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January 1991

Pravastatin vs Gemfibrozil in the Treatment of Primary Hypercholesterolemia: The Italian Multicenter Pravastatin Study I

Author Affiliations

From the Lipid Clinics, University of Padua (Italy) (Drs Crepaldi, Baggio, and Segato), University of Milan (Italy) (Drs C. R. Sirtori and M. Sirtori), University of Trieste (Italy) (Drs Cattin and Feruglio), University of Verona (Italy) (Drs Muggeo and Querena), University of Venice (Italy) (Drs Avogaro and Bittolo Bon), University of Bologna (Italy) (Drs Descovich and Gaddi), University of Pisa (Italy) (Drs Navalesi and Miccoli), University of Rome (Italy) (Drs Arca and Ricci), University of Perugia (Italy) (Drs Lupattelli and Ventura), University of Naples (Italy) (Drs Gnasso and Mancini), University of Bari (Italy) (Drs Capurso and Resta), University of Palermo (Italy) (Drs Avellone and Bompiani), University of Cagliari (Italy) (Drs Muntoni and Pintus); and with the collaboration of Squibb, Rome, Italy (Drs D'Alǒ, Liberatore, and Patrizi).

Arch Intern Med. 1991;151(1):146-152. doi:10.1001/archinte.1991.00400010148023

This study compared the efficacy and safety of pravastatin and gemfibrozil in the treatment of primary hypercholesterolemia. Three hundred eighty-five outpatients from 13 lipid clinics in Italy participated in this randomized double-blind study. Patients were assigned to receive either 40 mg once daily of pravastatin or 600 mg of gemfibrozil twice daily after an initial diet lead-in period. After 24 weeks, mean reductions from baseline values of plasma total and low-density lipoprotein cholesterol were, respectively, 23% and 30% with pravastatin and 14% and 17% with gemfibrozil. Significant lipid-lowering effects were noted within 4 weeks. Apolipoprotein B decrease was 21% with pravastatin and 13% with gemfibrozil. A statistically significant increase of high-density lipoprotein cholesterol of 5% was achieved with pravastatin compared with a 13% increase for gemfibrozil. Serum triglyceride values decreased 5% with pravastatin and 37% with gemfibrozil. Familial and polygenic hypercholesterolemic patients were also examined separately. Pravastatin effectiveness in reducing low-density lipoprotein cholesterol was greater by 6% in polygenic than in familial hypercholesterolemic patients. Treatment for 25 patients (eight treated with pravastatin and 17 treated with gemfibrozil) was discontinued during the study. The incidence of clinical symptoms and laboratory alterations was low for both treatment groups. Pravastatin and gemfibrozil were well tolerated, but pravastatin was significantly more effective in reducing total and low-density lipoprotein cholesterol levels in primary (either familial or polygenic) hypercholesterolemias than gemfibrozil.

(Arch Intern Med. 1990;151:146-152)