Patrice Wendling

CHICAGO — Combining the calcium channel blocker amlodipine with the angiotensin receptor blocker olmesartan provides greater reductions in blood pressure than does either agent used as monotherapy, Dr. Steven G. Chrysant said at the annual meeting of the American Society of Hypertension.

Daiichi Sankyo Inc. filed a new drug application in November 2006 for a fixed-dose combination of the two antihypertensives. Known as Azor, this investigational agent is under regulatory and trade name review in the United States.

Lead investigator Dr. Chrysant reported data from a phase III double-blind, placebo-controlled factorial study in which 1,940 patients with mild to severe hypertension were randomized to either monotherapy or co-administration of amlodipine 5–10 mg/day and olmesartan 10–20–40 mg/day for 8 weeks. Hypertension was defined as seated diastolic BP between 95 mm Hg and 120 mm Hg.

At admission, the average age of patients was 54 years, and their mean BP was 164/102 mm Hg; 13.5% of patients had diabetes, and 34% were hypertensive treatment-naive, said Dr. Chrysant, who reported that he has received grant and research support from the study sponsor, Daiichi Sankyo Pharma Development.

After 8 weeks, all combinations of amlodipine and olmesartan reduced blood pressure significantly more than either medication alone or placebo, said Dr. Chrysant, a cardiologist at the Oklahoma Cardiovascular and Hypertension Center, University of Oklahoma, Oklahoma City. Pressure reductions were dose related.

Amlodipine 10 mg/day plus olmesartan 40 mg/day produced the best results, reducing systolic BP an average of 30.1 mm Hg and diastolic BP an average of 19.0 mm Hg. In contrast, average reductions were 19.7/12.7 mm Hg for amlodipine 10 mg alone and 4.8/3.1 mm Hg for placebo. “Only the high-dose combination dropped the pressure below 140 over 90 [mm Hg],” Dr. Chrysant said at a press briefing.

Adverse events were comparable between the groups, occurring in 511 of 970 (53%) combination therapy patients and 91 of 162 placebo-treated patients (56%). There was one stroke in the olmesartan monotherapy group that was possibly drug related, he said.

Reports of headache, fatigue, and dizziness were highest in the placebo group. The highest incidence of edema (25%) was reported in the amlodipine monotherapy group.

But adding on 40 mg of olmesartan halved this incidence rate, said Dr. Chrysant. He suggests this could be an added benefit of the combination regimen, because many hypertensive patients stop taking their medication because of swollen feet.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Combining the calcium channel blocker amlodipine with the angiotensin receptor blocker olmesartan provides greater reductions in blood pressure than does either agent used as monotherapy, Dr. Steven G. Chrysant said at the annual meeting of the American Society of Hypertension.

Daiichi Sankyo Inc. filed a new drug application in November 2006 for a fixed-dose combination of the two antihypertensives. Known as Azor, this investigational agent is under regulatory and trade name review in the United States.

Lead investigator Dr. Chrysant reported data from a phase III double-blind, placebo-controlled factorial study in which 1,940 patients with mild to severe hypertension were randomized to either monotherapy or co-administration of amlodipine 5–10 mg/day and olmesartan 10–20–40 mg/day for 8 weeks. Hypertension was defined as seated diastolic BP between 95 mm Hg and 120 mm Hg.

At admission, the average age of patients was 54 years, and their mean BP was 164/102 mm Hg; 13.5% of patients had diabetes, and 34% were hypertensive treatment-naive, said Dr. Chrysant, who reported that he has received grant and research support from the study sponsor, Daiichi Sankyo Pharma Development.

After 8 weeks, all combinations of amlodipine and olmesartan reduced blood pressure significantly more than either medication alone or placebo, said Dr. Chrysant, a cardiologist at the Oklahoma Cardiovascular and Hypertension Center, University of Oklahoma, Oklahoma City. Pressure reductions were dose related.

Amlodipine 10 mg/day plus olmesartan 40 mg/day produced the best results, reducing systolic BP an average of 30.1 mm Hg and diastolic BP an average of 19.0 mm Hg. In contrast, average reductions were 19.7/12.7 mm Hg for amlodipine 10 mg alone and 4.8/3.1 mm Hg for placebo. “Only the high-dose combination dropped the pressure below 140 over 90 [mm Hg],” Dr. Chrysant said at a press briefing.

Adverse events were comparable between the groups, occurring in 511 of 970 (53%) combination therapy patients and 91 of 162 placebo-treated patients (56%). There was one stroke in the olmesartan monotherapy group that was possibly drug related, he said.

Reports of headache, fatigue, and dizziness were highest in the placebo group. The highest incidence of edema (25%) was reported in the amlodipine monotherapy group.

But adding on 40 mg of olmesartan halved this incidence rate, said Dr. Chrysant. He suggests this could be an added benefit of the combination regimen, because many hypertensive patients stop taking their medication because of swollen feet.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Combining the calcium channel blocker amlodipine with the angiotensin receptor blocker olmesartan provides greater reductions in blood pressure than does either agent used as monotherapy, Dr. Steven G. Chrysant said at the annual meeting of the American Society of Hypertension.

Daiichi Sankyo Inc. filed a new drug application in November 2006 for a fixed-dose combination of the two antihypertensives. Known as Azor, this investigational agent is under regulatory and trade name review in the United States.

Lead investigator Dr. Chrysant reported data from a phase III double-blind, placebo-controlled factorial study in which 1,940 patients with mild to severe hypertension were randomized to either monotherapy or co-administration of amlodipine 5–10 mg/day and olmesartan 10–20–40 mg/day for 8 weeks. Hypertension was defined as seated diastolic BP between 95 mm Hg and 120 mm Hg.

At admission, the average age of patients was 54 years, and their mean BP was 164/102 mm Hg; 13.5% of patients had diabetes, and 34% were hypertensive treatment-naive, said Dr. Chrysant, who reported that he has received grant and research support from the study sponsor, Daiichi Sankyo Pharma Development.

After 8 weeks, all combinations of amlodipine and olmesartan reduced blood pressure significantly more than either medication alone or placebo, said Dr. Chrysant, a cardiologist at the Oklahoma Cardiovascular and Hypertension Center, University of Oklahoma, Oklahoma City. Pressure reductions were dose related.

Amlodipine 10 mg/day plus olmesartan 40 mg/day produced the best results, reducing systolic BP an average of 30.1 mm Hg and diastolic BP an average of 19.0 mm Hg. In contrast, average reductions were 19.7/12.7 mm Hg for amlodipine 10 mg alone and 4.8/3.1 mm Hg for placebo. “Only the high-dose combination dropped the pressure below 140 over 90 [mm Hg],” Dr. Chrysant said at a press briefing.

Adverse events were comparable between the groups, occurring in 511 of 970 (53%) combination therapy patients and 91 of 162 placebo-treated patients (56%). There was one stroke in the olmesartan monotherapy group that was possibly drug related, he said.

Reports of headache, fatigue, and dizziness were highest in the placebo group. The highest incidence of edema (25%) was reported in the amlodipine monotherapy group.

But adding on 40 mg of olmesartan halved this incidence rate, said Dr. Chrysant. He suggests this could be an added benefit of the combination regimen, because many hypertensive patients stop taking their medication because of swollen feet.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Few adults with known hypertension are following the DASH diet plan, even though some evidence suggests that its effect is roughly the equivalent of that of being on a single blood pressure medication.

Moreover, accordance with the Dietary Approaches to Stop Hypertension (DASH) plan has deteriorated since it was incorporated into in national guidelines, Dr. Philip Mellen said at the annual meeting of the American Society of Hypertension.

“We appear to be improving somewhat with respect to awareness of hypertension and treatment of hypertension,” he said during a press briefing. “But overall, dietary patterns appear to be doing worse over time.”

The landmark 1997 DASH trial showed that a diet rich in fruits, vegetables, grains, and low-fat diary products lowered blood pressure among patients with hypertension by an average of 11.4 mm Hg systolic and 5.5 mm Hg diastolic (N. Engl. J. Med. 1997;336:1117–24).

The dietary guidelines were incorporated into the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure reports in 1998 (JNC 6) and 2003 (JNC 7).

Dr. Mellen and his colleagues at Wake Forest University, Winston-Salem, N.C., used 1999–2004 data from the ongoing National Health and Nutrition Examination Survey (NHANES) IV to generate a DASH score for 4,386 adults with hypertension. Scores were based on self-reported 24-hour intake of nine target nutrients identified in the study (fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, potassium, and sodium). Individuals with a score of 4.5 or more were considered accordant with the DASH diet. (The data did not indicate whether any of the participants had been instructed to follow the DASH diet.) These results were compared with scores calculated for 4,556 adults with hypertension in the NHANES III 1988–1994 survey.

DASH accordance fell significantly from 29.3% in NHANES III to 21.7% in NHANES IV.

The decline was due largely to significantly fewer Americans in the recent survey reaching targets for total fat, fiber, and magnesium, Dr. Mellen said.

The percentage of patients achieving the DASH goal of reducing total fat intake to less than 27% of calories fell from 43% in NHANES III to 36% in NHANES IV.

Similarly, the percentage of participants on a 2,100-kcal diet eating the DASH recommended 31 g of fiber daily decreased significantly (20% vs. 12%), as did the percentage ingesting the target 500 mg a day of magnesium (14% vs. 6%).

In a multivariate analysis that adjusted for caloric intake and poverty index ratio, participants were significantly more likely to be DASH accordant if they were aged 40–59 years (odds ratio 2.75, compared with those aged 20–39 years); aged 60 years or older (OR 3.94, compared with those aged 20–39 years); had more than a high school education (OR 1.80); or had diabetes (OR 1.53).

Blacks were significantly less likely than others to follow the DASH diet (OR 0.61), while there was a nonsignificant trend toward higher accordance among Mexican Americans compared with whites, Dr. Mellen said. Accordance did not differ between men and women.

Participants were significantly more likely to be DASH accordant if they had more than a high school education. DR. MELLEN

CHICAGO — Few adults with known hypertension are following the DASH diet plan, even though some evidence suggests that its effect is roughly the equivalent of that of being on a single blood pressure medication.

Moreover, accordance with the Dietary Approaches to Stop Hypertension (DASH) plan has deteriorated since it was incorporated into in national guidelines, Dr. Philip Mellen said at the annual meeting of the American Society of Hypertension.

“We appear to be improving somewhat with respect to awareness of hypertension and treatment of hypertension,” he said during a press briefing. “But overall, dietary patterns appear to be doing worse over time.”

The landmark 1997 DASH trial showed that a diet rich in fruits, vegetables, grains, and low-fat diary products lowered blood pressure among patients with hypertension by an average of 11.4 mm Hg systolic and 5.5 mm Hg diastolic (N. Engl. J. Med. 1997;336:1117–24).

The dietary guidelines were incorporated into the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure reports in 1998 (JNC 6) and 2003 (JNC 7).

Dr. Mellen and his colleagues at Wake Forest University, Winston-Salem, N.C., used 1999–2004 data from the ongoing National Health and Nutrition Examination Survey (NHANES) IV to generate a DASH score for 4,386 adults with hypertension. Scores were based on self-reported 24-hour intake of nine target nutrients identified in the study (fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, potassium, and sodium). Individuals with a score of 4.5 or more were considered accordant with the DASH diet. (The data did not indicate whether any of the participants had been instructed to follow the DASH diet.) These results were compared with scores calculated for 4,556 adults with hypertension in the NHANES III 1988–1994 survey.

DASH accordance fell significantly from 29.3% in NHANES III to 21.7% in NHANES IV.

The decline was due largely to significantly fewer Americans in the recent survey reaching targets for total fat, fiber, and magnesium, Dr. Mellen said.

The percentage of patients achieving the DASH goal of reducing total fat intake to less than 27% of calories fell from 43% in NHANES III to 36% in NHANES IV.

Similarly, the percentage of participants on a 2,100-kcal diet eating the DASH recommended 31 g of fiber daily decreased significantly (20% vs. 12%), as did the percentage ingesting the target 500 mg a day of magnesium (14% vs. 6%).

In a multivariate analysis that adjusted for caloric intake and poverty index ratio, participants were significantly more likely to be DASH accordant if they were aged 40–59 years (odds ratio 2.75, compared with those aged 20–39 years); aged 60 years or older (OR 3.94, compared with those aged 20–39 years); had more than a high school education (OR 1.80); or had diabetes (OR 1.53).

Blacks were significantly less likely than others to follow the DASH diet (OR 0.61), while there was a nonsignificant trend toward higher accordance among Mexican Americans compared with whites, Dr. Mellen said. Accordance did not differ between men and women.

Participants were significantly more likely to be DASH accordant if they had more than a high school education. DR. MELLEN

CHICAGO — Few adults with known hypertension are following the DASH diet plan, even though some evidence suggests that its effect is roughly the equivalent of that of being on a single blood pressure medication.

Moreover, accordance with the Dietary Approaches to Stop Hypertension (DASH) plan has deteriorated since it was incorporated into in national guidelines, Dr. Philip Mellen said at the annual meeting of the American Society of Hypertension.

“We appear to be improving somewhat with respect to awareness of hypertension and treatment of hypertension,” he said during a press briefing. “But overall, dietary patterns appear to be doing worse over time.”

The landmark 1997 DASH trial showed that a diet rich in fruits, vegetables, grains, and low-fat diary products lowered blood pressure among patients with hypertension by an average of 11.4 mm Hg systolic and 5.5 mm Hg diastolic (N. Engl. J. Med. 1997;336:1117–24).

The dietary guidelines were incorporated into the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure reports in 1998 (JNC 6) and 2003 (JNC 7).

Dr. Mellen and his colleagues at Wake Forest University, Winston-Salem, N.C., used 1999–2004 data from the ongoing National Health and Nutrition Examination Survey (NHANES) IV to generate a DASH score for 4,386 adults with hypertension. Scores were based on self-reported 24-hour intake of nine target nutrients identified in the study (fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, potassium, and sodium). Individuals with a score of 4.5 or more were considered accordant with the DASH diet. (The data did not indicate whether any of the participants had been instructed to follow the DASH diet.) These results were compared with scores calculated for 4,556 adults with hypertension in the NHANES III 1988–1994 survey.

DASH accordance fell significantly from 29.3% in NHANES III to 21.7% in NHANES IV.

The decline was due largely to significantly fewer Americans in the recent survey reaching targets for total fat, fiber, and magnesium, Dr. Mellen said.

The percentage of patients achieving the DASH goal of reducing total fat intake to less than 27% of calories fell from 43% in NHANES III to 36% in NHANES IV.

Similarly, the percentage of participants on a 2,100-kcal diet eating the DASH recommended 31 g of fiber daily decreased significantly (20% vs. 12%), as did the percentage ingesting the target 500 mg a day of magnesium (14% vs. 6%).

In a multivariate analysis that adjusted for caloric intake and poverty index ratio, participants were significantly more likely to be DASH accordant if they were aged 40–59 years (odds ratio 2.75, compared with those aged 20–39 years); aged 60 years or older (OR 3.94, compared with those aged 20–39 years); had more than a high school education (OR 1.80); or had diabetes (OR 1.53).

Blacks were significantly less likely than others to follow the DASH diet (OR 0.61), while there was a nonsignificant trend toward higher accordance among Mexican Americans compared with whites, Dr. Mellen said. Accordance did not differ between men and women.

Participants were significantly more likely to be DASH accordant if they had more than a high school education. DR. MELLEN

CHICAGO — Self-monitoring of blood glucose did not significantly improve hemoglobin A_1c levels in a trial of patients with type 2 diabetes not receiving insulin.

“Although patients with type 1 and insulin-treated type 2 diabetes benefit from self-monitoring, this trial does not provide convincing evidence of benefit in non-insulin-treated type 2 diabetes,” lead researcher Dr. Andrew J. Farmer said at the annual scientific sessions of the American Diabetes Association. His team conducted the trial, known as DiGEM (Diabetes Glycaemic Education and Monitoring).

Health costs and quality of life data have yet to be presented from the three-arm, randomized, parallel group trial of 453 patients managed in U.K. general practices with diet and oral hypoglycemic agents alone.

“In the meantime, the results do not support recommendations for routine self-monitoring of blood glucose in reasonably well-controlled patients with type 2 diabetes,” said Dr. Farmer, division of public health, University of Oxford (England).

The trial had an 80% power at a 5% level of significance to detect the primary outcome—a change in hemoglobin A_1c of 0.5 percentage points—among three groups. Patients were randomized to a control group with no blood glucose monitors and 3 monthly hemoglobin A_1c measurements; a less intensive self-monitoring group with the results interpreted by a nurse practitioner in addition to usual care; and a more intensive self-monitoring group that was given the usual care plus training in interpreting and applying the results in relation to diet, physical exercise and medication regimens. Patients in the more intensive group had more latitude regarding when they could test their glucose, and averaged six to seven tests per week. Those in the less intensive group were told to use their meters before meals and averaged five to six tests per week, Dr. Farmer explained.

There were 152 in the control group, 150 in the less intensive self-monitoring group, and 151 in the more intensive self-monitoring group. At admission, the average duration of diabetes was 3 years, and the mean HbA_1c was 7.5%. Overall, 67.5%–73% of patients in each of the groups had had no prior experience with self monitoring.

At 12 months, the mean HbA_1c value was 0.14 percentage points lower in the less intensive self-monitoring group than in the control group, and 0.17 percentage points lower in the more intensive self-monitoring group than in the control group. The differences between groups were not statistically significant.

Among secondary outcomes, there were no significant differences between groups in blood pressure control. Surprisingly, there was a significant difference between groups in change from baseline of total cholesterol, with a decrease of 0.14 mmol/L in the control group, 5.2 mmol/L in the less intensive group, and 5.4 mmol/L in the more intensive group.

Hypoglycemia was reported by patients in all three arms of the trial, with the number of reports significantly higher in the self-monitoring groups than in the control group. This finding may be attributable to increased awareness of low blood glucose more than a true biochemical difference arising from the use of the monitor, Dr. Farmer said.

Over the 12 months of the trial, between one-third and one-half of patients stopped using their monitors. In all, 57 patients (13%) were lost to follow-up.

Dr. Farmer speculated that for many patients, the small day-to-day improvement in glucose results may have been obscured by the measurement variation from day to day, and may have contributed to the reason some people gave up. “It's well recognized that, in some people, when the readings don't vary—or seem uninterpretable—[there is] a loss of motivation,” he said.

Interpretation of the DiGEM data will be hotly debated, in part because of the financial implications of self-monitoring on health care agencies and insurers. The study moves the field ahead, but leaves some questions unanswered, Dr. Bernard Zinman, director of diabetes care at Mount Sinai Hospital, Toronto, said in an interview.

“This study proves definitively that self-monitoring of blood glucose does not seem to have an impact on changing an individual's lifestyle … and therefore [on improving] control,” Dr. Zinman said. But he added that it didn't address the question of whether, “if you give patients instructions on how to modify their oral hypoglycemia or give their physicians the opportunity to modify [it], self-monitoring of blood glucose may be very valuable in this population.”

CHICAGO — Self-monitoring of blood glucose did not significantly improve hemoglobin A_1c levels in a trial of patients with type 2 diabetes not receiving insulin.

“Although patients with type 1 and insulin-treated type 2 diabetes benefit from self-monitoring, this trial does not provide convincing evidence of benefit in non-insulin-treated type 2 diabetes,” lead researcher Dr. Andrew J. Farmer said at the annual scientific sessions of the American Diabetes Association. His team conducted the trial, known as DiGEM (Diabetes Glycaemic Education and Monitoring).

Health costs and quality of life data have yet to be presented from the three-arm, randomized, parallel group trial of 453 patients managed in U.K. general practices with diet and oral hypoglycemic agents alone.

“In the meantime, the results do not support recommendations for routine self-monitoring of blood glucose in reasonably well-controlled patients with type 2 diabetes,” said Dr. Farmer, division of public health, University of Oxford (England).

The trial had an 80% power at a 5% level of significance to detect the primary outcome—a change in hemoglobin A_1c of 0.5 percentage points—among three groups. Patients were randomized to a control group with no blood glucose monitors and 3 monthly hemoglobin A_1c measurements; a less intensive self-monitoring group with the results interpreted by a nurse practitioner in addition to usual care; and a more intensive self-monitoring group that was given the usual care plus training in interpreting and applying the results in relation to diet, physical exercise and medication regimens. Patients in the more intensive group had more latitude regarding when they could test their glucose, and averaged six to seven tests per week. Those in the less intensive group were told to use their meters before meals and averaged five to six tests per week, Dr. Farmer explained.

There were 152 in the control group, 150 in the less intensive self-monitoring group, and 151 in the more intensive self-monitoring group. At admission, the average duration of diabetes was 3 years, and the mean HbA_1c was 7.5%. Overall, 67.5%–73% of patients in each of the groups had had no prior experience with self monitoring.

At 12 months, the mean HbA_1c value was 0.14 percentage points lower in the less intensive self-monitoring group than in the control group, and 0.17 percentage points lower in the more intensive self-monitoring group than in the control group. The differences between groups were not statistically significant.

Among secondary outcomes, there were no significant differences between groups in blood pressure control. Surprisingly, there was a significant difference between groups in change from baseline of total cholesterol, with a decrease of 0.14 mmol/L in the control group, 5.2 mmol/L in the less intensive group, and 5.4 mmol/L in the more intensive group.

Hypoglycemia was reported by patients in all three arms of the trial, with the number of reports significantly higher in the self-monitoring groups than in the control group. This finding may be attributable to increased awareness of low blood glucose more than a true biochemical difference arising from the use of the monitor, Dr. Farmer said.

Over the 12 months of the trial, between one-third and one-half of patients stopped using their monitors. In all, 57 patients (13%) were lost to follow-up.

Dr. Farmer speculated that for many patients, the small day-to-day improvement in glucose results may have been obscured by the measurement variation from day to day, and may have contributed to the reason some people gave up. “It's well recognized that, in some people, when the readings don't vary—or seem uninterpretable—[there is] a loss of motivation,” he said.

Interpretation of the DiGEM data will be hotly debated, in part because of the financial implications of self-monitoring on health care agencies and insurers. The study moves the field ahead, but leaves some questions unanswered, Dr. Bernard Zinman, director of diabetes care at Mount Sinai Hospital, Toronto, said in an interview.

“This study proves definitively that self-monitoring of blood glucose does not seem to have an impact on changing an individual's lifestyle … and therefore [on improving] control,” Dr. Zinman said. But he added that it didn't address the question of whether, “if you give patients instructions on how to modify their oral hypoglycemia or give their physicians the opportunity to modify [it], self-monitoring of blood glucose may be very valuable in this population.”

CHICAGO — Self-monitoring of blood glucose did not significantly improve hemoglobin A_1c levels in a trial of patients with type 2 diabetes not receiving insulin.

“Although patients with type 1 and insulin-treated type 2 diabetes benefit from self-monitoring, this trial does not provide convincing evidence of benefit in non-insulin-treated type 2 diabetes,” lead researcher Dr. Andrew J. Farmer said at the annual scientific sessions of the American Diabetes Association. His team conducted the trial, known as DiGEM (Diabetes Glycaemic Education and Monitoring).

Health costs and quality of life data have yet to be presented from the three-arm, randomized, parallel group trial of 453 patients managed in U.K. general practices with diet and oral hypoglycemic agents alone.

“In the meantime, the results do not support recommendations for routine self-monitoring of blood glucose in reasonably well-controlled patients with type 2 diabetes,” said Dr. Farmer, division of public health, University of Oxford (England).

The trial had an 80% power at a 5% level of significance to detect the primary outcome—a change in hemoglobin A_1c of 0.5 percentage points—among three groups. Patients were randomized to a control group with no blood glucose monitors and 3 monthly hemoglobin A_1c measurements; a less intensive self-monitoring group with the results interpreted by a nurse practitioner in addition to usual care; and a more intensive self-monitoring group that was given the usual care plus training in interpreting and applying the results in relation to diet, physical exercise and medication regimens. Patients in the more intensive group had more latitude regarding when they could test their glucose, and averaged six to seven tests per week. Those in the less intensive group were told to use their meters before meals and averaged five to six tests per week, Dr. Farmer explained.

There were 152 in the control group, 150 in the less intensive self-monitoring group, and 151 in the more intensive self-monitoring group. At admission, the average duration of diabetes was 3 years, and the mean HbA_1c was 7.5%. Overall, 67.5%–73% of patients in each of the groups had had no prior experience with self monitoring.

At 12 months, the mean HbA_1c value was 0.14 percentage points lower in the less intensive self-monitoring group than in the control group, and 0.17 percentage points lower in the more intensive self-monitoring group than in the control group. The differences between groups were not statistically significant.

Among secondary outcomes, there were no significant differences between groups in blood pressure control. Surprisingly, there was a significant difference between groups in change from baseline of total cholesterol, with a decrease of 0.14 mmol/L in the control group, 5.2 mmol/L in the less intensive group, and 5.4 mmol/L in the more intensive group.

Hypoglycemia was reported by patients in all three arms of the trial, with the number of reports significantly higher in the self-monitoring groups than in the control group. This finding may be attributable to increased awareness of low blood glucose more than a true biochemical difference arising from the use of the monitor, Dr. Farmer said.

Over the 12 months of the trial, between one-third and one-half of patients stopped using their monitors. In all, 57 patients (13%) were lost to follow-up.

Dr. Farmer speculated that for many patients, the small day-to-day improvement in glucose results may have been obscured by the measurement variation from day to day, and may have contributed to the reason some people gave up. “It's well recognized that, in some people, when the readings don't vary—or seem uninterpretable—[there is] a loss of motivation,” he said.

Interpretation of the DiGEM data will be hotly debated, in part because of the financial implications of self-monitoring on health care agencies and insurers. The study moves the field ahead, but leaves some questions unanswered, Dr. Bernard Zinman, director of diabetes care at Mount Sinai Hospital, Toronto, said in an interview.

“This study proves definitively that self-monitoring of blood glucose does not seem to have an impact on changing an individual's lifestyle … and therefore [on improving] control,” Dr. Zinman said. But he added that it didn't address the question of whether, “if you give patients instructions on how to modify their oral hypoglycemia or give their physicians the opportunity to modify [it], self-monitoring of blood glucose may be very valuable in this population.”

CHICAGO — Despite significant gains in disease control over the last 6 years, nearly half of patients with diabetes failed to reach national treatment goals in 2006.

An analysis of 22.7 million hemoglobin A_1c tests performed on 4.8 million patients with diabetes mellitus revealed that as of December 2006, 55% of patients had reached the American Diabetes Association (ADA) treatment target of hemoglobin A_1c levels less than 7 percent. This compares with 37.8% in 2001.

The analysis revealed that despite these overall gains, the decline in A_1c values has slowed since 2003, leaving 45% of Americans with diabetes short of ADA targets in 2006.

“For this 45 percent, we are going to need new approaches to control their diabetes,” coauthor Dr. Richard W. Furlanetto said at a press briefing during the annual scientific sessions of the ADA. “We'll need new medications certainly, but I think we'll need intensive education for these people and new ways of allowing them to live with their disease.”

Roughly 28% of patients with type 1 diabetes reached an A_1c level below 7 percent in 2001, compared with 35% in 2006. In contrast, 45% and 57% of patients with type 2 diabetes reached the target A_1c over the same time period, said Dr. Furlanetto, a pediatric endocrinologist and medical director of endocrinology at Quest Diagnostics Nichols Institute in Chantilly, Va.

In patients with type 2 diabetes, the overall mean A_1c values declined from 7.6% in 2001 to 7.3% in 2003, but then slowed significantly and stabilized at 7.2% in 2006, according to the analysis of data from the Quest Diagnostics Informatics Data Warehouse, a large private reference laboratory database.

The authors suggest that this HbA_1c plateau mirrors the clinical progression of the disease as well as treatment patterns. Longitudinal analysis indicates that A_1c values for individual patients decreased in the first 1–2 years, and then trended slowly upward. This could be a result of aggressive therapy and strict compliance in the early years, followed by worsening of the disease, which limits therapy, and less diligent treatment compliance, Dr. Furlanetto said.

One of the more striking findings in the study, which was presented as a poster at the meeting, was that A_1c levels show significant seasonal fluctuations, with A_1c levels peaking in the winter between January and March and falling between July and October.

The magnitude of the variation depended on patient age, diabetes type, and winter A_1c value. The variations were most apparent in those aged 80 years and older and those with the highest A_1c levels (9% or more).

HbA_1c measurements taken in late spring and late fall may be more representative of the annual mean A_1c level, Dr. Furlanetto suggested.

While the number of tests reported in the study is more than 50 times that of other published reports on diabetes health, reporters questioned how applicable the findings are to the average patient, given that the sample represents a fraction of the roughly 21 million Americans with diabetes.

Dr. Furlanetto acknowledged that the study was limited by its reliance on ICD-9 billing codes, but countered that the size of the database was substantial; that it covered all 50 states, the District of Columbia, and Puerto Rico; and that it may actually underrepresent the number of patients under the care of endocrinologists.

Session moderator Martha M. Funnell, a registered nurse and certified diabetes educator at the University of Michigan, Ann Arbor, said one of the strengths of the study was its size. “I realize it's not 100 percent of people with diabetes, but it's a very, very robust representation,” she said. Additionally, the patient population was a random sample, and the study underrepresented endocrinologists, who would presumably provide better diabetes management, she added.

CHICAGO — Despite significant gains in disease control over the last 6 years, nearly half of patients with diabetes failed to reach national treatment goals in 2006.

An analysis of 22.7 million hemoglobin A_1c tests performed on 4.8 million patients with diabetes mellitus revealed that as of December 2006, 55% of patients had reached the American Diabetes Association (ADA) treatment target of hemoglobin A_1c levels less than 7 percent. This compares with 37.8% in 2001.

The analysis revealed that despite these overall gains, the decline in A_1c values has slowed since 2003, leaving 45% of Americans with diabetes short of ADA targets in 2006.

“For this 45 percent, we are going to need new approaches to control their diabetes,” coauthor Dr. Richard W. Furlanetto said at a press briefing during the annual scientific sessions of the ADA. “We'll need new medications certainly, but I think we'll need intensive education for these people and new ways of allowing them to live with their disease.”

Roughly 28% of patients with type 1 diabetes reached an A_1c level below 7 percent in 2001, compared with 35% in 2006. In contrast, 45% and 57% of patients with type 2 diabetes reached the target A_1c over the same time period, said Dr. Furlanetto, a pediatric endocrinologist and medical director of endocrinology at Quest Diagnostics Nichols Institute in Chantilly, Va.

In patients with type 2 diabetes, the overall mean A_1c values declined from 7.6% in 2001 to 7.3% in 2003, but then slowed significantly and stabilized at 7.2% in 2006, according to the analysis of data from the Quest Diagnostics Informatics Data Warehouse, a large private reference laboratory database.

The authors suggest that this HbA_1c plateau mirrors the clinical progression of the disease as well as treatment patterns. Longitudinal analysis indicates that A_1c values for individual patients decreased in the first 1–2 years, and then trended slowly upward. This could be a result of aggressive therapy and strict compliance in the early years, followed by worsening of the disease, which limits therapy, and less diligent treatment compliance, Dr. Furlanetto said.

One of the more striking findings in the study, which was presented as a poster at the meeting, was that A_1c levels show significant seasonal fluctuations, with A_1c levels peaking in the winter between January and March and falling between July and October.

The magnitude of the variation depended on patient age, diabetes type, and winter A_1c value. The variations were most apparent in those aged 80 years and older and those with the highest A_1c levels (9% or more).

HbA_1c measurements taken in late spring and late fall may be more representative of the annual mean A_1c level, Dr. Furlanetto suggested.

While the number of tests reported in the study is more than 50 times that of other published reports on diabetes health, reporters questioned how applicable the findings are to the average patient, given that the sample represents a fraction of the roughly 21 million Americans with diabetes.

Dr. Furlanetto acknowledged that the study was limited by its reliance on ICD-9 billing codes, but countered that the size of the database was substantial; that it covered all 50 states, the District of Columbia, and Puerto Rico; and that it may actually underrepresent the number of patients under the care of endocrinologists.

Session moderator Martha M. Funnell, a registered nurse and certified diabetes educator at the University of Michigan, Ann Arbor, said one of the strengths of the study was its size. “I realize it's not 100 percent of people with diabetes, but it's a very, very robust representation,” she said. Additionally, the patient population was a random sample, and the study underrepresented endocrinologists, who would presumably provide better diabetes management, she added.

CHICAGO — Despite significant gains in disease control over the last 6 years, nearly half of patients with diabetes failed to reach national treatment goals in 2006.

An analysis of 22.7 million hemoglobin A_1c tests performed on 4.8 million patients with diabetes mellitus revealed that as of December 2006, 55% of patients had reached the American Diabetes Association (ADA) treatment target of hemoglobin A_1c levels less than 7 percent. This compares with 37.8% in 2001.

The analysis revealed that despite these overall gains, the decline in A_1c values has slowed since 2003, leaving 45% of Americans with diabetes short of ADA targets in 2006.

“For this 45 percent, we are going to need new approaches to control their diabetes,” coauthor Dr. Richard W. Furlanetto said at a press briefing during the annual scientific sessions of the ADA. “We'll need new medications certainly, but I think we'll need intensive education for these people and new ways of allowing them to live with their disease.”

Roughly 28% of patients with type 1 diabetes reached an A_1c level below 7 percent in 2001, compared with 35% in 2006. In contrast, 45% and 57% of patients with type 2 diabetes reached the target A_1c over the same time period, said Dr. Furlanetto, a pediatric endocrinologist and medical director of endocrinology at Quest Diagnostics Nichols Institute in Chantilly, Va.

In patients with type 2 diabetes, the overall mean A_1c values declined from 7.6% in 2001 to 7.3% in 2003, but then slowed significantly and stabilized at 7.2% in 2006, according to the analysis of data from the Quest Diagnostics Informatics Data Warehouse, a large private reference laboratory database.

The authors suggest that this HbA_1c plateau mirrors the clinical progression of the disease as well as treatment patterns. Longitudinal analysis indicates that A_1c values for individual patients decreased in the first 1–2 years, and then trended slowly upward. This could be a result of aggressive therapy and strict compliance in the early years, followed by worsening of the disease, which limits therapy, and less diligent treatment compliance, Dr. Furlanetto said.

One of the more striking findings in the study, which was presented as a poster at the meeting, was that A_1c levels show significant seasonal fluctuations, with A_1c levels peaking in the winter between January and March and falling between July and October.

The magnitude of the variation depended on patient age, diabetes type, and winter A_1c value. The variations were most apparent in those aged 80 years and older and those with the highest A_1c levels (9% or more).

HbA_1c measurements taken in late spring and late fall may be more representative of the annual mean A_1c level, Dr. Furlanetto suggested.

While the number of tests reported in the study is more than 50 times that of other published reports on diabetes health, reporters questioned how applicable the findings are to the average patient, given that the sample represents a fraction of the roughly 21 million Americans with diabetes.

Dr. Furlanetto acknowledged that the study was limited by its reliance on ICD-9 billing codes, but countered that the size of the database was substantial; that it covered all 50 states, the District of Columbia, and Puerto Rico; and that it may actually underrepresent the number of patients under the care of endocrinologists.

Session moderator Martha M. Funnell, a registered nurse and certified diabetes educator at the University of Michigan, Ann Arbor, said one of the strengths of the study was its size. “I realize it's not 100 percent of people with diabetes, but it's a very, very robust representation,” she said. Additionally, the patient population was a random sample, and the study underrepresented endocrinologists, who would presumably provide better diabetes management, she added.

CHICAGO — Telmisartan provides greater reduction in proteinuria than losartan does after 1 year of treatment in patients with hypertension and diabetic nephropathy, Dr. George Bakris said at the annual meeting of the American Society of Hypertension.

This difference can't be attributed to differences in blood pressure control, because blood pressure reductions were comparable in patients taking either angiotension II blocker (ARB), Dr. Bakris, who is lead investigator of the AMADEO study, said during a press briefing.

After stopping the drugs for 2 months, as per protocol, about twice as many patients on telmisartan were reported to have experienced a slightly greater antiproteinuric effect, compared with those on losartan. This is important to both the Food and Drug Administration and clinicians, because it suggests that telmisartan has done something independent of controlling blood pressure to change the natural history or biology of the disease, said Dr. Bakris.

“The differences between these ARBs in terms of receptor binding, lipophilicity, and duration of action may be responsible for the differences in the effects that you see,” said Dr. Bakris, professor of medicine and director of the hypertension unit at the University of Chicago.

“These data suggest that at similar levels of blood pressure control, the longer-acting, higher-binding telmisartan may confer relatively greater protection against the development of ESRD [end-stage renal disease], although that hypothesis needs to be tested prospectively,” he said.

Dr. Bakris and associates randomized 860 patients with type 2 diabetes mellitus, hypertension (defined as blood pressure greater than 130/80 mm Hg), and overt nephropathy to either telmisartan 40 mg or losartan 50 mg for 2 weeks, and then titrated to 80 mg and 100 mg, respectively. If blood pressure was not controlled, concomitant antihypertensives were allowed, except ARBs, angiotensin-converting enzyme inhibitors, and direct vasodilators.

At admission, the average systolic/diastolic blood pressure was 143/80 mm Hg in both groups; mean urinary protein:creatinine ratio was 1,971 mg/gCr in the telmisartan group vs. 2,010.5 mg/gCr in the losartan group; and the mean serum creatinine was 1.54 mg/dL in the telmisartan group vs. 1.55 mg/dL in the losartan group. In all, 827 patients were available for analysis.

After 1 year of treatment, the mean change in morning spot urinary protein:creatinine—the study's primary end point—was 0.71 for telmisartan and 0.80 for losartan. This translated to a 29% reduction from baseline for telmisartan and a 20% reduction for losartan.

Systolic and diastolic BP reductions were not significant between groups (−4.8/−3.2 mm Hg vs. −2.7/−2.9 mm Hg, respectively).

Among secondary end points, telmisartan produced superior reductions in urinary albumin:creatinine and prolonged the time to first cardiovascular event. No significant differences were reported between the two drugs in urinary sodium:creatinine, glomerular filtration rate, serum aldosterone, or high-sensitivity C-reactive protein.

Adverse events were not different between groups, reported Dr. Bakris, who disclosed that he is a consultant and speaker for Boehringer Ingelheim, which sponsored the study. Dr. Bakris also has received research support from the company.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Telmisartan provides greater reduction in proteinuria than losartan does after 1 year of treatment in patients with hypertension and diabetic nephropathy, Dr. George Bakris said at the annual meeting of the American Society of Hypertension.

This difference can't be attributed to differences in blood pressure control, because blood pressure reductions were comparable in patients taking either angiotension II blocker (ARB), Dr. Bakris, who is lead investigator of the AMADEO study, said during a press briefing.

After stopping the drugs for 2 months, as per protocol, about twice as many patients on telmisartan were reported to have experienced a slightly greater antiproteinuric effect, compared with those on losartan. This is important to both the Food and Drug Administration and clinicians, because it suggests that telmisartan has done something independent of controlling blood pressure to change the natural history or biology of the disease, said Dr. Bakris.

“The differences between these ARBs in terms of receptor binding, lipophilicity, and duration of action may be responsible for the differences in the effects that you see,” said Dr. Bakris, professor of medicine and director of the hypertension unit at the University of Chicago.

“These data suggest that at similar levels of blood pressure control, the longer-acting, higher-binding telmisartan may confer relatively greater protection against the development of ESRD [end-stage renal disease], although that hypothesis needs to be tested prospectively,” he said.

Dr. Bakris and associates randomized 860 patients with type 2 diabetes mellitus, hypertension (defined as blood pressure greater than 130/80 mm Hg), and overt nephropathy to either telmisartan 40 mg or losartan 50 mg for 2 weeks, and then titrated to 80 mg and 100 mg, respectively. If blood pressure was not controlled, concomitant antihypertensives were allowed, except ARBs, angiotensin-converting enzyme inhibitors, and direct vasodilators.

At admission, the average systolic/diastolic blood pressure was 143/80 mm Hg in both groups; mean urinary protein:creatinine ratio was 1,971 mg/gCr in the telmisartan group vs. 2,010.5 mg/gCr in the losartan group; and the mean serum creatinine was 1.54 mg/dL in the telmisartan group vs. 1.55 mg/dL in the losartan group. In all, 827 patients were available for analysis.

After 1 year of treatment, the mean change in morning spot urinary protein:creatinine—the study's primary end point—was 0.71 for telmisartan and 0.80 for losartan. This translated to a 29% reduction from baseline for telmisartan and a 20% reduction for losartan.

Systolic and diastolic BP reductions were not significant between groups (−4.8/−3.2 mm Hg vs. −2.7/−2.9 mm Hg, respectively).

Among secondary end points, telmisartan produced superior reductions in urinary albumin:creatinine and prolonged the time to first cardiovascular event. No significant differences were reported between the two drugs in urinary sodium:creatinine, glomerular filtration rate, serum aldosterone, or high-sensitivity C-reactive protein.

Adverse events were not different between groups, reported Dr. Bakris, who disclosed that he is a consultant and speaker for Boehringer Ingelheim, which sponsored the study. Dr. Bakris also has received research support from the company.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Telmisartan provides greater reduction in proteinuria than losartan does after 1 year of treatment in patients with hypertension and diabetic nephropathy, Dr. George Bakris said at the annual meeting of the American Society of Hypertension.

This difference can't be attributed to differences in blood pressure control, because blood pressure reductions were comparable in patients taking either angiotension II blocker (ARB), Dr. Bakris, who is lead investigator of the AMADEO study, said during a press briefing.

After stopping the drugs for 2 months, as per protocol, about twice as many patients on telmisartan were reported to have experienced a slightly greater antiproteinuric effect, compared with those on losartan. This is important to both the Food and Drug Administration and clinicians, because it suggests that telmisartan has done something independent of controlling blood pressure to change the natural history or biology of the disease, said Dr. Bakris.

“The differences between these ARBs in terms of receptor binding, lipophilicity, and duration of action may be responsible for the differences in the effects that you see,” said Dr. Bakris, professor of medicine and director of the hypertension unit at the University of Chicago.

“These data suggest that at similar levels of blood pressure control, the longer-acting, higher-binding telmisartan may confer relatively greater protection against the development of ESRD [end-stage renal disease], although that hypothesis needs to be tested prospectively,” he said.

Dr. Bakris and associates randomized 860 patients with type 2 diabetes mellitus, hypertension (defined as blood pressure greater than 130/80 mm Hg), and overt nephropathy to either telmisartan 40 mg or losartan 50 mg for 2 weeks, and then titrated to 80 mg and 100 mg, respectively. If blood pressure was not controlled, concomitant antihypertensives were allowed, except ARBs, angiotensin-converting enzyme inhibitors, and direct vasodilators.

At admission, the average systolic/diastolic blood pressure was 143/80 mm Hg in both groups; mean urinary protein:creatinine ratio was 1,971 mg/gCr in the telmisartan group vs. 2,010.5 mg/gCr in the losartan group; and the mean serum creatinine was 1.54 mg/dL in the telmisartan group vs. 1.55 mg/dL in the losartan group. In all, 827 patients were available for analysis.

After 1 year of treatment, the mean change in morning spot urinary protein:creatinine—the study's primary end point—was 0.71 for telmisartan and 0.80 for losartan. This translated to a 29% reduction from baseline for telmisartan and a 20% reduction for losartan.

Systolic and diastolic BP reductions were not significant between groups (−4.8/−3.2 mm Hg vs. −2.7/−2.9 mm Hg, respectively).

Among secondary end points, telmisartan produced superior reductions in urinary albumin:creatinine and prolonged the time to first cardiovascular event. No significant differences were reported between the two drugs in urinary sodium:creatinine, glomerular filtration rate, serum aldosterone, or high-sensitivity C-reactive protein.

Adverse events were not different between groups, reported Dr. Bakris, who disclosed that he is a consultant and speaker for Boehringer Ingelheim, which sponsored the study. Dr. Bakris also has received research support from the company.

ELSEVIER GLOBAL MEDICAL NEWS

KANSAS CITY, MO. — A staff and bilingual patient education program dramatically increased immunizations for pregnant women in Suffolk County, New York.

But progress in this massive county of 1.3 million residents could be thwarted by state legislation banning the use of vaccines containing thimerosal, Mary Koslap-Petraco said at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

A staff education program was developed for obstetricians, nurse-practitioners, and registered nurses at prenatal clinics in all eight primary health centers and three satellite offices run by the Suffolk County Department of Health Services (DHS). The nursing staff then developed a bilingual teaching program in Spanish and English for the women attending the clinics.

The largest ethnic group in the county is Hispanic, many of whom are immigrants, followed by African American, white, Asian, and Native American. All of the patients were enrolled in the Medicaid prenatal assistance program.

Immunization status was checked for each pregnant woman for three targeted vaccines: tetanus and diphtheria (Td), hepatitis A/B, and influenza. Each woman was then offered an immunization, and given vaccine-specific education. A written immunization record was provided for each patient to take home, noting when her next vaccination was due.

“When we started this program, we really didn't vaccinate pregnant women with much more than flu shots, if we even did that,” said Ms. Koslap-Petraco, a certified pediatric nurse-practitioner, and coordinator of child health for Suffolk County, Hauppauge, N.Y.

In 2005, 954 flu shots and no Td or hepatitis vaccines were administered. In 2006, those numbers jumped to 1,381 influenza, 505 Td, and 1,307 hepatitis A/B vaccines.

Vaccination of pregnant women remains unsupported among many health care professionals, and the current legislative climate provides yet another reason not to vaccinate. In 2006, New York, Missouri, and Washington joined California, Delaware, Illinois, and Iowa in enacting legislation that would restrict the use of thimerosal-containing vaccines. The law is not effective in New York until July 1, 2008.

But Suffolk County passed its own local ordinance in 2006 prohibiting thimerosal-containing vaccines for children up to age 4 years and pregnant women who attend county health centers. The local law caused many nurses to stop immunizing pregnant women for influenza once the supply of thimerosal-free vaccine ran out, Ms. Koslap-Petraco said.

KANSAS CITY, MO. — A staff and bilingual patient education program dramatically increased immunizations for pregnant women in Suffolk County, New York.

But progress in this massive county of 1.3 million residents could be thwarted by state legislation banning the use of vaccines containing thimerosal, Mary Koslap-Petraco said at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

A staff education program was developed for obstetricians, nurse-practitioners, and registered nurses at prenatal clinics in all eight primary health centers and three satellite offices run by the Suffolk County Department of Health Services (DHS). The nursing staff then developed a bilingual teaching program in Spanish and English for the women attending the clinics.

The largest ethnic group in the county is Hispanic, many of whom are immigrants, followed by African American, white, Asian, and Native American. All of the patients were enrolled in the Medicaid prenatal assistance program.

Immunization status was checked for each pregnant woman for three targeted vaccines: tetanus and diphtheria (Td), hepatitis A/B, and influenza. Each woman was then offered an immunization, and given vaccine-specific education. A written immunization record was provided for each patient to take home, noting when her next vaccination was due.

“When we started this program, we really didn't vaccinate pregnant women with much more than flu shots, if we even did that,” said Ms. Koslap-Petraco, a certified pediatric nurse-practitioner, and coordinator of child health for Suffolk County, Hauppauge, N.Y.

In 2005, 954 flu shots and no Td or hepatitis vaccines were administered. In 2006, those numbers jumped to 1,381 influenza, 505 Td, and 1,307 hepatitis A/B vaccines.

Vaccination of pregnant women remains unsupported among many health care professionals, and the current legislative climate provides yet another reason not to vaccinate. In 2006, New York, Missouri, and Washington joined California, Delaware, Illinois, and Iowa in enacting legislation that would restrict the use of thimerosal-containing vaccines. The law is not effective in New York until July 1, 2008.

But Suffolk County passed its own local ordinance in 2006 prohibiting thimerosal-containing vaccines for children up to age 4 years and pregnant women who attend county health centers. The local law caused many nurses to stop immunizing pregnant women for influenza once the supply of thimerosal-free vaccine ran out, Ms. Koslap-Petraco said.

KANSAS CITY, MO. — A staff and bilingual patient education program dramatically increased immunizations for pregnant women in Suffolk County, New York.

But progress in this massive county of 1.3 million residents could be thwarted by state legislation banning the use of vaccines containing thimerosal, Mary Koslap-Petraco said at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

A staff education program was developed for obstetricians, nurse-practitioners, and registered nurses at prenatal clinics in all eight primary health centers and three satellite offices run by the Suffolk County Department of Health Services (DHS). The nursing staff then developed a bilingual teaching program in Spanish and English for the women attending the clinics.

The largest ethnic group in the county is Hispanic, many of whom are immigrants, followed by African American, white, Asian, and Native American. All of the patients were enrolled in the Medicaid prenatal assistance program.

Immunization status was checked for each pregnant woman for three targeted vaccines: tetanus and diphtheria (Td), hepatitis A/B, and influenza. Each woman was then offered an immunization, and given vaccine-specific education. A written immunization record was provided for each patient to take home, noting when her next vaccination was due.

“When we started this program, we really didn't vaccinate pregnant women with much more than flu shots, if we even did that,” said Ms. Koslap-Petraco, a certified pediatric nurse-practitioner, and coordinator of child health for Suffolk County, Hauppauge, N.Y.

In 2005, 954 flu shots and no Td or hepatitis vaccines were administered. In 2006, those numbers jumped to 1,381 influenza, 505 Td, and 1,307 hepatitis A/B vaccines.

Vaccination of pregnant women remains unsupported among many health care professionals, and the current legislative climate provides yet another reason not to vaccinate. In 2006, New York, Missouri, and Washington joined California, Delaware, Illinois, and Iowa in enacting legislation that would restrict the use of thimerosal-containing vaccines. The law is not effective in New York until July 1, 2008.

But Suffolk County passed its own local ordinance in 2006 prohibiting thimerosal-containing vaccines for children up to age 4 years and pregnant women who attend county health centers. The local law caused many nurses to stop immunizing pregnant women for influenza once the supply of thimerosal-free vaccine ran out, Ms. Koslap-Petraco said.

TORONTO — Triple antiretroviral therapy during pregnancy was effective for preventing vertical transmission of HIV to newborns, and was not associated with an increased risk of prematurity, significant growth abnormalities, or malformations in a retrospective cohort of 206 mother-infant pairs, Dr. Sophie Alloul reported in a poster at the annual meeting of the Pediatric Academic Societies.

Nucleoside and nucleotide analogue reverse transcriptase inhibitors were used in 205 (99.5%) mothers, protease inhibitors in 177 (86%), nonnucleoside reverse transcriptase inhibitors in 40 (19%), and zidovudine during labor in 202 (98%). Nelfinavir (Viracept) was the most commonly used protease inhibitor. Most women were treated for a median of 20 weeks before delivery. Among newborns, 97% received a 6-week regimen of zidovudine, lamivudine, and nelfinavir from birth.

The transmission rate in the cohort was 0.5%, with only one infant contracting HIV during the study period of 1997–2005, said Dr. Alloul and her colleagues at Centre Hospitalier Universitaire (CHU) Sainte-Justine, Montreal.

The average gestational age was 38 weeks, and there was one stillbirth. The prevalence of prematurity was 8.5%, and premature infants' median weight was 2,257 g.

Term neonates had a median birth weight of 3,200 g, and 10.3% were small for gestational age (SGA), with a mean weight of 2,208 g. In all, 29 (14%) infants presented with minor malformations.

When compared with a control group of 91 newborns from noninfected, nontreated mothers, the prevalences of prematurity, SGA, and malformations were not significantly different, the authors said.

Centers for Disease Control and Prevention growth parameters—including weight, length, and head circumference—were all within normal range during the first 2 years of life for infants born to treated mothers.

The findings are reassuring, inasmuch as recent data suggest that the use of protease inhibitors is correlated with an increased rate of prematurity in newborns, Dr. Alloul said in an interview.

Triple therapy is now standard of care at CHU Sainte-Justine for all HIV-infected mothers and their offspring, she said.

TORONTO — Triple antiretroviral therapy during pregnancy was effective for preventing vertical transmission of HIV to newborns, and was not associated with an increased risk of prematurity, significant growth abnormalities, or malformations in a retrospective cohort of 206 mother-infant pairs, Dr. Sophie Alloul reported in a poster at the annual meeting of the Pediatric Academic Societies.

Nucleoside and nucleotide analogue reverse transcriptase inhibitors were used in 205 (99.5%) mothers, protease inhibitors in 177 (86%), nonnucleoside reverse transcriptase inhibitors in 40 (19%), and zidovudine during labor in 202 (98%). Nelfinavir (Viracept) was the most commonly used protease inhibitor. Most women were treated for a median of 20 weeks before delivery. Among newborns, 97% received a 6-week regimen of zidovudine, lamivudine, and nelfinavir from birth.

The transmission rate in the cohort was 0.5%, with only one infant contracting HIV during the study period of 1997–2005, said Dr. Alloul and her colleagues at Centre Hospitalier Universitaire (CHU) Sainte-Justine, Montreal.

The average gestational age was 38 weeks, and there was one stillbirth. The prevalence of prematurity was 8.5%, and premature infants' median weight was 2,257 g.

Term neonates had a median birth weight of 3,200 g, and 10.3% were small for gestational age (SGA), with a mean weight of 2,208 g. In all, 29 (14%) infants presented with minor malformations.

When compared with a control group of 91 newborns from noninfected, nontreated mothers, the prevalences of prematurity, SGA, and malformations were not significantly different, the authors said.

Centers for Disease Control and Prevention growth parameters—including weight, length, and head circumference—were all within normal range during the first 2 years of life for infants born to treated mothers.

The findings are reassuring, inasmuch as recent data suggest that the use of protease inhibitors is correlated with an increased rate of prematurity in newborns, Dr. Alloul said in an interview.

Triple therapy is now standard of care at CHU Sainte-Justine for all HIV-infected mothers and their offspring, she said.

TORONTO — Triple antiretroviral therapy during pregnancy was effective for preventing vertical transmission of HIV to newborns, and was not associated with an increased risk of prematurity, significant growth abnormalities, or malformations in a retrospective cohort of 206 mother-infant pairs, Dr. Sophie Alloul reported in a poster at the annual meeting of the Pediatric Academic Societies.

Nucleoside and nucleotide analogue reverse transcriptase inhibitors were used in 205 (99.5%) mothers, protease inhibitors in 177 (86%), nonnucleoside reverse transcriptase inhibitors in 40 (19%), and zidovudine during labor in 202 (98%). Nelfinavir (Viracept) was the most commonly used protease inhibitor. Most women were treated for a median of 20 weeks before delivery. Among newborns, 97% received a 6-week regimen of zidovudine, lamivudine, and nelfinavir from birth.

The transmission rate in the cohort was 0.5%, with only one infant contracting HIV during the study period of 1997–2005, said Dr. Alloul and her colleagues at Centre Hospitalier Universitaire (CHU) Sainte-Justine, Montreal.

The average gestational age was 38 weeks, and there was one stillbirth. The prevalence of prematurity was 8.5%, and premature infants' median weight was 2,257 g.

Term neonates had a median birth weight of 3,200 g, and 10.3% were small for gestational age (SGA), with a mean weight of 2,208 g. In all, 29 (14%) infants presented with minor malformations.

When compared with a control group of 91 newborns from noninfected, nontreated mothers, the prevalences of prematurity, SGA, and malformations were not significantly different, the authors said.

Centers for Disease Control and Prevention growth parameters—including weight, length, and head circumference—were all within normal range during the first 2 years of life for infants born to treated mothers.

The findings are reassuring, inasmuch as recent data suggest that the use of protease inhibitors is correlated with an increased rate of prematurity in newborns, Dr. Alloul said in an interview.

Triple therapy is now standard of care at CHU Sainte-Justine for all HIV-infected mothers and their offspring, she said.

CHICAGO — Combining the calcium channel blocker amlodipine with the angiotensin receptor blocker olmesartan provides greater reductions in blood pressure than does either agent used as monotherapy, Dr. Steven G. Chrysant said at the annual meeting of the American Society of Hypertension.

Daiichi Sankyo Inc. filed a new drug application in November 2006 for a fixed-dose combination of the two antihypertensives. Known as Azor, this investigational agent is under regulatory and trade name review in the United States.

Lead investigator Dr. Chrysant reported data from a phase III double-blind, placebo-controlled factorial study in which 1,940 patients with mild to severe hypertension were randomized to either monotherapy or co-administration of amlodipine 5-10 mg/day and olmesartan 10-20-40 mg/day for 8 weeks. Hypertension was defined as seated diastolic BP between 95 mm Hg and 120 mm Hg.

At admission, the average age of patients was 54 years, and their mean BP was 164/102 mm Hg; 13.5% had diabetes, and 34% were hypertensive treatment-naive, said Dr. Chrysant, who reported that he has received grant and research support from the study sponsor, Daiichi Sankyo Pharma Development.

After 8 weeks, all combinations of amlodipine and olmesartan resulted in significantly greater blood pressure reductions than either medication alone or placebo, said Dr. Chrysant, a cardiologist at the Oklahoma Cardiovascular and Hypertension Center, University of Oklahoma, Oklahoma City.

Amlodipine 10 mg/day plus olmesartan 40 mg/day produced the best results, reducing systolic BP an average of 30.1 mm Hg and diastolic BP an average of 19.0 mm Hg. In contrast, the average reductions were 19.7/12.7 mm Hg for amlodipine 10 mg alone and 4.8/3.1 mm Hg for placebo.

“Only the high-dose combination dropped the pressure below 140 over 90 [mm Hg],” Dr. Chrysant said at a press briefing.

Adverse events were comparable between groups, occurring in 511 of 970 (53%) combination therapy patients and in 91 of 162 placebo-treated patients (56%). There was one stroke in the olmesartan monotherapy group that was possibly drug related, he said.

Reports of headache, fatigue, and dizziness were highest in the placebo group. The highest incidence of edema (25%) was reported in the amlodipine monotherapy group. But adding on 40 mg of olmesartan halved this incidence rate, Dr. Chrysant said. He suggests this could be an added benefit of the combination regimen, because many hypertensive patients stop taking their medication because of swollen feet.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Combining the calcium channel blocker amlodipine with the angiotensin receptor blocker olmesartan provides greater reductions in blood pressure than does either agent used as monotherapy, Dr. Steven G. Chrysant said at the annual meeting of the American Society of Hypertension.

Daiichi Sankyo Inc. filed a new drug application in November 2006 for a fixed-dose combination of the two antihypertensives. Known as Azor, this investigational agent is under regulatory and trade name review in the United States.

Lead investigator Dr. Chrysant reported data from a phase III double-blind, placebo-controlled factorial study in which 1,940 patients with mild to severe hypertension were randomized to either monotherapy or co-administration of amlodipine 5-10 mg/day and olmesartan 10-20-40 mg/day for 8 weeks. Hypertension was defined as seated diastolic BP between 95 mm Hg and 120 mm Hg.

At admission, the average age of patients was 54 years, and their mean BP was 164/102 mm Hg; 13.5% had diabetes, and 34% were hypertensive treatment-naive, said Dr. Chrysant, who reported that he has received grant and research support from the study sponsor, Daiichi Sankyo Pharma Development.

After 8 weeks, all combinations of amlodipine and olmesartan resulted in significantly greater blood pressure reductions than either medication alone or placebo, said Dr. Chrysant, a cardiologist at the Oklahoma Cardiovascular and Hypertension Center, University of Oklahoma, Oklahoma City.

Amlodipine 10 mg/day plus olmesartan 40 mg/day produced the best results, reducing systolic BP an average of 30.1 mm Hg and diastolic BP an average of 19.0 mm Hg. In contrast, the average reductions were 19.7/12.7 mm Hg for amlodipine 10 mg alone and 4.8/3.1 mm Hg for placebo.

“Only the high-dose combination dropped the pressure below 140 over 90 [mm Hg],” Dr. Chrysant said at a press briefing.

Adverse events were comparable between groups, occurring in 511 of 970 (53%) combination therapy patients and in 91 of 162 placebo-treated patients (56%). There was one stroke in the olmesartan monotherapy group that was possibly drug related, he said.

Reports of headache, fatigue, and dizziness were highest in the placebo group. The highest incidence of edema (25%) was reported in the amlodipine monotherapy group. But adding on 40 mg of olmesartan halved this incidence rate, Dr. Chrysant said. He suggests this could be an added benefit of the combination regimen, because many hypertensive patients stop taking their medication because of swollen feet.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Combining the calcium channel blocker amlodipine with the angiotensin receptor blocker olmesartan provides greater reductions in blood pressure than does either agent used as monotherapy, Dr. Steven G. Chrysant said at the annual meeting of the American Society of Hypertension.

Daiichi Sankyo Inc. filed a new drug application in November 2006 for a fixed-dose combination of the two antihypertensives. Known as Azor, this investigational agent is under regulatory and trade name review in the United States.

Lead investigator Dr. Chrysant reported data from a phase III double-blind, placebo-controlled factorial study in which 1,940 patients with mild to severe hypertension were randomized to either monotherapy or co-administration of amlodipine 5-10 mg/day and olmesartan 10-20-40 mg/day for 8 weeks. Hypertension was defined as seated diastolic BP between 95 mm Hg and 120 mm Hg.

At admission, the average age of patients was 54 years, and their mean BP was 164/102 mm Hg; 13.5% had diabetes, and 34% were hypertensive treatment-naive, said Dr. Chrysant, who reported that he has received grant and research support from the study sponsor, Daiichi Sankyo Pharma Development.

After 8 weeks, all combinations of amlodipine and olmesartan resulted in significantly greater blood pressure reductions than either medication alone or placebo, said Dr. Chrysant, a cardiologist at the Oklahoma Cardiovascular and Hypertension Center, University of Oklahoma, Oklahoma City.

Amlodipine 10 mg/day plus olmesartan 40 mg/day produced the best results, reducing systolic BP an average of 30.1 mm Hg and diastolic BP an average of 19.0 mm Hg. In contrast, the average reductions were 19.7/12.7 mm Hg for amlodipine 10 mg alone and 4.8/3.1 mm Hg for placebo.

“Only the high-dose combination dropped the pressure below 140 over 90 [mm Hg],” Dr. Chrysant said at a press briefing.

Adverse events were comparable between groups, occurring in 511 of 970 (53%) combination therapy patients and in 91 of 162 placebo-treated patients (56%). There was one stroke in the olmesartan monotherapy group that was possibly drug related, he said.

Reports of headache, fatigue, and dizziness were highest in the placebo group. The highest incidence of edema (25%) was reported in the amlodipine monotherapy group. But adding on 40 mg of olmesartan halved this incidence rate, Dr. Chrysant said. He suggests this could be an added benefit of the combination regimen, because many hypertensive patients stop taking their medication because of swollen feet.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Few adults with known hypertension are following the DASH diet plan, even though some evidence suggests that it is roughly the equivalent of being on a single blood pressure medication.

Moreover, accordance with the Dietary Approaches to Stop Hypertension (DASH) plan has deteriorated since it was incorporated into in national guidelines, Dr. Philip Mellen said at the annual meeting of the American Society of Hypertension.

“We appear to be improving somewhat with respect to awareness of hypertension and treatment of hypertension,” he said during a press briefing. “But overall, dietary patterns appear to be doing worse over time.”

The landmark 1997 DASH trial showed that a diet rich in fruits, vegetables, grains, and low-fat diary products lowered blood pressure among patients with hypertension by an average of 11.4 mm Hg systolic and 5.5 mm Hg diastolic (N. Engl. J. Med. 1997;336:1117-24).

The dietary guidelines were incorporated into the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure reports in 1998 (JNC 6) and 2003 (JNC 7).

Dr. Mellen and his colleagues at Wake Forest University, Winston-Salem, N.C., used 1999-2004 data from the ongoing National Health and Nutrition Examination Survey (NHANES) IV to generate a DASH score for 4,386 adults with hypertension. Scores were based on self-reported 24-hour intake of nine target nutrients identified in the study (fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, potassium, and sodium). Individuals with a score of 4.5 or more were considered accordant with the DASH diet. (The data did not indicate whether any of the participants had been instructed to follow the DASH diet.) These results were compared with scores calculated for 4,556 adults with hypertension in the NHANES III 1988-1994 survey.

DASH accordance fell significantly from 29.3% in NHANES III to 21.7% in NHANES IV.

The decline was due largely to significantly fewer Americans in the recent survey reaching targets for total fat, fiber, and magnesium, Dr. Mellen said.

The percentage of patients achieving the DASH goal of reducing total fat intake to less than 27% of calories fell from 43% in NHANES III to 36% in NHANES IV.

Similarly, the percentage of participants on a 2,100-kcal diet eating the DASH recommended 31 grams of fiber daily decreased significantly (20% vs. 12%), as did the percentage ingesting the target 500 mg a day of magnesium (14% vs. 6%).

In a multivariate analysis that adjusted for caloric intake and poverty index ratio, participants were significantly more likely to be DASH-accordant if they were aged 40-59 years (odds ratio 2.75, versus those aged 20-39 years); were aged 60 years or older (OR 3.94, versus those aged 20-39 years); had more than a high school education (OR 1.80); or had diabetes (OR 1.53).

Blacks were significantly less likely than others to follow the DASH diet (OR 0.61), while there was a nonsignificant trend toward higher accordance among Mexican Americans compared with whites, Dr. Mellen said. Accordance did not differ between men and women.

Limited access to fresh fruits and vegetables in urban settings may contribute to poorer accordance among blacks and those with less education, he said in an interview.

Although treatment and awareness are improving, 'overall, dietary patterns appear to be doing worse over time.' DR. MELLEN

CHICAGO — Few adults with known hypertension are following the DASH diet plan, even though some evidence suggests that it is roughly the equivalent of being on a single blood pressure medication.

Moreover, accordance with the Dietary Approaches to Stop Hypertension (DASH) plan has deteriorated since it was incorporated into in national guidelines, Dr. Philip Mellen said at the annual meeting of the American Society of Hypertension.

“We appear to be improving somewhat with respect to awareness of hypertension and treatment of hypertension,” he said during a press briefing. “But overall, dietary patterns appear to be doing worse over time.”

The landmark 1997 DASH trial showed that a diet rich in fruits, vegetables, grains, and low-fat diary products lowered blood pressure among patients with hypertension by an average of 11.4 mm Hg systolic and 5.5 mm Hg diastolic (N. Engl. J. Med. 1997;336:1117-24).

The dietary guidelines were incorporated into the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure reports in 1998 (JNC 6) and 2003 (JNC 7).

Dr. Mellen and his colleagues at Wake Forest University, Winston-Salem, N.C., used 1999-2004 data from the ongoing National Health and Nutrition Examination Survey (NHANES) IV to generate a DASH score for 4,386 adults with hypertension. Scores were based on self-reported 24-hour intake of nine target nutrients identified in the study (fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, potassium, and sodium). Individuals with a score of 4.5 or more were considered accordant with the DASH diet. (The data did not indicate whether any of the participants had been instructed to follow the DASH diet.) These results were compared with scores calculated for 4,556 adults with hypertension in the NHANES III 1988-1994 survey.

DASH accordance fell significantly from 29.3% in NHANES III to 21.7% in NHANES IV.

The decline was due largely to significantly fewer Americans in the recent survey reaching targets for total fat, fiber, and magnesium, Dr. Mellen said.

The percentage of patients achieving the DASH goal of reducing total fat intake to less than 27% of calories fell from 43% in NHANES III to 36% in NHANES IV.

Similarly, the percentage of participants on a 2,100-kcal diet eating the DASH recommended 31 grams of fiber daily decreased significantly (20% vs. 12%), as did the percentage ingesting the target 500 mg a day of magnesium (14% vs. 6%).

In a multivariate analysis that adjusted for caloric intake and poverty index ratio, participants were significantly more likely to be DASH-accordant if they were aged 40-59 years (odds ratio 2.75, versus those aged 20-39 years); were aged 60 years or older (OR 3.94, versus those aged 20-39 years); had more than a high school education (OR 1.80); or had diabetes (OR 1.53).

Blacks were significantly less likely than others to follow the DASH diet (OR 0.61), while there was a nonsignificant trend toward higher accordance among Mexican Americans compared with whites, Dr. Mellen said. Accordance did not differ between men and women.

Limited access to fresh fruits and vegetables in urban settings may contribute to poorer accordance among blacks and those with less education, he said in an interview.

Although treatment and awareness are improving, 'overall, dietary patterns appear to be doing worse over time.' DR. MELLEN

CHICAGO — Few adults with known hypertension are following the DASH diet plan, even though some evidence suggests that it is roughly the equivalent of being on a single blood pressure medication.

Moreover, accordance with the Dietary Approaches to Stop Hypertension (DASH) plan has deteriorated since it was incorporated into in national guidelines, Dr. Philip Mellen said at the annual meeting of the American Society of Hypertension.

“We appear to be improving somewhat with respect to awareness of hypertension and treatment of hypertension,” he said during a press briefing. “But overall, dietary patterns appear to be doing worse over time.”

The landmark 1997 DASH trial showed that a diet rich in fruits, vegetables, grains, and low-fat diary products lowered blood pressure among patients with hypertension by an average of 11.4 mm Hg systolic and 5.5 mm Hg diastolic (N. Engl. J. Med. 1997;336:1117-24).

The dietary guidelines were incorporated into the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure reports in 1998 (JNC 6) and 2003 (JNC 7).

Dr. Mellen and his colleagues at Wake Forest University, Winston-Salem, N.C., used 1999-2004 data from the ongoing National Health and Nutrition Examination Survey (NHANES) IV to generate a DASH score for 4,386 adults with hypertension. Scores were based on self-reported 24-hour intake of nine target nutrients identified in the study (fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, potassium, and sodium). Individuals with a score of 4.5 or more were considered accordant with the DASH diet. (The data did not indicate whether any of the participants had been instructed to follow the DASH diet.) These results were compared with scores calculated for 4,556 adults with hypertension in the NHANES III 1988-1994 survey.

DASH accordance fell significantly from 29.3% in NHANES III to 21.7% in NHANES IV.

The decline was due largely to significantly fewer Americans in the recent survey reaching targets for total fat, fiber, and magnesium, Dr. Mellen said.

The percentage of patients achieving the DASH goal of reducing total fat intake to less than 27% of calories fell from 43% in NHANES III to 36% in NHANES IV.

Similarly, the percentage of participants on a 2,100-kcal diet eating the DASH recommended 31 grams of fiber daily decreased significantly (20% vs. 12%), as did the percentage ingesting the target 500 mg a day of magnesium (14% vs. 6%).

In a multivariate analysis that adjusted for caloric intake and poverty index ratio, participants were significantly more likely to be DASH-accordant if they were aged 40-59 years (odds ratio 2.75, versus those aged 20-39 years); were aged 60 years or older (OR 3.94, versus those aged 20-39 years); had more than a high school education (OR 1.80); or had diabetes (OR 1.53).

Blacks were significantly less likely than others to follow the DASH diet (OR 0.61), while there was a nonsignificant trend toward higher accordance among Mexican Americans compared with whites, Dr. Mellen said. Accordance did not differ between men and women.

Limited access to fresh fruits and vegetables in urban settings may contribute to poorer accordance among blacks and those with less education, he said in an interview.

Although treatment and awareness are improving, 'overall, dietary patterns appear to be doing worse over time.' DR. MELLEN

MILWAUKEE — Intensive behavioral therapy with laxatives is no better than conventional therapy in the treatment of childhood constipation, data from a randomized controlled trial show.

Little is known about the effectiveness of behavioral therapy in the treatment of constipation, although it is thought that learned behavior plays a role in the development of constipation, Dr. Marc Benninga reported at an international symposium sponsored by the International Foundation for Functional Gastrointestinal Disorders.

Children may consciously or unconsciously contract their pelvic and gluteal muscles when they feel the urge to defecate. Physiologically, the rectum becomes increasingly distended, which disrupts rectal compliance and the urge to defecate.

Behaviorally, the child experiences repeated difficulty with defecation and pain due to large or hard stools, reinforcing the stool-withholding behavior. The combination creates a vicious cycle of learned behavior that, in theory, could be unlearned through intensive behavioral therapy, Dr. Benninga explained.

Dr. Benninga and associates tested the theory in 129 youths aged 4–18 years who visited a gastrointestinal outpatient clinic for functional constipation. For the study, functional constipation was defined as the presence of at least two of the following criteria: defecation less than three times per week, fecal incontinence two or more times per week, and the presence of large amounts of stool or a palpable fecal mass.

Participants were randomized to 12 months of either conventional therapy—consisting of education, oral laxatives, toilet training, and dietary advice, or a five-element, age-based behavioral intervention program that was developed over a decade (Patient Educ. Couns. 2007 March 17 [Epub doi:10.1016/j.pec.2007.02.002]). Twelve sessions were held over the 12 months.

Children aged 4–8 received the following: education along with their parents that was designed to reinforce a nonaccusatory attitude regarding defecation; anxiety reduction through play therapy; laxatives and skill learning, including appropriate defecation straining; reinforcement using stickers; and establishment of a toileting routine.

The protocol for children older than 8 years did not include anxiety reduction, but instead focused on taking responsibility for their own bowel habits and keeping a bowel diary, said Dr. Benninga, of the department of pediatric gastroenterology and nutrition, Emma Children's Hospital/Academic Medical Center, University of Amsterdam.

Most participants were male, with an average age of 6.5 years in the conventional therapy (CT) group, compared with 7 years in the behavioral therapy (BT) group.

Data analysis was based on 58 patients in the BT group (9 treatment dropouts) and 56 in the CT group (2 treatment dropouts and 4 lost to follow-up).

Among the study's three primary outcomes, only defecation frequency per week showed a significant difference in favor of BT, but that difference was not sustained after 6 months of follow-up, said Dr. Benninga, who characterized the results as “not very convincing.”

Defecation frequency increased from 2.2/wk at baseline to 7.5/wk post treatment to 6.3/wk at follow-up in the BT group, compared with 2.2/wk, 5.5/wk, and 5.7/wk in the CT group, Dr. Benninga reported at the meeting, which was cosponsored by the University of Wisconsin.

Fecal incontinence frequency decreased significantly in both groups from 15 times per week to roughly 3 times per week at follow-up.

Treatment success was slightly higher at follow-up in the BT group (63%), compared with the CT group (54%), but again the difference was not significant. Success was defined as defecation frequency more than twice a week and fecal incontinence less than once every 2 weeks.

“The only striking finding of this study,” Dr. Benninga said, was that significantly fewer children treated by a psychologist had abnormal scores on the Child Behavior Checklist at follow-up, compared with those treated conventionally (38% vs. 82%).

Based on the findings of this investigation, Dr. Benninga recommended screening for behavioral problems in constipated children and referring those with problems to a pediatric psychologist or behavioral therapist.

MILWAUKEE — Intensive behavioral therapy with laxatives is no better than conventional therapy in the treatment of childhood constipation, data from a randomized controlled trial show.

Little is known about the effectiveness of behavioral therapy in the treatment of constipation, although it is thought that learned behavior plays a role in the development of constipation, Dr. Marc Benninga reported at an international symposium sponsored by the International Foundation for Functional Gastrointestinal Disorders.

Children may consciously or unconsciously contract their pelvic and gluteal muscles when they feel the urge to defecate. Physiologically, the rectum becomes increasingly distended, which disrupts rectal compliance and the urge to defecate.

Behaviorally, the child experiences repeated difficulty with defecation and pain due to large or hard stools, reinforcing the stool-withholding behavior. The combination creates a vicious cycle of learned behavior that, in theory, could be unlearned through intensive behavioral therapy, Dr. Benninga explained.

Dr. Benninga and associates tested the theory in 129 youths aged 4–18 years who visited a gastrointestinal outpatient clinic for functional constipation. For the study, functional constipation was defined as the presence of at least two of the following criteria: defecation less than three times per week, fecal incontinence two or more times per week, and the presence of large amounts of stool or a palpable fecal mass.

Participants were randomized to 12 months of either conventional therapy—consisting of education, oral laxatives, toilet training, and dietary advice, or a five-element, age-based behavioral intervention program that was developed over a decade (Patient Educ. Couns. 2007 March 17 [Epub doi:10.1016/j.pec.2007.02.002]). Twelve sessions were held over the 12 months.

Children aged 4–8 received the following: education along with their parents that was designed to reinforce a nonaccusatory attitude regarding defecation; anxiety reduction through play therapy; laxatives and skill learning, including appropriate defecation straining; reinforcement using stickers; and establishment of a toileting routine.

The protocol for children older than 8 years did not include anxiety reduction, but instead focused on taking responsibility for their own bowel habits and keeping a bowel diary, said Dr. Benninga, of the department of pediatric gastroenterology and nutrition, Emma Children's Hospital/Academic Medical Center, University of Amsterdam.

Most participants were male, with an average age of 6.5 years in the conventional therapy (CT) group, compared with 7 years in the behavioral therapy (BT) group.

Data analysis was based on 58 patients in the BT group (9 treatment dropouts) and 56 in the CT group (2 treatment dropouts and 4 lost to follow-up).

Among the study's three primary outcomes, only defecation frequency per week showed a significant difference in favor of BT, but that difference was not sustained after 6 months of follow-up, said Dr. Benninga, who characterized the results as “not very convincing.”

Defecation frequency increased from 2.2/wk at baseline to 7.5/wk post treatment to 6.3/wk at follow-up in the BT group, compared with 2.2/wk, 5.5/wk, and 5.7/wk in the CT group, Dr. Benninga reported at the meeting, which was cosponsored by the University of Wisconsin.

Fecal incontinence frequency decreased significantly in both groups from 15 times per week to roughly 3 times per week at follow-up.

Treatment success was slightly higher at follow-up in the BT group (63%), compared with the CT group (54%), but again the difference was not significant. Success was defined as defecation frequency more than twice a week and fecal incontinence less than once every 2 weeks.

“The only striking finding of this study,” Dr. Benninga said, was that significantly fewer children treated by a psychologist had abnormal scores on the Child Behavior Checklist at follow-up, compared with those treated conventionally (38% vs. 82%).

Based on the findings of this investigation, Dr. Benninga recommended screening for behavioral problems in constipated children and referring those with problems to a pediatric psychologist or behavioral therapist.

MILWAUKEE — Intensive behavioral therapy with laxatives is no better than conventional therapy in the treatment of childhood constipation, data from a randomized controlled trial show.

Little is known about the effectiveness of behavioral therapy in the treatment of constipation, although it is thought that learned behavior plays a role in the development of constipation, Dr. Marc Benninga reported at an international symposium sponsored by the International Foundation for Functional Gastrointestinal Disorders.

Children may consciously or unconsciously contract their pelvic and gluteal muscles when they feel the urge to defecate. Physiologically, the rectum becomes increasingly distended, which disrupts rectal compliance and the urge to defecate.

Behaviorally, the child experiences repeated difficulty with defecation and pain due to large or hard stools, reinforcing the stool-withholding behavior. The combination creates a vicious cycle of learned behavior that, in theory, could be unlearned through intensive behavioral therapy, Dr. Benninga explained.

Dr. Benninga and associates tested the theory in 129 youths aged 4–18 years who visited a gastrointestinal outpatient clinic for functional constipation. For the study, functional constipation was defined as the presence of at least two of the following criteria: defecation less than three times per week, fecal incontinence two or more times per week, and the presence of large amounts of stool or a palpable fecal mass.

Participants were randomized to 12 months of either conventional therapy—consisting of education, oral laxatives, toilet training, and dietary advice, or a five-element, age-based behavioral intervention program that was developed over a decade (Patient Educ. Couns. 2007 March 17 [Epub doi:10.1016/j.pec.2007.02.002]). Twelve sessions were held over the 12 months.

Children aged 4–8 received the following: education along with their parents that was designed to reinforce a nonaccusatory attitude regarding defecation; anxiety reduction through play therapy; laxatives and skill learning, including appropriate defecation straining; reinforcement using stickers; and establishment of a toileting routine.

The protocol for children older than 8 years did not include anxiety reduction, but instead focused on taking responsibility for their own bowel habits and keeping a bowel diary, said Dr. Benninga, of the department of pediatric gastroenterology and nutrition, Emma Children's Hospital/Academic Medical Center, University of Amsterdam.

Most participants were male, with an average age of 6.5 years in the conventional therapy (CT) group, compared with 7 years in the behavioral therapy (BT) group.

Data analysis was based on 58 patients in the BT group (9 treatment dropouts) and 56 in the CT group (2 treatment dropouts and 4 lost to follow-up).

Among the study's three primary outcomes, only defecation frequency per week showed a significant difference in favor of BT, but that difference was not sustained after 6 months of follow-up, said Dr. Benninga, who characterized the results as “not very convincing.”

Defecation frequency increased from 2.2/wk at baseline to 7.5/wk post treatment to 6.3/wk at follow-up in the BT group, compared with 2.2/wk, 5.5/wk, and 5.7/wk in the CT group, Dr. Benninga reported at the meeting, which was cosponsored by the University of Wisconsin.

Fecal incontinence frequency decreased significantly in both groups from 15 times per week to roughly 3 times per week at follow-up.

Treatment success was slightly higher at follow-up in the BT group (63%), compared with the CT group (54%), but again the difference was not significant. Success was defined as defecation frequency more than twice a week and fecal incontinence less than once every 2 weeks.

“The only striking finding of this study,” Dr. Benninga said, was that significantly fewer children treated by a psychologist had abnormal scores on the Child Behavior Checklist at follow-up, compared with those treated conventionally (38% vs. 82%).

Based on the findings of this investigation, Dr. Benninga recommended screening for behavioral problems in constipated children and referring those with problems to a pediatric psychologist or behavioral therapist.