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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy of benfluorex in combination with sulfonylurea in type 2 diabetic patients: An 18-week, randomized, double-blind study
Diabetes Care, Volume 29, No. 3, Year 2006
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Description
OBJECTIVE - 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. RESEARCH DESIGN AND METHODS - Type 2 diabetic patients with HbA1c (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. RESULTS - 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 (≤7%) was achieved in 34% of patients receiving benfluorex versus 12% of patients receiving placebo. Significant between-group differences in favor of benfluorex were observed for mean FPG (-1.65 mmol/l) (P < 0.001) and for homeostasis model assessment of insulin resistance. Overall tolerance was similar in both groups. Serious adverse events were more frequent in the benfluorex group, without evidence of causality relationship. CONCLUSIONS - Benfluorex as an add-on therapy was superior to placebo in lowering A1C with a between-group difference of 1% in type 2 diabetic patients whose disease was insufficiently controlled with sulfonylurea alone and in whom metformin was contraindicated or not tolerated. © 2006 by the American Diabetes Association.
Authors & Co-Authors
Moulin, Philippe
France, Villeurbanne
Université Claude Bernard Lyon 1
France, Lyon
Hopital Louis Pradel
André, Marie
France, Neuilly-sur-seine
Servier
Alawi, Hasan
Germany
Schwerpunkt Diabetologie Klinik
Santos, Lélita Conceição
Portugal, Coimbra
Centro Hospitalar e Universitário de Coimbra
Khalid, Abdul K.
Malaysia, Kuala Lumpur
Universiti Kebangsaan
Koev, Dragomir
Bulgaria, Sofia
Sofia University St. Kliment Ohridski
Moore, Ray
South Africa, Durban
Umhlanga Hospital
Şerban, Viorel
Timisoara
Spitalul Judetean
Picandet, Brigitte
France, Neuilly-sur-seine
Servier
Francillard, Marie
France, Neuilly-sur-seine
Servier
Statistics
Citations: 10
Authors: 10
Affiliations: 9
Identifiers
Doi:
10.2337/diacare.29.03.06.dc05-1439
ISSN:
01495992
e-ISSN:
01495992
Research Areas
Disability
Noncommunicable Diseases
Study Design
Cross Sectional Study