Heidi Splete

WASHINGTON – Flu vaccination rates in the United States are up, and more health care professionals are leading by example, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said at a press conference.

The annual flu vaccine is never perfect, but “we can say with certainty that the best way to protect yourself, your family, and your community is to get a flu shot,” Dr. Frieden said.

About 90 million doses of vaccine are now available, and 170 million doses are expected this year, he said. Availability of the flu vaccine should not be a concern this year, and now is a great time for health care professionals and the public to get their flu vaccines, he added.

Last year, 43% of Americans aged 6 months and older were vaccinated; 8 million more than the previous year, and more than ever before, Dr. Frieden said. The recommendations are the same as last year: “Everyone aged 6 months and older should get the flu vaccine, this year and every year,” he said. Flu shots are necessary each year, even though the strains of flu in this year's vaccine and the viruses seen so far this year are the same as for the 2010-2011 season, he added.

“You need this year's flu shot to protect you against this year's flu,” he said. One shot protects against the flu for the duration of the season, but protection wanes and can't be expected to carry over year to year, he said.

This year, four types of flu vaccine are available: the traditional intramuscular injection, a nasal spray, a high-dose injection for adults aged 65 years and older, and a new intradermal vaccine with a barely noticeable needle, approved for use in those aged 18-64 years.

About 51% of children in the United States received a flu vaccine last year, a 7% increase over the previous year, Dr. Frieden noted. Although the news on vaccination rates is encouraging, “It is critical to continue to make progress; there are too many illnesses and deaths from influenza each year,” he said.

Pediatricians have an important role to play in raising these rates higher, said Dr. O. Marion Burton, president of the American Academy of Pediatrics.

“Pediatricians are normally the first, and sometimes the only contact that some families have with a health care provider,” said Dr. Burton. “Every child needs an influenza vaccine if they are 6 months of age or older,” he said. The only contraindication is for children who have had Guillain-Barré syndrome after an immunization in the past, he said. Children with a moderate to high fever or febrile illness should not be vaccinated until the fever subsides, he said. Children aged 6 months to 8 years who received one dose of flu vaccine last year need only one dose this year, because the vaccine formula is the same, said Dr. Burton. But children aged 6 months to 8 years who are being vaccinated for the first time this year should receive two doses at least 4 weeks apart.

Dr. William Schaffner, president of the National Foundation for Infectious Diseases (NFID), noted that vaccination rates are up among health care workers and that doctors are getting better about recommending flu vaccination to their patients.

A total of 68% of adults said that a health care professional recommended that they get a flu vaccination this year, up from 58% in 2010 and 38% in 2008, according to a nationwide telephone survey of 1,006 adults conducted by the NFID. About 60% of adults who were vaccinated last year said that they did so because a health care professional recommended it.

Last year, 63.5% of health care workers were vaccinated. But there is room for improvement, Dr. Schaffner said.,“There are a lot of health care professionals who still don't understand that it's a patient safety issue,” he noted. “And among some health care professionals, there is that persistent myth that you can get the flu from the flu vaccine, which is incorrect,” he said.

Leadership from the top is essential to improving vaccination rates in health care professionals, Dr. Schaffner said. For example, “A strong senior administrator who makes it clear that we are going to make our hospital environment absolutely as safe as possible for our patients,” which means that flu vaccination is expected, “is essential for increasing flu vaccination among health care professionals,” he said.

To encourage vaccination this year, the NFID introduced a “leading by example” initiative that calls on health care professionals and community and business leaders to get vaccinated themselves.

The press conference was sponsored by the NFID. For updates on the 2011-2012 flu season, visit www.cdc.gov/fluwww.flu.gov

CDC Director Thomas Frieden rolled up his sleeve for a flu shot at a recent press conference as part of the “leading by example” initiative.

Source Heidi Splete/Elsevier Global Medical News

WASHINGTON – Flu vaccination rates in the United States are up, and more health care professionals are leading by example, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said at a press conference.

The annual flu vaccine is never perfect, but “we can say with certainty that the best way to protect yourself, your family, and your community is to get a flu shot,” Dr. Frieden said.

About 90 million doses of vaccine are now available, and 170 million doses are expected this year, he said. Availability of the flu vaccine should not be a concern this year, and now is a great time for health care professionals and the public to get their flu vaccines, he added.

Last year, 43% of Americans aged 6 months and older were vaccinated; 8 million more than the previous year, and more than ever before, Dr. Frieden said. The recommendations are the same as last year: “Everyone aged 6 months and older should get the flu vaccine, this year and every year,” he said. Flu shots are necessary each year, even though the strains of flu in this year's vaccine and the viruses seen so far this year are the same as for the 2010-2011 season, he added.

“You need this year's flu shot to protect you against this year's flu,” he said. One shot protects against the flu for the duration of the season, but protection wanes and can't be expected to carry over year to year, he said.

This year, four types of flu vaccine are available: the traditional intramuscular injection, a nasal spray, a high-dose injection for adults aged 65 years and older, and a new intradermal vaccine with a barely noticeable needle, approved for use in those aged 18-64 years.

About 51% of children in the United States received a flu vaccine last year, a 7% increase over the previous year, Dr. Frieden noted. Although the news on vaccination rates is encouraging, “It is critical to continue to make progress; there are too many illnesses and deaths from influenza each year,” he said.

Pediatricians have an important role to play in raising these rates higher, said Dr. O. Marion Burton, president of the American Academy of Pediatrics.

“Pediatricians are normally the first, and sometimes the only contact that some families have with a health care provider,” said Dr. Burton. “Every child needs an influenza vaccine if they are 6 months of age or older,” he said. The only contraindication is for children who have had Guillain-Barré syndrome after an immunization in the past, he said. Children with a moderate to high fever or febrile illness should not be vaccinated until the fever subsides, he said. Children aged 6 months to 8 years who received one dose of flu vaccine last year need only one dose this year, because the vaccine formula is the same, said Dr. Burton. But children aged 6 months to 8 years who are being vaccinated for the first time this year should receive two doses at least 4 weeks apart.

Dr. William Schaffner, president of the National Foundation for Infectious Diseases (NFID), noted that vaccination rates are up among health care workers and that doctors are getting better about recommending flu vaccination to their patients.

A total of 68% of adults said that a health care professional recommended that they get a flu vaccination this year, up from 58% in 2010 and 38% in 2008, according to a nationwide telephone survey of 1,006 adults conducted by the NFID. About 60% of adults who were vaccinated last year said that they did so because a health care professional recommended it.

Last year, 63.5% of health care workers were vaccinated. But there is room for improvement, Dr. Schaffner said.,“There are a lot of health care professionals who still don't understand that it's a patient safety issue,” he noted. “And among some health care professionals, there is that persistent myth that you can get the flu from the flu vaccine, which is incorrect,” he said.

Leadership from the top is essential to improving vaccination rates in health care professionals, Dr. Schaffner said. For example, “A strong senior administrator who makes it clear that we are going to make our hospital environment absolutely as safe as possible for our patients,” which means that flu vaccination is expected, “is essential for increasing flu vaccination among health care professionals,” he said.

To encourage vaccination this year, the NFID introduced a “leading by example” initiative that calls on health care professionals and community and business leaders to get vaccinated themselves.

The press conference was sponsored by the NFID. For updates on the 2011-2012 flu season, visit www.cdc.gov/fluwww.flu.gov

CDC Director Thomas Frieden rolled up his sleeve for a flu shot at a recent press conference as part of the “leading by example” initiative.

Source Heidi Splete/Elsevier Global Medical News

WASHINGTON – Flu vaccination rates in the United States are up, and more health care professionals are leading by example, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said at a press conference.

The annual flu vaccine is never perfect, but “we can say with certainty that the best way to protect yourself, your family, and your community is to get a flu shot,” Dr. Frieden said.

About 90 million doses of vaccine are now available, and 170 million doses are expected this year, he said. Availability of the flu vaccine should not be a concern this year, and now is a great time for health care professionals and the public to get their flu vaccines, he added.

Last year, 43% of Americans aged 6 months and older were vaccinated; 8 million more than the previous year, and more than ever before, Dr. Frieden said. The recommendations are the same as last year: “Everyone aged 6 months and older should get the flu vaccine, this year and every year,” he said. Flu shots are necessary each year, even though the strains of flu in this year's vaccine and the viruses seen so far this year are the same as for the 2010-2011 season, he added.

“You need this year's flu shot to protect you against this year's flu,” he said. One shot protects against the flu for the duration of the season, but protection wanes and can't be expected to carry over year to year, he said.

This year, four types of flu vaccine are available: the traditional intramuscular injection, a nasal spray, a high-dose injection for adults aged 65 years and older, and a new intradermal vaccine with a barely noticeable needle, approved for use in those aged 18-64 years.

About 51% of children in the United States received a flu vaccine last year, a 7% increase over the previous year, Dr. Frieden noted. Although the news on vaccination rates is encouraging, “It is critical to continue to make progress; there are too many illnesses and deaths from influenza each year,” he said.

Pediatricians have an important role to play in raising these rates higher, said Dr. O. Marion Burton, president of the American Academy of Pediatrics.

“Pediatricians are normally the first, and sometimes the only contact that some families have with a health care provider,” said Dr. Burton. “Every child needs an influenza vaccine if they are 6 months of age or older,” he said. The only contraindication is for children who have had Guillain-Barré syndrome after an immunization in the past, he said. Children with a moderate to high fever or febrile illness should not be vaccinated until the fever subsides, he said. Children aged 6 months to 8 years who received one dose of flu vaccine last year need only one dose this year, because the vaccine formula is the same, said Dr. Burton. But children aged 6 months to 8 years who are being vaccinated for the first time this year should receive two doses at least 4 weeks apart.

Dr. William Schaffner, president of the National Foundation for Infectious Diseases (NFID), noted that vaccination rates are up among health care workers and that doctors are getting better about recommending flu vaccination to their patients.

A total of 68% of adults said that a health care professional recommended that they get a flu vaccination this year, up from 58% in 2010 and 38% in 2008, according to a nationwide telephone survey of 1,006 adults conducted by the NFID. About 60% of adults who were vaccinated last year said that they did so because a health care professional recommended it.

Last year, 63.5% of health care workers were vaccinated. But there is room for improvement, Dr. Schaffner said.,“There are a lot of health care professionals who still don't understand that it's a patient safety issue,” he noted. “And among some health care professionals, there is that persistent myth that you can get the flu from the flu vaccine, which is incorrect,” he said.

Leadership from the top is essential to improving vaccination rates in health care professionals, Dr. Schaffner said. For example, “A strong senior administrator who makes it clear that we are going to make our hospital environment absolutely as safe as possible for our patients,” which means that flu vaccination is expected, “is essential for increasing flu vaccination among health care professionals,” he said.

To encourage vaccination this year, the NFID introduced a “leading by example” initiative that calls on health care professionals and community and business leaders to get vaccinated themselves.

The press conference was sponsored by the NFID. For updates on the 2011-2012 flu season, visit www.cdc.gov/fluwww.flu.gov

CDC Director Thomas Frieden rolled up his sleeve for a flu shot at a recent press conference as part of the “leading by example” initiative.

Source Heidi Splete/Elsevier Global Medical News

Major Finding: The mean difference in the global PSQI sleep scores, compared with a placebo, after 4 weeks of treatment was −1.74 in women who took 1,200 mg of gabapentin daily and −1.68 in women who took 1,800 mg daily; the differences were significant for both doses, compared with a placebo.

Data Source: The Breeze 1 and Breeze 2 studies, which were phase III, double-blind, placebo-controlled trials conducted at multiple sites in the United States.

Disclosures: The studies were supported by Depomed. Dr. Baron had no financial conflicts to disclose. One study coauthor is an employee of Depomed. Dr. Kagan disclosed serving as a consultant or advisory board member for multiple companies, including Amgen, Bionovo, Depomed, Merck, Pfizer, and Shionogi. She disclosed receiving research support from Bionovo, BioSante Pharmaceuticals, Boehringer–Ingelheim, Depomed, and Pfizer, and serving on the speakers bureau for Amgen, Novogyne, and Novo Nordisk.

NATIONAL HARBOR, MD. – Extended-release gabapentin at daily doses of either 1,200 mg or 1,800 mg significantly reduced the number and severity of hot flashes and significantly improved sleep problems, compared with a placebo, in postmenopausal women.

Currently, hormone therapy is the only approved treatment for hot flashes in North America and Europe, said Dr. Mira Baron of Rapid Medical Research Inc., Cleveland, and colleagues.

In previous studies, gabapentin has shown effectiveness in reducing the frequency and severity of hot flashes, but its short half-life may limit its usefulness, the researchers said. However, an extended-release, once-daily dose of gabapentin was approved by the Food and Drug Administration in February 2011 to treat postherpetic neuralgia, she said.

In Breeze 2, a phase III, double-blind, placebo-controlled trial conducted at 45 sites, Dr. Baron and colleagues compared the effectiveness of 1,200 mg of extended-release gabapentin once daily vs. 1,800 mg twice daily (600 mg in the morning and 1,200 mg at night) on frequency and severity of hot flashes.

A total of 559 women completed 12 weeks of treatment and were included in the intent-to-treat population; 190 were randomized to once-daily treatment, 186 were randomized to twice-daily treatment, and 183 were randomized to a placebo.

The average age of the patients was 53 years, and the mean age at menopause was 44 years. The eligible participants reported at least seven moderate to severe hot flashes per day during a 1-week baseline period before they started the study.

Overall, the median daily number of hot flashes dropped significantly after 12 weeks of treatment in both treatment groups, compared with the placebo group. The number of daily hot flashes dropped to three in the placebo group and to two in the two treatment groups.

In addition, the severity of the hot flashes decreased significantly from baseline in both treatment groups, compared with the placebo group. The mean change in vasomotor severity score, compared with baseline, was −0.9 in the once-daily group, −0.8 in the twice-daily group, and −0.6 in the placebo group. The reduction in the severity of vasomotor symptoms was significant for both treatment doses, compared with the placebo. “However, the 1,800-mg dosage yielded more significant changes than the 1,200-mg dosage,” the researchers noted.

In a second study, Dr. Risa Kagan of the Alta Bates Summit Medical Center, Berkeley, Calif., and colleagues studied the effectiveness of extended-release gabapentin on improving sleep problems commonly reported by postmenopausal women.

The researchers compared the effects of extended-release gabapentin vs. a placebo on sleep problems in postmenopausal women using data from the Breeze 1 study, which was a phase III, double-blind, placebo-controlled trial conducted at 48 sites. A total of 531 women made up the intent-to-treat population, and they were randomized to gabapentin 1,200 mg once daily, to 1,800 mg twice daily (600 mg in the morning and 1,200 mg at night), or to a placebo.

Overall, global scores on the PSQI (Pittsburgh Sleep Quality Index) improved significantly with both gabapentin doses, compared with the placebo, at three separate time points.

After 4 weeks, the mean difference in the global PSQI scores was −1.74 in the once-daily group and −1.68 in the twice-daily group. After 12 weeks, the mean differences in the global PSQI for the two treatment groups, compared with placebo, were −1.16 and −0.80, respectively. After 24 weeks, the mean differences in global PSQI scores for the two treatment groups, compared with placebo, were −0.77 and −0.93, respectively.

“The largest differences between the active arms and the placebo arm were observed at week 4,” the researchers said. “The decrease in the magnitude of improvement over time likely resulted from the fact that the PSQI instrument requests reporting for the previous 4 weeks.” However, the global scores did improve throughout the study, they noted.

Although the drug is not currently approved for this indication, the findings suggest that extended-release gabapentin might have potential as a treatment option for hot flashes and sleep disturbances in postmenopausal women who are reluctant to use hormonal therapies, the researchers said.

View on the News

A Reasonable Agent

Gabapentin is a very reasonable agent to study for hot flashes and sleep problems in postmenopausal women. Both of these problems are common concerns for midlife women. For women who cannot – or choose not to – take hormone therapy, a Food and Drug Administration–approved alternative is needed.

Small, randomized trials of non–extended-release gabapentin showed efficacy, compared with placebo. Side effects include drowsiness and sedation, so its use at bedtime often kills two birds with one stone. It's interesting that in these studies, daytime fatigue was not a side effect of this new extended-release formulation.

Gabapentin already is being used off label for night sweats and sleep problems in postmenopausal women. I discuss both gabapentin and SSRIs/SNRIs with my symptomatic patients who cannot – or choose not to – use hormone therapy, and they often elect a trial of gabapentin. If they're not depressed, many women do not like the idea of being on an antidepressant, and these agents have side effects as well. If daytime hot flashes are manageable, but night sweats and sleep disruption are a woman's principal concerns, then gabapentin is a very good off-label option.

JAN L. SHIFREN, M.D., is associate professor of ob.gyn. and reproductive biology at Harvard Medical School, Boston. She reported having no relevant conflicts of interest.

Major Finding: The mean difference in the global PSQI sleep scores, compared with a placebo, after 4 weeks of treatment was −1.74 in women who took 1,200 mg of gabapentin daily and −1.68 in women who took 1,800 mg daily; the differences were significant for both doses, compared with a placebo.

Data Source: The Breeze 1 and Breeze 2 studies, which were phase III, double-blind, placebo-controlled trials conducted at multiple sites in the United States.

Disclosures: The studies were supported by Depomed. Dr. Baron had no financial conflicts to disclose. One study coauthor is an employee of Depomed. Dr. Kagan disclosed serving as a consultant or advisory board member for multiple companies, including Amgen, Bionovo, Depomed, Merck, Pfizer, and Shionogi. She disclosed receiving research support from Bionovo, BioSante Pharmaceuticals, Boehringer–Ingelheim, Depomed, and Pfizer, and serving on the speakers bureau for Amgen, Novogyne, and Novo Nordisk.

NATIONAL HARBOR, MD. – Extended-release gabapentin at daily doses of either 1,200 mg or 1,800 mg significantly reduced the number and severity of hot flashes and significantly improved sleep problems, compared with a placebo, in postmenopausal women.

Currently, hormone therapy is the only approved treatment for hot flashes in North America and Europe, said Dr. Mira Baron of Rapid Medical Research Inc., Cleveland, and colleagues.

In previous studies, gabapentin has shown effectiveness in reducing the frequency and severity of hot flashes, but its short half-life may limit its usefulness, the researchers said. However, an extended-release, once-daily dose of gabapentin was approved by the Food and Drug Administration in February 2011 to treat postherpetic neuralgia, she said.

In Breeze 2, a phase III, double-blind, placebo-controlled trial conducted at 45 sites, Dr. Baron and colleagues compared the effectiveness of 1,200 mg of extended-release gabapentin once daily vs. 1,800 mg twice daily (600 mg in the morning and 1,200 mg at night) on frequency and severity of hot flashes.

A total of 559 women completed 12 weeks of treatment and were included in the intent-to-treat population; 190 were randomized to once-daily treatment, 186 were randomized to twice-daily treatment, and 183 were randomized to a placebo.

The average age of the patients was 53 years, and the mean age at menopause was 44 years. The eligible participants reported at least seven moderate to severe hot flashes per day during a 1-week baseline period before they started the study.

Overall, the median daily number of hot flashes dropped significantly after 12 weeks of treatment in both treatment groups, compared with the placebo group. The number of daily hot flashes dropped to three in the placebo group and to two in the two treatment groups.

In addition, the severity of the hot flashes decreased significantly from baseline in both treatment groups, compared with the placebo group. The mean change in vasomotor severity score, compared with baseline, was −0.9 in the once-daily group, −0.8 in the twice-daily group, and −0.6 in the placebo group. The reduction in the severity of vasomotor symptoms was significant for both treatment doses, compared with the placebo. “However, the 1,800-mg dosage yielded more significant changes than the 1,200-mg dosage,” the researchers noted.

In a second study, Dr. Risa Kagan of the Alta Bates Summit Medical Center, Berkeley, Calif., and colleagues studied the effectiveness of extended-release gabapentin on improving sleep problems commonly reported by postmenopausal women.

The researchers compared the effects of extended-release gabapentin vs. a placebo on sleep problems in postmenopausal women using data from the Breeze 1 study, which was a phase III, double-blind, placebo-controlled trial conducted at 48 sites. A total of 531 women made up the intent-to-treat population, and they were randomized to gabapentin 1,200 mg once daily, to 1,800 mg twice daily (600 mg in the morning and 1,200 mg at night), or to a placebo.

Overall, global scores on the PSQI (Pittsburgh Sleep Quality Index) improved significantly with both gabapentin doses, compared with the placebo, at three separate time points.

After 4 weeks, the mean difference in the global PSQI scores was −1.74 in the once-daily group and −1.68 in the twice-daily group. After 12 weeks, the mean differences in the global PSQI for the two treatment groups, compared with placebo, were −1.16 and −0.80, respectively. After 24 weeks, the mean differences in global PSQI scores for the two treatment groups, compared with placebo, were −0.77 and −0.93, respectively.

“The largest differences between the active arms and the placebo arm were observed at week 4,” the researchers said. “The decrease in the magnitude of improvement over time likely resulted from the fact that the PSQI instrument requests reporting for the previous 4 weeks.” However, the global scores did improve throughout the study, they noted.

Although the drug is not currently approved for this indication, the findings suggest that extended-release gabapentin might have potential as a treatment option for hot flashes and sleep disturbances in postmenopausal women who are reluctant to use hormonal therapies, the researchers said.

View on the News

A Reasonable Agent

Gabapentin is a very reasonable agent to study for hot flashes and sleep problems in postmenopausal women. Both of these problems are common concerns for midlife women. For women who cannot – or choose not to – take hormone therapy, a Food and Drug Administration–approved alternative is needed.

Small, randomized trials of non–extended-release gabapentin showed efficacy, compared with placebo. Side effects include drowsiness and sedation, so its use at bedtime often kills two birds with one stone. It's interesting that in these studies, daytime fatigue was not a side effect of this new extended-release formulation.

Gabapentin already is being used off label for night sweats and sleep problems in postmenopausal women. I discuss both gabapentin and SSRIs/SNRIs with my symptomatic patients who cannot – or choose not to – use hormone therapy, and they often elect a trial of gabapentin. If they're not depressed, many women do not like the idea of being on an antidepressant, and these agents have side effects as well. If daytime hot flashes are manageable, but night sweats and sleep disruption are a woman's principal concerns, then gabapentin is a very good off-label option.

JAN L. SHIFREN, M.D., is associate professor of ob.gyn. and reproductive biology at Harvard Medical School, Boston. She reported having no relevant conflicts of interest.

Major Finding: The mean difference in the global PSQI sleep scores, compared with a placebo, after 4 weeks of treatment was −1.74 in women who took 1,200 mg of gabapentin daily and −1.68 in women who took 1,800 mg daily; the differences were significant for both doses, compared with a placebo.

Data Source: The Breeze 1 and Breeze 2 studies, which were phase III, double-blind, placebo-controlled trials conducted at multiple sites in the United States.

Disclosures: The studies were supported by Depomed. Dr. Baron had no financial conflicts to disclose. One study coauthor is an employee of Depomed. Dr. Kagan disclosed serving as a consultant or advisory board member for multiple companies, including Amgen, Bionovo, Depomed, Merck, Pfizer, and Shionogi. She disclosed receiving research support from Bionovo, BioSante Pharmaceuticals, Boehringer–Ingelheim, Depomed, and Pfizer, and serving on the speakers bureau for Amgen, Novogyne, and Novo Nordisk.

NATIONAL HARBOR, MD. – Extended-release gabapentin at daily doses of either 1,200 mg or 1,800 mg significantly reduced the number and severity of hot flashes and significantly improved sleep problems, compared with a placebo, in postmenopausal women.

Currently, hormone therapy is the only approved treatment for hot flashes in North America and Europe, said Dr. Mira Baron of Rapid Medical Research Inc., Cleveland, and colleagues.

In previous studies, gabapentin has shown effectiveness in reducing the frequency and severity of hot flashes, but its short half-life may limit its usefulness, the researchers said. However, an extended-release, once-daily dose of gabapentin was approved by the Food and Drug Administration in February 2011 to treat postherpetic neuralgia, she said.

In Breeze 2, a phase III, double-blind, placebo-controlled trial conducted at 45 sites, Dr. Baron and colleagues compared the effectiveness of 1,200 mg of extended-release gabapentin once daily vs. 1,800 mg twice daily (600 mg in the morning and 1,200 mg at night) on frequency and severity of hot flashes.

A total of 559 women completed 12 weeks of treatment and were included in the intent-to-treat population; 190 were randomized to once-daily treatment, 186 were randomized to twice-daily treatment, and 183 were randomized to a placebo.

The average age of the patients was 53 years, and the mean age at menopause was 44 years. The eligible participants reported at least seven moderate to severe hot flashes per day during a 1-week baseline period before they started the study.

Overall, the median daily number of hot flashes dropped significantly after 12 weeks of treatment in both treatment groups, compared with the placebo group. The number of daily hot flashes dropped to three in the placebo group and to two in the two treatment groups.

In addition, the severity of the hot flashes decreased significantly from baseline in both treatment groups, compared with the placebo group. The mean change in vasomotor severity score, compared with baseline, was −0.9 in the once-daily group, −0.8 in the twice-daily group, and −0.6 in the placebo group. The reduction in the severity of vasomotor symptoms was significant for both treatment doses, compared with the placebo. “However, the 1,800-mg dosage yielded more significant changes than the 1,200-mg dosage,” the researchers noted.

In a second study, Dr. Risa Kagan of the Alta Bates Summit Medical Center, Berkeley, Calif., and colleagues studied the effectiveness of extended-release gabapentin on improving sleep problems commonly reported by postmenopausal women.

The researchers compared the effects of extended-release gabapentin vs. a placebo on sleep problems in postmenopausal women using data from the Breeze 1 study, which was a phase III, double-blind, placebo-controlled trial conducted at 48 sites. A total of 531 women made up the intent-to-treat population, and they were randomized to gabapentin 1,200 mg once daily, to 1,800 mg twice daily (600 mg in the morning and 1,200 mg at night), or to a placebo.

Overall, global scores on the PSQI (Pittsburgh Sleep Quality Index) improved significantly with both gabapentin doses, compared with the placebo, at three separate time points.

After 4 weeks, the mean difference in the global PSQI scores was −1.74 in the once-daily group and −1.68 in the twice-daily group. After 12 weeks, the mean differences in the global PSQI for the two treatment groups, compared with placebo, were −1.16 and −0.80, respectively. After 24 weeks, the mean differences in global PSQI scores for the two treatment groups, compared with placebo, were −0.77 and −0.93, respectively.

“The largest differences between the active arms and the placebo arm were observed at week 4,” the researchers said. “The decrease in the magnitude of improvement over time likely resulted from the fact that the PSQI instrument requests reporting for the previous 4 weeks.” However, the global scores did improve throughout the study, they noted.

Although the drug is not currently approved for this indication, the findings suggest that extended-release gabapentin might have potential as a treatment option for hot flashes and sleep disturbances in postmenopausal women who are reluctant to use hormonal therapies, the researchers said.

View on the News

A Reasonable Agent

Gabapentin is a very reasonable agent to study for hot flashes and sleep problems in postmenopausal women. Both of these problems are common concerns for midlife women. For women who cannot – or choose not to – take hormone therapy, a Food and Drug Administration–approved alternative is needed.

Small, randomized trials of non–extended-release gabapentin showed efficacy, compared with placebo. Side effects include drowsiness and sedation, so its use at bedtime often kills two birds with one stone. It's interesting that in these studies, daytime fatigue was not a side effect of this new extended-release formulation.

Gabapentin already is being used off label for night sweats and sleep problems in postmenopausal women. I discuss both gabapentin and SSRIs/SNRIs with my symptomatic patients who cannot – or choose not to – use hormone therapy, and they often elect a trial of gabapentin. If they're not depressed, many women do not like the idea of being on an antidepressant, and these agents have side effects as well. If daytime hot flashes are manageable, but night sweats and sleep disruption are a woman's principal concerns, then gabapentin is a very good off-label option.

JAN L. SHIFREN, M.D., is associate professor of ob.gyn. and reproductive biology at Harvard Medical School, Boston. She reported having no relevant conflicts of interest.

Major Finding: Each additional year of premenopausal estradiol exposure conveyed a 15% reduction in risk of depression during menopause (hazard ratio, 0.85).

Data Source: 1,282 women in the Study of Women's Health Across the Nation (SWAN).

Disclosures: The SWAN is supported by grants from the National Institutes of Health, the Department of Health and Human Services, the National Institute of Nursing Research, and the NIH Office of Research on Women's Health. Dr. Marsh reported having no relevant disclosures.

NATIONAL HARBOR, MD. – Women who had a longer exposure to estradiol before menopause had a significantly lower risk of developing depression during the menopausal transition, based on data from 1,282 women.

“It is unclear why some women are at increased risk of depression while undergoing the menopausal transition,” said Dr. Wendy Marsh of the University of Massachusetts, Worcester.

Data from previous studies have suggested that endocrine factors in general, and estrogen levels in particular, may contribute to a woman's susceptibility to depression during menopause, she noted.

Dr. Marsh and her colleagues reviewed data from 1,282 women participating in the Study of Women's Health Across the Nation (SWAN), a multisite, long-term epidemiologic study of women during midlife and through the menopausal transition. The women were premenopausal when they entered the study.

Each additional year of premenopausal estradiol exposure conveyed a 15% reduction in risk of experiencing depression during menopause (hazard ratio, 0.85) after confounding factors including premenopausal depression, baseline age, smoking status, education, antidepressant use, ethnicity, and length of time in the study were controlled for.

The average duration of estradiol exposure was 36 years. Longer exposure was significantly associated with a lower risk of having a score of 16 or higher on the Center for Epidemiologic Studies Depression (CES-D) scale.

Estradiol has been shown to affect mood regulation, Dr. Marsh noted, but “it is unknown how such a modulatory effect during premenopausal years would lead to a protective effect against depression during the menopausal transition,” she said.

Although these data are preliminary, they may provide a foundation for further research that may help clinicians identify and manage women at increased risk for depression during menopause.

“Additional analyses will further qualify and quantify other variables related to estrogen exposure, including use of oral contraceptives, pregnancies, and lactation,” Dr. Marsh said.

Major Finding: Each additional year of premenopausal estradiol exposure conveyed a 15% reduction in risk of depression during menopause (hazard ratio, 0.85).

Data Source: 1,282 women in the Study of Women's Health Across the Nation (SWAN).

Disclosures: The SWAN is supported by grants from the National Institutes of Health, the Department of Health and Human Services, the National Institute of Nursing Research, and the NIH Office of Research on Women's Health. Dr. Marsh reported having no relevant disclosures.

NATIONAL HARBOR, MD. – Women who had a longer exposure to estradiol before menopause had a significantly lower risk of developing depression during the menopausal transition, based on data from 1,282 women.

“It is unclear why some women are at increased risk of depression while undergoing the menopausal transition,” said Dr. Wendy Marsh of the University of Massachusetts, Worcester.

Data from previous studies have suggested that endocrine factors in general, and estrogen levels in particular, may contribute to a woman's susceptibility to depression during menopause, she noted.

Dr. Marsh and her colleagues reviewed data from 1,282 women participating in the Study of Women's Health Across the Nation (SWAN), a multisite, long-term epidemiologic study of women during midlife and through the menopausal transition. The women were premenopausal when they entered the study.

Each additional year of premenopausal estradiol exposure conveyed a 15% reduction in risk of experiencing depression during menopause (hazard ratio, 0.85) after confounding factors including premenopausal depression, baseline age, smoking status, education, antidepressant use, ethnicity, and length of time in the study were controlled for.

The average duration of estradiol exposure was 36 years. Longer exposure was significantly associated with a lower risk of having a score of 16 or higher on the Center for Epidemiologic Studies Depression (CES-D) scale.

Estradiol has been shown to affect mood regulation, Dr. Marsh noted, but “it is unknown how such a modulatory effect during premenopausal years would lead to a protective effect against depression during the menopausal transition,” she said.

Although these data are preliminary, they may provide a foundation for further research that may help clinicians identify and manage women at increased risk for depression during menopause.

“Additional analyses will further qualify and quantify other variables related to estrogen exposure, including use of oral contraceptives, pregnancies, and lactation,” Dr. Marsh said.

Major Finding: Each additional year of premenopausal estradiol exposure conveyed a 15% reduction in risk of depression during menopause (hazard ratio, 0.85).

Data Source: 1,282 women in the Study of Women's Health Across the Nation (SWAN).

Disclosures: The SWAN is supported by grants from the National Institutes of Health, the Department of Health and Human Services, the National Institute of Nursing Research, and the NIH Office of Research on Women's Health. Dr. Marsh reported having no relevant disclosures.

NATIONAL HARBOR, MD. – Women who had a longer exposure to estradiol before menopause had a significantly lower risk of developing depression during the menopausal transition, based on data from 1,282 women.

“It is unclear why some women are at increased risk of depression while undergoing the menopausal transition,” said Dr. Wendy Marsh of the University of Massachusetts, Worcester.

Data from previous studies have suggested that endocrine factors in general, and estrogen levels in particular, may contribute to a woman's susceptibility to depression during menopause, she noted.

Dr. Marsh and her colleagues reviewed data from 1,282 women participating in the Study of Women's Health Across the Nation (SWAN), a multisite, long-term epidemiologic study of women during midlife and through the menopausal transition. The women were premenopausal when they entered the study.

Each additional year of premenopausal estradiol exposure conveyed a 15% reduction in risk of experiencing depression during menopause (hazard ratio, 0.85) after confounding factors including premenopausal depression, baseline age, smoking status, education, antidepressant use, ethnicity, and length of time in the study were controlled for.

The average duration of estradiol exposure was 36 years. Longer exposure was significantly associated with a lower risk of having a score of 16 or higher on the Center for Epidemiologic Studies Depression (CES-D) scale.

Estradiol has been shown to affect mood regulation, Dr. Marsh noted, but “it is unknown how such a modulatory effect during premenopausal years would lead to a protective effect against depression during the menopausal transition,” she said.

Although these data are preliminary, they may provide a foundation for further research that may help clinicians identify and manage women at increased risk for depression during menopause.

“Additional analyses will further qualify and quantify other variables related to estrogen exposure, including use of oral contraceptives, pregnancies, and lactation,” Dr. Marsh said.

Major Finding: In an intent-to-treat population, the change in the vaginal dryness severity score improved in the OSP group vs. the placebo group (−1.3 vs. −1.1).

Data Source: A 12-week study of 314 postmenopausal women who had vaginal dryness and were randomized to 60 mg of OSP orally each morning or a placebo.

Disclosures: The study was sponsored in part by Shionogi, which developed and markets ospemifene, and several coinvestigators were Shionogi employees. Dr. Portman has received consulting fees, honoraria, and/or grant support from multiple companies including Shionogi, Bayer, Boehringer Ingelheim, Teva, Warner Chilcott, and Watson Pharmaceuticals.

NATIONAL HARBOR, MD. – A novel selective estrogen–receptor modulator called ospemifene was more effective than placebo for reducing symptoms of vaginal dryness and dyspareunia in a study of 919 postmenopausal women.

Only estrogen-based treatments have been approved in the United States to treat vulvovaginal atrophy (VVA) in postmenopausal women, but concerns about the effects of estrogen on breast and endometrial tissue have prompted doctors and patients to seek alternatives, said Dr. David Portman of the Columbus (Ohio) Center for Women's Health Research.

“We do need to find alternatives because many of our patients still have concerns even with local estrogen,” he emphasized.

Ospemifene (OSP), a selective estrogen–receptor modulator (SERM) – also referred to as a nonsteroidal estrogen–receptor agonist/antagonist – is distinct from other SERMs because its estrogenic activity occurs on the vaginal epithelium, “but not on the endometrium,” said Dr. Portman.

Previous studies have shown that ospemifene is well tolerated, with a favorable pharmacologic profile in postmenopausal women with VVA, he added.

In a 12-week randomized, double-blind, placebo-controlled, phase III parallel group study, Dr. Portman and his colleagues assessed the efficacy, safety, and tolerability of ospemifene for women with moderate to severe vaginal dryness or moderate to severe dyspareunia.

Dyspareunia symptoms and severity were self-reported, and use of a nonhormonal vaginal lubricant was permitted as needed.

Demographic characteristics were similar between the two groups.

The women ranged from 40 to 80 years of age at baseline.

Those with a body mass index of 37 kg/m

A total of 314 postmenopausal women who reported vaginal dryness as their primary symptom were randomized to 60 mg of OSP orally each morning or a placebo, the researchers said.

In the intent-to-treat population, the change in the vaginal dryness severity score improved in the OSP group vs. the placebo group (−1.3 vs. −1.1).

In addition, the percentages of superficial and parabasal cells were significantly different in the OSP group vs. the placebo group (12% vs. 3% and −32% vs. −4%, respectively).

Measuring these types of cells indicates changes in the vaginal microflora, which have been shown to affect vaginal dryness and pain.

The mean change in vaginal pH was −1.01 in the OSP group, compared with −0.25 in the placebo group, respectively.

An additional 605 women who reported dyspareunia as their primary symptom were randomized to 60 mg OSP orally each morning or a placebo.

In the intent-to-treat population, the change in the dyspareunia severity score improved in the OSP group vs. the placebo group (−1.5 vs. −1.2, P = .0001), a significant difference.

In addition, the percentages of superficial cells and parabasal cells were significantly different in the OSP vs. the placebo groups (12% vs. 2% and −40% vs. 0%, respectively).

The mean change in vaginal pH also differed significantly between the OSP and placebo groups (−1.0 vs. −0.06, respectively).

Overall, ospemifene had “a very clean safety profile,” Dr. Portman said.

The total number of treatment-emergent adverse events was not significantly different between the OSP and placebo groups (290 vs. 232).

A total of 122 treatment-related adverse events occurred in the OSP group, compared with 62 in the placebo group.

The number of serious adverse events and severe adverse events were similar between the groups (6 vs. 7 and 28 vs. 29, respectively).

The most common treatment-emergent adverse events in the OSP group were urinary tract infection (8%), hot flashes (7%), and vaginal discharge (5%).

No deaths, myocardial infarctions, and or breast cancer cases were reported in any of the patients during the study period.

While the drug is not yet approved for VVA, “this investigational SERM has the potential to be an efficacious, nonestrogen oral prescription therapy for this prevalent, bothersome, and undertreated condition,” according to Dr. Portman.

Major Finding: In an intent-to-treat population, the change in the vaginal dryness severity score improved in the OSP group vs. the placebo group (−1.3 vs. −1.1).

Data Source: A 12-week study of 314 postmenopausal women who had vaginal dryness and were randomized to 60 mg of OSP orally each morning or a placebo.

Disclosures: The study was sponsored in part by Shionogi, which developed and markets ospemifene, and several coinvestigators were Shionogi employees. Dr. Portman has received consulting fees, honoraria, and/or grant support from multiple companies including Shionogi, Bayer, Boehringer Ingelheim, Teva, Warner Chilcott, and Watson Pharmaceuticals.

NATIONAL HARBOR, MD. – A novel selective estrogen–receptor modulator called ospemifene was more effective than placebo for reducing symptoms of vaginal dryness and dyspareunia in a study of 919 postmenopausal women.

Only estrogen-based treatments have been approved in the United States to treat vulvovaginal atrophy (VVA) in postmenopausal women, but concerns about the effects of estrogen on breast and endometrial tissue have prompted doctors and patients to seek alternatives, said Dr. David Portman of the Columbus (Ohio) Center for Women's Health Research.

“We do need to find alternatives because many of our patients still have concerns even with local estrogen,” he emphasized.

Ospemifene (OSP), a selective estrogen–receptor modulator (SERM) – also referred to as a nonsteroidal estrogen–receptor agonist/antagonist – is distinct from other SERMs because its estrogenic activity occurs on the vaginal epithelium, “but not on the endometrium,” said Dr. Portman.

Previous studies have shown that ospemifene is well tolerated, with a favorable pharmacologic profile in postmenopausal women with VVA, he added.

In a 12-week randomized, double-blind, placebo-controlled, phase III parallel group study, Dr. Portman and his colleagues assessed the efficacy, safety, and tolerability of ospemifene for women with moderate to severe vaginal dryness or moderate to severe dyspareunia.

Dyspareunia symptoms and severity were self-reported, and use of a nonhormonal vaginal lubricant was permitted as needed.

Demographic characteristics were similar between the two groups.

The women ranged from 40 to 80 years of age at baseline.

Those with a body mass index of 37 kg/m

A total of 314 postmenopausal women who reported vaginal dryness as their primary symptom were randomized to 60 mg of OSP orally each morning or a placebo, the researchers said.

In the intent-to-treat population, the change in the vaginal dryness severity score improved in the OSP group vs. the placebo group (−1.3 vs. −1.1).

In addition, the percentages of superficial and parabasal cells were significantly different in the OSP group vs. the placebo group (12% vs. 3% and −32% vs. −4%, respectively).

Measuring these types of cells indicates changes in the vaginal microflora, which have been shown to affect vaginal dryness and pain.

The mean change in vaginal pH was −1.01 in the OSP group, compared with −0.25 in the placebo group, respectively.

An additional 605 women who reported dyspareunia as their primary symptom were randomized to 60 mg OSP orally each morning or a placebo.

In the intent-to-treat population, the change in the dyspareunia severity score improved in the OSP group vs. the placebo group (−1.5 vs. −1.2, P = .0001), a significant difference.

In addition, the percentages of superficial cells and parabasal cells were significantly different in the OSP vs. the placebo groups (12% vs. 2% and −40% vs. 0%, respectively).

The mean change in vaginal pH also differed significantly between the OSP and placebo groups (−1.0 vs. −0.06, respectively).

Overall, ospemifene had “a very clean safety profile,” Dr. Portman said.

The total number of treatment-emergent adverse events was not significantly different between the OSP and placebo groups (290 vs. 232).

A total of 122 treatment-related adverse events occurred in the OSP group, compared with 62 in the placebo group.

The number of serious adverse events and severe adverse events were similar between the groups (6 vs. 7 and 28 vs. 29, respectively).

The most common treatment-emergent adverse events in the OSP group were urinary tract infection (8%), hot flashes (7%), and vaginal discharge (5%).

No deaths, myocardial infarctions, and or breast cancer cases were reported in any of the patients during the study period.

While the drug is not yet approved for VVA, “this investigational SERM has the potential to be an efficacious, nonestrogen oral prescription therapy for this prevalent, bothersome, and undertreated condition,” according to Dr. Portman.

Major Finding: In an intent-to-treat population, the change in the vaginal dryness severity score improved in the OSP group vs. the placebo group (−1.3 vs. −1.1).

Data Source: A 12-week study of 314 postmenopausal women who had vaginal dryness and were randomized to 60 mg of OSP orally each morning or a placebo.

Disclosures: The study was sponsored in part by Shionogi, which developed and markets ospemifene, and several coinvestigators were Shionogi employees. Dr. Portman has received consulting fees, honoraria, and/or grant support from multiple companies including Shionogi, Bayer, Boehringer Ingelheim, Teva, Warner Chilcott, and Watson Pharmaceuticals.

NATIONAL HARBOR, MD. – A novel selective estrogen–receptor modulator called ospemifene was more effective than placebo for reducing symptoms of vaginal dryness and dyspareunia in a study of 919 postmenopausal women.

Only estrogen-based treatments have been approved in the United States to treat vulvovaginal atrophy (VVA) in postmenopausal women, but concerns about the effects of estrogen on breast and endometrial tissue have prompted doctors and patients to seek alternatives, said Dr. David Portman of the Columbus (Ohio) Center for Women's Health Research.

“We do need to find alternatives because many of our patients still have concerns even with local estrogen,” he emphasized.

Ospemifene (OSP), a selective estrogen–receptor modulator (SERM) – also referred to as a nonsteroidal estrogen–receptor agonist/antagonist – is distinct from other SERMs because its estrogenic activity occurs on the vaginal epithelium, “but not on the endometrium,” said Dr. Portman.

Previous studies have shown that ospemifene is well tolerated, with a favorable pharmacologic profile in postmenopausal women with VVA, he added.

In a 12-week randomized, double-blind, placebo-controlled, phase III parallel group study, Dr. Portman and his colleagues assessed the efficacy, safety, and tolerability of ospemifene for women with moderate to severe vaginal dryness or moderate to severe dyspareunia.

Dyspareunia symptoms and severity were self-reported, and use of a nonhormonal vaginal lubricant was permitted as needed.

Demographic characteristics were similar between the two groups.

The women ranged from 40 to 80 years of age at baseline.

Those with a body mass index of 37 kg/m

A total of 314 postmenopausal women who reported vaginal dryness as their primary symptom were randomized to 60 mg of OSP orally each morning or a placebo, the researchers said.

In the intent-to-treat population, the change in the vaginal dryness severity score improved in the OSP group vs. the placebo group (−1.3 vs. −1.1).

In addition, the percentages of superficial and parabasal cells were significantly different in the OSP group vs. the placebo group (12% vs. 3% and −32% vs. −4%, respectively).

Measuring these types of cells indicates changes in the vaginal microflora, which have been shown to affect vaginal dryness and pain.

The mean change in vaginal pH was −1.01 in the OSP group, compared with −0.25 in the placebo group, respectively.

An additional 605 women who reported dyspareunia as their primary symptom were randomized to 60 mg OSP orally each morning or a placebo.

In the intent-to-treat population, the change in the dyspareunia severity score improved in the OSP group vs. the placebo group (−1.5 vs. −1.2, P = .0001), a significant difference.

In addition, the percentages of superficial cells and parabasal cells were significantly different in the OSP vs. the placebo groups (12% vs. 2% and −40% vs. 0%, respectively).

The mean change in vaginal pH also differed significantly between the OSP and placebo groups (−1.0 vs. −0.06, respectively).

Overall, ospemifene had “a very clean safety profile,” Dr. Portman said.

The total number of treatment-emergent adverse events was not significantly different between the OSP and placebo groups (290 vs. 232).

A total of 122 treatment-related adverse events occurred in the OSP group, compared with 62 in the placebo group.

The number of serious adverse events and severe adverse events were similar between the groups (6 vs. 7 and 28 vs. 29, respectively).

The most common treatment-emergent adverse events in the OSP group were urinary tract infection (8%), hot flashes (7%), and vaginal discharge (5%).

No deaths, myocardial infarctions, and or breast cancer cases were reported in any of the patients during the study period.

While the drug is not yet approved for VVA, “this investigational SERM has the potential to be an efficacious, nonestrogen oral prescription therapy for this prevalent, bothersome, and undertreated condition,” according to Dr. Portman.

Major Finding: LDL levels among women with 6 or more days of hot flashes peaked at approximately 125 mg/dL during a 2-week period, compared with a peak of approximately 120 mg/dL among women with 1-5 days of hot flashes and a peak of approximately 118 mg/dL among women with no reported days of hot flashes.

Data Source: Data from 3,201 women enrolled in the Study of Women's Health Across the Nation (SWAN).

Disclosures: The study was supported by a grant from the National Institutes of Health. Dr. Thurston had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Frequent hot flashes in menopausal women were significantly associated with higher levels of low-density lipoproteins, high-density lipoproteins, and triglycerides during a 7-year follow-up study of 3,201women enrolled in an ongoing longitudinal study.

Previous investigations using the Study of Women's Health Across the Nation (SWAN) database have shown that women with more hot flashes have an elevated risk for subclinical cardiovascular disease, said Rebecca Thurston, Ph.D., of the University of Pittsburgh.

But “there is a lot we don't know about this association, including what could possibly explain this,” she commented.

Dr. Thurston and her colleagues examined hot flashes as they related to lipid profiles in women enrolled in SWAN.

The subjects' median age was 46 years, 48% were white, 46% were in early or perimenopause, and 26% reported hot flashes within the past 2 weeks.

Hot flashes were analyzed in relation to six lipid profiles, after controlling for age, race, menopausal status/cycle day, alcohol use, physical activity, smoking, anxiety, body mass index, cardiovascular disease status and medications, lipid-lowering medications, and estradiol.

Compared with women who reported no hot flashes, women who reported 1-5 days of hot flashes or 6 or more days of hot flashes during the past 2 weeks were significantly more likely to have elevated levels of LDL cholesterol, triglycerides, apolipoprotein B, and apolipoprotein A1.

For example, LDL levels among women with 6 or more days of hot flashes peaked at approximately 125 mg/dL during a 2-week period, compared with a peak of approximately 120 mg/dL among women with 1-5 days of hot flashes and a peak of approximately 118 mg/dL among women with no reported days of hot flashes.

Levels of HDL cholesterol were significantly higher in women who reported 6 or more days of hot flashes during the past 2 weeks, compared with those who reported no hot flashes, but HDL levels were not significantly different between women who reported 1-5 days of hot flashes and those who reported no hot flashes.

By contrast, levels of lipoprotein(a) were not significantly different among women who reported no hot flashes, women who reported 1 to 5 days of hot flashes, and women who reported 6 or more days of hot flashes.

The positive relationship between hot flashes and lipoprotein(a), and between hot flashes and HDL in some women, were surprising, Dr. Thurston commented.

“The cardioprotective nature of HDL may depend on particle size,” she noted.

HDL particles become smaller as women transition through men op ause, she added, which might explain the differences.

Major Finding: LDL levels among women with 6 or more days of hot flashes peaked at approximately 125 mg/dL during a 2-week period, compared with a peak of approximately 120 mg/dL among women with 1-5 days of hot flashes and a peak of approximately 118 mg/dL among women with no reported days of hot flashes.

Data Source: Data from 3,201 women enrolled in the Study of Women's Health Across the Nation (SWAN).

Disclosures: The study was supported by a grant from the National Institutes of Health. Dr. Thurston had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Frequent hot flashes in menopausal women were significantly associated with higher levels of low-density lipoproteins, high-density lipoproteins, and triglycerides during a 7-year follow-up study of 3,201women enrolled in an ongoing longitudinal study.

Previous investigations using the Study of Women's Health Across the Nation (SWAN) database have shown that women with more hot flashes have an elevated risk for subclinical cardiovascular disease, said Rebecca Thurston, Ph.D., of the University of Pittsburgh.

But “there is a lot we don't know about this association, including what could possibly explain this,” she commented.

Dr. Thurston and her colleagues examined hot flashes as they related to lipid profiles in women enrolled in SWAN.

The subjects' median age was 46 years, 48% were white, 46% were in early or perimenopause, and 26% reported hot flashes within the past 2 weeks.

Hot flashes were analyzed in relation to six lipid profiles, after controlling for age, race, menopausal status/cycle day, alcohol use, physical activity, smoking, anxiety, body mass index, cardiovascular disease status and medications, lipid-lowering medications, and estradiol.

Compared with women who reported no hot flashes, women who reported 1-5 days of hot flashes or 6 or more days of hot flashes during the past 2 weeks were significantly more likely to have elevated levels of LDL cholesterol, triglycerides, apolipoprotein B, and apolipoprotein A1.

For example, LDL levels among women with 6 or more days of hot flashes peaked at approximately 125 mg/dL during a 2-week period, compared with a peak of approximately 120 mg/dL among women with 1-5 days of hot flashes and a peak of approximately 118 mg/dL among women with no reported days of hot flashes.

Levels of HDL cholesterol were significantly higher in women who reported 6 or more days of hot flashes during the past 2 weeks, compared with those who reported no hot flashes, but HDL levels were not significantly different between women who reported 1-5 days of hot flashes and those who reported no hot flashes.

By contrast, levels of lipoprotein(a) were not significantly different among women who reported no hot flashes, women who reported 1 to 5 days of hot flashes, and women who reported 6 or more days of hot flashes.

The positive relationship between hot flashes and lipoprotein(a), and between hot flashes and HDL in some women, were surprising, Dr. Thurston commented.

“The cardioprotective nature of HDL may depend on particle size,” she noted.

HDL particles become smaller as women transition through men op ause, she added, which might explain the differences.

Major Finding: LDL levels among women with 6 or more days of hot flashes peaked at approximately 125 mg/dL during a 2-week period, compared with a peak of approximately 120 mg/dL among women with 1-5 days of hot flashes and a peak of approximately 118 mg/dL among women with no reported days of hot flashes.

Data Source: Data from 3,201 women enrolled in the Study of Women's Health Across the Nation (SWAN).

Disclosures: The study was supported by a grant from the National Institutes of Health. Dr. Thurston had no financial conflicts to disclose.

NATIONAL HARBOR, MD. – Frequent hot flashes in menopausal women were significantly associated with higher levels of low-density lipoproteins, high-density lipoproteins, and triglycerides during a 7-year follow-up study of 3,201women enrolled in an ongoing longitudinal study.

Previous investigations using the Study of Women's Health Across the Nation (SWAN) database have shown that women with more hot flashes have an elevated risk for subclinical cardiovascular disease, said Rebecca Thurston, Ph.D., of the University of Pittsburgh.

But “there is a lot we don't know about this association, including what could possibly explain this,” she commented.

Dr. Thurston and her colleagues examined hot flashes as they related to lipid profiles in women enrolled in SWAN.

The subjects' median age was 46 years, 48% were white, 46% were in early or perimenopause, and 26% reported hot flashes within the past 2 weeks.

Hot flashes were analyzed in relation to six lipid profiles, after controlling for age, race, menopausal status/cycle day, alcohol use, physical activity, smoking, anxiety, body mass index, cardiovascular disease status and medications, lipid-lowering medications, and estradiol.

Compared with women who reported no hot flashes, women who reported 1-5 days of hot flashes or 6 or more days of hot flashes during the past 2 weeks were significantly more likely to have elevated levels of LDL cholesterol, triglycerides, apolipoprotein B, and apolipoprotein A1.

For example, LDL levels among women with 6 or more days of hot flashes peaked at approximately 125 mg/dL during a 2-week period, compared with a peak of approximately 120 mg/dL among women with 1-5 days of hot flashes and a peak of approximately 118 mg/dL among women with no reported days of hot flashes.

Levels of HDL cholesterol were significantly higher in women who reported 6 or more days of hot flashes during the past 2 weeks, compared with those who reported no hot flashes, but HDL levels were not significantly different between women who reported 1-5 days of hot flashes and those who reported no hot flashes.

By contrast, levels of lipoprotein(a) were not significantly different among women who reported no hot flashes, women who reported 1 to 5 days of hot flashes, and women who reported 6 or more days of hot flashes.

The positive relationship between hot flashes and lipoprotein(a), and between hot flashes and HDL in some women, were surprising, Dr. Thurston commented.

“The cardioprotective nature of HDL may depend on particle size,” she noted.

HDL particles become smaller as women transition through men op ause, she added, which might explain the differences.

Major Finding: There were 0.40 events per 100 person-years in transdermal estrogen users and 0.56 events per 100 person-years in oral estrogen users (P= .006).

Data Source: Observational data from 50,000 women in the Thomas Reuters MarketScan database.

Disclosures: The study was sponsored by Novartis; several of the coinvestigators are employed by Novartis.

NATIONAL HARBOR, MD. – Women who used transdermal estrogen had a 30% lower risk of venous thromboembolism than did patients who used oral estrogen, based on data collected from more than 50,000 women, said Eric Beresford, Pharm.D., of Novartis.

The observation is limited, however, by the lack of data on specific estrogen doses in the oral estrogen users. Further, the data were not adjusted for the participants' weights or BMIs.

Transdermal estrogen has the potential to reduce VTE risk by delivering unmetabolized estradiol directly to the bloodstream, he said.

In a retrospective, matched-cohort study, Dr. Beresford and colleagues compared VTE incidence for up to 90 days in 27,018 women who began taking oral estrogen only, and in 27,018 who began using an estradiol transdermal system (ETS) between January 2002 and October 2009. The data were collected from the Thomson Reuters MarketScan database of health insurance claims.

The mean age of the women was 49 years, and 22% of them had menopausal or postmenopausal disorders.

Overall, 115 women (0.40 events per 100 person-years) in the ETS group developed VTE, compared with 164 women (0.56 events per 100 person-years) in the oral estrogen group; this difference was statistically significant (P = .006).

The incidence of hospitalization-related VTE events was significantly lower in the ETS group, compared with the oral estrogen group (24 vs. 44, respectively). The number of events per 100 person-years was 0.08 and 0.15, respectively.

VTE was defined as at least one diagnosis code for deep vein thrombosis or pulmonary embolism. Women with a prior VTE diagnosis were excluded from the study.

When shown on a Kaplan-Meier curve, the rates of VTE in the ETS group at 6, 12, and 24 months after the start of therapy were 0.24%, 0.42%, and 0.68%, respectively. The rates of VTE in the oral estrogen group were 0.31%, 0.59%, and 1.13%, respectively.

The differences between the two groups were statistically significant (P = .006).

The differences in VTE rates between the two groups were significant with ETS doses of either 0.075 mg/day or 0.1 mg/day, Dr. Beresford noted. The women in the oral estrogen hormone therapy group were taking a variety of brands of oral estrogen replacements in various dosages; the study was not designed to compare ETS with specific oral estrogen doses, he added.

The most common concomitant medications were antihypertensives, which were taken by 11% of the women in each group. The most common risk factor for VTE was surgical resection of abdominal or pelvic cancer (24%) and other major surgery (17%).

The findings were limited by the lack of information about the participants' weight or body mass index, which can affect the risk of thrombotic events, and by the observational nature of the study, Dr. Beresford said.

However, the results suggest that “women receiving ETS have a significantly lower incidence of VTE and hospitalization-related VTE than [do] women receiving oral estrogen–only hormone therapy,” he said.

More research is needed to assess transdermal estrogen as an option for women at increased risk for VTE.

Major Finding: There were 0.40 events per 100 person-years in transdermal estrogen users and 0.56 events per 100 person-years in oral estrogen users (P= .006).

Data Source: Observational data from 50,000 women in the Thomas Reuters MarketScan database.

Disclosures: The study was sponsored by Novartis; several of the coinvestigators are employed by Novartis.

NATIONAL HARBOR, MD. – Women who used transdermal estrogen had a 30% lower risk of venous thromboembolism than did patients who used oral estrogen, based on data collected from more than 50,000 women, said Eric Beresford, Pharm.D., of Novartis.

The observation is limited, however, by the lack of data on specific estrogen doses in the oral estrogen users. Further, the data were not adjusted for the participants' weights or BMIs.

Transdermal estrogen has the potential to reduce VTE risk by delivering unmetabolized estradiol directly to the bloodstream, he said.

In a retrospective, matched-cohort study, Dr. Beresford and colleagues compared VTE incidence for up to 90 days in 27,018 women who began taking oral estrogen only, and in 27,018 who began using an estradiol transdermal system (ETS) between January 2002 and October 2009. The data were collected from the Thomson Reuters MarketScan database of health insurance claims.

The mean age of the women was 49 years, and 22% of them had menopausal or postmenopausal disorders.

Overall, 115 women (0.40 events per 100 person-years) in the ETS group developed VTE, compared with 164 women (0.56 events per 100 person-years) in the oral estrogen group; this difference was statistically significant (P = .006).

The incidence of hospitalization-related VTE events was significantly lower in the ETS group, compared with the oral estrogen group (24 vs. 44, respectively). The number of events per 100 person-years was 0.08 and 0.15, respectively.

VTE was defined as at least one diagnosis code for deep vein thrombosis or pulmonary embolism. Women with a prior VTE diagnosis were excluded from the study.

When shown on a Kaplan-Meier curve, the rates of VTE in the ETS group at 6, 12, and 24 months after the start of therapy were 0.24%, 0.42%, and 0.68%, respectively. The rates of VTE in the oral estrogen group were 0.31%, 0.59%, and 1.13%, respectively.

The differences between the two groups were statistically significant (P = .006).

The differences in VTE rates between the two groups were significant with ETS doses of either 0.075 mg/day or 0.1 mg/day, Dr. Beresford noted. The women in the oral estrogen hormone therapy group were taking a variety of brands of oral estrogen replacements in various dosages; the study was not designed to compare ETS with specific oral estrogen doses, he added.

The most common concomitant medications were antihypertensives, which were taken by 11% of the women in each group. The most common risk factor for VTE was surgical resection of abdominal or pelvic cancer (24%) and other major surgery (17%).

The findings were limited by the lack of information about the participants' weight or body mass index, which can affect the risk of thrombotic events, and by the observational nature of the study, Dr. Beresford said.

However, the results suggest that “women receiving ETS have a significantly lower incidence of VTE and hospitalization-related VTE than [do] women receiving oral estrogen–only hormone therapy,” he said.

More research is needed to assess transdermal estrogen as an option for women at increased risk for VTE.

Major Finding: There were 0.40 events per 100 person-years in transdermal estrogen users and 0.56 events per 100 person-years in oral estrogen users (P= .006).

Data Source: Observational data from 50,000 women in the Thomas Reuters MarketScan database.

Disclosures: The study was sponsored by Novartis; several of the coinvestigators are employed by Novartis.

NATIONAL HARBOR, MD. – Women who used transdermal estrogen had a 30% lower risk of venous thromboembolism than did patients who used oral estrogen, based on data collected from more than 50,000 women, said Eric Beresford, Pharm.D., of Novartis.

The observation is limited, however, by the lack of data on specific estrogen doses in the oral estrogen users. Further, the data were not adjusted for the participants' weights or BMIs.

Transdermal estrogen has the potential to reduce VTE risk by delivering unmetabolized estradiol directly to the bloodstream, he said.

In a retrospective, matched-cohort study, Dr. Beresford and colleagues compared VTE incidence for up to 90 days in 27,018 women who began taking oral estrogen only, and in 27,018 who began using an estradiol transdermal system (ETS) between January 2002 and October 2009. The data were collected from the Thomson Reuters MarketScan database of health insurance claims.

The mean age of the women was 49 years, and 22% of them had menopausal or postmenopausal disorders.

Overall, 115 women (0.40 events per 100 person-years) in the ETS group developed VTE, compared with 164 women (0.56 events per 100 person-years) in the oral estrogen group; this difference was statistically significant (P = .006).

The incidence of hospitalization-related VTE events was significantly lower in the ETS group, compared with the oral estrogen group (24 vs. 44, respectively). The number of events per 100 person-years was 0.08 and 0.15, respectively.

VTE was defined as at least one diagnosis code for deep vein thrombosis or pulmonary embolism. Women with a prior VTE diagnosis were excluded from the study.

When shown on a Kaplan-Meier curve, the rates of VTE in the ETS group at 6, 12, and 24 months after the start of therapy were 0.24%, 0.42%, and 0.68%, respectively. The rates of VTE in the oral estrogen group were 0.31%, 0.59%, and 1.13%, respectively.

The differences between the two groups were statistically significant (P = .006).

The differences in VTE rates between the two groups were significant with ETS doses of either 0.075 mg/day or 0.1 mg/day, Dr. Beresford noted. The women in the oral estrogen hormone therapy group were taking a variety of brands of oral estrogen replacements in various dosages; the study was not designed to compare ETS with specific oral estrogen doses, he added.

The most common concomitant medications were antihypertensives, which were taken by 11% of the women in each group. The most common risk factor for VTE was surgical resection of abdominal or pelvic cancer (24%) and other major surgery (17%).

The findings were limited by the lack of information about the participants' weight or body mass index, which can affect the risk of thrombotic events, and by the observational nature of the study, Dr. Beresford said.

However, the results suggest that “women receiving ETS have a significantly lower incidence of VTE and hospitalization-related VTE than [do] women receiving oral estrogen–only hormone therapy,” he said.

More research is needed to assess transdermal estrogen as an option for women at increased risk for VTE.

TORONTO – Children and teens with bipolar disorder had a significantly longer recovery time and more recurrences if they had comorbid anxiety disorders, based on data from a longitudinal study.

Comorbid anxiety disorder has been previously associated with worse prognosis in teens with bipolar disorders, but the finding has based primarily on cross-sectional studies, and longitudinal data are limited, said Dr. Regina Sala of Columbia University in New York and her colleagues.

Data from the Course and Outcomes of Bipolar Youth study were reviewed for 413 youth aged 7-17 years (average age 13 years) with bipolar disorder; 256 study participants had comorbid anxiety.

The patients were assessed weekly for 5 years. After researchers adjusted for confounding variables, 37% of the children and teens with comorbid anxiety disorders and 55% of those without anxiety were asymptomatic on a weekly basis.

In addition, bipolar youth with comorbid anxiety took significantly longer to recover from their index episodes; the median times to recovery were 138 weeks for those with anxiety and 87 weeks for those without anxiety. Recurrence rates also were significantly higher at 76% for bipolar youth with comorbid anxiety and 57% for those without comorbid anxiety. The median time to recurrence was significantly shorter at 37 weeks in the comorbid group and 48 weeks with bipolar disorder alone.

The results suggest that characteristics of youth with comorbid bipolar and anxiety disorders include more syndromal and subsyndromal mixed cycling, more depression, and less euthymia than did bipolar youth without comorbid anxiety, the researchers said.

Dr. Sala was supported by a grant from the Alicia Koplowitz Foundation. Several study coauthors have received financial support and/or served as consultants or on advisory boards for multiple companies including Pfizer, Abbott, Schering-Plough, Bristol-Myers Squibb, and Forest.

TORONTO – Children and teens with bipolar disorder had a significantly longer recovery time and more recurrences if they had comorbid anxiety disorders, based on data from a longitudinal study.

Comorbid anxiety disorder has been previously associated with worse prognosis in teens with bipolar disorders, but the finding has based primarily on cross-sectional studies, and longitudinal data are limited, said Dr. Regina Sala of Columbia University in New York and her colleagues.

Data from the Course and Outcomes of Bipolar Youth study were reviewed for 413 youth aged 7-17 years (average age 13 years) with bipolar disorder; 256 study participants had comorbid anxiety.

The patients were assessed weekly for 5 years. After researchers adjusted for confounding variables, 37% of the children and teens with comorbid anxiety disorders and 55% of those without anxiety were asymptomatic on a weekly basis.

In addition, bipolar youth with comorbid anxiety took significantly longer to recover from their index episodes; the median times to recovery were 138 weeks for those with anxiety and 87 weeks for those without anxiety. Recurrence rates also were significantly higher at 76% for bipolar youth with comorbid anxiety and 57% for those without comorbid anxiety. The median time to recurrence was significantly shorter at 37 weeks in the comorbid group and 48 weeks with bipolar disorder alone.

The results suggest that characteristics of youth with comorbid bipolar and anxiety disorders include more syndromal and subsyndromal mixed cycling, more depression, and less euthymia than did bipolar youth without comorbid anxiety, the researchers said.

Dr. Sala was supported by a grant from the Alicia Koplowitz Foundation. Several study coauthors have received financial support and/or served as consultants or on advisory boards for multiple companies including Pfizer, Abbott, Schering-Plough, Bristol-Myers Squibb, and Forest.

TORONTO – Children and teens with bipolar disorder had a significantly longer recovery time and more recurrences if they had comorbid anxiety disorders, based on data from a longitudinal study.

Comorbid anxiety disorder has been previously associated with worse prognosis in teens with bipolar disorders, but the finding has based primarily on cross-sectional studies, and longitudinal data are limited, said Dr. Regina Sala of Columbia University in New York and her colleagues.

Data from the Course and Outcomes of Bipolar Youth study were reviewed for 413 youth aged 7-17 years (average age 13 years) with bipolar disorder; 256 study participants had comorbid anxiety.

The patients were assessed weekly for 5 years. After researchers adjusted for confounding variables, 37% of the children and teens with comorbid anxiety disorders and 55% of those without anxiety were asymptomatic on a weekly basis.

In addition, bipolar youth with comorbid anxiety took significantly longer to recover from their index episodes; the median times to recovery were 138 weeks for those with anxiety and 87 weeks for those without anxiety. Recurrence rates also were significantly higher at 76% for bipolar youth with comorbid anxiety and 57% for those without comorbid anxiety. The median time to recurrence was significantly shorter at 37 weeks in the comorbid group and 48 weeks with bipolar disorder alone.

The results suggest that characteristics of youth with comorbid bipolar and anxiety disorders include more syndromal and subsyndromal mixed cycling, more depression, and less euthymia than did bipolar youth without comorbid anxiety, the researchers said.

Dr. Sala was supported by a grant from the Alicia Koplowitz Foundation. Several study coauthors have received financial support and/or served as consultants or on advisory boards for multiple companies including Pfizer, Abbott, Schering-Plough, Bristol-Myers Squibb, and Forest.

TORONTO – Low vitamin D levels were associated with more psychotic features in mentally ill adolescents, based on data from 104 teens.

In previous studies, vitamin D deficiency has been linked with seasonal affective disorder, schizophrenia, and depression, said Dr. Barbara L. Gracious of the Ohio State University, Columbus, and her colleagues.

Dr. Gracious reported at the annual meeting of the American Academy of Child and Adolescent Psychiatry on 104 consecutive teens seen for acute or partial hospital stays for psychiatric symptoms during an 18-month period. The average age of the patients was 15 years; 27% were male, and 73% were white.

Overall, 72% of the study population had low vitamin D levels, defined as 25-OHD levels less than 30 ng/mL, and 34% were vitamin D deficient, defined as 25-OHD levels less than 20 ng/mL. By comparison, 9% of a cohort of teens from the NHANES (National Health and Nutrition Survey) were vitamin D deficient, the researchers noted.

Psychotic features were observed in 40% of the teens with low vitamin D levels and 16% of those with normal vitamin D levels, a statistically significant difference. Black ethnicity was associated with vitamin D deficiency, but vitamin D–deficient black teens were not significantly more likely than vitamin D–deficient white teens to exhibit psychotic features.

No studies indicate that vitamin D deficiency is a causative factor in psychosis.

Dr. Gracious is a consultant for Johnson & Johnson. None of her coauthors reported any financial conflicts. The study was supported by grants from several sources including the National Institutes of Health, the Ohio State University, and the University of Rochester (N.Y.).

TORONTO – Low vitamin D levels were associated with more psychotic features in mentally ill adolescents, based on data from 104 teens.

In previous studies, vitamin D deficiency has been linked with seasonal affective disorder, schizophrenia, and depression, said Dr. Barbara L. Gracious of the Ohio State University, Columbus, and her colleagues.

Dr. Gracious reported at the annual meeting of the American Academy of Child and Adolescent Psychiatry on 104 consecutive teens seen for acute or partial hospital stays for psychiatric symptoms during an 18-month period. The average age of the patients was 15 years; 27% were male, and 73% were white.

Overall, 72% of the study population had low vitamin D levels, defined as 25-OHD levels less than 30 ng/mL, and 34% were vitamin D deficient, defined as 25-OHD levels less than 20 ng/mL. By comparison, 9% of a cohort of teens from the NHANES (National Health and Nutrition Survey) were vitamin D deficient, the researchers noted.

Psychotic features were observed in 40% of the teens with low vitamin D levels and 16% of those with normal vitamin D levels, a statistically significant difference. Black ethnicity was associated with vitamin D deficiency, but vitamin D–deficient black teens were not significantly more likely than vitamin D–deficient white teens to exhibit psychotic features.

No studies indicate that vitamin D deficiency is a causative factor in psychosis.

Dr. Gracious is a consultant for Johnson & Johnson. None of her coauthors reported any financial conflicts. The study was supported by grants from several sources including the National Institutes of Health, the Ohio State University, and the University of Rochester (N.Y.).

TORONTO – Low vitamin D levels were associated with more psychotic features in mentally ill adolescents, based on data from 104 teens.

In previous studies, vitamin D deficiency has been linked with seasonal affective disorder, schizophrenia, and depression, said Dr. Barbara L. Gracious of the Ohio State University, Columbus, and her colleagues.

Dr. Gracious reported at the annual meeting of the American Academy of Child and Adolescent Psychiatry on 104 consecutive teens seen for acute or partial hospital stays for psychiatric symptoms during an 18-month period. The average age of the patients was 15 years; 27% were male, and 73% were white.

Overall, 72% of the study population had low vitamin D levels, defined as 25-OHD levels less than 30 ng/mL, and 34% were vitamin D deficient, defined as 25-OHD levels less than 20 ng/mL. By comparison, 9% of a cohort of teens from the NHANES (National Health and Nutrition Survey) were vitamin D deficient, the researchers noted.

Psychotic features were observed in 40% of the teens with low vitamin D levels and 16% of those with normal vitamin D levels, a statistically significant difference. Black ethnicity was associated with vitamin D deficiency, but vitamin D–deficient black teens were not significantly more likely than vitamin D–deficient white teens to exhibit psychotic features.

No studies indicate that vitamin D deficiency is a causative factor in psychosis.

Dr. Gracious is a consultant for Johnson & Johnson. None of her coauthors reported any financial conflicts. The study was supported by grants from several sources including the National Institutes of Health, the Ohio State University, and the University of Rochester (N.Y.).

A transdermal patch that delivers 20 mcg/hour of the opioid buprenorphine significantly improved pain scores in patients with moderate to severe chronic low back pain, compared with a transdermal dose of 5 mcg/hour or an active control, based on data from 660 patients in a phase III clinical trial.

Transdermal buprenorphine (Butrans) was approved by the Food and Drug Administration in June 2010 for management of chronic pain in adults, said Dr. Deborah Steiner of Purdue Pharma and her colleagues.

In this study, the researchers compared the buprenorphine transdermal system (BTDS), which delivered medication at an average buprenorphine dose of 20 mcg/hour over 7 days, to an average 5-mcg/hour transdermal dose and an active control consisting of 40 mg/day of immediate-release oxycodone capsules. The average age of the patients was 50 years, and the baseline demographics were similar among all three groups.

The findings were published online in the Journal of Pain (doi: 10.1016/j.jpain.2011.06.003).

Patients’ pain was assessed at weeks 4, 8, and 12 using the "average pain over the last 24 hours" scores. In all, 91% of the patients reported musculoskeletal pain as the primary source of their pain at baseline.

At baseline, the mean pain scores in the BTDS 20 group, BTDS 5 group, and oxycodone group were 6.4, 6.5, and 6.5, respectively. After 12 weeks, the mean pain scores in the three groups had dropped to 4.0, 3.3, and 3.3, respectively. The difference of –0.67 between the BTDS 20 and BTDS 5 scores was statistically significant.

"In general, the treatment-emergent adverse effects (TEAEs) observed in this study were similar to those expected with the use of opioid agonists and transdermal patches," the researchers noted. The incidence of TEAEs was 77% in the BTDS 20 group, 59% in the BTDS 5 group, and 73% in the oxycodone group. The most common TEAEs were application-site reactions, nausea, and headaches. The incidence of application-site reactions in the three groups was 29%, 17%, and 22%, respectively; the incidence of nausea was 12%, 8%, and 8%; and the incidence of headache was 11%, 5%, and 10%.

Four separate sensitivity analyses showed that BTDS 20 and oxycodone were significantly more effective for pain control than BTDS 5. In addition, post hoc analyses showed that significantly more patients in the BTDS 20 group than in the BTDS 5 group reported improvements in pain scores of at least 30% from baseline, the researchers said.

The study was sponsored by Purdue Pharma, and most of the study authors are full-time employees of Purdue Pharma.

A transdermal patch that delivers 20 mcg/hour of the opioid buprenorphine significantly improved pain scores in patients with moderate to severe chronic low back pain, compared with a transdermal dose of 5 mcg/hour or an active control, based on data from 660 patients in a phase III clinical trial.

Transdermal buprenorphine (Butrans) was approved by the Food and Drug Administration in June 2010 for management of chronic pain in adults, said Dr. Deborah Steiner of Purdue Pharma and her colleagues.

In this study, the researchers compared the buprenorphine transdermal system (BTDS), which delivered medication at an average buprenorphine dose of 20 mcg/hour over 7 days, to an average 5-mcg/hour transdermal dose and an active control consisting of 40 mg/day of immediate-release oxycodone capsules. The average age of the patients was 50 years, and the baseline demographics were similar among all three groups.

The findings were published online in the Journal of Pain (doi: 10.1016/j.jpain.2011.06.003).

Patients’ pain was assessed at weeks 4, 8, and 12 using the "average pain over the last 24 hours" scores. In all, 91% of the patients reported musculoskeletal pain as the primary source of their pain at baseline.

At baseline, the mean pain scores in the BTDS 20 group, BTDS 5 group, and oxycodone group were 6.4, 6.5, and 6.5, respectively. After 12 weeks, the mean pain scores in the three groups had dropped to 4.0, 3.3, and 3.3, respectively. The difference of –0.67 between the BTDS 20 and BTDS 5 scores was statistically significant.

"In general, the treatment-emergent adverse effects (TEAEs) observed in this study were similar to those expected with the use of opioid agonists and transdermal patches," the researchers noted. The incidence of TEAEs was 77% in the BTDS 20 group, 59% in the BTDS 5 group, and 73% in the oxycodone group. The most common TEAEs were application-site reactions, nausea, and headaches. The incidence of application-site reactions in the three groups was 29%, 17%, and 22%, respectively; the incidence of nausea was 12%, 8%, and 8%; and the incidence of headache was 11%, 5%, and 10%.

Four separate sensitivity analyses showed that BTDS 20 and oxycodone were significantly more effective for pain control than BTDS 5. In addition, post hoc analyses showed that significantly more patients in the BTDS 20 group than in the BTDS 5 group reported improvements in pain scores of at least 30% from baseline, the researchers said.

The study was sponsored by Purdue Pharma, and most of the study authors are full-time employees of Purdue Pharma.

A transdermal patch that delivers 20 mcg/hour of the opioid buprenorphine significantly improved pain scores in patients with moderate to severe chronic low back pain, compared with a transdermal dose of 5 mcg/hour or an active control, based on data from 660 patients in a phase III clinical trial.

Transdermal buprenorphine (Butrans) was approved by the Food and Drug Administration in June 2010 for management of chronic pain in adults, said Dr. Deborah Steiner of Purdue Pharma and her colleagues.

In this study, the researchers compared the buprenorphine transdermal system (BTDS), which delivered medication at an average buprenorphine dose of 20 mcg/hour over 7 days, to an average 5-mcg/hour transdermal dose and an active control consisting of 40 mg/day of immediate-release oxycodone capsules. The average age of the patients was 50 years, and the baseline demographics were similar among all three groups.

The findings were published online in the Journal of Pain (doi: 10.1016/j.jpain.2011.06.003).

Patients’ pain was assessed at weeks 4, 8, and 12 using the "average pain over the last 24 hours" scores. In all, 91% of the patients reported musculoskeletal pain as the primary source of their pain at baseline.

At baseline, the mean pain scores in the BTDS 20 group, BTDS 5 group, and oxycodone group were 6.4, 6.5, and 6.5, respectively. After 12 weeks, the mean pain scores in the three groups had dropped to 4.0, 3.3, and 3.3, respectively. The difference of –0.67 between the BTDS 20 and BTDS 5 scores was statistically significant.

"In general, the treatment-emergent adverse effects (TEAEs) observed in this study were similar to those expected with the use of opioid agonists and transdermal patches," the researchers noted. The incidence of TEAEs was 77% in the BTDS 20 group, 59% in the BTDS 5 group, and 73% in the oxycodone group. The most common TEAEs were application-site reactions, nausea, and headaches. The incidence of application-site reactions in the three groups was 29%, 17%, and 22%, respectively; the incidence of nausea was 12%, 8%, and 8%; and the incidence of headache was 11%, 5%, and 10%.

Four separate sensitivity analyses showed that BTDS 20 and oxycodone were significantly more effective for pain control than BTDS 5. In addition, post hoc analyses showed that significantly more patients in the BTDS 20 group than in the BTDS 5 group reported improvements in pain scores of at least 30% from baseline, the researchers said.

The study was sponsored by Purdue Pharma, and most of the study authors are full-time employees of Purdue Pharma.

The National Heart, Lung, and Blood Institute has halted the triple-drug therapy arm of a treatment trial for idiopathic pulmonary fibrosis because of poor outcomes, according to a statement issued by the National Institutes of Health.

Interim data from the study indicated that patients with idiopathic pulmonary fibrosis (IPF) who received a combined therapy of prednisone, azathioprine, and N-acetylcysteine (NAC) had no improvement in lung function, compared with a placebo group. In addition, compared with the placebo group, the treatment group had significantly higher rates of death (11% vs. 1%), hospitalization (29% vs. 8%), and serious adverse events (31% vs. 9%).

The study, known as PANTHER-IPF (Prednisone, Azathioprine, and N-acetylcysteine: A Study That Evaluates Response in Idiopathic Pulmonary Fibrosis), was designed to evaluate the effectiveness of a triple-therapy regimen in slowing disease progression and improving lung function in patients with moderate to severe IPF. The average age of the study participants at enrollment was 68 years.

"This combination therapy is widely used in patients with IPF but has not previously been studied in direct comparison to a placebo for all three drugs," Dr. Susan B. Shurin, acting director of the NHLBI, noted in a statement.

Patients in the other two treatment arms who are receiving NAC alone or a placebo will continue with their designated treatment protocols, which are scheduled to last up to 60 weeks, according to the NIH statement.

The researchers began enrolling patients in 2009. Completion of the first phase of the study with the two remaining treatment arms is expected by 2013. More details about the trial are available online.

The study was supported by National Institutes of Health and the Cowlin Family Fund at Chicago Community Trust. The NAC and matching placebo treatments were donated by Zambon; study funds were used to purchase the prednisone, azathioprine, and matching placebos.

The National Heart, Lung, and Blood Institute has halted the triple-drug therapy arm of a treatment trial for idiopathic pulmonary fibrosis because of poor outcomes, according to a statement issued by the National Institutes of Health.

Interim data from the study indicated that patients with idiopathic pulmonary fibrosis (IPF) who received a combined therapy of prednisone, azathioprine, and N-acetylcysteine (NAC) had no improvement in lung function, compared with a placebo group. In addition, compared with the placebo group, the treatment group had significantly higher rates of death (11% vs. 1%), hospitalization (29% vs. 8%), and serious adverse events (31% vs. 9%).

The study, known as PANTHER-IPF (Prednisone, Azathioprine, and N-acetylcysteine: A Study That Evaluates Response in Idiopathic Pulmonary Fibrosis), was designed to evaluate the effectiveness of a triple-therapy regimen in slowing disease progression and improving lung function in patients with moderate to severe IPF. The average age of the study participants at enrollment was 68 years.

"This combination therapy is widely used in patients with IPF but has not previously been studied in direct comparison to a placebo for all three drugs," Dr. Susan B. Shurin, acting director of the NHLBI, noted in a statement.

Patients in the other two treatment arms who are receiving NAC alone or a placebo will continue with their designated treatment protocols, which are scheduled to last up to 60 weeks, according to the NIH statement.

The researchers began enrolling patients in 2009. Completion of the first phase of the study with the two remaining treatment arms is expected by 2013. More details about the trial are available online.

The study was supported by National Institutes of Health and the Cowlin Family Fund at Chicago Community Trust. The NAC and matching placebo treatments were donated by Zambon; study funds were used to purchase the prednisone, azathioprine, and matching placebos.

The National Heart, Lung, and Blood Institute has halted the triple-drug therapy arm of a treatment trial for idiopathic pulmonary fibrosis because of poor outcomes, according to a statement issued by the National Institutes of Health.

Interim data from the study indicated that patients with idiopathic pulmonary fibrosis (IPF) who received a combined therapy of prednisone, azathioprine, and N-acetylcysteine (NAC) had no improvement in lung function, compared with a placebo group. In addition, compared with the placebo group, the treatment group had significantly higher rates of death (11% vs. 1%), hospitalization (29% vs. 8%), and serious adverse events (31% vs. 9%).

The study, known as PANTHER-IPF (Prednisone, Azathioprine, and N-acetylcysteine: A Study That Evaluates Response in Idiopathic Pulmonary Fibrosis), was designed to evaluate the effectiveness of a triple-therapy regimen in slowing disease progression and improving lung function in patients with moderate to severe IPF. The average age of the study participants at enrollment was 68 years.

"This combination therapy is widely used in patients with IPF but has not previously been studied in direct comparison to a placebo for all three drugs," Dr. Susan B. Shurin, acting director of the NHLBI, noted in a statement.

Patients in the other two treatment arms who are receiving NAC alone or a placebo will continue with their designated treatment protocols, which are scheduled to last up to 60 weeks, according to the NIH statement.

The researchers began enrolling patients in 2009. Completion of the first phase of the study with the two remaining treatment arms is expected by 2013. More details about the trial are available online.

The study was supported by National Institutes of Health and the Cowlin Family Fund at Chicago Community Trust. The NAC and matching placebo treatments were donated by Zambon; study funds were used to purchase the prednisone, azathioprine, and matching placebos.