Summary
An increase in total and low density lipoprotein (LDL) cholesterol concentrations is related to the incidence of cardiovascular heart disease. The purpose of this study was to compare the efficacy and safety of pravastatin, an HMG-CoA reductase inhibitor, versus gemfibrozil, a fibrate, in the treatment of primary hypercholesterolaemia. 855 subjects (males and females, aged between 18 and 70 years) with total cholesterol (TC) concentrations > 240 mg/dl and triglyceride (TG) concentrations < 250 mg/dl were enrolled. After a pretreatment diet period, patients received either pravastatin 20 mg/day (659 patients) or gemfibrozil 1200 mg/day (196 patients). At the end of the 12-week treatment period, reductions in TC (−23%) and LDL-C (−31%) were noted in the pravastatin group. Gemfibrozil reduced TC by 16% and LDL by 20%. High density lipoprotein (HDL) cholesterol concentrations increased in a similar way in the two groups: pravastatin +10%, gemfibrozil+11%. Triglycerides decreased by 14% with pravastatin and by 22% with gemfibrozil. Pravastatin and gemfibrozil were both well tolerated. No significant adverse events or variations in laboratory parameters occurred during this study.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Arntz H-R, Bonner G, Kikis D, Kirch W, Klor HU, et al. Efficacy of pravastatin and bezafibrate in primary hypercholesterolaemia. Deutsche Medizinische Wochenschrift 116: 7–12, 1991
Bailar JC III. Cause and effect in epidemiology. What do we know about hypertriglyceridemia. New England Journal of Medicine 302: 1417–1418, 1980
Blankenhorn DH, Nessim SA, Johnson RL, Sanmarco ME, Azem SP, et al. Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts. Journal of the American Medical Association 257: 3233–3240, 1987
Brown MS, Goldstein JL. Drugs used in the treatment of hyperlipoproteinemias. In Goodman & Gilman (Eds) The pharmacological basis of therapeutics, pp. 874–896, Pergamon Press 1990
Carmena R, de Oya M, Franco M, Martinez ML, Mata P, et al. Treatment of heterozygous familial hypercholesterolaemia with pravastatin (CS-514) and/or cholestyramine (The Spanish Multi-center Pravastatin Study). 8th International Symposium on Atherosclerosis, Rome, 9–13 October, pp. 757–760, 1988
Castelli WP, Doyle JT, Gordon T, Hames CG, Hjortland MC, et al. HDL cholesterol and other lipids in coronary artery disease. The cooperative lipoprotein phenotyping study. Circulation 55: 767–772, 1977
Crepaldi G, Baggio G, Arca M, Avellone G, Avogaro P, et al. Pravastatin vs gemfibrozil. in the treatment of primary hypercholesterolemia. The Italian Multicenter Pravastatin Study I. Archives of Internal Medicine 151: 146–152, 1991
Endo A, Kuroda M, Tanazawa K. Competitive inhibition of HMG CoA reductase by ML-236A and ML-236B, fungal metabolites having hypocholesterolemic activity. FEBS Letters 72: 323–326, 1976
Expert Panel. Report of the National Cholesterol Education Program Expert Panel on detection, evaluation and treatment of high blood cholesterol in adults. Archives of Internal Medicine 148: 36–69, 1988
Frick MH, Elo MO, Haapa K, et al. Helsinki Heart Study: primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia. New England Journal of Medicine 317: 1237–1245, 1987
Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clinical Chemistry 18: 499–552, 1972
Goto Y, Yamamoto A, Goto Y, Yoshido S, Saito Y, et al. Study on clinical efficacy of CS-514 (pravastatin) in long term treatment of hypercholesterolemia. Journal of Clinical Therapeutics and Medicines 4: 409–437, 1988a
Goto Y, Yamamoto A, Matsuzawa Y, Nakaya N, Hata Y, et al. Clinical usefulness of pravastatin (CS-514) in the treatment of patients with hyperlipemia: double-blind comparison with probucol. Journal of Clinical and Experimental Medicine 146: 927–955, 1988c
Goto Y, Yasugi T, Goto Y, Yoshida S, Saito Y, et al. Clinical evaluation of CS-514 (pravastatin) on hyperlipidemia: double blind study with clinofibrate. Clinical Evaluation 16: 211–249, 1988b
Gotto Jr AM. Pravastatin: a hydrophilic inhibitor of cholesterol synthesis. Journal of Drug Development 3: 155–161, 1990
Grundy SM. HMG CoA reductase inhibitors for treatment of hypercholesterolemia. New England Journal of Medicine 319: 24–33, 1988
Havel RJ. Familial dysbetalipoproteinemia. New aspects of pathogenesis and diagnosis. Medical Clinics of North America 66: 441–454, 1982
Havel RS, Hunninghake BD, Illingworth DR, et al. Lovastatin (Mevinolin) in the treatment of heterozygous familial hypercholesterolemia. Annals of Internal Medicine 107: 609–615, 1987
Hoeg JM, Brewer HB. HMG CoA reductase inhibitors in the treatment of hypercholesterolemia. Journal of the American Medical Association 258: 3532–3536, 1987
Hunninghake DB, Knopp RH, Schonfeld G, Goldberg AC, Brown WV, et al. Efficacy and safety of pravastatin in patients with primary hypercholesterolemia I. A dose-response study. Atherosclerosis 85: 219–227, 1990
Kazumi T, Yoshino G, Kasama T, Iwatani I, Iwai M, et al. Effects of CS-514, a new inhibitor of HMG CoA reductase, on plasma lipids, lipoproteins and apoproteins in patients with primary hypercholesterolemia. Hormone and Metabolic Research 18: 654–655, 1986
Koga T, Shimada Y, Kuroda M, Tsujita Y, Hasegawa K, et al. Tissue-selective inhibition of cholesterol synthesis in vivo by pravastatin sodium, an HMG CoA reductase inhibitor. Biochemica et Biophysica Acta 1045: 115–120, 1990
Lipid Research Clinics Coronary Primary Prevention Trial. Results, I: reduction in incidence of coronary heart disease. Journal of the American Medical Association 251: 351–364, 1984a
Lipid Research Clinics Coronary Primary Prevention Trial. Results, II: the relationship of reduction in incidence of coronary heart disease to cholesterol lowering. Journal of the American Medical Association 251: 365–374, 1984b
Lovastatin Study Group III. A multicenter comparison of lovastatin and cholestyramine therapy for severe primary hypercholesterolemia. Journal of the American Medical Association 260: 359–366, 1988
Mabuchi H, Takeda R. Inhibitors of 3-hydroxy-methylglutaryl coenzyme A reductase: compactin and its analogues. In Fears (Ed.) Pharmacological control of hyperlipidemia, pp. 251–266, JR Prous Science Publishers, Spain, 1986
Manninen V, Elo O, Frick MH, et al. Lipid alterations and decline in the incidence of coronary heart disease in the Helsinki Heart Study. Journal of the American Medical Association 260: 241–251, 1988
Nakaya N, Goto Y. Effect of CS-514 on hypercholesterolemic patients. In Paoletti (Ed.) Drugs affecting lipid metabolism, pp. 274–277, Springer-Verlag, Berlin, 1987
Nakaya N, Homma Y, Tamachi H, Goto Y. The effect of CS-514, an inhibitor of HMG CoA reductase, on serum lipids in healthy volunteers. Atherosclerosis 61: 125–128, 1986
Napoli C, Lepore S, Ambrosio G, Chiariello M. Evaluation of pravastatin in single therapy or in association with gemfibrozil in hypercholesterolemia associated with moderate hypertriglyceridemia. Cardiologia 37: 761–768, 1992
Newman TJ, Kassler-Taub KB, Gelarden RT, et al. Safety of pravastatin in long-term clinical trials conducted in the United States. Journal of Drug Development 3(Suppl. 1): 275–281, 1990
Pan HY, DeVault AR, Wang-Iverson D, Ivashkiv E, Swanson BN, et al. Comparative pharmacokinetics and pharmacodynamics of pravastatin and lovastatin. Journal of Clinical Pharmacology 28: 942, 1990
Pan HY, Triscari J, DeVault AR, Smith SA, Wang-Iverson D, et al. Pharmacokinetic interaction between propranolol and the HMG CoA reductase inhibitors pravastatin and lovastatin. British Journal of Clinical Pharmacology 31: 665–670, 1991
Pan HY, Willard DA, Funke PT, McKinsty DN. The clinical pharmacology of SQ 31.000 (CS 514) in healthy subjects. In Paoletti (Ed.) Drugs affecting lipid metabolism, pp. 255–259, Springer-Verlag, Berlin, 1987
Pekkanen J, Linn S, Heiss G, et al. Ten-year mortality from cardiovascular disease in relation to cholesterol level among men with and without preexisting cardiovascular disease. New England Journal of Medicine 332: 1700–1707, 1990
Reaven GM. Insulin resistance and the development of cardiovascular disease. Clinician 7: 10–14, 1989
Reihner E, Rudling M, Stahlberg D, Berglund L, Ewerth S, et al. Influence of pravastatin, a specific inhibitor of HMG CoA reductase, on hepatic metabolism of cholesterol. New England Journal of Medicine 323: 224–228, 1990
Schwartzkopff W, Bimmermann A, Schleicher J. Comparison of the efficacy on pravastatin and cholestyramine in hypercholesterolaemic patients. Arzneimittel-Forschung 40: 1322–1327, 1990
Shiomi M, Ito T, Watanabe Y, Tsujita Y, Kuroda M, et al. Suppression of the combination treatment with pravastatin sodium and cholestyramine of the progression of atherosclerosis and xanthoma in mature WHHL rabbits. Presented at the 8th International Symposium of Atherosclerosis, October 9–13, 1988
Summary of the Second Report of the National Cholesterol Education Program (NCEP) Expert Panel on detection, evaluation and treatment of high blood cholesterol in adults (Adult Treatment Panel II). Journal of the American Medical Association 269: 3015–3023, 1993
Tikkanen MJ, Helve E, Jaattela A, et al. Comparison between lovastatin and gemfibrozil in the treatment of primary hypercholesterolemia: the Finnish Multicenter Study. American Journal of Cardiology 62: 35J–43J, 1988
Vega GL, Krauss RM, Grundy SM. Pravastatin therapy in primary moderate hypercholesterolaemia: changes in metabolism of apolipoprotein B-containing lipoproteins. Journal of Internal Medicine 227: 81–94, 1990
Volpe R, Area M, Ginnetti MG, Urbinati GC. Efficacy and safety of pravastatin: comparison in patients with primary hypercholesterolaemia. Abstract. 56th European Atherosclerosis Congress, Cagliari, 1990
Wiklund O, Angelin B, Fager G, Eriksson M, Olofsson S-O, et al. Treatment of familial hypercholesterolaemia: a controlled trial of the effects of pravastatin or cholestyramine therapy on lipoprotein and apolipoprotein levels. Journal of Internal Medicine 228: 241–247, 1990
Yoshino G, Kazumi T, Matsushita M, Iwai M, Matsuba K, et al. Comparison of the effects of pravastatin and simvastatin in hypercholesterolemic subjects. Current Therapeutic Research 48: 259–267, 1990
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Malacco, E., Magni, A., Scandiani, L. et al. Pravastatin vs Gemfibrozil in the Treatment of Primary Hypercholesterolaemia. Drug Invest 7, 331–339 (1994). https://doi.org/10.1007/BF03258475
Published:
Issue Date:
DOI: https://doi.org/10.1007/BF03258475