Elderly patients with hypercholesterolaemia: a double-blind study of the efficacy, safety and tolerability of fluvastatin

BACKGROUND: Coronary heart disease is a major cause of morbidity and mortality in the elderly, a rapidly growing section of the population. Elderly patients have been excluded from most preventative risk factor trials. METHODS: We evaluated fluvastatin, a fully synthetic hydroxymethyl glutaryl coenzyme A reductase inhibitor, in white patients older than 60 years, in seven hospital centres. After an 8-week cholesterol-decreasing diet phase, patients were allocated to groups to receive fluvastatin 40 mg daily (n = 33) or placebo (n = 36) given for 12 weeks. All patients had low-density lipoprotein cholesterol concentrations > or = 4.1 mmol/l 1 week before they were allocated to a treatment at random. After receiving randomised treatment for 12 weeks, 50 patients then received fluvastatin 40 mg daily on an open basis for a further 12 weeks. RESULTS: Mean +/- SD age was 70.7 +/- 5.2 years for fluvastatin patients and 68.3 +/- 5.6 years for placebo. Mean +/- SD percentage changes in lipid concentrations from randomisation to the end of 12 weeks were calculated (n = 63) by intent-to-treat analysis. Total cholesterol decreased by 21.64 +/- 8.7% in the fluvastatin group and by 2.91 +/- 7.25% in the placebo group (P < 0.01); high-density lipoprotein cholesterol increased by 4.98 +/- 10.84% in the fluvastatin group and decreased by 0.05 +/- 8.68% in the placebo group (P = 0.05); low-density lipoprotein cholesterol decreased by 27.14 +/- 8.45% in the fluvastatin group and by 2.16 +/- 9.68% in the placebo group (P < 0.01); very-low-density lipoprotein cholesterol decreased by 30.70 +/- 30.65% in the fluvastatin group and by 9.80 +/- 28.6% in the placebo group (P < 0.01); triglyceride decreased by 18.13 +/- 17.35% in the fluvastatin group and by 2.97 +/- 21.85% in the placebo group (P < 0.01). There were no statistically significant differences between treatment groups for any other biochemical or haematological parameters. Adverse events were mainly mild, diminishing with continued treatment, and no event was serious by standard criteria. Patient-assessed tolerability after randomised treatment was 'very good' for 18 fluvastatin patients and for 26 placebo patients (P = 0.79). Seven patients withdrew from the 12-week follow-up (four from the fluvastatin group and three from the placebo group). CONCLUSIONS: We conclude that fluvastatin decreases lipid concentrations effectively and safely in elderly patients, producing clinically significant decreases in total cholesterol, low-density lipoprotein cholesterol, triglyceride and, especially, very-low-density lipoprotein cholesterol, while increasing high-density lipoprotein cholesterol moderately.