Robert Finn

Major Finding: Among medical students who completed a survey, 14% were moderately or severely depressed. Third- and fourth-year students with moderate to severe depression were more likely to report suicidal ideation than were first- and second-year students (7.9% vs. 1.4%).

Data Source: Cross-sectional, Internet-based survey of all 769 students enrolled in the medical school at the University of Michigan in September-November 2009.

Disclosures: The study was funded by the department of family medicine at the University of Michigan. The authors reported no financial disclosures.

A survey of more than 700 medical students found that 14% were moderately or severely depressed. Those depressed students were significantly more likely than students who were not depressed to express concern about stigmas associated with depression, according to the survey.

For example, 53% of the students with moderate to severe depression agreed with the statement, “Telling a counselor I am depressed would be risky,” compared with 17% of students with no or minimal depression.

The results come from a survey of all 769 students enrolled at the medical school of the University of Michigan, Ann Arbor, in September-November 2009. Of the students surveyed, 505 (66%) responded, reported Dr. Thomas L. Schwenk and his colleagues at the university (JAMA 2010;304:1181–90).

First- and second-year students were no more likely than third- or fourth-year students to report moderate to severe depression (13% vs. 15%). But significantly more women than men scored in the moderate to severe range (18% vs. 9%). Third- and fourth-year students with moderate to severe depression were more likely to report suicidal ideation than were first- and second-year students (7.9% vs. 1.4%).

Significant differences were found between students with moderate to severe depression and those with no or minimal depression on several other stigma-related statements. For example, 62% of the students with moderate to severe depression, compared with 34% of those with no or minimal depression, agreed with the statement, “If I were depressed and asked for help, I would be admitting that my coping skills are inadequate.”

Depressed students also expressed significantly more concern about being less competitive in their residency applications.

On the other hand, 86% of students with moderate to severe depression disagreed with the statement, “Medical students with depression are dangerous to their patients,” compared with 74% of students with no or minimal depression who disagreed with that statement. The difference was statistically significant.

“These results suggest that new approaches may be needed to reduce the stigma of depression and to enhance its prevention, detection, and treatment,” the investigators wrote.

“The effective care of mental illness, the maintenance of mental health and effective emotional function, and the care of professional colleagues with mental illness could be taught as part of the ethical and professional responsibilities of the outstanding physician and become a critical component of the teaching, role modeling, and professional guidance that medical students receive as part of their curriculum and professionalism.”

Major Finding: Among medical students who completed a survey, 14% were moderately or severely depressed. Third- and fourth-year students with moderate to severe depression were more likely to report suicidal ideation than were first- and second-year students (7.9% vs. 1.4%).

Data Source: Cross-sectional, Internet-based survey of all 769 students enrolled in the medical school at the University of Michigan in September-November 2009.

Disclosures: The study was funded by the department of family medicine at the University of Michigan. The authors reported no financial disclosures.

A survey of more than 700 medical students found that 14% were moderately or severely depressed. Those depressed students were significantly more likely than students who were not depressed to express concern about stigmas associated with depression, according to the survey.

For example, 53% of the students with moderate to severe depression agreed with the statement, “Telling a counselor I am depressed would be risky,” compared with 17% of students with no or minimal depression.

The results come from a survey of all 769 students enrolled at the medical school of the University of Michigan, Ann Arbor, in September-November 2009. Of the students surveyed, 505 (66%) responded, reported Dr. Thomas L. Schwenk and his colleagues at the university (JAMA 2010;304:1181–90).

First- and second-year students were no more likely than third- or fourth-year students to report moderate to severe depression (13% vs. 15%). But significantly more women than men scored in the moderate to severe range (18% vs. 9%). Third- and fourth-year students with moderate to severe depression were more likely to report suicidal ideation than were first- and second-year students (7.9% vs. 1.4%).

Significant differences were found between students with moderate to severe depression and those with no or minimal depression on several other stigma-related statements. For example, 62% of the students with moderate to severe depression, compared with 34% of those with no or minimal depression, agreed with the statement, “If I were depressed and asked for help, I would be admitting that my coping skills are inadequate.”

Depressed students also expressed significantly more concern about being less competitive in their residency applications.

On the other hand, 86% of students with moderate to severe depression disagreed with the statement, “Medical students with depression are dangerous to their patients,” compared with 74% of students with no or minimal depression who disagreed with that statement. The difference was statistically significant.

“These results suggest that new approaches may be needed to reduce the stigma of depression and to enhance its prevention, detection, and treatment,” the investigators wrote.

“The effective care of mental illness, the maintenance of mental health and effective emotional function, and the care of professional colleagues with mental illness could be taught as part of the ethical and professional responsibilities of the outstanding physician and become a critical component of the teaching, role modeling, and professional guidance that medical students receive as part of their curriculum and professionalism.”

Major Finding: Among medical students who completed a survey, 14% were moderately or severely depressed. Third- and fourth-year students with moderate to severe depression were more likely to report suicidal ideation than were first- and second-year students (7.9% vs. 1.4%).

Data Source: Cross-sectional, Internet-based survey of all 769 students enrolled in the medical school at the University of Michigan in September-November 2009.

Disclosures: The study was funded by the department of family medicine at the University of Michigan. The authors reported no financial disclosures.

A survey of more than 700 medical students found that 14% were moderately or severely depressed. Those depressed students were significantly more likely than students who were not depressed to express concern about stigmas associated with depression, according to the survey.

For example, 53% of the students with moderate to severe depression agreed with the statement, “Telling a counselor I am depressed would be risky,” compared with 17% of students with no or minimal depression.

The results come from a survey of all 769 students enrolled at the medical school of the University of Michigan, Ann Arbor, in September-November 2009. Of the students surveyed, 505 (66%) responded, reported Dr. Thomas L. Schwenk and his colleagues at the university (JAMA 2010;304:1181–90).

First- and second-year students were no more likely than third- or fourth-year students to report moderate to severe depression (13% vs. 15%). But significantly more women than men scored in the moderate to severe range (18% vs. 9%). Third- and fourth-year students with moderate to severe depression were more likely to report suicidal ideation than were first- and second-year students (7.9% vs. 1.4%).

Significant differences were found between students with moderate to severe depression and those with no or minimal depression on several other stigma-related statements. For example, 62% of the students with moderate to severe depression, compared with 34% of those with no or minimal depression, agreed with the statement, “If I were depressed and asked for help, I would be admitting that my coping skills are inadequate.”

Depressed students also expressed significantly more concern about being less competitive in their residency applications.

On the other hand, 86% of students with moderate to severe depression disagreed with the statement, “Medical students with depression are dangerous to their patients,” compared with 74% of students with no or minimal depression who disagreed with that statement. The difference was statistically significant.

“These results suggest that new approaches may be needed to reduce the stigma of depression and to enhance its prevention, detection, and treatment,” the investigators wrote.

“The effective care of mental illness, the maintenance of mental health and effective emotional function, and the care of professional colleagues with mental illness could be taught as part of the ethical and professional responsibilities of the outstanding physician and become a critical component of the teaching, role modeling, and professional guidance that medical students receive as part of their curriculum and professionalism.”

A single infusion of ketamine relieved bipolar depression within 40 minutes in patients with treatment-resistant bipolar disorder, according to a randomized, placebo-controlled, double-blind crossover study involving 18 patients.

The effect lasted at least 3 days, wrote Dr. Nancy Diazgranados and her colleagues from the National Institute of Mental Health. Patients in the study were an average of 48 years old, had suffered from bipolar I or bipolar II depression for an average of 28 years, and had failed an average of seven antidepressant treatments before the ketamine study. Fifty-five percent of the participants had failed to respond to electroconvulsive therapy.

Two-thirds of participants were on psychiatric disability, and all but one were unemployed (Arch. Gen. Psychiatry 2010;67:793-802).

Patients were randomly assigned to receive an infusion of 0.5 mg/kg of ketamine or placebo. Two weeks later, the patients who had been given ketamine were given placebo and vice versa. Of the 17 patients who completed the ketamine phase of the study, 12 (71%) responded to ketamine.

In contrast, of the 16 patients who completed the placebo phase of the study, only 1 (6%) responded to placebo.

Investigators assessed the patients at baseline using several rating scales, including the Montgomery-Åsberg Depression Rating Scale, the Hamilton Scale for Depression, and the Beck Depression Inventory. Patients showed statistically significant improvements in depression with ketamine, compared with placebo on all three scales beginning at 40 minutes after infusion and continuing for at least 3 days. Mean scores on the rating scales did not differ from placebo on days 7, 10, and 14.

Within 40 minutes, 9 of 16 patients receiving ketamine (56%) responded and an additional 2 (13%) experienced complete remission of their depression. One day after the infusion, 44% of the patients had responded and 31% had remitted.

None of the patients experienced serious adverse events during the study. Among the adverse events associated with ketamine and experienced by at least 10% of the patients were disassociation; feeling strange, weird, or bizarre; dry mouth; tachycardia; and increased blood pressure.

Ketamine has been used in human and veterinary medicine since 1962, most commonly for inducing and maintaining general anesthesia, sedation in intensive care, analgesia, and treatment of bronchospasm. In the late 1990s, it increasingly became known as a drug of abuse and a date-rape drug. A previous study showed that a single infusion of ketamine improved suicidal ideation within 40 minutes (“Single Ketamine Injection Reduces Suicidal Ideation,” November 2009, p. 13).

When used for general anesthesia, the initial dose of intravenous ketamine is typically 1.5-4.5 mg/kg, substantially higher than the level used in this study. Ketamine is thought to act as a noncompetitive inhibitor of the N-methyl-D-aspartate (NMDA) receptor, which is part of the glutaminergic neurotransmitter system. Several lines of evidence have implicated the glutaminergic system in bipolar disorder.

A single infusion of ketamine relieved bipolar depression within 40 minutes in patients with treatment-resistant bipolar disorder, according to a randomized, placebo-controlled, double-blind crossover study involving 18 patients.

The effect lasted at least 3 days, wrote Dr. Nancy Diazgranados and her colleagues from the National Institute of Mental Health. Patients in the study were an average of 48 years old, had suffered from bipolar I or bipolar II depression for an average of 28 years, and had failed an average of seven antidepressant treatments before the ketamine study. Fifty-five percent of the participants had failed to respond to electroconvulsive therapy.

Two-thirds of participants were on psychiatric disability, and all but one were unemployed (Arch. Gen. Psychiatry 2010;67:793-802).

Patients were randomly assigned to receive an infusion of 0.5 mg/kg of ketamine or placebo. Two weeks later, the patients who had been given ketamine were given placebo and vice versa. Of the 17 patients who completed the ketamine phase of the study, 12 (71%) responded to ketamine.

In contrast, of the 16 patients who completed the placebo phase of the study, only 1 (6%) responded to placebo.

Investigators assessed the patients at baseline using several rating scales, including the Montgomery-Åsberg Depression Rating Scale, the Hamilton Scale for Depression, and the Beck Depression Inventory. Patients showed statistically significant improvements in depression with ketamine, compared with placebo on all three scales beginning at 40 minutes after infusion and continuing for at least 3 days. Mean scores on the rating scales did not differ from placebo on days 7, 10, and 14.

Within 40 minutes, 9 of 16 patients receiving ketamine (56%) responded and an additional 2 (13%) experienced complete remission of their depression. One day after the infusion, 44% of the patients had responded and 31% had remitted.

None of the patients experienced serious adverse events during the study. Among the adverse events associated with ketamine and experienced by at least 10% of the patients were disassociation; feeling strange, weird, or bizarre; dry mouth; tachycardia; and increased blood pressure.

Ketamine has been used in human and veterinary medicine since 1962, most commonly for inducing and maintaining general anesthesia, sedation in intensive care, analgesia, and treatment of bronchospasm. In the late 1990s, it increasingly became known as a drug of abuse and a date-rape drug. A previous study showed that a single infusion of ketamine improved suicidal ideation within 40 minutes (“Single Ketamine Injection Reduces Suicidal Ideation,” November 2009, p. 13).

When used for general anesthesia, the initial dose of intravenous ketamine is typically 1.5-4.5 mg/kg, substantially higher than the level used in this study. Ketamine is thought to act as a noncompetitive inhibitor of the N-methyl-D-aspartate (NMDA) receptor, which is part of the glutaminergic neurotransmitter system. Several lines of evidence have implicated the glutaminergic system in bipolar disorder.

A single infusion of ketamine relieved bipolar depression within 40 minutes in patients with treatment-resistant bipolar disorder, according to a randomized, placebo-controlled, double-blind crossover study involving 18 patients.

The effect lasted at least 3 days, wrote Dr. Nancy Diazgranados and her colleagues from the National Institute of Mental Health. Patients in the study were an average of 48 years old, had suffered from bipolar I or bipolar II depression for an average of 28 years, and had failed an average of seven antidepressant treatments before the ketamine study. Fifty-five percent of the participants had failed to respond to electroconvulsive therapy.

Two-thirds of participants were on psychiatric disability, and all but one were unemployed (Arch. Gen. Psychiatry 2010;67:793-802).

Patients were randomly assigned to receive an infusion of 0.5 mg/kg of ketamine or placebo. Two weeks later, the patients who had been given ketamine were given placebo and vice versa. Of the 17 patients who completed the ketamine phase of the study, 12 (71%) responded to ketamine.

In contrast, of the 16 patients who completed the placebo phase of the study, only 1 (6%) responded to placebo.

Investigators assessed the patients at baseline using several rating scales, including the Montgomery-Åsberg Depression Rating Scale, the Hamilton Scale for Depression, and the Beck Depression Inventory. Patients showed statistically significant improvements in depression with ketamine, compared with placebo on all three scales beginning at 40 minutes after infusion and continuing for at least 3 days. Mean scores on the rating scales did not differ from placebo on days 7, 10, and 14.

Within 40 minutes, 9 of 16 patients receiving ketamine (56%) responded and an additional 2 (13%) experienced complete remission of their depression. One day after the infusion, 44% of the patients had responded and 31% had remitted.

None of the patients experienced serious adverse events during the study. Among the adverse events associated with ketamine and experienced by at least 10% of the patients were disassociation; feeling strange, weird, or bizarre; dry mouth; tachycardia; and increased blood pressure.

Ketamine has been used in human and veterinary medicine since 1962, most commonly for inducing and maintaining general anesthesia, sedation in intensive care, analgesia, and treatment of bronchospasm. In the late 1990s, it increasingly became known as a drug of abuse and a date-rape drug. A previous study showed that a single infusion of ketamine improved suicidal ideation within 40 minutes (“Single Ketamine Injection Reduces Suicidal Ideation,” November 2009, p. 13).

When used for general anesthesia, the initial dose of intravenous ketamine is typically 1.5-4.5 mg/kg, substantially higher than the level used in this study. Ketamine is thought to act as a noncompetitive inhibitor of the N-methyl-D-aspartate (NMDA) receptor, which is part of the glutaminergic neurotransmitter system. Several lines of evidence have implicated the glutaminergic system in bipolar disorder.

When a patient fails to respond to treatment for atopic dermatitis, it is important to consider whether nonadherence might be responsible, according to Dr. Lawrence F. Eichenfield.

Dr. Eichenfield, professor of pediatrics and dermatology at the University of California, San Diego, cited a study that found a low level of adherence in children whose use of twice daily triamcinolone ointment was monitored covertly for 8 weeks. Of 26 children who completed the study, the mean rate of adherence was only 32% (J. Am. Acad. Dermatol. 2007;56:211-6).

But the study offered at least one glimmer of hope on improving adherence. Among the children in the study, adherence was substantially higher on or near office-visit days, but rapidly dropped off. Given this finding, more frequent office visits appear to be indicated, Dr. Eichenfield reported at a seminar on women's and pediatric dermatology sponsored by Skin Disease Education Foundation.

Results of other studies suggest that physicians treating atopy should prescribe the simplest possible intervention. They should attend to the psychological and educational needs of patients and their parents. And they should keep therapies short, he said.

He put these lessons into practice when he established the Eczema Center at Rady Children's Hospital in San Diego. Among the most important features of the center is an intensive education component for patients and their families, which Dr. Eichenfield calls "atopic dermatitis school." It is led by a nurse with extensive training and experience in the disorder.

Dr. Eichenfield described the case of a 2-year-old child who had severe inflammatory eczema involving 60%-70% of body surface area with a secondary bacterial infection. The parents were using very small quantities of topical corticosteroids because of fear of possible side effects, and they could not recall the last time their child’s skin had been clear.

Dr. Eichenfield prescribed aggressive topical corticosteroid therapy with wet wraps and a standard course of antibiotics. In atopy school, the family learned not to fear using an appropriate quantity of mid-strength topical corticosteroid. In 2-3 weeks, the child was 90%-95% better and "was easily transitioned to a maintenance regimen of only intermittent prescriptive medicines with excellent disease control over the next 4 months," he said in an interview.

"The intervention wasn't different than what we did before the Eczema Center was established," Dr. Eichenfield added, "But having the dedicated nurse to explain how to do the wet wrap therapy, and providing the opportunity for the parents to explore their questions and concerns about safety with other families in the atopic dermatitis school, made them feel comfortable taking on a regimen that was very effective in treating the disease with a minimum of stronger medicine."

The Eczema Center's Web site includes printable handouts for families and a "Virtual Curriculum," which includes videos on the main topics covered in atopic dermatitis school

Disclosures: Dr. Eichenfield diisclosed serving as a clinical investigator and past consultant for Astellas, Galderma, Johnson & Johnson, Promius, and Stiefel/GSK. He said that neither he nor his family has any equity interest in these companies and no ongoing consultancy relationship, and that the companies had no influence on the content of any of his educational activities.

SDEF and this news organization are owned by Elsevier.

When a patient fails to respond to treatment for atopic dermatitis, it is important to consider whether nonadherence might be responsible, according to Dr. Lawrence F. Eichenfield.

Dr. Eichenfield, professor of pediatrics and dermatology at the University of California, San Diego, cited a study that found a low level of adherence in children whose use of twice daily triamcinolone ointment was monitored covertly for 8 weeks. Of 26 children who completed the study, the mean rate of adherence was only 32% (J. Am. Acad. Dermatol. 2007;56:211-6).

But the study offered at least one glimmer of hope on improving adherence. Among the children in the study, adherence was substantially higher on or near office-visit days, but rapidly dropped off. Given this finding, more frequent office visits appear to be indicated, Dr. Eichenfield reported at a seminar on women's and pediatric dermatology sponsored by Skin Disease Education Foundation.

Results of other studies suggest that physicians treating atopy should prescribe the simplest possible intervention. They should attend to the psychological and educational needs of patients and their parents. And they should keep therapies short, he said.

He put these lessons into practice when he established the Eczema Center at Rady Children's Hospital in San Diego. Among the most important features of the center is an intensive education component for patients and their families, which Dr. Eichenfield calls "atopic dermatitis school." It is led by a nurse with extensive training and experience in the disorder.

Dr. Eichenfield described the case of a 2-year-old child who had severe inflammatory eczema involving 60%-70% of body surface area with a secondary bacterial infection. The parents were using very small quantities of topical corticosteroids because of fear of possible side effects, and they could not recall the last time their child’s skin had been clear.

Dr. Eichenfield prescribed aggressive topical corticosteroid therapy with wet wraps and a standard course of antibiotics. In atopy school, the family learned not to fear using an appropriate quantity of mid-strength topical corticosteroid. In 2-3 weeks, the child was 90%-95% better and "was easily transitioned to a maintenance regimen of only intermittent prescriptive medicines with excellent disease control over the next 4 months," he said in an interview.

"The intervention wasn't different than what we did before the Eczema Center was established," Dr. Eichenfield added, "But having the dedicated nurse to explain how to do the wet wrap therapy, and providing the opportunity for the parents to explore their questions and concerns about safety with other families in the atopic dermatitis school, made them feel comfortable taking on a regimen that was very effective in treating the disease with a minimum of stronger medicine."

The Eczema Center's Web site includes printable handouts for families and a "Virtual Curriculum," which includes videos on the main topics covered in atopic dermatitis school

Disclosures: Dr. Eichenfield diisclosed serving as a clinical investigator and past consultant for Astellas, Galderma, Johnson & Johnson, Promius, and Stiefel/GSK. He said that neither he nor his family has any equity interest in these companies and no ongoing consultancy relationship, and that the companies had no influence on the content of any of his educational activities.

SDEF and this news organization are owned by Elsevier.

When a patient fails to respond to treatment for atopic dermatitis, it is important to consider whether nonadherence might be responsible, according to Dr. Lawrence F. Eichenfield.

Dr. Eichenfield, professor of pediatrics and dermatology at the University of California, San Diego, cited a study that found a low level of adherence in children whose use of twice daily triamcinolone ointment was monitored covertly for 8 weeks. Of 26 children who completed the study, the mean rate of adherence was only 32% (J. Am. Acad. Dermatol. 2007;56:211-6).

But the study offered at least one glimmer of hope on improving adherence. Among the children in the study, adherence was substantially higher on or near office-visit days, but rapidly dropped off. Given this finding, more frequent office visits appear to be indicated, Dr. Eichenfield reported at a seminar on women's and pediatric dermatology sponsored by Skin Disease Education Foundation.

Results of other studies suggest that physicians treating atopy should prescribe the simplest possible intervention. They should attend to the psychological and educational needs of patients and their parents. And they should keep therapies short, he said.

He put these lessons into practice when he established the Eczema Center at Rady Children's Hospital in San Diego. Among the most important features of the center is an intensive education component for patients and their families, which Dr. Eichenfield calls "atopic dermatitis school." It is led by a nurse with extensive training and experience in the disorder.

Dr. Eichenfield described the case of a 2-year-old child who had severe inflammatory eczema involving 60%-70% of body surface area with a secondary bacterial infection. The parents were using very small quantities of topical corticosteroids because of fear of possible side effects, and they could not recall the last time their child’s skin had been clear.

Dr. Eichenfield prescribed aggressive topical corticosteroid therapy with wet wraps and a standard course of antibiotics. In atopy school, the family learned not to fear using an appropriate quantity of mid-strength topical corticosteroid. In 2-3 weeks, the child was 90%-95% better and "was easily transitioned to a maintenance regimen of only intermittent prescriptive medicines with excellent disease control over the next 4 months," he said in an interview.

"The intervention wasn't different than what we did before the Eczema Center was established," Dr. Eichenfield added, "But having the dedicated nurse to explain how to do the wet wrap therapy, and providing the opportunity for the parents to explore their questions and concerns about safety with other families in the atopic dermatitis school, made them feel comfortable taking on a regimen that was very effective in treating the disease with a minimum of stronger medicine."

The Eczema Center's Web site includes printable handouts for families and a "Virtual Curriculum," which includes videos on the main topics covered in atopic dermatitis school

Disclosures: Dr. Eichenfield diisclosed serving as a clinical investigator and past consultant for Astellas, Galderma, Johnson & Johnson, Promius, and Stiefel/GSK. He said that neither he nor his family has any equity interest in these companies and no ongoing consultancy relationship, and that the companies had no influence on the content of any of his educational activities.

SDEF and this news organization are owned by Elsevier.

The U.S. Food and Drug Administration has announced that it is reviewing safety data on the diabetes drug Actos (pioglitazone).

The agency recently received preliminary results from a long-term study suggesting an increase in the risk of bladder cancer among patients taking Actos for the longest time with the largest cumulative doses.

A signal for bladder cancer with the drug was seen in preclinical studies in rats and in two controlled clinical trials. The 10-year observational study of nearly 200,000 patients with diabetes in the Kaiser Permanente Northern California health plan, is being conducted by the manufacturer, Takeda Pharmaceuticals North America Inc., specifically to examine this association. The results submitted to the FDA were from a planned 5-year interim analysis. They showed no overall increase in the risk of bladder cancer among patients taking Actos; however, once patients had been taking the drug for 2 years, the risk increased significantly, in a dose-dependent manner, according to the FDA.

Although it has begun a safety review, the FDA has not concluded that Actos increases bladder cancer risk, and the agency has advised patients to continue taking the drug unless instructed otherwise by their health care providers. Results of the review are expected to be announced in several months, the agency wrote.

The U.S. Food and Drug Administration has announced that it is reviewing safety data on the diabetes drug Actos (pioglitazone).

The agency recently received preliminary results from a long-term study suggesting an increase in the risk of bladder cancer among patients taking Actos for the longest time with the largest cumulative doses.

A signal for bladder cancer with the drug was seen in preclinical studies in rats and in two controlled clinical trials. The 10-year observational study of nearly 200,000 patients with diabetes in the Kaiser Permanente Northern California health plan, is being conducted by the manufacturer, Takeda Pharmaceuticals North America Inc., specifically to examine this association. The results submitted to the FDA were from a planned 5-year interim analysis. They showed no overall increase in the risk of bladder cancer among patients taking Actos; however, once patients had been taking the drug for 2 years, the risk increased significantly, in a dose-dependent manner, according to the FDA.

Although it has begun a safety review, the FDA has not concluded that Actos increases bladder cancer risk, and the agency has advised patients to continue taking the drug unless instructed otherwise by their health care providers. Results of the review are expected to be announced in several months, the agency wrote.

The U.S. Food and Drug Administration has announced that it is reviewing safety data on the diabetes drug Actos (pioglitazone).

The agency recently received preliminary results from a long-term study suggesting an increase in the risk of bladder cancer among patients taking Actos for the longest time with the largest cumulative doses.

A signal for bladder cancer with the drug was seen in preclinical studies in rats and in two controlled clinical trials. The 10-year observational study of nearly 200,000 patients with diabetes in the Kaiser Permanente Northern California health plan, is being conducted by the manufacturer, Takeda Pharmaceuticals North America Inc., specifically to examine this association. The results submitted to the FDA were from a planned 5-year interim analysis. They showed no overall increase in the risk of bladder cancer among patients taking Actos; however, once patients had been taking the drug for 2 years, the risk increased significantly, in a dose-dependent manner, according to the FDA.

Although it has begun a safety review, the FDA has not concluded that Actos increases bladder cancer risk, and the agency has advised patients to continue taking the drug unless instructed otherwise by their health care providers. Results of the review are expected to be announced in several months, the agency wrote.

The Food and Drug Administration, has approved a new indication for three cardiac resynchronization therapy defibrillators.

The devices, also called CRT-Ds, are now approved for use in patients with heart failure and left-bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. All three devices are manufactured by Boston Scientific.

CRT-Ds combine the function of an implantable cardioverter defibrillator (ICD) with cardiac resynchronization therapy, sending small electrical impulses to coordinate contraction of the left and right ventricles. The devices are used together with drug therapy and are not meant to replace that therapy.

The FDA based its Sept. 16 approval on the results of the multinational Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study, which followed 1,820 patients for an average of 3 years. In patients with left-bundle branch block, a CRT-D decreased the risk of heart failure or death by 57%, compared with ICD alone.

As a condition of approval, the FDA required Boston Scientific to undertake two postapproval studies to assess complications and long-term mortality in patients using the devices.

The Food and Drug Administration, has approved a new indication for three cardiac resynchronization therapy defibrillators.

The devices, also called CRT-Ds, are now approved for use in patients with heart failure and left-bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. All three devices are manufactured by Boston Scientific.

CRT-Ds combine the function of an implantable cardioverter defibrillator (ICD) with cardiac resynchronization therapy, sending small electrical impulses to coordinate contraction of the left and right ventricles. The devices are used together with drug therapy and are not meant to replace that therapy.

The FDA based its Sept. 16 approval on the results of the multinational Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study, which followed 1,820 patients for an average of 3 years. In patients with left-bundle branch block, a CRT-D decreased the risk of heart failure or death by 57%, compared with ICD alone.

As a condition of approval, the FDA required Boston Scientific to undertake two postapproval studies to assess complications and long-term mortality in patients using the devices.

The Food and Drug Administration, has approved a new indication for three cardiac resynchronization therapy defibrillators.

The devices, also called CRT-Ds, are now approved for use in patients with heart failure and left-bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. All three devices are manufactured by Boston Scientific.

CRT-Ds combine the function of an implantable cardioverter defibrillator (ICD) with cardiac resynchronization therapy, sending small electrical impulses to coordinate contraction of the left and right ventricles. The devices are used together with drug therapy and are not meant to replace that therapy.

The FDA based its Sept. 16 approval on the results of the multinational Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study, which followed 1,820 patients for an average of 3 years. In patients with left-bundle branch block, a CRT-D decreased the risk of heart failure or death by 57%, compared with ICD alone.

As a condition of approval, the FDA required Boston Scientific to undertake two postapproval studies to assess complications and long-term mortality in patients using the devices.

The Food and Drug Administration, has approved a new indication for three cardiac resynchronization therapy defibrillators.

The devices, also called CRT-Ds, are now approved for use in patients with heart failure and left-bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. All three devices are manufactured by Boston Scientific.

CRT-Ds combine the function of an implantable cardioverter defibrillator (ICD) with cardiac resynchronization therapy, sending small electrical impulses to coordinate contraction of the left and right ventricles. The devices are used together with drug therapy and are not meant to replace that therapy.

The FDA based its Sept. 16 approval on the results of the multinational Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study, which followed 1,820 patients for an average of 3 years. In patients with left-bundle branch block, a CRT-D decreased the risk of heart failure or death by 57%, compared with ICD alone.

As a condition of approval, the FDA required Boston Scientific to undertake two postapproval studies to assess complications and long-term mortality in patients using the devices.

The Food and Drug Administration, has approved a new indication for three cardiac resynchronization therapy defibrillators.

The devices, also called CRT-Ds, are now approved for use in patients with heart failure and left-bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. All three devices are manufactured by Boston Scientific.

CRT-Ds combine the function of an implantable cardioverter defibrillator (ICD) with cardiac resynchronization therapy, sending small electrical impulses to coordinate contraction of the left and right ventricles. The devices are used together with drug therapy and are not meant to replace that therapy.

The FDA based its Sept. 16 approval on the results of the multinational Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study, which followed 1,820 patients for an average of 3 years. In patients with left-bundle branch block, a CRT-D decreased the risk of heart failure or death by 57%, compared with ICD alone.

As a condition of approval, the FDA required Boston Scientific to undertake two postapproval studies to assess complications and long-term mortality in patients using the devices.

The Food and Drug Administration, has approved a new indication for three cardiac resynchronization therapy defibrillators.

The devices, also called CRT-Ds, are now approved for use in patients with heart failure and left-bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. All three devices are manufactured by Boston Scientific.

CRT-Ds combine the function of an implantable cardioverter defibrillator (ICD) with cardiac resynchronization therapy, sending small electrical impulses to coordinate contraction of the left and right ventricles. The devices are used together with drug therapy and are not meant to replace that therapy.

The FDA based its Sept. 16 approval on the results of the multinational Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study, which followed 1,820 patients for an average of 3 years. In patients with left-bundle branch block, a CRT-D decreased the risk of heart failure or death by 57%, compared with ICD alone.

As a condition of approval, the FDA required Boston Scientific to undertake two postapproval studies to assess complications and long-term mortality in patients using the devices.

Only 2% of U.S. hospitals surveyed between March and September 2009 would have qualified for federal stimulus funding incentive payments on the basis of their use of electronic health records, according to a survey of 4,493 hospitals.

The American Recovery and Reinvestment Act (ARRA) authorized incentive payments from Medicare and Medicaid to hospitals that both implement certified electronic health records (EHRs) and demonstrate their “meaningful use.”

The survey, whose results were published online, was conducted before the U.S. Department of Health and Human Services formally adopted the meaningful use criteria for 2011 and 2012.

Those criteria include a set of 14 “core” objectives and an additional 10 “menu” criteria. Hospitals must meet all 14 core criteria and 5 of the 10 menu criteria to qualify for ARRA funds.

In completing the survey, each hospital indicated which of 32 clinical functions of an electronic health record it had implemented. Because the survey was conducted before the meaningful use criteria were finalized, the investigators, led by Dr. Ashish K. Jha of Harvard Medical School, Boston, were only able to analyze responses related to nine of the core measures and three of the menu measures.

The survey's response rate was 69%. Nonresponders differed significantly from responders on several measures, but the investigators took this into account, creating national estimates that were adjusted for nonresponse (Health Affairs 2010 October [doi:10.1377/hlthaff.2010.0502]).

Adoption of basic or comprehensive electronic health records increased from 8.7% of hospitals in 2008 to 11.9% in 2009.

The most commonly implemented EHR functions were viewing of laboratory reports (82% of hospitals had fully implemented this in at least one of their units), viewing of radiology images (83%), and viewing of radiology reports (85%). Two-thirds of the hospitals had implemented medication lists, 63% had implemented drug allergy alerts, and 63% had implemented drug-drug interaction warnings.

However, only 33% of hospitals had implemented physician notes, 34% had implemented physician medication orders, and 32% had made clinical guidelines available through their EHR systems.

Large hospitals, major teaching hospitals, nonprofit hospitals, and urban hospitals were most likely to have implemented EHR systems. Small and medium hospitals, public hospitals, rural hospitals, and those that were not major teaching hospitals were significantly less likely to have implemented EHR.

For example, the odds that a small hospital had implemented EHR were 70% lower than for a large hospital. Public hospitals had 40% lower odds than did nonprofit hospitals, and the rural hospitals had 40% lower odds than did urban hospitals.

The investigators wrote that their 2% estimate was conservative, because they did not survey hospitals about all of the criteria.

“Thus, it is likely that the actual number of hospitals currently able to qualify as meaningful users is lower than our projection,” they wrote.

In addition, they noted, “If we wait until after 2011 to identify the early recipients of meaningful use incentives, it may be too late to reverse these trends in a timely fashion.”

They listed several policies that could, if implemented, make it easier for hospitals to adopt EHR systems and to meet meaningful use criteria. One approach would be to enlist the assistance of regional extension centers. Another would be to offer incentive payments or loans to smaller, public, or rural hospitals to assist them in purchasing or upgrading an EHR system.

“Federal policy makers need to take concrete actions now to address this emerging digital divide and to ensure that all Americans, regardless of where they receive care, derive the benefits that health [information technology] has to offer,” they wrote.

The HHS department and the Robert Wood Johnson Foundation supported the survey.

Only 2% of U.S. hospitals surveyed between March and September 2009 would have qualified for federal stimulus funding incentive payments on the basis of their use of electronic health records, according to a survey of 4,493 hospitals.

The American Recovery and Reinvestment Act (ARRA) authorized incentive payments from Medicare and Medicaid to hospitals that both implement certified electronic health records (EHRs) and demonstrate their “meaningful use.”

The survey, whose results were published online, was conducted before the U.S. Department of Health and Human Services formally adopted the meaningful use criteria for 2011 and 2012.

Those criteria include a set of 14 “core” objectives and an additional 10 “menu” criteria. Hospitals must meet all 14 core criteria and 5 of the 10 menu criteria to qualify for ARRA funds.

In completing the survey, each hospital indicated which of 32 clinical functions of an electronic health record it had implemented. Because the survey was conducted before the meaningful use criteria were finalized, the investigators, led by Dr. Ashish K. Jha of Harvard Medical School, Boston, were only able to analyze responses related to nine of the core measures and three of the menu measures.

The survey's response rate was 69%. Nonresponders differed significantly from responders on several measures, but the investigators took this into account, creating national estimates that were adjusted for nonresponse (Health Affairs 2010 October [doi:10.1377/hlthaff.2010.0502]).

Adoption of basic or comprehensive electronic health records increased from 8.7% of hospitals in 2008 to 11.9% in 2009.

The most commonly implemented EHR functions were viewing of laboratory reports (82% of hospitals had fully implemented this in at least one of their units), viewing of radiology images (83%), and viewing of radiology reports (85%). Two-thirds of the hospitals had implemented medication lists, 63% had implemented drug allergy alerts, and 63% had implemented drug-drug interaction warnings.

However, only 33% of hospitals had implemented physician notes, 34% had implemented physician medication orders, and 32% had made clinical guidelines available through their EHR systems.

Large hospitals, major teaching hospitals, nonprofit hospitals, and urban hospitals were most likely to have implemented EHR systems. Small and medium hospitals, public hospitals, rural hospitals, and those that were not major teaching hospitals were significantly less likely to have implemented EHR.

For example, the odds that a small hospital had implemented EHR were 70% lower than for a large hospital. Public hospitals had 40% lower odds than did nonprofit hospitals, and the rural hospitals had 40% lower odds than did urban hospitals.

The investigators wrote that their 2% estimate was conservative, because they did not survey hospitals about all of the criteria.

“Thus, it is likely that the actual number of hospitals currently able to qualify as meaningful users is lower than our projection,” they wrote.

In addition, they noted, “If we wait until after 2011 to identify the early recipients of meaningful use incentives, it may be too late to reverse these trends in a timely fashion.”

They listed several policies that could, if implemented, make it easier for hospitals to adopt EHR systems and to meet meaningful use criteria. One approach would be to enlist the assistance of regional extension centers. Another would be to offer incentive payments or loans to smaller, public, or rural hospitals to assist them in purchasing or upgrading an EHR system.

“Federal policy makers need to take concrete actions now to address this emerging digital divide and to ensure that all Americans, regardless of where they receive care, derive the benefits that health [information technology] has to offer,” they wrote.

The HHS department and the Robert Wood Johnson Foundation supported the survey.

Only 2% of U.S. hospitals surveyed between March and September 2009 would have qualified for federal stimulus funding incentive payments on the basis of their use of electronic health records, according to a survey of 4,493 hospitals.

The American Recovery and Reinvestment Act (ARRA) authorized incentive payments from Medicare and Medicaid to hospitals that both implement certified electronic health records (EHRs) and demonstrate their “meaningful use.”

The survey, whose results were published online, was conducted before the U.S. Department of Health and Human Services formally adopted the meaningful use criteria for 2011 and 2012.

Those criteria include a set of 14 “core” objectives and an additional 10 “menu” criteria. Hospitals must meet all 14 core criteria and 5 of the 10 menu criteria to qualify for ARRA funds.

In completing the survey, each hospital indicated which of 32 clinical functions of an electronic health record it had implemented. Because the survey was conducted before the meaningful use criteria were finalized, the investigators, led by Dr. Ashish K. Jha of Harvard Medical School, Boston, were only able to analyze responses related to nine of the core measures and three of the menu measures.

The survey's response rate was 69%. Nonresponders differed significantly from responders on several measures, but the investigators took this into account, creating national estimates that were adjusted for nonresponse (Health Affairs 2010 October [doi:10.1377/hlthaff.2010.0502]).

Adoption of basic or comprehensive electronic health records increased from 8.7% of hospitals in 2008 to 11.9% in 2009.

The most commonly implemented EHR functions were viewing of laboratory reports (82% of hospitals had fully implemented this in at least one of their units), viewing of radiology images (83%), and viewing of radiology reports (85%). Two-thirds of the hospitals had implemented medication lists, 63% had implemented drug allergy alerts, and 63% had implemented drug-drug interaction warnings.

However, only 33% of hospitals had implemented physician notes, 34% had implemented physician medication orders, and 32% had made clinical guidelines available through their EHR systems.

Large hospitals, major teaching hospitals, nonprofit hospitals, and urban hospitals were most likely to have implemented EHR systems. Small and medium hospitals, public hospitals, rural hospitals, and those that were not major teaching hospitals were significantly less likely to have implemented EHR.

For example, the odds that a small hospital had implemented EHR were 70% lower than for a large hospital. Public hospitals had 40% lower odds than did nonprofit hospitals, and the rural hospitals had 40% lower odds than did urban hospitals.

The investigators wrote that their 2% estimate was conservative, because they did not survey hospitals about all of the criteria.

“Thus, it is likely that the actual number of hospitals currently able to qualify as meaningful users is lower than our projection,” they wrote.

In addition, they noted, “If we wait until after 2011 to identify the early recipients of meaningful use incentives, it may be too late to reverse these trends in a timely fashion.”

They listed several policies that could, if implemented, make it easier for hospitals to adopt EHR systems and to meet meaningful use criteria. One approach would be to enlist the assistance of regional extension centers. Another would be to offer incentive payments or loans to smaller, public, or rural hospitals to assist them in purchasing or upgrading an EHR system.

“Federal policy makers need to take concrete actions now to address this emerging digital divide and to ensure that all Americans, regardless of where they receive care, derive the benefits that health [information technology] has to offer,” they wrote.

The HHS department and the Robert Wood Johnson Foundation supported the survey.

A prospective observational study that began following more than 50,000 California teachers in 1995 has confirmed reports linking hormone replacement therapy to breast cancer but suggests obesity may offer some protection.

Data from 56,867 women enrolled in the California Teachers Study indicate that women who used estrogen therapy for at least 15 years had a 19% increase in the risk of breast cancer, and women who used combined estrogen-progestin therapy had an 83% increase in breast cancer risk.

The increase in risk was confined to tumors that were positive for both estrogen and progesterone receptors, wrote Tanmei Saxena, an M.D./Ph.D. student at the University of Southern California, Los Angeles, and her coauthors. It was also more pronounced in women with low body mass index (BMI).

“These findings, taken in context of the larger literature on this topic, continue to underscore the need to personalize risk-benefit discussions for women contemplating the use of [hormone therapy],” they wrote (Cancer Epidemiol. Biomarkers Prev. 2010;19:OF1-13).

The California Teachers Study is a prospective cohort study of 133,479 women. For this study, the investigators excluded women who were not California residents, who had a previous or unknown history of breast cancer, who were older than 80 years at baseline, who were premenopausal or of unknown menopausal status, or who had an unknown history of hormone therapy.

Of the remaining 56,867 perimenopausal and postmenopausal teachers, 2,857 (5%) were diagnosed with pathologically confirmed invasive breast cancer. Average age at diagnosis was 67.1 years.

In a multivariate analysis, the investigators adjusted for race/ethnicity, first-degree family history of breast cancer, BMI, smoking history, alcohol consumption during the year prior to baseline, mammographic screening over the prior 2 years, parity and age at first full-term pregnancy, age at menarche, age at menopause, and history of breast biopsy.

Compared with women who never used any hormone therapy, those who did had a statistically significant 40% increase in the risk of breast cancer. The increase in risk was 19% for women who reported at least 15 years of estrogen-alone therapy, and 83% in women who reported at least 15 years of combined estrogen-progestin therapy.

Current use of hormonal therapy was associated with higher risk than past use. The greatest increase in risk—69%—was among women who were using estrogen-progestin therapy currently and had never used any other formulation. The investigators noted that duration of use tended to be shorter among former users.

The longer the women used hormone therapy, the greater the risk. The increase associated with duration of use was statistically significant for all forms of hormone therapy. For example, women using estrogen-progestin therapy for less than 2 years at baseline had a 12% increase in the risk of breast cancer compared with women who never used hormone therapy.

BMI seemed to modify the risk associated with hormonal therapy, the investigators reported. Among women with a BMI of 25 or less, the relative risk of breast cancer was 2.1 in current long-term users of estrogen and progestin, compared with women who had never used hormone therapy. In women with a BMI of 25-30, the relative risk was 1.9 in current long-term users of estrogen and progestin. However, the effect was not statistically significant in women with a BMI higher than 30.

The National Cancer Institute and the California Breast Cancer Research Fund sponsored the study. A coauthor disclosed serving as an expert witness for plaintiffs pursuing Prempro litigation.

A prospective observational study that began following more than 50,000 California teachers in 1995 has confirmed reports linking hormone replacement therapy to breast cancer but suggests obesity may offer some protection.

Data from 56,867 women enrolled in the California Teachers Study indicate that women who used estrogen therapy for at least 15 years had a 19% increase in the risk of breast cancer, and women who used combined estrogen-progestin therapy had an 83% increase in breast cancer risk.

The increase in risk was confined to tumors that were positive for both estrogen and progesterone receptors, wrote Tanmei Saxena, an M.D./Ph.D. student at the University of Southern California, Los Angeles, and her coauthors. It was also more pronounced in women with low body mass index (BMI).

“These findings, taken in context of the larger literature on this topic, continue to underscore the need to personalize risk-benefit discussions for women contemplating the use of [hormone therapy],” they wrote (Cancer Epidemiol. Biomarkers Prev. 2010;19:OF1-13).

The California Teachers Study is a prospective cohort study of 133,479 women. For this study, the investigators excluded women who were not California residents, who had a previous or unknown history of breast cancer, who were older than 80 years at baseline, who were premenopausal or of unknown menopausal status, or who had an unknown history of hormone therapy.

Of the remaining 56,867 perimenopausal and postmenopausal teachers, 2,857 (5%) were diagnosed with pathologically confirmed invasive breast cancer. Average age at diagnosis was 67.1 years.

In a multivariate analysis, the investigators adjusted for race/ethnicity, first-degree family history of breast cancer, BMI, smoking history, alcohol consumption during the year prior to baseline, mammographic screening over the prior 2 years, parity and age at first full-term pregnancy, age at menarche, age at menopause, and history of breast biopsy.

Compared with women who never used any hormone therapy, those who did had a statistically significant 40% increase in the risk of breast cancer. The increase in risk was 19% for women who reported at least 15 years of estrogen-alone therapy, and 83% in women who reported at least 15 years of combined estrogen-progestin therapy.

Current use of hormonal therapy was associated with higher risk than past use. The greatest increase in risk—69%—was among women who were using estrogen-progestin therapy currently and had never used any other formulation. The investigators noted that duration of use tended to be shorter among former users.

The longer the women used hormone therapy, the greater the risk. The increase associated with duration of use was statistically significant for all forms of hormone therapy. For example, women using estrogen-progestin therapy for less than 2 years at baseline had a 12% increase in the risk of breast cancer compared with women who never used hormone therapy.

BMI seemed to modify the risk associated with hormonal therapy, the investigators reported. Among women with a BMI of 25 or less, the relative risk of breast cancer was 2.1 in current long-term users of estrogen and progestin, compared with women who had never used hormone therapy. In women with a BMI of 25-30, the relative risk was 1.9 in current long-term users of estrogen and progestin. However, the effect was not statistically significant in women with a BMI higher than 30.

The National Cancer Institute and the California Breast Cancer Research Fund sponsored the study. A coauthor disclosed serving as an expert witness for plaintiffs pursuing Prempro litigation.

A prospective observational study that began following more than 50,000 California teachers in 1995 has confirmed reports linking hormone replacement therapy to breast cancer but suggests obesity may offer some protection.

Data from 56,867 women enrolled in the California Teachers Study indicate that women who used estrogen therapy for at least 15 years had a 19% increase in the risk of breast cancer, and women who used combined estrogen-progestin therapy had an 83% increase in breast cancer risk.

The increase in risk was confined to tumors that were positive for both estrogen and progesterone receptors, wrote Tanmei Saxena, an M.D./Ph.D. student at the University of Southern California, Los Angeles, and her coauthors. It was also more pronounced in women with low body mass index (BMI).

“These findings, taken in context of the larger literature on this topic, continue to underscore the need to personalize risk-benefit discussions for women contemplating the use of [hormone therapy],” they wrote (Cancer Epidemiol. Biomarkers Prev. 2010;19:OF1-13).

The California Teachers Study is a prospective cohort study of 133,479 women. For this study, the investigators excluded women who were not California residents, who had a previous or unknown history of breast cancer, who were older than 80 years at baseline, who were premenopausal or of unknown menopausal status, or who had an unknown history of hormone therapy.

Of the remaining 56,867 perimenopausal and postmenopausal teachers, 2,857 (5%) were diagnosed with pathologically confirmed invasive breast cancer. Average age at diagnosis was 67.1 years.

In a multivariate analysis, the investigators adjusted for race/ethnicity, first-degree family history of breast cancer, BMI, smoking history, alcohol consumption during the year prior to baseline, mammographic screening over the prior 2 years, parity and age at first full-term pregnancy, age at menarche, age at menopause, and history of breast biopsy.

Compared with women who never used any hormone therapy, those who did had a statistically significant 40% increase in the risk of breast cancer. The increase in risk was 19% for women who reported at least 15 years of estrogen-alone therapy, and 83% in women who reported at least 15 years of combined estrogen-progestin therapy.

Current use of hormonal therapy was associated with higher risk than past use. The greatest increase in risk—69%—was among women who were using estrogen-progestin therapy currently and had never used any other formulation. The investigators noted that duration of use tended to be shorter among former users.

The longer the women used hormone therapy, the greater the risk. The increase associated with duration of use was statistically significant for all forms of hormone therapy. For example, women using estrogen-progestin therapy for less than 2 years at baseline had a 12% increase in the risk of breast cancer compared with women who never used hormone therapy.

BMI seemed to modify the risk associated with hormonal therapy, the investigators reported. Among women with a BMI of 25 or less, the relative risk of breast cancer was 2.1 in current long-term users of estrogen and progestin, compared with women who had never used hormone therapy. In women with a BMI of 25-30, the relative risk was 1.9 in current long-term users of estrogen and progestin. However, the effect was not statistically significant in women with a BMI higher than 30.

The National Cancer Institute and the California Breast Cancer Research Fund sponsored the study. A coauthor disclosed serving as an expert witness for plaintiffs pursuing Prempro litigation.

Major Finding: A morning/morning regimen of 5% benzoyl peroxide wash plus tretinoin gel microsphere 0.04% is as safe and effective as a morning/evening regimen.

Data Source: Randomized, investigator-blinded, phase IV trial of 247 patients with moderate acne.

Disclosures: The study was sponsored by Johnson & Johnson, whose Ortho Dermatologics division markets the Retin-A Micro Pump. Two of the study investigators are employees of Johnson & Johnson, and several others have served as investigators for the company, including Dr. Fried. One of the authors owns stock in Johnson & Johnson.

Studies have shown that a combination of tretinoin and benzoyl peroxide is effective in treating acne; however, the products usually are not administered simultaneously. Tretinoin tends to be degraded by sunlight, so it is typically dosed in the evening. In addition, benzoyl peroxide hastens the breakdown of tretinoin.

But a new study suggests that when the tretinoin is delivered in a gel microsphere pump, the two agents are safe and effective when applied together in the morning (J. Drugs Dermatol. 2010;9:805-13).

The multicenter, phase IV study involved 247 otherwise healthy patients with moderate facial acne vulgaris who were randomized to a 12-week regimen of morning/morning treatment or morning/evening treatment. Physicians monitoring the patients were blinded to their group assignment.

The morning/morning group used a 5% benzoyl peroxide wash, then immediately applied two full pumps of the tretinoin gel microsphere (TGM) 0.04% (Retin-A Micro Pump). The morning/evening group applied the benzoyl peroxide each morning and the TGM pump each evening.

The mean age of the patients was 18.5 years, and 51% were female. At the outset, patients' mean acne lesion count was 72.7, of which 27.4 lesions were inflammatory and 45.3 lesions were noninflammatory. Two-thirds of the patients were white, 19% were Hispanic, 10% were black. The rest were of other or mixed races.

At 12 weeks, the mean lesion count of the patients in the morning/morning group was 39.2, compared with 41.4 in the morning/evening group. The difference was not significant. A separate statistical test demonstrated that the morning/morning regimen was “noninferior” to the morning/evening regimen.

In terms of Investigator's Global Assessment (IGA) score, 23.4% of patients in the morning/morning group and 21.9% in the morning/evening group were judged to be clear or almost clear of their acne lesions. Also, 45.9% of the patients in the morning/morning group and 47.4% in the morning/evening group improved by at least two IGA grades. Neither of these differences were significant.

There were no significant differences in side effects between the two groups. Patients in both groups experienced similar degrees of erythema, dryness, peeling/scaling, burning/stinging, and itching. Investigators described both regimens as “well tolerated.” Thirteen patients in the morning/morning group and 12 patients in the morning/evening group dropped out of the study.

In a statement, study coauthor Dr. Richard Fried, a dermatologist in Yardley, Penn., noted: “These newly published study results are significant for both acne patients and dermatologists as they reinforce the ability to develop skin care regimens that cater to each individual patient's lifestyle, which is important, as simple protocols provide the best chance for clear, beautiful skin.”

Major Finding: A morning/morning regimen of 5% benzoyl peroxide wash plus tretinoin gel microsphere 0.04% is as safe and effective as a morning/evening regimen.

Data Source: Randomized, investigator-blinded, phase IV trial of 247 patients with moderate acne.

Disclosures: The study was sponsored by Johnson & Johnson, whose Ortho Dermatologics division markets the Retin-A Micro Pump. Two of the study investigators are employees of Johnson & Johnson, and several others have served as investigators for the company, including Dr. Fried. One of the authors owns stock in Johnson & Johnson.

Studies have shown that a combination of tretinoin and benzoyl peroxide is effective in treating acne; however, the products usually are not administered simultaneously. Tretinoin tends to be degraded by sunlight, so it is typically dosed in the evening. In addition, benzoyl peroxide hastens the breakdown of tretinoin.

But a new study suggests that when the tretinoin is delivered in a gel microsphere pump, the two agents are safe and effective when applied together in the morning (J. Drugs Dermatol. 2010;9:805-13).

The multicenter, phase IV study involved 247 otherwise healthy patients with moderate facial acne vulgaris who were randomized to a 12-week regimen of morning/morning treatment or morning/evening treatment. Physicians monitoring the patients were blinded to their group assignment.

The morning/morning group used a 5% benzoyl peroxide wash, then immediately applied two full pumps of the tretinoin gel microsphere (TGM) 0.04% (Retin-A Micro Pump). The morning/evening group applied the benzoyl peroxide each morning and the TGM pump each evening.

The mean age of the patients was 18.5 years, and 51% were female. At the outset, patients' mean acne lesion count was 72.7, of which 27.4 lesions were inflammatory and 45.3 lesions were noninflammatory. Two-thirds of the patients were white, 19% were Hispanic, 10% were black. The rest were of other or mixed races.

At 12 weeks, the mean lesion count of the patients in the morning/morning group was 39.2, compared with 41.4 in the morning/evening group. The difference was not significant. A separate statistical test demonstrated that the morning/morning regimen was “noninferior” to the morning/evening regimen.

In terms of Investigator's Global Assessment (IGA) score, 23.4% of patients in the morning/morning group and 21.9% in the morning/evening group were judged to be clear or almost clear of their acne lesions. Also, 45.9% of the patients in the morning/morning group and 47.4% in the morning/evening group improved by at least two IGA grades. Neither of these differences were significant.

There were no significant differences in side effects between the two groups. Patients in both groups experienced similar degrees of erythema, dryness, peeling/scaling, burning/stinging, and itching. Investigators described both regimens as “well tolerated.” Thirteen patients in the morning/morning group and 12 patients in the morning/evening group dropped out of the study.

In a statement, study coauthor Dr. Richard Fried, a dermatologist in Yardley, Penn., noted: “These newly published study results are significant for both acne patients and dermatologists as they reinforce the ability to develop skin care regimens that cater to each individual patient's lifestyle, which is important, as simple protocols provide the best chance for clear, beautiful skin.”

Major Finding: A morning/morning regimen of 5% benzoyl peroxide wash plus tretinoin gel microsphere 0.04% is as safe and effective as a morning/evening regimen.

Data Source: Randomized, investigator-blinded, phase IV trial of 247 patients with moderate acne.

Disclosures: The study was sponsored by Johnson & Johnson, whose Ortho Dermatologics division markets the Retin-A Micro Pump. Two of the study investigators are employees of Johnson & Johnson, and several others have served as investigators for the company, including Dr. Fried. One of the authors owns stock in Johnson & Johnson.

Studies have shown that a combination of tretinoin and benzoyl peroxide is effective in treating acne; however, the products usually are not administered simultaneously. Tretinoin tends to be degraded by sunlight, so it is typically dosed in the evening. In addition, benzoyl peroxide hastens the breakdown of tretinoin.

But a new study suggests that when the tretinoin is delivered in a gel microsphere pump, the two agents are safe and effective when applied together in the morning (J. Drugs Dermatol. 2010;9:805-13).

The multicenter, phase IV study involved 247 otherwise healthy patients with moderate facial acne vulgaris who were randomized to a 12-week regimen of morning/morning treatment or morning/evening treatment. Physicians monitoring the patients were blinded to their group assignment.

The morning/morning group used a 5% benzoyl peroxide wash, then immediately applied two full pumps of the tretinoin gel microsphere (TGM) 0.04% (Retin-A Micro Pump). The morning/evening group applied the benzoyl peroxide each morning and the TGM pump each evening.

The mean age of the patients was 18.5 years, and 51% were female. At the outset, patients' mean acne lesion count was 72.7, of which 27.4 lesions were inflammatory and 45.3 lesions were noninflammatory. Two-thirds of the patients were white, 19% were Hispanic, 10% were black. The rest were of other or mixed races.

At 12 weeks, the mean lesion count of the patients in the morning/morning group was 39.2, compared with 41.4 in the morning/evening group. The difference was not significant. A separate statistical test demonstrated that the morning/morning regimen was “noninferior” to the morning/evening regimen.

In terms of Investigator's Global Assessment (IGA) score, 23.4% of patients in the morning/morning group and 21.9% in the morning/evening group were judged to be clear or almost clear of their acne lesions. Also, 45.9% of the patients in the morning/morning group and 47.4% in the morning/evening group improved by at least two IGA grades. Neither of these differences were significant.

There were no significant differences in side effects between the two groups. Patients in both groups experienced similar degrees of erythema, dryness, peeling/scaling, burning/stinging, and itching. Investigators described both regimens as “well tolerated.” Thirteen patients in the morning/morning group and 12 patients in the morning/evening group dropped out of the study.

In a statement, study coauthor Dr. Richard Fried, a dermatologist in Yardley, Penn., noted: “These newly published study results are significant for both acne patients and dermatologists as they reinforce the ability to develop skin care regimens that cater to each individual patient's lifestyle, which is important, as simple protocols provide the best chance for clear, beautiful skin.”

Major Finding: Patients receiving 32 mg naltrexone and 360 mg bupropion daily for 56 weeks lost 6.1% of their body weight on average compared with 1.3% for patients receiving placebo.

Data Source: Randomized, double-blind, placebo-controlled trial involving 1,742 men and women aged 18-65 years.

Disclosures: The study was funded by Orexigen Therapeutics, which manufactures the naltrexone-bupropion combination under the trade name Contrave. Dr. Greenway has received consulting fees and travel support from Orexigen; is a member of advisory boards for Orexigen, Baronova, Biologene, Catalyst Pharmaceutical Partners, GlaxoSmithKline, Jenny Craig, Leptos Biomedical, Novo Nordisk, Obecure, Schering-Plough Research Institute, NuMe, and Origin Biomed; is a consultant for Basic Research, Dow Chemical, General Nutrition, Lithera, Otsuka Pharmaceutical Development and Commercialization, and Third Rock Ventures; and has received research grants or has grants pending from Amylin, Lilly, Orexigen, Merck, Sanofi-Aventis, Arena Pfizer, Bristol-Myers Squibb, Nastech, Schering Plough, GlaxoSmithKline, and Hollis-Eden. He also holds three patents related to obesity treatment. Several of the other coauthors acknowledged membership on Orexigen's advisory board, receiving consulting fees as well as research grant support from Orexigen. Three other coauthors acknowledged being current or former employees of Orexigen and owning stock in the company.

Two different doses of naltrexone in combination with bupropion resulted in significantly more weight loss than did a placebo in a 56-week trial involving 1,742 overweight and obese participants.

According to the study, published online in the journal the Lancet on July 30, patients taking 32 mg of naltrexone together with 360 mg sustained- release bupropion daily lost on average 6.1% of their body weight (6.1 kg or 13.4 pounds), significantly more than patients taking placebo, who lost 1.3% of their body weight (1.4 kg or 3.1 pounds).

Patients taking a lower dose of naltrexone—16 mg daily—along with 360 mg bupropion lost 5.0% of their body weight (4.9 kg or 10.8 pounds). This too was significantly greater than placebo, according to Dr. Frank L. Greenway of Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, and colleagues (Lancet 2010 [doi:10.1016/S0140-6736(10)60888-4]).

Investigators conducted the study at 34 sites in the United States. The study population included men and women aged 18-65 years with a body mass index of 30-45 kg/m

Among patients who completed the trial, 62% on the higher dose medication and 55% on the lower dose medication lost at least 5% of their body weight, compared with just 23% of the patients taking placebo. Thirty-four percent of the completers on the higher-dose medication and 30% of those on the lower-dose medication lost at least 10% of their body weight, compared with 11% of those on placebo.

Patients on the combination treatment also experienced significant improvements in waist circumference, insulin resistance, HDL cholesterol, triglycerides, and high sensitivity C-reactive protein, compared with patients on placebo. However, while mean blood pressure decreased slightly from baseline in the placebo group, it was unchanged in either of the naltrexone-bupropion groups.

Only 50% of the participants completed all 56 weeks of the trial, with similar discontinuation rates in all three groups. While a total of 26 patients experienced serious adverse events, none of those was related to study treatments, according to the investigators.

Several adverse effects were significantly more frequent in the treatment groups than in the placebo group. These included nausea, headache, constipation, dizziness, vomiting, and dry mouth. No psychiatric adverse event, including insomnia, anxiety, and depression, was more common in the treatment groups than in the placebo group.

Compared with the placebo group, patients in the treatment groups reported experiencing significantly less hunger, and significantly less difficulty in controlling their eating. The naltrexone-bupropion combination is thought to affect two key systems in weight control. Bupropion affects the hypothalamic melanocortin system, which is thought to control feelings of hunger, while naltrexone affects the mesolimbic reward system.

Major Finding: Patients receiving 32 mg naltrexone and 360 mg bupropion daily for 56 weeks lost 6.1% of their body weight on average compared with 1.3% for patients receiving placebo.

Data Source: Randomized, double-blind, placebo-controlled trial involving 1,742 men and women aged 18-65 years.

Disclosures: The study was funded by Orexigen Therapeutics, which manufactures the naltrexone-bupropion combination under the trade name Contrave. Dr. Greenway has received consulting fees and travel support from Orexigen; is a member of advisory boards for Orexigen, Baronova, Biologene, Catalyst Pharmaceutical Partners, GlaxoSmithKline, Jenny Craig, Leptos Biomedical, Novo Nordisk, Obecure, Schering-Plough Research Institute, NuMe, and Origin Biomed; is a consultant for Basic Research, Dow Chemical, General Nutrition, Lithera, Otsuka Pharmaceutical Development and Commercialization, and Third Rock Ventures; and has received research grants or has grants pending from Amylin, Lilly, Orexigen, Merck, Sanofi-Aventis, Arena Pfizer, Bristol-Myers Squibb, Nastech, Schering Plough, GlaxoSmithKline, and Hollis-Eden. He also holds three patents related to obesity treatment. Several of the other coauthors acknowledged membership on Orexigen's advisory board, receiving consulting fees as well as research grant support from Orexigen. Three other coauthors acknowledged being current or former employees of Orexigen and owning stock in the company.

Two different doses of naltrexone in combination with bupropion resulted in significantly more weight loss than did a placebo in a 56-week trial involving 1,742 overweight and obese participants.

According to the study, published online in the journal the Lancet on July 30, patients taking 32 mg of naltrexone together with 360 mg sustained- release bupropion daily lost on average 6.1% of their body weight (6.1 kg or 13.4 pounds), significantly more than patients taking placebo, who lost 1.3% of their body weight (1.4 kg or 3.1 pounds).

Patients taking a lower dose of naltrexone—16 mg daily—along with 360 mg bupropion lost 5.0% of their body weight (4.9 kg or 10.8 pounds). This too was significantly greater than placebo, according to Dr. Frank L. Greenway of Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, and colleagues (Lancet 2010 [doi:10.1016/S0140-6736(10)60888-4]).

Investigators conducted the study at 34 sites in the United States. The study population included men and women aged 18-65 years with a body mass index of 30-45 kg/m

Among patients who completed the trial, 62% on the higher dose medication and 55% on the lower dose medication lost at least 5% of their body weight, compared with just 23% of the patients taking placebo. Thirty-four percent of the completers on the higher-dose medication and 30% of those on the lower-dose medication lost at least 10% of their body weight, compared with 11% of those on placebo.

Patients on the combination treatment also experienced significant improvements in waist circumference, insulin resistance, HDL cholesterol, triglycerides, and high sensitivity C-reactive protein, compared with patients on placebo. However, while mean blood pressure decreased slightly from baseline in the placebo group, it was unchanged in either of the naltrexone-bupropion groups.

Only 50% of the participants completed all 56 weeks of the trial, with similar discontinuation rates in all three groups. While a total of 26 patients experienced serious adverse events, none of those was related to study treatments, according to the investigators.

Several adverse effects were significantly more frequent in the treatment groups than in the placebo group. These included nausea, headache, constipation, dizziness, vomiting, and dry mouth. No psychiatric adverse event, including insomnia, anxiety, and depression, was more common in the treatment groups than in the placebo group.

Compared with the placebo group, patients in the treatment groups reported experiencing significantly less hunger, and significantly less difficulty in controlling their eating. The naltrexone-bupropion combination is thought to affect two key systems in weight control. Bupropion affects the hypothalamic melanocortin system, which is thought to control feelings of hunger, while naltrexone affects the mesolimbic reward system.

Major Finding: Patients receiving 32 mg naltrexone and 360 mg bupropion daily for 56 weeks lost 6.1% of their body weight on average compared with 1.3% for patients receiving placebo.

Data Source: Randomized, double-blind, placebo-controlled trial involving 1,742 men and women aged 18-65 years.

Disclosures: The study was funded by Orexigen Therapeutics, which manufactures the naltrexone-bupropion combination under the trade name Contrave. Dr. Greenway has received consulting fees and travel support from Orexigen; is a member of advisory boards for Orexigen, Baronova, Biologene, Catalyst Pharmaceutical Partners, GlaxoSmithKline, Jenny Craig, Leptos Biomedical, Novo Nordisk, Obecure, Schering-Plough Research Institute, NuMe, and Origin Biomed; is a consultant for Basic Research, Dow Chemical, General Nutrition, Lithera, Otsuka Pharmaceutical Development and Commercialization, and Third Rock Ventures; and has received research grants or has grants pending from Amylin, Lilly, Orexigen, Merck, Sanofi-Aventis, Arena Pfizer, Bristol-Myers Squibb, Nastech, Schering Plough, GlaxoSmithKline, and Hollis-Eden. He also holds three patents related to obesity treatment. Several of the other coauthors acknowledged membership on Orexigen's advisory board, receiving consulting fees as well as research grant support from Orexigen. Three other coauthors acknowledged being current or former employees of Orexigen and owning stock in the company.

Two different doses of naltrexone in combination with bupropion resulted in significantly more weight loss than did a placebo in a 56-week trial involving 1,742 overweight and obese participants.

According to the study, published online in the journal the Lancet on July 30, patients taking 32 mg of naltrexone together with 360 mg sustained- release bupropion daily lost on average 6.1% of their body weight (6.1 kg or 13.4 pounds), significantly more than patients taking placebo, who lost 1.3% of their body weight (1.4 kg or 3.1 pounds).

Patients taking a lower dose of naltrexone—16 mg daily—along with 360 mg bupropion lost 5.0% of their body weight (4.9 kg or 10.8 pounds). This too was significantly greater than placebo, according to Dr. Frank L. Greenway of Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, and colleagues (Lancet 2010 [doi:10.1016/S0140-6736(10)60888-4]).

Investigators conducted the study at 34 sites in the United States. The study population included men and women aged 18-65 years with a body mass index of 30-45 kg/m

Among patients who completed the trial, 62% on the higher dose medication and 55% on the lower dose medication lost at least 5% of their body weight, compared with just 23% of the patients taking placebo. Thirty-four percent of the completers on the higher-dose medication and 30% of those on the lower-dose medication lost at least 10% of their body weight, compared with 11% of those on placebo.

Patients on the combination treatment also experienced significant improvements in waist circumference, insulin resistance, HDL cholesterol, triglycerides, and high sensitivity C-reactive protein, compared with patients on placebo. However, while mean blood pressure decreased slightly from baseline in the placebo group, it was unchanged in either of the naltrexone-bupropion groups.

Only 50% of the participants completed all 56 weeks of the trial, with similar discontinuation rates in all three groups. While a total of 26 patients experienced serious adverse events, none of those was related to study treatments, according to the investigators.

Several adverse effects were significantly more frequent in the treatment groups than in the placebo group. These included nausea, headache, constipation, dizziness, vomiting, and dry mouth. No psychiatric adverse event, including insomnia, anxiety, and depression, was more common in the treatment groups than in the placebo group.

Compared with the placebo group, patients in the treatment groups reported experiencing significantly less hunger, and significantly less difficulty in controlling their eating. The naltrexone-bupropion combination is thought to affect two key systems in weight control. Bupropion affects the hypothalamic melanocortin system, which is thought to control feelings of hunger, while naltrexone affects the mesolimbic reward system.