Can sibutramine alter systemic blood pressure in obese patients? Systematic review and meta-analysis
Keywords:
Obesity, Body mass index, Overweight, Hypertension, Anti-obesity agentsAbstract
CONTEXT: Systemic arterial hypertension is part of the metabolic syndrome resulting from obesity. OBJECTIVE: To evaluate the effect of sibutramine on overweight and obese patients’ blood pressure through a systematic review. METHODS: All the studies included needed to be randomized controlled trials. The methodological quality of the selected trials was assessed using the criteria described in the Cochrane Handbook. The participants were overweight and obese patients; the intervention was sibutramine compared with placebo. The primary outcome measurement was systolic and diastolic blood pressure and the secondary measurement was blood pressure. Studies were identified by searching the following sources: Literatura LatinoAmericana e do Caribe em Ciências da Saúde (Lilacs), Medline, Cochrane reviews, manual searches, personal communication and contact with the pharmaceutical industry. There were no language, date or other restrictions. Data collection and extraction was performed by two reviewers, who independently obtained the full articles of all eligible papers. RESULTS: Three meta-analyses were produced: 1) systolic blood pressure outcome (eight studies) did not show statistical signifi cance between sibutramine and placebo: weighted mean difference (WMD) 1.57, confi dence interval (CI) -0.03 to 3.18; 2) diastolic blood pressure outcome (ten studies) did not show statistical signifi cance between sibutramine and placebo: WMD 1.13, CI -0.49 to 2.76; 3) blood pressure outcome (two studies) also did not show statistical signifi cance between the groups: relative risk (RR) 0.69, CI 0.07 to 7.01. CONCLUSIONS: The meta-analyses presented in this systematic review show that sibutramine does not have a statistically signifi cant effect on blood pressure, compared with placebo.
Downloads
References
Hodge AM, Zimmet PZ. The epidemiology of obesity. Baillieres Clin Endocrinol Metab. 1994;8(3):577-99.
Kissebah AH, Vydelingum N, Murray R, et al. Relation of body fat distribution to metabolic complications of obesity. J Clin Endocrinol Metab. 1982;54(2):254-60.
Larsson B, Svärdsudd K, Welin L, Wilhelmsen L, Björntorp P, Tibblin G. Abdominal adipose tissue distribution, obesity, and risk of cardiovascular disease and death: 13 year follow up of participants in the study of men born in 1913. Br Med J (ClinRes Ed). 1984;288(6428):1401-4.
Berne C. Insulin resistance in hypertension--a relationship with consequences? J Intern Med Suppl. 1991;735:65-73.
Moan A, Nordby G, Rostrup M, Eide I, Kjeldsen SE. Insulin sensitivity, sympathetic activity, and cardiovascular reactivity in young men. Am J Hypertens. 1995;8(3):268-75.
Hall JE. Louis K. Dahl Memorial Lecture. Renal and cardio- vascular mechanisms of hypertension in obesity. Hypertension. 1994;23(3):381-94.
Hall JE, Zappe DH, Alonso-Galicia M, Granger JP, Brands MW, Kassab SE. Mechanisms of obesity-induced hypertension. News Physiol Sci. 1996;11:255-61. [Abstract] Available from: http:// physiologyonline.physiology.org/cgi/content/abstract/11/6/255. Accessed in 2008 (Oct 7).
Hansen DL, Toubro S, Stock MJ, Macdonald IA, Astrup A. The effect of sibutramine on energy expenditure and appetite during chronic treatment without dietary restriction. Int J Obes Relat Metab Disord. 1999;23(10):1016-24.
James WP, Astrup A, Finer N, et al. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance. Lancet. 2000;356(9248):2119-25.
Seagle HM, Bessesen DH, Hill JO. Effects of sibutramine on resting metabolic rate and weight loss in overweight women. Obes Res. 1998;6(2):115-21.
Gundlah C, Martin KF, Heal DJ, Auerbach SB. In vivo criteria to differentiate monoamine reuptake inhibitors from releasing agents: sibutramine is a reuptake inhibitor. J Pharmacol Exp Ther. 1997;283(2):581-91.
Clarke M, Oxman AD, editors. Cochrane Reviewers’ Handbook
1.5 [updated April 2002]. In: The Cochrane Library, Issue 2. Oxford: Updated Software; 2002.
Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evi- dence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273(5):408-12.
Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327(7414):557-60.
Clarke M, Oxman AD, editors. Cochrane Reviewers’ Handbook
0. In: Review Manager (RevMan) [Computer program]. Version 4.0. Oxford, England: The Cochrane Collaboration; 1999.
Hazenberg BP. Randomized, double-blind, placebo-controlled, multicenter study of sibutramine in obese hypertensive patients. Cardiology. 2000;94(3):152-8.
Fanghänel G, Cortinas L, Sánchez-Reyes L, Berber A. A clini- cal trial of the use of sibutramine for the treatment of patients suffering essential obesity. Int J Obes Relat Metab Disord. 2000;24(2):144-50.
Faria AN, Ribeiro Filho FF, Lerario DD, Kohlmann N, Ferreira SR, Zanella MT. Effects of sibutramine on the treatment of obesity in patients with arterial hypertension. Arq Bras Cardiol. 2002;78(2):172-80.
Fujioka K, Seaton TB, Rowe E, et al. Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2000;2(3):175-87.
Godoy-Matos A, Carraro L, Vieira A, et al. Treatment of obese adolescents with sibutramine: a randomized, double-blind, con- trolled study. J Clin Endocrinol Metab. 2005;90(3):1460-5.
Sramek JJ, Leibowitz MT, Weinstein SP, et al. Efficacy and safety of sibutramine for weight loss in obese patients with hypertension well controlled by beta-adrenergic blocking agents: a placebo-controlled, double-blind, randomised trial. J Hum Hypertens. 2002;16(1):13-9.
Zannad F, Gille B, Grentzinger A, et al. Effects of sibutramine on ventricular dimensions and heart valves in obese patients during weight reduction. Am Heart J. 2002;144(3):508-15.
Apfelbaum M, Vague P, Ziegler O, Hanotin C, Thomas F, Leutenegger E. 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(2):179-84.
Cuellar GE, Ruiz AM, Monsalve MC, Berber A. Six-month treatment of obesity with sibutramine 15 mg; a double-blind, placebo-controlled monocenter clinical trial in a Hispanic population. Obes Res. 2000;8(1):71-82.
McMahon FG, Weinstein SP, Rowe E, et al. Sibutramine is safe and effective for weight loss in obese patients whose hypertension is well controlled with angiotensin-converting enzyme inhibi- tors. J Hum Hypertens. 2002;16(1):5-11.
Finer N, Bloom SR, Frost GS, Banks LM, Griffiths J. Sibutramine is effective for weight loss and diabetic control in obesity with type 2 diabetes: a randomised, double-blind, placebo-controlled study. Diabetes Obes Metab. 2000;2(2):105- 12.
McMahon FG, Fujioka K, Singh BN, et al. Efficacy and safety of sibutramine in obese white and African American patients with hypertension: a 1-year, double-blind, placebo-controlled, multicenter trial. Arch Intern Med. 2000;160(14):2185-91.
Filippatos TD, Kiortsis DN, Liberopoulos EN, Mikhailidis DP, Elisaf MS. A review of the metabolic effects of sibutramine. Curr Med Res Opin. 2005;21(3):457-68.
Padwal R, Li SK, Lau DC. Long-term pharmacotherapy for obesity and overweight. Cochrane Database Syst Rev. 2004;(3):CD004094.
Rucker D, Padwal R, Li SK, Curioni C, Lau DC. Long term pharmacotherapy for obesity and overweight: updated meta- analysis. BMJ. 2007;335(7631):1194-9.
Horvath K, Jeitler K, Siering U, et al. Long-term effects of weight-reducing interventions in hypertensive patients: systematic review and meta-analysis. Arch Intern Med. 2008;168(6):571-80.
