Efficacy and Safety of Sibutramine in Obese White and African American Patients With Hypertension

McMahon, F. Gilbert; Fujioka, Ken; Singh, Bramah N.; Mendel, Carl M.; Rowe, Everton; Rolston, Kelly; Johnson, Franklin K.; Mooradian, Arshag D.

doi:10.1001/archinte.160.14.2185

Cited by 236 publications

(130 citation statements)

References 50 publications

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“…These results confirm the safety and efficacy of sibutramine treat-ment in those patients with hypertension controlled by calcium channel blockers. 19 Patients with hypertension controlled with either calcium channel blockers or ACE inhibitors can lose more weight on a programme that includes sibutramine compared with a programme that includes placebo. Effects on BP with either calcium channel blockers or ACE inhibitors are minimal with sibutramine treatment.…”

Section: Discussionmentioning

confidence: 99%

Sibutramine is safe and effective for weight loss in obese patients whose hypertension is well controlled with angiotensin-converting enzyme inhibitors

McMahon¹,

et al. 2002

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Sibutramine treatment in obesity results in significantly greater weight reduction compared with placebo, although weight loss with sibutramine may be accompanied by small but statistically significant mean increases in blood pressure (BP). This 52-week, placebo-controlled, double-blind, randomised study investigated the effects of sibutramine 20 mg once daily or placebo on body weight in 220 obese (body mass index (BMI) 27-40 kg/m 2 ), hypertensive patients. At randomisation, hypertension was well controlled (р95 mm Hg diastolic blood pressure (DBP)) with an angiotensinconverting enzyme (ACE) inhibitor, with or without concomitant thiazide diuretic therapy. Therapy for hypertension continued for the 52 weeks of the study. Sibutramine 20 mg produced significantly greater weight loss compared with placebo: 4.5 kg with sibutramine compared with 0.4 kg with placebo (last observation carried forward (LOCF); P р 0.05). A total of 62 patients (42.8%) treated with sibutramine lost у5% of their body weight compared with six patients (8.3%) treated with placebo; 19 patients (13.1%) treated with sibutramine lost у10% of their body weight compared with two patients (2.8%) treated with placebo (LOCF; P р 0.05 for both comparisons). Hypertension remained well controlled for the 52 weeks of the study with both sibutramine and placebo treatment. After 52 weeks, the differences between placebo treatment and sibutramine

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Section: Discussionmentioning

confidence: 99%

Sibutramine is safe and effective for weight loss in obese patients whose hypertension is well controlled with angiotensin-converting enzyme inhibitors

McMahon¹,

et al. 2002

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“…65,66 The greatest improvements in glycemic control occurred in subjects with type 2 diabetes. 67,68 There were no significant effects of sibutramine therapy compared to diet-only therapy on lipids and glycemic control, but sibutramine was associated with higher systolic (1-4 mmHg) and diastolic (2-4 mmHg) blood pressure, 72,73,75,76 including subjects with treated hypertension. 73,75 Metformin had no effect on lipids or glycemic or blood pressure control in one study, 78 but in another study of subjects with impaired glucose tolerance, 77 metformin therapy conferred a 31% lower risk for type 2 diabetes.…”

Section: Jd Douketis Et Almentioning

confidence: 97%

“…No study reported on weight loss and its effects of cardiovascular risk factors in high-risk groups, unless the study was limited to high-risk subjects. 67,68,70,71,73,[75][76][77] …”

Section: Jd Douketis Et Almentioning

confidence: 99%

Systematic review of long-term weight loss studies in obese adults: clinical significance and applicability to clinical practice

et al. 2005

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BACKGROUND: Obesity is a common health problem that requires a long-term care approach. We systematically reviewed long-term (Z2 y) studies investigating dietary/lifestyle, pharmacologic, and surgical weight loss methods to assess (1) weight loss efficacy, defined by absolute weight loss and the proportion of subjects with Z5% weight loss, (2) effects of weight loss on cardiovascular risk factors, and (3) applicability of findings from studies to everyday clinical practice. METHODS: The MEDLINE, HealthSTAR, and the Cochrane Controlled Trials databases were searched for studies investigating the long-term efficacy of weight loss methods in overweight and obese adults. Data were extracted for (i) weight loss after 1 y (pharmacologic studies only), 2 y, 3 y, and 4 y, (ii) proportion of subjects with Z5% weight loss at the end of follow-up, and (iii) changes (end-of follow-up minus baseline values) in blood lipids, fasting blood glucose, and systolic and diastolic blood pressure. RESULTS: Dietary/lifestyle therapy provides o5 kg weight loss after 2-4 y, pharmacologic therapy provides 5-10 kg weight loss after 1-2 y, and surgical therapy provides 25-75 kg weight loss after 2-4 y. Weight loss of Z5% baseline weight is not consistently associated with improvements in cardiovascular risk factors and these benefits appear to be intervention specific and occur mainly in people with concomitant cardiovascular risk factors. Weight loss studies have methodologic limitations that restrict the applicability of findings to unselected obese people assessed in everyday clinical practice. These limitations include an inadequate study duration, large proportions of subjects lost to follow-up, a lack of an appropriate usual care group, and a lack of reporting of outcomes in high-risk subgroups. CONCLUSIONS: Dietary/lifestyle and pharmacologic weight loss interventions provide modest weight loss, and may improve markers of cardiovascular risk factors although these benefits occur mainly in patients with cardiovascular risks. Studies investigating weight loss have methodologic limitations that restrict the applicability of findings to obese patients assessed in clinical practice.

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“…14 When hypertension is well controlled with medication, treatment with sibutramine results in reduced body weight with no adverse effects on blood pressure control. [15][16][17] Table 1 highlights what this study adds to what is already known about obesity and its risk factors.…”

Section: Introductionmentioning

confidence: 93%

Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study

Gaciong

Placha

2005

J Hum Hypertens

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This study aims to determine the efficacy and tolerability of sibutramine hydrochloride in overweight and obese patients with cardiovascular risk factors. This was a 12-week, open-label, observational trial carried out in primary care settings. Patients' data were obtained from questionnaires received from 153 physicians. A total of 2225 overweight and obese (BMIX27 kg/m 2 ) patients received sibutramine in single daily doses of 10 and/or 15 mg. The study population included patients in general good health and with controlled hypertension (41.2%), type II diabetes mellitus (15.6%), hyperlipidaemia (45.5%), and who were chronic tobacco users (smokers) (37.0%). The main outcome measures were changes in body weight, blood pressure and heart rate, and evaluation of reported adverse events. Reduction of body weight of at least 45% from baseline to week 12 was achieved in 2030 (91%) patients and 410% was achieved in 987 (44%) patients. Baseline differences in the percentages of male and female patients, presence or absence of hyperlipidaemia or smoking status did not appear to affect the rate of weight change. Weight loss was less in patients with type II diabetes mellitus and/or controlled systolic hypertension at baseline compared to those patients without these conditions. Mean systolic and diastolic blood pressure and heart rate decreased from baseline to week 12. Overall, sibutramine was well tolerated. In conclusions, treatment with sibutramine resulted in clinically significant weight loss during short-term therapy in obese adults with a range of cardiovascular risk factors.

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Efficacy and Safety of Sibutramine in Obese White and African American Patients With Hypertension

Cited by 236 publications

References 50 publications

Sibutramine is safe and effective for weight loss in obese patients whose hypertension is well controlled with angiotensin-converting enzyme inhibitors

Sibutramine is safe and effective for weight loss in obese patients whose hypertension is well controlled with angiotensin-converting enzyme inhibitors

Systematic review of long-term weight loss studies in obese adults: clinical significance and applicability to clinical practice

Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study

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