Doug Brunk

Major Finding: The age- and sex-adjusted incidence of acute MI decreased by 24% between 1999 and 2008.

Data Source: A study of 46,086 Kaiser Permanente Northern California members aged 30 years and older who were hospitalized with a primary discharge diagnosis of acute MI.

Disclosures: The study was supported by funding from the Permanente Medical Group and by a Schering-Plough Future Leaders in Cardiovascular Medical Research grant. Three of the study authors are employed by Permanente Medical Group.

The incidence of myocardial infarction declined by 24% between 1999 and 2008, and the decline was most significant among those with ST-segment elevation myo-cardial infarction, according to findings from a large community-based population study.

In addition, 30-day mortality rates improved, driven mostly by declining case fatality rates among patients with non–ST-segment elevation myocardial infarction (non-STEMI).

Researchers identified 46,086 members of Kaiser Permanente Northern California aged 30 years and older who were hospitalized between 1999 and 2008 with a primary discharge diagnosis of acute MI. The 46,086 hospitalizations represented 18,691,131 person-years of follow-up, reported the researchers, led by Dr. Robert W. Yeh of the department of medicine at Massachusetts General Hospital, Boston.

The researchers used ICD-9-CM codes to classify MI hospitalizations as STEMI or non-STEMI and to calculate age- and sex-adjusted incidence rates. They used administrative databases, state death data, and Social Security Administration data to determine 30-day mortality, and also identified patient characteristics, outpatient medications, and levels of cardiac biomarkers during hospitalization (N. Engl. J. Med. 2010;362:2155-65).

After adjustment for age and sex, the overall incidence of MI rose from 274 cases per 100,000 person-years in 1999 to 287 cases per 100,000 person-years in 2000, then fell each year thereafter, reaching 208 per 100,000 person-years in 2008—a significant 24% decrease over the study period. In addition, 30-day mortality after acute MI was significantly lower in 2008 than in 1999 (adjusted odds ratio, 0.76).

The incidence of age- and sex-adjusted STEMI decreased each year, from 133 per 100,000 person-years in 1999 to 50 per 100,000 person-years in 2008, a decline of 62%. However, the incidence of non-STEMI increased from 155 cases per 100,000 person-years in 1999 to 202 cases per 100,000 person-years in 2004, the year that use of troponin testing stabilized, and decreased thereafter. Adjusted 30-day mortality decreased significantly from 1999 to 2008 in patients with non-STEMI (OR, 0.82) but did not change significantly in those with STEMI (OR, 0.93).

The researchers suggested the declining incidence of MI can be attributed at least in part to “substantial improvements in primary-prevention efforts” implemented at Kaiser. The decline occurred “despite the increased sensitivity of new biomarkers for the diagnosis of myocardial infarction” and the increasing prevalence of obesity and diabetes. The increased use of troponin testing would be expected to increase the incidence of MI, so “the observed decreases in myocardial infarction since 2000 are even more striking.”

They acknowledged certain limitations of their study, including the fact that “the true effect of changes in diagnostic sensitivity with changing biomarker use cannot be comprehensively quantified. However, the expected bias would be an overestimation of the incidence of myocardial infarction in later years. Thus, actual decreases in the incidence of myocardial infarction since 2000 may, in fact, be greater than we observed.” They also noted the results might not be generalizable.

Major Finding: The age- and sex-adjusted incidence of acute MI decreased by 24% between 1999 and 2008.

Data Source: A study of 46,086 Kaiser Permanente Northern California members aged 30 years and older who were hospitalized with a primary discharge diagnosis of acute MI.

Disclosures: The study was supported by funding from the Permanente Medical Group and by a Schering-Plough Future Leaders in Cardiovascular Medical Research grant. Three of the study authors are employed by Permanente Medical Group.

The incidence of myocardial infarction declined by 24% between 1999 and 2008, and the decline was most significant among those with ST-segment elevation myo-cardial infarction, according to findings from a large community-based population study.

In addition, 30-day mortality rates improved, driven mostly by declining case fatality rates among patients with non–ST-segment elevation myocardial infarction (non-STEMI).

Researchers identified 46,086 members of Kaiser Permanente Northern California aged 30 years and older who were hospitalized between 1999 and 2008 with a primary discharge diagnosis of acute MI. The 46,086 hospitalizations represented 18,691,131 person-years of follow-up, reported the researchers, led by Dr. Robert W. Yeh of the department of medicine at Massachusetts General Hospital, Boston.

The researchers used ICD-9-CM codes to classify MI hospitalizations as STEMI or non-STEMI and to calculate age- and sex-adjusted incidence rates. They used administrative databases, state death data, and Social Security Administration data to determine 30-day mortality, and also identified patient characteristics, outpatient medications, and levels of cardiac biomarkers during hospitalization (N. Engl. J. Med. 2010;362:2155-65).

After adjustment for age and sex, the overall incidence of MI rose from 274 cases per 100,000 person-years in 1999 to 287 cases per 100,000 person-years in 2000, then fell each year thereafter, reaching 208 per 100,000 person-years in 2008—a significant 24% decrease over the study period. In addition, 30-day mortality after acute MI was significantly lower in 2008 than in 1999 (adjusted odds ratio, 0.76).

The incidence of age- and sex-adjusted STEMI decreased each year, from 133 per 100,000 person-years in 1999 to 50 per 100,000 person-years in 2008, a decline of 62%. However, the incidence of non-STEMI increased from 155 cases per 100,000 person-years in 1999 to 202 cases per 100,000 person-years in 2004, the year that use of troponin testing stabilized, and decreased thereafter. Adjusted 30-day mortality decreased significantly from 1999 to 2008 in patients with non-STEMI (OR, 0.82) but did not change significantly in those with STEMI (OR, 0.93).

The researchers suggested the declining incidence of MI can be attributed at least in part to “substantial improvements in primary-prevention efforts” implemented at Kaiser. The decline occurred “despite the increased sensitivity of new biomarkers for the diagnosis of myocardial infarction” and the increasing prevalence of obesity and diabetes. The increased use of troponin testing would be expected to increase the incidence of MI, so “the observed decreases in myocardial infarction since 2000 are even more striking.”

They acknowledged certain limitations of their study, including the fact that “the true effect of changes in diagnostic sensitivity with changing biomarker use cannot be comprehensively quantified. However, the expected bias would be an overestimation of the incidence of myocardial infarction in later years. Thus, actual decreases in the incidence of myocardial infarction since 2000 may, in fact, be greater than we observed.” They also noted the results might not be generalizable.

Major Finding: The age- and sex-adjusted incidence of acute MI decreased by 24% between 1999 and 2008.

Data Source: A study of 46,086 Kaiser Permanente Northern California members aged 30 years and older who were hospitalized with a primary discharge diagnosis of acute MI.

Disclosures: The study was supported by funding from the Permanente Medical Group and by a Schering-Plough Future Leaders in Cardiovascular Medical Research grant. Three of the study authors are employed by Permanente Medical Group.

The incidence of myocardial infarction declined by 24% between 1999 and 2008, and the decline was most significant among those with ST-segment elevation myo-cardial infarction, according to findings from a large community-based population study.

In addition, 30-day mortality rates improved, driven mostly by declining case fatality rates among patients with non–ST-segment elevation myocardial infarction (non-STEMI).

Researchers identified 46,086 members of Kaiser Permanente Northern California aged 30 years and older who were hospitalized between 1999 and 2008 with a primary discharge diagnosis of acute MI. The 46,086 hospitalizations represented 18,691,131 person-years of follow-up, reported the researchers, led by Dr. Robert W. Yeh of the department of medicine at Massachusetts General Hospital, Boston.

The researchers used ICD-9-CM codes to classify MI hospitalizations as STEMI or non-STEMI and to calculate age- and sex-adjusted incidence rates. They used administrative databases, state death data, and Social Security Administration data to determine 30-day mortality, and also identified patient characteristics, outpatient medications, and levels of cardiac biomarkers during hospitalization (N. Engl. J. Med. 2010;362:2155-65).

After adjustment for age and sex, the overall incidence of MI rose from 274 cases per 100,000 person-years in 1999 to 287 cases per 100,000 person-years in 2000, then fell each year thereafter, reaching 208 per 100,000 person-years in 2008—a significant 24% decrease over the study period. In addition, 30-day mortality after acute MI was significantly lower in 2008 than in 1999 (adjusted odds ratio, 0.76).

The incidence of age- and sex-adjusted STEMI decreased each year, from 133 per 100,000 person-years in 1999 to 50 per 100,000 person-years in 2008, a decline of 62%. However, the incidence of non-STEMI increased from 155 cases per 100,000 person-years in 1999 to 202 cases per 100,000 person-years in 2004, the year that use of troponin testing stabilized, and decreased thereafter. Adjusted 30-day mortality decreased significantly from 1999 to 2008 in patients with non-STEMI (OR, 0.82) but did not change significantly in those with STEMI (OR, 0.93).

The researchers suggested the declining incidence of MI can be attributed at least in part to “substantial improvements in primary-prevention efforts” implemented at Kaiser. The decline occurred “despite the increased sensitivity of new biomarkers for the diagnosis of myocardial infarction” and the increasing prevalence of obesity and diabetes. The increased use of troponin testing would be expected to increase the incidence of MI, so “the observed decreases in myocardial infarction since 2000 are even more striking.”

They acknowledged certain limitations of their study, including the fact that “the true effect of changes in diagnostic sensitivity with changing biomarker use cannot be comprehensively quantified. However, the expected bias would be an overestimation of the incidence of myocardial infarction in later years. Thus, actual decreases in the incidence of myocardial infarction since 2000 may, in fact, be greater than we observed.” They also noted the results might not be generalizable.

Major Finding: IgE levels predicted worsening of depressive symptoms during high pollen season in patients with recurrent mood disorders.

Data Source: A blinded study of 100 patients.

Disclosures: The National Institute of Mental Health funded the study. The researchers had no relevant financial disclosures to make.

Allergen-specific immunoglobulin E and allergy symptoms are associated with worsening of depression scores in patients with mood disorders who are exposed to seasonal pollen peaks, preliminary results from a novel study suggest.

“We already know that depression is a very common disorder, but allergy is even more common,” Dr. Partam Manalai of the mood and anxiety program in the department of psychiatry at the University of Maryland School of Medicine, Baltimore, said at a press briefing.

“One in every two people might have some kind of sensitivity to some allergen, and one in five people may have allergic rhinitis. During exacerbations of allergic rhinitis, people experience worsening of mood, cognition, and overall well-being.”

Dr. Manalai went on to note that there is a spring peak in pollen count that corresponds with tree pollen, while there is a somewhat smaller fall peak in pollen count, which corresponds with ragweed and grass pollen. At the same time, he said, several previously published studies have found a peak in the rate of completed suicides in the spring, and a somewhat smaller peak in the fall.

“To our knowledge, this is the first report of a biological marker of allergic sensitization (allergen-specific IgE) predicting worsening in depressive symptoms during the high pollen season,” Dr. Manalai said.

“In a group of patients with allergy and depression, prophylactic treatment of these conditions may prevent worsening of mood during peak allergen season. Our findings may be conducive to research on new preventative and therapeutic targets in the management of mood disorders.”

In the study, researchers blinded to the patients' IgE status evaluated 100 patients from Baltimore and Washington, with diagnoses of recurrent mood disorder– once during a low pollen period and once during the preceding or subsequent peak high pollen period.

Patients taking antihistamines and decongestants were included in the analysis, but those with active substance-related or psychotic disorders were excluded, as were those taking montelukast or intranasal corticosteroids.

The researchers administered the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version and the Allergy Symptom Severity Assessment and compared the scores during the low and high pollen periods.

As recommended by the National Allergy Bureau, they conducted volumetric sampling for pollen in grains/m

The mean age of patients was 44 years, and 60 were men. Nearly half (47) were IgE positive for tree and/or ragweed pollen, while the rest (53) were IgE negative.

Dr. Manalai reported that changes in typical depression scores were significantly related to worsening of allergy symptoms (P = .008) while changes in atypical depression scores were significantly related to allergy-specific IgE positivity (P = .033), but not to worsening of allergy symptoms.

“The worse the allergy symptoms, the worse the depression scores,” Dr. Manalai said.

Specifically, during low pollen season, the mean SIGH-SAD score for those in the allergen-specific IgE-positive group who had typical depression was 11.77, compared with a mean score of 9.8 for their counterparts in the allergen-specific IgE negative group. The SIGH-SAD score was also higher for those in the allergen-specific IgE-positive group who had atypical depression (a mean of 5.27, compared with a mean of 4.37 for their counterparts in the allergen-specific IgE negative group).

During high pollen season, the mean SIGH-SAD score for those in the allergen-specific IgE-positive group who had typical depression was 11.54, compared with a mean score of 9.76 for their counterparts in the allergen-specific IgE negative group.

The SIGH-SAD score was also higher for those in the allergen-specific IgE-positive group who had atypical depression (a mean of 6.9, compared with 5.13 for their counterparts in the allergen-specific IgE negative group).

In a later interview, lead author Dr. Teodor T. Postolache, who directs the University of Maryland psychiatry department's mood and anxiety program, pointed out that these mean scores “need to be adjusted for C-reactive protein. C-reactive protein changes were used in the models to adjust for and minimize the masking effects of nonallergic inflammation during the duration of the study (such as virus infections, sinus infections, to name a few).”

Major Finding: IgE levels predicted worsening of depressive symptoms during high pollen season in patients with recurrent mood disorders.

Data Source: A blinded study of 100 patients.

Disclosures: The National Institute of Mental Health funded the study. The researchers had no relevant financial disclosures to make.

Allergen-specific immunoglobulin E and allergy symptoms are associated with worsening of depression scores in patients with mood disorders who are exposed to seasonal pollen peaks, preliminary results from a novel study suggest.

“We already know that depression is a very common disorder, but allergy is even more common,” Dr. Partam Manalai of the mood and anxiety program in the department of psychiatry at the University of Maryland School of Medicine, Baltimore, said at a press briefing.

“One in every two people might have some kind of sensitivity to some allergen, and one in five people may have allergic rhinitis. During exacerbations of allergic rhinitis, people experience worsening of mood, cognition, and overall well-being.”

Dr. Manalai went on to note that there is a spring peak in pollen count that corresponds with tree pollen, while there is a somewhat smaller fall peak in pollen count, which corresponds with ragweed and grass pollen. At the same time, he said, several previously published studies have found a peak in the rate of completed suicides in the spring, and a somewhat smaller peak in the fall.

“To our knowledge, this is the first report of a biological marker of allergic sensitization (allergen-specific IgE) predicting worsening in depressive symptoms during the high pollen season,” Dr. Manalai said.

“In a group of patients with allergy and depression, prophylactic treatment of these conditions may prevent worsening of mood during peak allergen season. Our findings may be conducive to research on new preventative and therapeutic targets in the management of mood disorders.”

In the study, researchers blinded to the patients' IgE status evaluated 100 patients from Baltimore and Washington, with diagnoses of recurrent mood disorder– once during a low pollen period and once during the preceding or subsequent peak high pollen period.

Patients taking antihistamines and decongestants were included in the analysis, but those with active substance-related or psychotic disorders were excluded, as were those taking montelukast or intranasal corticosteroids.

The researchers administered the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version and the Allergy Symptom Severity Assessment and compared the scores during the low and high pollen periods.

As recommended by the National Allergy Bureau, they conducted volumetric sampling for pollen in grains/m

The mean age of patients was 44 years, and 60 were men. Nearly half (47) were IgE positive for tree and/or ragweed pollen, while the rest (53) were IgE negative.

Dr. Manalai reported that changes in typical depression scores were significantly related to worsening of allergy symptoms (P = .008) while changes in atypical depression scores were significantly related to allergy-specific IgE positivity (P = .033), but not to worsening of allergy symptoms.

“The worse the allergy symptoms, the worse the depression scores,” Dr. Manalai said.

Specifically, during low pollen season, the mean SIGH-SAD score for those in the allergen-specific IgE-positive group who had typical depression was 11.77, compared with a mean score of 9.8 for their counterparts in the allergen-specific IgE negative group. The SIGH-SAD score was also higher for those in the allergen-specific IgE-positive group who had atypical depression (a mean of 5.27, compared with a mean of 4.37 for their counterparts in the allergen-specific IgE negative group).

During high pollen season, the mean SIGH-SAD score for those in the allergen-specific IgE-positive group who had typical depression was 11.54, compared with a mean score of 9.76 for their counterparts in the allergen-specific IgE negative group.

The SIGH-SAD score was also higher for those in the allergen-specific IgE-positive group who had atypical depression (a mean of 6.9, compared with 5.13 for their counterparts in the allergen-specific IgE negative group).

In a later interview, lead author Dr. Teodor T. Postolache, who directs the University of Maryland psychiatry department's mood and anxiety program, pointed out that these mean scores “need to be adjusted for C-reactive protein. C-reactive protein changes were used in the models to adjust for and minimize the masking effects of nonallergic inflammation during the duration of the study (such as virus infections, sinus infections, to name a few).”

Major Finding: IgE levels predicted worsening of depressive symptoms during high pollen season in patients with recurrent mood disorders.

Data Source: A blinded study of 100 patients.

Disclosures: The National Institute of Mental Health funded the study. The researchers had no relevant financial disclosures to make.

Allergen-specific immunoglobulin E and allergy symptoms are associated with worsening of depression scores in patients with mood disorders who are exposed to seasonal pollen peaks, preliminary results from a novel study suggest.

“We already know that depression is a very common disorder, but allergy is even more common,” Dr. Partam Manalai of the mood and anxiety program in the department of psychiatry at the University of Maryland School of Medicine, Baltimore, said at a press briefing.

“One in every two people might have some kind of sensitivity to some allergen, and one in five people may have allergic rhinitis. During exacerbations of allergic rhinitis, people experience worsening of mood, cognition, and overall well-being.”

Dr. Manalai went on to note that there is a spring peak in pollen count that corresponds with tree pollen, while there is a somewhat smaller fall peak in pollen count, which corresponds with ragweed and grass pollen. At the same time, he said, several previously published studies have found a peak in the rate of completed suicides in the spring, and a somewhat smaller peak in the fall.

“To our knowledge, this is the first report of a biological marker of allergic sensitization (allergen-specific IgE) predicting worsening in depressive symptoms during the high pollen season,” Dr. Manalai said.

“In a group of patients with allergy and depression, prophylactic treatment of these conditions may prevent worsening of mood during peak allergen season. Our findings may be conducive to research on new preventative and therapeutic targets in the management of mood disorders.”

In the study, researchers blinded to the patients' IgE status evaluated 100 patients from Baltimore and Washington, with diagnoses of recurrent mood disorder– once during a low pollen period and once during the preceding or subsequent peak high pollen period.

Patients taking antihistamines and decongestants were included in the analysis, but those with active substance-related or psychotic disorders were excluded, as were those taking montelukast or intranasal corticosteroids.

The researchers administered the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version and the Allergy Symptom Severity Assessment and compared the scores during the low and high pollen periods.

As recommended by the National Allergy Bureau, they conducted volumetric sampling for pollen in grains/m

The mean age of patients was 44 years, and 60 were men. Nearly half (47) were IgE positive for tree and/or ragweed pollen, while the rest (53) were IgE negative.

Dr. Manalai reported that changes in typical depression scores were significantly related to worsening of allergy symptoms (P = .008) while changes in atypical depression scores were significantly related to allergy-specific IgE positivity (P = .033), but not to worsening of allergy symptoms.

“The worse the allergy symptoms, the worse the depression scores,” Dr. Manalai said.

Specifically, during low pollen season, the mean SIGH-SAD score for those in the allergen-specific IgE-positive group who had typical depression was 11.77, compared with a mean score of 9.8 for their counterparts in the allergen-specific IgE negative group. The SIGH-SAD score was also higher for those in the allergen-specific IgE-positive group who had atypical depression (a mean of 5.27, compared with a mean of 4.37 for their counterparts in the allergen-specific IgE negative group).

During high pollen season, the mean SIGH-SAD score for those in the allergen-specific IgE-positive group who had typical depression was 11.54, compared with a mean score of 9.76 for their counterparts in the allergen-specific IgE negative group.

The SIGH-SAD score was also higher for those in the allergen-specific IgE-positive group who had atypical depression (a mean of 6.9, compared with 5.13 for their counterparts in the allergen-specific IgE negative group).

In a later interview, lead author Dr. Teodor T. Postolache, who directs the University of Maryland psychiatry department's mood and anxiety program, pointed out that these mean scores “need to be adjusted for C-reactive protein. C-reactive protein changes were used in the models to adjust for and minimize the masking effects of nonallergic inflammation during the duration of the study (such as virus infections, sinus infections, to name a few).”

SANTA FE, N.M. - Treatment of bacterial vaginitis with tinidazole at 500 mg twice a day for 7 days was not significantly more efficacious than the standard dose of metronidazole, results from a single-center study demonstrated.

“BV is extremely common and has associated complications, but the therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV,” Dr. Jane R. Schwebke said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “Tinidazole was licensed in the U.S. for BV based on a placebo controlled study, so we really have no data to compare the efficacy of tinidazole for the treatment of BV ... with metronidazole.”

In what she described as the first study of its kind, Dr. Schwebke and her associates randomized 593 women with symptomatic BV who attended an STD clinic in Birmingham, Ala., over 4 years to one of three regimens: metronidazole 500 mg b.i.d. for 7 days, tinidazole 500 mg b.i.d. for 7 days, or tinidazole 1 g b.i.d. for 7 days. The researchers conducted follow-up visits at 14 and 28 days and then monthly for two additional visits. Cure was defined as a Nugent score of less than 7 among any of the treatment groups.

The mean age of the study participants was 28 years and most (92%) were black. Dr. Schwebke, professor of medicine at the University of Alabama, Birmingham, reported that there were no statistically significant differences between the cure rates at the day-14 visit or at the day-28 visit among any of the treatment groups. Cure rates at the day 14 visit for the metronidazole, tinidazole 1 g b.i.d., and tinidazole 500 mg b.i.d. were 82%, 73%, and 73%, respectively, while the cure rates at the day 28 visit were 64%, 68%, and 62%.

“Interestingly, neither baseline Nugent score, consistent use of condoms, sex with a new partner, nor sex with multiple partners were associated with treatment outcome,” Dr. Schwebke said. “However, women who engaged in sex during the study were more likely to have BV at follow-up, which has been a consistent finding among most studies of late.”

The side effect profiles were similar among treatment groups, with the most common side effects being yeast infections, nausea/vomiting, and a bad taste in the mouth.

SANTA FE, N.M. - Treatment of bacterial vaginitis with tinidazole at 500 mg twice a day for 7 days was not significantly more efficacious than the standard dose of metronidazole, results from a single-center study demonstrated.

“BV is extremely common and has associated complications, but the therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV,” Dr. Jane R. Schwebke said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “Tinidazole was licensed in the U.S. for BV based on a placebo controlled study, so we really have no data to compare the efficacy of tinidazole for the treatment of BV ... with metronidazole.”

In what she described as the first study of its kind, Dr. Schwebke and her associates randomized 593 women with symptomatic BV who attended an STD clinic in Birmingham, Ala., over 4 years to one of three regimens: metronidazole 500 mg b.i.d. for 7 days, tinidazole 500 mg b.i.d. for 7 days, or tinidazole 1 g b.i.d. for 7 days. The researchers conducted follow-up visits at 14 and 28 days and then monthly for two additional visits. Cure was defined as a Nugent score of less than 7 among any of the treatment groups.

The mean age of the study participants was 28 years and most (92%) were black. Dr. Schwebke, professor of medicine at the University of Alabama, Birmingham, reported that there were no statistically significant differences between the cure rates at the day-14 visit or at the day-28 visit among any of the treatment groups. Cure rates at the day 14 visit for the metronidazole, tinidazole 1 g b.i.d., and tinidazole 500 mg b.i.d. were 82%, 73%, and 73%, respectively, while the cure rates at the day 28 visit were 64%, 68%, and 62%.

“Interestingly, neither baseline Nugent score, consistent use of condoms, sex with a new partner, nor sex with multiple partners were associated with treatment outcome,” Dr. Schwebke said. “However, women who engaged in sex during the study were more likely to have BV at follow-up, which has been a consistent finding among most studies of late.”

The side effect profiles were similar among treatment groups, with the most common side effects being yeast infections, nausea/vomiting, and a bad taste in the mouth.

SANTA FE, N.M. - Treatment of bacterial vaginitis with tinidazole at 500 mg twice a day for 7 days was not significantly more efficacious than the standard dose of metronidazole, results from a single-center study demonstrated.

“BV is extremely common and has associated complications, but the therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV,” Dr. Jane R. Schwebke said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “Tinidazole was licensed in the U.S. for BV based on a placebo controlled study, so we really have no data to compare the efficacy of tinidazole for the treatment of BV ... with metronidazole.”

In what she described as the first study of its kind, Dr. Schwebke and her associates randomized 593 women with symptomatic BV who attended an STD clinic in Birmingham, Ala., over 4 years to one of three regimens: metronidazole 500 mg b.i.d. for 7 days, tinidazole 500 mg b.i.d. for 7 days, or tinidazole 1 g b.i.d. for 7 days. The researchers conducted follow-up visits at 14 and 28 days and then monthly for two additional visits. Cure was defined as a Nugent score of less than 7 among any of the treatment groups.

The mean age of the study participants was 28 years and most (92%) were black. Dr. Schwebke, professor of medicine at the University of Alabama, Birmingham, reported that there were no statistically significant differences between the cure rates at the day-14 visit or at the day-28 visit among any of the treatment groups. Cure rates at the day 14 visit for the metronidazole, tinidazole 1 g b.i.d., and tinidazole 500 mg b.i.d. were 82%, 73%, and 73%, respectively, while the cure rates at the day 28 visit were 64%, 68%, and 62%.

“Interestingly, neither baseline Nugent score, consistent use of condoms, sex with a new partner, nor sex with multiple partners were associated with treatment outcome,” Dr. Schwebke said. “However, women who engaged in sex during the study were more likely to have BV at follow-up, which has been a consistent finding among most studies of late.”

The side effect profiles were similar among treatment groups, with the most common side effects being yeast infections, nausea/vomiting, and a bad taste in the mouth.

SANTA FE, N.M. – Treatment of bacterial vaginitis with tinidazole at 500 mg twice a day for 7 days was not significantly more efficacious than the standard dose of metronidazole, results from a single-center study demonstrated.

“BV is extremely common and has associated complications, but the therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV,” Dr. Jane R. Schwebke said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “Tinidazole was licensed in the U.S. for BV based on a placebo controlled study, so we really have no data to compare the efficacy of tinidazole for the treatment of BV ... with metronidazole.”

In what she described as the first study of its kind, Dr. Schwebke and her associates randomized 593 women with symptomatic BV who attended an STD clinic in Birmingham, Ala., over 4 years to one of three regimens: metronidazole 500 mg b.i.d. for 7 days, tinidazole 500 mg b.i.d. for 7 days, or tinidazole 1 g b.i.d. for 7 days. The researchers conducted follow-up visits at 14 and 28 days and then monthly for two additional visits. Cure was defined as a Nugent score of less than 7 among any of the treatment groups.

The mean age of the study participants was 28 years and most (92%) were black. Dr. Schwebke, professor of medicine at the University of Alabama, Birmingham, reported that there were no statistically significant differences between the cure rates at the day-14 visit or at the day-28 visit among any of the treatment groups. Cure rates at the day 14 visit for the metronidazole, tinidazole 1 g b.i.d., and tinidazole 500 mg b.i.d. were 82%, 73%, and 73%, respectively, while the cure rates at the day 28 visit were 64%, 68%, and 62%.

“Interestingly, neither baseline Nugent score, consistent use of condoms, sex with a new partner, nor sex with multiple partners were associated with treatment outcome,” Dr. Schwebke said. “However, women who engaged in sex during the study were more likely to have BV at follow-up, which has been a consistent finding among most studies of late.”

The side effect profiles were similar among treatment groups, with the most common side effects being yeast infections, nausea/vomiting, and a bad taste in the mouth.

The study was funded by the National Institute of Allergy and Infectious Diseases. Mission Pharmacal Co. provided the tinidazole.

Dr. Schwebke said that she had no relevant financial disclosures to make.

SANTA FE, N.M. – Treatment of bacterial vaginitis with tinidazole at 500 mg twice a day for 7 days was not significantly more efficacious than the standard dose of metronidazole, results from a single-center study demonstrated.

“BV is extremely common and has associated complications, but the therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV,” Dr. Jane R. Schwebke said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “Tinidazole was licensed in the U.S. for BV based on a placebo controlled study, so we really have no data to compare the efficacy of tinidazole for the treatment of BV ... with metronidazole.”

In what she described as the first study of its kind, Dr. Schwebke and her associates randomized 593 women with symptomatic BV who attended an STD clinic in Birmingham, Ala., over 4 years to one of three regimens: metronidazole 500 mg b.i.d. for 7 days, tinidazole 500 mg b.i.d. for 7 days, or tinidazole 1 g b.i.d. for 7 days. The researchers conducted follow-up visits at 14 and 28 days and then monthly for two additional visits. Cure was defined as a Nugent score of less than 7 among any of the treatment groups.

The mean age of the study participants was 28 years and most (92%) were black. Dr. Schwebke, professor of medicine at the University of Alabama, Birmingham, reported that there were no statistically significant differences between the cure rates at the day-14 visit or at the day-28 visit among any of the treatment groups. Cure rates at the day 14 visit for the metronidazole, tinidazole 1 g b.i.d., and tinidazole 500 mg b.i.d. were 82%, 73%, and 73%, respectively, while the cure rates at the day 28 visit were 64%, 68%, and 62%.

“Interestingly, neither baseline Nugent score, consistent use of condoms, sex with a new partner, nor sex with multiple partners were associated with treatment outcome,” Dr. Schwebke said. “However, women who engaged in sex during the study were more likely to have BV at follow-up, which has been a consistent finding among most studies of late.”

The side effect profiles were similar among treatment groups, with the most common side effects being yeast infections, nausea/vomiting, and a bad taste in the mouth.

The study was funded by the National Institute of Allergy and Infectious Diseases. Mission Pharmacal Co. provided the tinidazole.

Dr. Schwebke said that she had no relevant financial disclosures to make.

SANTA FE, N.M. – Treatment of bacterial vaginitis with tinidazole at 500 mg twice a day for 7 days was not significantly more efficacious than the standard dose of metronidazole, results from a single-center study demonstrated.

“BV is extremely common and has associated complications, but the therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV,” Dr. Jane R. Schwebke said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “Tinidazole was licensed in the U.S. for BV based on a placebo controlled study, so we really have no data to compare the efficacy of tinidazole for the treatment of BV ... with metronidazole.”

In what she described as the first study of its kind, Dr. Schwebke and her associates randomized 593 women with symptomatic BV who attended an STD clinic in Birmingham, Ala., over 4 years to one of three regimens: metronidazole 500 mg b.i.d. for 7 days, tinidazole 500 mg b.i.d. for 7 days, or tinidazole 1 g b.i.d. for 7 days. The researchers conducted follow-up visits at 14 and 28 days and then monthly for two additional visits. Cure was defined as a Nugent score of less than 7 among any of the treatment groups.

The mean age of the study participants was 28 years and most (92%) were black. Dr. Schwebke, professor of medicine at the University of Alabama, Birmingham, reported that there were no statistically significant differences between the cure rates at the day-14 visit or at the day-28 visit among any of the treatment groups. Cure rates at the day 14 visit for the metronidazole, tinidazole 1 g b.i.d., and tinidazole 500 mg b.i.d. were 82%, 73%, and 73%, respectively, while the cure rates at the day 28 visit were 64%, 68%, and 62%.

“Interestingly, neither baseline Nugent score, consistent use of condoms, sex with a new partner, nor sex with multiple partners were associated with treatment outcome,” Dr. Schwebke said. “However, women who engaged in sex during the study were more likely to have BV at follow-up, which has been a consistent finding among most studies of late.”

The side effect profiles were similar among treatment groups, with the most common side effects being yeast infections, nausea/vomiting, and a bad taste in the mouth.

The study was funded by the National Institute of Allergy and Infectious Diseases. Mission Pharmacal Co. provided the tinidazole.

Dr. Schwebke said that she had no relevant financial disclosures to make.

SANTA FE, N.M. – Molecular diagnostic tests appear to be overused for the diagnosis of lower genital tract infections in women, results from an analysis of national practice patterns showed.

In fact, the use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommended molecular tests alone.

Vaginitis is a common clinical problem in which accurate diagnosis “can be challenging,” Dr. Linda O’Neal Eckert said during the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “In fact, many of us make a living by trying to accurately diagnose challenging cases of vaginitis. The availability of molecular testing for female genital tract infections is definitely increasing. Their use may offer appeal, partly because there’s a perception of accuracy when you can get the result back and hope that that might determine the etiology of the symptoms, and also because using these tests does not require a microscope.”

Dr. Eckert of the University of Washington, Seattle, and her associates conducted a cross-sectional study of laboratory claims within a large national insurance database for the year 2008. “This database represents 3.5 million commercially insured patients,” she said. “More than 500 laboratories are in this database, including both commercial and hospital laboratories.”

The researchers used ICD-9 codes to select women who presented for a first evaluation of vaginal and cervical infections, and then identified molecular tests performed to detect infections from laboratory CPT codes that were billed on the same visit. They used published guidelines (N. Engl. J. Med 2006;355:1244-52; ACOG Practice Bulletin No. 72, May 2006, reaffirmed 2008) to classify molecular tests as either recommended (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, herpes simplex virus) or not recommended (Candida species and subspecies, Gardnerella vaginalis, staphylococcus, streptococcus, enterococcus, cytomegalovirus, and others) for use in this setting.

Of 211,933 women in the database, 82,443 met criteria for inclusion in the study. Of these patients, 61,132 (74%) had recommended tests, 17,934 (22%) had both recommended and nonrecommended tests, and 3,377 (4%) had only nonrecommended tests performed at their initial visits.

The most common molecular test classified as not recommended that was ordered was for the detection of an agent not otherwise specified by amplified DNA probe method. Dr. Eckert reported that this test was performed 15,526 times at an average cost of $21.60 per test, for a total amount spent of $335,290.

The second most common test performed was a direct DNA probe to search for G. vaginalis. This test was performed 14,698 times at an average cost of $21.30 per test, for a total amount spent of $313,298. The third most common test performed was a direct DNA probe for Candida species and subspecies. This test was performed 14,630 times at an average cost of $21.37 per test, for a total amount spent of $312,707.

Overall, a total of $6,328,168 was spent on molecular testing, Dr. Eckert said. Of this total, the cost of recommended tests amounted to $4,816,407 (76.1%), whereas the cost of nonrecommended tests amounted to $1,408,270 million (22.3%). The use of nonspecified molecular tests accounted for the remaining 1.6%, or $103,491.

The researchers determined that the average cost of recommended testing was $61 per patient visit, whereas the average cost of additional unrecommended testing was $66 per visit. In the aggregate, use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommend testing alone.

One of the meeting attendees, Dr. Harold C. Wiesenfeld, director of the division of reproductive infectious diseases in the University of Pittsburgh, said that some of his patients who aren’t covered by insurance are getting bills approaching $1,400 for vaginitis panels. “There is no data that any clinical outcome is improved based on these tests,” he commented.

Dr. Eckert noted that one of the labs studied accounted for the vast majority of nonrecommended molecular testing. “There is a significant variation that occurs between laboratories for the use of recommended vs. nonrecommended molecular tests,” she said.

She acknowledged certain limitations of the study, including the fact that she and her associates defined the recommended and nonrecommended molecular tests. “These definitions might not be shared by all,” she said. “Also, this study is not representative of all practices. It only included individuals who had commercial insurance, and not all geographic regions were equally represented.”

She concluded that improved education and the utilization of management “that guides practitioners to appropriate diagnostic tests may result in considerable cost savings, but also improve patient outcomes if we work toward the more accurate etiology of these symptoms vs. just randomly testing for these types of bacteria in the vagina.”

Dr. Eckert said that she had no relevant financial conflicts to disclose.

SANTA FE, N.M. – Molecular diagnostic tests appear to be overused for the diagnosis of lower genital tract infections in women, results from an analysis of national practice patterns showed.

In fact, the use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommended molecular tests alone.

Vaginitis is a common clinical problem in which accurate diagnosis “can be challenging,” Dr. Linda O’Neal Eckert said during the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “In fact, many of us make a living by trying to accurately diagnose challenging cases of vaginitis. The availability of molecular testing for female genital tract infections is definitely increasing. Their use may offer appeal, partly because there’s a perception of accuracy when you can get the result back and hope that that might determine the etiology of the symptoms, and also because using these tests does not require a microscope.”

Dr. Eckert of the University of Washington, Seattle, and her associates conducted a cross-sectional study of laboratory claims within a large national insurance database for the year 2008. “This database represents 3.5 million commercially insured patients,” she said. “More than 500 laboratories are in this database, including both commercial and hospital laboratories.”

The researchers used ICD-9 codes to select women who presented for a first evaluation of vaginal and cervical infections, and then identified molecular tests performed to detect infections from laboratory CPT codes that were billed on the same visit. They used published guidelines (N. Engl. J. Med 2006;355:1244-52; ACOG Practice Bulletin No. 72, May 2006, reaffirmed 2008) to classify molecular tests as either recommended (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, herpes simplex virus) or not recommended (Candida species and subspecies, Gardnerella vaginalis, staphylococcus, streptococcus, enterococcus, cytomegalovirus, and others) for use in this setting.

Of 211,933 women in the database, 82,443 met criteria for inclusion in the study. Of these patients, 61,132 (74%) had recommended tests, 17,934 (22%) had both recommended and nonrecommended tests, and 3,377 (4%) had only nonrecommended tests performed at their initial visits.

The most common molecular test classified as not recommended that was ordered was for the detection of an agent not otherwise specified by amplified DNA probe method. Dr. Eckert reported that this test was performed 15,526 times at an average cost of $21.60 per test, for a total amount spent of $335,290.

The second most common test performed was a direct DNA probe to search for G. vaginalis. This test was performed 14,698 times at an average cost of $21.30 per test, for a total amount spent of $313,298. The third most common test performed was a direct DNA probe for Candida species and subspecies. This test was performed 14,630 times at an average cost of $21.37 per test, for a total amount spent of $312,707.

Overall, a total of $6,328,168 was spent on molecular testing, Dr. Eckert said. Of this total, the cost of recommended tests amounted to $4,816,407 (76.1%), whereas the cost of nonrecommended tests amounted to $1,408,270 million (22.3%). The use of nonspecified molecular tests accounted for the remaining 1.6%, or $103,491.

The researchers determined that the average cost of recommended testing was $61 per patient visit, whereas the average cost of additional unrecommended testing was $66 per visit. In the aggregate, use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommend testing alone.

One of the meeting attendees, Dr. Harold C. Wiesenfeld, director of the division of reproductive infectious diseases in the University of Pittsburgh, said that some of his patients who aren’t covered by insurance are getting bills approaching $1,400 for vaginitis panels. “There is no data that any clinical outcome is improved based on these tests,” he commented.

Dr. Eckert noted that one of the labs studied accounted for the vast majority of nonrecommended molecular testing. “There is a significant variation that occurs between laboratories for the use of recommended vs. nonrecommended molecular tests,” she said.

She acknowledged certain limitations of the study, including the fact that she and her associates defined the recommended and nonrecommended molecular tests. “These definitions might not be shared by all,” she said. “Also, this study is not representative of all practices. It only included individuals who had commercial insurance, and not all geographic regions were equally represented.”

She concluded that improved education and the utilization of management “that guides practitioners to appropriate diagnostic tests may result in considerable cost savings, but also improve patient outcomes if we work toward the more accurate etiology of these symptoms vs. just randomly testing for these types of bacteria in the vagina.”

Dr. Eckert said that she had no relevant financial conflicts to disclose.

SANTA FE, N.M. – Molecular diagnostic tests appear to be overused for the diagnosis of lower genital tract infections in women, results from an analysis of national practice patterns showed.

In fact, the use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommended molecular tests alone.

Vaginitis is a common clinical problem in which accurate diagnosis “can be challenging,” Dr. Linda O’Neal Eckert said during the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “In fact, many of us make a living by trying to accurately diagnose challenging cases of vaginitis. The availability of molecular testing for female genital tract infections is definitely increasing. Their use may offer appeal, partly because there’s a perception of accuracy when you can get the result back and hope that that might determine the etiology of the symptoms, and also because using these tests does not require a microscope.”

Dr. Eckert of the University of Washington, Seattle, and her associates conducted a cross-sectional study of laboratory claims within a large national insurance database for the year 2008. “This database represents 3.5 million commercially insured patients,” she said. “More than 500 laboratories are in this database, including both commercial and hospital laboratories.”

The researchers used ICD-9 codes to select women who presented for a first evaluation of vaginal and cervical infections, and then identified molecular tests performed to detect infections from laboratory CPT codes that were billed on the same visit. They used published guidelines (N. Engl. J. Med 2006;355:1244-52; ACOG Practice Bulletin No. 72, May 2006, reaffirmed 2008) to classify molecular tests as either recommended (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, herpes simplex virus) or not recommended (Candida species and subspecies, Gardnerella vaginalis, staphylococcus, streptococcus, enterococcus, cytomegalovirus, and others) for use in this setting.

Of 211,933 women in the database, 82,443 met criteria for inclusion in the study. Of these patients, 61,132 (74%) had recommended tests, 17,934 (22%) had both recommended and nonrecommended tests, and 3,377 (4%) had only nonrecommended tests performed at their initial visits.

The most common molecular test classified as not recommended that was ordered was for the detection of an agent not otherwise specified by amplified DNA probe method. Dr. Eckert reported that this test was performed 15,526 times at an average cost of $21.60 per test, for a total amount spent of $335,290.

The second most common test performed was a direct DNA probe to search for G. vaginalis. This test was performed 14,698 times at an average cost of $21.30 per test, for a total amount spent of $313,298. The third most common test performed was a direct DNA probe for Candida species and subspecies. This test was performed 14,630 times at an average cost of $21.37 per test, for a total amount spent of $312,707.

Overall, a total of $6,328,168 was spent on molecular testing, Dr. Eckert said. Of this total, the cost of recommended tests amounted to $4,816,407 (76.1%), whereas the cost of nonrecommended tests amounted to $1,408,270 million (22.3%). The use of nonspecified molecular tests accounted for the remaining 1.6%, or $103,491.

The researchers determined that the average cost of recommended testing was $61 per patient visit, whereas the average cost of additional unrecommended testing was $66 per visit. In the aggregate, use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommend testing alone.

One of the meeting attendees, Dr. Harold C. Wiesenfeld, director of the division of reproductive infectious diseases in the University of Pittsburgh, said that some of his patients who aren’t covered by insurance are getting bills approaching $1,400 for vaginitis panels. “There is no data that any clinical outcome is improved based on these tests,” he commented.

Dr. Eckert noted that one of the labs studied accounted for the vast majority of nonrecommended molecular testing. “There is a significant variation that occurs between laboratories for the use of recommended vs. nonrecommended molecular tests,” she said.

She acknowledged certain limitations of the study, including the fact that she and her associates defined the recommended and nonrecommended molecular tests. “These definitions might not be shared by all,” she said. “Also, this study is not representative of all practices. It only included individuals who had commercial insurance, and not all geographic regions were equally represented.”

She concluded that improved education and the utilization of management “that guides practitioners to appropriate diagnostic tests may result in considerable cost savings, but also improve patient outcomes if we work toward the more accurate etiology of these symptoms vs. just randomly testing for these types of bacteria in the vagina.”

Dr. Eckert said that she had no relevant financial conflicts to disclose.

SANTA FE, N.M. – A single dose of an inactivated 2009 H1N1 influenza vaccine administered to pregnant women that contained 25 mcg of hemagglutinin antigen generated an antibody response typically associated with protection against influenza, results from a multicenter comparative trial showed.

Dr. Geeta K. Swamy

“It was anticipated and subsequently proven that a single dose of vaccine would be adequately immunogenic in the nonpregnant adult population,” Dr. Geeta K. Swamy reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “But there were questions raised as to what the appropriate dose should be during pregnancy, because there are issues with development of tolerance to foreign antigens during pregnancy. There is also a decrease in total circulating immunoglobulin levels during pregnancy, and there are concerns that this might have some modulation of effect on immune response to vaccines.”

In what she said is the first study of its kind, Dr. Swamy of Duke University Medical Center, Durham, N.C., and her associates at five other sites enrolled 120 women during their second or third trimester of pregnancy between Sept. 9, 2009, and Oct. 16, 2009. The women were randomized to receive either 25 mcg or 49 mcg of hemagglutinin antigen in a two-dose series separated by 21 days. The researchers used standard methods to test for hemagglutinin inhibition (HAI) in serum samples obtained before each vaccination and 21 days after the second vaccination.

The median age of study participants was 32 years, and most were white (85% of those in the 25-mcg group and 80% of those in the 49-mcg group). The sites included Duke; Group Health Research Institute, Seattle (lead site); Baylor College of Medicine, Houston; St. Louis (Mo.) University; Vanderbilt University, Nashville, Tenn.; and the University of Maryland, Baltimore.

Dr. Swamy reported that after the first vaccination, HAI titers of 1:40 or greater were detected in 93% of women in the 25-mcg group and 97% of women in the 49-mcg group, while the rate of seroconversion (defined as a fourfold increase in HAI titer from baseline) was 89% in the 25-mcg group and 97% in the 49-mcg group.

The geometric mean titers peaked after the first vaccination and did not increase further after the second vaccination. The vaccine was well tolerated, with mild-to-moderate transient side effects including tenderness at the injection site, malaise, and headache. “There was not any statistically significant difference between the 25-mcg dose and the 49-mcg dose, although the women in the higher-dose group did report more local tenderness and pain at the vaccine injection site,” Dr. Swamy said.

A stratified analysis of study participants who reported prior receipt of seasonal influenza vaccine showed trends toward a decline in geometric mean titers after the second dose of hemagglutinin antibody.

Further analyses are planned, she said, including investigating the optimal timing of vaccine administration during pregnancy.

The study was sponsored by the National Institute of Allergy and Infectious Diseases’ Vaccine and Treatment Evaluation Units network. Sanofi Pasteur provided the vaccine used in the study, but the company had no role in the conduct of the study or in analysis of the data.

Dr. Swamy said that she had no relevant financial conflicts to disclose.

SANTA FE, N.M. – A single dose of an inactivated 2009 H1N1 influenza vaccine administered to pregnant women that contained 25 mcg of hemagglutinin antigen generated an antibody response typically associated with protection against influenza, results from a multicenter comparative trial showed.

Dr. Geeta K. Swamy

“It was anticipated and subsequently proven that a single dose of vaccine would be adequately immunogenic in the nonpregnant adult population,” Dr. Geeta K. Swamy reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “But there were questions raised as to what the appropriate dose should be during pregnancy, because there are issues with development of tolerance to foreign antigens during pregnancy. There is also a decrease in total circulating immunoglobulin levels during pregnancy, and there are concerns that this might have some modulation of effect on immune response to vaccines.”

In what she said is the first study of its kind, Dr. Swamy of Duke University Medical Center, Durham, N.C., and her associates at five other sites enrolled 120 women during their second or third trimester of pregnancy between Sept. 9, 2009, and Oct. 16, 2009. The women were randomized to receive either 25 mcg or 49 mcg of hemagglutinin antigen in a two-dose series separated by 21 days. The researchers used standard methods to test for hemagglutinin inhibition (HAI) in serum samples obtained before each vaccination and 21 days after the second vaccination.

The median age of study participants was 32 years, and most were white (85% of those in the 25-mcg group and 80% of those in the 49-mcg group). The sites included Duke; Group Health Research Institute, Seattle (lead site); Baylor College of Medicine, Houston; St. Louis (Mo.) University; Vanderbilt University, Nashville, Tenn.; and the University of Maryland, Baltimore.

Dr. Swamy reported that after the first vaccination, HAI titers of 1:40 or greater were detected in 93% of women in the 25-mcg group and 97% of women in the 49-mcg group, while the rate of seroconversion (defined as a fourfold increase in HAI titer from baseline) was 89% in the 25-mcg group and 97% in the 49-mcg group.

The geometric mean titers peaked after the first vaccination and did not increase further after the second vaccination. The vaccine was well tolerated, with mild-to-moderate transient side effects including tenderness at the injection site, malaise, and headache. “There was not any statistically significant difference between the 25-mcg dose and the 49-mcg dose, although the women in the higher-dose group did report more local tenderness and pain at the vaccine injection site,” Dr. Swamy said.

A stratified analysis of study participants who reported prior receipt of seasonal influenza vaccine showed trends toward a decline in geometric mean titers after the second dose of hemagglutinin antibody.

Further analyses are planned, she said, including investigating the optimal timing of vaccine administration during pregnancy.

The study was sponsored by the National Institute of Allergy and Infectious Diseases’ Vaccine and Treatment Evaluation Units network. Sanofi Pasteur provided the vaccine used in the study, but the company had no role in the conduct of the study or in analysis of the data.

Dr. Swamy said that she had no relevant financial conflicts to disclose.

SANTA FE, N.M. – A single dose of an inactivated 2009 H1N1 influenza vaccine administered to pregnant women that contained 25 mcg of hemagglutinin antigen generated an antibody response typically associated with protection against influenza, results from a multicenter comparative trial showed.

Dr. Geeta K. Swamy

“It was anticipated and subsequently proven that a single dose of vaccine would be adequately immunogenic in the nonpregnant adult population,” Dr. Geeta K. Swamy reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “But there were questions raised as to what the appropriate dose should be during pregnancy, because there are issues with development of tolerance to foreign antigens during pregnancy. There is also a decrease in total circulating immunoglobulin levels during pregnancy, and there are concerns that this might have some modulation of effect on immune response to vaccines.”

In what she said is the first study of its kind, Dr. Swamy of Duke University Medical Center, Durham, N.C., and her associates at five other sites enrolled 120 women during their second or third trimester of pregnancy between Sept. 9, 2009, and Oct. 16, 2009. The women were randomized to receive either 25 mcg or 49 mcg of hemagglutinin antigen in a two-dose series separated by 21 days. The researchers used standard methods to test for hemagglutinin inhibition (HAI) in serum samples obtained before each vaccination and 21 days after the second vaccination.

The median age of study participants was 32 years, and most were white (85% of those in the 25-mcg group and 80% of those in the 49-mcg group). The sites included Duke; Group Health Research Institute, Seattle (lead site); Baylor College of Medicine, Houston; St. Louis (Mo.) University; Vanderbilt University, Nashville, Tenn.; and the University of Maryland, Baltimore.

Dr. Swamy reported that after the first vaccination, HAI titers of 1:40 or greater were detected in 93% of women in the 25-mcg group and 97% of women in the 49-mcg group, while the rate of seroconversion (defined as a fourfold increase in HAI titer from baseline) was 89% in the 25-mcg group and 97% in the 49-mcg group.

The geometric mean titers peaked after the first vaccination and did not increase further after the second vaccination. The vaccine was well tolerated, with mild-to-moderate transient side effects including tenderness at the injection site, malaise, and headache. “There was not any statistically significant difference between the 25-mcg dose and the 49-mcg dose, although the women in the higher-dose group did report more local tenderness and pain at the vaccine injection site,” Dr. Swamy said.

A stratified analysis of study participants who reported prior receipt of seasonal influenza vaccine showed trends toward a decline in geometric mean titers after the second dose of hemagglutinin antibody.

Further analyses are planned, she said, including investigating the optimal timing of vaccine administration during pregnancy.

The study was sponsored by the National Institute of Allergy and Infectious Diseases’ Vaccine and Treatment Evaluation Units network. Sanofi Pasteur provided the vaccine used in the study, but the company had no role in the conduct of the study or in analysis of the data.

Dr. Swamy said that she had no relevant financial conflicts to disclose.

SANTA FE, N.M. – A single dose of an inactivated 2009 H1N1 influenza vaccine administered to pregnant women that contained 25 mcg of hemagglutinin antigen generated an antibody response typically associated with protection against influenza, results from a multicenter comparative trial showed.

Dr. Geeta K. Swamy

“It was anticipated and subsequently proven that a single dose of vaccine would be adequately immunogenic in the nonpregnant adult population,” Dr. Geeta K. Swamy reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “But there were questions raised as to what the appropriate dose should be during pregnancy, because there are issues with development of tolerance to foreign antigens during pregnancy. There is also a decrease in total circulating immunoglobulin levels during pregnancy, and there are concerns that this might have some modulation of effect on immune response to vaccines.”

In what she said is the first study of its kind, Dr. Swamy of Duke University Medical Center, Durham, N.C., and her associates at five other sites enrolled 120 women during their second or third trimester of pregnancy between Sept. 9, 2009, and Oct. 16, 2009. The women were randomized to receive either 25 mcg or 49 mcg of hemagglutinin antigen in a two-dose series separated by 21 days. The researchers used standard methods to test for hemagglutinin inhibition (HAI) in serum samples obtained before each vaccination and 21 days after the second vaccination.

The median age of study participants was 32 years, and most were white (85% of those in the 25-mcg group and 80% of those in the 49-mcg group). The sites included Duke; Group Health Research Institute, Seattle (lead site); Baylor College of Medicine, Houston; St. Louis (Mo.) University; Vanderbilt University, Nashville, Tenn.; and the University of Maryland, Baltimore.

Dr. Swamy reported that after the first vaccination, HAI titers of 1:40 or greater were detected in 93% of women in the 25-mcg group and 97% of women in the 49-mcg group, while the rate of seroconversion (defined as a fourfold increase in HAI titer from baseline) was 89% in the 25-mcg group and 97% in the 49-mcg group.

The geometric mean titers peaked after the first vaccination and did not increase further after the second vaccination. The vaccine was well tolerated, with mild-to-moderate transient side effects including tenderness at the injection site, malaise, and headache. “There was not any statistically significant difference between the 25-mcg dose and the 49-mcg dose, although the women in the higher-dose group did report more local tenderness and pain at the vaccine injection site,” Dr. Swamy said.

A stratified analysis of study participants who reported prior receipt of seasonal influenza vaccine showed trends toward a decline in geometric mean titers after the second dose of hemagglutinin antibody.

Further analyses are planned, she said, including investigating the optimal timing of vaccine administration during pregnancy.

The study was sponsored by the National Institute of Allergy and Infectious Diseases’ Vaccine and Treatment Evaluation Units network. Sanofi Pasteur provided the vaccine used in the study, but the company had no role in the conduct of the study or in analysis of the data.

Dr. Swamy said that she had no relevant financial conflicts to disclose.

Geeta K. Swamy

SANTA FE, N.M. – A single dose of an inactivated 2009 H1N1 influenza vaccine administered to pregnant women that contained 25 mcg of hemagglutinin antigen generated an antibody response typically associated with protection against influenza, results from a multicenter comparative trial showed.

Dr. Geeta K. Swamy

“It was anticipated and subsequently proven that a single dose of vaccine would be adequately immunogenic in the nonpregnant adult population,” Dr. Geeta K. Swamy reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “But there were questions raised as to what the appropriate dose should be during pregnancy, because there are issues with development of tolerance to foreign antigens during pregnancy. There is also a decrease in total circulating immunoglobulin levels during pregnancy, and there are concerns that this might have some modulation of effect on immune response to vaccines.”

In what she said is the first study of its kind, Dr. Swamy of Duke University Medical Center, Durham, N.C., and her associates at five other sites enrolled 120 women during their second or third trimester of pregnancy between Sept. 9, 2009, and Oct. 16, 2009. The women were randomized to receive either 25 mcg or 49 mcg of hemagglutinin antigen in a two-dose series separated by 21 days. The researchers used standard methods to test for hemagglutinin inhibition (HAI) in serum samples obtained before each vaccination and 21 days after the second vaccination.

The median age of study participants was 32 years, and most were white (85% of those in the 25-mcg group and 80% of those in the 49-mcg group). The sites included Duke; Group Health Research Institute, Seattle (lead site); Baylor College of Medicine, Houston; St. Louis (Mo.) University; Vanderbilt University, Nashville, Tenn.; and the University of Maryland, Baltimore.

Dr. Swamy reported that after the first vaccination, HAI titers of 1:40 or greater were detected in 93% of women in the 25-mcg group and 97% of women in the 49-mcg group, while the rate of seroconversion (defined as a fourfold increase in HAI titer from baseline) was 89% in the 25-mcg group and 97% in the 49-mcg group.

The geometric mean titers peaked after the first vaccination and did not increase further after the second vaccination. The vaccine was well tolerated, with mild-to-moderate transient side effects including tenderness at the injection site, malaise, and headache. “There was not any statistically significant difference between the 25-mcg dose and the 49-mcg dose, although the women in the higher-dose group did report more local tenderness and pain at the vaccine injection site,” Dr. Swamy said.

A stratified analysis of study participants who reported prior receipt of seasonal influenza vaccine showed trends toward a decline in geometric mean titers after the second dose of hemagglutinin antibody.

Further analyses are planned, she said, including investigating the optimal timing of vaccine administration during pregnancy.

The study was sponsored by the National Institute of Allergy and Infectious Diseases’ Vaccine and Treatment Evaluation Units network. Sanofi Pasteur provided the vaccine used in the study, but the company had no role in the conduct of the study or in analysis of the data.

Dr. Swamy said that she had no relevant financial conflicts to disclose.

Geeta K. Swamy

SANTA FE, N.M. – A single dose of an inactivated 2009 H1N1 influenza vaccine administered to pregnant women that contained 25 mcg of hemagglutinin antigen generated an antibody response typically associated with protection against influenza, results from a multicenter comparative trial showed.

Dr. Geeta K. Swamy

“It was anticipated and subsequently proven that a single dose of vaccine would be adequately immunogenic in the nonpregnant adult population,” Dr. Geeta K. Swamy reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. “But there were questions raised as to what the appropriate dose should be during pregnancy, because there are issues with development of tolerance to foreign antigens during pregnancy. There is also a decrease in total circulating immunoglobulin levels during pregnancy, and there are concerns that this might have some modulation of effect on immune response to vaccines.”

In what she said is the first study of its kind, Dr. Swamy of Duke University Medical Center, Durham, N.C., and her associates at five other sites enrolled 120 women during their second or third trimester of pregnancy between Sept. 9, 2009, and Oct. 16, 2009. The women were randomized to receive either 25 mcg or 49 mcg of hemagglutinin antigen in a two-dose series separated by 21 days. The researchers used standard methods to test for hemagglutinin inhibition (HAI) in serum samples obtained before each vaccination and 21 days after the second vaccination.

The median age of study participants was 32 years, and most were white (85% of those in the 25-mcg group and 80% of those in the 49-mcg group). The sites included Duke; Group Health Research Institute, Seattle (lead site); Baylor College of Medicine, Houston; St. Louis (Mo.) University; Vanderbilt University, Nashville, Tenn.; and the University of Maryland, Baltimore.

Dr. Swamy reported that after the first vaccination, HAI titers of 1:40 or greater were detected in 93% of women in the 25-mcg group and 97% of women in the 49-mcg group, while the rate of seroconversion (defined as a fourfold increase in HAI titer from baseline) was 89% in the 25-mcg group and 97% in the 49-mcg group.

The geometric mean titers peaked after the first vaccination and did not increase further after the second vaccination. The vaccine was well tolerated, with mild-to-moderate transient side effects including tenderness at the injection site, malaise, and headache. “There was not any statistically significant difference between the 25-mcg dose and the 49-mcg dose, although the women in the higher-dose group did report more local tenderness and pain at the vaccine injection site,” Dr. Swamy said.

A stratified analysis of study participants who reported prior receipt of seasonal influenza vaccine showed trends toward a decline in geometric mean titers after the second dose of hemagglutinin antibody.

Further analyses are planned, she said, including investigating the optimal timing of vaccine administration during pregnancy.

The study was sponsored by the National Institute of Allergy and Infectious Diseases’ Vaccine and Treatment Evaluation Units network. Sanofi Pasteur provided the vaccine used in the study, but the company had no role in the conduct of the study or in analysis of the data.

Dr. Swamy said that she had no relevant financial conflicts to disclose.

Geeta K. Swamy

Major Finding: Subcutaneous administration of the hormone ghrelin mimicked fasting in biasing food appeal toward high-calorie foods.

Data Source: A randomized study of 18 healthy, nonobese patients with a mean age of 23 years.

Disclosures: Dr. Goldstone said that he had no relevant financial disclosures. The study was supported by funding from the U.K. Medical Research Council, the Wellcome Trust, the European Union Nutrient Sensing in Satiety Control and Obesity, the U.K. National Institute for Health Research, and Imperial College Healthcare Charity.

SAN DIEGO — The hormone ghrelin, a circulating hormone created mainly in the stomach, mimicked fasting in biasing food appeal toward high-calorie foods, results from a small study showed.

The finding suggests that “changes in the hedonics of food—how pleasurable we find food when either missing meals or eating meals—may be explained by changes in the levels of ghrelin circulating in the blood,” Dr. Anthony Goldstone said during a press briefing.

“Given that ghrelin increases the rewarding value of food, it suggests that drugs that block the action of ghrelin may have a potential role in treating obesity—particularly craving for high-calorie foods—and also binge-eating disorder.”

Previous work by Dr. Goldstone and his associates has shown that fasting biases activation in reward systems and food appeal toward high-calorie foods in humans (Eur. J. Neurosci. 2009;30:1625-35), but the processes that regulate how we choose the sorts of foods we want to eat remain unclear. Findings from various animal studies have suggested that ghrelin may stimulate dopaminergic brain reward systems, “which regulate how rewarding we find food,” said Dr. Goldstone, a consultant endocrinologist with the MRC Clinical Sciences Center at Imperial College London.

“We wanted to ask a simple question: whether the effects of fasting on food reward could be mimicked by giving ghrelin to fed subjects, to switch them into a hormonally fasted state.”

To find out, the researchers recruited 18 nonobese adults with a mean age of 23 years and mean body mass index of 24 kg/m

The subjects underwent functional MRI 40 minutes later and were asked to view blocks of photographs that showed high-calorie foods (such as chocolate, cake, and pizza), or low-calorie foods (such as vegetables, fish, and salads). Each picture was shown for about 2.5 seconds; subjects used a handheld key pad to rate the appeal of each food on a scale of 1-5, with 5 being most desirable.

Both fasting and the administration of ghrelin significantly increased the appeal of high-calorie but not low-calorie foods. “This was particularly seen for sweet high-calorie foods,” he said.

MRI imaging showed that fasting and the administration of ghrelin “increased activation of the orbitofrontal cortex, which is known to be involved in encoding the reward value of food,” Dr. Goldstone said. “Ghrelin is able to mimic the effects of fasting to bias our brain reward system toward high-calorie foods.”

'Drugs that block the action of ghrelin may have a potential role in treating obesity.'

Source DR. GOLDSTONE

Major Finding: Subcutaneous administration of the hormone ghrelin mimicked fasting in biasing food appeal toward high-calorie foods.

Data Source: A randomized study of 18 healthy, nonobese patients with a mean age of 23 years.

Disclosures: Dr. Goldstone said that he had no relevant financial disclosures. The study was supported by funding from the U.K. Medical Research Council, the Wellcome Trust, the European Union Nutrient Sensing in Satiety Control and Obesity, the U.K. National Institute for Health Research, and Imperial College Healthcare Charity.

SAN DIEGO — The hormone ghrelin, a circulating hormone created mainly in the stomach, mimicked fasting in biasing food appeal toward high-calorie foods, results from a small study showed.

The finding suggests that “changes in the hedonics of food—how pleasurable we find food when either missing meals or eating meals—may be explained by changes in the levels of ghrelin circulating in the blood,” Dr. Anthony Goldstone said during a press briefing.

“Given that ghrelin increases the rewarding value of food, it suggests that drugs that block the action of ghrelin may have a potential role in treating obesity—particularly craving for high-calorie foods—and also binge-eating disorder.”

Previous work by Dr. Goldstone and his associates has shown that fasting biases activation in reward systems and food appeal toward high-calorie foods in humans (Eur. J. Neurosci. 2009;30:1625-35), but the processes that regulate how we choose the sorts of foods we want to eat remain unclear. Findings from various animal studies have suggested that ghrelin may stimulate dopaminergic brain reward systems, “which regulate how rewarding we find food,” said Dr. Goldstone, a consultant endocrinologist with the MRC Clinical Sciences Center at Imperial College London.

“We wanted to ask a simple question: whether the effects of fasting on food reward could be mimicked by giving ghrelin to fed subjects, to switch them into a hormonally fasted state.”

To find out, the researchers recruited 18 nonobese adults with a mean age of 23 years and mean body mass index of 24 kg/m

The subjects underwent functional MRI 40 minutes later and were asked to view blocks of photographs that showed high-calorie foods (such as chocolate, cake, and pizza), or low-calorie foods (such as vegetables, fish, and salads). Each picture was shown for about 2.5 seconds; subjects used a handheld key pad to rate the appeal of each food on a scale of 1-5, with 5 being most desirable.

Both fasting and the administration of ghrelin significantly increased the appeal of high-calorie but not low-calorie foods. “This was particularly seen for sweet high-calorie foods,” he said.

MRI imaging showed that fasting and the administration of ghrelin “increased activation of the orbitofrontal cortex, which is known to be involved in encoding the reward value of food,” Dr. Goldstone said. “Ghrelin is able to mimic the effects of fasting to bias our brain reward system toward high-calorie foods.”

'Drugs that block the action of ghrelin may have a potential role in treating obesity.'

Source DR. GOLDSTONE

Major Finding: Subcutaneous administration of the hormone ghrelin mimicked fasting in biasing food appeal toward high-calorie foods.

Data Source: A randomized study of 18 healthy, nonobese patients with a mean age of 23 years.

Disclosures: Dr. Goldstone said that he had no relevant financial disclosures. The study was supported by funding from the U.K. Medical Research Council, the Wellcome Trust, the European Union Nutrient Sensing in Satiety Control and Obesity, the U.K. National Institute for Health Research, and Imperial College Healthcare Charity.

SAN DIEGO — The hormone ghrelin, a circulating hormone created mainly in the stomach, mimicked fasting in biasing food appeal toward high-calorie foods, results from a small study showed.

The finding suggests that “changes in the hedonics of food—how pleasurable we find food when either missing meals or eating meals—may be explained by changes in the levels of ghrelin circulating in the blood,” Dr. Anthony Goldstone said during a press briefing.

“Given that ghrelin increases the rewarding value of food, it suggests that drugs that block the action of ghrelin may have a potential role in treating obesity—particularly craving for high-calorie foods—and also binge-eating disorder.”

Previous work by Dr. Goldstone and his associates has shown that fasting biases activation in reward systems and food appeal toward high-calorie foods in humans (Eur. J. Neurosci. 2009;30:1625-35), but the processes that regulate how we choose the sorts of foods we want to eat remain unclear. Findings from various animal studies have suggested that ghrelin may stimulate dopaminergic brain reward systems, “which regulate how rewarding we find food,” said Dr. Goldstone, a consultant endocrinologist with the MRC Clinical Sciences Center at Imperial College London.

“We wanted to ask a simple question: whether the effects of fasting on food reward could be mimicked by giving ghrelin to fed subjects, to switch them into a hormonally fasted state.”

To find out, the researchers recruited 18 nonobese adults with a mean age of 23 years and mean body mass index of 24 kg/m

The subjects underwent functional MRI 40 minutes later and were asked to view blocks of photographs that showed high-calorie foods (such as chocolate, cake, and pizza), or low-calorie foods (such as vegetables, fish, and salads). Each picture was shown for about 2.5 seconds; subjects used a handheld key pad to rate the appeal of each food on a scale of 1-5, with 5 being most desirable.

Both fasting and the administration of ghrelin significantly increased the appeal of high-calorie but not low-calorie foods. “This was particularly seen for sweet high-calorie foods,” he said.

MRI imaging showed that fasting and the administration of ghrelin “increased activation of the orbitofrontal cortex, which is known to be involved in encoding the reward value of food,” Dr. Goldstone said. “Ghrelin is able to mimic the effects of fasting to bias our brain reward system toward high-calorie foods.”

'Drugs that block the action of ghrelin may have a potential role in treating obesity.'

Source DR. GOLDSTONE

Major Finding: Women who had menopause before age 46 were 2.1 times more likely to have a CVD event later in life, compared with those who had menopause later.

Data Source: A cohort analysis of 2,509 women in MESA followed for an average of 7 years.

Disclosures: The study was funded by the National Heart, Lung, and Blood Institute.

SAN DIEGO — Women who go through menopause before age 46 are twice as likely to have a heart attack, stroke, or other cardiovascular event later in life as are women who do not go through early menopause, results from a large, multiethnic study showed.

“Our study is observational, so we cannot conclude that early menopause somehow causes these cardiovascular disease events, but our findings support using early menopause as a marker of increased cardiovascular disease risk,” Dr. Melissa F. Wellons said during a press briefing at the meeting.

“Getting clinicians to ask women about menopause and about when they went through menopause is an important part of potentially determining what their risk of CVD is in the future. Doing that can give them information on placing these women with early menopause into a higher-risk group and counseling them appropriately, such as encouraging them to stop smoking, exercise, and lose weight.”

Dr. Wellons, a fellow in the department of medicine at the University of Alabama at Birmingham, and her associates evaluated data from 2,509 women enrolled in the observational Multi-Ethnic Study of Atherosclerosis (MESA), funded by the National Institutes of Health. It included more than 6,000 women, from six communities in the United States, who were recruited in 2000 and followed for an average of 7 years. Most (40%) were white, 25% were black, 22% were Hispanic, and 13% were Chinese American.

“Our work is important because previous studies that have found a relationship between early menopause and cardiovascular disease events have taken place in primarily European and white cohorts,” Dr. Wellons noted.

The researchers defined early menopause as occurring before age 46, either naturally or surgically through removal of both ovaries, and they tracked the incidence of CVD among all study participants. At baseline, the women ranged in age from 45 to 84 years. Of the 2,509 women, 693 (28%) reported early menopause. Of these, 446 (64%) had natural menopause and 247 (36%) had surgical menopause.

In the early menopause group, 41 women (5.9%) had CVD events during the study period. Among those who did not have early menopause, 47 women (2.6%) had CVD events. The difference was significant.

After adjusting for race/ethnicity, level of education, smoking history, hypertension, total cholesterol, HDL cholesterol, diabetes, and whether the menopause was natural or surgical, the investigators found that women in the early menopause group were 2.1 times more likely to experience a CVD event than were women who didn't have early menopause. Further adjustment for current or previous use of hormone therapy and body mass index produced identical results.

“The risk of having a heart attack, stroke, or other cardiovascular disease event later in life doubles in women with early menopause,” Dr. Wellons concluded. “We found [this] in a large, U.S., multiethnic cohort, so our findings are generalizable to the U.S. population.”

'We found [this risk] in a large, U.S., multiethnic cohort, so our findings are generalizable.'

Source DR. WELLONS

Major Finding: Women who had menopause before age 46 were 2.1 times more likely to have a CVD event later in life, compared with those who had menopause later.

Data Source: A cohort analysis of 2,509 women in MESA followed for an average of 7 years.

Disclosures: The study was funded by the National Heart, Lung, and Blood Institute.

SAN DIEGO — Women who go through menopause before age 46 are twice as likely to have a heart attack, stroke, or other cardiovascular event later in life as are women who do not go through early menopause, results from a large, multiethnic study showed.

“Our study is observational, so we cannot conclude that early menopause somehow causes these cardiovascular disease events, but our findings support using early menopause as a marker of increased cardiovascular disease risk,” Dr. Melissa F. Wellons said during a press briefing at the meeting.

“Getting clinicians to ask women about menopause and about when they went through menopause is an important part of potentially determining what their risk of CVD is in the future. Doing that can give them information on placing these women with early menopause into a higher-risk group and counseling them appropriately, such as encouraging them to stop smoking, exercise, and lose weight.”

Dr. Wellons, a fellow in the department of medicine at the University of Alabama at Birmingham, and her associates evaluated data from 2,509 women enrolled in the observational Multi-Ethnic Study of Atherosclerosis (MESA), funded by the National Institutes of Health. It included more than 6,000 women, from six communities in the United States, who were recruited in 2000 and followed for an average of 7 years. Most (40%) were white, 25% were black, 22% were Hispanic, and 13% were Chinese American.

“Our work is important because previous studies that have found a relationship between early menopause and cardiovascular disease events have taken place in primarily European and white cohorts,” Dr. Wellons noted.

The researchers defined early menopause as occurring before age 46, either naturally or surgically through removal of both ovaries, and they tracked the incidence of CVD among all study participants. At baseline, the women ranged in age from 45 to 84 years. Of the 2,509 women, 693 (28%) reported early menopause. Of these, 446 (64%) had natural menopause and 247 (36%) had surgical menopause.

In the early menopause group, 41 women (5.9%) had CVD events during the study period. Among those who did not have early menopause, 47 women (2.6%) had CVD events. The difference was significant.

After adjusting for race/ethnicity, level of education, smoking history, hypertension, total cholesterol, HDL cholesterol, diabetes, and whether the menopause was natural or surgical, the investigators found that women in the early menopause group were 2.1 times more likely to experience a CVD event than were women who didn't have early menopause. Further adjustment for current or previous use of hormone therapy and body mass index produced identical results.

“The risk of having a heart attack, stroke, or other cardiovascular disease event later in life doubles in women with early menopause,” Dr. Wellons concluded. “We found [this] in a large, U.S., multiethnic cohort, so our findings are generalizable to the U.S. population.”

'We found [this risk] in a large, U.S., multiethnic cohort, so our findings are generalizable.'

Source DR. WELLONS

Major Finding: Women who had menopause before age 46 were 2.1 times more likely to have a CVD event later in life, compared with those who had menopause later.

Data Source: A cohort analysis of 2,509 women in MESA followed for an average of 7 years.

Disclosures: The study was funded by the National Heart, Lung, and Blood Institute.

SAN DIEGO — Women who go through menopause before age 46 are twice as likely to have a heart attack, stroke, or other cardiovascular event later in life as are women who do not go through early menopause, results from a large, multiethnic study showed.

“Our study is observational, so we cannot conclude that early menopause somehow causes these cardiovascular disease events, but our findings support using early menopause as a marker of increased cardiovascular disease risk,” Dr. Melissa F. Wellons said during a press briefing at the meeting.

“Getting clinicians to ask women about menopause and about when they went through menopause is an important part of potentially determining what their risk of CVD is in the future. Doing that can give them information on placing these women with early menopause into a higher-risk group and counseling them appropriately, such as encouraging them to stop smoking, exercise, and lose weight.”

Dr. Wellons, a fellow in the department of medicine at the University of Alabama at Birmingham, and her associates evaluated data from 2,509 women enrolled in the observational Multi-Ethnic Study of Atherosclerosis (MESA), funded by the National Institutes of Health. It included more than 6,000 women, from six communities in the United States, who were recruited in 2000 and followed for an average of 7 years. Most (40%) were white, 25% were black, 22% were Hispanic, and 13% were Chinese American.

“Our work is important because previous studies that have found a relationship between early menopause and cardiovascular disease events have taken place in primarily European and white cohorts,” Dr. Wellons noted.

The researchers defined early menopause as occurring before age 46, either naturally or surgically through removal of both ovaries, and they tracked the incidence of CVD among all study participants. At baseline, the women ranged in age from 45 to 84 years. Of the 2,509 women, 693 (28%) reported early menopause. Of these, 446 (64%) had natural menopause and 247 (36%) had surgical menopause.

In the early menopause group, 41 women (5.9%) had CVD events during the study period. Among those who did not have early menopause, 47 women (2.6%) had CVD events. The difference was significant.

After adjusting for race/ethnicity, level of education, smoking history, hypertension, total cholesterol, HDL cholesterol, diabetes, and whether the menopause was natural or surgical, the investigators found that women in the early menopause group were 2.1 times more likely to experience a CVD event than were women who didn't have early menopause. Further adjustment for current or previous use of hormone therapy and body mass index produced identical results.

“The risk of having a heart attack, stroke, or other cardiovascular disease event later in life doubles in women with early menopause,” Dr. Wellons concluded. “We found [this] in a large, U.S., multiethnic cohort, so our findings are generalizable to the U.S. population.”

'We found [this risk] in a large, U.S., multiethnic cohort, so our findings are generalizable.'

Source DR. WELLONS

Major Finding: Cancer survivors randomized to standard care plus 4 weeks of yoga classes reported better quality of sleep, less fatigue, and better quality of life than did those who received standard care alone.

Data Source: A randomized, multicenter study of 410 cancer survivors who reported sleeping problems between 2 and 24 months after completing adjuvant therapy.

Disclosures: Supported by grants from the National Cancer Institute. The researchers had nothing to disclose.

Yoga, widely practiced for maintaining flexibility and coping with stress, may also benefit cancer survivors who report impaired sleep quality and fatigue, results from a nationwide study demonstrated.

During a press briefing at the meeting, lead author Karen Mustian, Ph.D., of the University of Rochester (N.Y.) Medical Center, discussed results from what she said is the largest randomized, controlled study to date examining a yoga program designed specifically for cancer survivors.

The researchers used the University of Rochester Cancer Center Community Clinical Oncology Program (CCOP) Research Base to conduct a phase II/III randomized, controlled clinical trial at nine CCOP centers in the United States, examining the efficacy of yoga for improving sleep quality, fatigue, and quality of life among 410 cancer survivors who reported problems sleeping between 2 and 24 months after completing adjuvant therapy for their cancer.

To be eligible for the study, patients were required to have a sleep disturbance level of 3 or greater on a scale ranging from 0-10, Dr. Mustian said. Those who had attended a yoga class within the last 3 months were excluded from the study, as were those with sleep apnea and those with distant metastatic disease.

Patients were randomized to standard follow-up care or to standard follow-up care plus enrollment in Yoga for Cancer Survivors, (YOCAS), which encompasses components of hatha yoga and restorative yoga, including postures, breathing exercises, and mindfulness (including meditation exercises and visualization). The 75-minute classes were led by instructors certified in the techniques and met twice each week for 4 weeks.

At baseline and at the end of 4 weeks the researchers used the Pittsburgh Sleep Quality Index (PSQI) to measure sleep, the Multidimensional Fatigue Symptom Inventory to measure fatigue, and the Functional Assessment of Chronic Illness Therapy measurement system to assess quality of life. The mean age of the study participants was 56, most (96%) were female, and 75% were breast cancer patients.

Dr. Mustian reported that at the end of 4 weeks patients in the yoga group improved their overall sleep quality by 22%, while patients in the control group improved their overall sleep quality by 12%, a difference that was statistically significant.

At baseline, 84% of patients in the yoga group and 83% of patients in the control group had clinically impaired sleep quality defined as a PSQI score of 5 or higher.

At the end of the 4-week study, 31% of patients in the yoga group recovered and no longer had clinically impaired sleep quality, while only 16% of patients in the control group recovered.

Dr. Mustian also reported that, compared with their counterparts in the control group, patients in the yoga group had significantly greater reductions in fatigue (42% vs. 12%, respectively), daytime sleepiness (29% vs. 5%), and quality of life (6% vs. 0%).

In addition, use of sleep medication decreased by 21% in the yoga group but increased by 5% in the control group.

“Gentle hatha yoga classes and restorative yoga classes might be useful to cancer survivors in communities across the United States for helping these side effects, which create impairments in quality of life,” Dr. Mustian concluded. She added that it remains unclear whether other forms of yoga, “such as heated yoga or more rigorous types of yoga, would be effective in mitigating these side effects or [be] safe for cancer survivors.”

Dr. George W. Sledge Jr., ACSO's president-elect, called the YOCAS program “a readily applicable approach that improves quality of life and reduced medicine intake in cancer survivors. This is a real positive, [and] emphasizes the increasing importance of ameliorating complications of therapy in long-term cancer survivors. There are millions of patients to whom this might be applicable.”

The Yoga for Cancer Survivors program includes postures and breathing exercises from hatha yoga and restorative yoga.

Source ©Noam Armonn/iStockphoto.com

Major Finding: Cancer survivors randomized to standard care plus 4 weeks of yoga classes reported better quality of sleep, less fatigue, and better quality of life than did those who received standard care alone.

Data Source: A randomized, multicenter study of 410 cancer survivors who reported sleeping problems between 2 and 24 months after completing adjuvant therapy.

Disclosures: Supported by grants from the National Cancer Institute. The researchers had nothing to disclose.

Yoga, widely practiced for maintaining flexibility and coping with stress, may also benefit cancer survivors who report impaired sleep quality and fatigue, results from a nationwide study demonstrated.

During a press briefing at the meeting, lead author Karen Mustian, Ph.D., of the University of Rochester (N.Y.) Medical Center, discussed results from what she said is the largest randomized, controlled study to date examining a yoga program designed specifically for cancer survivors.

The researchers used the University of Rochester Cancer Center Community Clinical Oncology Program (CCOP) Research Base to conduct a phase II/III randomized, controlled clinical trial at nine CCOP centers in the United States, examining the efficacy of yoga for improving sleep quality, fatigue, and quality of life among 410 cancer survivors who reported problems sleeping between 2 and 24 months after completing adjuvant therapy for their cancer.

To be eligible for the study, patients were required to have a sleep disturbance level of 3 or greater on a scale ranging from 0-10, Dr. Mustian said. Those who had attended a yoga class within the last 3 months were excluded from the study, as were those with sleep apnea and those with distant metastatic disease.

Patients were randomized to standard follow-up care or to standard follow-up care plus enrollment in Yoga for Cancer Survivors, (YOCAS), which encompasses components of hatha yoga and restorative yoga, including postures, breathing exercises, and mindfulness (including meditation exercises and visualization). The 75-minute classes were led by instructors certified in the techniques and met twice each week for 4 weeks.

At baseline and at the end of 4 weeks the researchers used the Pittsburgh Sleep Quality Index (PSQI) to measure sleep, the Multidimensional Fatigue Symptom Inventory to measure fatigue, and the Functional Assessment of Chronic Illness Therapy measurement system to assess quality of life. The mean age of the study participants was 56, most (96%) were female, and 75% were breast cancer patients.

Dr. Mustian reported that at the end of 4 weeks patients in the yoga group improved their overall sleep quality by 22%, while patients in the control group improved their overall sleep quality by 12%, a difference that was statistically significant.

At baseline, 84% of patients in the yoga group and 83% of patients in the control group had clinically impaired sleep quality defined as a PSQI score of 5 or higher.

At the end of the 4-week study, 31% of patients in the yoga group recovered and no longer had clinically impaired sleep quality, while only 16% of patients in the control group recovered.

Dr. Mustian also reported that, compared with their counterparts in the control group, patients in the yoga group had significantly greater reductions in fatigue (42% vs. 12%, respectively), daytime sleepiness (29% vs. 5%), and quality of life (6% vs. 0%).

In addition, use of sleep medication decreased by 21% in the yoga group but increased by 5% in the control group.

“Gentle hatha yoga classes and restorative yoga classes might be useful to cancer survivors in communities across the United States for helping these side effects, which create impairments in quality of life,” Dr. Mustian concluded. She added that it remains unclear whether other forms of yoga, “such as heated yoga or more rigorous types of yoga, would be effective in mitigating these side effects or [be] safe for cancer survivors.”

Dr. George W. Sledge Jr., ACSO's president-elect, called the YOCAS program “a readily applicable approach that improves quality of life and reduced medicine intake in cancer survivors. This is a real positive, [and] emphasizes the increasing importance of ameliorating complications of therapy in long-term cancer survivors. There are millions of patients to whom this might be applicable.”

The Yoga for Cancer Survivors program includes postures and breathing exercises from hatha yoga and restorative yoga.

Source ©Noam Armonn/iStockphoto.com

Major Finding: Cancer survivors randomized to standard care plus 4 weeks of yoga classes reported better quality of sleep, less fatigue, and better quality of life than did those who received standard care alone.

Data Source: A randomized, multicenter study of 410 cancer survivors who reported sleeping problems between 2 and 24 months after completing adjuvant therapy.

Disclosures: Supported by grants from the National Cancer Institute. The researchers had nothing to disclose.

Yoga, widely practiced for maintaining flexibility and coping with stress, may also benefit cancer survivors who report impaired sleep quality and fatigue, results from a nationwide study demonstrated.

During a press briefing at the meeting, lead author Karen Mustian, Ph.D., of the University of Rochester (N.Y.) Medical Center, discussed results from what she said is the largest randomized, controlled study to date examining a yoga program designed specifically for cancer survivors.

The researchers used the University of Rochester Cancer Center Community Clinical Oncology Program (CCOP) Research Base to conduct a phase II/III randomized, controlled clinical trial at nine CCOP centers in the United States, examining the efficacy of yoga for improving sleep quality, fatigue, and quality of life among 410 cancer survivors who reported problems sleeping between 2 and 24 months after completing adjuvant therapy for their cancer.

To be eligible for the study, patients were required to have a sleep disturbance level of 3 or greater on a scale ranging from 0-10, Dr. Mustian said. Those who had attended a yoga class within the last 3 months were excluded from the study, as were those with sleep apnea and those with distant metastatic disease.

Patients were randomized to standard follow-up care or to standard follow-up care plus enrollment in Yoga for Cancer Survivors, (YOCAS), which encompasses components of hatha yoga and restorative yoga, including postures, breathing exercises, and mindfulness (including meditation exercises and visualization). The 75-minute classes were led by instructors certified in the techniques and met twice each week for 4 weeks.

At baseline and at the end of 4 weeks the researchers used the Pittsburgh Sleep Quality Index (PSQI) to measure sleep, the Multidimensional Fatigue Symptom Inventory to measure fatigue, and the Functional Assessment of Chronic Illness Therapy measurement system to assess quality of life. The mean age of the study participants was 56, most (96%) were female, and 75% were breast cancer patients.

Dr. Mustian reported that at the end of 4 weeks patients in the yoga group improved their overall sleep quality by 22%, while patients in the control group improved their overall sleep quality by 12%, a difference that was statistically significant.

At baseline, 84% of patients in the yoga group and 83% of patients in the control group had clinically impaired sleep quality defined as a PSQI score of 5 or higher.

At the end of the 4-week study, 31% of patients in the yoga group recovered and no longer had clinically impaired sleep quality, while only 16% of patients in the control group recovered.

Dr. Mustian also reported that, compared with their counterparts in the control group, patients in the yoga group had significantly greater reductions in fatigue (42% vs. 12%, respectively), daytime sleepiness (29% vs. 5%), and quality of life (6% vs. 0%).

In addition, use of sleep medication decreased by 21% in the yoga group but increased by 5% in the control group.

“Gentle hatha yoga classes and restorative yoga classes might be useful to cancer survivors in communities across the United States for helping these side effects, which create impairments in quality of life,” Dr. Mustian concluded. She added that it remains unclear whether other forms of yoga, “such as heated yoga or more rigorous types of yoga, would be effective in mitigating these side effects or [be] safe for cancer survivors.”

Dr. George W. Sledge Jr., ACSO's president-elect, called the YOCAS program “a readily applicable approach that improves quality of life and reduced medicine intake in cancer survivors. This is a real positive, [and] emphasizes the increasing importance of ameliorating complications of therapy in long-term cancer survivors. There are millions of patients to whom this might be applicable.”

The Yoga for Cancer Survivors program includes postures and breathing exercises from hatha yoga and restorative yoga.

Source ©Noam Armonn/iStockphoto.com