications that could interfere with bone or vitamin D metabolism.

The National Institute on Aging funded the study. Dr. Sai reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Taking 800 IU/day of vitamin D₃ supplements for 1 year pushed serum levels into acceptable ranges in 98% of postmenopausal white women with vitamin D insufficiency, and 600 IU/day may work just as well, a study of 163 patients found.

The study was the first long-term, randomized, double-blind placebo-controlled comparison of multiple dosages of vitamin D supplements, Dr. Adarsh J. Sai and his associates reported at the annual meeting of the American College of Physicians. Many trials of vitamin D supplementation in osteoporotic women studied mainly single dosages.

Participants started out with serum levels of 25 hydroxyvitamin D, or 25-(OH)D, greater than 5 ng/mL but less than 20 ng/mL. The World Health Organization and Institute of Medicine consider normal levels to be above 20 ng/mL(or greater than 50 nmol/L), although the 2011 Endocrine Society guidelines define normal as above 30 ng/mL, he said.

The study randomized participants to daily supplementation with placebo or one of seven doses of vitamin D₃: 400, 800, 1,600, 2,400, 3,200, 4,000, or 4,800 IU/day. They also received calcium citrate supplements based on a 7-day food diary to increase daily calcium intake to 1,200-1,400 mg/day (Ann. Intern. Med. 2012;156:425-37).

Serum 25-(OH)D levels increased to above 20 ng/mL in 98% of women on the 800-IU dose, which is the current recommended dietary allowance of vitamin D to maintain normal serum levels in at least 98% of people, he said. A 600-IU dose, however, could achieve the same blood levels, a modeling analysis predicted, though that dose was not provided to women in the study, said Dr. Sai of Loma Linda (Calif.) University.

Prospective trials are needed to confirm whether 600 IU/day would be sufficient supplementation, he said.

After a year of supplementation, serum 25-(OH)D levels were higher in the 31 women with a normal body mass index (BMI), compared with the 65 overweight women or 76 obese women. The normal-weight women’s serum 25-(OH)D levels were 5 ng/mL higher than those of the overweight women and 7 ng/mL higher than those of the obese women.

Serum parathyroid hormone levels decreased with increasing doses of vitamin D. Hypercalcemia occurred in 9% of patients, and hypercalciuria developed in 33%. No patients developed kidney stones.

"The long-term safety of vitamin D combined with calcium needs to be considered," Dr. Sai said at the meeting. "As a reminder, in the Women’s Health Initiative study of approximately 40,000 women on vitamin D 400 IU plus calcium 2,000 mg, the kidney stones incidence increased by about 20%."

At the start of the study, patients had a mean age of 67 years and a mean body mass index of 30 kg/m². The mean serum 25-(OH)D level was 15 ng/mL. During the study, a mean of 94% of patients adhered to vitamin D supplementation, and 91% adhered to calcium supplementation.

The study excluded women with significant comorbidities, active kidney stone disease, or a body mass index greater than 45 kg/m², and women taking any medications that could interfere with bone or vitamin D metabolism.

The National Institute on Aging funded the study. Dr. Sai reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Taking 800 IU/day of vitamin D₃ supplements for 1 year pushed serum levels into acceptable ranges in 98% of postmenopausal white women with vitamin D insufficiency, and 600 IU/day may work just as well, a study of 163 patients found.

The study was the first long-term, randomized, double-blind placebo-controlled comparison of multiple dosages of vitamin D supplements, Dr. Adarsh J. Sai and his associates reported at the annual meeting of the American College of Physicians. Many trials of vitamin D supplementation in osteoporotic women studied mainly single dosages.

Participants started out with serum levels of 25 hydroxyvitamin D, or 25-(OH)D, greater than 5 ng/mL but less than 20 ng/mL. The World Health Organization and Institute of Medicine consider normal levels to be above 20 ng/mL(or greater than 50 nmol/L), although the 2011 Endocrine Society guidelines define normal as above 30 ng/mL, he said.

The study randomized participants to daily supplementation with placebo or one of seven doses of vitamin D₃: 400, 800, 1,600, 2,400, 3,200, 4,000, or 4,800 IU/day. They also received calcium citrate supplements based on a 7-day food diary to increase daily calcium intake to 1,200-1,400 mg/day (Ann. Intern. Med. 2012;156:425-37).

Serum 25-(OH)D levels increased to above 20 ng/mL in 98% of women on the 800-IU dose, which is the current recommended dietary allowance of vitamin D to maintain normal serum levels in at least 98% of people, he said. A 600-IU dose, however, could achieve the same blood levels, a modeling analysis predicted, though that dose was not provided to women in the study, said Dr. Sai of Loma Linda (Calif.) University.

Prospective trials are needed to confirm whether 600 IU/day would be sufficient supplementation, he said.

After a year of supplementation, serum 25-(OH)D levels were higher in the 31 women with a normal body mass index (BMI), compared with the 65 overweight women or 76 obese women. The normal-weight women’s serum 25-(OH)D levels were 5 ng/mL higher than those of the overweight women and 7 ng/mL higher than those of the obese women.

Serum parathyroid hormone levels decreased with increasing doses of vitamin D. Hypercalcemia occurred in 9% of patients, and hypercalciuria developed in 33%. No patients developed kidney stones.

"The long-term safety of vitamin D combined with calcium needs to be considered," Dr. Sai said at the meeting. "As a reminder, in the Women’s Health Initiative study of approximately 40,000 women on vitamin D 400 IU plus calcium 2,000 mg, the kidney stones incidence increased by about 20%."

At the start of the study, patients had a mean age of 67 years and a mean body mass index of 30 kg/m². The mean serum 25-(OH)D level was 15 ng/mL. During the study, a mean of 94% of patients adhered to vitamin D supplementation, and 91% adhered to calcium supplementation.

The study excluded women with significant comorbidities, active kidney stone disease, or a body mass index greater than 45 kg/m², and women taking any medications that could interfere with bone or vitamin D metabolism.

The National Institute on Aging funded the study. Dr. Sai reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The use of "appreciative inquiry" elicited the ways in which families may engage in their adolescents’ weight-management efforts, findings from focus groups of 44 parents or guardians suggested.

The results will inform the design of interventions in a year-long pilot study in 25 obese youths and their families. That will be followed by a three-arm randomized study of weight-management interventions for 360 obese sixth-grade students from urban schools, Shirley M. Moore, Ph.D., said at the annual meeting of the Society of Behavioral Medicine.

She and her associates conducted 16 focus groups involving 44 parents or guardians of obese sixth-graders who were participating in a school-based, YMCA-sponsored exercise program in Cleveland, which perennially vies with Detroit for the title of the poorest U.S. city, said Dr. Moore, professor of nursing at Case Western Reserve University, Cleveland. Of the adults 84% were female, 64% were African American, and 15% were Hispanic; they ranged in age from 39 to 85 years (mean, 43 years). One-fifth of families had incomes of less than $15,000 per year.

Each adult received $50 to attend one of four 2-hour focus group sessions at the local YMCA. Staff running the focus groups were trained in the appreciative inquiry process. They conducted thematic qualitative analyses.

Unlike conventional approaches that tend to elicit from participants information on the barriers, problems, and concerns they face in helping their children manage weight and live healthy lives, the use of appreciative inquiry highlights individuals’ and families’ strengths. It’s an affirmation model versus a deficit model for creating change, Dr. Moore said.

"My experience is the energy that comes from it is so amazing in terms of moving people forward," she said.

Participants were asked, for example, to describe a time when they felt really good about the health of their child and his or her living habits. Focus group leaders then probed deeper. What was good about that experience? What made them feel proud about it? What was it about themselves that made this happen? What was it about others that made this happen? What environmental factors helped make this a positive experience?

Major recurring themes emerged from their answers: Having healthy children is a joy. Becoming healthy is a process. Engaging in healthy habits is a family affair. Acquiring good health can be achieved despite obstacles. Sustaining a child’s interest in maintaining good health habits is a challenge.

Participants indicated that they could promote healthy habits by being role models, through their relationships within the family, and through their communities. "That was one of the big, informing things for us, is how entangled they felt in their communities, and the interrelationship between family and community," Dr. Moore said.

The parents/guardians recognized their potentially great influence as positive role models for their children, which was a bit surprising, given that approximately 80% of the adults seemed to be obese, she added. The power to grow healthy children is a joy and a source of pride, the adults said. The parents/guardians described their personal role in maintaining healthy children as that of a healer, caregiver, village mother, activist, and ambassador. They liked the idea of incorporating health-promoting activities in their daily family routines, from preparing food together to rooting for their children’s sports teams.

Dr. Moore and her associates used the findings in designing the weight-management interventions for the upcoming studies. Reminders to parents to attend group meetings, for example, will employ positive messages thanking them for being role models. The intervention has built-in chances for children to succeed (such as a rock wall climbing session), and gaming strategies so that parents can root for their kids. Ways to engage with communities are built in, too – participants will have to do community projects and some neighborhood and block projects. The investigators hired a chef to come teach healthy ways for parents and kids to shop and cook together.

"Raising healthy children is a great sense of joy for parents, and we should use this energy when designing interventions," Dr. Moore said. Appreciative inquiry, if done properly, can employ the positive aspects in people’s lives to effect change, but it’s a process requiring some training, she added.

Dr. Moore reported having no relevant financial disclosures. The studies are being funded by the National Heart, Lung, and Blood Institute; the Institute of Child Health and Human Development; and the Office of Behavioral and Social Sciences Research.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The use of "appreciative inquiry" elicited the ways in which families may engage in their adolescents’ weight-management efforts, findings from focus groups of 44 parents or guardians suggested.

The results will inform the design of interventions in a year-long pilot study in 25 obese youths and their families. That will be followed by a three-arm randomized study of weight-management interventions for 360 obese sixth-grade students from urban schools, Shirley M. Moore, Ph.D., said at the annual meeting of the Society of Behavioral Medicine.

She and her associates conducted 16 focus groups involving 44 parents or guardians of obese sixth-graders who were participating in a school-based, YMCA-sponsored exercise program in Cleveland, which perennially vies with Detroit for the title of the poorest U.S. city, said Dr. Moore, professor of nursing at Case Western Reserve University, Cleveland. Of the adults 84% were female, 64% were African American, and 15% were Hispanic; they ranged in age from 39 to 85 years (mean, 43 years). One-fifth of families had incomes of less than $15,000 per year.

Each adult received $50 to attend one of four 2-hour focus group sessions at the local YMCA. Staff running the focus groups were trained in the appreciative inquiry process. They conducted thematic qualitative analyses.

Unlike conventional approaches that tend to elicit from participants information on the barriers, problems, and concerns they face in helping their children manage weight and live healthy lives, the use of appreciative inquiry highlights individuals’ and families’ strengths. It’s an affirmation model versus a deficit model for creating change, Dr. Moore said.

"My experience is the energy that comes from it is so amazing in terms of moving people forward," she said.

Participants were asked, for example, to describe a time when they felt really good about the health of their child and his or her living habits. Focus group leaders then probed deeper. What was good about that experience? What made them feel proud about it? What was it about themselves that made this happen? What was it about others that made this happen? What environmental factors helped make this a positive experience?

Major recurring themes emerged from their answers: Having healthy children is a joy. Becoming healthy is a process. Engaging in healthy habits is a family affair. Acquiring good health can be achieved despite obstacles. Sustaining a child’s interest in maintaining good health habits is a challenge.

Participants indicated that they could promote healthy habits by being role models, through their relationships within the family, and through their communities. "That was one of the big, informing things for us, is how entangled they felt in their communities, and the interrelationship between family and community," Dr. Moore said.

The parents/guardians recognized their potentially great influence as positive role models for their children, which was a bit surprising, given that approximately 80% of the adults seemed to be obese, she added. The power to grow healthy children is a joy and a source of pride, the adults said. The parents/guardians described their personal role in maintaining healthy children as that of a healer, caregiver, village mother, activist, and ambassador. They liked the idea of incorporating health-promoting activities in their daily family routines, from preparing food together to rooting for their children’s sports teams.

Dr. Moore and her associates used the findings in designing the weight-management interventions for the upcoming studies. Reminders to parents to attend group meetings, for example, will employ positive messages thanking them for being role models. The intervention has built-in chances for children to succeed (such as a rock wall climbing session), and gaming strategies so that parents can root for their kids. Ways to engage with communities are built in, too – participants will have to do community projects and some neighborhood and block projects. The investigators hired a chef to come teach healthy ways for parents and kids to shop and cook together.

"Raising healthy children is a great sense of joy for parents, and we should use this energy when designing interventions," Dr. Moore said. Appreciative inquiry, if done properly, can employ the positive aspects in people’s lives to effect change, but it’s a process requiring some training, she added.

Dr. Moore reported having no relevant financial disclosures. The studies are being funded by the National Heart, Lung, and Blood Institute; the Institute of Child Health and Human Development; and the Office of Behavioral and Social Sciences Research.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The use of "appreciative inquiry" elicited the ways in which families may engage in their adolescents’ weight-management efforts, findings from focus groups of 44 parents or guardians suggested.

The results will inform the design of interventions in a year-long pilot study in 25 obese youths and their families. That will be followed by a three-arm randomized study of weight-management interventions for 360 obese sixth-grade students from urban schools, Shirley M. Moore, Ph.D., said at the annual meeting of the Society of Behavioral Medicine.

She and her associates conducted 16 focus groups involving 44 parents or guardians of obese sixth-graders who were participating in a school-based, YMCA-sponsored exercise program in Cleveland, which perennially vies with Detroit for the title of the poorest U.S. city, said Dr. Moore, professor of nursing at Case Western Reserve University, Cleveland. Of the adults 84% were female, 64% were African American, and 15% were Hispanic; they ranged in age from 39 to 85 years (mean, 43 years). One-fifth of families had incomes of less than $15,000 per year.

Each adult received $50 to attend one of four 2-hour focus group sessions at the local YMCA. Staff running the focus groups were trained in the appreciative inquiry process. They conducted thematic qualitative analyses.

Unlike conventional approaches that tend to elicit from participants information on the barriers, problems, and concerns they face in helping their children manage weight and live healthy lives, the use of appreciative inquiry highlights individuals’ and families’ strengths. It’s an affirmation model versus a deficit model for creating change, Dr. Moore said.

"My experience is the energy that comes from it is so amazing in terms of moving people forward," she said.

Participants were asked, for example, to describe a time when they felt really good about the health of their child and his or her living habits. Focus group leaders then probed deeper. What was good about that experience? What made them feel proud about it? What was it about themselves that made this happen? What was it about others that made this happen? What environmental factors helped make this a positive experience?

Major recurring themes emerged from their answers: Having healthy children is a joy. Becoming healthy is a process. Engaging in healthy habits is a family affair. Acquiring good health can be achieved despite obstacles. Sustaining a child’s interest in maintaining good health habits is a challenge.

Participants indicated that they could promote healthy habits by being role models, through their relationships within the family, and through their communities. "That was one of the big, informing things for us, is how entangled they felt in their communities, and the interrelationship between family and community," Dr. Moore said.

The parents/guardians recognized their potentially great influence as positive role models for their children, which was a bit surprising, given that approximately 80% of the adults seemed to be obese, she added. The power to grow healthy children is a joy and a source of pride, the adults said. The parents/guardians described their personal role in maintaining healthy children as that of a healer, caregiver, village mother, activist, and ambassador. They liked the idea of incorporating health-promoting activities in their daily family routines, from preparing food together to rooting for their children’s sports teams.

Dr. Moore and her associates used the findings in designing the weight-management interventions for the upcoming studies. Reminders to parents to attend group meetings, for example, will employ positive messages thanking them for being role models. The intervention has built-in chances for children to succeed (such as a rock wall climbing session), and gaming strategies so that parents can root for their kids. Ways to engage with communities are built in, too – participants will have to do community projects and some neighborhood and block projects. The investigators hired a chef to come teach healthy ways for parents and kids to shop and cook together.

"Raising healthy children is a great sense of joy for parents, and we should use this energy when designing interventions," Dr. Moore said. Appreciative inquiry, if done properly, can employ the positive aspects in people’s lives to effect change, but it’s a process requiring some training, she added.

Dr. Moore reported having no relevant financial disclosures. The studies are being funded by the National Heart, Lung, and Blood Institute; the Institute of Child Health and Human Development; and the Office of Behavioral and Social Sciences Research.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Treating erectile dysfunction with sildenafil plus testosterone worked no better than sildenafil alone in a randomized, controlled trial of 140 men. Dr. Matthew Spitzer discusses the results of the study.

Treating erectile dysfunction with sildenafil plus testosterone worked no better than sildenafil alone in a randomized, controlled trial of 140 men. Dr. Matthew Spitzer discusses the results of the study.

Treating erectile dysfunction with sildenafil plus testosterone worked no better than sildenafil alone in a randomized, controlled trial of 140 men. Dr. Matthew Spitzer discusses the results of the study.

Patients whose localized prostate cancer contained a loss of the phosphatase and tensin homolog gene and amplification of the v-myc myelocytomatosis viral oncogene homolog gene were 53 times as likely to die from the disease, compared with similar patients without the genetic changes.

The increased risk was seen despite similarly staged tumors and similar levels of prostate-specific antigen (PSA) at the time of diagnosis in analyses of 458 patients in multiple cohorts, according to Wennuan Liu, Ph.D., and his associates.

If the findings are confirmed, they could help clinicians decide which patients would best benefit from aggressive treatment with prostatectomy or radiation and which might be fine with conservative management.

The investigators first assayed DNA samples from 125 patients who underwent prostatectomy for localized prostate cancer at Johns Hopkins Hospital, in Baltimore between 1988 and 2004. They found 20 significant regions of chromosomal copy number alterations in the cancer cells, including four copy number alterations and the target genes within those alterations that had not been identified before (Cancer 2013 April 22 [doi:10.1002/cncr.27954]).

Alterations in the chromosomal copy numbers of the phosphatase and tensin homolog (PTEN) and v-myc myelocytomatosis viral oncogene homolog (MYC) genes, when occurring together, were associated with a 53-fold increased risk of death from prostate cancer in a multivariate analysis. That prognostic information was independent of information gleaned from pathologic stage, Gleason score, and initial PSA level, reported Dr. Liu of Wake Forest University’s Center for Cancer Genomics and Center for Genomics and Personalized Medicine Research, in Winston-Salem, N.C.

Independently, loss of PTEN was associated with a sevenfold increased risk of death from prostate cancer, while gain in MYC was associated with an eightfold increased risk of disease-related death. The prognostic information from the chromosomal copy number alterations was most relevant for patients whose tumors had a pathologic Gleason score of 7 or less.

Many of the patients in the initial cohort had aggressive prostate cancer, with a Gleason score of 8 or greater in 34% of patients, a pathologic stage of T3b or higher in 33%, and a pretreatment PSA level higher than 10 ng/mL in 44% of patients. Twenty-two patients in this cohort died of prostate cancer (18%); the rest are alive or died of other causes.

The investigators confirmed the relationship between fatal prostate cancer and copy number alterations of PTEN and MYC in analyses of three subsequent cohorts.

Among 103 patients who underwent prostatectomy at the Karolinska University Hospital in Sweden, most had less-aggressive prostate cancer, with a pathologic Gleason score of 7 or lower in 85% of patients, a pathologic stage less than T3 in 82%, and a pretreatment PSA no greater than 10 ng/mL in 64%. Four of these patients died of prostate cancer (4%). They also analyzed publicly available clinicopathologic and survival information for 216 patients treated at Memorial Sloan-Kettering Cancer Center in New York, 4 of whom died of prostate cancer (2%).

When the Karolinska and Memorial Sloan-Kettering cohorts were combined, only 1 of 201 patients who lacked the chromosomal copy number alterations in PTEN and MYC died of prostate cancer (0.5%), compared with death from prostate cancer in 6% of the remaining patients, whose tumors did have one or both of the prognostic markers, Dr. Liu reported.

Analyses of tumor samples obtained at autopsy for 14 separate patients seen at Johns Hopkins who died of progressive prostate cancer found chromosomal copy number alterations in one of the genes in 100% of patients, and alterations in both genes in 57%. In comparison, 58% of the original cohort of 125 patients treated for localized disease at Johns Hopkins had alterations in one of the genes, and 10% had alterations in both.

The findings are supported by previous in-vitro and animal studies, the investigators noted, but more studies are needed because of the relatively small number of deaths in the Karolinska and Memorial Sloan-Kettering cohorts.

The study was limited by the possibility of mutations influencing tumor phenotype or the selection of specific copy number alterations. The median clinical follow-up of 5-7 years may not be predictive of long-term mortality risk.

Further research into the lethal tumor phenotype’s effect on tumor evolution may lead to the design of therapies to interrupt disease progression, Dr. Liu noted.

Prostate cancer is the most common cancer among men. Approximately 28,000 U.S. men die from the cancer each year. Prostatectomy improves 15-year mortality rates modestly, compared with conservative management – 15% vs. 21%, respectively – and 1 in 7 patients who undergo prostatectomy relapse and die of prostate cancer. These statistics have propelled efforts to identify better prognostic markers and therapies.

The study was funded by the National Institutes of Health and the U.S. Department of Defense. Dr. Liu and his associates made no disclosures regarding potential conflicts of interest.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Patients whose localized prostate cancer contained a loss of the phosphatase and tensin homolog gene and amplification of the v-myc myelocytomatosis viral oncogene homolog gene were 53 times as likely to die from the disease, compared with similar patients without the genetic changes.

The increased risk was seen despite similarly staged tumors and similar levels of prostate-specific antigen (PSA) at the time of diagnosis in analyses of 458 patients in multiple cohorts, according to Wennuan Liu, Ph.D., and his associates.

If the findings are confirmed, they could help clinicians decide which patients would best benefit from aggressive treatment with prostatectomy or radiation and which might be fine with conservative management.

The investigators first assayed DNA samples from 125 patients who underwent prostatectomy for localized prostate cancer at Johns Hopkins Hospital, in Baltimore between 1988 and 2004. They found 20 significant regions of chromosomal copy number alterations in the cancer cells, including four copy number alterations and the target genes within those alterations that had not been identified before (Cancer 2013 April 22 [doi:10.1002/cncr.27954]).

Alterations in the chromosomal copy numbers of the phosphatase and tensin homolog (PTEN) and v-myc myelocytomatosis viral oncogene homolog (MYC) genes, when occurring together, were associated with a 53-fold increased risk of death from prostate cancer in a multivariate analysis. That prognostic information was independent of information gleaned from pathologic stage, Gleason score, and initial PSA level, reported Dr. Liu of Wake Forest University’s Center for Cancer Genomics and Center for Genomics and Personalized Medicine Research, in Winston-Salem, N.C.

Independently, loss of PTEN was associated with a sevenfold increased risk of death from prostate cancer, while gain in MYC was associated with an eightfold increased risk of disease-related death. The prognostic information from the chromosomal copy number alterations was most relevant for patients whose tumors had a pathologic Gleason score of 7 or less.

Many of the patients in the initial cohort had aggressive prostate cancer, with a Gleason score of 8 or greater in 34% of patients, a pathologic stage of T3b or higher in 33%, and a pretreatment PSA level higher than 10 ng/mL in 44% of patients. Twenty-two patients in this cohort died of prostate cancer (18%); the rest are alive or died of other causes.

The investigators confirmed the relationship between fatal prostate cancer and copy number alterations of PTEN and MYC in analyses of three subsequent cohorts.

Among 103 patients who underwent prostatectomy at the Karolinska University Hospital in Sweden, most had less-aggressive prostate cancer, with a pathologic Gleason score of 7 or lower in 85% of patients, a pathologic stage less than T3 in 82%, and a pretreatment PSA no greater than 10 ng/mL in 64%. Four of these patients died of prostate cancer (4%). They also analyzed publicly available clinicopathologic and survival information for 216 patients treated at Memorial Sloan-Kettering Cancer Center in New York, 4 of whom died of prostate cancer (2%).

When the Karolinska and Memorial Sloan-Kettering cohorts were combined, only 1 of 201 patients who lacked the chromosomal copy number alterations in PTEN and MYC died of prostate cancer (0.5%), compared with death from prostate cancer in 6% of the remaining patients, whose tumors did have one or both of the prognostic markers, Dr. Liu reported.

Analyses of tumor samples obtained at autopsy for 14 separate patients seen at Johns Hopkins who died of progressive prostate cancer found chromosomal copy number alterations in one of the genes in 100% of patients, and alterations in both genes in 57%. In comparison, 58% of the original cohort of 125 patients treated for localized disease at Johns Hopkins had alterations in one of the genes, and 10% had alterations in both.

The findings are supported by previous in-vitro and animal studies, the investigators noted, but more studies are needed because of the relatively small number of deaths in the Karolinska and Memorial Sloan-Kettering cohorts.

The study was limited by the possibility of mutations influencing tumor phenotype or the selection of specific copy number alterations. The median clinical follow-up of 5-7 years may not be predictive of long-term mortality risk.

Further research into the lethal tumor phenotype’s effect on tumor evolution may lead to the design of therapies to interrupt disease progression, Dr. Liu noted.

Prostate cancer is the most common cancer among men. Approximately 28,000 U.S. men die from the cancer each year. Prostatectomy improves 15-year mortality rates modestly, compared with conservative management – 15% vs. 21%, respectively – and 1 in 7 patients who undergo prostatectomy relapse and die of prostate cancer. These statistics have propelled efforts to identify better prognostic markers and therapies.

The study was funded by the National Institutes of Health and the U.S. Department of Defense. Dr. Liu and his associates made no disclosures regarding potential conflicts of interest.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Patients whose localized prostate cancer contained a loss of the phosphatase and tensin homolog gene and amplification of the v-myc myelocytomatosis viral oncogene homolog gene were 53 times as likely to die from the disease, compared with similar patients without the genetic changes.

The increased risk was seen despite similarly staged tumors and similar levels of prostate-specific antigen (PSA) at the time of diagnosis in analyses of 458 patients in multiple cohorts, according to Wennuan Liu, Ph.D., and his associates.

If the findings are confirmed, they could help clinicians decide which patients would best benefit from aggressive treatment with prostatectomy or radiation and which might be fine with conservative management.

The investigators first assayed DNA samples from 125 patients who underwent prostatectomy for localized prostate cancer at Johns Hopkins Hospital, in Baltimore between 1988 and 2004. They found 20 significant regions of chromosomal copy number alterations in the cancer cells, including four copy number alterations and the target genes within those alterations that had not been identified before (Cancer 2013 April 22 [doi:10.1002/cncr.27954]).

Alterations in the chromosomal copy numbers of the phosphatase and tensin homolog (PTEN) and v-myc myelocytomatosis viral oncogene homolog (MYC) genes, when occurring together, were associated with a 53-fold increased risk of death from prostate cancer in a multivariate analysis. That prognostic information was independent of information gleaned from pathologic stage, Gleason score, and initial PSA level, reported Dr. Liu of Wake Forest University’s Center for Cancer Genomics and Center for Genomics and Personalized Medicine Research, in Winston-Salem, N.C.

Independently, loss of PTEN was associated with a sevenfold increased risk of death from prostate cancer, while gain in MYC was associated with an eightfold increased risk of disease-related death. The prognostic information from the chromosomal copy number alterations was most relevant for patients whose tumors had a pathologic Gleason score of 7 or less.

Many of the patients in the initial cohort had aggressive prostate cancer, with a Gleason score of 8 or greater in 34% of patients, a pathologic stage of T3b or higher in 33%, and a pretreatment PSA level higher than 10 ng/mL in 44% of patients. Twenty-two patients in this cohort died of prostate cancer (18%); the rest are alive or died of other causes.

The investigators confirmed the relationship between fatal prostate cancer and copy number alterations of PTEN and MYC in analyses of three subsequent cohorts.

Among 103 patients who underwent prostatectomy at the Karolinska University Hospital in Sweden, most had less-aggressive prostate cancer, with a pathologic Gleason score of 7 or lower in 85% of patients, a pathologic stage less than T3 in 82%, and a pretreatment PSA no greater than 10 ng/mL in 64%. Four of these patients died of prostate cancer (4%). They also analyzed publicly available clinicopathologic and survival information for 216 patients treated at Memorial Sloan-Kettering Cancer Center in New York, 4 of whom died of prostate cancer (2%).

When the Karolinska and Memorial Sloan-Kettering cohorts were combined, only 1 of 201 patients who lacked the chromosomal copy number alterations in PTEN and MYC died of prostate cancer (0.5%), compared with death from prostate cancer in 6% of the remaining patients, whose tumors did have one or both of the prognostic markers, Dr. Liu reported.

Analyses of tumor samples obtained at autopsy for 14 separate patients seen at Johns Hopkins who died of progressive prostate cancer found chromosomal copy number alterations in one of the genes in 100% of patients, and alterations in both genes in 57%. In comparison, 58% of the original cohort of 125 patients treated for localized disease at Johns Hopkins had alterations in one of the genes, and 10% had alterations in both.

The findings are supported by previous in-vitro and animal studies, the investigators noted, but more studies are needed because of the relatively small number of deaths in the Karolinska and Memorial Sloan-Kettering cohorts.

The study was limited by the possibility of mutations influencing tumor phenotype or the selection of specific copy number alterations. The median clinical follow-up of 5-7 years may not be predictive of long-term mortality risk.

Further research into the lethal tumor phenotype’s effect on tumor evolution may lead to the design of therapies to interrupt disease progression, Dr. Liu noted.

Prostate cancer is the most common cancer among men. Approximately 28,000 U.S. men die from the cancer each year. Prostatectomy improves 15-year mortality rates modestly, compared with conservative management – 15% vs. 21%, respectively – and 1 in 7 patients who undergo prostatectomy relapse and die of prostate cancer. These statistics have propelled efforts to identify better prognostic markers and therapies.

The study was funded by the National Institutes of Health and the U.S. Department of Defense. Dr. Liu and his associates made no disclosures regarding potential conflicts of interest.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Vanity works better than fear in getting adolescents to use sunscreen, a small randomized study of 50 patients suggests.

Patients watched one of two educational videos promoting sunscreen use among adolescents. One video emphasized the premature photoaging effects of UV light on skin appearance. The other video focused on the relationship between UV light and skin cancer risk.

© Yuri Arcurs/Fotolia.com

Six weeks later, sunscreen use had increased significantly in the appearance-video group, from a mean of 0.6 days/week before watching the video to 2.8 times/week at follow-up. Sunscreen use in the health-video group increased by a statistically insignificant amount, from 0.7 days/week at baseline to 0.9 days/week 6 weeks later, William Tuong and Dr. April W. Armstrong reported in a poster presentation at the annual meeting of the Society of Behavioral Medicine.

The difference between groups was significant. The appearance-video groups added 2.2 days/week of sunscreen use while the health-video group added just 0.3 days/week, reported Mr. Tuong, a medical student at the University of California, Davis, and Dr. Armstrong, director of the clinical research unit and the teledermatology program in the university’s department of dermatology.

Skin cancer prevention studies usually employ health-based messaging, but perhaps that should change, they suggested.

The two groups were similar at baseline, with a mean age of 17 years, and females accounting for 19 of 25 (76%) patients in the appearance-video group and 21 of 25 (84%) patients in the health-video group. Hispanics were the largest ethnic group (10 and 13 patients, respectively), followed by "others" (6 and 7 patients, respectively), blacks (6 and 4 patients), and whites (3 and 1 patients in the two groups). Seventeen patients in the appearance-video group and 18 in the health-video group had Fitzpatrick Skin Types IV-VI, and the rest had Skin Types I-III.

The appearance video delivered messages such as, "Skin damage can show up as wrinkles, dark spots, uneven skin tone, sagging skin, and rough leathery skin." Patients learned that UVA light from the sun causes the skin damage that makes skin look older and "less attractive." The video asked, "You don’t want to look like your grandparents, right?" and warned, "When you go out in the sun without sunscreen, you’re causing your skin to age faster, which might make you look older than you really are."

The health video asked, "Did you know that having one bad sunburn in your life increases your chances of getting melanoma?" It explained that melanoma, the deadliest of skin cancers, can happen to anyone and is one of the most common cancers in young adults "like you." Even though it’s less common in blacks, it can happen and usually is deadly because it’s usually found too late, the video said. As melanoma "gets worse, it can spread to other organs in your body, like your liver, lungs, and brain. When it’s found too late, melanoma can kill you," the video added.

The study used standard questions on sun protective behaviors from the National Health and Nutrition Examination Survey to assess sunscreen use.

The investigators reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Vanity works better than fear in getting adolescents to use sunscreen, a small randomized study of 50 patients suggests.

Patients watched one of two educational videos promoting sunscreen use among adolescents. One video emphasized the premature photoaging effects of UV light on skin appearance. The other video focused on the relationship between UV light and skin cancer risk.

© Yuri Arcurs/Fotolia.com

Six weeks later, sunscreen use had increased significantly in the appearance-video group, from a mean of 0.6 days/week before watching the video to 2.8 times/week at follow-up. Sunscreen use in the health-video group increased by a statistically insignificant amount, from 0.7 days/week at baseline to 0.9 days/week 6 weeks later, William Tuong and Dr. April W. Armstrong reported in a poster presentation at the annual meeting of the Society of Behavioral Medicine.

The difference between groups was significant. The appearance-video groups added 2.2 days/week of sunscreen use while the health-video group added just 0.3 days/week, reported Mr. Tuong, a medical student at the University of California, Davis, and Dr. Armstrong, director of the clinical research unit and the teledermatology program in the university’s department of dermatology.

Skin cancer prevention studies usually employ health-based messaging, but perhaps that should change, they suggested.

The two groups were similar at baseline, with a mean age of 17 years, and females accounting for 19 of 25 (76%) patients in the appearance-video group and 21 of 25 (84%) patients in the health-video group. Hispanics were the largest ethnic group (10 and 13 patients, respectively), followed by "others" (6 and 7 patients, respectively), blacks (6 and 4 patients), and whites (3 and 1 patients in the two groups). Seventeen patients in the appearance-video group and 18 in the health-video group had Fitzpatrick Skin Types IV-VI, and the rest had Skin Types I-III.

The appearance video delivered messages such as, "Skin damage can show up as wrinkles, dark spots, uneven skin tone, sagging skin, and rough leathery skin." Patients learned that UVA light from the sun causes the skin damage that makes skin look older and "less attractive." The video asked, "You don’t want to look like your grandparents, right?" and warned, "When you go out in the sun without sunscreen, you’re causing your skin to age faster, which might make you look older than you really are."

The health video asked, "Did you know that having one bad sunburn in your life increases your chances of getting melanoma?" It explained that melanoma, the deadliest of skin cancers, can happen to anyone and is one of the most common cancers in young adults "like you." Even though it’s less common in blacks, it can happen and usually is deadly because it’s usually found too late, the video said. As melanoma "gets worse, it can spread to other organs in your body, like your liver, lungs, and brain. When it’s found too late, melanoma can kill you," the video added.

The study used standard questions on sun protective behaviors from the National Health and Nutrition Examination Survey to assess sunscreen use.

The investigators reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Vanity works better than fear in getting adolescents to use sunscreen, a small randomized study of 50 patients suggests.

Patients watched one of two educational videos promoting sunscreen use among adolescents. One video emphasized the premature photoaging effects of UV light on skin appearance. The other video focused on the relationship between UV light and skin cancer risk.

© Yuri Arcurs/Fotolia.com

Six weeks later, sunscreen use had increased significantly in the appearance-video group, from a mean of 0.6 days/week before watching the video to 2.8 times/week at follow-up. Sunscreen use in the health-video group increased by a statistically insignificant amount, from 0.7 days/week at baseline to 0.9 days/week 6 weeks later, William Tuong and Dr. April W. Armstrong reported in a poster presentation at the annual meeting of the Society of Behavioral Medicine.

The difference between groups was significant. The appearance-video groups added 2.2 days/week of sunscreen use while the health-video group added just 0.3 days/week, reported Mr. Tuong, a medical student at the University of California, Davis, and Dr. Armstrong, director of the clinical research unit and the teledermatology program in the university’s department of dermatology.

Skin cancer prevention studies usually employ health-based messaging, but perhaps that should change, they suggested.

The two groups were similar at baseline, with a mean age of 17 years, and females accounting for 19 of 25 (76%) patients in the appearance-video group and 21 of 25 (84%) patients in the health-video group. Hispanics were the largest ethnic group (10 and 13 patients, respectively), followed by "others" (6 and 7 patients, respectively), blacks (6 and 4 patients), and whites (3 and 1 patients in the two groups). Seventeen patients in the appearance-video group and 18 in the health-video group had Fitzpatrick Skin Types IV-VI, and the rest had Skin Types I-III.

The appearance video delivered messages such as, "Skin damage can show up as wrinkles, dark spots, uneven skin tone, sagging skin, and rough leathery skin." Patients learned that UVA light from the sun causes the skin damage that makes skin look older and "less attractive." The video asked, "You don’t want to look like your grandparents, right?" and warned, "When you go out in the sun without sunscreen, you’re causing your skin to age faster, which might make you look older than you really are."

The health video asked, "Did you know that having one bad sunburn in your life increases your chances of getting melanoma?" It explained that melanoma, the deadliest of skin cancers, can happen to anyone and is one of the most common cancers in young adults "like you." Even though it’s less common in blacks, it can happen and usually is deadly because it’s usually found too late, the video said. As melanoma "gets worse, it can spread to other organs in your body, like your liver, lungs, and brain. When it’s found too late, melanoma can kill you," the video added.

The study used standard questions on sun protective behaviors from the National Health and Nutrition Examination Survey to assess sunscreen use.

The investigators reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

SAN FRANCISCO– A 24-week program combining weight-loss efforts with continuous positive airway pressure produced significantly greater reductions in systolic blood pressure in obese patients with obstructive sleep apnea, compared with either intervention alone, a study of 181 adults found.

In an intent-to-treat analysis, all three groups reduced systolic pressures to a statistically similar extent, compared with baseline – decreases of approximately 8 mm Hg in the combination group and 4 mm Hg with either monotherapy. Among 136 patients who adhered to therapy by completing the trial, however, systolic blood pressure decreased by a mean of 14 mm Hg in the 62 patients randomized to the combination of weight-loss efforts and continuous positive airway pressure (CPAP), a significantly greater decrease than the reductions of approximately 7 mm Hg in 61 patients randomized to weight-loss efforts alone and 3 mm Hg in 58 patients who got CPAP alone.

A 14 mm Hg–drop in systolic blood pressure is an "important reduction" with potentially significant clinical benefits in obese patients with obstructive sleep apnea, Dr. Julio A. Chirinos said at the annual meeting of the American College of Cardiology.

Previous observational studies have shown strong associations in obesity, obstructive sleep apnea, and hypertension but have not been able to assess whether there is any incremental blood pressure benefit to combining treatments for obesity and sleep apnea.

Dr. Chirinos and his associates conducted an ancillary analysis of data from the Cardiovascular Consequences of Obstructive Sleep Apnea trial, which focused primarily on the treatments’ effects on C-reactive protein levels. The study randomized adults with at least moderate obesity and moderate to severe obstructive sleep apnea and C-reactive protein levels greater than 1 mg/L to the three intervention groups. Baseline characteristics were similar among groups. Approximately 41% of patients were hypertensive at baseline.

In the per-protocol analysis of patients who adhered to therapy, the decreases in systolic blood pressure, compared with baseline, were statistically significant in the combination and weight-loss groups but not the CPAP group, reported Dr. Chirinos of the University of Pennsylvania, Philadelphia.

Body weight and body mass index decreased significantly in the weight-loss and combination groups compared with baseline but did not change significantly in the CPAP group. Patients in the weight-loss and combination groups dropped approximately 7 kg in the intent-to-treat analysis and 10-11 kg in the per-protocol analysis. Body mass index decreased by a mean of two to three points in the intent-to-treat analysis and by approximately four points among those who adhered to therapy. No details were provided about the specifics of the weight-loss efforts.

Mean arterial pressure decreased significantly in all three groups, compared with baseline, in both intent-to-treat and per-protocol analyses, but fell significantly more in the combination group, compared with monotherapy, in the per-protocol analysis. Among patients adherent to treatment, mean arterial pressure decreased by more than 10 mm Hg in the combination group, compared with approximately 4 mm Hg–declines with either monotherapy.

Only combination therapy significantly reduced brachial pulse pressure, compared with baseline (by approximately 3 mm Hg), in the intent-to-treat analysis. In the per-protocol analysis, brachial pulse pressure dropped significantly, compared with baseline, in the combination group (a 6 mm Hg decrease) and the weight-loss group (a 4 mm Hg–decrease) but not in the CPAP group.

Brachial pulse pressure decreased significantly with combination therapy in the intent-to-treat analysis but not with either treatment alone. Mean brachial pulse pressure in the per-protocol analysis decreased significantly with combination therapy (a 6 mm Hg–reduction) or weight-loss therapy (a 4 mm Hg–decrease) but increased in the CPAP group.

Carotid-radial pulse pressure amplification measurements did not change significantly from baseline in any group, suggesting that the study’s results were not brought about by missing some changes in central pressure that were not being picked up by brachial measurements, Dr. Chirinos said.

In general, approximately 50% of people with obstructive sleep apnea have hypertension, and around 30% of hypertensive patients have obstructive sleep apnea, he said.

The findings are limited by the study’s strict criteria for patient inclusion or exclusion, its lack of arterial blood pressure monitoring, the use of noninvasive estimates of central pressure measurements, and its duration of only 6 months. The study used carotid tonometry to measure central pulse pressure.

The study excluded patients with blood pressures greater than 160/95 mm Hg, those with predominantly central sleep apnea, patients using supplemental oxygen, and anyone in a high-risk occupation or with a record of dangerous driving. Also excluded were patients with confounders of systemic inflammation, sustained arrhythmia, unstable cardiopulmonary disease, severe restless leg syndrome or chronic pain causing frequent night awakenings, pregnancy, severe depression or other serious medical or psychological conditions that might compromise their safety in the study, and prior CPAP within 8 weeks of the study.

The American Heart Association funded Dr. Chirinos’s analysis. Dr. Chirinos reported having no financial disclosures. Some of his associates reported financial relationships with multiple pharmaceutical companies.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

SAN FRANCISCO– A 24-week program combining weight-loss efforts with continuous positive airway pressure produced significantly greater reductions in systolic blood pressure in obese patients with obstructive sleep apnea, compared with either intervention alone, a study of 181 adults found.

In an intent-to-treat analysis, all three groups reduced systolic pressures to a statistically similar extent, compared with baseline – decreases of approximately 8 mm Hg in the combination group and 4 mm Hg with either monotherapy. Among 136 patients who adhered to therapy by completing the trial, however, systolic blood pressure decreased by a mean of 14 mm Hg in the 62 patients randomized to the combination of weight-loss efforts and continuous positive airway pressure (CPAP), a significantly greater decrease than the reductions of approximately 7 mm Hg in 61 patients randomized to weight-loss efforts alone and 3 mm Hg in 58 patients who got CPAP alone.

A 14 mm Hg–drop in systolic blood pressure is an "important reduction" with potentially significant clinical benefits in obese patients with obstructive sleep apnea, Dr. Julio A. Chirinos said at the annual meeting of the American College of Cardiology.

Previous observational studies have shown strong associations in obesity, obstructive sleep apnea, and hypertension but have not been able to assess whether there is any incremental blood pressure benefit to combining treatments for obesity and sleep apnea.

Dr. Chirinos and his associates conducted an ancillary analysis of data from the Cardiovascular Consequences of Obstructive Sleep Apnea trial, which focused primarily on the treatments’ effects on C-reactive protein levels. The study randomized adults with at least moderate obesity and moderate to severe obstructive sleep apnea and C-reactive protein levels greater than 1 mg/L to the three intervention groups. Baseline characteristics were similar among groups. Approximately 41% of patients were hypertensive at baseline.

In the per-protocol analysis of patients who adhered to therapy, the decreases in systolic blood pressure, compared with baseline, were statistically significant in the combination and weight-loss groups but not the CPAP group, reported Dr. Chirinos of the University of Pennsylvania, Philadelphia.

Body weight and body mass index decreased significantly in the weight-loss and combination groups compared with baseline but did not change significantly in the CPAP group. Patients in the weight-loss and combination groups dropped approximately 7 kg in the intent-to-treat analysis and 10-11 kg in the per-protocol analysis. Body mass index decreased by a mean of two to three points in the intent-to-treat analysis and by approximately four points among those who adhered to therapy. No details were provided about the specifics of the weight-loss efforts.

Mean arterial pressure decreased significantly in all three groups, compared with baseline, in both intent-to-treat and per-protocol analyses, but fell significantly more in the combination group, compared with monotherapy, in the per-protocol analysis. Among patients adherent to treatment, mean arterial pressure decreased by more than 10 mm Hg in the combination group, compared with approximately 4 mm Hg–declines with either monotherapy.

Only combination therapy significantly reduced brachial pulse pressure, compared with baseline (by approximately 3 mm Hg), in the intent-to-treat analysis. In the per-protocol analysis, brachial pulse pressure dropped significantly, compared with baseline, in the combination group (a 6 mm Hg decrease) and the weight-loss group (a 4 mm Hg–decrease) but not in the CPAP group.

Brachial pulse pressure decreased significantly with combination therapy in the intent-to-treat analysis but not with either treatment alone. Mean brachial pulse pressure in the per-protocol analysis decreased significantly with combination therapy (a 6 mm Hg–reduction) or weight-loss therapy (a 4 mm Hg–decrease) but increased in the CPAP group.

Carotid-radial pulse pressure amplification measurements did not change significantly from baseline in any group, suggesting that the study’s results were not brought about by missing some changes in central pressure that were not being picked up by brachial measurements, Dr. Chirinos said.

In general, approximately 50% of people with obstructive sleep apnea have hypertension, and around 30% of hypertensive patients have obstructive sleep apnea, he said.

The findings are limited by the study’s strict criteria for patient inclusion or exclusion, its lack of arterial blood pressure monitoring, the use of noninvasive estimates of central pressure measurements, and its duration of only 6 months. The study used carotid tonometry to measure central pulse pressure.

The study excluded patients with blood pressures greater than 160/95 mm Hg, those with predominantly central sleep apnea, patients using supplemental oxygen, and anyone in a high-risk occupation or with a record of dangerous driving. Also excluded were patients with confounders of systemic inflammation, sustained arrhythmia, unstable cardiopulmonary disease, severe restless leg syndrome or chronic pain causing frequent night awakenings, pregnancy, severe depression or other serious medical or psychological conditions that might compromise their safety in the study, and prior CPAP within 8 weeks of the study.

The American Heart Association funded Dr. Chirinos’s analysis. Dr. Chirinos reported having no financial disclosures. Some of his associates reported financial relationships with multiple pharmaceutical companies.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

SAN FRANCISCO– A 24-week program combining weight-loss efforts with continuous positive airway pressure produced significantly greater reductions in systolic blood pressure in obese patients with obstructive sleep apnea, compared with either intervention alone, a study of 181 adults found.

In an intent-to-treat analysis, all three groups reduced systolic pressures to a statistically similar extent, compared with baseline – decreases of approximately 8 mm Hg in the combination group and 4 mm Hg with either monotherapy. Among 136 patients who adhered to therapy by completing the trial, however, systolic blood pressure decreased by a mean of 14 mm Hg in the 62 patients randomized to the combination of weight-loss efforts and continuous positive airway pressure (CPAP), a significantly greater decrease than the reductions of approximately 7 mm Hg in 61 patients randomized to weight-loss efforts alone and 3 mm Hg in 58 patients who got CPAP alone.

A 14 mm Hg–drop in systolic blood pressure is an "important reduction" with potentially significant clinical benefits in obese patients with obstructive sleep apnea, Dr. Julio A. Chirinos said at the annual meeting of the American College of Cardiology.

Previous observational studies have shown strong associations in obesity, obstructive sleep apnea, and hypertension but have not been able to assess whether there is any incremental blood pressure benefit to combining treatments for obesity and sleep apnea.

Dr. Chirinos and his associates conducted an ancillary analysis of data from the Cardiovascular Consequences of Obstructive Sleep Apnea trial, which focused primarily on the treatments’ effects on C-reactive protein levels. The study randomized adults with at least moderate obesity and moderate to severe obstructive sleep apnea and C-reactive protein levels greater than 1 mg/L to the three intervention groups. Baseline characteristics were similar among groups. Approximately 41% of patients were hypertensive at baseline.

In the per-protocol analysis of patients who adhered to therapy, the decreases in systolic blood pressure, compared with baseline, were statistically significant in the combination and weight-loss groups but not the CPAP group, reported Dr. Chirinos of the University of Pennsylvania, Philadelphia.

Body weight and body mass index decreased significantly in the weight-loss and combination groups compared with baseline but did not change significantly in the CPAP group. Patients in the weight-loss and combination groups dropped approximately 7 kg in the intent-to-treat analysis and 10-11 kg in the per-protocol analysis. Body mass index decreased by a mean of two to three points in the intent-to-treat analysis and by approximately four points among those who adhered to therapy. No details were provided about the specifics of the weight-loss efforts.

Mean arterial pressure decreased significantly in all three groups, compared with baseline, in both intent-to-treat and per-protocol analyses, but fell significantly more in the combination group, compared with monotherapy, in the per-protocol analysis. Among patients adherent to treatment, mean arterial pressure decreased by more than 10 mm Hg in the combination group, compared with approximately 4 mm Hg–declines with either monotherapy.

Only combination therapy significantly reduced brachial pulse pressure, compared with baseline (by approximately 3 mm Hg), in the intent-to-treat analysis. In the per-protocol analysis, brachial pulse pressure dropped significantly, compared with baseline, in the combination group (a 6 mm Hg decrease) and the weight-loss group (a 4 mm Hg–decrease) but not in the CPAP group.

Brachial pulse pressure decreased significantly with combination therapy in the intent-to-treat analysis but not with either treatment alone. Mean brachial pulse pressure in the per-protocol analysis decreased significantly with combination therapy (a 6 mm Hg–reduction) or weight-loss therapy (a 4 mm Hg–decrease) but increased in the CPAP group.

Carotid-radial pulse pressure amplification measurements did not change significantly from baseline in any group, suggesting that the study’s results were not brought about by missing some changes in central pressure that were not being picked up by brachial measurements, Dr. Chirinos said.

In general, approximately 50% of people with obstructive sleep apnea have hypertension, and around 30% of hypertensive patients have obstructive sleep apnea, he said.

The findings are limited by the study’s strict criteria for patient inclusion or exclusion, its lack of arterial blood pressure monitoring, the use of noninvasive estimates of central pressure measurements, and its duration of only 6 months. The study used carotid tonometry to measure central pulse pressure.

The study excluded patients with blood pressures greater than 160/95 mm Hg, those with predominantly central sleep apnea, patients using supplemental oxygen, and anyone in a high-risk occupation or with a record of dangerous driving. Also excluded were patients with confounders of systemic inflammation, sustained arrhythmia, unstable cardiopulmonary disease, severe restless leg syndrome or chronic pain causing frequent night awakenings, pregnancy, severe depression or other serious medical or psychological conditions that might compromise their safety in the study, and prior CPAP within 8 weeks of the study.

The American Heart Association funded Dr. Chirinos’s analysis. Dr. Chirinos reported having no financial disclosures. Some of his associates reported financial relationships with multiple pharmaceutical companies.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO– A 24-week program combining weight-loss efforts with continuous positive airway pressure produced significantly greater reductions in systolic blood pressure in obese patients with obstructive sleep apnea, compared with either intervention alone, a study of 181 adults found.

In an intent-to-treat analysis, all three groups reduced systolic pressures to a statistically similar extent, compared with baseline – decreases of approximately 8 mm Hg in the combination group and 4 mm Hg with either monotherapy. Among 136 patients who adhered to therapy by completing the trial, however, systolic blood pressure decreased by a mean of 14 mm Hg in the 62 patients randomized to the combination of weight-loss efforts and continuous positive airway pressure (CPAP), a significantly greater decrease than the reductions of approximately 7 mm Hg in 61 patients randomized to weight-loss efforts alone and 3 mm Hg in 58 patients who got CPAP alone.

A 14 mm Hg–drop in systolic blood pressure is an "important reduction" with potentially significant clinical benefits in obese patients with obstructive sleep apnea, Dr. Julio A. Chirinos said at the annual meeting of the American College of Cardiology.

Previous observational studies have shown strong associations in obesity, obstructive sleep apnea, and hypertension but have not been able to assess whether there is any incremental blood pressure benefit to combining treatments for obesity and sleep apnea.

Dr. Chirinos and his associates conducted an ancillary analysis of data from the Cardiovascular Consequences of Obstructive Sleep Apnea trial, which focused primarily on the treatments’ effects on C-reactive protein levels. The study randomized adults with at least moderate obesity and moderate to severe obstructive sleep apnea and C-reactive protein levels greater than 1 mg/L to the three intervention groups. Baseline characteristics were similar among groups. Approximately 41% of patients were hypertensive at baseline.

In the per-protocol analysis of patients who adhered to therapy, the decreases in systolic blood pressure, compared with baseline, were statistically significant in the combination and weight-loss groups but not the CPAP group, reported Dr. Chirinos of the University of Pennsylvania, Philadelphia.

Body weight and body mass index decreased significantly in the weight-loss and combination groups compared with baseline but did not change significantly in the CPAP group. Patients in the weight-loss and combination groups dropped approximately 7 kg in the intent-to-treat analysis and 10-11 kg in the per-protocol analysis. Body mass index decreased by a mean of two to three points in the intent-to-treat analysis and by approximately four points among those who adhered to therapy. No details were provided about the specifics of the weight-loss efforts.

Mean arterial pressure decreased significantly in all three groups, compared with baseline, in both intent-to-treat and per-protocol analyses, but fell significantly more in the combination group, compared with monotherapy, in the per-protocol analysis. Among patients adherent to treatment, mean arterial pressure decreased by more than 10 mm Hg in the combination group, compared with approximately 4 mm Hg–declines with either monotherapy.

Only combination therapy significantly reduced brachial pulse pressure, compared with baseline (by approximately 3 mm Hg), in the intent-to-treat analysis. In the per-protocol analysis, brachial pulse pressure dropped significantly, compared with baseline, in the combination group (a 6 mm Hg decrease) and the weight-loss group (a 4 mm Hg–decrease) but not in the CPAP group.

Brachial pulse pressure decreased significantly with combination therapy in the intent-to-treat analysis but not with either treatment alone. Mean brachial pulse pressure in the per-protocol analysis decreased significantly with combination therapy (a 6 mm Hg–reduction) or weight-loss therapy (a 4 mm Hg–decrease) but increased in the CPAP group.

Carotid-radial pulse pressure amplification measurements did not change significantly from baseline in any group, suggesting that the study’s results were not brought about by missing some changes in central pressure that were not being picked up by brachial measurements, Dr. Chirinos said.

In general, approximately 50% of people with obstructive sleep apnea have hypertension, and around 30% of hypertensive patients have obstructive sleep apnea, he said.

The findings are limited by the study’s strict criteria for patient inclusion or exclusion, its lack of arterial blood pressure monitoring, the use of noninvasive estimates of central pressure measurements, and its duration of only 6 months. The study used carotid tonometry to measure central pulse pressure.

The study excluded patients with blood pressures greater than 160/95 mm Hg, those with predominantly central sleep apnea, patients using supplemental oxygen, and anyone in a high-risk occupation or with a record of dangerous driving. Also excluded were patients with confounders of systemic inflammation, sustained arrhythmia, unstable cardiopulmonary disease, severe restless leg syndrome or chronic pain causing frequent night awakenings, pregnancy, severe depression or other serious medical or psychological conditions that might compromise their safety in the study, and prior CPAP within 8 weeks of the study.

The American Heart Association funded Dr. Chirinos’s analysis. Dr. Chirinos reported having no financial disclosures. Some of his associates reported financial relationships with multiple pharmaceutical companies.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO– A 24-week program combining weight-loss efforts with continuous positive airway pressure produced significantly greater reductions in systolic blood pressure in obese patients with obstructive sleep apnea, compared with either intervention alone, a study of 181 adults found.

In an intent-to-treat analysis, all three groups reduced systolic pressures to a statistically similar extent, compared with baseline – decreases of approximately 8 mm Hg in the combination group and 4 mm Hg with either monotherapy. Among 136 patients who adhered to therapy by completing the trial, however, systolic blood pressure decreased by a mean of 14 mm Hg in the 62 patients randomized to the combination of weight-loss efforts and continuous positive airway pressure (CPAP), a significantly greater decrease than the reductions of approximately 7 mm Hg in 61 patients randomized to weight-loss efforts alone and 3 mm Hg in 58 patients who got CPAP alone.

A 14 mm Hg–drop in systolic blood pressure is an "important reduction" with potentially significant clinical benefits in obese patients with obstructive sleep apnea, Dr. Julio A. Chirinos said at the annual meeting of the American College of Cardiology.

Previous observational studies have shown strong associations in obesity, obstructive sleep apnea, and hypertension but have not been able to assess whether there is any incremental blood pressure benefit to combining treatments for obesity and sleep apnea.

Dr. Chirinos and his associates conducted an ancillary analysis of data from the Cardiovascular Consequences of Obstructive Sleep Apnea trial, which focused primarily on the treatments’ effects on C-reactive protein levels. The study randomized adults with at least moderate obesity and moderate to severe obstructive sleep apnea and C-reactive protein levels greater than 1 mg/L to the three intervention groups. Baseline characteristics were similar among groups. Approximately 41% of patients were hypertensive at baseline.

In the per-protocol analysis of patients who adhered to therapy, the decreases in systolic blood pressure, compared with baseline, were statistically significant in the combination and weight-loss groups but not the CPAP group, reported Dr. Chirinos of the University of Pennsylvania, Philadelphia.

Body weight and body mass index decreased significantly in the weight-loss and combination groups compared with baseline but did not change significantly in the CPAP group. Patients in the weight-loss and combination groups dropped approximately 7 kg in the intent-to-treat analysis and 10-11 kg in the per-protocol analysis. Body mass index decreased by a mean of two to three points in the intent-to-treat analysis and by approximately four points among those who adhered to therapy. No details were provided about the specifics of the weight-loss efforts.

Mean arterial pressure decreased significantly in all three groups, compared with baseline, in both intent-to-treat and per-protocol analyses, but fell significantly more in the combination group, compared with monotherapy, in the per-protocol analysis. Among patients adherent to treatment, mean arterial pressure decreased by more than 10 mm Hg in the combination group, compared with approximately 4 mm Hg–declines with either monotherapy.

Only combination therapy significantly reduced brachial pulse pressure, compared with baseline (by approximately 3 mm Hg), in the intent-to-treat analysis. In the per-protocol analysis, brachial pulse pressure dropped significantly, compared with baseline, in the combination group (a 6 mm Hg decrease) and the weight-loss group (a 4 mm Hg–decrease) but not in the CPAP group.

Brachial pulse pressure decreased significantly with combination therapy in the intent-to-treat analysis but not with either treatment alone. Mean brachial pulse pressure in the per-protocol analysis decreased significantly with combination therapy (a 6 mm Hg–reduction) or weight-loss therapy (a 4 mm Hg–decrease) but increased in the CPAP group.

Carotid-radial pulse pressure amplification measurements did not change significantly from baseline in any group, suggesting that the study’s results were not brought about by missing some changes in central pressure that were not being picked up by brachial measurements, Dr. Chirinos said.

In general, approximately 50% of people with obstructive sleep apnea have hypertension, and around 30% of hypertensive patients have obstructive sleep apnea, he said.

The findings are limited by the study’s strict criteria for patient inclusion or exclusion, its lack of arterial blood pressure monitoring, the use of noninvasive estimates of central pressure measurements, and its duration of only 6 months. The study used carotid tonometry to measure central pulse pressure.

The study excluded patients with blood pressures greater than 160/95 mm Hg, those with predominantly central sleep apnea, patients using supplemental oxygen, and anyone in a high-risk occupation or with a record of dangerous driving. Also excluded were patients with confounders of systemic inflammation, sustained arrhythmia, unstable cardiopulmonary disease, severe restless leg syndrome or chronic pain causing frequent night awakenings, pregnancy, severe depression or other serious medical or psychological conditions that might compromise their safety in the study, and prior CPAP within 8 weeks of the study.

The American Heart Association funded Dr. Chirinos’s analysis. Dr. Chirinos reported having no financial disclosures. Some of his associates reported financial relationships with multiple pharmaceutical companies.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO– A 24-week program combining weight-loss efforts with continuous positive airway pressure produced significantly greater reductions in systolic blood pressure in obese patients with obstructive sleep apnea, compared with either intervention alone, a study of 181 adults found.

In an intent-to-treat analysis, all three groups reduced systolic pressures to a statistically similar extent, compared with baseline – decreases of approximately 8 mm Hg in the combination group and 4 mm Hg with either monotherapy. Among 136 patients who adhered to therapy by completing the trial, however, systolic blood pressure decreased by a mean of 14 mm Hg in the 62 patients randomized to the combination of weight-loss efforts and continuous positive airway pressure (CPAP), a significantly greater decrease than the reductions of approximately 7 mm Hg in 61 patients randomized to weight-loss efforts alone and 3 mm Hg in 58 patients who got CPAP alone.

A 14 mm Hg–drop in systolic blood pressure is an "important reduction" with potentially significant clinical benefits in obese patients with obstructive sleep apnea, Dr. Julio A. Chirinos said at the annual meeting of the American College of Cardiology.

Previous observational studies have shown strong associations in obesity, obstructive sleep apnea, and hypertension but have not been able to assess whether there is any incremental blood pressure benefit to combining treatments for obesity and sleep apnea.

Dr. Chirinos and his associates conducted an ancillary analysis of data from the Cardiovascular Consequences of Obstructive Sleep Apnea trial, which focused primarily on the treatments’ effects on C-reactive protein levels. The study randomized adults with at least moderate obesity and moderate to severe obstructive sleep apnea and C-reactive protein levels greater than 1 mg/L to the three intervention groups. Baseline characteristics were similar among groups. Approximately 41% of patients were hypertensive at baseline.

In the per-protocol analysis of patients who adhered to therapy, the decreases in systolic blood pressure, compared with baseline, were statistically significant in the combination and weight-loss groups but not the CPAP group, reported Dr. Chirinos of the University of Pennsylvania, Philadelphia.

Body weight and body mass index decreased significantly in the weight-loss and combination groups compared with baseline but did not change significantly in the CPAP group. Patients in the weight-loss and combination groups dropped approximately 7 kg in the intent-to-treat analysis and 10-11 kg in the per-protocol analysis. Body mass index decreased by a mean of two to three points in the intent-to-treat analysis and by approximately four points among those who adhered to therapy. No details were provided about the specifics of the weight-loss efforts.

Mean arterial pressure decreased significantly in all three groups, compared with baseline, in both intent-to-treat and per-protocol analyses, but fell significantly more in the combination group, compared with monotherapy, in the per-protocol analysis. Among patients adherent to treatment, mean arterial pressure decreased by more than 10 mm Hg in the combination group, compared with approximately 4 mm Hg–declines with either monotherapy.

Only combination therapy significantly reduced brachial pulse pressure, compared with baseline (by approximately 3 mm Hg), in the intent-to-treat analysis. In the per-protocol analysis, brachial pulse pressure dropped significantly, compared with baseline, in the combination group (a 6 mm Hg decrease) and the weight-loss group (a 4 mm Hg–decrease) but not in the CPAP group.

Brachial pulse pressure decreased significantly with combination therapy in the intent-to-treat analysis but not with either treatment alone. Mean brachial pulse pressure in the per-protocol analysis decreased significantly with combination therapy (a 6 mm Hg–reduction) or weight-loss therapy (a 4 mm Hg–decrease) but increased in the CPAP group.

Carotid-radial pulse pressure amplification measurements did not change significantly from baseline in any group, suggesting that the study’s results were not brought about by missing some changes in central pressure that were not being picked up by brachial measurements, Dr. Chirinos said.

In general, approximately 50% of people with obstructive sleep apnea have hypertension, and around 30% of hypertensive patients have obstructive sleep apnea, he said.

The findings are limited by the study’s strict criteria for patient inclusion or exclusion, its lack of arterial blood pressure monitoring, the use of noninvasive estimates of central pressure measurements, and its duration of only 6 months. The study used carotid tonometry to measure central pulse pressure.

The study excluded patients with blood pressures greater than 160/95 mm Hg, those with predominantly central sleep apnea, patients using supplemental oxygen, and anyone in a high-risk occupation or with a record of dangerous driving. Also excluded were patients with confounders of systemic inflammation, sustained arrhythmia, unstable cardiopulmonary disease, severe restless leg syndrome or chronic pain causing frequent night awakenings, pregnancy, severe depression or other serious medical or psychological conditions that might compromise their safety in the study, and prior CPAP within 8 weeks of the study.

The American Heart Association funded Dr. Chirinos’s analysis. Dr. Chirinos reported having no financial disclosures. Some of his associates reported financial relationships with multiple pharmaceutical companies.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Women who were referred to an electrophysiologist were just as likely as men to get an implantable cardioverter-defibrillator, but women developed more complications and were less likely to receive an appropriate ICD shock or appropriate ICD-delivered therapy, a study of 6,902 patients found.

Previous studies have suggested that women are less likely than men are to get ICDs. If that’s true, the disparity may be happening before patients are referred for consideration of ICD implantation, Dr. Derek R. MacFadden said at the annual meeting of the American College of Physicians.

He and his associates analyzed data from a prospective registry of all 6,902 patients in the province of Ont., Canada, who were referred for consideration of an ICD or had one implanted between February 2007 and July 2010. Men and women were equally likely to be among the 5,450 patients who received ICDs and the 571 who did not receive ICDs (because they did not meet implantation criteria, refused implantation, or deferred a decision until after therapy could be optimized), reported Dr. MacFadden of the University of Toronto. The analysis excluded 881 patients with missing data.

Previous studies have reported higher risks for complications in women who get ICDs, as well as sex differences in arrhythmia patterns after implantation. Follow-up data on complications at 45 days in the current study were available in 4,830 patients, and an analysis of outcomes and complications at 1 year included 5,213 patients (Ann. Intern. Med. 2012;156:195-203).

At 45 days, rates of any major or minor complication were significantly higher in women (5.4% and 5.8%), compared with men (3.3% and 3.8%), Dr. MacFadden reported. These included significantly higher rates of lead replacement in women, compared with men (1.9% vs. 0.7%, respectively), and of pulmonary edema (0.6% and 0.2%, respectively).

At the 1-year follow-up, women were 91% more likely than were men to have a major complication, 56% more likely to have a minor complication, and 55% more likely to have any complication, compared with men, after researchers adjusted for confounding factors.

Women were significantly less likely at 1 year to have received an appropriate shock (5%) or appropriate therapy (11%), compared with men (8% and 15%, respectively). When appropriate shocks or therapy were delivered, men received it significantly sooner than did women, he said. The rates of inappropriate shocks (3%) or death (3%) were similar between the sexes.

"Greater risk of complications and the possibility of decreased therapeutic benefit should be considered in women who are referred for ICD implantation," Dr. MacFadden said.

The higher rates of complications in women may be due to bodily differences or physical characteristics, compared with men, he speculated.

At the time of referral for consideration of an ICD, the women were significantly younger than the men were (63 years vs. 65 years). Women had a significantly higher left ventricular ejection fraction (31% vs. 29%). Rates for many cardiac and noncardiac conditions differed significantly by sex. Women were less likely to have had percutaneous coronary intervention, coronary artery bypass graft surgery, atrial fibrillation, dyslipidemia, hypertension, stroke, and peripheral vascular disease, and they were more likely to have a family history of sudden cardiac death, severe valvular disease, or inactive cancer.

The ICDs were implanted for primary prevention in 3,822 patients and for secondary prevention in 1,628 patients.

Women account for approximately 43% of sudden cardiac deaths. Guidelines for ICD implantation to prevent sudden cardiac death are the same for women and men, and are based on randomized, controlled trials with only small percentages of women in their cohorts, he said.

Dr. MacFadden reported having no financial disclosures. Some of his associates reported financial relationships with Biosense, Boehringer, Boston Scientific, Medtronic, and Sanofi.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Women who were referred to an electrophysiologist were just as likely as men to get an implantable cardioverter-defibrillator, but women developed more complications and were less likely to receive an appropriate ICD shock or appropriate ICD-delivered therapy, a study of 6,902 patients found.

Previous studies have suggested that women are less likely than men are to get ICDs. If that’s true, the disparity may be happening before patients are referred for consideration of ICD implantation, Dr. Derek R. MacFadden said at the annual meeting of the American College of Physicians.

He and his associates analyzed data from a prospective registry of all 6,902 patients in the province of Ont., Canada, who were referred for consideration of an ICD or had one implanted between February 2007 and July 2010. Men and women were equally likely to be among the 5,450 patients who received ICDs and the 571 who did not receive ICDs (because they did not meet implantation criteria, refused implantation, or deferred a decision until after therapy could be optimized), reported Dr. MacFadden of the University of Toronto. The analysis excluded 881 patients with missing data.

Previous studies have reported higher risks for complications in women who get ICDs, as well as sex differences in arrhythmia patterns after implantation. Follow-up data on complications at 45 days in the current study were available in 4,830 patients, and an analysis of outcomes and complications at 1 year included 5,213 patients (Ann. Intern. Med. 2012;156:195-203).

At 45 days, rates of any major or minor complication were significantly higher in women (5.4% and 5.8%), compared with men (3.3% and 3.8%), Dr. MacFadden reported. These included significantly higher rates of lead replacement in women, compared with men (1.9% vs. 0.7%, respectively), and of pulmonary edema (0.6% and 0.2%, respectively).

At the 1-year follow-up, women were 91% more likely than were men to have a major complication, 56% more likely to have a minor complication, and 55% more likely to have any complication, compared with men, after researchers adjusted for confounding factors.

Women were significantly less likely at 1 year to have received an appropriate shock (5%) or appropriate therapy (11%), compared with men (8% and 15%, respectively). When appropriate shocks or therapy were delivered, men received it significantly sooner than did women, he said. The rates of inappropriate shocks (3%) or death (3%) were similar between the sexes.

"Greater risk of complications and the possibility of decreased therapeutic benefit should be considered in women who are referred for ICD implantation," Dr. MacFadden said.

The higher rates of complications in women may be due to bodily differences or physical characteristics, compared with men, he speculated.

At the time of referral for consideration of an ICD, the women were significantly younger than the men were (63 years vs. 65 years). Women had a significantly higher left ventricular ejection fraction (31% vs. 29%). Rates for many cardiac and noncardiac conditions differed significantly by sex. Women were less likely to have had percutaneous coronary intervention, coronary artery bypass graft surgery, atrial fibrillation, dyslipidemia, hypertension, stroke, and peripheral vascular disease, and they were more likely to have a family history of sudden cardiac death, severe valvular disease, or inactive cancer.

The ICDs were implanted for primary prevention in 3,822 patients and for secondary prevention in 1,628 patients.

Women account for approximately 43% of sudden cardiac deaths. Guidelines for ICD implantation to prevent sudden cardiac death are the same for women and men, and are based on randomized, controlled trials with only small percentages of women in their cohorts, he said.

Dr. MacFadden reported having no financial disclosures. Some of his associates reported financial relationships with Biosense, Boehringer, Boston Scientific, Medtronic, and Sanofi.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Women who were referred to an electrophysiologist were just as likely as men to get an implantable cardioverter-defibrillator, but women developed more complications and were less likely to receive an appropriate ICD shock or appropriate ICD-delivered therapy, a study of 6,902 patients found.

Previous studies have suggested that women are less likely than men are to get ICDs. If that’s true, the disparity may be happening before patients are referred for consideration of ICD implantation, Dr. Derek R. MacFadden said at the annual meeting of the American College of Physicians.

He and his associates analyzed data from a prospective registry of all 6,902 patients in the province of Ont., Canada, who were referred for consideration of an ICD or had one implanted between February 2007 and July 2010. Men and women were equally likely to be among the 5,450 patients who received ICDs and the 571 who did not receive ICDs (because they did not meet implantation criteria, refused implantation, or deferred a decision until after therapy could be optimized), reported Dr. MacFadden of the University of Toronto. The analysis excluded 881 patients with missing data.

Previous studies have reported higher risks for complications in women who get ICDs, as well as sex differences in arrhythmia patterns after implantation. Follow-up data on complications at 45 days in the current study were available in 4,830 patients, and an analysis of outcomes and complications at 1 year included 5,213 patients (Ann. Intern. Med. 2012;156:195-203).

At 45 days, rates of any major or minor complication were significantly higher in women (5.4% and 5.8%), compared with men (3.3% and 3.8%), Dr. MacFadden reported. These included significantly higher rates of lead replacement in women, compared with men (1.9% vs. 0.7%, respectively), and of pulmonary edema (0.6% and 0.2%, respectively).

At the 1-year follow-up, women were 91% more likely than were men to have a major complication, 56% more likely to have a minor complication, and 55% more likely to have any complication, compared with men, after researchers adjusted for confounding factors.

Women were significantly less likely at 1 year to have received an appropriate shock (5%) or appropriate therapy (11%), compared with men (8% and 15%, respectively). When appropriate shocks or therapy were delivered, men received it significantly sooner than did women, he said. The rates of inappropriate shocks (3%) or death (3%) were similar between the sexes.

"Greater risk of complications and the possibility of decreased therapeutic benefit should be considered in women who are referred for ICD implantation," Dr. MacFadden said.

The higher rates of complications in women may be due to bodily differences or physical characteristics, compared with men, he speculated.

At the time of referral for consideration of an ICD, the women were significantly younger than the men were (63 years vs. 65 years). Women had a significantly higher left ventricular ejection fraction (31% vs. 29%). Rates for many cardiac and noncardiac conditions differed significantly by sex. Women were less likely to have had percutaneous coronary intervention, coronary artery bypass graft surgery, atrial fibrillation, dyslipidemia, hypertension, stroke, and peripheral vascular disease, and they were more likely to have a family history of sudden cardiac death, severe valvular disease, or inactive cancer.

The ICDs were implanted for primary prevention in 3,822 patients and for secondary prevention in 1,628 patients.

Women account for approximately 43% of sudden cardiac deaths. Guidelines for ICD implantation to prevent sudden cardiac death are the same for women and men, and are based on randomized, controlled trials with only small percentages of women in their cohorts, he said.

Dr. MacFadden reported having no financial disclosures. Some of his associates reported financial relationships with Biosense, Boehringer, Boston Scientific, Medtronic, and Sanofi.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Draft recommendations being considered by the U.S. Preventive Services Task Force encourage clinicians to offer tamoxifen or raloxifene to women who have an increased risk of developing a first breast cancer and a low risk of side effects.

The document reaffirms 2002 recommendations from the Task Force with updated evidence on the risks and benefits of this prophylactic strategy and somewhat stronger wording, saying clinicians should "offer to prescribe" the drugs to appropriate candidates rather than simply "discuss" this option and "inform" patients of the risks and benefits.

The Task Force is accepting online comments about its draft until May 13 before finalizing its recommendations.

The draft document was informed by a systematic review of the literature that suggests tamoxifen or raloxifene can reduce the incidence of invasive breast cancer in higher-risk women by 7-9 cases per 100,000 women over 5 years, compared with placebo. The review by Dr. Heidi D. Nelson and her associates was published online in advance of print by the Task Force and by the Annals of Internal Medicine (Ann. Intern. Med. 2013;158:604-14). The incidence of breast cancer was lower with tamoxifen in a head-to-head trial, the Study of Tamoxifen and Raloxifene (STAR), with 5 fewer cases per 1,000 women on tamoxifen compared with raloxifene.

The drugs also reduce the incidence of fracture, with 7 fewer vertebral fractures per 1,000 women on raloxifene or 3 fewer nonvertebral fractures per 1,000 women on tamoxifen, the literature suggests.

Neither drug reduced deaths from breast cancer or deaths from any cause in the published studies, reported Dr. Nelson, a research professor in the departments of medical informatics and clinical epidemiology and medicine at Oregon Health and Sciences University, Portland. Data were lacking on use of these drugs by nonwhite, premenopausal, or elderly women who have comorbid conditions or are taking other medications

Because both of these selective estrogen receptor modulator drugs have potentially serious side effects, the Task Force recommended in both its 2002 guidelines and the 2013 draft that they not be used by women who are not at increased risk for breast cancer. In higher-risk women, both drugs increase the risk of thromboembolic events. Studies have associated tamoxifen with 4 extra thromboembolic events per 1,000 women and raloxifene with 7 excess events per 1,000 women. Tamoxifen use was associated with 4 extra endometrial cancers compared with placebo and increased the risk for ischemic stroke and cataracts. Both drugs can cause less serious side effects, most commonly vasomotor symptoms (hot flashes).

Few U.S. women use tamoxifen or raloxifene to prevent primary breast cancer, in part because it is not clear how to indentify candidates for this therapy, according to Dr. Nelson’s report. Models estimate that women with at least a 3% risk of developing breast cancer in the next 5 years are more likely to benefit than be harmed from tamoxifen or raloxifene, the Task Force draft states. The recommendations would apply to asymptomatic women aged 40-70 years with no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or thromboembolic events.

An online risk assessment tool from the National Cancer Institute that is based on the Gail model of risk assessment can help estimate a person’s 5-year risk of invasive breast cancer, one of 13 risk-stratification models examined in the medical literature. Most models performed only slightly better than use of age alone to predict risk, Dr. Nelson reported. The Food and Drug Administration approved use of tamoxifen or raloxifene to prevent breast cancer if the 5-year risk is at least 1.67% under the Gail model, but women aged 60 years or older who had no other risk factors would meet this threshold using age alone, her review found.

Data are lacking on the optimal doses, and the duration and timing of therapy. The typical doses used to reduce invasive breast cancer risk in several randomized trials are 20 mg/day of tamoxifen or 60 mg/day of raloxifene for 5 years.

The Task Force draft deals only with tamoxifen and raloxifene because these are the only two drugs approved by the FDA to reduce the risk of hormone receptor–positive breast cancer. The draft recommendations note, however, that more data should be coming from trials of possible drug candidates such as aromatase inhibitors. Dr. Nelson’s review notes that tibolone, lasofoxifene, and exemestane reduced breast cancer risk in some trials and "may expand clinical options."

The American Cancer Society in 2013 urged women who are considering chemoprevention for breast cancer to discuss the risks and benefits with their physicians. A 2009 clinical practice guideline update by the American Society of Clinical Oncology said tamoxifen may be offered to women at increased risk of breast cancer and raloxifene may be offered to postmenopausal women at increased risk (J. Clin. Oncol. 2009;27:3235-58).

The American College of Obstetricians and Gynecologists’ 2002 Practice Bulletin #39 on selective estrogen receptor modulators said tamoxifen may be offered to women at high risk of breast cancer (Obstet. Gynecol. 2002;100:839-44). Joint guidelines from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative’ Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer suggested in 2001 that women whose 5-year risk for breast cancer under the Gail model exceeds 5% may be candidates for tamoxifen preventive therapy (CMAJ 2001;164:1681-90).

The National Cancer Institute estimates that 232,340 breast cancers will be diagnosed in 2013 and 39,620 women will die from the disease.

Dr. Nelson and her associates reported having no financial disclosures other than receiving grants from the Agency for Healthcare Research and Quality, which funded the study.

sboschert@frontlinemedcom.com

Twitter: @sherryboschert

Draft recommendations being considered by the U.S. Preventive Services Task Force encourage clinicians to offer tamoxifen or raloxifene to women who have an increased risk of developing a first breast cancer and a low risk of side effects.

The document reaffirms 2002 recommendations from the Task Force with updated evidence on the risks and benefits of this prophylactic strategy and somewhat stronger wording, saying clinicians should "offer to prescribe" the drugs to appropriate candidates rather than simply "discuss" this option and "inform" patients of the risks and benefits.

The Task Force is accepting online comments about its draft until May 13 before finalizing its recommendations.

The draft document was informed by a systematic review of the literature that suggests tamoxifen or raloxifene can reduce the incidence of invasive breast cancer in higher-risk women by 7-9 cases per 100,000 women over 5 years, compared with placebo. The review by Dr. Heidi D. Nelson and her associates was published online in advance of print by the Task Force and by the Annals of Internal Medicine (Ann. Intern. Med. 2013;158:604-14). The incidence of breast cancer was lower with tamoxifen in a head-to-head trial, the Study of Tamoxifen and Raloxifene (STAR), with 5 fewer cases per 1,000 women on tamoxifen compared with raloxifene.

The drugs also reduce the incidence of fracture, with 7 fewer vertebral fractures per 1,000 women on raloxifene or 3 fewer nonvertebral fractures per 1,000 women on tamoxifen, the literature suggests.

Neither drug reduced deaths from breast cancer or deaths from any cause in the published studies, reported Dr. Nelson, a research professor in the departments of medical informatics and clinical epidemiology and medicine at Oregon Health and Sciences University, Portland. Data were lacking on use of these drugs by nonwhite, premenopausal, or elderly women who have comorbid conditions or are taking other medications

Because both of these selective estrogen receptor modulator drugs have potentially serious side effects, the Task Force recommended in both its 2002 guidelines and the 2013 draft that they not be used by women who are not at increased risk for breast cancer. In higher-risk women, both drugs increase the risk of thromboembolic events. Studies have associated tamoxifen with 4 extra thromboembolic events per 1,000 women and raloxifene with 7 excess events per 1,000 women. Tamoxifen use was associated with 4 extra endometrial cancers compared with placebo and increased the risk for ischemic stroke and cataracts. Both drugs can cause less serious side effects, most commonly vasomotor symptoms (hot flashes).

Few U.S. women use tamoxifen or raloxifene to prevent primary breast cancer, in part because it is not clear how to indentify candidates for this therapy, according to Dr. Nelson’s report. Models estimate that women with at least a 3% risk of developing breast cancer in the next 5 years are more likely to benefit than be harmed from tamoxifen or raloxifene, the Task Force draft states. The recommendations would apply to asymptomatic women aged 40-70 years with no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or thromboembolic events.

An online risk assessment tool from the National Cancer Institute that is based on the Gail model of risk assessment can help estimate a person’s 5-year risk of invasive breast cancer, one of 13 risk-stratification models examined in the medical literature. Most models performed only slightly better than use of age alone to predict risk, Dr. Nelson reported. The Food and Drug Administration approved use of tamoxifen or raloxifene to prevent breast cancer if the 5-year risk is at least 1.67% under the Gail model, but women aged 60 years or older who had no other risk factors would meet this threshold using age alone, her review found.

Data are lacking on the optimal doses, and the duration and timing of therapy. The typical doses used to reduce invasive breast cancer risk in several randomized trials are 20 mg/day of tamoxifen or 60 mg/day of raloxifene for 5 years.

The Task Force draft deals only with tamoxifen and raloxifene because these are the only two drugs approved by the FDA to reduce the risk of hormone receptor–positive breast cancer. The draft recommendations note, however, that more data should be coming from trials of possible drug candidates such as aromatase inhibitors. Dr. Nelson’s review notes that tibolone, lasofoxifene, and exemestane reduced breast cancer risk in some trials and "may expand clinical options."

The American Cancer Society in 2013 urged women who are considering chemoprevention for breast cancer to discuss the risks and benefits with their physicians. A 2009 clinical practice guideline update by the American Society of Clinical Oncology said tamoxifen may be offered to women at increased risk of breast cancer and raloxifene may be offered to postmenopausal women at increased risk (J. Clin. Oncol. 2009;27:3235-58).

The American College of Obstetricians and Gynecologists’ 2002 Practice Bulletin #39 on selective estrogen receptor modulators said tamoxifen may be offered to women at high risk of breast cancer (Obstet. Gynecol. 2002;100:839-44). Joint guidelines from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative’ Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer suggested in 2001 that women whose 5-year risk for breast cancer under the Gail model exceeds 5% may be candidates for tamoxifen preventive therapy (CMAJ 2001;164:1681-90).

The National Cancer Institute estimates that 232,340 breast cancers will be diagnosed in 2013 and 39,620 women will die from the disease.

Dr. Nelson and her associates reported having no financial disclosures other than receiving grants from the Agency for Healthcare Research and Quality, which funded the study.

sboschert@frontlinemedcom.com

Twitter: @sherryboschert

Draft recommendations being considered by the U.S. Preventive Services Task Force encourage clinicians to offer tamoxifen or raloxifene to women who have an increased risk of developing a first breast cancer and a low risk of side effects.

The document reaffirms 2002 recommendations from the Task Force with updated evidence on the risks and benefits of this prophylactic strategy and somewhat stronger wording, saying clinicians should "offer to prescribe" the drugs to appropriate candidates rather than simply "discuss" this option and "inform" patients of the risks and benefits.

The Task Force is accepting online comments about its draft until May 13 before finalizing its recommendations.

The draft document was informed by a systematic review of the literature that suggests tamoxifen or raloxifene can reduce the incidence of invasive breast cancer in higher-risk women by 7-9 cases per 100,000 women over 5 years, compared with placebo. The review by Dr. Heidi D. Nelson and her associates was published online in advance of print by the Task Force and by the Annals of Internal Medicine (Ann. Intern. Med. 2013;158:604-14). The incidence of breast cancer was lower with tamoxifen in a head-to-head trial, the Study of Tamoxifen and Raloxifene (STAR), with 5 fewer cases per 1,000 women on tamoxifen compared with raloxifene.

The drugs also reduce the incidence of fracture, with 7 fewer vertebral fractures per 1,000 women on raloxifene or 3 fewer nonvertebral fractures per 1,000 women on tamoxifen, the literature suggests.

Neither drug reduced deaths from breast cancer or deaths from any cause in the published studies, reported Dr. Nelson, a research professor in the departments of medical informatics and clinical epidemiology and medicine at Oregon Health and Sciences University, Portland. Data were lacking on use of these drugs by nonwhite, premenopausal, or elderly women who have comorbid conditions or are taking other medications

Because both of these selective estrogen receptor modulator drugs have potentially serious side effects, the Task Force recommended in both its 2002 guidelines and the 2013 draft that they not be used by women who are not at increased risk for breast cancer. In higher-risk women, both drugs increase the risk of thromboembolic events. Studies have associated tamoxifen with 4 extra thromboembolic events per 1,000 women and raloxifene with 7 excess events per 1,000 women. Tamoxifen use was associated with 4 extra endometrial cancers compared with placebo and increased the risk for ischemic stroke and cataracts. Both drugs can cause less serious side effects, most commonly vasomotor symptoms (hot flashes).

Few U.S. women use tamoxifen or raloxifene to prevent primary breast cancer, in part because it is not clear how to indentify candidates for this therapy, according to Dr. Nelson’s report. Models estimate that women with at least a 3% risk of developing breast cancer in the next 5 years are more likely to benefit than be harmed from tamoxifen or raloxifene, the Task Force draft states. The recommendations would apply to asymptomatic women aged 40-70 years with no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or thromboembolic events.

An online risk assessment tool from the National Cancer Institute that is based on the Gail model of risk assessment can help estimate a person’s 5-year risk of invasive breast cancer, one of 13 risk-stratification models examined in the medical literature. Most models performed only slightly better than use of age alone to predict risk, Dr. Nelson reported. The Food and Drug Administration approved use of tamoxifen or raloxifene to prevent breast cancer if the 5-year risk is at least 1.67% under the Gail model, but women aged 60 years or older who had no other risk factors would meet this threshold using age alone, her review found.

Data are lacking on the optimal doses, and the duration and timing of therapy. The typical doses used to reduce invasive breast cancer risk in several randomized trials are 20 mg/day of tamoxifen or 60 mg/day of raloxifene for 5 years.

The Task Force draft deals only with tamoxifen and raloxifene because these are the only two drugs approved by the FDA to reduce the risk of hormone receptor–positive breast cancer. The draft recommendations note, however, that more data should be coming from trials of possible drug candidates such as aromatase inhibitors. Dr. Nelson’s review notes that tibolone, lasofoxifene, and exemestane reduced breast cancer risk in some trials and "may expand clinical options."

The American Cancer Society in 2013 urged women who are considering chemoprevention for breast cancer to discuss the risks and benefits with their physicians. A 2009 clinical practice guideline update by the American Society of Clinical Oncology said tamoxifen may be offered to women at increased risk of breast cancer and raloxifene may be offered to postmenopausal women at increased risk (J. Clin. Oncol. 2009;27:3235-58).

The American College of Obstetricians and Gynecologists’ 2002 Practice Bulletin #39 on selective estrogen receptor modulators said tamoxifen may be offered to women at high risk of breast cancer (Obstet. Gynecol. 2002;100:839-44). Joint guidelines from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative’ Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer suggested in 2001 that women whose 5-year risk for breast cancer under the Gail model exceeds 5% may be candidates for tamoxifen preventive therapy (CMAJ 2001;164:1681-90).

The National Cancer Institute estimates that 232,340 breast cancers will be diagnosed in 2013 and 39,620 women will die from the disease.

Dr. Nelson and her associates reported having no financial disclosures other than receiving grants from the Agency for Healthcare Research and Quality, which funded the study.

sboschert@frontlinemedcom.com

Twitter: @sherryboschert

SAN FRANCISCO – The American College of Physicians released new, free, print handouts for patients and clinicians to help reduce the approximately 20% rate of readmissions after hospitalizations for acute coronary events.

Studies have shown reduced readmission rates in patients who have a follow-up visit within 7 days of discharge for an acute coronary syndrome event such as a heart attacks or unstable angina.

The new tools should help patients transition from the hospital to home and then to the first post-discharge visit, and help clinicians be ready to make the most of the post-discharge visit, leaders of the American College of Physicians (ACP) said at the college’s annual meeting.

Previous handouts for patients with acute coronary events didn’t address this crucial transition, instead giving patients general tips on how to keep their hearts healthy, said Dr. Doron Schneider, a leader on the ACP team that created the tools.

For physicians, the tools could help them meet increasing expectations to reduce costs by reducing rehospitalizations. "These patients are at very high risk of readmission," said Dr. Steven E. Weinberger, ACP chief executive officer.

Clinicians can download the handouts or order copies through the ACP website. Videos to complement the tools should be posted on YouTube and the ACP site next week, one to be viewed before or shortly after leaving the hospital, and another focusing on medications. "Many patients don’t fill their first prescription or don’t adhere to their first prescription" after an acute coronary event, Dr. Schneider noted.

The 22-page patient pamphlet’s large print, simple layout, and checklists reflect the patient-centered approach that the ACP used in developing it. The group conducted four focus groups of patients who’d had an acute coronary syndrome event in the past year and their spouses or significant others, to find out what they felt patients and families needed to know. The pamphlet uses patients’ words and its photos are of real patients, said Dr. Schneider, chief patient safety and quality officer at Abington (Pa.) Memorial Hospital.

The two-page handout for clinicians lists core aspects to be addressed in the first post-hospitalization visit and suggests concrete steps to make sure the key areas get covered. For example, it suggests having a morning staff huddle to make sure patient charts have what’s needed before the patient arrives for the first follow-up visit, including a discharge summary, discharge instructions, and lab test results that were pending at the time of discharge.

The patient pamphlet starts with information on "What happened to me?" and discusses how patients can take charge of their health, and how to stay healthy.

Six pages are devoted to medicines, with room for patients to write down their own and check off reasons why they have stopped or changed any medicines.

Four pages discuss aspects of recovery, including feelings, work, activities, and sex. Symptoms described in a "Red Zone" help patients decide when they need to call 911, a "Yellow Zone" suggests when to call their doctors, and a "Green Zone" describes what "going well" looks like.

Three separate checklists help patients "Before you leave the hospital," "When you get home," and at "Your first follow-up visit."

A grant from Janssen Pharmaceuticals funded creation of the new tools.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The American College of Physicians released new, free, print handouts for patients and clinicians to help reduce the approximately 20% rate of readmissions after hospitalizations for acute coronary events.

Studies have shown reduced readmission rates in patients who have a follow-up visit within 7 days of discharge for an acute coronary syndrome event such as a heart attacks or unstable angina.

The new tools should help patients transition from the hospital to home and then to the first post-discharge visit, and help clinicians be ready to make the most of the post-discharge visit, leaders of the American College of Physicians (ACP) said at the college’s annual meeting.

Previous handouts for patients with acute coronary events didn’t address this crucial transition, instead giving patients general tips on how to keep their hearts healthy, said Dr. Doron Schneider, a leader on the ACP team that created the tools.

For physicians, the tools could help them meet increasing expectations to reduce costs by reducing rehospitalizations. "These patients are at very high risk of readmission," said Dr. Steven E. Weinberger, ACP chief executive officer.

Clinicians can download the handouts or order copies through the ACP website. Videos to complement the tools should be posted on YouTube and the ACP site next week, one to be viewed before or shortly after leaving the hospital, and another focusing on medications. "Many patients don’t fill their first prescription or don’t adhere to their first prescription" after an acute coronary event, Dr. Schneider noted.

The 22-page patient pamphlet’s large print, simple layout, and checklists reflect the patient-centered approach that the ACP used in developing it. The group conducted four focus groups of patients who’d had an acute coronary syndrome event in the past year and their spouses or significant others, to find out what they felt patients and families needed to know. The pamphlet uses patients’ words and its photos are of real patients, said Dr. Schneider, chief patient safety and quality officer at Abington (Pa.) Memorial Hospital.

The two-page handout for clinicians lists core aspects to be addressed in the first post-hospitalization visit and suggests concrete steps to make sure the key areas get covered. For example, it suggests having a morning staff huddle to make sure patient charts have what’s needed before the patient arrives for the first follow-up visit, including a discharge summary, discharge instructions, and lab test results that were pending at the time of discharge.

The patient pamphlet starts with information on "What happened to me?" and discusses how patients can take charge of their health, and how to stay healthy.

Six pages are devoted to medicines, with room for patients to write down their own and check off reasons why they have stopped or changed any medicines.

Four pages discuss aspects of recovery, including feelings, work, activities, and sex. Symptoms described in a "Red Zone" help patients decide when they need to call 911, a "Yellow Zone" suggests when to call their doctors, and a "Green Zone" describes what "going well" looks like.

Three separate checklists help patients "Before you leave the hospital," "When you get home," and at "Your first follow-up visit."

A grant from Janssen Pharmaceuticals funded creation of the new tools.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The American College of Physicians released new, free, print handouts for patients and clinicians to help reduce the approximately 20% rate of readmissions after hospitalizations for acute coronary events.

Studies have shown reduced readmission rates in patients who have a follow-up visit within 7 days of discharge for an acute coronary syndrome event such as a heart attacks or unstable angina.

The new tools should help patients transition from the hospital to home and then to the first post-discharge visit, and help clinicians be ready to make the most of the post-discharge visit, leaders of the American College of Physicians (ACP) said at the college’s annual meeting.

Previous handouts for patients with acute coronary events didn’t address this crucial transition, instead giving patients general tips on how to keep their hearts healthy, said Dr. Doron Schneider, a leader on the ACP team that created the tools.

For physicians, the tools could help them meet increasing expectations to reduce costs by reducing rehospitalizations. "These patients are at very high risk of readmission," said Dr. Steven E. Weinberger, ACP chief executive officer.

Clinicians can download the handouts or order copies through the ACP website. Videos to complement the tools should be posted on YouTube and the ACP site next week, one to be viewed before or shortly after leaving the hospital, and another focusing on medications. "Many patients don’t fill their first prescription or don’t adhere to their first prescription" after an acute coronary event, Dr. Schneider noted.

The 22-page patient pamphlet’s large print, simple layout, and checklists reflect the patient-centered approach that the ACP used in developing it. The group conducted four focus groups of patients who’d had an acute coronary syndrome event in the past year and their spouses or significant others, to find out what they felt patients and families needed to know. The pamphlet uses patients’ words and its photos are of real patients, said Dr. Schneider, chief patient safety and quality officer at Abington (Pa.) Memorial Hospital.

The two-page handout for clinicians lists core aspects to be addressed in the first post-hospitalization visit and suggests concrete steps to make sure the key areas get covered. For example, it suggests having a morning staff huddle to make sure patient charts have what’s needed before the patient arrives for the first follow-up visit, including a discharge summary, discharge instructions, and lab test results that were pending at the time of discharge.

The patient pamphlet starts with information on "What happened to me?" and discusses how patients can take charge of their health, and how to stay healthy.

Six pages are devoted to medicines, with room for patients to write down their own and check off reasons why they have stopped or changed any medicines.

Four pages discuss aspects of recovery, including feelings, work, activities, and sex. Symptoms described in a "Red Zone" help patients decide when they need to call 911, a "Yellow Zone" suggests when to call their doctors, and a "Green Zone" describes what "going well" looks like.

Three separate checklists help patients "Before you leave the hospital," "When you get home," and at "Your first follow-up visit."

A grant from Janssen Pharmaceuticals funded creation of the new tools.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert