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Echocardiographic Evidence for Valvular Toxicity of Benfluorex: A Double-Blind Randomised Trial in Patients with Type 2 Diabetes Mellitus

Author

Listed:
  • Geneviève Derumeaux
  • Laura Ernande
  • André Serusclat
  • Evelyne Servan
  • Eric Bruckert
  • Hugues Rousset
  • Stephen Senn
  • Luc Van Gaal
  • Brigitte Picandet
  • François Gavini
  • Philippe Moulin
  • on behalf the REGULATE trial investigators

Abstract

Objectives: REGULATE trial was designed to compare the efficacy and safety of benfluorex versus pioglitazone in type 2 diabetes mellitus (DM) patients. Methods: Double-blind, parallel-group, international, randomised, non-inferiority trial. More than half of the 196 participating centres were primary care centres. Patients eligible had type 2 DM uncontrolled on sulfonylurea. 846 were randomised. They received study treatment for 1 year. 423 patients were allocated to benfluorex (150 to 450 mg/day) and 423 were allocated to pioglitazone (30 to 45 mg/day). Primary efficacy criterion was HbA1c. Safety assessment included blinded echocardiographic evaluation of cardiac and valvular status. Results: At baseline, patients were 59.1±10.5 years old with HbA1c 8.3±0.8%, and DM duration 7.1±6.0 years. During the study, mean HbA1c significantly decreased in both groups (benfluorex: from 8.30±0.80 to 7.77±1.31 versus pioglitazone: from 8.30±0.80 to 7.45±1.30%). The last HbA1c value was significantly lower with pioglitazone than with benfluorex (p

Suggested Citation

  • Geneviève Derumeaux & Laura Ernande & André Serusclat & Evelyne Servan & Eric Bruckert & Hugues Rousset & Stephen Senn & Luc Van Gaal & Brigitte Picandet & François Gavini & Philippe Moulin & on behal, 2012. "Echocardiographic Evidence for Valvular Toxicity of Benfluorex: A Double-Blind Randomised Trial in Patients with Type 2 Diabetes Mellitus," PLOS ONE, Public Library of Science, vol. 7(6), pages 1-12, June.
    • Handle: RePEc:plo:pone00:0038273
    DOI: 10.1371/journal.pone.0038273
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