Efficacy of benfluorex in combination with sulfonylurea in type 2 diabetic patients: an 18-week, randomized, double-blind study

Diabetes Care
Philippe MoulinMarie Francillard

Abstract

The aim of this study was to demonstrate the superiority of benfluorex over placebo as an add-on therapy in type 2 diabetic patients in whom diabetes is insufficiently controlled by sulfonylurea monotherapy and who have a limitation for the use of metformin. Type 2 diabetic patients with HbA(1c) (A1C) (7-10%) who were receiving the maximum tolerated sulfonylurea dose and had a contraindication to or poor tolerance of metformin were randomly assigned (double blind) to receive benfluorex 450 mg/day (n = 165) or placebo (n = 160) for 18 weeks. The main efficacy criterion was A1C, analyzed as the change from baseline to the end of treatment using ANCOVA with baseline and country as covariates. Secondary criteria were fasting plasma glucose (FPG), insulin resistance, and plasma lipid level. Both groups were similar at baseline in the intention-to-treat population. A1C significantly decreased with benfluorex from 8.34 +/- 0.83 to 7.52 +/- 1.04% (P < 0.001) and tended to increase with placebo from 8.33 +/- 0.87 to 8.52 +/- 1.36% (NS), resulting in a mean adjusted difference between groups of -1.01% (95% CI -1.26 to -0.76; P < 0.001). The target A1C (< or =7%) was achieved in 34% of patients receiving benfluorex versus 12% of patients ...Continue Reading

References

Jan 1, 1976·Nephron·D W Cockcroft, M H Gault
Sep 1, 1996·Journal of Diabetes and Its Complications·N StucciF Tomasi
Jul 7, 1999·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·H C Howlett, C J Bailey
Oct 8, 1999·Diabetic Medicine : a Journal of the British Diabetic Association
May 23, 2001·JAMA : the Journal of the American Medical Association·UNKNOWN Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults
Dec 25, 2004·Diabetes Care·UNKNOWN American Diabetes Association

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Citations

Jun 15, 2011·Lancet·Lucy VincentEmmanuel Canet
Jun 15, 2011·La Presse médicale·Rémy Boussageon
Oct 11, 2011·La Presse médicale·Christophe TribouilloyMichel Andréjak
May 17, 2013·ACS Chemical Biology·Seung-Hee LeeFred Levine
Mar 20, 2010·European Journal of Echocardiography : the Journal of the Working Group on Echocardiography of the European Society of Cardiology·Christophe TribouilloyThierry Caus
Jan 5, 2011·European Journal of Echocardiography : the Journal of the Working Group on Echocardiography of the European Society of Cardiology·Florent Le VenYves Etienne
Apr 26, 2021·Pharmacology & Therapeutics·Reem OdiEmilio Perucca

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