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Effects of sibutramine on body weight and serum lipids: a double-blind, randomized, placebo-controlled study in 322 overweight and obese patients with dyslipidemia.
Am Heart J 2001; 142(3):489-97AH

Abstract

BACKGROUND

Cardiovascular risk factors associated with obesity, including dyslipidemia, can be improved by weight loss. The main dyslipidemia associated with obesity is elevated serum triglyceride and decreased serum high-density lipoprotein cholesterol (HDL-C) levels.

METHODS

A total of 322 obese patients (body mass index > or = 27) with serum triglyceride levels > or = 250 mg/dL and < or = 1000 mg/dL and serum HDL-C levels < or = 45 mg/dL (women) and < or = 40 mg/dL (men) were placed on a step I American Heart Association diet and subsequently randomized to sibutramine 20 mg (n = 162) or placebo (n = 160) once daily for 24 weeks.

RESULTS

Patients taking sibutramine had significantly greater mean weight loss than those receiving placebo (-4.9 kg vs -0.6 kg, P < or = .05). Forty-two percent of the sibutramine group lost > or = 5% of baseline weight and 12% lost > or = 10% compared with 8% and 3%, respectively, of the placebo group (P < or = .05). Mean decreases in serum triglyceride levels among 5% and 10% weight-loss responders in the sibutramine group were 33.4 mg/dL and 72.3 mg/dL, respectively, compared with an increase of 31.7 mg/dL among all patients receiving placebo (P < or = .05). Mean increases in serum HDL-C levels for 5% and 10% weight-loss responders in the sibutramine group were 4.9 mg/dL and 6.7 mg/dL, respectively, compared with an increase of 1.7 mg/dL among all patients in the placebo group (P < or = .05). Adverse events and discontinuation rates were similar in the sibutramine and placebo groups, although sibutramine-treated patients had mean increases in systolic and diastolic blood pressure of 2 to 3 mm Hg relative to placebo.

CONCLUSIONS

In overweight and obese patients with high serum triglyceride levels and low serum HDL-C levels, treatment with sibutramine was associated with significant improvements in body weight and in serum triglyceride and HDL-C levels.

Authors+Show Affiliations

Kansas Foundation for Clinical Pharmacology, Radiant Research-Kansas City, Overland Park, Kan, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

11526363

Citation

Dujovne, C A., et al. "Effects of Sibutramine On Body Weight and Serum Lipids: a Double-blind, Randomized, Placebo-controlled Study in 322 Overweight and Obese Patients With Dyslipidemia." American Heart Journal, vol. 142, no. 3, 2001, pp. 489-97.
Dujovne CA, Zavoral JH, Rowe E, et al. Effects of sibutramine on body weight and serum lipids: a double-blind, randomized, placebo-controlled study in 322 overweight and obese patients with dyslipidemia. Am Heart J. 2001;142(3):489-97.
Dujovne, C. A., Zavoral, J. H., Rowe, E., & Mendel, C. M. (2001). Effects of sibutramine on body weight and serum lipids: a double-blind, randomized, placebo-controlled study in 322 overweight and obese patients with dyslipidemia. American Heart Journal, 142(3), pp. 489-97.
Dujovne CA, et al. Effects of Sibutramine On Body Weight and Serum Lipids: a Double-blind, Randomized, Placebo-controlled Study in 322 Overweight and Obese Patients With Dyslipidemia. Am Heart J. 2001;142(3):489-97. PubMed PMID: 11526363.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of sibutramine on body weight and serum lipids: a double-blind, randomized, placebo-controlled study in 322 overweight and obese patients with dyslipidemia. AU - Dujovne,C A, AU - Zavoral,J H, AU - Rowe,E, AU - Mendel,C M, AU - ,, PY - 2001/8/30/pubmed PY - 2001/9/21/medline PY - 2001/8/30/entrez SP - 489 EP - 97 JF - American heart journal JO - Am. Heart J. VL - 142 IS - 3 N2 - BACKGROUND: Cardiovascular risk factors associated with obesity, including dyslipidemia, can be improved by weight loss. The main dyslipidemia associated with obesity is elevated serum triglyceride and decreased serum high-density lipoprotein cholesterol (HDL-C) levels. METHODS: A total of 322 obese patients (body mass index > or = 27) with serum triglyceride levels > or = 250 mg/dL and < or = 1000 mg/dL and serum HDL-C levels < or = 45 mg/dL (women) and < or = 40 mg/dL (men) were placed on a step I American Heart Association diet and subsequently randomized to sibutramine 20 mg (n = 162) or placebo (n = 160) once daily for 24 weeks. RESULTS: Patients taking sibutramine had significantly greater mean weight loss than those receiving placebo (-4.9 kg vs -0.6 kg, P < or = .05). Forty-two percent of the sibutramine group lost > or = 5% of baseline weight and 12% lost > or = 10% compared with 8% and 3%, respectively, of the placebo group (P < or = .05). Mean decreases in serum triglyceride levels among 5% and 10% weight-loss responders in the sibutramine group were 33.4 mg/dL and 72.3 mg/dL, respectively, compared with an increase of 31.7 mg/dL among all patients receiving placebo (P < or = .05). Mean increases in serum HDL-C levels for 5% and 10% weight-loss responders in the sibutramine group were 4.9 mg/dL and 6.7 mg/dL, respectively, compared with an increase of 1.7 mg/dL among all patients in the placebo group (P < or = .05). Adverse events and discontinuation rates were similar in the sibutramine and placebo groups, although sibutramine-treated patients had mean increases in systolic and diastolic blood pressure of 2 to 3 mm Hg relative to placebo. CONCLUSIONS: In overweight and obese patients with high serum triglyceride levels and low serum HDL-C levels, treatment with sibutramine was associated with significant improvements in body weight and in serum triglyceride and HDL-C levels. SN - 0002-8703 UR - https://www.unboundmedicine.com/medline/citation/11526363/Effects_of_sibutramine_on_body_weight_and_serum_lipids:_a_double_blind_randomized_placebo_controlled_study_in_322_overweight_and_obese_patients_with_dyslipidemia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(01)25318-6 DB - PRIME DP - Unbound Medicine ER -