Sherry Boschert

SAN FRANCISCO — Hyperglycemia and ethnicity each were independently associated with a greater risk for cardiovascular problems in a large, prospective study of 48,444 New Zealanders.

The magnitude of the association between hyperglycemia and cardiovascular events in the study was smaller than has been suggested in previous studies, but the current data confirm the association between glycemic control and cardiac risk, Dr. Paul L. Drury said at the annual scientific sessions of the American Diabetes Association.

The information came from a New Zealand Ministry of Health program in which primary care physicians across the country were paid to collect and report data on patients with type 2 diabetes who had no history of cardiovascular disease and who were attending free annual visits for their diabetes. The investigators matched the glycemic data with national data on hospital admissions and death records to identify first cardiovascular events (ischemic heart disease, cerebrovascular accident, transient ischemic attack, or peripheral vascular disease).

During follow-up lasting a median of 2.4 years, 12% of the cohort had a first cardiovascular event. Each 1% increase in hemoglobin A1c (HbA1c) level was associated with a hazard ratio of 1.08, a statistically significant increase in risk, reported Dr. Drury, clinical director of diabetes services for the Auckland (New Zealand) District Health Board, and his associates. He has been an adviser to Eli Lilly & Co. and to Merck & Co., which make antidiabetes drugs.

The association between HbA1c and a first cardiovascular event was significant for both sexes. The results accounted for the effects of age at diagnosis, duration of diabetes, gender, ethnicity, socioeconomic status, smoking, systolic blood pressure, body mass index, the ratio of serum total cholesterol to HDL level, and the urine albumin-creatinine ratio.

Secondary analyses showed that Maori ethnicity was associated with a hazard ratio of 1.3 for developing a cardiovascular event, compared with non-Maori patients, after the researchers controlled for other factors. The study also confirmed the importance of classical risk factors for cardiovascular problems in patients with diabetes, Dr. Drury said. Diabetes duration, a high systolic blood pressure, a high lipid ratio, and macroalbuminuria each were significantly associated with increased risk. “BMI, to our surprise, was not relevant when all other variables were considered,” Dr. Drury said.

Patients had had diabetes for a median of 3 years and showed “reasonable glycemic control,” he noted, with a median HbA1c level of 7.1%. The median age was 60 years and the median BMI was 31; 15% of patients were current smokers and 23% were former smokers. The mean blood pressure was 138/81 mm Hg.

A previous meta-analysis of 17 studies found an increased risk of cardiovascular disease with increasing HbA1c levels (Ann. Intern. Med. 2004;141:421-31). The hazard ratio for each 1% increase in HbA1c was 1.18 for cardiovascular disease and 1.17 for stroke in the meta-analysis, compared with 1.08 for a cardiovascular event in the current study. The meta-analysis considered data only from 7,435 highly selected subjects with type 2 diabetes, Dr. Drury noted, while the current large study encompassed 60%-70% of all New Zealanders with type 2 diabetes.

The 12% rate of first cardiovascular events in the current study was higher than seen in previous studies. “We did raise our eyebrows at the event rate,” he said. “Much of that is not the harder material. If you look at an independent analysis of just myocardial infarction and stroke, rates are comparable to other published clinical trials” when not including things like transient ischemic attacks or angina.

Separate, controlled studies are needed to determine if treatment to avoid hyperglycemia would reduce the risk for cardiovascular events, he said.

SAN FRANCISCO — Hyperglycemia and ethnicity each were independently associated with a greater risk for cardiovascular problems in a large, prospective study of 48,444 New Zealanders.

The magnitude of the association between hyperglycemia and cardiovascular events in the study was smaller than has been suggested in previous studies, but the current data confirm the association between glycemic control and cardiac risk, Dr. Paul L. Drury said at the annual scientific sessions of the American Diabetes Association.

The information came from a New Zealand Ministry of Health program in which primary care physicians across the country were paid to collect and report data on patients with type 2 diabetes who had no history of cardiovascular disease and who were attending free annual visits for their diabetes. The investigators matched the glycemic data with national data on hospital admissions and death records to identify first cardiovascular events (ischemic heart disease, cerebrovascular accident, transient ischemic attack, or peripheral vascular disease).

During follow-up lasting a median of 2.4 years, 12% of the cohort had a first cardiovascular event. Each 1% increase in hemoglobin A1c (HbA1c) level was associated with a hazard ratio of 1.08, a statistically significant increase in risk, reported Dr. Drury, clinical director of diabetes services for the Auckland (New Zealand) District Health Board, and his associates. He has been an adviser to Eli Lilly & Co. and to Merck & Co., which make antidiabetes drugs.

The association between HbA1c and a first cardiovascular event was significant for both sexes. The results accounted for the effects of age at diagnosis, duration of diabetes, gender, ethnicity, socioeconomic status, smoking, systolic blood pressure, body mass index, the ratio of serum total cholesterol to HDL level, and the urine albumin-creatinine ratio.

Secondary analyses showed that Maori ethnicity was associated with a hazard ratio of 1.3 for developing a cardiovascular event, compared with non-Maori patients, after the researchers controlled for other factors. The study also confirmed the importance of classical risk factors for cardiovascular problems in patients with diabetes, Dr. Drury said. Diabetes duration, a high systolic blood pressure, a high lipid ratio, and macroalbuminuria each were significantly associated with increased risk. “BMI, to our surprise, was not relevant when all other variables were considered,” Dr. Drury said.

Patients had had diabetes for a median of 3 years and showed “reasonable glycemic control,” he noted, with a median HbA1c level of 7.1%. The median age was 60 years and the median BMI was 31; 15% of patients were current smokers and 23% were former smokers. The mean blood pressure was 138/81 mm Hg.

A previous meta-analysis of 17 studies found an increased risk of cardiovascular disease with increasing HbA1c levels (Ann. Intern. Med. 2004;141:421-31). The hazard ratio for each 1% increase in HbA1c was 1.18 for cardiovascular disease and 1.17 for stroke in the meta-analysis, compared with 1.08 for a cardiovascular event in the current study. The meta-analysis considered data only from 7,435 highly selected subjects with type 2 diabetes, Dr. Drury noted, while the current large study encompassed 60%-70% of all New Zealanders with type 2 diabetes.

The 12% rate of first cardiovascular events in the current study was higher than seen in previous studies. “We did raise our eyebrows at the event rate,” he said. “Much of that is not the harder material. If you look at an independent analysis of just myocardial infarction and stroke, rates are comparable to other published clinical trials” when not including things like transient ischemic attacks or angina.

Separate, controlled studies are needed to determine if treatment to avoid hyperglycemia would reduce the risk for cardiovascular events, he said.

SAN FRANCISCO — Hyperglycemia and ethnicity each were independently associated with a greater risk for cardiovascular problems in a large, prospective study of 48,444 New Zealanders.

The magnitude of the association between hyperglycemia and cardiovascular events in the study was smaller than has been suggested in previous studies, but the current data confirm the association between glycemic control and cardiac risk, Dr. Paul L. Drury said at the annual scientific sessions of the American Diabetes Association.

The information came from a New Zealand Ministry of Health program in which primary care physicians across the country were paid to collect and report data on patients with type 2 diabetes who had no history of cardiovascular disease and who were attending free annual visits for their diabetes. The investigators matched the glycemic data with national data on hospital admissions and death records to identify first cardiovascular events (ischemic heart disease, cerebrovascular accident, transient ischemic attack, or peripheral vascular disease).

During follow-up lasting a median of 2.4 years, 12% of the cohort had a first cardiovascular event. Each 1% increase in hemoglobin A1c (HbA1c) level was associated with a hazard ratio of 1.08, a statistically significant increase in risk, reported Dr. Drury, clinical director of diabetes services for the Auckland (New Zealand) District Health Board, and his associates. He has been an adviser to Eli Lilly & Co. and to Merck & Co., which make antidiabetes drugs.

The association between HbA1c and a first cardiovascular event was significant for both sexes. The results accounted for the effects of age at diagnosis, duration of diabetes, gender, ethnicity, socioeconomic status, smoking, systolic blood pressure, body mass index, the ratio of serum total cholesterol to HDL level, and the urine albumin-creatinine ratio.

Secondary analyses showed that Maori ethnicity was associated with a hazard ratio of 1.3 for developing a cardiovascular event, compared with non-Maori patients, after the researchers controlled for other factors. The study also confirmed the importance of classical risk factors for cardiovascular problems in patients with diabetes, Dr. Drury said. Diabetes duration, a high systolic blood pressure, a high lipid ratio, and macroalbuminuria each were significantly associated with increased risk. “BMI, to our surprise, was not relevant when all other variables were considered,” Dr. Drury said.

Patients had had diabetes for a median of 3 years and showed “reasonable glycemic control,” he noted, with a median HbA1c level of 7.1%. The median age was 60 years and the median BMI was 31; 15% of patients were current smokers and 23% were former smokers. The mean blood pressure was 138/81 mm Hg.

A previous meta-analysis of 17 studies found an increased risk of cardiovascular disease with increasing HbA1c levels (Ann. Intern. Med. 2004;141:421-31). The hazard ratio for each 1% increase in HbA1c was 1.18 for cardiovascular disease and 1.17 for stroke in the meta-analysis, compared with 1.08 for a cardiovascular event in the current study. The meta-analysis considered data only from 7,435 highly selected subjects with type 2 diabetes, Dr. Drury noted, while the current large study encompassed 60%-70% of all New Zealanders with type 2 diabetes.

The 12% rate of first cardiovascular events in the current study was higher than seen in previous studies. “We did raise our eyebrows at the event rate,” he said. “Much of that is not the harder material. If you look at an independent analysis of just myocardial infarction and stroke, rates are comparable to other published clinical trials” when not including things like transient ischemic attacks or angina.

Separate, controlled studies are needed to determine if treatment to avoid hyperglycemia would reduce the risk for cardiovascular events, he said.

NEWPORT BEACH, CALIF. — Like the rest of the U.S. population, pregnant adolescents have gotten heavier since 1990, but that hasn't resulted in fewer preterm or small-for-gestational-age babies born to teenage mothers, according to data gathered on 1,187 such first-time mothers.

“They're not benefiting the babies by adding the extra weight,” Jeanelle Sheeder said in a presentation at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Ms. Sheeder of the University of Colorado, Denver, and her associates analyzed data on 1,187 primigravida participants who enrolled consecutively between 1990 and 2005 in the Colorado Adolescent Maternity Program (CAMP) at the university. All were 13-18 years old and of diverse racial and ethnic backgrounds.

In that 15-year time period, there were significant increases in maternal weight, body mass index, proportion of overweight or obese mothers, age, proportion of Hispanics, and rate of induced labors. “Oddly,” Ms. Sheeder noted, maternal height decreased significantly. There also were significant decreases in the rate of pregnancy-induced hypertension and in the proportion of those who were white.

No differences over time were seen, however, in any infant outcomes, including birth weight, gestational age, preterm birth rate, and proportions of infants who were small, average, or large for gestational age. On average, the babies born to this adolescent cohort were a bit smaller than babies typically born to adult women, Ms. Sheeder said.

After adjustment of the data for significant factors, including age and race or ethnicity, only the increase in maternal weight and the decrease in maternal height remained statistically significant. No other maternal or infant measures changed significantly over time. Average maternal weight increased from 124 pounds in the early 1990s to 132 pounds in 2005, an 8-pound gain. Average maternal height decreased from 5 feet 4 inches to 5 feet 3 inches. Average birth weights were 3,170 g in 1990 and 3,000 g in 2005; the difference is within a normal 200-g fluctuation seen from year to year in this population, she said.

Maternal body mass index increased from 22 kg/m

Maternal age increased from 16.1 years to 16.7 years on average. The increasing age of the primigravid adolescents in the program over time cheered the investigators. “We were happy to see that they were getting older,” she said.

When the investigators looked at the amount of weight the mothers gained during gestation, they initially were pleased that the mothers tended to gain more pounds during pregnancy as the years progressed; they hoped that this trend would translate into bigger, healthier babies.

Unlike trends in adults, however, in which both mothers and their infants have gotten bigger, in adolescents only the moms got bigger. “This leads us to believe that adolescents probably transfer less of the weight that they gain” to infants, she said, noting that studies on appropriate weight for adolescent mothers may be warranted.

NEWPORT BEACH, CALIF. — Like the rest of the U.S. population, pregnant adolescents have gotten heavier since 1990, but that hasn't resulted in fewer preterm or small-for-gestational-age babies born to teenage mothers, according to data gathered on 1,187 such first-time mothers.

“They're not benefiting the babies by adding the extra weight,” Jeanelle Sheeder said in a presentation at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Ms. Sheeder of the University of Colorado, Denver, and her associates analyzed data on 1,187 primigravida participants who enrolled consecutively between 1990 and 2005 in the Colorado Adolescent Maternity Program (CAMP) at the university. All were 13-18 years old and of diverse racial and ethnic backgrounds.

In that 15-year time period, there were significant increases in maternal weight, body mass index, proportion of overweight or obese mothers, age, proportion of Hispanics, and rate of induced labors. “Oddly,” Ms. Sheeder noted, maternal height decreased significantly. There also were significant decreases in the rate of pregnancy-induced hypertension and in the proportion of those who were white.

No differences over time were seen, however, in any infant outcomes, including birth weight, gestational age, preterm birth rate, and proportions of infants who were small, average, or large for gestational age. On average, the babies born to this adolescent cohort were a bit smaller than babies typically born to adult women, Ms. Sheeder said.

After adjustment of the data for significant factors, including age and race or ethnicity, only the increase in maternal weight and the decrease in maternal height remained statistically significant. No other maternal or infant measures changed significantly over time. Average maternal weight increased from 124 pounds in the early 1990s to 132 pounds in 2005, an 8-pound gain. Average maternal height decreased from 5 feet 4 inches to 5 feet 3 inches. Average birth weights were 3,170 g in 1990 and 3,000 g in 2005; the difference is within a normal 200-g fluctuation seen from year to year in this population, she said.

Maternal body mass index increased from 22 kg/m

Maternal age increased from 16.1 years to 16.7 years on average. The increasing age of the primigravid adolescents in the program over time cheered the investigators. “We were happy to see that they were getting older,” she said.

When the investigators looked at the amount of weight the mothers gained during gestation, they initially were pleased that the mothers tended to gain more pounds during pregnancy as the years progressed; they hoped that this trend would translate into bigger, healthier babies.

Unlike trends in adults, however, in which both mothers and their infants have gotten bigger, in adolescents only the moms got bigger. “This leads us to believe that adolescents probably transfer less of the weight that they gain” to infants, she said, noting that studies on appropriate weight for adolescent mothers may be warranted.

NEWPORT BEACH, CALIF. — Like the rest of the U.S. population, pregnant adolescents have gotten heavier since 1990, but that hasn't resulted in fewer preterm or small-for-gestational-age babies born to teenage mothers, according to data gathered on 1,187 such first-time mothers.

“They're not benefiting the babies by adding the extra weight,” Jeanelle Sheeder said in a presentation at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Ms. Sheeder of the University of Colorado, Denver, and her associates analyzed data on 1,187 primigravida participants who enrolled consecutively between 1990 and 2005 in the Colorado Adolescent Maternity Program (CAMP) at the university. All were 13-18 years old and of diverse racial and ethnic backgrounds.

In that 15-year time period, there were significant increases in maternal weight, body mass index, proportion of overweight or obese mothers, age, proportion of Hispanics, and rate of induced labors. “Oddly,” Ms. Sheeder noted, maternal height decreased significantly. There also were significant decreases in the rate of pregnancy-induced hypertension and in the proportion of those who were white.

No differences over time were seen, however, in any infant outcomes, including birth weight, gestational age, preterm birth rate, and proportions of infants who were small, average, or large for gestational age. On average, the babies born to this adolescent cohort were a bit smaller than babies typically born to adult women, Ms. Sheeder said.

After adjustment of the data for significant factors, including age and race or ethnicity, only the increase in maternal weight and the decrease in maternal height remained statistically significant. No other maternal or infant measures changed significantly over time. Average maternal weight increased from 124 pounds in the early 1990s to 132 pounds in 2005, an 8-pound gain. Average maternal height decreased from 5 feet 4 inches to 5 feet 3 inches. Average birth weights were 3,170 g in 1990 and 3,000 g in 2005; the difference is within a normal 200-g fluctuation seen from year to year in this population, she said.

Maternal body mass index increased from 22 kg/m

Maternal age increased from 16.1 years to 16.7 years on average. The increasing age of the primigravid adolescents in the program over time cheered the investigators. “We were happy to see that they were getting older,” she said.

When the investigators looked at the amount of weight the mothers gained during gestation, they initially were pleased that the mothers tended to gain more pounds during pregnancy as the years progressed; they hoped that this trend would translate into bigger, healthier babies.

Unlike trends in adults, however, in which both mothers and their infants have gotten bigger, in adolescents only the moms got bigger. “This leads us to believe that adolescents probably transfer less of the weight that they gain” to infants, she said, noting that studies on appropriate weight for adolescent mothers may be warranted.

PHOENIX — Nortriptyline was more effective than paroxetine or placebo in treating depression in patients with Parkinson's disease, an 8-week pilot study of 52 patients found.

The study is the largest placebo-controlled trial of depression treatment in PD and the first in this population to compare a tricyclic antidepressant with a selective serotonin reuptake inhibitor (SSRI), in this case, controlled-release paroxetine (paroxetine CR), Dr. Matthew A. Menza said at a meeting of the New Clinical Drug Evaluation Unit.

Only 7% of patients with PD and depression are on a tricyclic antidepressant, noted Dr. Menza, professor of psychiatry and neurology at the University of Medicine and Dentistry of New Jersey, Newark.

The National Institute of Neurological Disorders and Stroke funded the study. Dr. Menza has financial ties to Eli Lilly & Co., which makes a brand of nortriptyline, and to GlaxoSmithKline, which makes paroxetine CR and provided the drug and matching placebo for the study.

The study randomized patients to 8 weeks of blinded treatment with nortriptyline, paroxetine CR, or placebo. About one-third of patients in each group discontinued treatment. Of those who completed the study, the average dose by the end of 8 weeks was 63 mg/day nortriptyline, 32 mg/day paroxetine CR, or two pills of placebo.

The nortriptyline group showed better results on the two primary end points—Hamilton Depression Rating Scale (HAM-D) scores and the proportion that showed a response to therapy, reported Dr. Menza and his associates.

Scores on the HAM-D changed by 11 points in the nortriptyline group, 7 in the paroxetine CR group, and 3 in the placebo group. The differences between the nortriptyline and paroxetine groups were significant at weeks 2 and 4, with a trend toward significance at week 8. Scores in the nortriptyline group were significantly different from the placebo group at all visits.

The proportion of patients who responded to therapy was 53% in the nortriptyline group, 11% in the paroxetine group, and 24% on placebo. The nortriptyline response rate was significantly higher, compared with the paroxetine group, but not compared with placebo.

The total number of side effects did not differ significantly between groups, but the nortriptyline group had more anticholinergic effects, including constipation and dry mouth. No worsening in cognition or movement was seen.

Among the patients who showed an improvement in depression scores, 20 continued therapy in a 4-month blinded extension period after the 8 weeks ended. Two measures suggested that quality of life improved in these patients, whose depression improved, compared with baseline, he said.

The study excluded patients with dementia, psychosis, or motor fluctuations. Patients averaged 62 years in age and had had PD for 6 years on average. The cohort included 25 women and 27 men.

In two previous trials of 12 and 37 patients with PD, an SSRI showed no advantage over placebo, he said.

Total side effects did not differ between groups, but nortriptyline was tied to more anticholinergic effects. DR. MENZA

PHOENIX — Nortriptyline was more effective than paroxetine or placebo in treating depression in patients with Parkinson's disease, an 8-week pilot study of 52 patients found.

The study is the largest placebo-controlled trial of depression treatment in PD and the first in this population to compare a tricyclic antidepressant with a selective serotonin reuptake inhibitor (SSRI), in this case, controlled-release paroxetine (paroxetine CR), Dr. Matthew A. Menza said at a meeting of the New Clinical Drug Evaluation Unit.

Only 7% of patients with PD and depression are on a tricyclic antidepressant, noted Dr. Menza, professor of psychiatry and neurology at the University of Medicine and Dentistry of New Jersey, Newark.

The National Institute of Neurological Disorders and Stroke funded the study. Dr. Menza has financial ties to Eli Lilly & Co., which makes a brand of nortriptyline, and to GlaxoSmithKline, which makes paroxetine CR and provided the drug and matching placebo for the study.

The study randomized patients to 8 weeks of blinded treatment with nortriptyline, paroxetine CR, or placebo. About one-third of patients in each group discontinued treatment. Of those who completed the study, the average dose by the end of 8 weeks was 63 mg/day nortriptyline, 32 mg/day paroxetine CR, or two pills of placebo.

The nortriptyline group showed better results on the two primary end points—Hamilton Depression Rating Scale (HAM-D) scores and the proportion that showed a response to therapy, reported Dr. Menza and his associates.

Scores on the HAM-D changed by 11 points in the nortriptyline group, 7 in the paroxetine CR group, and 3 in the placebo group. The differences between the nortriptyline and paroxetine groups were significant at weeks 2 and 4, with a trend toward significance at week 8. Scores in the nortriptyline group were significantly different from the placebo group at all visits.

The proportion of patients who responded to therapy was 53% in the nortriptyline group, 11% in the paroxetine group, and 24% on placebo. The nortriptyline response rate was significantly higher, compared with the paroxetine group, but not compared with placebo.

The total number of side effects did not differ significantly between groups, but the nortriptyline group had more anticholinergic effects, including constipation and dry mouth. No worsening in cognition or movement was seen.

Among the patients who showed an improvement in depression scores, 20 continued therapy in a 4-month blinded extension period after the 8 weeks ended. Two measures suggested that quality of life improved in these patients, whose depression improved, compared with baseline, he said.

The study excluded patients with dementia, psychosis, or motor fluctuations. Patients averaged 62 years in age and had had PD for 6 years on average. The cohort included 25 women and 27 men.

In two previous trials of 12 and 37 patients with PD, an SSRI showed no advantage over placebo, he said.

Total side effects did not differ between groups, but nortriptyline was tied to more anticholinergic effects. DR. MENZA

PHOENIX — Nortriptyline was more effective than paroxetine or placebo in treating depression in patients with Parkinson's disease, an 8-week pilot study of 52 patients found.

The study is the largest placebo-controlled trial of depression treatment in PD and the first in this population to compare a tricyclic antidepressant with a selective serotonin reuptake inhibitor (SSRI), in this case, controlled-release paroxetine (paroxetine CR), Dr. Matthew A. Menza said at a meeting of the New Clinical Drug Evaluation Unit.

Only 7% of patients with PD and depression are on a tricyclic antidepressant, noted Dr. Menza, professor of psychiatry and neurology at the University of Medicine and Dentistry of New Jersey, Newark.

The National Institute of Neurological Disorders and Stroke funded the study. Dr. Menza has financial ties to Eli Lilly & Co., which makes a brand of nortriptyline, and to GlaxoSmithKline, which makes paroxetine CR and provided the drug and matching placebo for the study.

The study randomized patients to 8 weeks of blinded treatment with nortriptyline, paroxetine CR, or placebo. About one-third of patients in each group discontinued treatment. Of those who completed the study, the average dose by the end of 8 weeks was 63 mg/day nortriptyline, 32 mg/day paroxetine CR, or two pills of placebo.

The nortriptyline group showed better results on the two primary end points—Hamilton Depression Rating Scale (HAM-D) scores and the proportion that showed a response to therapy, reported Dr. Menza and his associates.

Scores on the HAM-D changed by 11 points in the nortriptyline group, 7 in the paroxetine CR group, and 3 in the placebo group. The differences between the nortriptyline and paroxetine groups were significant at weeks 2 and 4, with a trend toward significance at week 8. Scores in the nortriptyline group were significantly different from the placebo group at all visits.

The proportion of patients who responded to therapy was 53% in the nortriptyline group, 11% in the paroxetine group, and 24% on placebo. The nortriptyline response rate was significantly higher, compared with the paroxetine group, but not compared with placebo.

The total number of side effects did not differ significantly between groups, but the nortriptyline group had more anticholinergic effects, including constipation and dry mouth. No worsening in cognition or movement was seen.

Among the patients who showed an improvement in depression scores, 20 continued therapy in a 4-month blinded extension period after the 8 weeks ended. Two measures suggested that quality of life improved in these patients, whose depression improved, compared with baseline, he said.

The study excluded patients with dementia, psychosis, or motor fluctuations. Patients averaged 62 years in age and had had PD for 6 years on average. The cohort included 25 women and 27 men.

In two previous trials of 12 and 37 patients with PD, an SSRI showed no advantage over placebo, he said.

Total side effects did not differ between groups, but nortriptyline was tied to more anticholinergic effects. DR. MENZA

SAN FRANCISCO — From age 15 years onward, Hispanic females in the United States are significantly more likely to be diagnosed with incident type 2 diabetes than type 1 diabetes, according to an analysis of data from the Search for Diabetes in Youth study.

In addition, at ages 10–14 years, Hispanic females in the United States had twice the incidence of type 2 diabetes in 2002–2005, compared with Hispanic males. The study looked at youths less than 20 years old in populations from six states, Jean M. Lawrence and her associates reported at the annual scientific sessions of the American Diabetes Association.

During that period, 635 youths were diagnosed with diabetes out of a population of more than 3 million, with incidence rates peaking for females at ages 5–9 years and for males at ages 10–14 years, said Ms. Lawrence of Kaiser Permanente Southern California, in Pasadena. She had no conflicts of interest related to the study.

Incidence rates for type 1 diabetes in girls were 9/100,000 in ages 0–4 years, 20/100,000 in ages 5–9 years, 16/100,000 in ages 10–14 years, and 7/100,000 in ages 15–19 years. For boys, incidence rates for type 1 diabetes were 11/100,000 in ages 0–4 years, 16/100,000 in ages 5–9 years, 20/100,000 in ages 10–14 years, and 9/100,000 in ages 15–19 years.

Type 2 diabetes rarely was diagnosed in children less than 10 years old. For ages 10–14 years, the incidence of type 2 diabetes was 15/100,000 for girls and 7/100,000 for boys. For ages 15–19 years, the incidence was 13/100,000 for girls and 11/100,000 for boys.

The study identified prevalent diabetes in the year 2001 in 781 out of more than 641,000 Hispanic youths—most of it type 1. Prevalence rates did not differ significantly by sex in any of the age groups for either type of diabetes.

The prevalence increased with age for both diabetes types in both sexes. In those aged 15–17 years, the prevalence of type 1 diabetes was 1.6/1,000 for girls and 1.8/1,000 for boys, and the prevalence of type 2 diabetes was 0.8/1,000 for girls and 0.6/1,000 for boys.

Data from two other studies presented during the same session at the meeting showed steep increases in the incidence and prevalence of diabetes in Canadians and a faster than predicted rise in type 1 diabetes in Finland, which has long held the record for having the highest national incidence of type 1 diabetes.

In the Canadian study, data on diabetes in residents younger than 20 years of age in the province of Alberta showed 2,301 prevalent cases in 840,000 children and adolescents, for a rate of 28/10,000. About 80% of cases were in 10- to 19-year-olds, said Jeffrey A. Johnson, Ph.D., of the University of Alberta, Edmonton, and his associates. The prevalence of diabetes increased by 47% between 1995 and 2006, from 19/10,000 to 28/10,000, said Dr. Johnson, who had no conflicts of interest related to the study.

The annual incidence rate in Alberta increased from 2/10,000 in 1995 to 3/10,000 in 2006, with most of that in patients younger than 10 years. The researchers weren't “able to separate diabetes types” in their study, but Dr. Johnson noted that other epidemiologic data suggest “this is likely an increase in type 1 diabetes.”

Incidence rates increased 68% for ages 1–4 years, 68% for ages 5–9 years, 43% for ages 10–14 years, and 3% for ages 15–19 years. The annual incidence rate rose about 5% annually through 2002, then hit a plateau or declined in subsequent years. It's not clear if the declines were real or artifacts related to changes in the Canadian health system, he said.

In Finland, the most recent analysis of nationwide data shows an even steeper increase in incidence than expected, said Dr. Jaako Tuomilehto of the University of Helsinki. The incidence of type 1 diabetes rose from 34/100,000 residents in 1984 to 64/100,000 in 2005. A 2% annual increase in diabetes incidence before the 1990s doubled in more recent years, with the greatest relative increase in ages 0–4 years. He has been an adviser, speaker, or board member for, or received research funds from, Novo Nordisk, Merck & Co., and other makers of diabetes drugs or equipment.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — From age 15 years onward, Hispanic females in the United States are significantly more likely to be diagnosed with incident type 2 diabetes than type 1 diabetes, according to an analysis of data from the Search for Diabetes in Youth study.

In addition, at ages 10–14 years, Hispanic females in the United States had twice the incidence of type 2 diabetes in 2002–2005, compared with Hispanic males. The study looked at youths less than 20 years old in populations from six states, Jean M. Lawrence and her associates reported at the annual scientific sessions of the American Diabetes Association.

During that period, 635 youths were diagnosed with diabetes out of a population of more than 3 million, with incidence rates peaking for females at ages 5–9 years and for males at ages 10–14 years, said Ms. Lawrence of Kaiser Permanente Southern California, in Pasadena. She had no conflicts of interest related to the study.

Incidence rates for type 1 diabetes in girls were 9/100,000 in ages 0–4 years, 20/100,000 in ages 5–9 years, 16/100,000 in ages 10–14 years, and 7/100,000 in ages 15–19 years. For boys, incidence rates for type 1 diabetes were 11/100,000 in ages 0–4 years, 16/100,000 in ages 5–9 years, 20/100,000 in ages 10–14 years, and 9/100,000 in ages 15–19 years.

Type 2 diabetes rarely was diagnosed in children less than 10 years old. For ages 10–14 years, the incidence of type 2 diabetes was 15/100,000 for girls and 7/100,000 for boys. For ages 15–19 years, the incidence was 13/100,000 for girls and 11/100,000 for boys.

The study identified prevalent diabetes in the year 2001 in 781 out of more than 641,000 Hispanic youths—most of it type 1. Prevalence rates did not differ significantly by sex in any of the age groups for either type of diabetes.

The prevalence increased with age for both diabetes types in both sexes. In those aged 15–17 years, the prevalence of type 1 diabetes was 1.6/1,000 for girls and 1.8/1,000 for boys, and the prevalence of type 2 diabetes was 0.8/1,000 for girls and 0.6/1,000 for boys.

Data from two other studies presented during the same session at the meeting showed steep increases in the incidence and prevalence of diabetes in Canadians and a faster than predicted rise in type 1 diabetes in Finland, which has long held the record for having the highest national incidence of type 1 diabetes.

In the Canadian study, data on diabetes in residents younger than 20 years of age in the province of Alberta showed 2,301 prevalent cases in 840,000 children and adolescents, for a rate of 28/10,000. About 80% of cases were in 10- to 19-year-olds, said Jeffrey A. Johnson, Ph.D., of the University of Alberta, Edmonton, and his associates. The prevalence of diabetes increased by 47% between 1995 and 2006, from 19/10,000 to 28/10,000, said Dr. Johnson, who had no conflicts of interest related to the study.

The annual incidence rate in Alberta increased from 2/10,000 in 1995 to 3/10,000 in 2006, with most of that in patients younger than 10 years. The researchers weren't “able to separate diabetes types” in their study, but Dr. Johnson noted that other epidemiologic data suggest “this is likely an increase in type 1 diabetes.”

Incidence rates increased 68% for ages 1–4 years, 68% for ages 5–9 years, 43% for ages 10–14 years, and 3% for ages 15–19 years. The annual incidence rate rose about 5% annually through 2002, then hit a plateau or declined in subsequent years. It's not clear if the declines were real or artifacts related to changes in the Canadian health system, he said.

In Finland, the most recent analysis of nationwide data shows an even steeper increase in incidence than expected, said Dr. Jaako Tuomilehto of the University of Helsinki. The incidence of type 1 diabetes rose from 34/100,000 residents in 1984 to 64/100,000 in 2005. A 2% annual increase in diabetes incidence before the 1990s doubled in more recent years, with the greatest relative increase in ages 0–4 years. He has been an adviser, speaker, or board member for, or received research funds from, Novo Nordisk, Merck & Co., and other makers of diabetes drugs or equipment.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — From age 15 years onward, Hispanic females in the United States are significantly more likely to be diagnosed with incident type 2 diabetes than type 1 diabetes, according to an analysis of data from the Search for Diabetes in Youth study.

In addition, at ages 10–14 years, Hispanic females in the United States had twice the incidence of type 2 diabetes in 2002–2005, compared with Hispanic males. The study looked at youths less than 20 years old in populations from six states, Jean M. Lawrence and her associates reported at the annual scientific sessions of the American Diabetes Association.

During that period, 635 youths were diagnosed with diabetes out of a population of more than 3 million, with incidence rates peaking for females at ages 5–9 years and for males at ages 10–14 years, said Ms. Lawrence of Kaiser Permanente Southern California, in Pasadena. She had no conflicts of interest related to the study.

Incidence rates for type 1 diabetes in girls were 9/100,000 in ages 0–4 years, 20/100,000 in ages 5–9 years, 16/100,000 in ages 10–14 years, and 7/100,000 in ages 15–19 years. For boys, incidence rates for type 1 diabetes were 11/100,000 in ages 0–4 years, 16/100,000 in ages 5–9 years, 20/100,000 in ages 10–14 years, and 9/100,000 in ages 15–19 years.

Type 2 diabetes rarely was diagnosed in children less than 10 years old. For ages 10–14 years, the incidence of type 2 diabetes was 15/100,000 for girls and 7/100,000 for boys. For ages 15–19 years, the incidence was 13/100,000 for girls and 11/100,000 for boys.

The study identified prevalent diabetes in the year 2001 in 781 out of more than 641,000 Hispanic youths—most of it type 1. Prevalence rates did not differ significantly by sex in any of the age groups for either type of diabetes.

The prevalence increased with age for both diabetes types in both sexes. In those aged 15–17 years, the prevalence of type 1 diabetes was 1.6/1,000 for girls and 1.8/1,000 for boys, and the prevalence of type 2 diabetes was 0.8/1,000 for girls and 0.6/1,000 for boys.

Data from two other studies presented during the same session at the meeting showed steep increases in the incidence and prevalence of diabetes in Canadians and a faster than predicted rise in type 1 diabetes in Finland, which has long held the record for having the highest national incidence of type 1 diabetes.

In the Canadian study, data on diabetes in residents younger than 20 years of age in the province of Alberta showed 2,301 prevalent cases in 840,000 children and adolescents, for a rate of 28/10,000. About 80% of cases were in 10- to 19-year-olds, said Jeffrey A. Johnson, Ph.D., of the University of Alberta, Edmonton, and his associates. The prevalence of diabetes increased by 47% between 1995 and 2006, from 19/10,000 to 28/10,000, said Dr. Johnson, who had no conflicts of interest related to the study.

The annual incidence rate in Alberta increased from 2/10,000 in 1995 to 3/10,000 in 2006, with most of that in patients younger than 10 years. The researchers weren't “able to separate diabetes types” in their study, but Dr. Johnson noted that other epidemiologic data suggest “this is likely an increase in type 1 diabetes.”

Incidence rates increased 68% for ages 1–4 years, 68% for ages 5–9 years, 43% for ages 10–14 years, and 3% for ages 15–19 years. The annual incidence rate rose about 5% annually through 2002, then hit a plateau or declined in subsequent years. It's not clear if the declines were real or artifacts related to changes in the Canadian health system, he said.

In Finland, the most recent analysis of nationwide data shows an even steeper increase in incidence than expected, said Dr. Jaako Tuomilehto of the University of Helsinki. The incidence of type 1 diabetes rose from 34/100,000 residents in 1984 to 64/100,000 in 2005. A 2% annual increase in diabetes incidence before the 1990s doubled in more recent years, with the greatest relative increase in ages 0–4 years. He has been an adviser, speaker, or board member for, or received research funds from, Novo Nordisk, Merck & Co., and other makers of diabetes drugs or equipment.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — Checking bone mineral density in the forearm as well as the spine and hip in 181 men taking androgen deprivation therapy identified more patients with bone loss than did using densitometry on the spine and hip alone, according to data from a recent study.

Dual-energy x-ray absorptiometry (DXA) scans of the hip and spine have been the accepted standard for osteoporosis screening in men taking androgen deprivation therapy for prostate cancer. The therapy is well known to cause bone loss, Dr. Paul R. Sieber and his associates said.

Interpreting lumbar spine DXA results in these patients can be problematic, so the researchers started adding routine DXA scans of the distal third of the radius to the hip and spine scans of patients using androgen deprivation therapy. They compared results using just the hip and spine scans with results using those plus the forearm scan. The patients had a mean age of 77 years; duration of therapy was up to 10 years.

With the central DXA scans alone, 30 patients (17%) were classified as normal (T score of −1.0 or better), 101 (56%) were osteopenic (T score of −1.0 to −2.5), and 50 (28%) were considered to have osteoporosis (T score less than −2.5). The percentages were rounded.

Adding in the results of the peripheral scan moved seven patients (23% of the normal group) out of the normal range and increased the numbers of osteopenic and osteoporotic patients, the researchers said in a poster presentation at the annual meeting of the International Society for Clinical Densitometry.

With the central plus peripheral DXA scan results, 23 patients (13%) had normal bone density, 93 (52%) were classified as osteopenic, and 65 (36%) had osteoporosis, said Dr. Sieber, of Urological Associates of Lancaster, Penn.

Nine DXA scans of the hip and 42 scans of the spine were uninterpretable, underscoring the need for forearm bone density measurements when screening these patients.

He did not disclose any potential relationships with DXA scan providers or manufacturers, or with companies that make osteoporosis treatments.

SAN FRANCISCO — Checking bone mineral density in the forearm as well as the spine and hip in 181 men taking androgen deprivation therapy identified more patients with bone loss than did using densitometry on the spine and hip alone, according to data from a recent study.

Dual-energy x-ray absorptiometry (DXA) scans of the hip and spine have been the accepted standard for osteoporosis screening in men taking androgen deprivation therapy for prostate cancer. The therapy is well known to cause bone loss, Dr. Paul R. Sieber and his associates said.

Interpreting lumbar spine DXA results in these patients can be problematic, so the researchers started adding routine DXA scans of the distal third of the radius to the hip and spine scans of patients using androgen deprivation therapy. They compared results using just the hip and spine scans with results using those plus the forearm scan. The patients had a mean age of 77 years; duration of therapy was up to 10 years.

With the central DXA scans alone, 30 patients (17%) were classified as normal (T score of −1.0 or better), 101 (56%) were osteopenic (T score of −1.0 to −2.5), and 50 (28%) were considered to have osteoporosis (T score less than −2.5). The percentages were rounded.

Adding in the results of the peripheral scan moved seven patients (23% of the normal group) out of the normal range and increased the numbers of osteopenic and osteoporotic patients, the researchers said in a poster presentation at the annual meeting of the International Society for Clinical Densitometry.

With the central plus peripheral DXA scan results, 23 patients (13%) had normal bone density, 93 (52%) were classified as osteopenic, and 65 (36%) had osteoporosis, said Dr. Sieber, of Urological Associates of Lancaster, Penn.

Nine DXA scans of the hip and 42 scans of the spine were uninterpretable, underscoring the need for forearm bone density measurements when screening these patients.

He did not disclose any potential relationships with DXA scan providers or manufacturers, or with companies that make osteoporosis treatments.

SAN FRANCISCO — Checking bone mineral density in the forearm as well as the spine and hip in 181 men taking androgen deprivation therapy identified more patients with bone loss than did using densitometry on the spine and hip alone, according to data from a recent study.

Dual-energy x-ray absorptiometry (DXA) scans of the hip and spine have been the accepted standard for osteoporosis screening in men taking androgen deprivation therapy for prostate cancer. The therapy is well known to cause bone loss, Dr. Paul R. Sieber and his associates said.

Interpreting lumbar spine DXA results in these patients can be problematic, so the researchers started adding routine DXA scans of the distal third of the radius to the hip and spine scans of patients using androgen deprivation therapy. They compared results using just the hip and spine scans with results using those plus the forearm scan. The patients had a mean age of 77 years; duration of therapy was up to 10 years.

With the central DXA scans alone, 30 patients (17%) were classified as normal (T score of −1.0 or better), 101 (56%) were osteopenic (T score of −1.0 to −2.5), and 50 (28%) were considered to have osteoporosis (T score less than −2.5). The percentages were rounded.

Adding in the results of the peripheral scan moved seven patients (23% of the normal group) out of the normal range and increased the numbers of osteopenic and osteoporotic patients, the researchers said in a poster presentation at the annual meeting of the International Society for Clinical Densitometry.

With the central plus peripheral DXA scan results, 23 patients (13%) had normal bone density, 93 (52%) were classified as osteopenic, and 65 (36%) had osteoporosis, said Dr. Sieber, of Urological Associates of Lancaster, Penn.

Nine DXA scans of the hip and 42 scans of the spine were uninterpretable, underscoring the need for forearm bone density measurements when screening these patients.

He did not disclose any potential relationships with DXA scan providers or manufacturers, or with companies that make osteoporosis treatments.

SAN FRANCISCO — Postmenopausal women with coronary heart disease were less likely to develop atrial fibrillation if they were taking statins, a secondary analysis of data on 2,673 patients found.

The prevalence of atrial fibrillation was 65% lower, and the incidence was 55% lower, in women on statin therapy after adjustment for the effects of age, race, heart failure, or history of MI or revascularization. Several previous studies have shown a reduced risk for atrial fibrillation in patients with coronary disease on statins, but those cohorts were 75% male. This is the first study to show a specific benefit in women, Dr. Cara N. Pellegrini of the University of California, San Francisco, and her associates reported at the annual meeting of the Heart Rhythm Society.

The findings are not a reason to use statins specifically to prevent atrial fibrillation in this population, but do provide another reason for women with coronary disease who are on statins to keep taking them, said Dr. Pellegrini, who reported no potential conflicts of interest related to the study.

The data came from the Heart and Estrogen-Progestin Replacement Study (HERS) of 2,763 postmenopausal wom-en with coronary heart disease who were randomized to treatment with hormone replacement therapy or placebo, and followed for cardiovascular outcomes for more than 4 years. The current analysis excluded 90 women because of the presence of other arrhythmias at enrollment.

Compared with the women with no atrial fibrillation, the 88 patients (3%) with atrial fibrillation during the study were significantly more likely to be older (70 years vs. 67 years), have a history of heart failure (35% vs. 12%), and be on an antiarrhythmic medication (5% vs. 1%). In the atrial fibrillation group, 22% were on statins, compared with 37% who did not have atrial fibrillation, a significant difference.

Although statin therapy protected against atrial fibrillation in several previous studies, mostly in men, atrial fibrillation is different in women. They are more likely to have higher heart rates in atrial fibrillation, and to develop paroxysms, thromboembolism, or bleeding, among other differences. Such differences prompted the current study, Dr. Pellegrini said.

An increasing understanding of inflammation's role in atrial fibrillation has increased exploration of nonanti-arrhythmic agents such as statins for prevention of atrial fibrillation. Previous studies linking atrial fibrillation and inflammation focused on men and did not look at community-based populations, which the HERS trial did.

SAN FRANCISCO — Postmenopausal women with coronary heart disease were less likely to develop atrial fibrillation if they were taking statins, a secondary analysis of data on 2,673 patients found.

The prevalence of atrial fibrillation was 65% lower, and the incidence was 55% lower, in women on statin therapy after adjustment for the effects of age, race, heart failure, or history of MI or revascularization. Several previous studies have shown a reduced risk for atrial fibrillation in patients with coronary disease on statins, but those cohorts were 75% male. This is the first study to show a specific benefit in women, Dr. Cara N. Pellegrini of the University of California, San Francisco, and her associates reported at the annual meeting of the Heart Rhythm Society.

The findings are not a reason to use statins specifically to prevent atrial fibrillation in this population, but do provide another reason for women with coronary disease who are on statins to keep taking them, said Dr. Pellegrini, who reported no potential conflicts of interest related to the study.

The data came from the Heart and Estrogen-Progestin Replacement Study (HERS) of 2,763 postmenopausal wom-en with coronary heart disease who were randomized to treatment with hormone replacement therapy or placebo, and followed for cardiovascular outcomes for more than 4 years. The current analysis excluded 90 women because of the presence of other arrhythmias at enrollment.

Compared with the women with no atrial fibrillation, the 88 patients (3%) with atrial fibrillation during the study were significantly more likely to be older (70 years vs. 67 years), have a history of heart failure (35% vs. 12%), and be on an antiarrhythmic medication (5% vs. 1%). In the atrial fibrillation group, 22% were on statins, compared with 37% who did not have atrial fibrillation, a significant difference.

Although statin therapy protected against atrial fibrillation in several previous studies, mostly in men, atrial fibrillation is different in women. They are more likely to have higher heart rates in atrial fibrillation, and to develop paroxysms, thromboembolism, or bleeding, among other differences. Such differences prompted the current study, Dr. Pellegrini said.

An increasing understanding of inflammation's role in atrial fibrillation has increased exploration of nonanti-arrhythmic agents such as statins for prevention of atrial fibrillation. Previous studies linking atrial fibrillation and inflammation focused on men and did not look at community-based populations, which the HERS trial did.

SAN FRANCISCO — Postmenopausal women with coronary heart disease were less likely to develop atrial fibrillation if they were taking statins, a secondary analysis of data on 2,673 patients found.

The prevalence of atrial fibrillation was 65% lower, and the incidence was 55% lower, in women on statin therapy after adjustment for the effects of age, race, heart failure, or history of MI or revascularization. Several previous studies have shown a reduced risk for atrial fibrillation in patients with coronary disease on statins, but those cohorts were 75% male. This is the first study to show a specific benefit in women, Dr. Cara N. Pellegrini of the University of California, San Francisco, and her associates reported at the annual meeting of the Heart Rhythm Society.

The findings are not a reason to use statins specifically to prevent atrial fibrillation in this population, but do provide another reason for women with coronary disease who are on statins to keep taking them, said Dr. Pellegrini, who reported no potential conflicts of interest related to the study.

The data came from the Heart and Estrogen-Progestin Replacement Study (HERS) of 2,763 postmenopausal wom-en with coronary heart disease who were randomized to treatment with hormone replacement therapy or placebo, and followed for cardiovascular outcomes for more than 4 years. The current analysis excluded 90 women because of the presence of other arrhythmias at enrollment.

Compared with the women with no atrial fibrillation, the 88 patients (3%) with atrial fibrillation during the study were significantly more likely to be older (70 years vs. 67 years), have a history of heart failure (35% vs. 12%), and be on an antiarrhythmic medication (5% vs. 1%). In the atrial fibrillation group, 22% were on statins, compared with 37% who did not have atrial fibrillation, a significant difference.

Although statin therapy protected against atrial fibrillation in several previous studies, mostly in men, atrial fibrillation is different in women. They are more likely to have higher heart rates in atrial fibrillation, and to develop paroxysms, thromboembolism, or bleeding, among other differences. Such differences prompted the current study, Dr. Pellegrini said.

An increasing understanding of inflammation's role in atrial fibrillation has increased exploration of nonanti-arrhythmic agents such as statins for prevention of atrial fibrillation. Previous studies linking atrial fibrillation and inflammation focused on men and did not look at community-based populations, which the HERS trial did.

SAN FRANCISCO — Atrial fibrillation affects the quality of life of both patients and their spouses in equal measure, a survey of 264 patients and 94 spouses suggests.

“When you're educating patients about atrial fibrillation, it's important to educate the spouses as well,” Dr. Bruce A. Koplan said at the annual meeting of the Heart Rhythm Society. “Don't leave the spouses sitting out in the waiting room. Encourage patients to bring in their spouses for their clinic visit, especially the first visit, when they're learning about the condition.”

Asked to rate the extent of the effect of atrial fibrillation on their quality of life, 45% of patients and 43% of spouses said it had no effect or a minor effect, 29% of patients and 26% of spouses noted a moderate effect, and 26% of patients and 31% of spouses noted a significant effect. Differences between groups were not statistically significant.

Ratings also did not differ between patients and spouses when asked about the effects of atrial fibrillation on specific aspects of quality of life, including daily activities, work/professional life, and sex life.

The effects of atrial fibrillation on the quality of daily activities were rated mild by 56% of patients and 54% of spouses, rated as moderate by 30% of patients and 36% of spouses, and rated as significant by 12% of patients and 10% of spouses.

Atrial fibrillation had a mild effect on the quality of work/professional life, according to 72% of patients and 80% of spouses. Another 19% of patients and 14% of spouses reported a moderate effect, and 29% of patients and 26% of spouses reported a significant effect on the quality of work/professional life.

The effects on the quality of sex life were rated as mild by 62% of each group, as moderate by 14% of patients and 13% of spouses, and as significant by 23% of patients and 24% of spouses.

“Atrial fibrillation [alone] is almost never a life-threatening condition,” Dr. Koplan noted. “When we treat atrial fibrillation, we're reducing the risk of stroke and we're reducing the fast heart rate, but the other important aspect in management is the effect is has on overall quality of life, not quantity of life.”

Anxiety about atrial fibrillation and lack of understanding of the condition play a role in perception of quality of life. Some patients end up on psychiatric medications to deal with anxiety or depression related to atrial fibrillation. “If you're not addressing the spouse as well, you're not completely dealing with the condition,” said Dr. Koplan, of Brigham and Women's Hospital, Boston.

Patients with atrial fibrillation were significantly older (67 years on average), compared with spouses (63 years), with significantly more men (65% vs. 25%, respectively).

Dr. Koplan has been a consultant for and received honoraria from Boston Scientific, Medtronic, St. Jude Medical, and St. Jude Inc.

SAN FRANCISCO — Atrial fibrillation affects the quality of life of both patients and their spouses in equal measure, a survey of 264 patients and 94 spouses suggests.

“When you're educating patients about atrial fibrillation, it's important to educate the spouses as well,” Dr. Bruce A. Koplan said at the annual meeting of the Heart Rhythm Society. “Don't leave the spouses sitting out in the waiting room. Encourage patients to bring in their spouses for their clinic visit, especially the first visit, when they're learning about the condition.”

Asked to rate the extent of the effect of atrial fibrillation on their quality of life, 45% of patients and 43% of spouses said it had no effect or a minor effect, 29% of patients and 26% of spouses noted a moderate effect, and 26% of patients and 31% of spouses noted a significant effect. Differences between groups were not statistically significant.

Ratings also did not differ between patients and spouses when asked about the effects of atrial fibrillation on specific aspects of quality of life, including daily activities, work/professional life, and sex life.

The effects of atrial fibrillation on the quality of daily activities were rated mild by 56% of patients and 54% of spouses, rated as moderate by 30% of patients and 36% of spouses, and rated as significant by 12% of patients and 10% of spouses.

Atrial fibrillation had a mild effect on the quality of work/professional life, according to 72% of patients and 80% of spouses. Another 19% of patients and 14% of spouses reported a moderate effect, and 29% of patients and 26% of spouses reported a significant effect on the quality of work/professional life.

The effects on the quality of sex life were rated as mild by 62% of each group, as moderate by 14% of patients and 13% of spouses, and as significant by 23% of patients and 24% of spouses.

“Atrial fibrillation [alone] is almost never a life-threatening condition,” Dr. Koplan noted. “When we treat atrial fibrillation, we're reducing the risk of stroke and we're reducing the fast heart rate, but the other important aspect in management is the effect is has on overall quality of life, not quantity of life.”

Anxiety about atrial fibrillation and lack of understanding of the condition play a role in perception of quality of life. Some patients end up on psychiatric medications to deal with anxiety or depression related to atrial fibrillation. “If you're not addressing the spouse as well, you're not completely dealing with the condition,” said Dr. Koplan, of Brigham and Women's Hospital, Boston.

Patients with atrial fibrillation were significantly older (67 years on average), compared with spouses (63 years), with significantly more men (65% vs. 25%, respectively).

Dr. Koplan has been a consultant for and received honoraria from Boston Scientific, Medtronic, St. Jude Medical, and St. Jude Inc.

SAN FRANCISCO — Atrial fibrillation affects the quality of life of both patients and their spouses in equal measure, a survey of 264 patients and 94 spouses suggests.

“When you're educating patients about atrial fibrillation, it's important to educate the spouses as well,” Dr. Bruce A. Koplan said at the annual meeting of the Heart Rhythm Society. “Don't leave the spouses sitting out in the waiting room. Encourage patients to bring in their spouses for their clinic visit, especially the first visit, when they're learning about the condition.”

Asked to rate the extent of the effect of atrial fibrillation on their quality of life, 45% of patients and 43% of spouses said it had no effect or a minor effect, 29% of patients and 26% of spouses noted a moderate effect, and 26% of patients and 31% of spouses noted a significant effect. Differences between groups were not statistically significant.

Ratings also did not differ between patients and spouses when asked about the effects of atrial fibrillation on specific aspects of quality of life, including daily activities, work/professional life, and sex life.

The effects of atrial fibrillation on the quality of daily activities were rated mild by 56% of patients and 54% of spouses, rated as moderate by 30% of patients and 36% of spouses, and rated as significant by 12% of patients and 10% of spouses.

Atrial fibrillation had a mild effect on the quality of work/professional life, according to 72% of patients and 80% of spouses. Another 19% of patients and 14% of spouses reported a moderate effect, and 29% of patients and 26% of spouses reported a significant effect on the quality of work/professional life.

The effects on the quality of sex life were rated as mild by 62% of each group, as moderate by 14% of patients and 13% of spouses, and as significant by 23% of patients and 24% of spouses.

“Atrial fibrillation [alone] is almost never a life-threatening condition,” Dr. Koplan noted. “When we treat atrial fibrillation, we're reducing the risk of stroke and we're reducing the fast heart rate, but the other important aspect in management is the effect is has on overall quality of life, not quantity of life.”

Anxiety about atrial fibrillation and lack of understanding of the condition play a role in perception of quality of life. Some patients end up on psychiatric medications to deal with anxiety or depression related to atrial fibrillation. “If you're not addressing the spouse as well, you're not completely dealing with the condition,” said Dr. Koplan, of Brigham and Women's Hospital, Boston.

Patients with atrial fibrillation were significantly older (67 years on average), compared with spouses (63 years), with significantly more men (65% vs. 25%, respectively).

Dr. Koplan has been a consultant for and received honoraria from Boston Scientific, Medtronic, St. Jude Medical, and St. Jude Inc.

PHOENIX – Preliminary data on the off-label use of sodium oxybate suggest that it improved sleep in a randomized, placebo-controlled study of 151 patients with fibromyalgia who completed 8 weeks of treatment at 21 medical centers.

The study enrolled 195 patients who started with a drug washout period and were randomized to continue for 8 weeks on sodium oxybate 4.5 g/day or 6 g/day or placebo. Doses were split; patients took a half-dose at bedtime, then awoke 4 hours later for the other half.

Forty-four patients (23%) withdrew before completion, mostly from the higher-dose group and primarily because of side effects, including headache, dizziness, and nausea, Dr. Harvey Moldofsky reported at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Both objective and subjective measures of sleep improved in the drug groups, compared with placebo–for those who finished the study–more so with the 6-g/day dose, said Dr. Moldofsky, president and director of the Centre for Sleep and Chronobiology, Toronto, and emeritus professor of medicine at the University of Toronto.

The study was funded by Jazz Pharmaceuticals, the company that makes sodium oxybate. Dr. Moldofsky is a consultant to and an advisory board member for the company.

Many patients with fibromyalgia have sleep disturbances, he noted.

Sleep polysomnography showed significant objective improvements in the high-dose group in the following areas: amount of time spent sleeping; sleep efficiency (the proportion of time spent sleeping, compared with time in bed); and the amount of deep, or slow-wave, sleep, he reported.

Subjective results from patient self-reports on several scales showed that they experienced improvements with either dose, compared with placebo, in pain and fatigue (Visual Analog Scale), daytime sleepiness (Epworth Sleepiness Scale), impaired sleep (Jenkins Scale), and daytime functioning (Functional Outcome of Sleep Questionnaire, SF-36 Vitality scale, and Fibromyalgia Impact Questionnaire).

The study provides a proof of concept, but more research is needed before the drug is used by patients with fibromyalgia, he said.

Besides headache, dizziness, and nausea, other side effects that occurred more frequently in the drug groups than in the placebo group included vomiting, nasopharyngitis, extremity pain, muscle cramp, nervous system disorders, restlessness, and incontinence or other renal/urinary disorders.

In 2002 sodium oxybate was approved in the United States to reduce cataplexy attacks in patients with narcolepsy, but the drug is under tightly restricted distribution from Jazz Pharmaceuticals alone – not from pharmacies.

The agent, more commonly known as gamma hydroxybutyrate, or GHB, entered the U.S. market as a dietary supplement in the early 1990s. It subsequently gained favor as a party drug, was used to perpetrate date rape because of its intoxicating effects, and caused many serious adverse events and some deaths from its use and misuse.

More research would be needed to determine whether the improvements in sleep seen in the current study were independent of subjective improvements in pain and functionality, Dr. Moldofsky said.

PHOENIX – Preliminary data on the off-label use of sodium oxybate suggest that it improved sleep in a randomized, placebo-controlled study of 151 patients with fibromyalgia who completed 8 weeks of treatment at 21 medical centers.

The study enrolled 195 patients who started with a drug washout period and were randomized to continue for 8 weeks on sodium oxybate 4.5 g/day or 6 g/day or placebo. Doses were split; patients took a half-dose at bedtime, then awoke 4 hours later for the other half.

Forty-four patients (23%) withdrew before completion, mostly from the higher-dose group and primarily because of side effects, including headache, dizziness, and nausea, Dr. Harvey Moldofsky reported at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Both objective and subjective measures of sleep improved in the drug groups, compared with placebo–for those who finished the study–more so with the 6-g/day dose, said Dr. Moldofsky, president and director of the Centre for Sleep and Chronobiology, Toronto, and emeritus professor of medicine at the University of Toronto.

The study was funded by Jazz Pharmaceuticals, the company that makes sodium oxybate. Dr. Moldofsky is a consultant to and an advisory board member for the company.

Many patients with fibromyalgia have sleep disturbances, he noted.

Sleep polysomnography showed significant objective improvements in the high-dose group in the following areas: amount of time spent sleeping; sleep efficiency (the proportion of time spent sleeping, compared with time in bed); and the amount of deep, or slow-wave, sleep, he reported.

Subjective results from patient self-reports on several scales showed that they experienced improvements with either dose, compared with placebo, in pain and fatigue (Visual Analog Scale), daytime sleepiness (Epworth Sleepiness Scale), impaired sleep (Jenkins Scale), and daytime functioning (Functional Outcome of Sleep Questionnaire, SF-36 Vitality scale, and Fibromyalgia Impact Questionnaire).

The study provides a proof of concept, but more research is needed before the drug is used by patients with fibromyalgia, he said.

Besides headache, dizziness, and nausea, other side effects that occurred more frequently in the drug groups than in the placebo group included vomiting, nasopharyngitis, extremity pain, muscle cramp, nervous system disorders, restlessness, and incontinence or other renal/urinary disorders.

In 2002 sodium oxybate was approved in the United States to reduce cataplexy attacks in patients with narcolepsy, but the drug is under tightly restricted distribution from Jazz Pharmaceuticals alone – not from pharmacies.

The agent, more commonly known as gamma hydroxybutyrate, or GHB, entered the U.S. market as a dietary supplement in the early 1990s. It subsequently gained favor as a party drug, was used to perpetrate date rape because of its intoxicating effects, and caused many serious adverse events and some deaths from its use and misuse.

More research would be needed to determine whether the improvements in sleep seen in the current study were independent of subjective improvements in pain and functionality, Dr. Moldofsky said.

PHOENIX – Preliminary data on the off-label use of sodium oxybate suggest that it improved sleep in a randomized, placebo-controlled study of 151 patients with fibromyalgia who completed 8 weeks of treatment at 21 medical centers.

The study enrolled 195 patients who started with a drug washout period and were randomized to continue for 8 weeks on sodium oxybate 4.5 g/day or 6 g/day or placebo. Doses were split; patients took a half-dose at bedtime, then awoke 4 hours later for the other half.

Forty-four patients (23%) withdrew before completion, mostly from the higher-dose group and primarily because of side effects, including headache, dizziness, and nausea, Dr. Harvey Moldofsky reported at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Both objective and subjective measures of sleep improved in the drug groups, compared with placebo–for those who finished the study–more so with the 6-g/day dose, said Dr. Moldofsky, president and director of the Centre for Sleep and Chronobiology, Toronto, and emeritus professor of medicine at the University of Toronto.

The study was funded by Jazz Pharmaceuticals, the company that makes sodium oxybate. Dr. Moldofsky is a consultant to and an advisory board member for the company.

Many patients with fibromyalgia have sleep disturbances, he noted.

Sleep polysomnography showed significant objective improvements in the high-dose group in the following areas: amount of time spent sleeping; sleep efficiency (the proportion of time spent sleeping, compared with time in bed); and the amount of deep, or slow-wave, sleep, he reported.

Subjective results from patient self-reports on several scales showed that they experienced improvements with either dose, compared with placebo, in pain and fatigue (Visual Analog Scale), daytime sleepiness (Epworth Sleepiness Scale), impaired sleep (Jenkins Scale), and daytime functioning (Functional Outcome of Sleep Questionnaire, SF-36 Vitality scale, and Fibromyalgia Impact Questionnaire).

The study provides a proof of concept, but more research is needed before the drug is used by patients with fibromyalgia, he said.

Besides headache, dizziness, and nausea, other side effects that occurred more frequently in the drug groups than in the placebo group included vomiting, nasopharyngitis, extremity pain, muscle cramp, nervous system disorders, restlessness, and incontinence or other renal/urinary disorders.

In 2002 sodium oxybate was approved in the United States to reduce cataplexy attacks in patients with narcolepsy, but the drug is under tightly restricted distribution from Jazz Pharmaceuticals alone – not from pharmacies.

The agent, more commonly known as gamma hydroxybutyrate, or GHB, entered the U.S. market as a dietary supplement in the early 1990s. It subsequently gained favor as a party drug, was used to perpetrate date rape because of its intoxicating effects, and caused many serious adverse events and some deaths from its use and misuse.

More research would be needed to determine whether the improvements in sleep seen in the current study were independent of subjective improvements in pain and functionality, Dr. Moldofsky said.

PHOENIX – To continue second-generation antipsychotics in adolescents with bipolar disorder after their psychosis or aggression has stabilized may not be helpful beyond 6 months of therapy, preliminary data from a randomized, controlled trial suggest.

Details on 21 of 68 patients who were randomized to continue combination treatment with a second-generation antipsychotic plus mood stabilizers or to replace the antipsychotic with placebo showed that a slightly greater proportion (4 of 12, or 33%) in the combination group maintained remission at 48 weeks, compared with the placebo group (2 of 9, or 22%). But the difference between groups was not statistically significant, Dr. Vivian Kafantaris and her associates reported.

Patients gained a “shocking” amount of weight because of the antipsychotics–two pounds per week during 6 months of open treatment, followed by more weight gain in those randomized to stay on an antipsychotic rather than placebo for maintenance therapy, she said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institutes for Mental Health.

“There does not appear to be a very large protective effect of continuing antipsychotic medications for an additional 48 weeks, once remission is achieved and functional recovery is underway,” said Dr. Kafantaris, director of research in child and adolescent psychiatry at the Zucker Hillside Hospital, Glen Oaks, N.Y.

The single-center study was funded by the National Institutes of Mental Health. Pharmaceutical companies donated the medications and matching placebos used in the trial. Dr. Kafantaris reported no other potential conflicts of interest.

The addition of a second-generation antipsychotic to treatment with a mood stabilizer has been shown to rapidly stabilize mania in children and adults, but it's unclear how long to continue this adjunctive use of antipsychotics once initial symptoms have resolved, she said.

Earlier case series in which patients were tapered off a second-generation antipsychotic after achieving therapeutic serum levels of lithium showed that reducing the antipsychotic dose after only a week or a month of lithium therapy led to high relapse rates, she said. In the current study, patients with bipolar disorder and psychotic features or severe aggression started with 6 months of open treatment using lithium (and valproic acid if needed) for mood stabilization and a second-generation antipsychotic–initially olanzapine (Zyprexa), with switches permitted to risperidone (Risperdal) or quetiapine (Seroquel).

Weight gain was a problem during this open-treatment phase. “We had a very difficult time. We would switch from one atypical to a different one, and we really didn't see much benefit” in weight, she said.

At the end of the 6-month open treatment, patients could be randomized to blinded maintenance therapy if they'd had 8 weeks free of psychosis, physical aggression, mania, depression, and mixed mania-depressive episodes, if they had been in school for 8 weeks, and if they'd had consistent therapeutic levels of a mood stabilizer on blood tests.

Twelve patients continued their combined treatment regimen as maintenance therapy for 48 weeks. Nine patients tapered off the antipsychotic over a 4-week period, replacing it with placebo, and continued on placebo plus mood stabilizers for 44 more weeks.

Compared with their prerandomization weights (after 6 months on open treatment), patients who continued the drug combination gained 4% in weight, and those on placebo and mood stabilizers lost 4% in weight after 48 weeks of maintenance therapy.

The investigators had hypothesized that remission would be maintained in 90% of the patients who continued the combination therapy and in 60% of the patients on placebo and mood stabilizers, but neither group came close to those expectations.

“There is a critical need for effective and well-tolerated maintenance medication strategies for this population,” Dr. Kafantaris said. “They will likely have a high recurrence rate and require intensive mental health care for life.”

PHOENIX – To continue second-generation antipsychotics in adolescents with bipolar disorder after their psychosis or aggression has stabilized may not be helpful beyond 6 months of therapy, preliminary data from a randomized, controlled trial suggest.

Details on 21 of 68 patients who were randomized to continue combination treatment with a second-generation antipsychotic plus mood stabilizers or to replace the antipsychotic with placebo showed that a slightly greater proportion (4 of 12, or 33%) in the combination group maintained remission at 48 weeks, compared with the placebo group (2 of 9, or 22%). But the difference between groups was not statistically significant, Dr. Vivian Kafantaris and her associates reported.

Patients gained a “shocking” amount of weight because of the antipsychotics–two pounds per week during 6 months of open treatment, followed by more weight gain in those randomized to stay on an antipsychotic rather than placebo for maintenance therapy, she said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institutes for Mental Health.

“There does not appear to be a very large protective effect of continuing antipsychotic medications for an additional 48 weeks, once remission is achieved and functional recovery is underway,” said Dr. Kafantaris, director of research in child and adolescent psychiatry at the Zucker Hillside Hospital, Glen Oaks, N.Y.

The single-center study was funded by the National Institutes of Mental Health. Pharmaceutical companies donated the medications and matching placebos used in the trial. Dr. Kafantaris reported no other potential conflicts of interest.

The addition of a second-generation antipsychotic to treatment with a mood stabilizer has been shown to rapidly stabilize mania in children and adults, but it's unclear how long to continue this adjunctive use of antipsychotics once initial symptoms have resolved, she said.

Earlier case series in which patients were tapered off a second-generation antipsychotic after achieving therapeutic serum levels of lithium showed that reducing the antipsychotic dose after only a week or a month of lithium therapy led to high relapse rates, she said. In the current study, patients with bipolar disorder and psychotic features or severe aggression started with 6 months of open treatment using lithium (and valproic acid if needed) for mood stabilization and a second-generation antipsychotic–initially olanzapine (Zyprexa), with switches permitted to risperidone (Risperdal) or quetiapine (Seroquel).

Weight gain was a problem during this open-treatment phase. “We had a very difficult time. We would switch from one atypical to a different one, and we really didn't see much benefit” in weight, she said.

At the end of the 6-month open treatment, patients could be randomized to blinded maintenance therapy if they'd had 8 weeks free of psychosis, physical aggression, mania, depression, and mixed mania-depressive episodes, if they had been in school for 8 weeks, and if they'd had consistent therapeutic levels of a mood stabilizer on blood tests.

Twelve patients continued their combined treatment regimen as maintenance therapy for 48 weeks. Nine patients tapered off the antipsychotic over a 4-week period, replacing it with placebo, and continued on placebo plus mood stabilizers for 44 more weeks.

Compared with their prerandomization weights (after 6 months on open treatment), patients who continued the drug combination gained 4% in weight, and those on placebo and mood stabilizers lost 4% in weight after 48 weeks of maintenance therapy.

The investigators had hypothesized that remission would be maintained in 90% of the patients who continued the combination therapy and in 60% of the patients on placebo and mood stabilizers, but neither group came close to those expectations.

“There is a critical need for effective and well-tolerated maintenance medication strategies for this population,” Dr. Kafantaris said. “They will likely have a high recurrence rate and require intensive mental health care for life.”

PHOENIX – To continue second-generation antipsychotics in adolescents with bipolar disorder after their psychosis or aggression has stabilized may not be helpful beyond 6 months of therapy, preliminary data from a randomized, controlled trial suggest.

Details on 21 of 68 patients who were randomized to continue combination treatment with a second-generation antipsychotic plus mood stabilizers or to replace the antipsychotic with placebo showed that a slightly greater proportion (4 of 12, or 33%) in the combination group maintained remission at 48 weeks, compared with the placebo group (2 of 9, or 22%). But the difference between groups was not statistically significant, Dr. Vivian Kafantaris and her associates reported.

Patients gained a “shocking” amount of weight because of the antipsychotics–two pounds per week during 6 months of open treatment, followed by more weight gain in those randomized to stay on an antipsychotic rather than placebo for maintenance therapy, she said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institutes for Mental Health.

“There does not appear to be a very large protective effect of continuing antipsychotic medications for an additional 48 weeks, once remission is achieved and functional recovery is underway,” said Dr. Kafantaris, director of research in child and adolescent psychiatry at the Zucker Hillside Hospital, Glen Oaks, N.Y.

The single-center study was funded by the National Institutes of Mental Health. Pharmaceutical companies donated the medications and matching placebos used in the trial. Dr. Kafantaris reported no other potential conflicts of interest.

The addition of a second-generation antipsychotic to treatment with a mood stabilizer has been shown to rapidly stabilize mania in children and adults, but it's unclear how long to continue this adjunctive use of antipsychotics once initial symptoms have resolved, she said.

Earlier case series in which patients were tapered off a second-generation antipsychotic after achieving therapeutic serum levels of lithium showed that reducing the antipsychotic dose after only a week or a month of lithium therapy led to high relapse rates, she said. In the current study, patients with bipolar disorder and psychotic features or severe aggression started with 6 months of open treatment using lithium (and valproic acid if needed) for mood stabilization and a second-generation antipsychotic–initially olanzapine (Zyprexa), with switches permitted to risperidone (Risperdal) or quetiapine (Seroquel).

Weight gain was a problem during this open-treatment phase. “We had a very difficult time. We would switch from one atypical to a different one, and we really didn't see much benefit” in weight, she said.

At the end of the 6-month open treatment, patients could be randomized to blinded maintenance therapy if they'd had 8 weeks free of psychosis, physical aggression, mania, depression, and mixed mania-depressive episodes, if they had been in school for 8 weeks, and if they'd had consistent therapeutic levels of a mood stabilizer on blood tests.

Twelve patients continued their combined treatment regimen as maintenance therapy for 48 weeks. Nine patients tapered off the antipsychotic over a 4-week period, replacing it with placebo, and continued on placebo plus mood stabilizers for 44 more weeks.

Compared with their prerandomization weights (after 6 months on open treatment), patients who continued the drug combination gained 4% in weight, and those on placebo and mood stabilizers lost 4% in weight after 48 weeks of maintenance therapy.

The investigators had hypothesized that remission would be maintained in 90% of the patients who continued the combination therapy and in 60% of the patients on placebo and mood stabilizers, but neither group came close to those expectations.

“There is a critical need for effective and well-tolerated maintenance medication strategies for this population,” Dr. Kafantaris said. “They will likely have a high recurrence rate and require intensive mental health care for life.”

PHOENIX — Second-generation antidepressants do not differ significantly from each other in efficacy or effectiveness, a study funded by the federal Agency for Healthcare Research and Quality shows.

There are some differences, however, in the rapidity of drug action and in rates of individual adverse events that may help providers choose among these medications, Dr. Bradley N. Gaynes said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institutes for Mental Health.

Use of the 12 second-generation antidepressants has skyrocketed over the past 15 years, easily eclipsing the use of tricyclic antidepressants in managing major depressive disorder. The retrospective analysis included results from 203 studies culled from the medical literature, online libraries, international pharmaceutical abstracts, and unpublished data from three drug companies.

No significant differences were found between second-generation antidepressants in either efficacy or quality of life measures in 80 head-to-head comparisons that included more than 17,000 adults, noted Dr. Gaynes of the University of North Carolina, Chapel Hill, and his associates.

A meta-analysis of 62 placebo-controlled trials was performed for indirect comparisons between second-generation antidepressants, which showed a few statistically significant differences that were modest and “likely not clinically important,” he said.

For example, seven studies comparing escitalopram (Lexapro) with citalopram (Celexa) found a slightly greater response to escitalopram, but the magnitude of difference was about a third of what would be needed to be considered clinically significant. Slightly greater efficacy seen with sertraline compared with fluoxetine, or with venlafaxine (Effexor) compared with fluoxetine, comprised “a small fraction” of what would be needed to show a clinically meaningful difference between drugs, he noted.

Results from three studies of effectiveness under real-world conditions were similar to those from efficacy trials, with no significant differences in effectiveness or quality of life between drugs. “Although efficacy was similar, it didn't mean that all of the antidepressants were the same. They're not identical,” Dr. Gaynes said.

Mirtazapine (Remeron), for example, showed a more rapid onset of action than did selective serotonin reuptake inhibitors in seven trials after a week or two of treatment, but the difference between drugs disappeared by 4 weeks of treatment. “Whether this could be extrapolated to other second-generation antidepressants is unclear,” he commented.

Analyses of adverse events reported in 80 head-to-head, randomized, controlled trials and 42 other experimental and observational studies showed that about 23% of patients on any second-generation antidepressant discontinue the medication. Patients who were on venlafaxine were more likely to discontinue treatment because of side effects but less likely to stop treatment from lack of efficacy compared with other second- generation antidepressants.

Nausea and vomiting were more common with the serotonin-norepinephrine reuptake inhibitor (SNRI) venlafaxine (33%) than with SSRIs (22%). Diarrhea was more common with sertraline (Zoloft) (11%) than with other medications (8%). Weight gain was more likely with mirtazapine than with SSRIs and ranged from 0.8 to 3 kg after 6–8 weeks.

Trazodone caused more somnolence than did other medications with which it was compared. The SSRIs were more likely than was bupropion to cause sexual dysfunction. Among SSRIs, sexual dysfunction rates were higher with paroxetine (Paxil) (21%) compared with other SSRIs (5%), though the strength of the evidence was mild, he said.

Dr. Gaynes is associated with several companies that make antidepressants. He has been an adviser or consultant to Pfizer and Shire Pharmaceuticals, has received grants from Pfizer and Ovation Pharmaceuticals, and has been a speaker for GlaxoSmithKline.

Pharmaceutical companies funded 69% of the studies included in the analysis. Government or independent sources funded 9%, and the source of funding wasn't clear for 22% of the studies.

PHOENIX — Second-generation antidepressants do not differ significantly from each other in efficacy or effectiveness, a study funded by the federal Agency for Healthcare Research and Quality shows.

There are some differences, however, in the rapidity of drug action and in rates of individual adverse events that may help providers choose among these medications, Dr. Bradley N. Gaynes said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institutes for Mental Health.

Use of the 12 second-generation antidepressants has skyrocketed over the past 15 years, easily eclipsing the use of tricyclic antidepressants in managing major depressive disorder. The retrospective analysis included results from 203 studies culled from the medical literature, online libraries, international pharmaceutical abstracts, and unpublished data from three drug companies.

No significant differences were found between second-generation antidepressants in either efficacy or quality of life measures in 80 head-to-head comparisons that included more than 17,000 adults, noted Dr. Gaynes of the University of North Carolina, Chapel Hill, and his associates.

A meta-analysis of 62 placebo-controlled trials was performed for indirect comparisons between second-generation antidepressants, which showed a few statistically significant differences that were modest and “likely not clinically important,” he said.

For example, seven studies comparing escitalopram (Lexapro) with citalopram (Celexa) found a slightly greater response to escitalopram, but the magnitude of difference was about a third of what would be needed to be considered clinically significant. Slightly greater efficacy seen with sertraline compared with fluoxetine, or with venlafaxine (Effexor) compared with fluoxetine, comprised “a small fraction” of what would be needed to show a clinically meaningful difference between drugs, he noted.

Results from three studies of effectiveness under real-world conditions were similar to those from efficacy trials, with no significant differences in effectiveness or quality of life between drugs. “Although efficacy was similar, it didn't mean that all of the antidepressants were the same. They're not identical,” Dr. Gaynes said.

Mirtazapine (Remeron), for example, showed a more rapid onset of action than did selective serotonin reuptake inhibitors in seven trials after a week or two of treatment, but the difference between drugs disappeared by 4 weeks of treatment. “Whether this could be extrapolated to other second-generation antidepressants is unclear,” he commented.

Analyses of adverse events reported in 80 head-to-head, randomized, controlled trials and 42 other experimental and observational studies showed that about 23% of patients on any second-generation antidepressant discontinue the medication. Patients who were on venlafaxine were more likely to discontinue treatment because of side effects but less likely to stop treatment from lack of efficacy compared with other second- generation antidepressants.

Nausea and vomiting were more common with the serotonin-norepinephrine reuptake inhibitor (SNRI) venlafaxine (33%) than with SSRIs (22%). Diarrhea was more common with sertraline (Zoloft) (11%) than with other medications (8%). Weight gain was more likely with mirtazapine than with SSRIs and ranged from 0.8 to 3 kg after 6–8 weeks.

Trazodone caused more somnolence than did other medications with which it was compared. The SSRIs were more likely than was bupropion to cause sexual dysfunction. Among SSRIs, sexual dysfunction rates were higher with paroxetine (Paxil) (21%) compared with other SSRIs (5%), though the strength of the evidence was mild, he said.

Dr. Gaynes is associated with several companies that make antidepressants. He has been an adviser or consultant to Pfizer and Shire Pharmaceuticals, has received grants from Pfizer and Ovation Pharmaceuticals, and has been a speaker for GlaxoSmithKline.

Pharmaceutical companies funded 69% of the studies included in the analysis. Government or independent sources funded 9%, and the source of funding wasn't clear for 22% of the studies.

PHOENIX — Second-generation antidepressants do not differ significantly from each other in efficacy or effectiveness, a study funded by the federal Agency for Healthcare Research and Quality shows.

There are some differences, however, in the rapidity of drug action and in rates of individual adverse events that may help providers choose among these medications, Dr. Bradley N. Gaynes said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institutes for Mental Health.

Use of the 12 second-generation antidepressants has skyrocketed over the past 15 years, easily eclipsing the use of tricyclic antidepressants in managing major depressive disorder. The retrospective analysis included results from 203 studies culled from the medical literature, online libraries, international pharmaceutical abstracts, and unpublished data from three drug companies.

No significant differences were found between second-generation antidepressants in either efficacy or quality of life measures in 80 head-to-head comparisons that included more than 17,000 adults, noted Dr. Gaynes of the University of North Carolina, Chapel Hill, and his associates.

A meta-analysis of 62 placebo-controlled trials was performed for indirect comparisons between second-generation antidepressants, which showed a few statistically significant differences that were modest and “likely not clinically important,” he said.

For example, seven studies comparing escitalopram (Lexapro) with citalopram (Celexa) found a slightly greater response to escitalopram, but the magnitude of difference was about a third of what would be needed to be considered clinically significant. Slightly greater efficacy seen with sertraline compared with fluoxetine, or with venlafaxine (Effexor) compared with fluoxetine, comprised “a small fraction” of what would be needed to show a clinically meaningful difference between drugs, he noted.

Results from three studies of effectiveness under real-world conditions were similar to those from efficacy trials, with no significant differences in effectiveness or quality of life between drugs. “Although efficacy was similar, it didn't mean that all of the antidepressants were the same. They're not identical,” Dr. Gaynes said.

Mirtazapine (Remeron), for example, showed a more rapid onset of action than did selective serotonin reuptake inhibitors in seven trials after a week or two of treatment, but the difference between drugs disappeared by 4 weeks of treatment. “Whether this could be extrapolated to other second-generation antidepressants is unclear,” he commented.

Analyses of adverse events reported in 80 head-to-head, randomized, controlled trials and 42 other experimental and observational studies showed that about 23% of patients on any second-generation antidepressant discontinue the medication. Patients who were on venlafaxine were more likely to discontinue treatment because of side effects but less likely to stop treatment from lack of efficacy compared with other second- generation antidepressants.

Nausea and vomiting were more common with the serotonin-norepinephrine reuptake inhibitor (SNRI) venlafaxine (33%) than with SSRIs (22%). Diarrhea was more common with sertraline (Zoloft) (11%) than with other medications (8%). Weight gain was more likely with mirtazapine than with SSRIs and ranged from 0.8 to 3 kg after 6–8 weeks.

Trazodone caused more somnolence than did other medications with which it was compared. The SSRIs were more likely than was bupropion to cause sexual dysfunction. Among SSRIs, sexual dysfunction rates were higher with paroxetine (Paxil) (21%) compared with other SSRIs (5%), though the strength of the evidence was mild, he said.

Dr. Gaynes is associated with several companies that make antidepressants. He has been an adviser or consultant to Pfizer and Shire Pharmaceuticals, has received grants from Pfizer and Ovation Pharmaceuticals, and has been a speaker for GlaxoSmithKline.

Pharmaceutical companies funded 69% of the studies included in the analysis. Government or independent sources funded 9%, and the source of funding wasn't clear for 22% of the studies.