Dan Hurley

New York — Hypertension treatment for African Americans should begin at a blood pressure of 135/85 mm Hg, rather than the previously recommended 140/90 mm, according to upcoming guidelines from the International Society on Hypertension in Blacks.

The guidelines now favor chlorthalidone as the preferred thiazide-like diuretic (not hydrochlorothiazide), with the initial dose at 25 mg per day, not 12 mg per day as previously recommended.

Perhaps most significantly, the guidelines call for the target BP levels to be seen by physicians as ceilings, not floors.

“We encourage you to drive the blood pressures significantly under the targets,” said Dr. John M. Flack, chairman of the working group that developed the ISHB consensus statement on the management of hypertension in African Americans at the meeting.

Current control rates of BP in African Americans remain poor, said Dr. Flack, professor of medicine and physiology and chairman of the department of internal medicine at Wayne State University, Detroit, as well as principal investigator of the university's Center for Urban and African American Health.

“We've had a slight improvement in control rates over the past decade, so we're trending in the right direction,” he said. But recent studies have found that only 29.9% of non-Hispanic black men have their hypertension properly controlled, and 36.0% of black women.

What's more, death rates from hypertension remain more than double that of whites, he noted, accounting for 30% of deaths in hypertensive African American men, and 20% of hypertensive African American women.

The new guidelines stratify risk into primary and secondary prevention. Primary prevention applies to patients with a BP of at least 135/85 mm Hg without target-organ damage, or cardiovascular disease —even if it is preclinical. Secondary prevention applies to those with BP of at least 130/80 and target-organ injury or any degree of cardiovascular disease.

By those risk stratums, the target BP level for primary prevention should be 135/85 mm Hg, or 130/80 mm Hg for secondary prevention.

Even if BP is at 115/75 mm Hg, comprehensive lifestyle modifications should be recommended: weight loss, dietary change, a limit on alcohol, regular physical activity, and stopping smoking.

The key therapeutic recommendations for primary prevention in patients with a BP less than 145/90 mm Hg are optional comprehensive lifestyle modifications for up to 3 months, and then antihypertensive drugs. Preferred agents are a thiazide diuretic or calcium channel blocker, with a RAS blocker as an alternative, and a beta-blocker as optional.

In primary prevention where the patient's blood pressure is greater than 15/10 above goal, two-drug therapy should be initiated, with the preferred combination being either a calcium channel blocker and RAS blocker or a thiazide and RAS blocker. The alternative would be a thiazide and beta-blocker or thiazide and calcium channel blocker. The optional combination would be a thiazide and aldosterone antagonist.

The key therapeutic recommendations for secondary prevention in which the patient's blood pressure is greater than 15/10 above goal would be combination therapy using drugs with compelling indications. If the patient's BP is less than 15/10 above goal, a single agent with a compelling indication would be used, with a diuretic or calcium channel blocker preferred; a RAS blocker as an alternative; and a beta-blocker as optional.

Dr. Flack has received grants and research support from Merck, Novartis, Pfizer, GlaxoSmithKline, Astra Merck, Astra Zeneca, Mannheim, Cardiodynamics, and Daiichi Sankyo. He has been a consultant to Merck, GlaxoSmith-Kline, Bristol Myers Squibb, Novartis, CVRx, and Myogen.

New York — Hypertension treatment for African Americans should begin at a blood pressure of 135/85 mm Hg, rather than the previously recommended 140/90 mm, according to upcoming guidelines from the International Society on Hypertension in Blacks.

The guidelines now favor chlorthalidone as the preferred thiazide-like diuretic (not hydrochlorothiazide), with the initial dose at 25 mg per day, not 12 mg per day as previously recommended.

Perhaps most significantly, the guidelines call for the target BP levels to be seen by physicians as ceilings, not floors.

“We encourage you to drive the blood pressures significantly under the targets,” said Dr. John M. Flack, chairman of the working group that developed the ISHB consensus statement on the management of hypertension in African Americans at the meeting.

Current control rates of BP in African Americans remain poor, said Dr. Flack, professor of medicine and physiology and chairman of the department of internal medicine at Wayne State University, Detroit, as well as principal investigator of the university's Center for Urban and African American Health.

“We've had a slight improvement in control rates over the past decade, so we're trending in the right direction,” he said. But recent studies have found that only 29.9% of non-Hispanic black men have their hypertension properly controlled, and 36.0% of black women.

What's more, death rates from hypertension remain more than double that of whites, he noted, accounting for 30% of deaths in hypertensive African American men, and 20% of hypertensive African American women.

The new guidelines stratify risk into primary and secondary prevention. Primary prevention applies to patients with a BP of at least 135/85 mm Hg without target-organ damage, or cardiovascular disease —even if it is preclinical. Secondary prevention applies to those with BP of at least 130/80 and target-organ injury or any degree of cardiovascular disease.

By those risk stratums, the target BP level for primary prevention should be 135/85 mm Hg, or 130/80 mm Hg for secondary prevention.

Even if BP is at 115/75 mm Hg, comprehensive lifestyle modifications should be recommended: weight loss, dietary change, a limit on alcohol, regular physical activity, and stopping smoking.

The key therapeutic recommendations for primary prevention in patients with a BP less than 145/90 mm Hg are optional comprehensive lifestyle modifications for up to 3 months, and then antihypertensive drugs. Preferred agents are a thiazide diuretic or calcium channel blocker, with a RAS blocker as an alternative, and a beta-blocker as optional.

In primary prevention where the patient's blood pressure is greater than 15/10 above goal, two-drug therapy should be initiated, with the preferred combination being either a calcium channel blocker and RAS blocker or a thiazide and RAS blocker. The alternative would be a thiazide and beta-blocker or thiazide and calcium channel blocker. The optional combination would be a thiazide and aldosterone antagonist.

The key therapeutic recommendations for secondary prevention in which the patient's blood pressure is greater than 15/10 above goal would be combination therapy using drugs with compelling indications. If the patient's BP is less than 15/10 above goal, a single agent with a compelling indication would be used, with a diuretic or calcium channel blocker preferred; a RAS blocker as an alternative; and a beta-blocker as optional.

Dr. Flack has received grants and research support from Merck, Novartis, Pfizer, GlaxoSmithKline, Astra Merck, Astra Zeneca, Mannheim, Cardiodynamics, and Daiichi Sankyo. He has been a consultant to Merck, GlaxoSmith-Kline, Bristol Myers Squibb, Novartis, CVRx, and Myogen.

New York — Hypertension treatment for African Americans should begin at a blood pressure of 135/85 mm Hg, rather than the previously recommended 140/90 mm, according to upcoming guidelines from the International Society on Hypertension in Blacks.

The guidelines now favor chlorthalidone as the preferred thiazide-like diuretic (not hydrochlorothiazide), with the initial dose at 25 mg per day, not 12 mg per day as previously recommended.

Perhaps most significantly, the guidelines call for the target BP levels to be seen by physicians as ceilings, not floors.

“We encourage you to drive the blood pressures significantly under the targets,” said Dr. John M. Flack, chairman of the working group that developed the ISHB consensus statement on the management of hypertension in African Americans at the meeting.

Current control rates of BP in African Americans remain poor, said Dr. Flack, professor of medicine and physiology and chairman of the department of internal medicine at Wayne State University, Detroit, as well as principal investigator of the university's Center for Urban and African American Health.

“We've had a slight improvement in control rates over the past decade, so we're trending in the right direction,” he said. But recent studies have found that only 29.9% of non-Hispanic black men have their hypertension properly controlled, and 36.0% of black women.

What's more, death rates from hypertension remain more than double that of whites, he noted, accounting for 30% of deaths in hypertensive African American men, and 20% of hypertensive African American women.

The new guidelines stratify risk into primary and secondary prevention. Primary prevention applies to patients with a BP of at least 135/85 mm Hg without target-organ damage, or cardiovascular disease —even if it is preclinical. Secondary prevention applies to those with BP of at least 130/80 and target-organ injury or any degree of cardiovascular disease.

By those risk stratums, the target BP level for primary prevention should be 135/85 mm Hg, or 130/80 mm Hg for secondary prevention.

Even if BP is at 115/75 mm Hg, comprehensive lifestyle modifications should be recommended: weight loss, dietary change, a limit on alcohol, regular physical activity, and stopping smoking.

The key therapeutic recommendations for primary prevention in patients with a BP less than 145/90 mm Hg are optional comprehensive lifestyle modifications for up to 3 months, and then antihypertensive drugs. Preferred agents are a thiazide diuretic or calcium channel blocker, with a RAS blocker as an alternative, and a beta-blocker as optional.

In primary prevention where the patient's blood pressure is greater than 15/10 above goal, two-drug therapy should be initiated, with the preferred combination being either a calcium channel blocker and RAS blocker or a thiazide and RAS blocker. The alternative would be a thiazide and beta-blocker or thiazide and calcium channel blocker. The optional combination would be a thiazide and aldosterone antagonist.

The key therapeutic recommendations for secondary prevention in which the patient's blood pressure is greater than 15/10 above goal would be combination therapy using drugs with compelling indications. If the patient's BP is less than 15/10 above goal, a single agent with a compelling indication would be used, with a diuretic or calcium channel blocker preferred; a RAS blocker as an alternative; and a beta-blocker as optional.

Dr. Flack has received grants and research support from Merck, Novartis, Pfizer, GlaxoSmithKline, Astra Merck, Astra Zeneca, Mannheim, Cardiodynamics, and Daiichi Sankyo. He has been a consultant to Merck, GlaxoSmith-Kline, Bristol Myers Squibb, Novartis, CVRx, and Myogen.

NEW YORK — Guidelines for detecting masked hypertension in adults should by changed to take into account pre-existing conditions such as diabetes and kidney disease, Dr. Robert A. Phillips said at the meeting.

“In my opinion, masked hypertension isn't adequately addressed by current guidelines,” said Dr. Phillips, director of the Heart and Vascular Center of Excellence and professor of medicine at the University of Massachusetts, Worcester. “We're only beginning to understand how prevalent it is, and how dangerous.”

He reviewed a host of studies indicating that recent recommendations for when to use home and ambulatory blood pressure monitoring (ABPM) would miss the majority of those affected (J. Am. Soc. Hypertens. 2008;2:119-24). Rather than selecting those with borderline hypertension for ambulatory monitoring, he urged hypertension specialists to focus on other risk factors supported by a growing body of evidence: smoking, diabetes, chronic kidney disease, left ventricular hypertrophy, microalbuminuria, and obstructive sleep apnea.

Support for the view that borderline blood pressure is a red herring—not a red flag—when it comes to masked hypertension was found in a study presented at ASH. Fourteen percent of children aged 5-15 whose blood pressure readings were normal when measured at a hypertension referral clinic nevertheless met diagnostic criteria for masked hypertension when assessed by ABPM, a Brazilian researcher reported.

The study involved 99 children who had been referred to have their BP evaluated at a pediatric hypertension clinic at the Federal University of Goiás in Brazil. Of these, 17 were diagnosed in the clinic as having an office BP higher than the 95th percentile. The remaining 82 subjects were all assessed by ABPM.

None of the 12 children who had previously been found to have borderline high BP in the office (greater than 90th but less than 95th percentile) showed evidence of masked hypertension according to the ABPM. But 10 of the 70 children who had normal BP during the office visit had masked hypertension.

Surprisingly, the critical factors found to be associated with increased risk of masked hypertension were in the children's parents—not in the children themselves. Children of hypertensive parents had a 4.3-fold increased risk of masked hypertension compared with children whose parents had normal BP. Children whose parents had a waist-to-hip ratio of at least 0.9 had a ninefold increased risk of masked hypertension, compared with children whose parents did not have abdominal obesity.

“When children are referred to you for possible hypertension, and their parents have these characteristics, you should consider assessing them for masked hypertension,” said the lead author of the study, Dr. Claudia Maria Salgado of Federal University of Goiás's department of pediatrics and hypertension league.

The 2008 recommendations suggest the use of self-measurement home BP or ABPM when patients' office BP is greater than 125/75 but less than 135/85 mm Hg. But Dr. Phillips said that following those recommendations will fail to identify many of the patients at risk for the condition. For instance, he cited a paper showing that patients with type 2 diabetes who have normal BP during office visits are 1.6 times more likely to have masked hypertension than are patients without diabetes (Arch. Intern. Med. 2007;167:2139-42).

He proposed new guidelines: Patients with one of the risk factors for masked hypertension, as indicated by pre-existing conditions, should be advised to conduct self-measurements of BP at home. Based on self-monitoring, those with BP of at least 135/85 mm Hg should have their drug treatment intensified; those with a BP of less than 125/75 mm Hg should be considered normal; while those between those two poles should be assessed by ABPM. In those diagnosed as having masked hypertension, Dr. Phillips urged physicians to treat them by lowering nocturnal BP.

NEW YORK — Guidelines for detecting masked hypertension in adults should by changed to take into account pre-existing conditions such as diabetes and kidney disease, Dr. Robert A. Phillips said at the meeting.

“In my opinion, masked hypertension isn't adequately addressed by current guidelines,” said Dr. Phillips, director of the Heart and Vascular Center of Excellence and professor of medicine at the University of Massachusetts, Worcester. “We're only beginning to understand how prevalent it is, and how dangerous.”

He reviewed a host of studies indicating that recent recommendations for when to use home and ambulatory blood pressure monitoring (ABPM) would miss the majority of those affected (J. Am. Soc. Hypertens. 2008;2:119-24). Rather than selecting those with borderline hypertension for ambulatory monitoring, he urged hypertension specialists to focus on other risk factors supported by a growing body of evidence: smoking, diabetes, chronic kidney disease, left ventricular hypertrophy, microalbuminuria, and obstructive sleep apnea.

Support for the view that borderline blood pressure is a red herring—not a red flag—when it comes to masked hypertension was found in a study presented at ASH. Fourteen percent of children aged 5-15 whose blood pressure readings were normal when measured at a hypertension referral clinic nevertheless met diagnostic criteria for masked hypertension when assessed by ABPM, a Brazilian researcher reported.

The study involved 99 children who had been referred to have their BP evaluated at a pediatric hypertension clinic at the Federal University of Goiás in Brazil. Of these, 17 were diagnosed in the clinic as having an office BP higher than the 95th percentile. The remaining 82 subjects were all assessed by ABPM.

None of the 12 children who had previously been found to have borderline high BP in the office (greater than 90th but less than 95th percentile) showed evidence of masked hypertension according to the ABPM. But 10 of the 70 children who had normal BP during the office visit had masked hypertension.

Surprisingly, the critical factors found to be associated with increased risk of masked hypertension were in the children's parents—not in the children themselves. Children of hypertensive parents had a 4.3-fold increased risk of masked hypertension compared with children whose parents had normal BP. Children whose parents had a waist-to-hip ratio of at least 0.9 had a ninefold increased risk of masked hypertension, compared with children whose parents did not have abdominal obesity.

“When children are referred to you for possible hypertension, and their parents have these characteristics, you should consider assessing them for masked hypertension,” said the lead author of the study, Dr. Claudia Maria Salgado of Federal University of Goiás's department of pediatrics and hypertension league.

The 2008 recommendations suggest the use of self-measurement home BP or ABPM when patients' office BP is greater than 125/75 but less than 135/85 mm Hg. But Dr. Phillips said that following those recommendations will fail to identify many of the patients at risk for the condition. For instance, he cited a paper showing that patients with type 2 diabetes who have normal BP during office visits are 1.6 times more likely to have masked hypertension than are patients without diabetes (Arch. Intern. Med. 2007;167:2139-42).

He proposed new guidelines: Patients with one of the risk factors for masked hypertension, as indicated by pre-existing conditions, should be advised to conduct self-measurements of BP at home. Based on self-monitoring, those with BP of at least 135/85 mm Hg should have their drug treatment intensified; those with a BP of less than 125/75 mm Hg should be considered normal; while those between those two poles should be assessed by ABPM. In those diagnosed as having masked hypertension, Dr. Phillips urged physicians to treat them by lowering nocturnal BP.

NEW YORK — Guidelines for detecting masked hypertension in adults should by changed to take into account pre-existing conditions such as diabetes and kidney disease, Dr. Robert A. Phillips said at the meeting.

“In my opinion, masked hypertension isn't adequately addressed by current guidelines,” said Dr. Phillips, director of the Heart and Vascular Center of Excellence and professor of medicine at the University of Massachusetts, Worcester. “We're only beginning to understand how prevalent it is, and how dangerous.”

He reviewed a host of studies indicating that recent recommendations for when to use home and ambulatory blood pressure monitoring (ABPM) would miss the majority of those affected (J. Am. Soc. Hypertens. 2008;2:119-24). Rather than selecting those with borderline hypertension for ambulatory monitoring, he urged hypertension specialists to focus on other risk factors supported by a growing body of evidence: smoking, diabetes, chronic kidney disease, left ventricular hypertrophy, microalbuminuria, and obstructive sleep apnea.

Support for the view that borderline blood pressure is a red herring—not a red flag—when it comes to masked hypertension was found in a study presented at ASH. Fourteen percent of children aged 5-15 whose blood pressure readings were normal when measured at a hypertension referral clinic nevertheless met diagnostic criteria for masked hypertension when assessed by ABPM, a Brazilian researcher reported.

The study involved 99 children who had been referred to have their BP evaluated at a pediatric hypertension clinic at the Federal University of Goiás in Brazil. Of these, 17 were diagnosed in the clinic as having an office BP higher than the 95th percentile. The remaining 82 subjects were all assessed by ABPM.

None of the 12 children who had previously been found to have borderline high BP in the office (greater than 90th but less than 95th percentile) showed evidence of masked hypertension according to the ABPM. But 10 of the 70 children who had normal BP during the office visit had masked hypertension.

Surprisingly, the critical factors found to be associated with increased risk of masked hypertension were in the children's parents—not in the children themselves. Children of hypertensive parents had a 4.3-fold increased risk of masked hypertension compared with children whose parents had normal BP. Children whose parents had a waist-to-hip ratio of at least 0.9 had a ninefold increased risk of masked hypertension, compared with children whose parents did not have abdominal obesity.

“When children are referred to you for possible hypertension, and their parents have these characteristics, you should consider assessing them for masked hypertension,” said the lead author of the study, Dr. Claudia Maria Salgado of Federal University of Goiás's department of pediatrics and hypertension league.

The 2008 recommendations suggest the use of self-measurement home BP or ABPM when patients' office BP is greater than 125/75 but less than 135/85 mm Hg. But Dr. Phillips said that following those recommendations will fail to identify many of the patients at risk for the condition. For instance, he cited a paper showing that patients with type 2 diabetes who have normal BP during office visits are 1.6 times more likely to have masked hypertension than are patients without diabetes (Arch. Intern. Med. 2007;167:2139-42).

He proposed new guidelines: Patients with one of the risk factors for masked hypertension, as indicated by pre-existing conditions, should be advised to conduct self-measurements of BP at home. Based on self-monitoring, those with BP of at least 135/85 mm Hg should have their drug treatment intensified; those with a BP of less than 125/75 mm Hg should be considered normal; while those between those two poles should be assessed by ABPM. In those diagnosed as having masked hypertension, Dr. Phillips urged physicians to treat them by lowering nocturnal BP.

NEW YORK — Getting fewer than 7.5 hours of sleep significantly raised the risk of clinically overt stroke in hypertensive patients with a history of silent cerebral infarct, according to multicenter study.

The study, designed to settle some of the controversy regarding the relation between sleep duration and stroke, found a modest but nonsignificant increasein risk in those without evidence of silent cerebral infarct (SCI).

By contrast, after 5 years of follow-up, those who slept less than 7.5 hours per night and had SCI had about a 1-in-4 risk of stroke, compared with a 1-in-10 risk in those who slept longer than 7.5 hours. After adjustment for age, sex, body mass index, smoking, diabetes, and other risk factors, the researchers found that the hazard ratio for stroke in patients who slept less than 7.5 hours per night and had a prior SCI was 2.52.

Dr. Kazuo Eguchi, professor of cardiovascular medicine at Jichi Medical University in Tochigi, Japan, and colleagues performed ambulatory BP monitoring in 1,268 hypertensives with a mean age of 70.4 and followed them for an average of 50 months. Brain MRI performed in 932 of these patients showed that 517 had prior SCI and 415 did not. A multivariate Cox analysis showed that, among all these patients, those who slept at least 7.5 hours per night had a significant, 20% reduced risk of stroke events, Dr. Eguchi said at the meeting.

Disclosures: Dr. Eguchi reported having no relevant financial conflicts.

NEW YORK — Getting fewer than 7.5 hours of sleep significantly raised the risk of clinically overt stroke in hypertensive patients with a history of silent cerebral infarct, according to multicenter study.

The study, designed to settle some of the controversy regarding the relation between sleep duration and stroke, found a modest but nonsignificant increasein risk in those without evidence of silent cerebral infarct (SCI).

By contrast, after 5 years of follow-up, those who slept less than 7.5 hours per night and had SCI had about a 1-in-4 risk of stroke, compared with a 1-in-10 risk in those who slept longer than 7.5 hours. After adjustment for age, sex, body mass index, smoking, diabetes, and other risk factors, the researchers found that the hazard ratio for stroke in patients who slept less than 7.5 hours per night and had a prior SCI was 2.52.

Dr. Kazuo Eguchi, professor of cardiovascular medicine at Jichi Medical University in Tochigi, Japan, and colleagues performed ambulatory BP monitoring in 1,268 hypertensives with a mean age of 70.4 and followed them for an average of 50 months. Brain MRI performed in 932 of these patients showed that 517 had prior SCI and 415 did not. A multivariate Cox analysis showed that, among all these patients, those who slept at least 7.5 hours per night had a significant, 20% reduced risk of stroke events, Dr. Eguchi said at the meeting.

Disclosures: Dr. Eguchi reported having no relevant financial conflicts.

NEW YORK — Getting fewer than 7.5 hours of sleep significantly raised the risk of clinically overt stroke in hypertensive patients with a history of silent cerebral infarct, according to multicenter study.

The study, designed to settle some of the controversy regarding the relation between sleep duration and stroke, found a modest but nonsignificant increasein risk in those without evidence of silent cerebral infarct (SCI).

By contrast, after 5 years of follow-up, those who slept less than 7.5 hours per night and had SCI had about a 1-in-4 risk of stroke, compared with a 1-in-10 risk in those who slept longer than 7.5 hours. After adjustment for age, sex, body mass index, smoking, diabetes, and other risk factors, the researchers found that the hazard ratio for stroke in patients who slept less than 7.5 hours per night and had a prior SCI was 2.52.

Dr. Kazuo Eguchi, professor of cardiovascular medicine at Jichi Medical University in Tochigi, Japan, and colleagues performed ambulatory BP monitoring in 1,268 hypertensives with a mean age of 70.4 and followed them for an average of 50 months. Brain MRI performed in 932 of these patients showed that 517 had prior SCI and 415 did not. A multivariate Cox analysis showed that, among all these patients, those who slept at least 7.5 hours per night had a significant, 20% reduced risk of stroke events, Dr. Eguchi said at the meeting.

Disclosures: Dr. Eguchi reported having no relevant financial conflicts.

Major Finding: In patients on the highest dose of phentermine plus controlled-release topiramate, systolic BP reductions were significantly lower than with placebo: 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER.

Data Source: Pooled analysis of data on 3,985 patients in three clinical trials.

Disclosures: Dr. Oparil disclosed relationships with Vivus and numerous other pharmaceutical companies.

NEW YORK — An investigational weight-loss agent that combines two drugs slightly reduced blood pressure in an analysis of three large placebo-controlled clinical trials in a total of 3,985 patients.

The once-daily drug combines a low dose of the generic stimulant phentermine with a low-dose, controlled-release version of the antiepileptic topiramate. The two drugs have been shown previously to cause weight loss by different mechanisms, Dr. Suzanne Oparil said at the meeting.

Higher doses of phentermine are occasionally associated with increased BP, but the combined product appeared to produce enough weight loss—more than 10% of body weight after 56 weeks in two of the studies—to result in modestly lower BP, reported Dr. Oparil, professor of medicine, physiology, and biophysics and director of the vascular biology and hypertension program at the University of Alabama at Birmingham.

“We need a well-tolerated, safe, and effective weight-loss treatment,” said Dr. Oparil, who conducted the analysis as a consultant to Vivus, which is developing the combined agent under the brand name Qnexa.

But some physicians at the ASH meeting said they were not entirely convinced of the agent's safety. At the highest dose, a heart rate increase of about 1.5 beats per minute was observed.

The 56-week EQUIP trial enrolled 1,267 obese adults and compared the high-dose combination (phentermine 15 mg and topiramate 92 mg) and a low-dose combination (phentermine 3.75 mg and topiramate 23 mg) with placebo. The 28-week EQUATE trial enrolled 756 obese adults and compared the high-dose formulation and a mid-dose formulation (phentermine 7.5 mg and topiramate 46 mg) with placebo and with the respective single agents. The 56-week CONQUER trial enrolled 2,487 overweight and obese adults with two or more weight-related comorbidities and compared the high- and mid-dose combinations with placebo. Of the 4,510 patients who were initially enrolled in the three trials, 3,985 completed the studies.

In Dr. Oparil's pooled analysis of the three trials, the mean weight loss at week 28 was 1.9% of total body weight for the 1,579 patients on placebo, 5.1% for the 234 patients on the lowest dose of the drug, 8.0% for the 591 patients on the middle dose, and 9.9% for the 1,581 patients on the highest dose. All three active-treatment groups had significantly more weight loss than did the placebo group.

In the two trials that went to 56 weeks, CONQUER and EQUIP, weight loss reached 10.4% of body weight with the highest dose, significantly higher than the 1.5% with placebo.

The reductions in systolic BP in patients on the high-dose combination, compared with placebo, were 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER; all three reductions were significant. Significant reductions in systolic BP also were seen with some of the lower doses of the combined product. For diastolic BP, only two of the higher-dose groups had significantly greater reductions than that seen with placebo.

Major Finding: In patients on the highest dose of phentermine plus controlled-release topiramate, systolic BP reductions were significantly lower than with placebo: 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER.

Data Source: Pooled analysis of data on 3,985 patients in three clinical trials.

Disclosures: Dr. Oparil disclosed relationships with Vivus and numerous other pharmaceutical companies.

NEW YORK — An investigational weight-loss agent that combines two drugs slightly reduced blood pressure in an analysis of three large placebo-controlled clinical trials in a total of 3,985 patients.

The once-daily drug combines a low dose of the generic stimulant phentermine with a low-dose, controlled-release version of the antiepileptic topiramate. The two drugs have been shown previously to cause weight loss by different mechanisms, Dr. Suzanne Oparil said at the meeting.

Higher doses of phentermine are occasionally associated with increased BP, but the combined product appeared to produce enough weight loss—more than 10% of body weight after 56 weeks in two of the studies—to result in modestly lower BP, reported Dr. Oparil, professor of medicine, physiology, and biophysics and director of the vascular biology and hypertension program at the University of Alabama at Birmingham.

“We need a well-tolerated, safe, and effective weight-loss treatment,” said Dr. Oparil, who conducted the analysis as a consultant to Vivus, which is developing the combined agent under the brand name Qnexa.

But some physicians at the ASH meeting said they were not entirely convinced of the agent's safety. At the highest dose, a heart rate increase of about 1.5 beats per minute was observed.

The 56-week EQUIP trial enrolled 1,267 obese adults and compared the high-dose combination (phentermine 15 mg and topiramate 92 mg) and a low-dose combination (phentermine 3.75 mg and topiramate 23 mg) with placebo. The 28-week EQUATE trial enrolled 756 obese adults and compared the high-dose formulation and a mid-dose formulation (phentermine 7.5 mg and topiramate 46 mg) with placebo and with the respective single agents. The 56-week CONQUER trial enrolled 2,487 overweight and obese adults with two or more weight-related comorbidities and compared the high- and mid-dose combinations with placebo. Of the 4,510 patients who were initially enrolled in the three trials, 3,985 completed the studies.

In Dr. Oparil's pooled analysis of the three trials, the mean weight loss at week 28 was 1.9% of total body weight for the 1,579 patients on placebo, 5.1% for the 234 patients on the lowest dose of the drug, 8.0% for the 591 patients on the middle dose, and 9.9% for the 1,581 patients on the highest dose. All three active-treatment groups had significantly more weight loss than did the placebo group.

In the two trials that went to 56 weeks, CONQUER and EQUIP, weight loss reached 10.4% of body weight with the highest dose, significantly higher than the 1.5% with placebo.

The reductions in systolic BP in patients on the high-dose combination, compared with placebo, were 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER; all three reductions were significant. Significant reductions in systolic BP also were seen with some of the lower doses of the combined product. For diastolic BP, only two of the higher-dose groups had significantly greater reductions than that seen with placebo.

Major Finding: In patients on the highest dose of phentermine plus controlled-release topiramate, systolic BP reductions were significantly lower than with placebo: 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER.

Data Source: Pooled analysis of data on 3,985 patients in three clinical trials.

Disclosures: Dr. Oparil disclosed relationships with Vivus and numerous other pharmaceutical companies.

NEW YORK — An investigational weight-loss agent that combines two drugs slightly reduced blood pressure in an analysis of three large placebo-controlled clinical trials in a total of 3,985 patients.

The once-daily drug combines a low dose of the generic stimulant phentermine with a low-dose, controlled-release version of the antiepileptic topiramate. The two drugs have been shown previously to cause weight loss by different mechanisms, Dr. Suzanne Oparil said at the meeting.

Higher doses of phentermine are occasionally associated with increased BP, but the combined product appeared to produce enough weight loss—more than 10% of body weight after 56 weeks in two of the studies—to result in modestly lower BP, reported Dr. Oparil, professor of medicine, physiology, and biophysics and director of the vascular biology and hypertension program at the University of Alabama at Birmingham.

“We need a well-tolerated, safe, and effective weight-loss treatment,” said Dr. Oparil, who conducted the analysis as a consultant to Vivus, which is developing the combined agent under the brand name Qnexa.

But some physicians at the ASH meeting said they were not entirely convinced of the agent's safety. At the highest dose, a heart rate increase of about 1.5 beats per minute was observed.

The 56-week EQUIP trial enrolled 1,267 obese adults and compared the high-dose combination (phentermine 15 mg and topiramate 92 mg) and a low-dose combination (phentermine 3.75 mg and topiramate 23 mg) with placebo. The 28-week EQUATE trial enrolled 756 obese adults and compared the high-dose formulation and a mid-dose formulation (phentermine 7.5 mg and topiramate 46 mg) with placebo and with the respective single agents. The 56-week CONQUER trial enrolled 2,487 overweight and obese adults with two or more weight-related comorbidities and compared the high- and mid-dose combinations with placebo. Of the 4,510 patients who were initially enrolled in the three trials, 3,985 completed the studies.

In Dr. Oparil's pooled analysis of the three trials, the mean weight loss at week 28 was 1.9% of total body weight for the 1,579 patients on placebo, 5.1% for the 234 patients on the lowest dose of the drug, 8.0% for the 591 patients on the middle dose, and 9.9% for the 1,581 patients on the highest dose. All three active-treatment groups had significantly more weight loss than did the placebo group.

In the two trials that went to 56 weeks, CONQUER and EQUIP, weight loss reached 10.4% of body weight with the highest dose, significantly higher than the 1.5% with placebo.

The reductions in systolic BP in patients on the high-dose combination, compared with placebo, were 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER; all three reductions were significant. Significant reductions in systolic BP also were seen with some of the lower doses of the combined product. For diastolic BP, only two of the higher-dose groups had significantly greater reductions than that seen with placebo.

NEW YORK — Is that 3-year-old child with a limp and a low-grade fever just another case of transient synovitis, or is it a much more serious but far rarer case of septic arthritis?

With published decision rules in conflict on how to distinguish one from the other, physicians need to apply clinical judgment appropriate to their available resources, Dr. Martin G. Hellman said at the meeting sponsored by the American College of Emergency Physicians.

“Even a very experienced clinician is not going to see many cases of septic arthritis on a routine or even a nonroutine basis,” said Dr. Hellman, clinical assistant professor of pediatrics at the University of Pittsburgh.

Findings from a study of children presenting to Children's Hospital Boston, between 1979 and 1996, identified four clinical predictors that, taken together, could reliably differentiate between septic arthritis and transient synovitis: history of fever, non-weight-bearing status, erythrocyte sedimentation rate (ESR) of at least 40 mm/hr, and serum white blood cell (WBC) count of more than 12,000 cells/mm

But researchers at St. Louis Children's Hospital asserted that a better set of variables would be to check for a history of fever, a serum total WBC count of greater than 12,000 cells/mm

A prospective study from Children's Hospital of Philadelphia described 53 children for whom the suspicion of septic arthritis was so strong that they had undergone hip taps. The researchers concluded that a C-reactive protein (CRP) level greater than 2 mg/dL was a strong risk factor for septic arthritis. Fever above 38.5° C was the most influential risk factor; no patients with transient synovitis had a fever above that temperature (J. Bone Joint Surg. Am. 2006;88:1251–7). “However, temperature less than 38.5° C had a false negative more than 50% of the time. And 12% of the septic arthritis cases had zero or one of the factors. That's a little scary,” he said.

Dr. Hellman proposed the following plan for evaluation and consultation of hip pain.

“Begin with a careful physical exam,” Dr. Hellman said. “Don't forget the possibility of abdominal problems.”

For an afebrile child who looks well aside from limited range of motion in the hip and refusal to bear weight, he recommended that physicians take plain x-rays of the pelvis and frog lateral. The physician could choose to stop testing at that point, or could consider obtaining lab tests for CRP, ESR, and WBC. Assuming all tests come up negative, parents should still be given strict instructions to return for immediate evaluation if symptoms worsen.

On the other hand, with a febrile child who does not look well, lab tests would be strongly advised.

NEW YORK — Is that 3-year-old child with a limp and a low-grade fever just another case of transient synovitis, or is it a much more serious but far rarer case of septic arthritis?

With published decision rules in conflict on how to distinguish one from the other, physicians need to apply clinical judgment appropriate to their available resources, Dr. Martin G. Hellman said at the meeting sponsored by the American College of Emergency Physicians.

“Even a very experienced clinician is not going to see many cases of septic arthritis on a routine or even a nonroutine basis,” said Dr. Hellman, clinical assistant professor of pediatrics at the University of Pittsburgh.

Findings from a study of children presenting to Children's Hospital Boston, between 1979 and 1996, identified four clinical predictors that, taken together, could reliably differentiate between septic arthritis and transient synovitis: history of fever, non-weight-bearing status, erythrocyte sedimentation rate (ESR) of at least 40 mm/hr, and serum white blood cell (WBC) count of more than 12,000 cells/mm

But researchers at St. Louis Children's Hospital asserted that a better set of variables would be to check for a history of fever, a serum total WBC count of greater than 12,000 cells/mm

A prospective study from Children's Hospital of Philadelphia described 53 children for whom the suspicion of septic arthritis was so strong that they had undergone hip taps. The researchers concluded that a C-reactive protein (CRP) level greater than 2 mg/dL was a strong risk factor for septic arthritis. Fever above 38.5° C was the most influential risk factor; no patients with transient synovitis had a fever above that temperature (J. Bone Joint Surg. Am. 2006;88:1251–7). “However, temperature less than 38.5° C had a false negative more than 50% of the time. And 12% of the septic arthritis cases had zero or one of the factors. That's a little scary,” he said.

Dr. Hellman proposed the following plan for evaluation and consultation of hip pain.

“Begin with a careful physical exam,” Dr. Hellman said. “Don't forget the possibility of abdominal problems.”

For an afebrile child who looks well aside from limited range of motion in the hip and refusal to bear weight, he recommended that physicians take plain x-rays of the pelvis and frog lateral. The physician could choose to stop testing at that point, or could consider obtaining lab tests for CRP, ESR, and WBC. Assuming all tests come up negative, parents should still be given strict instructions to return for immediate evaluation if symptoms worsen.

On the other hand, with a febrile child who does not look well, lab tests would be strongly advised.

NEW YORK — Is that 3-year-old child with a limp and a low-grade fever just another case of transient synovitis, or is it a much more serious but far rarer case of septic arthritis?

With published decision rules in conflict on how to distinguish one from the other, physicians need to apply clinical judgment appropriate to their available resources, Dr. Martin G. Hellman said at the meeting sponsored by the American College of Emergency Physicians.

“Even a very experienced clinician is not going to see many cases of septic arthritis on a routine or even a nonroutine basis,” said Dr. Hellman, clinical assistant professor of pediatrics at the University of Pittsburgh.

Findings from a study of children presenting to Children's Hospital Boston, between 1979 and 1996, identified four clinical predictors that, taken together, could reliably differentiate between septic arthritis and transient synovitis: history of fever, non-weight-bearing status, erythrocyte sedimentation rate (ESR) of at least 40 mm/hr, and serum white blood cell (WBC) count of more than 12,000 cells/mm

But researchers at St. Louis Children's Hospital asserted that a better set of variables would be to check for a history of fever, a serum total WBC count of greater than 12,000 cells/mm

A prospective study from Children's Hospital of Philadelphia described 53 children for whom the suspicion of septic arthritis was so strong that they had undergone hip taps. The researchers concluded that a C-reactive protein (CRP) level greater than 2 mg/dL was a strong risk factor for septic arthritis. Fever above 38.5° C was the most influential risk factor; no patients with transient synovitis had a fever above that temperature (J. Bone Joint Surg. Am. 2006;88:1251–7). “However, temperature less than 38.5° C had a false negative more than 50% of the time. And 12% of the septic arthritis cases had zero or one of the factors. That's a little scary,” he said.

Dr. Hellman proposed the following plan for evaluation and consultation of hip pain.

“Begin with a careful physical exam,” Dr. Hellman said. “Don't forget the possibility of abdominal problems.”

For an afebrile child who looks well aside from limited range of motion in the hip and refusal to bear weight, he recommended that physicians take plain x-rays of the pelvis and frog lateral. The physician could choose to stop testing at that point, or could consider obtaining lab tests for CRP, ESR, and WBC. Assuming all tests come up negative, parents should still be given strict instructions to return for immediate evaluation if symptoms worsen.

On the other hand, with a febrile child who does not look well, lab tests would be strongly advised.

NEW YORK — Guidelines for detecting masked hypertension in adults should by changed to account for pre-existing conditions such as diabetes and kidney disease, Dr. Robert A. Phillips said at the meeting.

“Masked hypertension isn't adequately addressed by current guidelines,” said Dr. Phillips, director of the Heart and Vascular Center of Excellence and professor of medicine at the University of Massachusetts, Worcester. “We're only beginning to understand how prevalent it is, and how dangerous.”

He reviewed a host of studies indicating that recent recommendations for when to use home and ambulatory blood pressure monitoring (ABPM) would miss the majority of those affected (J. Am. Soc. Hypertens. 2008;2:119–24). Rather than selecting those with borderline hypertension for ambulatory monitoring, he urged hypertension specialists to focus on other risk factors supported by a growing body of evidence: smoking, diabetes, chronic kidney disease, left ventricular hypertrophy, microalbuminuria, and obstructive sleep apnea.

Support for the view that borderline blood pressure is a red herring—not a red flag—in the case of masked hypertension was found in a study presented at ASH. Fourteen percent of children aged 5–15 whose BP readings were normal when measured at a hypertension referral clinic nevertheless met diagnostic criteria for masked hypertension when assessed by ABPM, a Brazilian researcher reported.

The study involved 99 children who had been referred to have their BP evaluated at a pediatric hypertension clinic at the Federal University of Goi´s in Brazil. Of these, 17 were diagnosed in the clinic as having an office BP higher than the 95th percentile. The remaining 82 subjects were all assessed by ABPM.

None of the 12 children who had previously been found to have borderline high BP in the office (greater than 90th but less than 95th percentile) showed evidence of masked hypertension according to the ABPM. But 10 of the 70 children who had normal BP during the office visit had masked hypertension.

The critical factors associated with increased risk of masked hypertension were in the children's parents—not in the children themselves. Children of hypertensive parents had a 4.3-fold increased risk of masked hypertension compared with children whose parents had normal BP. Children whose parents had a waist-to-hip ratio of at least 0.9 had a ninefold increased risk of masked hypertension, compared with those whose parents did not have abdominal obesity.

“When children are referred to you for possible hypertension, and their parents have these characteristics, you should consider assessing them for masked hypertension,” said the study's lead author, Dr. Claudia Maria Salgado of Federal University of Goiás's department of pediatrics and hypertension league.

The 2008 recommendations suggest the use of self-measurement home BP or ABPM when patients' office BP is greater than 125/75 but less than 135/85 mm Hg. But Dr. Phillips said that following those recommendations will fail to identify many of the patients at risk for the condition. Patients with type 2 diabetes who have normal BP during office visits are 1.6 times more likely to have masked hypertension than are patients without diabetes (Arch. Intern. Med. 2007;167:2139–42).

He proposed new guidelines: Patients with one of the risk factors for masked hypertension should conduct self-measurements of BP at home. Those with self-monitored BP of at least 135/85 mm Hg should have their drug treatment intensified; those with a BP of less than 125/75 mm Hg should be considered normal; and those between the two poles should be assessed by ABPM.

In those diagnosed as having masked hypertension, Dr. Phillips urged physicians to treat them by lowering nocturnal BP.

NEW YORK — Guidelines for detecting masked hypertension in adults should by changed to account for pre-existing conditions such as diabetes and kidney disease, Dr. Robert A. Phillips said at the meeting.

“Masked hypertension isn't adequately addressed by current guidelines,” said Dr. Phillips, director of the Heart and Vascular Center of Excellence and professor of medicine at the University of Massachusetts, Worcester. “We're only beginning to understand how prevalent it is, and how dangerous.”

He reviewed a host of studies indicating that recent recommendations for when to use home and ambulatory blood pressure monitoring (ABPM) would miss the majority of those affected (J. Am. Soc. Hypertens. 2008;2:119–24). Rather than selecting those with borderline hypertension for ambulatory monitoring, he urged hypertension specialists to focus on other risk factors supported by a growing body of evidence: smoking, diabetes, chronic kidney disease, left ventricular hypertrophy, microalbuminuria, and obstructive sleep apnea.

Support for the view that borderline blood pressure is a red herring—not a red flag—in the case of masked hypertension was found in a study presented at ASH. Fourteen percent of children aged 5–15 whose BP readings were normal when measured at a hypertension referral clinic nevertheless met diagnostic criteria for masked hypertension when assessed by ABPM, a Brazilian researcher reported.

The study involved 99 children who had been referred to have their BP evaluated at a pediatric hypertension clinic at the Federal University of Goi´s in Brazil. Of these, 17 were diagnosed in the clinic as having an office BP higher than the 95th percentile. The remaining 82 subjects were all assessed by ABPM.

None of the 12 children who had previously been found to have borderline high BP in the office (greater than 90th but less than 95th percentile) showed evidence of masked hypertension according to the ABPM. But 10 of the 70 children who had normal BP during the office visit had masked hypertension.

The critical factors associated with increased risk of masked hypertension were in the children's parents—not in the children themselves. Children of hypertensive parents had a 4.3-fold increased risk of masked hypertension compared with children whose parents had normal BP. Children whose parents had a waist-to-hip ratio of at least 0.9 had a ninefold increased risk of masked hypertension, compared with those whose parents did not have abdominal obesity.

“When children are referred to you for possible hypertension, and their parents have these characteristics, you should consider assessing them for masked hypertension,” said the study's lead author, Dr. Claudia Maria Salgado of Federal University of Goiás's department of pediatrics and hypertension league.

The 2008 recommendations suggest the use of self-measurement home BP or ABPM when patients' office BP is greater than 125/75 but less than 135/85 mm Hg. But Dr. Phillips said that following those recommendations will fail to identify many of the patients at risk for the condition. Patients with type 2 diabetes who have normal BP during office visits are 1.6 times more likely to have masked hypertension than are patients without diabetes (Arch. Intern. Med. 2007;167:2139–42).

He proposed new guidelines: Patients with one of the risk factors for masked hypertension should conduct self-measurements of BP at home. Those with self-monitored BP of at least 135/85 mm Hg should have their drug treatment intensified; those with a BP of less than 125/75 mm Hg should be considered normal; and those between the two poles should be assessed by ABPM.

In those diagnosed as having masked hypertension, Dr. Phillips urged physicians to treat them by lowering nocturnal BP.

NEW YORK — Guidelines for detecting masked hypertension in adults should by changed to account for pre-existing conditions such as diabetes and kidney disease, Dr. Robert A. Phillips said at the meeting.

“Masked hypertension isn't adequately addressed by current guidelines,” said Dr. Phillips, director of the Heart and Vascular Center of Excellence and professor of medicine at the University of Massachusetts, Worcester. “We're only beginning to understand how prevalent it is, and how dangerous.”

He reviewed a host of studies indicating that recent recommendations for when to use home and ambulatory blood pressure monitoring (ABPM) would miss the majority of those affected (J. Am. Soc. Hypertens. 2008;2:119–24). Rather than selecting those with borderline hypertension for ambulatory monitoring, he urged hypertension specialists to focus on other risk factors supported by a growing body of evidence: smoking, diabetes, chronic kidney disease, left ventricular hypertrophy, microalbuminuria, and obstructive sleep apnea.

Support for the view that borderline blood pressure is a red herring—not a red flag—in the case of masked hypertension was found in a study presented at ASH. Fourteen percent of children aged 5–15 whose BP readings were normal when measured at a hypertension referral clinic nevertheless met diagnostic criteria for masked hypertension when assessed by ABPM, a Brazilian researcher reported.

The study involved 99 children who had been referred to have their BP evaluated at a pediatric hypertension clinic at the Federal University of Goi´s in Brazil. Of these, 17 were diagnosed in the clinic as having an office BP higher than the 95th percentile. The remaining 82 subjects were all assessed by ABPM.

None of the 12 children who had previously been found to have borderline high BP in the office (greater than 90th but less than 95th percentile) showed evidence of masked hypertension according to the ABPM. But 10 of the 70 children who had normal BP during the office visit had masked hypertension.

The critical factors associated with increased risk of masked hypertension were in the children's parents—not in the children themselves. Children of hypertensive parents had a 4.3-fold increased risk of masked hypertension compared with children whose parents had normal BP. Children whose parents had a waist-to-hip ratio of at least 0.9 had a ninefold increased risk of masked hypertension, compared with those whose parents did not have abdominal obesity.

“When children are referred to you for possible hypertension, and their parents have these characteristics, you should consider assessing them for masked hypertension,” said the study's lead author, Dr. Claudia Maria Salgado of Federal University of Goiás's department of pediatrics and hypertension league.

The 2008 recommendations suggest the use of self-measurement home BP or ABPM when patients' office BP is greater than 125/75 but less than 135/85 mm Hg. But Dr. Phillips said that following those recommendations will fail to identify many of the patients at risk for the condition. Patients with type 2 diabetes who have normal BP during office visits are 1.6 times more likely to have masked hypertension than are patients without diabetes (Arch. Intern. Med. 2007;167:2139–42).

He proposed new guidelines: Patients with one of the risk factors for masked hypertension should conduct self-measurements of BP at home. Those with self-monitored BP of at least 135/85 mm Hg should have their drug treatment intensified; those with a BP of less than 125/75 mm Hg should be considered normal; and those between the two poles should be assessed by ABPM.

In those diagnosed as having masked hypertension, Dr. Phillips urged physicians to treat them by lowering nocturnal BP.

Major Finding: In patients on the highest dose of phentermine plus controlled-release topiramate, systolic blood pressure reductions were significantly lower than with placebo: 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER.

Data Source: Pooled analysis of data on 3,985 patients in three clinical trials.

Disclosures: Dr. Oparil disclosed relationships with Vivus as well as with Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Forest, Gilead, Merck, NicOx, Novartis, the Salt Institute, Sanofi-Aventis, and Takeda. Dr. Bakris has reported financial relationships with Abbott, Gilead, GlaxoSmithKline, Merck, Novartis, and other companies.

NEW YORK — An investigational weight-loss agent that combines two drugs slightly reduced blood pressure in an analysis of three large placebo-controlled clinical trials involving a total of 3,985 patients.

The once-daily drug combines a low dose of the generic stimulant phentermine with a low-dose, controlled-release version of the antiepileptic topiramate. The two drugs have been shown previously to cause weight loss by different mechanisms, Dr. Suzanne Oparil said at the meeting.

Higher doses of phentermine are occasionally associated with increased blood pressure, but the combined product appeared to produce enough weight loss—more than 10% of body weight after 56 weeks in two of the studies—to result in modestly lower blood pressure, reported Dr. Oparil, director of the vascular biology and hypertension program at the University of Alabama at Birmingham.

“We really need a well-tolerated, safe, and effective weight-loss treatment,” commented Dr. Oparil, a past president of ASH who conducted the analysis as a consultant to Vivus, which is developing the combined agent under the brand name Qnexa.

But some physicians at the ASH meeting said they were not entirely convinced of the agent's safety. At the highest dose, a heart rate increase of about 1.5 beats per minute was observed. And none of the trials used 24-hour ambulatory blood pressure monitoring.

“I would want to see data on the drug's effect on 24-hour blood pressure,” said Dr. George L. Bakris, professor of medicine and director of the Hypertension Center at the University of Chicago.

The 56-week EQUIP trial enrolled 1,267 obese adults and compared the high-dose combination (phentermine 15 mg and topiramate 92 mg) and a low-dose combination (phentermine 3.75 mg and topiramate 23 mg) with placebo. The 28-week EQUATE trial (enrolled 756 obese adults and compared the high-dose formulation and a mid-dose formulation (phentermine 7.5 mg and topiramate 46 mg) with placebo and with the respective single agents. The 56-week CONQUER trial enrolled 2,487 overweight and obese adults with two or more weight-related comorbidities: increased waist circumference, type 2 diabetes, elevated triglycerides, and elevated blood pressure. It compared the high-dose and mid-dose combinations with placebo. Of the total 4,510 patients who were initially enrolled in the three trials, 3,985 completed the studies.

In Dr. Oparil's pooled analysis of the three trials, the mean weight loss at week 28 was 1.9% of total body weight for the 1,579 patients on placebo, 5.1% for the 234 patients on the lowest dose of the drug, 8.0% for the 591 patients on the middle dose, and 9.9% for the 1,581 patients on the highest dose. All three active-treatment groups had significantly more weight loss, compared with the placebo group.

In the two trials that went to 56 weeks, CONQUER and EQUIP, weight loss reached 10.4% of body weight with the highest dose, compared with 1.5% with placebo, also a significant difference.

The reductions in systolic blood pressure in patients on the high-dose combination, compared with placebo, were 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER; all three reductions were statistically significant. Significant reductions in systolic blood pressure also were seen with some of the lower doses of the combined product. For diastolic blood pressure, only two of the higher-dose groups had reductions that were significantly greater than that seen with placebo.

“In the hypertensive subgroup [of CONQUER], there were significant and dose-related reductions in both systolic and diastolic blood pressure,” Dr. Oparil said. In that subgroup, the mean drop in systolic blood pressure was 6.9 mm Hg for the 256 patients given the middle dose of the drug and 9.1 mm Hg for the 514 patients given the highest dose of the drug; both reductions were significantly greater than the 4.9–mm Hg reduction in the 516 patients on placebo. Reductions in diastolic blood pressure in these patients were 5.2 mm Hg for the middle dose and 5.8 mm Hg for the highest dose; both reductions were significantly greater than the 3.9–mm Hg drop with placebo.

'I would want to see data on the drug's effect on 24-hour blood pressure.'

Source DR. BAKRIS

Major Finding: In patients on the highest dose of phentermine plus controlled-release topiramate, systolic blood pressure reductions were significantly lower than with placebo: 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER.

Data Source: Pooled analysis of data on 3,985 patients in three clinical trials.

Disclosures: Dr. Oparil disclosed relationships with Vivus as well as with Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Forest, Gilead, Merck, NicOx, Novartis, the Salt Institute, Sanofi-Aventis, and Takeda. Dr. Bakris has reported financial relationships with Abbott, Gilead, GlaxoSmithKline, Merck, Novartis, and other companies.

NEW YORK — An investigational weight-loss agent that combines two drugs slightly reduced blood pressure in an analysis of three large placebo-controlled clinical trials involving a total of 3,985 patients.

The once-daily drug combines a low dose of the generic stimulant phentermine with a low-dose, controlled-release version of the antiepileptic topiramate. The two drugs have been shown previously to cause weight loss by different mechanisms, Dr. Suzanne Oparil said at the meeting.

Higher doses of phentermine are occasionally associated with increased blood pressure, but the combined product appeared to produce enough weight loss—more than 10% of body weight after 56 weeks in two of the studies—to result in modestly lower blood pressure, reported Dr. Oparil, director of the vascular biology and hypertension program at the University of Alabama at Birmingham.

“We really need a well-tolerated, safe, and effective weight-loss treatment,” commented Dr. Oparil, a past president of ASH who conducted the analysis as a consultant to Vivus, which is developing the combined agent under the brand name Qnexa.

But some physicians at the ASH meeting said they were not entirely convinced of the agent's safety. At the highest dose, a heart rate increase of about 1.5 beats per minute was observed. And none of the trials used 24-hour ambulatory blood pressure monitoring.

“I would want to see data on the drug's effect on 24-hour blood pressure,” said Dr. George L. Bakris, professor of medicine and director of the Hypertension Center at the University of Chicago.

The 56-week EQUIP trial enrolled 1,267 obese adults and compared the high-dose combination (phentermine 15 mg and topiramate 92 mg) and a low-dose combination (phentermine 3.75 mg and topiramate 23 mg) with placebo. The 28-week EQUATE trial (enrolled 756 obese adults and compared the high-dose formulation and a mid-dose formulation (phentermine 7.5 mg and topiramate 46 mg) with placebo and with the respective single agents. The 56-week CONQUER trial enrolled 2,487 overweight and obese adults with two or more weight-related comorbidities: increased waist circumference, type 2 diabetes, elevated triglycerides, and elevated blood pressure. It compared the high-dose and mid-dose combinations with placebo. Of the total 4,510 patients who were initially enrolled in the three trials, 3,985 completed the studies.

In Dr. Oparil's pooled analysis of the three trials, the mean weight loss at week 28 was 1.9% of total body weight for the 1,579 patients on placebo, 5.1% for the 234 patients on the lowest dose of the drug, 8.0% for the 591 patients on the middle dose, and 9.9% for the 1,581 patients on the highest dose. All three active-treatment groups had significantly more weight loss, compared with the placebo group.

In the two trials that went to 56 weeks, CONQUER and EQUIP, weight loss reached 10.4% of body weight with the highest dose, compared with 1.5% with placebo, also a significant difference.

The reductions in systolic blood pressure in patients on the high-dose combination, compared with placebo, were 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER; all three reductions were statistically significant. Significant reductions in systolic blood pressure also were seen with some of the lower doses of the combined product. For diastolic blood pressure, only two of the higher-dose groups had reductions that were significantly greater than that seen with placebo.

“In the hypertensive subgroup [of CONQUER], there were significant and dose-related reductions in both systolic and diastolic blood pressure,” Dr. Oparil said. In that subgroup, the mean drop in systolic blood pressure was 6.9 mm Hg for the 256 patients given the middle dose of the drug and 9.1 mm Hg for the 514 patients given the highest dose of the drug; both reductions were significantly greater than the 4.9–mm Hg reduction in the 516 patients on placebo. Reductions in diastolic blood pressure in these patients were 5.2 mm Hg for the middle dose and 5.8 mm Hg for the highest dose; both reductions were significantly greater than the 3.9–mm Hg drop with placebo.

'I would want to see data on the drug's effect on 24-hour blood pressure.'

Source DR. BAKRIS

Major Finding: In patients on the highest dose of phentermine plus controlled-release topiramate, systolic blood pressure reductions were significantly lower than with placebo: 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER.

Data Source: Pooled analysis of data on 3,985 patients in three clinical trials.

Disclosures: Dr. Oparil disclosed relationships with Vivus as well as with Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Forest, Gilead, Merck, NicOx, Novartis, the Salt Institute, Sanofi-Aventis, and Takeda. Dr. Bakris has reported financial relationships with Abbott, Gilead, GlaxoSmithKline, Merck, Novartis, and other companies.

NEW YORK — An investigational weight-loss agent that combines two drugs slightly reduced blood pressure in an analysis of three large placebo-controlled clinical trials involving a total of 3,985 patients.

The once-daily drug combines a low dose of the generic stimulant phentermine with a low-dose, controlled-release version of the antiepileptic topiramate. The two drugs have been shown previously to cause weight loss by different mechanisms, Dr. Suzanne Oparil said at the meeting.

Higher doses of phentermine are occasionally associated with increased blood pressure, but the combined product appeared to produce enough weight loss—more than 10% of body weight after 56 weeks in two of the studies—to result in modestly lower blood pressure, reported Dr. Oparil, director of the vascular biology and hypertension program at the University of Alabama at Birmingham.

“We really need a well-tolerated, safe, and effective weight-loss treatment,” commented Dr. Oparil, a past president of ASH who conducted the analysis as a consultant to Vivus, which is developing the combined agent under the brand name Qnexa.

But some physicians at the ASH meeting said they were not entirely convinced of the agent's safety. At the highest dose, a heart rate increase of about 1.5 beats per minute was observed. And none of the trials used 24-hour ambulatory blood pressure monitoring.

“I would want to see data on the drug's effect on 24-hour blood pressure,” said Dr. George L. Bakris, professor of medicine and director of the Hypertension Center at the University of Chicago.

The 56-week EQUIP trial enrolled 1,267 obese adults and compared the high-dose combination (phentermine 15 mg and topiramate 92 mg) and a low-dose combination (phentermine 3.75 mg and topiramate 23 mg) with placebo. The 28-week EQUATE trial (enrolled 756 obese adults and compared the high-dose formulation and a mid-dose formulation (phentermine 7.5 mg and topiramate 46 mg) with placebo and with the respective single agents. The 56-week CONQUER trial enrolled 2,487 overweight and obese adults with two or more weight-related comorbidities: increased waist circumference, type 2 diabetes, elevated triglycerides, and elevated blood pressure. It compared the high-dose and mid-dose combinations with placebo. Of the total 4,510 patients who were initially enrolled in the three trials, 3,985 completed the studies.

In Dr. Oparil's pooled analysis of the three trials, the mean weight loss at week 28 was 1.9% of total body weight for the 1,579 patients on placebo, 5.1% for the 234 patients on the lowest dose of the drug, 8.0% for the 591 patients on the middle dose, and 9.9% for the 1,581 patients on the highest dose. All three active-treatment groups had significantly more weight loss, compared with the placebo group.

In the two trials that went to 56 weeks, CONQUER and EQUIP, weight loss reached 10.4% of body weight with the highest dose, compared with 1.5% with placebo, also a significant difference.

The reductions in systolic blood pressure in patients on the high-dose combination, compared with placebo, were 3.4 mm Hg after 28 weeks in EQUATE, 3.8 mm Hg after 56 weeks in EQUIP, and 3.2 mm Hg after 56 weeks in CONQUER; all three reductions were statistically significant. Significant reductions in systolic blood pressure also were seen with some of the lower doses of the combined product. For diastolic blood pressure, only two of the higher-dose groups had reductions that were significantly greater than that seen with placebo.

“In the hypertensive subgroup [of CONQUER], there were significant and dose-related reductions in both systolic and diastolic blood pressure,” Dr. Oparil said. In that subgroup, the mean drop in systolic blood pressure was 6.9 mm Hg for the 256 patients given the middle dose of the drug and 9.1 mm Hg for the 514 patients given the highest dose of the drug; both reductions were significantly greater than the 4.9–mm Hg reduction in the 516 patients on placebo. Reductions in diastolic blood pressure in these patients were 5.2 mm Hg for the middle dose and 5.8 mm Hg for the highest dose; both reductions were significantly greater than the 3.9–mm Hg drop with placebo.

'I would want to see data on the drug's effect on 24-hour blood pressure.'

Source DR. BAKRIS

NEW YORK — Hypertension treatment for African Americans should begin at a blood pressure of 135/85 mm Hg, rather than the previously recommended 140/90 mm, according to forthcoming guidelines from the International Society on Hypertension in Blacks.

In addition, the guidelines now favor chlorthalidone as the preferred thiazide-like diuretic (not hydrochlorothiazide), with the initial dose at 25 mg per day, not 12 mg per day as previously recommended.

Perhaps most significantly, the guidelines call for the target BP levels to be seen by physicians as ceilings, not floors.

“We encourage you to drive the blood pressures significantly under the targets,” said Dr. John M. Flack, chairman of the working group that developed the International Society on Hypertension in Blacks (ISHIB) consensus statement on the management of hypertension in African Americans at the meeting “If you drive just to the target, the patient will oscillate above and below it.”

Current blood pressure control rates in African Americans remain poor, said Dr. Flack, professor of medicine and physiology and chairman of the department of internal medicine at Wayne State University, Detroit, as well as principal investigator of the university's Center for Urban and African American Health.

“We've had a slight improvement in control rates over the past decade, so we're trending in the right direction,” he said. But, he noted, recent studies have found that only 29.9% of non-Hispanic black men have their hypertension properly controlled, and 36.0% of black women.

What's more, death rates from hypertension remain more than double that of whites, he noted, accounting for 30% of deaths in hypertensive African American men, and 20% of hypertensive African American women.

The new guidelines stratify risk into primary and secondary prevention. Primary prevention applies to patients with a BP of at least 135/85 mm Hg without target-organ damage, or cardiovascular disease—even if the CVD is preclinical. Secondary prevention applies to those with BP of at least 130/80 and target-organ injury or any degree of cardiovascular disease.

By those risk stratums, the target BP level for primary prevention should be 135/85 mm Hg, or 130/80 mm Hg for secondary prevention.

Even if BP is at 115/75 mm Hg, comprehensive lifestyle modifications should be recommended: weight loss if overweight, dietary change (low fat, low sodium, high potassium, adequate calcium), a limit on alcohol, regular physical activity, and avoiding or stopping smoking.

The key therapeutic recommendations for primary prevention in patients with a BP less than 145/90 mm Hg are optional comprehensive lifestyle modifications for up to 3 months, and then antihypertensive drugs. Preferred agents are a thiazide diuretic or calcium channel blocker, with a RAS blocker as an alternative, and a beta-blocker as optional.

In primary prevention where the patient's blood pressure is greater than 15/10 above goal, two-drug therapy should be initiated, with the preferred combination being either a calcium channel blocker and RAS blocker or a thiazide and RAS blocker. The alternative would be a thiazide and beta-blocker or thiazide and calcium channel blocker. The optional combination would be a thiazide and aldosterone antagonist.

The key therapeutic recommendations for secondary prevention in which the patient's blood pressure is greater than 15/10 above goal would be combination therapy using drugs with compelling indications. If the patient's BP is less than 15/10 above goal, a single agent with a compelling indication would be used, with a diuretic or calcium channel blocker preferred; a RAS blocker as an alternative; and a beta-blocker as optional.

“There was a lot of debate about which drug lowers blood pressure more or less,” Dr. Flack said. But, he added, “Most African Americans are not going to hit target with a single drug, so the argument over which is best is largely irrelevant.”

The central point, he said, is that physicians need to work harder to bring their African Americans' BP levels below targets. “If these guidelines are implemented,” he said, “they will improve outcomes for our African American patients.”

Dr. Flack has received grants and research support from Merck & Co., Novartis, Pfizer Inc., GlaxoSmithKline, Astra Merck Inc., Astra Zeneca, Boehringer Mannheim Pharmaceuticals, Cardiodynamics, and Daiichi Sankyo Co. He has been a consultant to Merck, GlaxoSmithKline, Bristol-Myers Squibb, Novartis, CVRx Inc, and Myogen Inc.

NEW YORK — Hypertension treatment for African Americans should begin at a blood pressure of 135/85 mm Hg, rather than the previously recommended 140/90 mm, according to forthcoming guidelines from the International Society on Hypertension in Blacks.

In addition, the guidelines now favor chlorthalidone as the preferred thiazide-like diuretic (not hydrochlorothiazide), with the initial dose at 25 mg per day, not 12 mg per day as previously recommended.

Perhaps most significantly, the guidelines call for the target BP levels to be seen by physicians as ceilings, not floors.

“We encourage you to drive the blood pressures significantly under the targets,” said Dr. John M. Flack, chairman of the working group that developed the International Society on Hypertension in Blacks (ISHIB) consensus statement on the management of hypertension in African Americans at the meeting “If you drive just to the target, the patient will oscillate above and below it.”

Current blood pressure control rates in African Americans remain poor, said Dr. Flack, professor of medicine and physiology and chairman of the department of internal medicine at Wayne State University, Detroit, as well as principal investigator of the university's Center for Urban and African American Health.

“We've had a slight improvement in control rates over the past decade, so we're trending in the right direction,” he said. But, he noted, recent studies have found that only 29.9% of non-Hispanic black men have their hypertension properly controlled, and 36.0% of black women.

What's more, death rates from hypertension remain more than double that of whites, he noted, accounting for 30% of deaths in hypertensive African American men, and 20% of hypertensive African American women.

The new guidelines stratify risk into primary and secondary prevention. Primary prevention applies to patients with a BP of at least 135/85 mm Hg without target-organ damage, or cardiovascular disease—even if the CVD is preclinical. Secondary prevention applies to those with BP of at least 130/80 and target-organ injury or any degree of cardiovascular disease.

By those risk stratums, the target BP level for primary prevention should be 135/85 mm Hg, or 130/80 mm Hg for secondary prevention.

Even if BP is at 115/75 mm Hg, comprehensive lifestyle modifications should be recommended: weight loss if overweight, dietary change (low fat, low sodium, high potassium, adequate calcium), a limit on alcohol, regular physical activity, and avoiding or stopping smoking.

The key therapeutic recommendations for primary prevention in patients with a BP less than 145/90 mm Hg are optional comprehensive lifestyle modifications for up to 3 months, and then antihypertensive drugs. Preferred agents are a thiazide diuretic or calcium channel blocker, with a RAS blocker as an alternative, and a beta-blocker as optional.

In primary prevention where the patient's blood pressure is greater than 15/10 above goal, two-drug therapy should be initiated, with the preferred combination being either a calcium channel blocker and RAS blocker or a thiazide and RAS blocker. The alternative would be a thiazide and beta-blocker or thiazide and calcium channel blocker. The optional combination would be a thiazide and aldosterone antagonist.

The key therapeutic recommendations for secondary prevention in which the patient's blood pressure is greater than 15/10 above goal would be combination therapy using drugs with compelling indications. If the patient's BP is less than 15/10 above goal, a single agent with a compelling indication would be used, with a diuretic or calcium channel blocker preferred; a RAS blocker as an alternative; and a beta-blocker as optional.

“There was a lot of debate about which drug lowers blood pressure more or less,” Dr. Flack said. But, he added, “Most African Americans are not going to hit target with a single drug, so the argument over which is best is largely irrelevant.”

The central point, he said, is that physicians need to work harder to bring their African Americans' BP levels below targets. “If these guidelines are implemented,” he said, “they will improve outcomes for our African American patients.”

Dr. Flack has received grants and research support from Merck & Co., Novartis, Pfizer Inc., GlaxoSmithKline, Astra Merck Inc., Astra Zeneca, Boehringer Mannheim Pharmaceuticals, Cardiodynamics, and Daiichi Sankyo Co. He has been a consultant to Merck, GlaxoSmithKline, Bristol-Myers Squibb, Novartis, CVRx Inc, and Myogen Inc.

NEW YORK — Hypertension treatment for African Americans should begin at a blood pressure of 135/85 mm Hg, rather than the previously recommended 140/90 mm, according to forthcoming guidelines from the International Society on Hypertension in Blacks.

In addition, the guidelines now favor chlorthalidone as the preferred thiazide-like diuretic (not hydrochlorothiazide), with the initial dose at 25 mg per day, not 12 mg per day as previously recommended.

Perhaps most significantly, the guidelines call for the target BP levels to be seen by physicians as ceilings, not floors.

“We encourage you to drive the blood pressures significantly under the targets,” said Dr. John M. Flack, chairman of the working group that developed the International Society on Hypertension in Blacks (ISHIB) consensus statement on the management of hypertension in African Americans at the meeting “If you drive just to the target, the patient will oscillate above and below it.”

Current blood pressure control rates in African Americans remain poor, said Dr. Flack, professor of medicine and physiology and chairman of the department of internal medicine at Wayne State University, Detroit, as well as principal investigator of the university's Center for Urban and African American Health.

“We've had a slight improvement in control rates over the past decade, so we're trending in the right direction,” he said. But, he noted, recent studies have found that only 29.9% of non-Hispanic black men have their hypertension properly controlled, and 36.0% of black women.

What's more, death rates from hypertension remain more than double that of whites, he noted, accounting for 30% of deaths in hypertensive African American men, and 20% of hypertensive African American women.

The new guidelines stratify risk into primary and secondary prevention. Primary prevention applies to patients with a BP of at least 135/85 mm Hg without target-organ damage, or cardiovascular disease—even if the CVD is preclinical. Secondary prevention applies to those with BP of at least 130/80 and target-organ injury or any degree of cardiovascular disease.

By those risk stratums, the target BP level for primary prevention should be 135/85 mm Hg, or 130/80 mm Hg for secondary prevention.

Even if BP is at 115/75 mm Hg, comprehensive lifestyle modifications should be recommended: weight loss if overweight, dietary change (low fat, low sodium, high potassium, adequate calcium), a limit on alcohol, regular physical activity, and avoiding or stopping smoking.

The key therapeutic recommendations for primary prevention in patients with a BP less than 145/90 mm Hg are optional comprehensive lifestyle modifications for up to 3 months, and then antihypertensive drugs. Preferred agents are a thiazide diuretic or calcium channel blocker, with a RAS blocker as an alternative, and a beta-blocker as optional.

In primary prevention where the patient's blood pressure is greater than 15/10 above goal, two-drug therapy should be initiated, with the preferred combination being either a calcium channel blocker and RAS blocker or a thiazide and RAS blocker. The alternative would be a thiazide and beta-blocker or thiazide and calcium channel blocker. The optional combination would be a thiazide and aldosterone antagonist.

The key therapeutic recommendations for secondary prevention in which the patient's blood pressure is greater than 15/10 above goal would be combination therapy using drugs with compelling indications. If the patient's BP is less than 15/10 above goal, a single agent with a compelling indication would be used, with a diuretic or calcium channel blocker preferred; a RAS blocker as an alternative; and a beta-blocker as optional.

“There was a lot of debate about which drug lowers blood pressure more or less,” Dr. Flack said. But, he added, “Most African Americans are not going to hit target with a single drug, so the argument over which is best is largely irrelevant.”

The central point, he said, is that physicians need to work harder to bring their African Americans' BP levels below targets. “If these guidelines are implemented,” he said, “they will improve outcomes for our African American patients.”

Dr. Flack has received grants and research support from Merck & Co., Novartis, Pfizer Inc., GlaxoSmithKline, Astra Merck Inc., Astra Zeneca, Boehringer Mannheim Pharmaceuticals, Cardiodynamics, and Daiichi Sankyo Co. He has been a consultant to Merck, GlaxoSmithKline, Bristol-Myers Squibb, Novartis, CVRx Inc, and Myogen Inc.

NEW YORK – Clinical acumen and up-to-date knowledge about the literature remain paramount in diagnosing and treating pediatric tics, Tourette syndrome, and obsessive-compulsive disorder in the continuing absence of rigid treatment protocols, according to Dr. Barbara J. Coffey.

“Until we reach the point of having genomics and medical data available to help us treat our patients, we have to rely upon our own clinical acumen and a whole array of treatments,” Dr. Coffey, director of the Tics and Tourette's Clinical and Research Program at NYU Child Study Center, said at a psychopharmacology update sponsored by the American Academy of Child and Adolescent Psychiatry.

She began by pointing out that not all tics need to be treated.

The way in which young patients who need treatment are identified is the challenge, said Dr. Coffey, also an associate professor in the department of child and adolescent psychiatry at the New York University. “The most important part of treatment is sorting out the diagnostic picture and targeting symptoms.”

Even so, she added: “The tics might be mild, but the kid can have tremendous distress about it. On the other hand, I've seen kids who have tremendous tics and are shouting out but are not distressed about it. So part of the work in a case like that is really settling the environment down.”

Although the DSM-IV defines a transient tic disorder as lasting at least 4 weeks, Dr. Coffey said she sees children as early as 2 weeks after the onset of tics. “Parents want to know: 'Is my child going to have Tourette's?' Sorting that out is part of the diagnostic challenge,” she said.

A diagnosis of Tourette, she noted, requires a year-long period of frequent daily tics in which there was never more than 3 continuous tic-free months. “You have to be precise,” she said. “Was it exactly 3 months?” Parents often want to know, she said, whether the child's Tourette will last the rest of his or her life.

“The DSM says the duration is usually lifelong,” Dr. Coffey said. “The good news is that research in the past decade finds that peak lifetime severity occurs at about age 10 or 11, with improvement through adolescence.” To support that view, she cited her 2004 prospective study in the Journal of Nervous and Mental Disease (192:776–80).

“The take-home point is this is a childhood disorder,” Dr. Coffey said. “About two-thirds of children will have their symptoms attenuated by adolescence, if not in complete remission.”

Still, she added: “There's good news and bad news about clinically referred children with Tourette's. The bad news is that OCD tends to kick in and become more prevalent after puberty. Tic severity goes down over time; OCD severity goes up over time. You're kind of trading one disorder for another. When you see a child in the clinic, there's a great likelihood they're going to have these together.”

When parents ask her what they can expect from medications to treat Tourette, Dr. Coffey said she tells them they generally provide about a 30% improvement on symptom scores. “This doesn't fly too well with the parents,” she said. “But this is what we have. If you treat kids with Tourette's, you're always looking for something new in terms of efficacy and tolerability.”

She pointed to an open-label safety and tolerability study she recently published on the use of aripiprazole for children and adolescents with Tourette disorder (J. Child Adolesc. Psychopharm. 2009;19:623–33).

“We saw this as a pilot study,” Dr. Coffey said. “We found it really did seem to help tics over time. The downside is we did see a fair amount of appetite increase and weight gain.”

For the treatment of OCD, she described the Pediatric OCD Treatment Study (POTS), and early, unpublished results from the new Pediatric OCT Treatment Study (POTS II).

“If there's a trend in our field, we have to pay attention to this: The treatment effect size was higher for cognitive-behavioral therapy (CBT) than for sertraline alone,” Dr. Coffey said. “The challenge in real life is that it's very hard to find well-trained cognitive-behavioral therapists for children. But I think CBT is going to be the wave of the future.”

A particularly effective use of CBT, she said, is for the treatment of tics, using procedures that train patients to become aware of premonitory sensations prior to the tic, and then taught a competing response. “It can be done with motor tics, complex tics, simple tics,” Dr. Coffey said. “The effect size is at least comparable to what we're getting with medication, and there are no side effects.”

So effective is CBT for tics, she said, that she generally tries it first, before medications. For physicians who wish to learn the technique, she said, “the manual is out there” (see “Managing Tourette Syndrome: A Behavioral Intevention for Children and Adults: Therapist Guide,”New York: Oxford University Press, 2008).

The most difficult tic to treat with CBT, she said, is eye blinking. An alternative response for the child to try when feeling the urge to blink, she said, is to widen the eyes. But, Dr. Coffey added: “The response doesn't always need to be in the muscular area where the tic is occurring. You could suggest that the child clenches his fist, or takes a deep breath.”

When a medication is used and found effective, she said, treatment should generally be continued for at least 12 months and then reevaluated.

“I've had parents who are extremely anxious about taking their child off the medication, even though I know it's time to do that,” Dr. Coffey said. “A lot of support during that time is essential.”

Dr. Coffey disclosed that she has served as an adviser/consultant to Jazz Pharmaceuticals and the Novartis Pharmaceutical Corp. She has received research support from several pharmaceutical companies, including Bristol-Myers Squibb, maker of aripiprazole.

'The good news is that research in the past decade finds that peak lifetime severity occurs at about 10 or 11.'

Source DR. COFFEY

NEW YORK – Clinical acumen and up-to-date knowledge about the literature remain paramount in diagnosing and treating pediatric tics, Tourette syndrome, and obsessive-compulsive disorder in the continuing absence of rigid treatment protocols, according to Dr. Barbara J. Coffey.

“Until we reach the point of having genomics and medical data available to help us treat our patients, we have to rely upon our own clinical acumen and a whole array of treatments,” Dr. Coffey, director of the Tics and Tourette's Clinical and Research Program at NYU Child Study Center, said at a psychopharmacology update sponsored by the American Academy of Child and Adolescent Psychiatry.

She began by pointing out that not all tics need to be treated.

The way in which young patients who need treatment are identified is the challenge, said Dr. Coffey, also an associate professor in the department of child and adolescent psychiatry at the New York University. “The most important part of treatment is sorting out the diagnostic picture and targeting symptoms.”

Even so, she added: “The tics might be mild, but the kid can have tremendous distress about it. On the other hand, I've seen kids who have tremendous tics and are shouting out but are not distressed about it. So part of the work in a case like that is really settling the environment down.”

Although the DSM-IV defines a transient tic disorder as lasting at least 4 weeks, Dr. Coffey said she sees children as early as 2 weeks after the onset of tics. “Parents want to know: 'Is my child going to have Tourette's?' Sorting that out is part of the diagnostic challenge,” she said.

A diagnosis of Tourette, she noted, requires a year-long period of frequent daily tics in which there was never more than 3 continuous tic-free months. “You have to be precise,” she said. “Was it exactly 3 months?” Parents often want to know, she said, whether the child's Tourette will last the rest of his or her life.

“The DSM says the duration is usually lifelong,” Dr. Coffey said. “The good news is that research in the past decade finds that peak lifetime severity occurs at about age 10 or 11, with improvement through adolescence.” To support that view, she cited her 2004 prospective study in the Journal of Nervous and Mental Disease (192:776–80).

“The take-home point is this is a childhood disorder,” Dr. Coffey said. “About two-thirds of children will have their symptoms attenuated by adolescence, if not in complete remission.”

Still, she added: “There's good news and bad news about clinically referred children with Tourette's. The bad news is that OCD tends to kick in and become more prevalent after puberty. Tic severity goes down over time; OCD severity goes up over time. You're kind of trading one disorder for another. When you see a child in the clinic, there's a great likelihood they're going to have these together.”

When parents ask her what they can expect from medications to treat Tourette, Dr. Coffey said she tells them they generally provide about a 30% improvement on symptom scores. “This doesn't fly too well with the parents,” she said. “But this is what we have. If you treat kids with Tourette's, you're always looking for something new in terms of efficacy and tolerability.”

She pointed to an open-label safety and tolerability study she recently published on the use of aripiprazole for children and adolescents with Tourette disorder (J. Child Adolesc. Psychopharm. 2009;19:623–33).

“We saw this as a pilot study,” Dr. Coffey said. “We found it really did seem to help tics over time. The downside is we did see a fair amount of appetite increase and weight gain.”

For the treatment of OCD, she described the Pediatric OCD Treatment Study (POTS), and early, unpublished results from the new Pediatric OCT Treatment Study (POTS II).

“If there's a trend in our field, we have to pay attention to this: The treatment effect size was higher for cognitive-behavioral therapy (CBT) than for sertraline alone,” Dr. Coffey said. “The challenge in real life is that it's very hard to find well-trained cognitive-behavioral therapists for children. But I think CBT is going to be the wave of the future.”

A particularly effective use of CBT, she said, is for the treatment of tics, using procedures that train patients to become aware of premonitory sensations prior to the tic, and then taught a competing response. “It can be done with motor tics, complex tics, simple tics,” Dr. Coffey said. “The effect size is at least comparable to what we're getting with medication, and there are no side effects.”

So effective is CBT for tics, she said, that she generally tries it first, before medications. For physicians who wish to learn the technique, she said, “the manual is out there” (see “Managing Tourette Syndrome: A Behavioral Intevention for Children and Adults: Therapist Guide,”New York: Oxford University Press, 2008).

The most difficult tic to treat with CBT, she said, is eye blinking. An alternative response for the child to try when feeling the urge to blink, she said, is to widen the eyes. But, Dr. Coffey added: “The response doesn't always need to be in the muscular area where the tic is occurring. You could suggest that the child clenches his fist, or takes a deep breath.”

When a medication is used and found effective, she said, treatment should generally be continued for at least 12 months and then reevaluated.

“I've had parents who are extremely anxious about taking their child off the medication, even though I know it's time to do that,” Dr. Coffey said. “A lot of support during that time is essential.”

Dr. Coffey disclosed that she has served as an adviser/consultant to Jazz Pharmaceuticals and the Novartis Pharmaceutical Corp. She has received research support from several pharmaceutical companies, including Bristol-Myers Squibb, maker of aripiprazole.

'The good news is that research in the past decade finds that peak lifetime severity occurs at about 10 or 11.'

Source DR. COFFEY

NEW YORK – Clinical acumen and up-to-date knowledge about the literature remain paramount in diagnosing and treating pediatric tics, Tourette syndrome, and obsessive-compulsive disorder in the continuing absence of rigid treatment protocols, according to Dr. Barbara J. Coffey.

“Until we reach the point of having genomics and medical data available to help us treat our patients, we have to rely upon our own clinical acumen and a whole array of treatments,” Dr. Coffey, director of the Tics and Tourette's Clinical and Research Program at NYU Child Study Center, said at a psychopharmacology update sponsored by the American Academy of Child and Adolescent Psychiatry.

She began by pointing out that not all tics need to be treated.

The way in which young patients who need treatment are identified is the challenge, said Dr. Coffey, also an associate professor in the department of child and adolescent psychiatry at the New York University. “The most important part of treatment is sorting out the diagnostic picture and targeting symptoms.”

Even so, she added: “The tics might be mild, but the kid can have tremendous distress about it. On the other hand, I've seen kids who have tremendous tics and are shouting out but are not distressed about it. So part of the work in a case like that is really settling the environment down.”

Although the DSM-IV defines a transient tic disorder as lasting at least 4 weeks, Dr. Coffey said she sees children as early as 2 weeks after the onset of tics. “Parents want to know: 'Is my child going to have Tourette's?' Sorting that out is part of the diagnostic challenge,” she said.

A diagnosis of Tourette, she noted, requires a year-long period of frequent daily tics in which there was never more than 3 continuous tic-free months. “You have to be precise,” she said. “Was it exactly 3 months?” Parents often want to know, she said, whether the child's Tourette will last the rest of his or her life.

“The DSM says the duration is usually lifelong,” Dr. Coffey said. “The good news is that research in the past decade finds that peak lifetime severity occurs at about age 10 or 11, with improvement through adolescence.” To support that view, she cited her 2004 prospective study in the Journal of Nervous and Mental Disease (192:776–80).

“The take-home point is this is a childhood disorder,” Dr. Coffey said. “About two-thirds of children will have their symptoms attenuated by adolescence, if not in complete remission.”

Still, she added: “There's good news and bad news about clinically referred children with Tourette's. The bad news is that OCD tends to kick in and become more prevalent after puberty. Tic severity goes down over time; OCD severity goes up over time. You're kind of trading one disorder for another. When you see a child in the clinic, there's a great likelihood they're going to have these together.”

When parents ask her what they can expect from medications to treat Tourette, Dr. Coffey said she tells them they generally provide about a 30% improvement on symptom scores. “This doesn't fly too well with the parents,” she said. “But this is what we have. If you treat kids with Tourette's, you're always looking for something new in terms of efficacy and tolerability.”

She pointed to an open-label safety and tolerability study she recently published on the use of aripiprazole for children and adolescents with Tourette disorder (J. Child Adolesc. Psychopharm. 2009;19:623–33).

“We saw this as a pilot study,” Dr. Coffey said. “We found it really did seem to help tics over time. The downside is we did see a fair amount of appetite increase and weight gain.”

For the treatment of OCD, she described the Pediatric OCD Treatment Study (POTS), and early, unpublished results from the new Pediatric OCT Treatment Study (POTS II).

“If there's a trend in our field, we have to pay attention to this: The treatment effect size was higher for cognitive-behavioral therapy (CBT) than for sertraline alone,” Dr. Coffey said. “The challenge in real life is that it's very hard to find well-trained cognitive-behavioral therapists for children. But I think CBT is going to be the wave of the future.”

A particularly effective use of CBT, she said, is for the treatment of tics, using procedures that train patients to become aware of premonitory sensations prior to the tic, and then taught a competing response. “It can be done with motor tics, complex tics, simple tics,” Dr. Coffey said. “The effect size is at least comparable to what we're getting with medication, and there are no side effects.”

So effective is CBT for tics, she said, that she generally tries it first, before medications. For physicians who wish to learn the technique, she said, “the manual is out there” (see “Managing Tourette Syndrome: A Behavioral Intevention for Children and Adults: Therapist Guide,”New York: Oxford University Press, 2008).

The most difficult tic to treat with CBT, she said, is eye blinking. An alternative response for the child to try when feeling the urge to blink, she said, is to widen the eyes. But, Dr. Coffey added: “The response doesn't always need to be in the muscular area where the tic is occurring. You could suggest that the child clenches his fist, or takes a deep breath.”

When a medication is used and found effective, she said, treatment should generally be continued for at least 12 months and then reevaluated.

“I've had parents who are extremely anxious about taking their child off the medication, even though I know it's time to do that,” Dr. Coffey said. “A lot of support during that time is essential.”

Dr. Coffey disclosed that she has served as an adviser/consultant to Jazz Pharmaceuticals and the Novartis Pharmaceutical Corp. She has received research support from several pharmaceutical companies, including Bristol-Myers Squibb, maker of aripiprazole.

'The good news is that research in the past decade finds that peak lifetime severity occurs at about 10 or 11.'

Source DR. COFFEY

NEW YORK – Managing adherence, selecting the proper agent, and keeping a keen watch out for the risk of substance abuse are key to successfully treating attention-deficit/hyperactivity disorder in older adolescents and adults, according to Dr. Timothy E. Wilens.

“One thing we don't talk enough about is adherence,” Dr. Wilens, associate professor of psychiatry at Harvard Medical School, Boston, said at a pharmacology update sponsored by the American Academy of Child and Adolescent Psychiatrists. “You can do everything right, and still, when you look at adherence, it's terrible.”

He cited a study presented in 2005 at the annual international conference of Children and Adults with Attention Deficit/Hyperactivity Disorder showing that among 5,600 patients prescribed medications for ADHD, 50% stopped taking the drugs within 3 months, and 80% discontinued by 18 months.

Perhaps the gravest risk in treating older adolescents and adults for ADHD, and one which Dr. Wilens has studied extensively, is the abuse of substances–whether cigarettes, marijuana, or the very medications being prescribed for the ADHD. “Substance abuse is a major consideration,” he said, citing a study he presented last year at a meeting of the American Academy of Addiction Psychiatry showing that 20% or so of ADHD patients are dependent on an addictive substance at the age of 25. That comes to more than twice the rate of controls.

Because most ADHD patients are treated well before adulthood, he said, talking with patients early about substance abuse as a risk factor is important. “ADHD doubles their risk of having substance abuse 10 years later,” said Dr. Wilens, who also serves as director of substance abuse services, clinical and research programs in pediatric psychopharmacology at Massachusetts General Hospital. “Fifty percent of the kids who have ADHD and are smoking will go on to substance abuse. I say to them when they're young, 'I'm really concerned that you have twice the risk of becoming an addict with marijuana if you begin using it.' I tell them this over and over, 'You cannot do like your friends.'”

A reassuring result was seen in a case-controlled, prospective study led by Dr. Wilens involving 114 female adolescents diagnosed with ADHD. Five years after initial treatment, those who had received stimulant medications were significantly less likely to be smoking, drinking alcohol, or abusing drugs than were those who had not undergone treatment with stimulants (Arch. Pediatr. Adolesc. Med. 2008;162:916-21). “Treatment reduced cigarette smoking and substance abuse,” Dr. Wilens said. “That is great news.”

Other studies tracking such patients into adulthood, he noted, have likewise found that stimulant treatment for ADHD does not raise the subsequent risk of substance abuse, although most have found that it does not lower the risk, either.

For patients already diagnosed as substance abusers, Dr. Wilens said, there have been four double-blind studies showing that treating them with stimulants for ADHD results in no significant improvement of either condition.

“From the safety side, there was no worsening of substance use,” he said. “But it's not doing much. So if you have an active abuser who comes to you and says, 'You need to treat my ADHD so I'll get better,' don't fall for that.”

For patients who admit to using marijuana, he recommended asking about weekly frequency. “I would not refuse to treat their ADHD because they're smoking marijuana on weekends,” Dr. Wilens said. “But if they're smoking seven to eight joints a week, there's no evidence that treating for ADHD will benefit it. And telling them you won't treat until they stop gives them a message.”

If a physician suspects that a new patient is seeking ADHD medication merely to abuse or sell it, Dr. Wilens said: “Have them come back for a second session before you give them a prescription. Slow down the evaluation process. Ask them to bring in something from their parents or elsewhere to confirm the diagnosis. If they're trying to scam you, if they think you're onto them, they often won't come back for a second visit.”

When prescribing a stimulant to ADHD patients in whom the potential for abuse is suspected, he added, “I like to use extended release. Don't hand somebody you're worried about an immediate-release methylphenidate. If you do, you might as well hand them a mortar and pestle.” Indeed, while 11% of patients he's been tracking in an ongoing study have sold the stimulant medications they were prescribed for ADHD, all those cases involved immediate-release formulations rather than sustained release.

Beyond the risks of substance abuse, Dr. Wilens addressed other issues unique to older adolescents and adults with ADHD. He cited his own recent paper in the Journal of Clinical Psychiatry (2009;70:1557-62) showing that the most common presenting symptom in adult ADHD, present in more than 90% of cases, is being easily distracted.

The impulsivity component of the disorder can have serious consequences in adulthood, he said. The hyperactivity component typically seen in children, however, often changes into inner restlessness, resulting in fidgeting, excessive talking, and self-selection of an active job.

“You have to set expectations,” he said, emphasizing that most younger people today will be quick to search online. “Direct them to sites that are balanced and have good information,” he urged.

While noting that pharmacotherapy is considered a first-line treatment option and more effective than behavioral treatment alone, Dr. Wilens warned against agents that have yet to gain a Food and Drug Administration indication for adult ADHD. Studies are continuing to investigate nicotinic agents, modafinil, and fish oils, he said, but most published trials so far have been negative. “I want you to focus on what's approved in adolescents and adults,” he said.

Dr. Wilens receives or has received research support, served as a consultant, and/or served on speakers bureaus for several companies that make drugs used to treat ADHD.

'Fifty percent of the kids who have ADHD and are smoking will go on to substance abuse.'

Source DR. WILENS

NEW YORK – Managing adherence, selecting the proper agent, and keeping a keen watch out for the risk of substance abuse are key to successfully treating attention-deficit/hyperactivity disorder in older adolescents and adults, according to Dr. Timothy E. Wilens.

“One thing we don't talk enough about is adherence,” Dr. Wilens, associate professor of psychiatry at Harvard Medical School, Boston, said at a pharmacology update sponsored by the American Academy of Child and Adolescent Psychiatrists. “You can do everything right, and still, when you look at adherence, it's terrible.”

He cited a study presented in 2005 at the annual international conference of Children and Adults with Attention Deficit/Hyperactivity Disorder showing that among 5,600 patients prescribed medications for ADHD, 50% stopped taking the drugs within 3 months, and 80% discontinued by 18 months.

Perhaps the gravest risk in treating older adolescents and adults for ADHD, and one which Dr. Wilens has studied extensively, is the abuse of substances–whether cigarettes, marijuana, or the very medications being prescribed for the ADHD. “Substance abuse is a major consideration,” he said, citing a study he presented last year at a meeting of the American Academy of Addiction Psychiatry showing that 20% or so of ADHD patients are dependent on an addictive substance at the age of 25. That comes to more than twice the rate of controls.

Because most ADHD patients are treated well before adulthood, he said, talking with patients early about substance abuse as a risk factor is important. “ADHD doubles their risk of having substance abuse 10 years later,” said Dr. Wilens, who also serves as director of substance abuse services, clinical and research programs in pediatric psychopharmacology at Massachusetts General Hospital. “Fifty percent of the kids who have ADHD and are smoking will go on to substance abuse. I say to them when they're young, 'I'm really concerned that you have twice the risk of becoming an addict with marijuana if you begin using it.' I tell them this over and over, 'You cannot do like your friends.'”

A reassuring result was seen in a case-controlled, prospective study led by Dr. Wilens involving 114 female adolescents diagnosed with ADHD. Five years after initial treatment, those who had received stimulant medications were significantly less likely to be smoking, drinking alcohol, or abusing drugs than were those who had not undergone treatment with stimulants (Arch. Pediatr. Adolesc. Med. 2008;162:916-21). “Treatment reduced cigarette smoking and substance abuse,” Dr. Wilens said. “That is great news.”

Other studies tracking such patients into adulthood, he noted, have likewise found that stimulant treatment for ADHD does not raise the subsequent risk of substance abuse, although most have found that it does not lower the risk, either.

For patients already diagnosed as substance abusers, Dr. Wilens said, there have been four double-blind studies showing that treating them with stimulants for ADHD results in no significant improvement of either condition.

“From the safety side, there was no worsening of substance use,” he said. “But it's not doing much. So if you have an active abuser who comes to you and says, 'You need to treat my ADHD so I'll get better,' don't fall for that.”

For patients who admit to using marijuana, he recommended asking about weekly frequency. “I would not refuse to treat their ADHD because they're smoking marijuana on weekends,” Dr. Wilens said. “But if they're smoking seven to eight joints a week, there's no evidence that treating for ADHD will benefit it. And telling them you won't treat until they stop gives them a message.”

If a physician suspects that a new patient is seeking ADHD medication merely to abuse or sell it, Dr. Wilens said: “Have them come back for a second session before you give them a prescription. Slow down the evaluation process. Ask them to bring in something from their parents or elsewhere to confirm the diagnosis. If they're trying to scam you, if they think you're onto them, they often won't come back for a second visit.”

When prescribing a stimulant to ADHD patients in whom the potential for abuse is suspected, he added, “I like to use extended release. Don't hand somebody you're worried about an immediate-release methylphenidate. If you do, you might as well hand them a mortar and pestle.” Indeed, while 11% of patients he's been tracking in an ongoing study have sold the stimulant medications they were prescribed for ADHD, all those cases involved immediate-release formulations rather than sustained release.

Beyond the risks of substance abuse, Dr. Wilens addressed other issues unique to older adolescents and adults with ADHD. He cited his own recent paper in the Journal of Clinical Psychiatry (2009;70:1557-62) showing that the most common presenting symptom in adult ADHD, present in more than 90% of cases, is being easily distracted.

The impulsivity component of the disorder can have serious consequences in adulthood, he said. The hyperactivity component typically seen in children, however, often changes into inner restlessness, resulting in fidgeting, excessive talking, and self-selection of an active job.

“You have to set expectations,” he said, emphasizing that most younger people today will be quick to search online. “Direct them to sites that are balanced and have good information,” he urged.

While noting that pharmacotherapy is considered a first-line treatment option and more effective than behavioral treatment alone, Dr. Wilens warned against agents that have yet to gain a Food and Drug Administration indication for adult ADHD. Studies are continuing to investigate nicotinic agents, modafinil, and fish oils, he said, but most published trials so far have been negative. “I want you to focus on what's approved in adolescents and adults,” he said.

Dr. Wilens receives or has received research support, served as a consultant, and/or served on speakers bureaus for several companies that make drugs used to treat ADHD.

'Fifty percent of the kids who have ADHD and are smoking will go on to substance abuse.'

Source DR. WILENS

NEW YORK – Managing adherence, selecting the proper agent, and keeping a keen watch out for the risk of substance abuse are key to successfully treating attention-deficit/hyperactivity disorder in older adolescents and adults, according to Dr. Timothy E. Wilens.

“One thing we don't talk enough about is adherence,” Dr. Wilens, associate professor of psychiatry at Harvard Medical School, Boston, said at a pharmacology update sponsored by the American Academy of Child and Adolescent Psychiatrists. “You can do everything right, and still, when you look at adherence, it's terrible.”

He cited a study presented in 2005 at the annual international conference of Children and Adults with Attention Deficit/Hyperactivity Disorder showing that among 5,600 patients prescribed medications for ADHD, 50% stopped taking the drugs within 3 months, and 80% discontinued by 18 months.

Perhaps the gravest risk in treating older adolescents and adults for ADHD, and one which Dr. Wilens has studied extensively, is the abuse of substances–whether cigarettes, marijuana, or the very medications being prescribed for the ADHD. “Substance abuse is a major consideration,” he said, citing a study he presented last year at a meeting of the American Academy of Addiction Psychiatry showing that 20% or so of ADHD patients are dependent on an addictive substance at the age of 25. That comes to more than twice the rate of controls.

Because most ADHD patients are treated well before adulthood, he said, talking with patients early about substance abuse as a risk factor is important. “ADHD doubles their risk of having substance abuse 10 years later,” said Dr. Wilens, who also serves as director of substance abuse services, clinical and research programs in pediatric psychopharmacology at Massachusetts General Hospital. “Fifty percent of the kids who have ADHD and are smoking will go on to substance abuse. I say to them when they're young, 'I'm really concerned that you have twice the risk of becoming an addict with marijuana if you begin using it.' I tell them this over and over, 'You cannot do like your friends.'”

A reassuring result was seen in a case-controlled, prospective study led by Dr. Wilens involving 114 female adolescents diagnosed with ADHD. Five years after initial treatment, those who had received stimulant medications were significantly less likely to be smoking, drinking alcohol, or abusing drugs than were those who had not undergone treatment with stimulants (Arch. Pediatr. Adolesc. Med. 2008;162:916-21). “Treatment reduced cigarette smoking and substance abuse,” Dr. Wilens said. “That is great news.”

Other studies tracking such patients into adulthood, he noted, have likewise found that stimulant treatment for ADHD does not raise the subsequent risk of substance abuse, although most have found that it does not lower the risk, either.

For patients already diagnosed as substance abusers, Dr. Wilens said, there have been four double-blind studies showing that treating them with stimulants for ADHD results in no significant improvement of either condition.

“From the safety side, there was no worsening of substance use,” he said. “But it's not doing much. So if you have an active abuser who comes to you and says, 'You need to treat my ADHD so I'll get better,' don't fall for that.”

For patients who admit to using marijuana, he recommended asking about weekly frequency. “I would not refuse to treat their ADHD because they're smoking marijuana on weekends,” Dr. Wilens said. “But if they're smoking seven to eight joints a week, there's no evidence that treating for ADHD will benefit it. And telling them you won't treat until they stop gives them a message.”

If a physician suspects that a new patient is seeking ADHD medication merely to abuse or sell it, Dr. Wilens said: “Have them come back for a second session before you give them a prescription. Slow down the evaluation process. Ask them to bring in something from their parents or elsewhere to confirm the diagnosis. If they're trying to scam you, if they think you're onto them, they often won't come back for a second visit.”

When prescribing a stimulant to ADHD patients in whom the potential for abuse is suspected, he added, “I like to use extended release. Don't hand somebody you're worried about an immediate-release methylphenidate. If you do, you might as well hand them a mortar and pestle.” Indeed, while 11% of patients he's been tracking in an ongoing study have sold the stimulant medications they were prescribed for ADHD, all those cases involved immediate-release formulations rather than sustained release.

Beyond the risks of substance abuse, Dr. Wilens addressed other issues unique to older adolescents and adults with ADHD. He cited his own recent paper in the Journal of Clinical Psychiatry (2009;70:1557-62) showing that the most common presenting symptom in adult ADHD, present in more than 90% of cases, is being easily distracted.

The impulsivity component of the disorder can have serious consequences in adulthood, he said. The hyperactivity component typically seen in children, however, often changes into inner restlessness, resulting in fidgeting, excessive talking, and self-selection of an active job.

“You have to set expectations,” he said, emphasizing that most younger people today will be quick to search online. “Direct them to sites that are balanced and have good information,” he urged.

While noting that pharmacotherapy is considered a first-line treatment option and more effective than behavioral treatment alone, Dr. Wilens warned against agents that have yet to gain a Food and Drug Administration indication for adult ADHD. Studies are continuing to investigate nicotinic agents, modafinil, and fish oils, he said, but most published trials so far have been negative. “I want you to focus on what's approved in adolescents and adults,” he said.

Dr. Wilens receives or has received research support, served as a consultant, and/or served on speakers bureaus for several companies that make drugs used to treat ADHD.

'Fifty percent of the kids who have ADHD and are smoking will go on to substance abuse.'

Source DR. WILENS