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Long-term safety of pravastatin-gemfibrozil therapy in mixed hyperlipidemia
1Preventive Cardiology Center, Rush Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, USA.
Insights
This study shows that combining pravastatin and gemfibrozil is a safe and effective treatment for mixed hyperlipidemia, significantly improving lipid levels over a long-term period.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
Background:
- Mixed hyperlipidemia often requires combination therapy with HMG-CoA reductase inhibitors and fibric acid derivatives for effective lipid reduction.
- Myopathy risk has historically limited the combined use of these lipid-lowering agents.
Purpose of the Study:
- To evaluate the long-term safety and efficacy of combined pravastatin and gemfibrozil therapy in patients with mixed hyperlipidemia.
Main Methods:
- Eighty-three hyperlipidemia patients received combined pravastatin and gemfibrozil for a median of 44 months.
- Regular monitoring of plasma lipids, liver function, creatinine, and creatinine kinase (CK) levels was performed.
Main Results:
- The combination therapy demonstrated significant reductions in total cholesterol (25%), triglycerides (53%), and LDL cholesterol (14%).
- High-density lipoprotein (HDL) cholesterol increased by 20% with no significant changes in liver function tests.
- Adverse events were minimal, including one case of myalgia and transient CK elevations in three patients.
Conclusions:
- Combined pravastatin and gemfibrozil therapy is safe and efficacious for long-term management of mixed hyperlipidemia.
- The observed safety profile is consistent with shorter-term studies, supporting its clinical utility.
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.