Damian McNamara

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG

PHOENIX — Investigators found significant decreases in thigh circumference following multiple treatments with a dual-wavelength laser system with mechanical manipulation, compared with untreated thighs, in a multicenter study.

Dr. Michael H. Gold and his colleagues assessed 83 women 1 month after treatment with the SmoothShapes dual-energy laser and mechanical manipulation system (Elemé Medical Inc.). Each participant had one thigh selected randomly for treatment twice a week for 4 weeks, while their other thigh served as a control.

Significant reductions in circumference were noted at the upper, mid, and lower thigh, compared with baseline and the untreated thigh, at each assessment. “The SmoothShapes two-wavelength system was highly effective in producing thigh circumference reduction at each location and at each time point,” said Dr. Gold, who is in private practice in Nashville, Tenn., and is also with Vanderbilt University in Nashville. He is a consultant for Elemé Medical, which funded the study.

A total of 59 patients were considered responders (71%), and this group achieved a 3.5-cm average thigh circumference reduction at 1 month, Dr. Gold said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Mean circumference reductions on the treated thighs were “consistently, statistically significantly greater at all time points,” Dr. Gold said. “Three months' follow-up was also statistically significant.”

Investigators enrolled participants at one of five sites in the United States and one in France. The laser system features a 915-nm wavelength that liquefies fat. The device also has a 650-nm wavelength to increase fat cell membrane permeability. Contoured rollers then move liquefied lipids from the interstitial space to the lymphatic system for drainage, according to the manufacturer. The Food and Drug Administration cleared marketing of the device for the temporary reduction in the appearance of cellulite.

With laser and manipulation system treatment, reductions in thigh circumference were noted in patients at 1 month.

Source Photos courtesy Dr. Robert A. Weiss

PHOENIX — Investigators found significant decreases in thigh circumference following multiple treatments with a dual-wavelength laser system with mechanical manipulation, compared with untreated thighs, in a multicenter study.

Dr. Michael H. Gold and his colleagues assessed 83 women 1 month after treatment with the SmoothShapes dual-energy laser and mechanical manipulation system (Elemé Medical Inc.). Each participant had one thigh selected randomly for treatment twice a week for 4 weeks, while their other thigh served as a control.

Significant reductions in circumference were noted at the upper, mid, and lower thigh, compared with baseline and the untreated thigh, at each assessment. “The SmoothShapes two-wavelength system was highly effective in producing thigh circumference reduction at each location and at each time point,” said Dr. Gold, who is in private practice in Nashville, Tenn., and is also with Vanderbilt University in Nashville. He is a consultant for Elemé Medical, which funded the study.

A total of 59 patients were considered responders (71%), and this group achieved a 3.5-cm average thigh circumference reduction at 1 month, Dr. Gold said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Mean circumference reductions on the treated thighs were “consistently, statistically significantly greater at all time points,” Dr. Gold said. “Three months' follow-up was also statistically significant.”

Investigators enrolled participants at one of five sites in the United States and one in France. The laser system features a 915-nm wavelength that liquefies fat. The device also has a 650-nm wavelength to increase fat cell membrane permeability. Contoured rollers then move liquefied lipids from the interstitial space to the lymphatic system for drainage, according to the manufacturer. The Food and Drug Administration cleared marketing of the device for the temporary reduction in the appearance of cellulite.

With laser and manipulation system treatment, reductions in thigh circumference were noted in patients at 1 month.

Source Photos courtesy Dr. Robert A. Weiss

PHOENIX — Investigators found significant decreases in thigh circumference following multiple treatments with a dual-wavelength laser system with mechanical manipulation, compared with untreated thighs, in a multicenter study.

Dr. Michael H. Gold and his colleagues assessed 83 women 1 month after treatment with the SmoothShapes dual-energy laser and mechanical manipulation system (Elemé Medical Inc.). Each participant had one thigh selected randomly for treatment twice a week for 4 weeks, while their other thigh served as a control.

Significant reductions in circumference were noted at the upper, mid, and lower thigh, compared with baseline and the untreated thigh, at each assessment. “The SmoothShapes two-wavelength system was highly effective in producing thigh circumference reduction at each location and at each time point,” said Dr. Gold, who is in private practice in Nashville, Tenn., and is also with Vanderbilt University in Nashville. He is a consultant for Elemé Medical, which funded the study.

A total of 59 patients were considered responders (71%), and this group achieved a 3.5-cm average thigh circumference reduction at 1 month, Dr. Gold said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Mean circumference reductions on the treated thighs were “consistently, statistically significantly greater at all time points,” Dr. Gold said. “Three months' follow-up was also statistically significant.”

Investigators enrolled participants at one of five sites in the United States and one in France. The laser system features a 915-nm wavelength that liquefies fat. The device also has a 650-nm wavelength to increase fat cell membrane permeability. Contoured rollers then move liquefied lipids from the interstitial space to the lymphatic system for drainage, according to the manufacturer. The Food and Drug Administration cleared marketing of the device for the temporary reduction in the appearance of cellulite.

With laser and manipulation system treatment, reductions in thigh circumference were noted in patients at 1 month.

Source Photos courtesy Dr. Robert A. Weiss

The newly formed American Board of Addiction Medicine has certified more than 1,600 physicians as specialists in addiction medicine so far this year.

Doctors from multiple disciplines who meet expertise criteria are taking advantage of the opportunity to be “grandfathered in” to the nascent specialty by taking a special 6-hour certifying examination.

Certification efforts so far have been “very successful,” Dr. Kevin B. Kunz, president of the American Board of Addiction Medicine (ABAM), said in an interview. “There has been an extraordinary response.”

The 15 doctors on the ABAM board of directors will create a new examination to certify physicians after the grandfathering option ends in December 2009. Previously, only psychiatrists could claim addiction-related board certification. Official recognition of addiction expertise is being expanded to include obstetricians and gynecologists, internists, family physicians, and numerous other specialists.

“We need a cadre of physicians in each specialty,” said Dr. Kunz, who is an addiction specialist in Kailua Kona, Hawaii.

“Substance abuse is a giant problem. The [number of] health issues related to smoking, drinking, and use of illicit substances is mind boggling,” said Dr. Robert J. Sokol, an ob.gyn. on the ABAM board of directors, and director of the C.S. Mott Center for Human Growth and Development at Wayne State University in Detroit.

Currently there are fewer than 10 ob.gyns. boarded in addiction medicine in this country. Dr. Sokol said this is similar to the situation a few decades ago in other specialized areas of obstetrics and gynecology, such as maternal-fetal medicine, pelvic reconstructive surgery, and genetics.

Awareness is increasing, and the American College of Obstetricians and Gynecologists is on top of this, he said.

“For a large majority of premenopausal American women, their only consistent provider of medical care is their ob.gyn.,” Dr. Sokol said. These women are counseled on smoking cessation, on prevention of fetal alcohol spectrum disorders, and about illicit substance use both during pregnancy and at other times.

“Our specialty supports screening for substance abuse and brief intervention, but would benefit from having more trusted voices for these issues in our specialty,” he said.

“There are already folks out there toiling in relative obscurity in addiction medicine,” Dr. Peter D. Friedmann said in an interview. “Creation of the ABAM was driven by the need for better recognition within medicine.”

The American Society of Addiction Medicine provided a certification exam for years, “but it was not accorded the same respect and gravitas as fields that have their own subspecialty boards,” he said. Dr. Friedmann, professor of medicine and community health at Brown University in Providence, R.I., is one of the internists who took advantage of the grandfathering option.

Criteria for certification grandfathering include at least 1,950 hours over the past decade providing addiction-related care, research, and/or education; 50 hours of CME related to addiction medicine in the past 2 years; letters of recommendation supporting proficiency in this area; and successful completion of the examination.

Primary care physicians will continue to play a large role in addiction care because “there will never be enough ABAM-certified specialists to treat everyone,” Dr. Friedmann said.

About 22% of patients presenting to primary care will need some form of intervention, and 6% will need an addiction medicine specialist, Dr. Kunz said. One full-time addiction specialist will be needed to serve 50,000-60,000 members of most U.S. communities, or 1 per 30,000 residents in smaller communities, he estimated.

The ABAM plans to establish addiction medicine residency programs and get them recognized by the Accreditation Council for Graduate Medical Education (ACGME). “We expect these programs to be in place by 2011, after which time we will add a residency requirement to ABAM certification, as well as a maintenance-of-certification program,” Dr. Kunz said.

Once these requirements are all in place, ABAM will seek recognition from the American Board of Medical Specialties (ABMS). Dr. Sokol estimated it will take another 4-6 years to earn ABMS approval.

Reimbursement for addiction-related services remains a challenge. “These are difficult patients who take time and for whom there has been little reimbursement,” Dr. Kunz said.

Although reimbursement codes for addiction screening and brief intervention in addiction are recognized by Medicare, some states, and some private insurers, “reimbursement for doing this work is still quite low,” Dr. Friedmann said. Better financial incentives are needed to encourage physicians to get into this field and make it a career, he added.

The codes for screening and intervention “are very important. You can't get doctors to do something they won't get paid to do,” Dr. Sokol said.

The next ABAM examination is scheduled for Dec. 11, 2010. Application deadlines are Oct. 31, 2009; Jan. 31, 2010; and April 30, 2010. More information is available at www.asam.org/ABAM.html

The newly formed American Board of Addiction Medicine has certified more than 1,600 physicians as specialists in addiction medicine so far this year.

Doctors from multiple disciplines who meet expertise criteria are taking advantage of the opportunity to be “grandfathered in” to the nascent specialty by taking a special 6-hour certifying examination.

Certification efforts so far have been “very successful,” Dr. Kevin B. Kunz, president of the American Board of Addiction Medicine (ABAM), said in an interview. “There has been an extraordinary response.”

The 15 doctors on the ABAM board of directors will create a new examination to certify physicians after the grandfathering option ends in December 2009. Previously, only psychiatrists could claim addiction-related board certification. Official recognition of addiction expertise is being expanded to include obstetricians and gynecologists, internists, family physicians, and numerous other specialists.

“We need a cadre of physicians in each specialty,” said Dr. Kunz, who is an addiction specialist in Kailua Kona, Hawaii.

“Substance abuse is a giant problem. The [number of] health issues related to smoking, drinking, and use of illicit substances is mind boggling,” said Dr. Robert J. Sokol, an ob.gyn. on the ABAM board of directors, and director of the C.S. Mott Center for Human Growth and Development at Wayne State University in Detroit.

Currently there are fewer than 10 ob.gyns. boarded in addiction medicine in this country. Dr. Sokol said this is similar to the situation a few decades ago in other specialized areas of obstetrics and gynecology, such as maternal-fetal medicine, pelvic reconstructive surgery, and genetics.

Awareness is increasing, and the American College of Obstetricians and Gynecologists is on top of this, he said.

“For a large majority of premenopausal American women, their only consistent provider of medical care is their ob.gyn.,” Dr. Sokol said. These women are counseled on smoking cessation, on prevention of fetal alcohol spectrum disorders, and about illicit substance use both during pregnancy and at other times.

“Our specialty supports screening for substance abuse and brief intervention, but would benefit from having more trusted voices for these issues in our specialty,” he said.

“There are already folks out there toiling in relative obscurity in addiction medicine,” Dr. Peter D. Friedmann said in an interview. “Creation of the ABAM was driven by the need for better recognition within medicine.”

The American Society of Addiction Medicine provided a certification exam for years, “but it was not accorded the same respect and gravitas as fields that have their own subspecialty boards,” he said. Dr. Friedmann, professor of medicine and community health at Brown University in Providence, R.I., is one of the internists who took advantage of the grandfathering option.

Criteria for certification grandfathering include at least 1,950 hours over the past decade providing addiction-related care, research, and/or education; 50 hours of CME related to addiction medicine in the past 2 years; letters of recommendation supporting proficiency in this area; and successful completion of the examination.

Primary care physicians will continue to play a large role in addiction care because “there will never be enough ABAM-certified specialists to treat everyone,” Dr. Friedmann said.

About 22% of patients presenting to primary care will need some form of intervention, and 6% will need an addiction medicine specialist, Dr. Kunz said. One full-time addiction specialist will be needed to serve 50,000-60,000 members of most U.S. communities, or 1 per 30,000 residents in smaller communities, he estimated.

The ABAM plans to establish addiction medicine residency programs and get them recognized by the Accreditation Council for Graduate Medical Education (ACGME). “We expect these programs to be in place by 2011, after which time we will add a residency requirement to ABAM certification, as well as a maintenance-of-certification program,” Dr. Kunz said.

Once these requirements are all in place, ABAM will seek recognition from the American Board of Medical Specialties (ABMS). Dr. Sokol estimated it will take another 4-6 years to earn ABMS approval.

Reimbursement for addiction-related services remains a challenge. “These are difficult patients who take time and for whom there has been little reimbursement,” Dr. Kunz said.

Although reimbursement codes for addiction screening and brief intervention in addiction are recognized by Medicare, some states, and some private insurers, “reimbursement for doing this work is still quite low,” Dr. Friedmann said. Better financial incentives are needed to encourage physicians to get into this field and make it a career, he added.

The codes for screening and intervention “are very important. You can't get doctors to do something they won't get paid to do,” Dr. Sokol said.

The next ABAM examination is scheduled for Dec. 11, 2010. Application deadlines are Oct. 31, 2009; Jan. 31, 2010; and April 30, 2010. More information is available at www.asam.org/ABAM.html

The newly formed American Board of Addiction Medicine has certified more than 1,600 physicians as specialists in addiction medicine so far this year.

Doctors from multiple disciplines who meet expertise criteria are taking advantage of the opportunity to be “grandfathered in” to the nascent specialty by taking a special 6-hour certifying examination.

Certification efforts so far have been “very successful,” Dr. Kevin B. Kunz, president of the American Board of Addiction Medicine (ABAM), said in an interview. “There has been an extraordinary response.”

The 15 doctors on the ABAM board of directors will create a new examination to certify physicians after the grandfathering option ends in December 2009. Previously, only psychiatrists could claim addiction-related board certification. Official recognition of addiction expertise is being expanded to include obstetricians and gynecologists, internists, family physicians, and numerous other specialists.

“We need a cadre of physicians in each specialty,” said Dr. Kunz, who is an addiction specialist in Kailua Kona, Hawaii.

“Substance abuse is a giant problem. The [number of] health issues related to smoking, drinking, and use of illicit substances is mind boggling,” said Dr. Robert J. Sokol, an ob.gyn. on the ABAM board of directors, and director of the C.S. Mott Center for Human Growth and Development at Wayne State University in Detroit.

Currently there are fewer than 10 ob.gyns. boarded in addiction medicine in this country. Dr. Sokol said this is similar to the situation a few decades ago in other specialized areas of obstetrics and gynecology, such as maternal-fetal medicine, pelvic reconstructive surgery, and genetics.

Awareness is increasing, and the American College of Obstetricians and Gynecologists is on top of this, he said.

“For a large majority of premenopausal American women, their only consistent provider of medical care is their ob.gyn.,” Dr. Sokol said. These women are counseled on smoking cessation, on prevention of fetal alcohol spectrum disorders, and about illicit substance use both during pregnancy and at other times.

“Our specialty supports screening for substance abuse and brief intervention, but would benefit from having more trusted voices for these issues in our specialty,” he said.

“There are already folks out there toiling in relative obscurity in addiction medicine,” Dr. Peter D. Friedmann said in an interview. “Creation of the ABAM was driven by the need for better recognition within medicine.”

The American Society of Addiction Medicine provided a certification exam for years, “but it was not accorded the same respect and gravitas as fields that have their own subspecialty boards,” he said. Dr. Friedmann, professor of medicine and community health at Brown University in Providence, R.I., is one of the internists who took advantage of the grandfathering option.

Criteria for certification grandfathering include at least 1,950 hours over the past decade providing addiction-related care, research, and/or education; 50 hours of CME related to addiction medicine in the past 2 years; letters of recommendation supporting proficiency in this area; and successful completion of the examination.

Primary care physicians will continue to play a large role in addiction care because “there will never be enough ABAM-certified specialists to treat everyone,” Dr. Friedmann said.

About 22% of patients presenting to primary care will need some form of intervention, and 6% will need an addiction medicine specialist, Dr. Kunz said. One full-time addiction specialist will be needed to serve 50,000-60,000 members of most U.S. communities, or 1 per 30,000 residents in smaller communities, he estimated.

The ABAM plans to establish addiction medicine residency programs and get them recognized by the Accreditation Council for Graduate Medical Education (ACGME). “We expect these programs to be in place by 2011, after which time we will add a residency requirement to ABAM certification, as well as a maintenance-of-certification program,” Dr. Kunz said.

Once these requirements are all in place, ABAM will seek recognition from the American Board of Medical Specialties (ABMS). Dr. Sokol estimated it will take another 4-6 years to earn ABMS approval.

Reimbursement for addiction-related services remains a challenge. “These are difficult patients who take time and for whom there has been little reimbursement,” Dr. Kunz said.

Although reimbursement codes for addiction screening and brief intervention in addiction are recognized by Medicare, some states, and some private insurers, “reimbursement for doing this work is still quite low,” Dr. Friedmann said. Better financial incentives are needed to encourage physicians to get into this field and make it a career, he added.

The codes for screening and intervention “are very important. You can't get doctors to do something they won't get paid to do,” Dr. Sokol said.

The next ABAM examination is scheduled for Dec. 11, 2010. Application deadlines are Oct. 31, 2009; Jan. 31, 2010; and April 30, 2010. More information is available at www.asam.org/ABAM.html

Patients with dermatomyositis or polymyositis are at increased risk for arterial thrombotic events that immunosupressant use may lessen, according to a case-control study.

These autoimmune diseases are known to cause muscle inflammation, weakness, and significant morbidity. However, there are fewer data on the risk for arterial events in affected patients.

So Dr. Christian A. Pineau and colleagues assessed 607 people with dermatomyositis (DM) or polymyositis (PM). The researchers measured events such as acute myocardial infarction, stroke, and ischemic heart disease in this cohort during 1994–2003.

Patients were identified from the province of Quebec's physician billing, hospitalization, and pharmacy databases. Their average age was 62 years, and women accounted for 70% of the cohort. All patients were beneficiaries of the public drug insurance plan, which covers approximately 42% of the residents of Quebec. The investigators reported their findings in the Journal of Rheumatology (2009 July 31 [doi:10.3899/jrheum.090061

Results suggest a high incidence of arterial events in DM and PM. There were 124 arterial events experienced by 80 patients during the study period. Events included 34 incident cases of acute MI (equivalent to 13.8 per 1,000 person-years). The investigators estimated that they would expect about 17 acute MIs during this time in the same number of people in the general population, so the study cohort's relative risk was 1.95.

There were 13 strokes during the study (a rate of 5.2 per 1,000 person-years), similar to the rate of 5.1 per 1,000 person-years reported in rheumatoid arthritis (Ann. Rheum. Dis. 2006;65:1608–12). Stroke incidence in the general Canadian population is estimated at 3.1 per 1,000 person-years, suggesting a near doubling of risk for people with one of these inflammatory myopathies.

“As rheumatologists, we should be sensitive to the fact that comorbidities such as coronary artery disease represent a high burden for our patients,” said Dr. Pineau, a rheumatologist at McGill University Health Centre in Montreal.

Nonatherosclerotic heart disease, hypertension, and lipid disorders were important determinants of arterial events in the study. For example, risk for an event in someone with a lipid disorder carried an adjusted rate ratio of 4.9; heart failure or valve disease, 3.0; and hypertension, 2.5, according to a multivariate analysis.

In contrast, exposure to nonsteroidal immunomodulators was associated with a significantly lower arterial event rate (adjusted RR, 0.5). “The use of immunosuppressants, which improve disease control and minimize the need for steroids, could in theory have the potential to lower the risk of coronary artery disease,” Dr. Pineau said.

A majority (85% of the cohort) was exposed to systemic glucocorticoids; 26% to methotrexate; 21% to azathioprine; 14% to antimalarial drugs; and 6% to cyclophosphamide.

An unanswered question is why the researchers found a higher rate of arterial thrombotic events for people with DM or PM, compared with the general population. “I would like rheumatologists to see all rheumatic diseases in the same light as they see rheumatoid arthritis,” Dr. Pineau said.

Although the use of disease-modifying antirheumatic drugs is the cornerstone of therapy in rheumatoid arthritis, many rheumatic diseases such as PM and DM are primarily—and often exclusively—treated with steroids, he said. At the same time, other immunosuppressants take only a secondary role. “As exemplified in this study, this strategy could potentially lead to increased morbidity, either through the toxicity associated with the use of higher steroid doses, or because of a higher inflammatory burden brought upon by a suboptimal control of the disease.”

The study was supported by a grant from the Canadian Institutes of Health Research. Dr. Pineau had no relevant disclosures. Additional research in this area is warranted, the authors wrote.

Patients with dermatomyositis or polymyositis are at increased risk for arterial thrombotic events that immunosupressant use may lessen, according to a case-control study.

These autoimmune diseases are known to cause muscle inflammation, weakness, and significant morbidity. However, there are fewer data on the risk for arterial events in affected patients.

So Dr. Christian A. Pineau and colleagues assessed 607 people with dermatomyositis (DM) or polymyositis (PM). The researchers measured events such as acute myocardial infarction, stroke, and ischemic heart disease in this cohort during 1994–2003.

Patients were identified from the province of Quebec's physician billing, hospitalization, and pharmacy databases. Their average age was 62 years, and women accounted for 70% of the cohort. All patients were beneficiaries of the public drug insurance plan, which covers approximately 42% of the residents of Quebec. The investigators reported their findings in the Journal of Rheumatology (2009 July 31 [doi:10.3899/jrheum.090061

Results suggest a high incidence of arterial events in DM and PM. There were 124 arterial events experienced by 80 patients during the study period. Events included 34 incident cases of acute MI (equivalent to 13.8 per 1,000 person-years). The investigators estimated that they would expect about 17 acute MIs during this time in the same number of people in the general population, so the study cohort's relative risk was 1.95.

There were 13 strokes during the study (a rate of 5.2 per 1,000 person-years), similar to the rate of 5.1 per 1,000 person-years reported in rheumatoid arthritis (Ann. Rheum. Dis. 2006;65:1608–12). Stroke incidence in the general Canadian population is estimated at 3.1 per 1,000 person-years, suggesting a near doubling of risk for people with one of these inflammatory myopathies.

“As rheumatologists, we should be sensitive to the fact that comorbidities such as coronary artery disease represent a high burden for our patients,” said Dr. Pineau, a rheumatologist at McGill University Health Centre in Montreal.

Nonatherosclerotic heart disease, hypertension, and lipid disorders were important determinants of arterial events in the study. For example, risk for an event in someone with a lipid disorder carried an adjusted rate ratio of 4.9; heart failure or valve disease, 3.0; and hypertension, 2.5, according to a multivariate analysis.

In contrast, exposure to nonsteroidal immunomodulators was associated with a significantly lower arterial event rate (adjusted RR, 0.5). “The use of immunosuppressants, which improve disease control and minimize the need for steroids, could in theory have the potential to lower the risk of coronary artery disease,” Dr. Pineau said.

A majority (85% of the cohort) was exposed to systemic glucocorticoids; 26% to methotrexate; 21% to azathioprine; 14% to antimalarial drugs; and 6% to cyclophosphamide.

An unanswered question is why the researchers found a higher rate of arterial thrombotic events for people with DM or PM, compared with the general population. “I would like rheumatologists to see all rheumatic diseases in the same light as they see rheumatoid arthritis,” Dr. Pineau said.

Although the use of disease-modifying antirheumatic drugs is the cornerstone of therapy in rheumatoid arthritis, many rheumatic diseases such as PM and DM are primarily—and often exclusively—treated with steroids, he said. At the same time, other immunosuppressants take only a secondary role. “As exemplified in this study, this strategy could potentially lead to increased morbidity, either through the toxicity associated with the use of higher steroid doses, or because of a higher inflammatory burden brought upon by a suboptimal control of the disease.”

The study was supported by a grant from the Canadian Institutes of Health Research. Dr. Pineau had no relevant disclosures. Additional research in this area is warranted, the authors wrote.

Patients with dermatomyositis or polymyositis are at increased risk for arterial thrombotic events that immunosupressant use may lessen, according to a case-control study.

These autoimmune diseases are known to cause muscle inflammation, weakness, and significant morbidity. However, there are fewer data on the risk for arterial events in affected patients.

So Dr. Christian A. Pineau and colleagues assessed 607 people with dermatomyositis (DM) or polymyositis (PM). The researchers measured events such as acute myocardial infarction, stroke, and ischemic heart disease in this cohort during 1994–2003.

Patients were identified from the province of Quebec's physician billing, hospitalization, and pharmacy databases. Their average age was 62 years, and women accounted for 70% of the cohort. All patients were beneficiaries of the public drug insurance plan, which covers approximately 42% of the residents of Quebec. The investigators reported their findings in the Journal of Rheumatology (2009 July 31 [doi:10.3899/jrheum.090061

Results suggest a high incidence of arterial events in DM and PM. There were 124 arterial events experienced by 80 patients during the study period. Events included 34 incident cases of acute MI (equivalent to 13.8 per 1,000 person-years). The investigators estimated that they would expect about 17 acute MIs during this time in the same number of people in the general population, so the study cohort's relative risk was 1.95.

There were 13 strokes during the study (a rate of 5.2 per 1,000 person-years), similar to the rate of 5.1 per 1,000 person-years reported in rheumatoid arthritis (Ann. Rheum. Dis. 2006;65:1608–12). Stroke incidence in the general Canadian population is estimated at 3.1 per 1,000 person-years, suggesting a near doubling of risk for people with one of these inflammatory myopathies.

“As rheumatologists, we should be sensitive to the fact that comorbidities such as coronary artery disease represent a high burden for our patients,” said Dr. Pineau, a rheumatologist at McGill University Health Centre in Montreal.

Nonatherosclerotic heart disease, hypertension, and lipid disorders were important determinants of arterial events in the study. For example, risk for an event in someone with a lipid disorder carried an adjusted rate ratio of 4.9; heart failure or valve disease, 3.0; and hypertension, 2.5, according to a multivariate analysis.

In contrast, exposure to nonsteroidal immunomodulators was associated with a significantly lower arterial event rate (adjusted RR, 0.5). “The use of immunosuppressants, which improve disease control and minimize the need for steroids, could in theory have the potential to lower the risk of coronary artery disease,” Dr. Pineau said.

A majority (85% of the cohort) was exposed to systemic glucocorticoids; 26% to methotrexate; 21% to azathioprine; 14% to antimalarial drugs; and 6% to cyclophosphamide.

An unanswered question is why the researchers found a higher rate of arterial thrombotic events for people with DM or PM, compared with the general population. “I would like rheumatologists to see all rheumatic diseases in the same light as they see rheumatoid arthritis,” Dr. Pineau said.

Although the use of disease-modifying antirheumatic drugs is the cornerstone of therapy in rheumatoid arthritis, many rheumatic diseases such as PM and DM are primarily—and often exclusively—treated with steroids, he said. At the same time, other immunosuppressants take only a secondary role. “As exemplified in this study, this strategy could potentially lead to increased morbidity, either through the toxicity associated with the use of higher steroid doses, or because of a higher inflammatory burden brought upon by a suboptimal control of the disease.”

The study was supported by a grant from the Canadian Institutes of Health Research. Dr. Pineau had no relevant disclosures. Additional research in this area is warranted, the authors wrote.

HOLLYWOOD, FLA. — Sertraline did not significantly improve depressive symptoms or cardiovascular status among depressed patients with heart failure, compared with placebo in a 12-week, randomized, double-blind study.

A second, posthoc analysis of the data indicates patients who achieve depression remission experience prognostic and functional improvements, including statistically fewer mean cardiovascular events during long-term follow-up, compared with nonremitters.

Dr. Wei Jiang presented results of both the primary and secondary analyses of the Sertraline Antidepressant Heart Attack Randomized Trial in Congestive Heart Failure (SADHART-CHF) at a meeting of the New Clinical Drug Evaluation Unit (NCDEU) sponsored by the National Institute of Mental Health.

She and her associates assessed depressive symptoms, cardiovascular status, and long-term mortality rates between 234 patients randomized to sertraline (Zoloft, Pfizer Inc.) and an additional 235 who received placebo in an intent-to-treat analysis. At the end of the 12-week trial, there were 144 patients remaining on treatment and 146 others in the placebo group.

There was a significant reduction in Hamilton Depression Rating Scale scores in both groups, compared with baseline. However, no significant differences were found between groups in these Hamilton scores, composite cardiovascular scores, fatal or nonfatal cardiovascular events, or results of the Kansas City Cardiomyopathy Questionnaire. In addition, long-term survival did not differ significantly between groups.

The null findings might result from an effect of a nurse-facilitated supportive intervention for all participants, Dr. Jiang said. “But a placebo effect cannot be ruled out.”

Dr. Jiang receives research support from the NIMH (sponsor of the study), the National Heart, Lung, and Blood Institute, and from Pfizer for an unrelated study. Pfizer's only role in SADHART-CHF was to supply the sertraline, she added.

“We spent 6 years doing the study, and now we are stuck … Other than sertraline, almost all other classes of antidepressants… have cardiovascular concerns,” said Dr. Jiang, who is on both the internal medicine and the psychiatry and behavioral sciences faculties at Duke University, Durham, N.C.

The 469 participants in the primary analysis were 45 years or older, had a New York Heart Association classification of II or higher, and a left ventricular ejection fraction of 45% or less. Mean age was 63 years in the treatment cohort and 62 years in the placebo group. Men comprised 57% and 62%, respectively, of these cohorts.

Those randomized to treatment received sertraline between 50 mg/day and 200 mg/day or matched placebo. The average sertraline dose was 69 mg/day and 75 mg/day for placebo. “That is too low,” a meeting attendee said during a question-and-answer session. “That is what we thought, also,” Dr. Jiang said. “I agree with you, but we felt many patients would drop out [if dosing were higher]. Remember that 41% of the sertraline arm dropped out.”

The same person commented further that sertraline might have been more effective at a higher dose. “There are studies showing 50 mg is enough, so I don't know the right answer,” she replied.

Dr. Jiang also presented results of a posthoc analysis of remission using Hamilton Depression scores. Remission was associated with prognostic and functional improvement in depressed heart failure patients during the 12-week intervention phase. In addition, there was a statistical difference in mean overall cardiovascular events, that favored remitters (1.11) versus nonremitters (1.66) during follow-up.

Again, there was no significant difference in long-term survival between the 208 remitters and 194 nonremitting patients (mean survival of 866 days versus 793 days). The remaining 67 patients were classified as early terminators because they dropped out of the study prior to the first treatment.

Achievement of remission should be a target for additional studies of patients with heart failure and comorbid depression, Dr. Jiang said. In addition, more data are needed to identify factors that might indicate which heart failure patients are likely to respond to different antidepressant modalities, she said.

HOLLYWOOD, FLA. — Sertraline did not significantly improve depressive symptoms or cardiovascular status among depressed patients with heart failure, compared with placebo in a 12-week, randomized, double-blind study.

A second, posthoc analysis of the data indicates patients who achieve depression remission experience prognostic and functional improvements, including statistically fewer mean cardiovascular events during long-term follow-up, compared with nonremitters.

Dr. Wei Jiang presented results of both the primary and secondary analyses of the Sertraline Antidepressant Heart Attack Randomized Trial in Congestive Heart Failure (SADHART-CHF) at a meeting of the New Clinical Drug Evaluation Unit (NCDEU) sponsored by the National Institute of Mental Health.

She and her associates assessed depressive symptoms, cardiovascular status, and long-term mortality rates between 234 patients randomized to sertraline (Zoloft, Pfizer Inc.) and an additional 235 who received placebo in an intent-to-treat analysis. At the end of the 12-week trial, there were 144 patients remaining on treatment and 146 others in the placebo group.

There was a significant reduction in Hamilton Depression Rating Scale scores in both groups, compared with baseline. However, no significant differences were found between groups in these Hamilton scores, composite cardiovascular scores, fatal or nonfatal cardiovascular events, or results of the Kansas City Cardiomyopathy Questionnaire. In addition, long-term survival did not differ significantly between groups.

The null findings might result from an effect of a nurse-facilitated supportive intervention for all participants, Dr. Jiang said. “But a placebo effect cannot be ruled out.”

Dr. Jiang receives research support from the NIMH (sponsor of the study), the National Heart, Lung, and Blood Institute, and from Pfizer for an unrelated study. Pfizer's only role in SADHART-CHF was to supply the sertraline, she added.

“We spent 6 years doing the study, and now we are stuck … Other than sertraline, almost all other classes of antidepressants… have cardiovascular concerns,” said Dr. Jiang, who is on both the internal medicine and the psychiatry and behavioral sciences faculties at Duke University, Durham, N.C.

The 469 participants in the primary analysis were 45 years or older, had a New York Heart Association classification of II or higher, and a left ventricular ejection fraction of 45% or less. Mean age was 63 years in the treatment cohort and 62 years in the placebo group. Men comprised 57% and 62%, respectively, of these cohorts.

Those randomized to treatment received sertraline between 50 mg/day and 200 mg/day or matched placebo. The average sertraline dose was 69 mg/day and 75 mg/day for placebo. “That is too low,” a meeting attendee said during a question-and-answer session. “That is what we thought, also,” Dr. Jiang said. “I agree with you, but we felt many patients would drop out [if dosing were higher]. Remember that 41% of the sertraline arm dropped out.”

The same person commented further that sertraline might have been more effective at a higher dose. “There are studies showing 50 mg is enough, so I don't know the right answer,” she replied.

Dr. Jiang also presented results of a posthoc analysis of remission using Hamilton Depression scores. Remission was associated with prognostic and functional improvement in depressed heart failure patients during the 12-week intervention phase. In addition, there was a statistical difference in mean overall cardiovascular events, that favored remitters (1.11) versus nonremitters (1.66) during follow-up.

Again, there was no significant difference in long-term survival between the 208 remitters and 194 nonremitting patients (mean survival of 866 days versus 793 days). The remaining 67 patients were classified as early terminators because they dropped out of the study prior to the first treatment.

Achievement of remission should be a target for additional studies of patients with heart failure and comorbid depression, Dr. Jiang said. In addition, more data are needed to identify factors that might indicate which heart failure patients are likely to respond to different antidepressant modalities, she said.

HOLLYWOOD, FLA. — Sertraline did not significantly improve depressive symptoms or cardiovascular status among depressed patients with heart failure, compared with placebo in a 12-week, randomized, double-blind study.

A second, posthoc analysis of the data indicates patients who achieve depression remission experience prognostic and functional improvements, including statistically fewer mean cardiovascular events during long-term follow-up, compared with nonremitters.

Dr. Wei Jiang presented results of both the primary and secondary analyses of the Sertraline Antidepressant Heart Attack Randomized Trial in Congestive Heart Failure (SADHART-CHF) at a meeting of the New Clinical Drug Evaluation Unit (NCDEU) sponsored by the National Institute of Mental Health.

She and her associates assessed depressive symptoms, cardiovascular status, and long-term mortality rates between 234 patients randomized to sertraline (Zoloft, Pfizer Inc.) and an additional 235 who received placebo in an intent-to-treat analysis. At the end of the 12-week trial, there were 144 patients remaining on treatment and 146 others in the placebo group.

There was a significant reduction in Hamilton Depression Rating Scale scores in both groups, compared with baseline. However, no significant differences were found between groups in these Hamilton scores, composite cardiovascular scores, fatal or nonfatal cardiovascular events, or results of the Kansas City Cardiomyopathy Questionnaire. In addition, long-term survival did not differ significantly between groups.

The null findings might result from an effect of a nurse-facilitated supportive intervention for all participants, Dr. Jiang said. “But a placebo effect cannot be ruled out.”

Dr. Jiang receives research support from the NIMH (sponsor of the study), the National Heart, Lung, and Blood Institute, and from Pfizer for an unrelated study. Pfizer's only role in SADHART-CHF was to supply the sertraline, she added.

“We spent 6 years doing the study, and now we are stuck … Other than sertraline, almost all other classes of antidepressants… have cardiovascular concerns,” said Dr. Jiang, who is on both the internal medicine and the psychiatry and behavioral sciences faculties at Duke University, Durham, N.C.

The 469 participants in the primary analysis were 45 years or older, had a New York Heart Association classification of II or higher, and a left ventricular ejection fraction of 45% or less. Mean age was 63 years in the treatment cohort and 62 years in the placebo group. Men comprised 57% and 62%, respectively, of these cohorts.

Those randomized to treatment received sertraline between 50 mg/day and 200 mg/day or matched placebo. The average sertraline dose was 69 mg/day and 75 mg/day for placebo. “That is too low,” a meeting attendee said during a question-and-answer session. “That is what we thought, also,” Dr. Jiang said. “I agree with you, but we felt many patients would drop out [if dosing were higher]. Remember that 41% of the sertraline arm dropped out.”

The same person commented further that sertraline might have been more effective at a higher dose. “There are studies showing 50 mg is enough, so I don't know the right answer,” she replied.

Dr. Jiang also presented results of a posthoc analysis of remission using Hamilton Depression scores. Remission was associated with prognostic and functional improvement in depressed heart failure patients during the 12-week intervention phase. In addition, there was a statistical difference in mean overall cardiovascular events, that favored remitters (1.11) versus nonremitters (1.66) during follow-up.

Again, there was no significant difference in long-term survival between the 208 remitters and 194 nonremitting patients (mean survival of 866 days versus 793 days). The remaining 67 patients were classified as early terminators because they dropped out of the study prior to the first treatment.

Achievement of remission should be a target for additional studies of patients with heart failure and comorbid depression, Dr. Jiang said. In addition, more data are needed to identify factors that might indicate which heart failure patients are likely to respond to different antidepressant modalities, she said.

HOLLYWOOD, FLA. – Gabapentin significantly decreases weekly cannabis use while significantly improving craving, depression, and sleep quality symptoms, compared with placebo, the results of a phase II, double-blind, randomized study show.

Cannabis dependence is the most common illicit substance disorder in the United States, Barbara J. Mason, Ph.D., said. However, there are no medications approved by the Food and Drug Administration for withdrawal or relapse prevention in this population.

Dr. Mason placed an advertisement in a free newspaper in San Diego in which she invited potential participants to contact her. She received 745 telephone inquiries. Of those, almost half–350 people–did not return a subsequent telephone call. After excluding a similar number (for example, for comorbid depression and/or anxiety), the final cohort was 50 treatment-seeking outpatients who met DSM-IV criteria for cannabis dependence.

The cohort was “solidly dependent,” according to Dr. Mason. “Nearly every one of the seven criteria for dependence were met, despite a need for only three,” she said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Compared with placebo, gabapentin significantly reduced cannabis use and tetrahydrocannabinol (THC)/creatinine levels, improved mood and sleep quality, and improved executive function.

The participants reported an average 12-year history of daily marijuana smoking. At baseline, they had average urine TCH/creatinine ratio of 673 ng/mg and reported smoking an average 11 grams a week. Dr. Mason said this amount was equivalent to about one to two marijuana cigarettes a day. The gabapentin group demonstrated significant decreases in grams/week of cannabis smoking (P less than .01) and in THC/creatinine levels (P less than .02), compared with placebo.

Similarly, those in the gabapentin group showed significantly greater improvements in marijuana craving severity (P less than .01), Beck Depression Inventory scores (P less than .05), and the Pittsburgh Sleep Quality Index components. “Gabapentin had a rather dramatic effect on daytime dysfunction for week 1 to 8,” said Dr. Mason, professor and member of the Committee on the Neurobiology of Addictive Disorders at the Scripps Research Institute in La Jolla, Calif.

A neuropsychologist joined the study to assess executive function. There was a statistically significant higher number of improvements on the various executive function tasks in the gabapentin group than in the placebo group.

The participants were equally randomized to 12 weeks of 1,200 mg/day gabapentin (available as a generic) or placebo. Men comprised 92% of the treatment and 84% of the placebo cohort. The mean age was 34 years, and 76% of the participants were white. Participants were not paid.

Dr. Mason was surprised at how motivated participants were to quit cannabis use. “Over the course of 12 weeks, between screening and week 0, people cut back on grams-per-week use, with a decrease in THC/creatinine ratio,” Dr. Mason said. “So they were motivated to cut down from their first call to their clinic.”

Before randomized, they underwent 4 weeks of motivational interviewing to set a quit date. This cognitive-behavioral relapse prevention therapy was included “because we thought there would not be a willingness to set a quit date, and we were wrong,” said Dr. Mason, who plans to change the protocol in future study.

“We are not starting with 4 weeks of motivational interviewing. This is a group already coming in willing to start, and it's a mixed signal to tell them to wait 4 weeks.”

A meeting attendee asked Dr. Mason why she chose to study gabapentin.

“It normalizes some CRF [corticotrophin-releasing factor] systems associated with drug withdrawal, as well as the profile with mood and sleep, so we thought we would give it a try,” Dr. Mason said. When it came to sleep, somnolence associated with gabapentin could improve the protracted insomnia typically experienced when people stop using marijuana.

“This is one area where a side effect of a drug … was in the service of the greater good in this population,” Dr. Mason said.

Gabapentin was well tolerated, Dr. Mason said. Dizziness was the only adverse event significantly higher in the treatment group and was reported by 22%, compared with none of the placebo participants.

Dr. Mason said she had no relevant financial disclosures. The study was funded by National Institute on Drug Abuse.

HOLLYWOOD, FLA. – Gabapentin significantly decreases weekly cannabis use while significantly improving craving, depression, and sleep quality symptoms, compared with placebo, the results of a phase II, double-blind, randomized study show.

Cannabis dependence is the most common illicit substance disorder in the United States, Barbara J. Mason, Ph.D., said. However, there are no medications approved by the Food and Drug Administration for withdrawal or relapse prevention in this population.

Dr. Mason placed an advertisement in a free newspaper in San Diego in which she invited potential participants to contact her. She received 745 telephone inquiries. Of those, almost half–350 people–did not return a subsequent telephone call. After excluding a similar number (for example, for comorbid depression and/or anxiety), the final cohort was 50 treatment-seeking outpatients who met DSM-IV criteria for cannabis dependence.

The cohort was “solidly dependent,” according to Dr. Mason. “Nearly every one of the seven criteria for dependence were met, despite a need for only three,” she said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Compared with placebo, gabapentin significantly reduced cannabis use and tetrahydrocannabinol (THC)/creatinine levels, improved mood and sleep quality, and improved executive function.

The participants reported an average 12-year history of daily marijuana smoking. At baseline, they had average urine TCH/creatinine ratio of 673 ng/mg and reported smoking an average 11 grams a week. Dr. Mason said this amount was equivalent to about one to two marijuana cigarettes a day. The gabapentin group demonstrated significant decreases in grams/week of cannabis smoking (P less than .01) and in THC/creatinine levels (P less than .02), compared with placebo.

Similarly, those in the gabapentin group showed significantly greater improvements in marijuana craving severity (P less than .01), Beck Depression Inventory scores (P less than .05), and the Pittsburgh Sleep Quality Index components. “Gabapentin had a rather dramatic effect on daytime dysfunction for week 1 to 8,” said Dr. Mason, professor and member of the Committee on the Neurobiology of Addictive Disorders at the Scripps Research Institute in La Jolla, Calif.

A neuropsychologist joined the study to assess executive function. There was a statistically significant higher number of improvements on the various executive function tasks in the gabapentin group than in the placebo group.

The participants were equally randomized to 12 weeks of 1,200 mg/day gabapentin (available as a generic) or placebo. Men comprised 92% of the treatment and 84% of the placebo cohort. The mean age was 34 years, and 76% of the participants were white. Participants were not paid.

Dr. Mason was surprised at how motivated participants were to quit cannabis use. “Over the course of 12 weeks, between screening and week 0, people cut back on grams-per-week use, with a decrease in THC/creatinine ratio,” Dr. Mason said. “So they were motivated to cut down from their first call to their clinic.”

Before randomized, they underwent 4 weeks of motivational interviewing to set a quit date. This cognitive-behavioral relapse prevention therapy was included “because we thought there would not be a willingness to set a quit date, and we were wrong,” said Dr. Mason, who plans to change the protocol in future study.

“We are not starting with 4 weeks of motivational interviewing. This is a group already coming in willing to start, and it's a mixed signal to tell them to wait 4 weeks.”

A meeting attendee asked Dr. Mason why she chose to study gabapentin.

“It normalizes some CRF [corticotrophin-releasing factor] systems associated with drug withdrawal, as well as the profile with mood and sleep, so we thought we would give it a try,” Dr. Mason said. When it came to sleep, somnolence associated with gabapentin could improve the protracted insomnia typically experienced when people stop using marijuana.

“This is one area where a side effect of a drug … was in the service of the greater good in this population,” Dr. Mason said.

Gabapentin was well tolerated, Dr. Mason said. Dizziness was the only adverse event significantly higher in the treatment group and was reported by 22%, compared with none of the placebo participants.

Dr. Mason said she had no relevant financial disclosures. The study was funded by National Institute on Drug Abuse.

HOLLYWOOD, FLA. – Gabapentin significantly decreases weekly cannabis use while significantly improving craving, depression, and sleep quality symptoms, compared with placebo, the results of a phase II, double-blind, randomized study show.

Cannabis dependence is the most common illicit substance disorder in the United States, Barbara J. Mason, Ph.D., said. However, there are no medications approved by the Food and Drug Administration for withdrawal or relapse prevention in this population.

Dr. Mason placed an advertisement in a free newspaper in San Diego in which she invited potential participants to contact her. She received 745 telephone inquiries. Of those, almost half–350 people–did not return a subsequent telephone call. After excluding a similar number (for example, for comorbid depression and/or anxiety), the final cohort was 50 treatment-seeking outpatients who met DSM-IV criteria for cannabis dependence.

The cohort was “solidly dependent,” according to Dr. Mason. “Nearly every one of the seven criteria for dependence were met, despite a need for only three,” she said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Compared with placebo, gabapentin significantly reduced cannabis use and tetrahydrocannabinol (THC)/creatinine levels, improved mood and sleep quality, and improved executive function.

The participants reported an average 12-year history of daily marijuana smoking. At baseline, they had average urine TCH/creatinine ratio of 673 ng/mg and reported smoking an average 11 grams a week. Dr. Mason said this amount was equivalent to about one to two marijuana cigarettes a day. The gabapentin group demonstrated significant decreases in grams/week of cannabis smoking (P less than .01) and in THC/creatinine levels (P less than .02), compared with placebo.

Similarly, those in the gabapentin group showed significantly greater improvements in marijuana craving severity (P less than .01), Beck Depression Inventory scores (P less than .05), and the Pittsburgh Sleep Quality Index components. “Gabapentin had a rather dramatic effect on daytime dysfunction for week 1 to 8,” said Dr. Mason, professor and member of the Committee on the Neurobiology of Addictive Disorders at the Scripps Research Institute in La Jolla, Calif.

A neuropsychologist joined the study to assess executive function. There was a statistically significant higher number of improvements on the various executive function tasks in the gabapentin group than in the placebo group.

The participants were equally randomized to 12 weeks of 1,200 mg/day gabapentin (available as a generic) or placebo. Men comprised 92% of the treatment and 84% of the placebo cohort. The mean age was 34 years, and 76% of the participants were white. Participants were not paid.

Dr. Mason was surprised at how motivated participants were to quit cannabis use. “Over the course of 12 weeks, between screening and week 0, people cut back on grams-per-week use, with a decrease in THC/creatinine ratio,” Dr. Mason said. “So they were motivated to cut down from their first call to their clinic.”

Before randomized, they underwent 4 weeks of motivational interviewing to set a quit date. This cognitive-behavioral relapse prevention therapy was included “because we thought there would not be a willingness to set a quit date, and we were wrong,” said Dr. Mason, who plans to change the protocol in future study.

“We are not starting with 4 weeks of motivational interviewing. This is a group already coming in willing to start, and it's a mixed signal to tell them to wait 4 weeks.”

A meeting attendee asked Dr. Mason why she chose to study gabapentin.

“It normalizes some CRF [corticotrophin-releasing factor] systems associated with drug withdrawal, as well as the profile with mood and sleep, so we thought we would give it a try,” Dr. Mason said. When it came to sleep, somnolence associated with gabapentin could improve the protracted insomnia typically experienced when people stop using marijuana.

“This is one area where a side effect of a drug … was in the service of the greater good in this population,” Dr. Mason said.

Gabapentin was well tolerated, Dr. Mason said. Dizziness was the only adverse event significantly higher in the treatment group and was reported by 22%, compared with none of the placebo participants.

Dr. Mason said she had no relevant financial disclosures. The study was funded by National Institute on Drug Abuse.

HOLLYWOOD, FLA. — A screen that detects multiple psychiatric disorders in primary care is accurate, fast, and easy to use, according to a validation study of 647 consecutive adults at a primary care clinic.

Psychiatric clinicians and researchers designed the 27-item My Mood Monitor checklist for primary care physicians to detect anxiety, depression, post-traumatic stress disorder (PTSD), and bipolar disorder. The study showed that the combined screening tool has sensitivity and specificity rates similar to that of single-disorder screens commonly used in primary care, according to Dr. Bradley N. Gaynes, associate professor of psychiatry at the University of North Carolina in Chapel Hill.

“I was surprised it did so well with multiple disorders. I didn't think it would line up so well with the single measures,” Dr. Bradley said in an interview at his poster during a meeting of the New Clinical Drug Evaluation Unit, sponsored by the National Institute of Mental Health.

The My Mood Monitor, created for M-3 Information, a not-for-profit entity, had an overall sensitivity of 83% and specificity of 76% (as a screen for any of the four disorders). Sensitivity and specificity for anxiety were 82% and 78%, respectively; for depression, 84% and 80%; for PTSD, 88% and 76%; and for bipolar disorder, 88% and 70%.

For each diagnosis, sensitivity and specificity met or exceeded that for single-item screeners such as the Generalized Anxiety Disorder–7 scale (GAD-7) for anxiety, the Patient Health Questionnaire–9 (PHQ-9) for depression, the Clinician-Administered PTSD Scale (CAPS), and the Mood Disorders Questionnaire for bipolar disorder, Dr. Gaynes said.

The checklist, which takes about 3 to 4 minutes to fill out, can be completed on paper or online at www.mymoodmonitor.com

“It is helpful to review mental health symptoms and emotional symptoms,” Dr. Gaynes said. A total of 80% of doctors found it was helpful to review patients' emotional health, he added.

My Mood Monitor is available for free and is written at a sixth-grade reading level, Dr. Gaynes said.

A reference standard diagnostic interview showed that about one -third of the study cohort screened positive for a disorder. Anywhere “from 25% to 35% [of the general primary care population] might have a psychiatric illness, so we we're in the right general ballpark.”

The study was funded by M-3 Information. Dr. Gaynes received grants and research support from the M-3 Corp. developer of educational software.

Dr. Gaynes has also received support from or been a consultant for Bristol-Myers Squibb Co., Novartis, Pfizer Inc., Ovation Pharmaceuticals, Shire Pharmaceuticals, and Wyeth-Ayerst. He has also received a speaker's honorarium from GlaxoSmithKline.

The checklist, which takes about 3 to 4 minutes to fill out, can be completed on paper or online.

Source DR. GAYNES

HOLLYWOOD, FLA. — A screen that detects multiple psychiatric disorders in primary care is accurate, fast, and easy to use, according to a validation study of 647 consecutive adults at a primary care clinic.

Psychiatric clinicians and researchers designed the 27-item My Mood Monitor checklist for primary care physicians to detect anxiety, depression, post-traumatic stress disorder (PTSD), and bipolar disorder. The study showed that the combined screening tool has sensitivity and specificity rates similar to that of single-disorder screens commonly used in primary care, according to Dr. Bradley N. Gaynes, associate professor of psychiatry at the University of North Carolina in Chapel Hill.

“I was surprised it did so well with multiple disorders. I didn't think it would line up so well with the single measures,” Dr. Bradley said in an interview at his poster during a meeting of the New Clinical Drug Evaluation Unit, sponsored by the National Institute of Mental Health.

The My Mood Monitor, created for M-3 Information, a not-for-profit entity, had an overall sensitivity of 83% and specificity of 76% (as a screen for any of the four disorders). Sensitivity and specificity for anxiety were 82% and 78%, respectively; for depression, 84% and 80%; for PTSD, 88% and 76%; and for bipolar disorder, 88% and 70%.

For each diagnosis, sensitivity and specificity met or exceeded that for single-item screeners such as the Generalized Anxiety Disorder–7 scale (GAD-7) for anxiety, the Patient Health Questionnaire–9 (PHQ-9) for depression, the Clinician-Administered PTSD Scale (CAPS), and the Mood Disorders Questionnaire for bipolar disorder, Dr. Gaynes said.

The checklist, which takes about 3 to 4 minutes to fill out, can be completed on paper or online at www.mymoodmonitor.com

“It is helpful to review mental health symptoms and emotional symptoms,” Dr. Gaynes said. A total of 80% of doctors found it was helpful to review patients' emotional health, he added.

My Mood Monitor is available for free and is written at a sixth-grade reading level, Dr. Gaynes said.

A reference standard diagnostic interview showed that about one -third of the study cohort screened positive for a disorder. Anywhere “from 25% to 35% [of the general primary care population] might have a psychiatric illness, so we we're in the right general ballpark.”

The study was funded by M-3 Information. Dr. Gaynes received grants and research support from the M-3 Corp. developer of educational software.

Dr. Gaynes has also received support from or been a consultant for Bristol-Myers Squibb Co., Novartis, Pfizer Inc., Ovation Pharmaceuticals, Shire Pharmaceuticals, and Wyeth-Ayerst. He has also received a speaker's honorarium from GlaxoSmithKline.

The checklist, which takes about 3 to 4 minutes to fill out, can be completed on paper or online.

Source DR. GAYNES

HOLLYWOOD, FLA. — A screen that detects multiple psychiatric disorders in primary care is accurate, fast, and easy to use, according to a validation study of 647 consecutive adults at a primary care clinic.

Psychiatric clinicians and researchers designed the 27-item My Mood Monitor checklist for primary care physicians to detect anxiety, depression, post-traumatic stress disorder (PTSD), and bipolar disorder. The study showed that the combined screening tool has sensitivity and specificity rates similar to that of single-disorder screens commonly used in primary care, according to Dr. Bradley N. Gaynes, associate professor of psychiatry at the University of North Carolina in Chapel Hill.

“I was surprised it did so well with multiple disorders. I didn't think it would line up so well with the single measures,” Dr. Bradley said in an interview at his poster during a meeting of the New Clinical Drug Evaluation Unit, sponsored by the National Institute of Mental Health.

The My Mood Monitor, created for M-3 Information, a not-for-profit entity, had an overall sensitivity of 83% and specificity of 76% (as a screen for any of the four disorders). Sensitivity and specificity for anxiety were 82% and 78%, respectively; for depression, 84% and 80%; for PTSD, 88% and 76%; and for bipolar disorder, 88% and 70%.

For each diagnosis, sensitivity and specificity met or exceeded that for single-item screeners such as the Generalized Anxiety Disorder–7 scale (GAD-7) for anxiety, the Patient Health Questionnaire–9 (PHQ-9) for depression, the Clinician-Administered PTSD Scale (CAPS), and the Mood Disorders Questionnaire for bipolar disorder, Dr. Gaynes said.

The checklist, which takes about 3 to 4 minutes to fill out, can be completed on paper or online at www.mymoodmonitor.com

“It is helpful to review mental health symptoms and emotional symptoms,” Dr. Gaynes said. A total of 80% of doctors found it was helpful to review patients' emotional health, he added.

My Mood Monitor is available for free and is written at a sixth-grade reading level, Dr. Gaynes said.

A reference standard diagnostic interview showed that about one -third of the study cohort screened positive for a disorder. Anywhere “from 25% to 35% [of the general primary care population] might have a psychiatric illness, so we we're in the right general ballpark.”

The study was funded by M-3 Information. Dr. Gaynes received grants and research support from the M-3 Corp. developer of educational software.

Dr. Gaynes has also received support from or been a consultant for Bristol-Myers Squibb Co., Novartis, Pfizer Inc., Ovation Pharmaceuticals, Shire Pharmaceuticals, and Wyeth-Ayerst. He has also received a speaker's honorarium from GlaxoSmithKline.

The checklist, which takes about 3 to 4 minutes to fill out, can be completed on paper or online.

Source DR. GAYNES

MIAMI BEACH — A value-based insurance program with lower copayments significantly increased use of medications for secondary prevention among people with diabetes, compared with traditional insurance coverage, according to a prospective, controlled study.

The prescription fill rate increased by nearly 5% for metformin, by almost 9% for ACE inhibitors or angiotensin II receptor blockers (ARBs), and by more than 9% for statins among 1,777 diabetics with value-based insurance, compared with a control group of 3,273 diabetics with conventional insurance.

With value-based insurance design (VBID), copayments are lowered for procedures or medications deemed beneficial according to the evidence-based literature. At the same time, copayments are increased for services or drugs that are not well demonstrated to improve outcomes. This design, therefore, acts as both incentive and disincentive for patients to improve health outcomes and control costs, Dr. Allison B. Rosen said at the annual meeting of the Society of General Internal Medicine.

VBID also improved the other primary study outcome, medication adherence, by leading to a significant 7% increase in ACE inhibitor/ARB adherence.

Although evidence-based medicine supports the use of many secondary prevention agents for people with diabetes, underutilization remains a concern, Dr. Rosen said. High out-of-pocket costs are often cited as a culprit, and VBID might make a difference by linking patient copayments to value. “There are few rigorous studies to support these positive claims,” said Dr. Rosen of the University of Michigan, Ann Arbor.

So she and her colleagues enrolled active University of Michigan employees and their dependents with diabetes into a VBID program that reduced their copays for antihypertensive, lipid-lowering, and glucose-lowering agents starting in July 2006. The control patients were employees of other institutions or companies and their dependents with diabetes enrolled in the same managed care plan.

The prescription fill rate at baseline ranged from 53% for statins to 65% for metformin. Following implementation of the VBID program, there was a significant increase in the prescription fill rate for medications from all drug classes in the intervention group, compared with the control group: There was a 4.8% increase for metformin, a 8.5% increase for ACE inhibitors/ARBs, and a 9.3% increase for statins, she reported.

Increases in adherence were less striking. The only significant improvement relative to controls was a 7% increase in adherence to ACE inhibitors or ARBs in the intervention group. Dr. Rosen said that the limited impact was because “baseline adherence rates were quite high, surprisingly so.”

In response to a meeting attendee's question, Dr. Rosen said that for VBID to work effectively, “you cannot just lower all copays. We [also] have to increase copays for low-value interventions.” This was outside the scope of the current study but would need to be incorporated in a complete VBID program.

The study was funded by the National Institutes of Health, the University of Michigan, and the John A. Hartford Foundation.

A related video is at www.youtube.com/InternalMedicineNews

'You cannot just lower all copays. We [also] have to increase copays for low-value interventions.'

Source DR. ROSEN

MIAMI BEACH — A value-based insurance program with lower copayments significantly increased use of medications for secondary prevention among people with diabetes, compared with traditional insurance coverage, according to a prospective, controlled study.

The prescription fill rate increased by nearly 5% for metformin, by almost 9% for ACE inhibitors or angiotensin II receptor blockers (ARBs), and by more than 9% for statins among 1,777 diabetics with value-based insurance, compared with a control group of 3,273 diabetics with conventional insurance.

With value-based insurance design (VBID), copayments are lowered for procedures or medications deemed beneficial according to the evidence-based literature. At the same time, copayments are increased for services or drugs that are not well demonstrated to improve outcomes. This design, therefore, acts as both incentive and disincentive for patients to improve health outcomes and control costs, Dr. Allison B. Rosen said at the annual meeting of the Society of General Internal Medicine.

VBID also improved the other primary study outcome, medication adherence, by leading to a significant 7% increase in ACE inhibitor/ARB adherence.

Although evidence-based medicine supports the use of many secondary prevention agents for people with diabetes, underutilization remains a concern, Dr. Rosen said. High out-of-pocket costs are often cited as a culprit, and VBID might make a difference by linking patient copayments to value. “There are few rigorous studies to support these positive claims,” said Dr. Rosen of the University of Michigan, Ann Arbor.

So she and her colleagues enrolled active University of Michigan employees and their dependents with diabetes into a VBID program that reduced their copays for antihypertensive, lipid-lowering, and glucose-lowering agents starting in July 2006. The control patients were employees of other institutions or companies and their dependents with diabetes enrolled in the same managed care plan.

The prescription fill rate at baseline ranged from 53% for statins to 65% for metformin. Following implementation of the VBID program, there was a significant increase in the prescription fill rate for medications from all drug classes in the intervention group, compared with the control group: There was a 4.8% increase for metformin, a 8.5% increase for ACE inhibitors/ARBs, and a 9.3% increase for statins, she reported.

Increases in adherence were less striking. The only significant improvement relative to controls was a 7% increase in adherence to ACE inhibitors or ARBs in the intervention group. Dr. Rosen said that the limited impact was because “baseline adherence rates were quite high, surprisingly so.”

In response to a meeting attendee's question, Dr. Rosen said that for VBID to work effectively, “you cannot just lower all copays. We [also] have to increase copays for low-value interventions.” This was outside the scope of the current study but would need to be incorporated in a complete VBID program.

The study was funded by the National Institutes of Health, the University of Michigan, and the John A. Hartford Foundation.

A related video is at www.youtube.com/InternalMedicineNews

'You cannot just lower all copays. We [also] have to increase copays for low-value interventions.'

Source DR. ROSEN

MIAMI BEACH — A value-based insurance program with lower copayments significantly increased use of medications for secondary prevention among people with diabetes, compared with traditional insurance coverage, according to a prospective, controlled study.

The prescription fill rate increased by nearly 5% for metformin, by almost 9% for ACE inhibitors or angiotensin II receptor blockers (ARBs), and by more than 9% for statins among 1,777 diabetics with value-based insurance, compared with a control group of 3,273 diabetics with conventional insurance.

With value-based insurance design (VBID), copayments are lowered for procedures or medications deemed beneficial according to the evidence-based literature. At the same time, copayments are increased for services or drugs that are not well demonstrated to improve outcomes. This design, therefore, acts as both incentive and disincentive for patients to improve health outcomes and control costs, Dr. Allison B. Rosen said at the annual meeting of the Society of General Internal Medicine.

VBID also improved the other primary study outcome, medication adherence, by leading to a significant 7% increase in ACE inhibitor/ARB adherence.

Although evidence-based medicine supports the use of many secondary prevention agents for people with diabetes, underutilization remains a concern, Dr. Rosen said. High out-of-pocket costs are often cited as a culprit, and VBID might make a difference by linking patient copayments to value. “There are few rigorous studies to support these positive claims,” said Dr. Rosen of the University of Michigan, Ann Arbor.

So she and her colleagues enrolled active University of Michigan employees and their dependents with diabetes into a VBID program that reduced their copays for antihypertensive, lipid-lowering, and glucose-lowering agents starting in July 2006. The control patients were employees of other institutions or companies and their dependents with diabetes enrolled in the same managed care plan.

The prescription fill rate at baseline ranged from 53% for statins to 65% for metformin. Following implementation of the VBID program, there was a significant increase in the prescription fill rate for medications from all drug classes in the intervention group, compared with the control group: There was a 4.8% increase for metformin, a 8.5% increase for ACE inhibitors/ARBs, and a 9.3% increase for statins, she reported.

Increases in adherence were less striking. The only significant improvement relative to controls was a 7% increase in adherence to ACE inhibitors or ARBs in the intervention group. Dr. Rosen said that the limited impact was because “baseline adherence rates were quite high, surprisingly so.”

In response to a meeting attendee's question, Dr. Rosen said that for VBID to work effectively, “you cannot just lower all copays. We [also] have to increase copays for low-value interventions.” This was outside the scope of the current study but would need to be incorporated in a complete VBID program.

The study was funded by the National Institutes of Health, the University of Michigan, and the John A. Hartford Foundation.

A related video is at www.youtube.com/InternalMedicineNews

'You cannot just lower all copays. We [also] have to increase copays for low-value interventions.'

Source DR. ROSEN

HOLLYWOOD, FLA. — Sertraline did not significantly improve depressive symptoms or cardiovascular status among depressed patients with heart failure, compared with placebo in a 12-week, randomized, double-blind study.

A second, posthoc analysis of the data indicates that patients who achieve remission of depression experience prognostic and functional improvements, including statistically fewer mean cardiovascular events during long-term follow-up, compared with nonremitters.

Dr. Wei Jiang presented results of both the primary and secondary analyses of the Sertraline Antidepressant Heart Attack Randomized Trial in Congestive Heart Failure (SADHART-CHF) at a meeting of the New Clinical Drug Evaluation Unit (NCDEU) sponsored by the National Institute of Mental Health.

She and her associates assessed depressive symptoms, cardiovascular status, and long-term mortality rates in 234 patients who were randomized to sertraline (Zoloft, Pfizer Inc.) and an additional 235 who received placebo. At the end of the 12-week trial, there were 144 patients remaining on treatment and 146 others in the placebo group.

In an intent-to-treat analysis, there was a significant reduction in Hamilton Depression Rating Scale scores in both groups, compared with baseline. However, no significant differences were found between groups in these Hamilton scores, composite cardiovascular scores, fatal or nonfatal cardiovascular events, or results of the Kansas City Cardiomyopathy Questionnaire. In addition, long-term survival did not differ significantly between groups.

The null findings might result from an effect of a nurse-facilitated supportive intervention for all participants, Dr. Jiang said. “But a placebo effect cannot be ruled out.”

Dr. Jiang receives research support from the NIMH (sponsor of the study), the National Heart, Lung, and Blood Institute, and from Pfizer for an unrelated study. Pfizer's only role in SADHART-CHF was to supply the sertraline, she added.

“We spent 6 years doing the study, and now we are stuck. There is no antidepressant we can recommend to cardiologists for this population. Other than sertraline, almost all other classes of antidepressants … have cardiovascular concerns,” said Dr. Jiang, who is on both the internal medicine and the psychiatry and behavioral sciences faculties at Duke University, Durham, N.C.

The search for a safe and effective treatment for depression is important and should continue, Dr. Jiang said, because depression is “highly prevalent” in patients with heart failure. A 22% prevalence of depression was found in a meta-analysis, for example (J. Am. Coll. Cardiol. 2006;48:1527-37).

This study suggested that there was an increased risk for death and secondary cardiac events in depressed versus nondepressed patients (risk ratio 2.1).

The 469 participants in the primary analysis were 45 years or older, had a New York Heart Association classification of II or higher, and a left ventricular ejection fraction of 45% or less. Mean age was 63 years in the treatment cohort and 62 years in the placebo group. Men comprised 57% and 62%, respectively, of these cohorts.

Those randomized to treatment received sertraline between 50 mg/day and 200 mg/day or matched placebo. The average sertraline dose was 69 mg/day and 75 mg/day for placebo. “That is too low,” a meeting attendee said during a question-and-answer session. “That is what we thought, also,” Dr. Jiang said. “I agree with you, but we felt many patients would drop out [if dosing were higher]. Remember that 41% of the sertraline arm dropped out.”

The same person commented further that sertraline might have been more effective at a higher dose. “There are studies showing 50 mg is enough, so I don't know the right answer,” she replied.

Dr. Jiang also presented results of a posthoc analysis of remission using Hamilton Depression scores. Remission was associated with prognostic and functional improvement in depressed heart failure patients during the 12-week intervention phase. In addition, there was a statistical difference in mean overall cardiovascular events between that favored remitters (1.11) versus nonremitters (1.66) during follow-up.

Again, there was no significant difference in long-term survival between the 208 remitters and 194 nonremitting patients (mean survival of 866 days versus 793 days). The remaining 67 patients were classified as early terminators because they dropped out of the study prior to the first treatment.

Achievement of remission should be a target for additional studies of patients with heart failure and comorbid depression, Dr. Jiang said.

In addition, more data are needed to identify factors that might indicate which heart failure patients are likely to respond to different antidepressant modalities, she said.

HOLLYWOOD, FLA. — Sertraline did not significantly improve depressive symptoms or cardiovascular status among depressed patients with heart failure, compared with placebo in a 12-week, randomized, double-blind study.

A second, posthoc analysis of the data indicates that patients who achieve remission of depression experience prognostic and functional improvements, including statistically fewer mean cardiovascular events during long-term follow-up, compared with nonremitters.

Dr. Wei Jiang presented results of both the primary and secondary analyses of the Sertraline Antidepressant Heart Attack Randomized Trial in Congestive Heart Failure (SADHART-CHF) at a meeting of the New Clinical Drug Evaluation Unit (NCDEU) sponsored by the National Institute of Mental Health.

She and her associates assessed depressive symptoms, cardiovascular status, and long-term mortality rates in 234 patients who were randomized to sertraline (Zoloft, Pfizer Inc.) and an additional 235 who received placebo. At the end of the 12-week trial, there were 144 patients remaining on treatment and 146 others in the placebo group.

In an intent-to-treat analysis, there was a significant reduction in Hamilton Depression Rating Scale scores in both groups, compared with baseline. However, no significant differences were found between groups in these Hamilton scores, composite cardiovascular scores, fatal or nonfatal cardiovascular events, or results of the Kansas City Cardiomyopathy Questionnaire. In addition, long-term survival did not differ significantly between groups.

The null findings might result from an effect of a nurse-facilitated supportive intervention for all participants, Dr. Jiang said. “But a placebo effect cannot be ruled out.”

Dr. Jiang receives research support from the NIMH (sponsor of the study), the National Heart, Lung, and Blood Institute, and from Pfizer for an unrelated study. Pfizer's only role in SADHART-CHF was to supply the sertraline, she added.

“We spent 6 years doing the study, and now we are stuck. There is no antidepressant we can recommend to cardiologists for this population. Other than sertraline, almost all other classes of antidepressants … have cardiovascular concerns,” said Dr. Jiang, who is on both the internal medicine and the psychiatry and behavioral sciences faculties at Duke University, Durham, N.C.

The search for a safe and effective treatment for depression is important and should continue, Dr. Jiang said, because depression is “highly prevalent” in patients with heart failure. A 22% prevalence of depression was found in a meta-analysis, for example (J. Am. Coll. Cardiol. 2006;48:1527-37).

This study suggested that there was an increased risk for death and secondary cardiac events in depressed versus nondepressed patients (risk ratio 2.1).

The 469 participants in the primary analysis were 45 years or older, had a New York Heart Association classification of II or higher, and a left ventricular ejection fraction of 45% or less. Mean age was 63 years in the treatment cohort and 62 years in the placebo group. Men comprised 57% and 62%, respectively, of these cohorts.

Those randomized to treatment received sertraline between 50 mg/day and 200 mg/day or matched placebo. The average sertraline dose was 69 mg/day and 75 mg/day for placebo. “That is too low,” a meeting attendee said during a question-and-answer session. “That is what we thought, also,” Dr. Jiang said. “I agree with you, but we felt many patients would drop out [if dosing were higher]. Remember that 41% of the sertraline arm dropped out.”

The same person commented further that sertraline might have been more effective at a higher dose. “There are studies showing 50 mg is enough, so I don't know the right answer,” she replied.

Dr. Jiang also presented results of a posthoc analysis of remission using Hamilton Depression scores. Remission was associated with prognostic and functional improvement in depressed heart failure patients during the 12-week intervention phase. In addition, there was a statistical difference in mean overall cardiovascular events between that favored remitters (1.11) versus nonremitters (1.66) during follow-up.

Again, there was no significant difference in long-term survival between the 208 remitters and 194 nonremitting patients (mean survival of 866 days versus 793 days). The remaining 67 patients were classified as early terminators because they dropped out of the study prior to the first treatment.

Achievement of remission should be a target for additional studies of patients with heart failure and comorbid depression, Dr. Jiang said.

In addition, more data are needed to identify factors that might indicate which heart failure patients are likely to respond to different antidepressant modalities, she said.

HOLLYWOOD, FLA. — Sertraline did not significantly improve depressive symptoms or cardiovascular status among depressed patients with heart failure, compared with placebo in a 12-week, randomized, double-blind study.

A second, posthoc analysis of the data indicates that patients who achieve remission of depression experience prognostic and functional improvements, including statistically fewer mean cardiovascular events during long-term follow-up, compared with nonremitters.

Dr. Wei Jiang presented results of both the primary and secondary analyses of the Sertraline Antidepressant Heart Attack Randomized Trial in Congestive Heart Failure (SADHART-CHF) at a meeting of the New Clinical Drug Evaluation Unit (NCDEU) sponsored by the National Institute of Mental Health.

She and her associates assessed depressive symptoms, cardiovascular status, and long-term mortality rates in 234 patients who were randomized to sertraline (Zoloft, Pfizer Inc.) and an additional 235 who received placebo. At the end of the 12-week trial, there were 144 patients remaining on treatment and 146 others in the placebo group.

In an intent-to-treat analysis, there was a significant reduction in Hamilton Depression Rating Scale scores in both groups, compared with baseline. However, no significant differences were found between groups in these Hamilton scores, composite cardiovascular scores, fatal or nonfatal cardiovascular events, or results of the Kansas City Cardiomyopathy Questionnaire. In addition, long-term survival did not differ significantly between groups.

The null findings might result from an effect of a nurse-facilitated supportive intervention for all participants, Dr. Jiang said. “But a placebo effect cannot be ruled out.”

Dr. Jiang receives research support from the NIMH (sponsor of the study), the National Heart, Lung, and Blood Institute, and from Pfizer for an unrelated study. Pfizer's only role in SADHART-CHF was to supply the sertraline, she added.

“We spent 6 years doing the study, and now we are stuck. There is no antidepressant we can recommend to cardiologists for this population. Other than sertraline, almost all other classes of antidepressants … have cardiovascular concerns,” said Dr. Jiang, who is on both the internal medicine and the psychiatry and behavioral sciences faculties at Duke University, Durham, N.C.

The search for a safe and effective treatment for depression is important and should continue, Dr. Jiang said, because depression is “highly prevalent” in patients with heart failure. A 22% prevalence of depression was found in a meta-analysis, for example (J. Am. Coll. Cardiol. 2006;48:1527-37).

This study suggested that there was an increased risk for death and secondary cardiac events in depressed versus nondepressed patients (risk ratio 2.1).

The 469 participants in the primary analysis were 45 years or older, had a New York Heart Association classification of II or higher, and a left ventricular ejection fraction of 45% or less. Mean age was 63 years in the treatment cohort and 62 years in the placebo group. Men comprised 57% and 62%, respectively, of these cohorts.

Those randomized to treatment received sertraline between 50 mg/day and 200 mg/day or matched placebo. The average sertraline dose was 69 mg/day and 75 mg/day for placebo. “That is too low,” a meeting attendee said during a question-and-answer session. “That is what we thought, also,” Dr. Jiang said. “I agree with you, but we felt many patients would drop out [if dosing were higher]. Remember that 41% of the sertraline arm dropped out.”

The same person commented further that sertraline might have been more effective at a higher dose. “There are studies showing 50 mg is enough, so I don't know the right answer,” she replied.

Dr. Jiang also presented results of a posthoc analysis of remission using Hamilton Depression scores. Remission was associated with prognostic and functional improvement in depressed heart failure patients during the 12-week intervention phase. In addition, there was a statistical difference in mean overall cardiovascular events between that favored remitters (1.11) versus nonremitters (1.66) during follow-up.

Again, there was no significant difference in long-term survival between the 208 remitters and 194 nonremitting patients (mean survival of 866 days versus 793 days). The remaining 67 patients were classified as early terminators because they dropped out of the study prior to the first treatment.

Achievement of remission should be a target for additional studies of patients with heart failure and comorbid depression, Dr. Jiang said.

In addition, more data are needed to identify factors that might indicate which heart failure patients are likely to respond to different antidepressant modalities, she said.

ORLANDO — Vitamin D deficiency is highly prevalent among patients with gastrointestinal cancers, but even a short course of oral supplementation significantly raises vitamin D levels, according to a retrospective study presented as a poster at the annual meeting of the American Society of Clinical Oncology.

Colleen Gilmore, R.N., and her colleagues studied the charts of 100 men and 102 women treated for a variety of gastrointestinal cancers from December 2007 to September 2008 at Washington University in St. Louis. She described the equal sex distribution in the study as important.

“We always look at bone health with women,” Ms. Gilmore said. But vitamin D deficiency “is just as prevalent in men in the cancer and general populations.”

At baseline, the prevalence of vitamin D deficiency was nearly 88%, including 61% of patients who met criteria for moderate to severe deficiency. Therefore, routine evaluation of vitamin D levels in patients with gastrointestinal cancers is warranted, said Ms. Gilmore, a researcher at Washington University's Siteman Cancer Center. She had no financial disclosures.

In all, 92 patients were reevaluated following 8-12 weeks of oral vitamin D supplementation. The percentage of patients with any vitamin D deficiency decreased from 91% to 58% in this group, with moderate to severe deficiency falling from 72% to 13%. There were no significant differences in response by sex, age (65 years or younger vs. older than 65), or tumor type.

The response to vitamin D supplementation was quickest and most striking among black patients, compared with white patients, Ms. Gilmore said in an interview. “They responded the best to oral supplements,” she said. “The African Americans normalized” their vitamin D levels much more quickly.

The researchers identified a subgroup of patients—those who underwent a gastrectomy or a Whipple procedure for cancer resection—who were at particularly elevated risk. “These patients had a more persistent need for supplementation,” Ms. Gilmore said. Closely monitor serum vitamin D levels in these patients, and consider a higher maintenance dose of vitamin D supplementation, she advised.

The study included 98 patients with colorectal cancer and 41 with pancreatic cancer. Other malignancies included neuroendocrine cancer in 18 patients, biliary in 16, gastric in 9, gastrointestinal stromal tumor in 9, hepatocellular carcinoma in 4, and other malignancies in 7.

Vitamin D deficiency was defined as serum 25(OH)D levels less than 30 ng/mL. Mild deficiency was 21-30 ng/mL, moderate was 10-20 ng/mL, and severe deficiency was less than 10 ng/mL.

Participants with a baseline serum vitamin D level of 20 ng/mL or less received prescription vitamin D (50,000 IU) every week for 12 weeks. Patients with a serum baseline level of 21-50 ng/mL received 50,000 IU every week for 8 weeks, and then had their serum levels rechecked. If they remained deficient, they continued the same regimen for another 4 weeks. If their serum levels were greater than 50 ng/mL, they switched to 1,000 IU per day of over-the-counter vitamin D supplements.

Because the study was a retrospective chart review, there were no compliance data, a potential limitation, Ms. Gilmore noted. She added that in the future, prospective studies that assess vitamin D deficiency and supplementation could improve supportive care in patients with GI malignancies. She would like to study the effect of vitamin D supplementation by stage of GI cancer and chemotherapy regimen, and to assess quality of life. “Are we impacting their lives by giving them this supplementation?” she asked.

ORLANDO — Vitamin D deficiency is highly prevalent among patients with gastrointestinal cancers, but even a short course of oral supplementation significantly raises vitamin D levels, according to a retrospective study presented as a poster at the annual meeting of the American Society of Clinical Oncology.

Colleen Gilmore, R.N., and her colleagues studied the charts of 100 men and 102 women treated for a variety of gastrointestinal cancers from December 2007 to September 2008 at Washington University in St. Louis. She described the equal sex distribution in the study as important.

“We always look at bone health with women,” Ms. Gilmore said. But vitamin D deficiency “is just as prevalent in men in the cancer and general populations.”

At baseline, the prevalence of vitamin D deficiency was nearly 88%, including 61% of patients who met criteria for moderate to severe deficiency. Therefore, routine evaluation of vitamin D levels in patients with gastrointestinal cancers is warranted, said Ms. Gilmore, a researcher at Washington University's Siteman Cancer Center. She had no financial disclosures.

In all, 92 patients were reevaluated following 8-12 weeks of oral vitamin D supplementation. The percentage of patients with any vitamin D deficiency decreased from 91% to 58% in this group, with moderate to severe deficiency falling from 72% to 13%. There were no significant differences in response by sex, age (65 years or younger vs. older than 65), or tumor type.

The response to vitamin D supplementation was quickest and most striking among black patients, compared with white patients, Ms. Gilmore said in an interview. “They responded the best to oral supplements,” she said. “The African Americans normalized” their vitamin D levels much more quickly.

The researchers identified a subgroup of patients—those who underwent a gastrectomy or a Whipple procedure for cancer resection—who were at particularly elevated risk. “These patients had a more persistent need for supplementation,” Ms. Gilmore said. Closely monitor serum vitamin D levels in these patients, and consider a higher maintenance dose of vitamin D supplementation, she advised.

The study included 98 patients with colorectal cancer and 41 with pancreatic cancer. Other malignancies included neuroendocrine cancer in 18 patients, biliary in 16, gastric in 9, gastrointestinal stromal tumor in 9, hepatocellular carcinoma in 4, and other malignancies in 7.

Vitamin D deficiency was defined as serum 25(OH)D levels less than 30 ng/mL. Mild deficiency was 21-30 ng/mL, moderate was 10-20 ng/mL, and severe deficiency was less than 10 ng/mL.

Participants with a baseline serum vitamin D level of 20 ng/mL or less received prescription vitamin D (50,000 IU) every week for 12 weeks. Patients with a serum baseline level of 21-50 ng/mL received 50,000 IU every week for 8 weeks, and then had their serum levels rechecked. If they remained deficient, they continued the same regimen for another 4 weeks. If their serum levels were greater than 50 ng/mL, they switched to 1,000 IU per day of over-the-counter vitamin D supplements.

Because the study was a retrospective chart review, there were no compliance data, a potential limitation, Ms. Gilmore noted. She added that in the future, prospective studies that assess vitamin D deficiency and supplementation could improve supportive care in patients with GI malignancies. She would like to study the effect of vitamin D supplementation by stage of GI cancer and chemotherapy regimen, and to assess quality of life. “Are we impacting their lives by giving them this supplementation?” she asked.

ORLANDO — Vitamin D deficiency is highly prevalent among patients with gastrointestinal cancers, but even a short course of oral supplementation significantly raises vitamin D levels, according to a retrospective study presented as a poster at the annual meeting of the American Society of Clinical Oncology.

Colleen Gilmore, R.N., and her colleagues studied the charts of 100 men and 102 women treated for a variety of gastrointestinal cancers from December 2007 to September 2008 at Washington University in St. Louis. She described the equal sex distribution in the study as important.

“We always look at bone health with women,” Ms. Gilmore said. But vitamin D deficiency “is just as prevalent in men in the cancer and general populations.”

At baseline, the prevalence of vitamin D deficiency was nearly 88%, including 61% of patients who met criteria for moderate to severe deficiency. Therefore, routine evaluation of vitamin D levels in patients with gastrointestinal cancers is warranted, said Ms. Gilmore, a researcher at Washington University's Siteman Cancer Center. She had no financial disclosures.

In all, 92 patients were reevaluated following 8-12 weeks of oral vitamin D supplementation. The percentage of patients with any vitamin D deficiency decreased from 91% to 58% in this group, with moderate to severe deficiency falling from 72% to 13%. There were no significant differences in response by sex, age (65 years or younger vs. older than 65), or tumor type.

The response to vitamin D supplementation was quickest and most striking among black patients, compared with white patients, Ms. Gilmore said in an interview. “They responded the best to oral supplements,” she said. “The African Americans normalized” their vitamin D levels much more quickly.

The researchers identified a subgroup of patients—those who underwent a gastrectomy or a Whipple procedure for cancer resection—who were at particularly elevated risk. “These patients had a more persistent need for supplementation,” Ms. Gilmore said. Closely monitor serum vitamin D levels in these patients, and consider a higher maintenance dose of vitamin D supplementation, she advised.

The study included 98 patients with colorectal cancer and 41 with pancreatic cancer. Other malignancies included neuroendocrine cancer in 18 patients, biliary in 16, gastric in 9, gastrointestinal stromal tumor in 9, hepatocellular carcinoma in 4, and other malignancies in 7.

Vitamin D deficiency was defined as serum 25(OH)D levels less than 30 ng/mL. Mild deficiency was 21-30 ng/mL, moderate was 10-20 ng/mL, and severe deficiency was less than 10 ng/mL.

Participants with a baseline serum vitamin D level of 20 ng/mL or less received prescription vitamin D (50,000 IU) every week for 12 weeks. Patients with a serum baseline level of 21-50 ng/mL received 50,000 IU every week for 8 weeks, and then had their serum levels rechecked. If they remained deficient, they continued the same regimen for another 4 weeks. If their serum levels were greater than 50 ng/mL, they switched to 1,000 IU per day of over-the-counter vitamin D supplements.

Because the study was a retrospective chart review, there were no compliance data, a potential limitation, Ms. Gilmore noted. She added that in the future, prospective studies that assess vitamin D deficiency and supplementation could improve supportive care in patients with GI malignancies. She would like to study the effect of vitamin D supplementation by stage of GI cancer and chemotherapy regimen, and to assess quality of life. “Are we impacting their lives by giving them this supplementation?” she asked.