 |
|
Efficacy and Safety of Sibutramine in Obese White and African American Patients With Hypertension
A 1-Year, Double-blind, Placebo-Controlled, Multicenter Trial
F. Gilbert McMahon, MD, MS, FAACP;
Ken Fujioka, MD;
Bramah N. Singh, MD, PhD;
Carl M. Mendel, MD;
Everton Rowe, PhD;
Kelly Rolston;
Franklin Johnson, MS;
Arshag D. Mooradian, MD
Arch Intern Med. 2000;160:2185-2191.
Background Obesity is a highly prevalent medical condition and is commonly accompanied by hypertension. This study assessed the efficacy and safety of treatment with sibutramine hydrochloride for promoting and maintaining weight loss in obese patients with controlled hypertension, including a subset analysis of African American patients.
Patients and Methods Obese patients with a body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) between 27 and 40 and a history of hypertension controlled with a calcium channel blocker (with or without concomitant thiazide diuretic treatment) were randomized to receive sibutramine (n = 150) or placebo (n = 74) with minimal behavioral intervention for 52 weeks. African Americans constituted 36% of enrolled patients. Efficacy assessments were body weight and related parameters (BMI and waist and hip circumferences), metabolic parameters (serum levels of triglycerides, high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], total cholesterol, glucose, and uric acid), and quality-of-life measures. Safety assessments included recording of blood pressure, pulse rate, adverse events, and reasons for discontinuation.
Results For patients receiving sibutramine, weight loss occurred during the first 6 months of the trial and was maintained to the end of the 12-month treatment period. Among patients receiving sibutramine, 40.1% lost 5% or more of body weight (5% responders) and 13.4% lost 10% or more of body weight (10% responders) compared with 8.7% and 4.3% of patients in the placebo group, respectively (P<.05). Changes in body weight were similar among African Americans and whites. Sibutramine-induced weight loss was associated with significant improvements in serum levels of triglycerides, HDL-C, glucose, and uric acid. Waist circumference and quality-of-life measures also improved significantly in patients receiving sibutramine. Sibutramine-treated patients had small but statistically significant mean increases in diastolic blood pressure (2.0 mm Hg) and pulse rate (4.9 beats/min) compared with placebo-treated patients (–1.3 mm Hg and 0.0 beats/min; P<.05); these changes were similar among African Americans and whites. Most adverse events were mild to moderate in severity and transient. The most common adverse event resulting in discontinuation among patients receiving sibutramine was hypertension (5.3% of patients receiving sibutramine vs 1.4% of patients receiving placebo).
Conclusions In obese patients with controlled hypertension, sibutramine was an effective and well-tolerated treatment for weight loss and maintenance. Sibutramine-induced weight loss resulted in improvements in serum levels of triglycerides, HDL-C, uric acid, and glucose, and in waist circumference and quality-of-life measures. Blood pressure and heart rate increased by a small amount. Efficacy and safety profiles for sibutramine among African American and white obese patients with controlled hypertension were similar.
From the Clinical Research Center, New Orleans, La (Dr McMahon); Scripps Clinic, San Diego, Calif (Dr Fujioka); University of California–Los Angeles and West Los Angeles Veterans Affairs Medical Center, Los Angeles, Calif (Dr Singh); Knoll Pharmaceutical Company, Mount Olive, NJ (Drs Mendel and Rowe, Mr Johnson, and Ms Rolston); and the Division of Endocrinology, Department of Internal Medicine, St Louis University School of Medicine, St Louis, Mo (Dr Mooradian).
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Rimonabant and Progression of Atherosclerosis in Obese Persons
Dora and Scheffel
JAMA 2008;300:280-280.
FULL TEXT
Long-term Effects of Weight-Reducing Interventions in Hypertensive Patients: Systematic Review and Meta-analysis
Horvath et al.
Arch Intern Med 2008;168:571-580.
ABSTRACT
| FULL TEXT
Another dangerous combination for hypoglycemic coma: concurrent use of sibutramine and lorazepam
Lin et al.
QJM 2008;101:243-245.
FULL TEXT
State of the Art Review: Long-term Pharmacotherapy for Overweight and Obesity: A Review of Sibutramine, Orlistat, and Rimonabant
Dunican et al.
AMERICAN JOURNAL OF LIFESTYLE MEDICINE 2007;1:367-388.
ABSTRACT
Pharmacological Treatment of the Overweight Patient
Bray and Greenway
Pharmacol. Rev. 2007;59:151-184.
FULL TEXT
Open Channel Block of A-Type, Kv4.3, and Delayed Rectifier K+ Channels, Kv1.3 and Kv3.1, by Sibutramine
Kim et al.
J. Pharmacol. Exp. Ther. 2007;321:753-762.
ABSTRACT
| FULL TEXT
Effects of Sibutramine Treatment in Obese Adolescents: A Randomized Trial
Berkowitz et al.
ANN INTERN MED 2006;145:81-90.
ABSTRACT
| FULL TEXT
The SCOUT study: risk-benefit profile of sibutramine in overweight high-risk cardiovascular patients
James
Eur Heart J Suppl 2005;7:L44-L48.
ABSTRACT
| FULL TEXT
Effect of Sibutramine on Weight Management and Metabolic Control in Type 2 Diabetes: A meta-analysis of clinical studies
Vettor et al.
Diabetes Care 2005;28:942-949.
ABSTRACT
| FULL TEXT
Clinical Implications of Obesity With Specific Focus on Cardiovascular Disease: A Statement for Professionals From the American Heart Association Council on Nutrition, Physical Activity, and Metabolism: Endorsed by the American College of Cardiology Foundation
Klein et al.
Circulation 2004;110:2952-2967.
ABSTRACT
| FULL TEXT
Diagnosis and Treatment of Obesity in Adults: An Applied Evidence-Based Review
Orzano and Scott
J Am Board Fam Med 2004;17:359-369.
ABSTRACT
| FULL TEXT
Hypertension and Obesity
Aneja et al.
Recent Prog Horm Res 2004;59:169-205.
ABSTRACT
| FULL TEXT
Screening and Interventions for Obesity in Adults: Summary of the Evidence for the U.S. Preventive Services Task Force
McTigue et al.
ANN INTERN MED 2003;139:933-949.
ABSTRACT
| FULL TEXT
Pharmacological Therapy of Obesity: Past, Present, and Future
Weigle
J. Clin. Endocrinol. Metab. 2003;88:2462-2469.
FULL TEXT
Lifestyle Intervention of Hypocaloric Dieting and Walking Reduces Abdominal Obesity and Improves Coronary Heart Disease Risk Factors in Obese, Postmenopausal, African-American and Caucasian Women
Nicklas et al.
J. Gerontol. A Biol. Sci. Med. Sci. 2003;58:M181-189.
ABSTRACT
| FULL TEXT
Anesthetic Considerations for Bariatric Surgery
Ogunnaike et al.
Anesth. Analg. 2002;95:1793-1805.
FULL TEXT
Effects of Obesity Surgery on Non-Insulin-Dependent Diabetes Mellitus
Greenway et al.
Arch Surg 2002;137:1109-1117.
ABSTRACT
| FULL TEXT
Sibutramine update
Day and Bailey
British Journal of Diabetes & Vascular Disease 2002;2:392-397.
ABSTRACT
Obesity drug sibutramine (Meridia): hypertension and cardiac arrhythmias
Wooltorton
CMAJ 2002;166:1307-1308.
FULL TEXT
Obesity, weight reduction and survival in heart failure: Reply
Fonarow et al.
J Am Coll Cardiol 2002;39:1563-1564.
FULL TEXT
Obesity
Yanovski and Yanovski
NEJM 2002;346:591-602.
FULL TEXT
The Treatment of Hypertension in Adult Patients With Diabetes
Arauz-Pacheco et al.
Diabetes Care 2002;25:134-147.
FULL TEXT
Extracts from ""Clinical Evidence"": Obesity
Arterburn and Noel
BMJ 2001;322:1406-1409.
FULL TEXT
|
