High incidence of reduced plasma HDL cholesterol in diabetic patients treated with rosiglitazone and fibrate

• Published in: Pharmacoepidemiology and drug safety 2007-11, Vol.16 (11), p.1192-1194
• Main Authors: Keidar, Shlomo, Guttmann, Hadassa, Stam, Tamar, Fishman, Ilana, Shapira, Chen
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anticholesteremic Agents - administration & dosage; Anticholesteremic Agents - adverse effects; Anticholesteremic Agents - therapeutic use; Cardiovascular Diseases - etiology; Cardiovascular Diseases - prevention & control; Cholesterol, HDL - blood; Cholesterol, HDL - drug effects; Clofibric Acid - administration & dosage; Clofibric Acid - adverse effects; Clofibric Acid - therapeutic use; diabetes; Diabetes Complications - prevention & control; Diabetes Mellitus - drug therapy; Dose-Response Relationship, Drug; Drug Interactions; Female; fibrate; HDL-C; Humans; hyperlipidemia; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Incidence; Male; Middle Aged; Retrospective Studies; Risk Factors; thiazolidinediones; Thiazolidinediones - administration & dosage; Thiazolidinediones - adverse effects; Thiazolidinediones - therapeutic use
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/pds.1448

Background A paradoxical plasma HDL‐Cholesterol (HDL‐C) reducing effect following combined fibrate and thiazolidinediones (TZDs) therapy was recently reported in occasional cases. As HDL‐C level is inversely related to cardiovascular disease (CVD) risk, we have studied the incidence of reduced HDL‐C level following mono‐ and combined therapy with these drugs in a large diabetic population. Methods This study was designed as a retrospective 5‐year study. Lipid profile records of 54 000 diabetic patients were searched for transient reduction of HDL‐C to levels lower than 17 mg/dL, which was correlated with fibrates and/or TZD treatment. Results Transient reduction in plasma HDL‐C to values lower than 17 mg/dL was observed in 0.02% (2/11 175) of the patients treated with fibrates alone, none of the rosiglitazone‐treated patients (0/3213) and in 1.39% (9/649) of patients treated with combination of fibrate and TZD. HDL‐C lowering effect was reversible upon stopping either fibrate or rosiglitazone and in some patients it occurred within 2 weeks. In two of the patients, the effect was dose‐dependent. Conclusion Severe reduction in plasma HDL‐C is not rare when TZD and fibrates are co‐administrated to diabetic hyperlipidemic patients. As low plasma HDL cholesterol is a risk factor for CVD, the physician should be alert to this phenomenon. Copyright © 2007 John Wiley & Sons, Ltd.