Abstract
This 6-month randomized study evaluated the safety and efficacy of sibutramine in 57 overweight Hispanic patients with hypertension. Following a 2-week washout to confirm the diagnosis of hypertension, antihypertensive medication was adjusted to achieve a blood pressure less than 140/90 mm Hg before institution of either sibutramine 10 mg or placebo once a day. A body mass index in excess of 27 kg/m2 was required for entry. At study end, weight had changed from 75.4±9.6 to 70.0±9.5 kg in the sibutramine group and from 77.9±9.0 to 74.5±9.4 kg in the placebo group. In the sibutramine group, systolic blood pressure was 127.8±5.8 mm Hg after stabilization and 125.2±8.5 mm Hg after completion of the trial; respective values for diastolic blood pressure were 82.4±3.7 and 81.5±4.6 mm Hg. With placebo, blood pressure dropped from 129.0±7.1/80.9±4.9 mm Hg to 122.8±9.7/80.3±5.4 mm Hg at the same timepoints. In the sibutramine group, 14 patients reported 21 adverse events, most frequently headache (n=5), constipation (n=4), and dry mouth (n=4). In the placebo group, 13 patients had 20 adverse events. Sibutramine is safe and effective in overweight Hispanic patients with hypertension, but monitoring of blood pressure and titration of antihypertensive medication are necessary.
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Williamson DF, Kahn HS, Byers T. The 10-y incidence of obesity and major weight gain in black and white US women aged 30–55 y.Am J Clin Nutr. 1991;53(6 suppl):1515S-1518S.
Willett WC, Manson JE, Stampfer MJ, et al. Weight, weight change, and coronary heart disease in women. Risk within the “normal” weight range.JAMA. 1995;273:461–465.
Pi-Sunyer FX. Medical hazards of obesity.Ann Intern Med. 1993;119:655–660.
Carey VJ, Walters EE, Colditz GA, et al. Body fat distribution and risk of non-insulin-dependent diabetes mellitus in women. The Nurses’ Health Study.Am J Epidemiol. 1997;145:614–619.
Stamler R, Stamler J, Riedlinger WF, Algera G, Roberts RH. Weight and blood pressure. Findings in hypertension screening of 1 million Americans.JAMA. 1978;240:1607–1610.
Garrison RJ, Kannel WB, Stokes J, Castelli WP. Incidence and precursors of hypertension in young adults: the Framingham Offspring Study.Prev Med. 1987;16:235–251.
Expert Panel on the Identification, Evaluation, and Treatment of Overweight in Adults. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: executive summary.Am J Clin Nutr. 1998;68:899–917.
Pi-Sunyer FX. A review of long-term studies evaluating the efficacy of weight loss in ameliorating disorders associated with obesity.Clin Ther. 1996;18:1006–1035.
National Institutes of Health.The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda, Md: National High Blood Pressure Education Program; 1997. NIH Publication 98-4080.
Stock MJ. Sibutramine: a review of the pharmacology of a novel anti-obesity agent.Int J Obes Relat Metab Disord. 1997;21(suppl 1):S25-S29.
Weintraub M, Rubio A, Golik A, Byrne L, Scheinbaum ML. Sibutramine in weight control: a dose-ranging, efficacy study.Clin Pharmacol Ther. 1991;50:330–337.
Hansen DL, Toubro S, Stock MJ, Macdonald IA, Astrup A. Thermogenic effects of sibutramine in humans.Am J Clin Nutr. 1998;68:1180–1186.
McNeely W, Goa KL. Sibutramine. A review of its contribution to the management of obesity.Drugs. 1998;56:1093–1124.
Martínez-Cuellar GE, Martínez-Ruiz AM, Revilla-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;8:71–82.
Fanghanel G, Cortinas L, Sanchez-Reyes L, Berber A. A clinical trial of the use of sibutramine for the treatment of patients suffering essential obesity.Int J Obes Relat Metab Disord. 2000;24: 144–150.
Bray GA, Blackburn GL, Ferguson JM, et al. Sibutramine produces dose-related weight loss.Obes Res. 1999;7:189–198.
James WP, Astrup A, Finer N, et al. Effect of sibutramine on weight maintenance after weight loss: a randomized trial. Sibutramine Trial of Obesity Reduction and Maintenance.Lancet. 2000; 356:2119–2125.
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;160:2185–2191.
Hazenberg BP. Randomized, double-blind, placebo-controlled, multicenter study of sibutramine in obese hypertensive patients.Cardiology. 2000;94:152–158.
Harris MI, Flegal KM, Cowie CC, et al. Prevalence of diabetes, impaired fasting glucose and impaired glucose tolerance in U.S. adults.Diabetes Care. 1998;21:518–524.
Sorel JE, Ragland DR, Syme SL. Blood pressure in Mexican-Americans, whites and blacks. The second National Health and Nutrition Examination Survey and the Hispanic Health and Nutrition Examination Survey.Am J Epidemiol. 1991;134:370–378.
Gillum RF. Epidemiology of stroke in Hispanic Americans.Stroke. 1995;26:1707–1712.
Harris-Hooker S, Sanford GL. Lipids and lipoproteins and coronary heart disease in minority populations.Atherosclerosis. 1994;108(suppl):S83-S104.
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Fanghänel, G., Cortinas, L., Sánchez-Reyes, L. et al. Safety and efficacy of sibutramine in overweight Hispanic patients with hypertension. Adv Therapy 20, 101–113 (2003). https://doi.org/10.1007/BF02850257
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DOI: https://doi.org/10.1007/BF02850257