PRAVASTATIN EXPERIENCE IN ELDERLY AND NON-ELDERLY PATIENTS

Epidemiologic evidence linking elevated cholesterol concentrations and coronary heart disease (CHD) through the eighth decade of life provid es a rationale for lowering cholesterol concentrations to reduce morbi dity and mortality from CHD. Pravastatin, a well tolerated HMG CoA red uctase inhibitor with a convenient once-daily dosing regimen, has been shown to effectively lower total and low density lipoprotein (LDL) ch olesterol. Individual data from more than 1800 hypercholesterolemic pa tients enrolled in six double-blind, randomized, multicenter studies w ere pooled and then analyzed to compare the safety and efficacy of pra vastatin in the elderly (i.e., patients at least 65 years old) and the non-elderly. In short-term studies (8-16 weeks), response was dose-re lated and similar in elderly and non-elderly subjects. Pravastatin 20 or 40 mg daily lowered total cholesterol 19-25%, LDL-cholesterol 25-33 %, and triglycerides 14-23%; high density lipoprotein (HDL) cholestero l increased 5-10%. During long-term studies, improvements were sustain ed for more than 24 months in both the non-elderly and elderly. The in cidences of adverse drug events and laboratory abnormalities were simi lar in the elderly and non-elderly patients in all groups (active trea tment control with resin, pravastatin alone, or combination therapy). In short-term studies, treatment was discontinued because of adverse e vents in < 1% of all patients treated with pravastatin (all doses) or placebo. The frequency and profile of adverse events were similar amon g patients treated with pravastatin or placebo. In long-term studies, treatment was discontinued in 0.4% of patients in the pravastatin grou p and in 0.3% of the patients in the bile-acid-binding resin group. If drug therapy is warranted, pravastatin appears to be safe and effecti ve for long-term use in elderly patients with hypercholesterolemia.