Abstract
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/m2), hypertensive patients. At randomisation, hypertension was well controlled (⩽95 mm Hg diastolic blood pressure (DBP)) with an angiotensin-converting 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 ⩽ 0.05). A total of 62 patients (42.8%) treated with sibutramine lost ⩾5% of their body weight compared with six patients (8.3%) treated with placebo; 19 patients (13.1%) treated with sibutramine lost ⩾10% of their body weight compared with two patients (2.8%) treated with placebo (LOCF; P⩽ 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 treatment for both mean supine systolic blood pressure (SBP) and DBP were approximately 3 mm Hg: mean DBP was 82.8 mm Hg with placebo treatment compared with 85.5 mm Hg with sibutramine treatment (LOCF; P = 0.004) and mean SBP was 130.4 mm Hg with placebo compared with 133.1 mm Hg with sibutramine (LOCF; P = 0.0497; both comparisons, sibutramine vs placebo). The mean increases in SBP and DBP did not appear to change the overall risk category for coronary heart disease end points. Changes in pulse rate at week 52 were a decrease of 0.3 beats per minute (bpm) for placebo treatment compared with an increase of 5.7 bpm for sibutramine treatment (P < 0.001). Mandated withdrawals from the study due to protocol-defined changes in BP were not statistically different between the two treatment groups. Greater favourable changes in lipid profile, serum glucose, and uric acid could be accounted for by greater weight losses occurring in the sibutramine treatment group. Sibutramine was well tolerated. This study indicates that in obese patients whose hypertension is well controlled at the outset with an ACE inhibitor, with or without concomitant thiazide diuretic therapy, sibutramine safely and effectively achieves weight loss without compromising good BP control.
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 12 digital issues and online access to articles
$119.00 per year
only $9.92 per issue
Rent or buy this article
Prices vary by article type
from$1.95
to$39.95
Prices may be subject to local taxes which are calculated during checkout
Similar content being viewed by others
References
Eckel RH and for the Nutrition Committee. Obesity and heart disease. A statement for healthcare professionals from the Nutrition Committee, American Heart Association Circulation 1997 96: 3248–3250
Rimm EB et al. Body size and fat distribution as predictors of coronary heart disease among middle-aged and older US men Am J Epidemiol 1995 141: 1117–1127
Van Itallie TB . Health implications of overweight and obesity in the United States Ann Intern Med 1985 103: 983–988
Calle EE et al. Body-mass index and mortality in a prospective cohort of U.S. adults N Engl J Med 1999 341: 1097–1105
Expert Panel on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Executive summary of the clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults Arch Intern Med 1998 158: 1855–1867
Bray GA et al. Sibutramine produces dose-related weight loss Obes Res 1999 7: 189–198
James WPT et al. Effect of sibutramine on weight maintenance after weight loss: a randomised trial Lancet 2000 356: 2119–2125
Hansen DL et al. Thermogenic effects of sibutramine in humans Am J Clin Nutr 1998 68: 1180–1186
Eckel RH, Krauss RM for the AHA Nutrition Committee. American Heart Association call to action: obesity as a major risk factor for coronary heart disease Circulation 1998 97: 2099–2100
Goldstein DJ . Beneficial health effects of modest weight loss Int J Obes Relat Metab Disord 1992 16: 397–415
Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure Arch Intern Med 1997 157: 2413–2446
Luque CA, Rey JA . Sibutramine: a serotonin-norepinephrine reuptake-inhibitor for the treatment ofobesity Ann Pharmacother 1999 33: 968–978
Apfelbaum M et al. Long-term maintenance of weight loss after a very-low-calorie diet: a randomized blinded trial of the efficacy and tolerability of sibutramine Am J Med 1999 106: 179–184
Hansson L . The Hypertension Optimal Treatment study and the importance of lowering blood pressure J Hypertens 1999 17 (Suppl 1): S9–S13
Hansson L et al. Effects of intensive blood-pressure lowering and low-dose aspirin inpatients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial Lancet 1998 351: 1755–1762
Finer N et al. One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor Int J Obes 2000 24: 306–313
Fujioka K et al. Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obesepatients with type 2 diabetes mellitus Diabetes Obes Metab 2000 2: 175–187
Lauterbach K, Evers T . Framingham analysis: coronary heart disease risk reduction with weight loss in obesity on sibutramine treatment. [abstract PB 83] Obes Res 2000 8 (Suppl 1): 88S
McMahon FG et al. Efficacy and safety of sibutramine in obese white and African Americanpatients with hypertension: a 1-year, double-blind, placebo-controlled, multicenter trial Arch Intern Med 2000 160: 2185–2191
Acknowledgements
This study was supported by Abbott Laboratories, Abbott Park, Illinois, USA. Study team members: Bramah Singh MD, PhD; F Gilbert McMahon, MD; Arshag Mooradian, MD; Steven P Weinstein, MD, PhD; Ken Fujioka, MD; Everton Rowe, PhD; Kate Ernst.
Author information
Authors and Affiliations
Consortia
Corresponding author
Rights and permissions
About this article
Cite this article
McMahon, F., Weinstein, S., Rowe, E. et al. Sibutramine is safe and effective for weight loss in obese patients whose hypertension is well controlled with angiotensin-converting enzyme inhibitors. J Hum Hypertens 16, 5–11 (2002). https://doi.org/10.1038/sj.jhh.1001298
Published:
Issue Date:
DOI: https://doi.org/10.1038/sj.jhh.1001298
Keywords
This article is cited by
-
Pharmacotherapy of Obesity: Limits and Perspectives
American Journal of Cardiovascular Drugs (2019)
-
A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study
International Journal of Obesity (2010)
-
Industry funding and the reporting quality of large long-term weight loss trials
International Journal of Obesity (2008)
-
Cost-effectiveness of pharmacological anti-obesity treatments: a systematic review
International Journal of Obesity (2008)
-
Treatment strategies for obesity-related hypertension
Current Hypertension Reports (2008)