Efficacy and safety of fluvastatin in elderly hypercholesterolemic patients: A pilot study

Abstract

In an open-label, 6-week study, we evaluated the efficacy, safety, and tolerability of fluvastatin, the first fully synthetic 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, in elderly patients with type IIA primary hypercholesterolemia. After completing a 4-week, single-blind, placebo period, 39 elderly patients (17 men and 22 women; mean age, 67 ± 4 years) whose low-density lipoprotein cholesterol (LDL-C) was greater than 160 mg/dL were treated with fluvastatin 40 mg once daily in the evening. Total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglycerides were measured after placebo administration (baseline) and 3 and 6 weeks of fluvastatin treatment. Apolipoproteins B (apo B) and A1 (apo A1) were measured at baseline and after 6 weeks of treatment. Safety and tolerability were assessed by monitoring routine laboratory parameters and recording spontaneously reported adverse effects. At baseline, the mean ± SD levels of total cholesterol, LDL-C, triglycerides, HDL-C, apo B, and apo A1 were 316 ± 44, 229 ± 43, 145 ± 67, 58 ± 16, 217 ± 55, and 163 ± 24 mg/dL, respectively. After 6 weeks of treatment with fluvastatin, the levels of total cholesterol, LDL-C, and apo B decreased by 22%, 29%, and 23%, respectively ( P < 0.001). The decreases were apparent by week 3 (total cholesterol, −21%; LDL-C, −27%). The total cholesterol: HDL-C ratios were reduced by 22% at week 3 and by 21% at week 6. Triglycerides were reduced by 19% at week 3 and 13% at week 6, but the change was not significant. No significant increases in aspartate aminotransferase, alanine aminotransferase, or creatinine occurred during the study period. Drug-related side effects (gastrointestinal complaints), which were mild and transient in nature, were reported by three patients. One patient withdrew from the study because of epigastralgia. No muscle-related side effects were reported. Fluvastatin 40 mg once daily in the evening is an effective, safe, and well-tolerated drug for the treatment of primary hypercholesterolemia in elderly patients.