Long‐Term safety of pravastatin‐gemfibrozil therapy in mixed hyperlipidemia

• Published in: Clinical cardiology (Mahwah, N.J.) Vol. 22; no. 1; pp. 25 - 28
• Main Authors: Iliadis, Elias A., Rosenson, Robert S.
• Format: Journal Article
• Language: English
• Published: New York Wiley Periodicals, Inc 01.01.1999; Wiley
• Subjects: Biological and medical sciences; Cholesterol, HDL - blood; Cholesterol, LDL - blood; Clinical Investigation; Clinical Investigations; Creatine - blood; Creatine Kinase - blood; Drug Therapy, Combination; Drug toxicity and drugs side effects treatment; Female; fibric acid derivative; Follow-Up Studies; Gemfibrozil - therapeutic use; HMG‐CoA reductase inhibitor; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hyperlipidemias - blood; Hyperlipidemias - drug therapy; Liver Function Tests; Male; Medical sciences; Middle Aged; mixed hyperlipidemia; myopathy; Pharmacology. Drug treatments; Pravastatin - therapeutic use; Retrospective Studies; Safety; statin; Toxicity: nervous system and muscle; Treatment Outcome; Triglycerides - blood; Human; Drug combination; Enzyme; Fibrate derivatives; Toxicity; Hydroxymethylglutaryl-CoA synthase; Enzyme inhibitor; Metabolic diseases; Lipids; Lyases; Myalgia; Pravastatin; Oxo-acid-lyases; Carbon-carbon lyases; Striated muscle disease; Chemotherapy; Pain; Treatment; Mixed; Gemfibrozil; Hyperlipemia; Dyslipemia; Antilipemic agent
• ISSN: 0160-9289; 1932-8737
• DOI: 10.1002/clc.4960220110

Background: Combined HMG‐CoA reductase inhibitor and fibric acid derivative therapy is often necessary for the effective reduction of concentrations of low‐density lipoprotein (LDL) cholesterol and triglycerides in patients with mixed hyperlipidemia; however, the potential risk of myopathy has limited the use of these agents. Hypothesis: This study evaluated long‐term safety and efficacy of combined pravastatin and gemfibrozil therapy. Methods: Eighty‐three patients with hyperlipidemia were treated with combined pravastatin and gemfibrozil therapy for a median of 44 months (range 9–78 months). Plasma lipids, serum liver function tests, creatinine, and creatinine kinase (CK) levels were measured every 3 to 4 months. Results: One patient developed myalgia with a normal CK level after 4 months of combination therapy. Three patients had transient elevations in CK levels that ranged from 3 to 5 times the upper limits of “normal” and that returned to normal upon repeat testing. Liver function tests did not change significantly from baseline. in a subset of 26 previously untreated patients, combined pravastatin (mean daily dose 22 mg) and gemfibrozil (mean daily dose 1,154 mg) therapy lowered total cholesterol by 25% (p<0.001), triglycerides by 53% (p = 0.0001), LDL cholesterol by 14% (p = 0.24), and increased high‐density lipoprotein (HDL) cholesterol by 20% (p = 0.012). Conclusion: Pravastatin and gemfibrozil therapy is safe and efficacious in patients with mixed hyperlipidemia. The long‐term safety results are consistent with other reports on follow‐up of shorter duration.