An open label multicenter study to evaluate the efficacy and tolerability of gemfibrozil in elderly hyperlipidemic patients

Abstract: Background and Aim: To evaluate the efficacy and the tolerability of a consecutive treatment regimen with gemfibrozil (GM) 600 mg BID for three months followed by 900 mg QD for three further months in elderly hyperlipidemic patients. Methods and Results: A total of 64 dyslipidemic patients (22 men, 42 women, aged between 65 and 79 years) were enrolled by 6 Italian Centers. Polygenic hypercholesterolemia was diagnosed in 33% of patients, combined hyperlipidemia in 33% and the remaining 33% had WHO phenotype IV. Hypertension and obesity were the most frequent concomitant diseases. GM 600 mg BID significantly decreased total cholesterol (TC) by 13.9% and low-density lipoprotein cholesterol (LDL) by 12.4%. These attained levels were maintained during the second phase. High-density lipoprotein cholesterol (HDL) concentration increased by 12.6 and 141% after 12 and 24 weeks, respectively. Serum triglycerides (TG) decreased by 40.8% after 12 weeks, followed by an additional 6% decrease in the second phase. Ratios of TC/HDL and LDL/HDL showed parallel decreases of about 20% at week 12, then to about 22% at week 24. GM was well tolerated: the incidence of clinical symptoms and laboratory adverse experiences was minimal. Gastrointestinal discomfort was the most frequently reported symptom. It was generally mild and transient and rarely resulted in discontinuation of the trial. Conclusions: A treatment regimen with GM 600 mg BID for three months, followed by 900 mg QD for the ensuing three months appeared to be safe and effective in these elderly people.