Fluvastatin and niacin in hypercholesterolemia: a preliminary report on gender differences in efficacy

A total of 74 hypercholesterolemic patients were randomized to receive double-blind treatment for 6 weeks with either 20 mg of fluvastatin daily or placebo. Open-label niacin, to a maximum of 3 g daily, was added to each treatment for a further 9 weeks. Changes in lipid parameters were derived from averaged data, with monotherapy at weeks 3 and 6 and with combination therapy at weeks 12 and 15. The reduction in low-density lipoprotein cholesterol (LDL-C) was significantly greater with fluvastatin (20.8%) compared with placebo (p < 0.001) after 3-6 weeks of treatment. At the end of 12-15 weeks, the addition of niacin potentiated the response to 43.7% with the fluvastatin+niacin combination and to 26.5% with the placebo+niacin combination (p < 0.001, vs baseline and between treatment groups). Significant gender differences were noted in the LDL-C response to the fluvastatin+niacin combination. Women achieved LDL-C reductions of 54.6% whereas men achieved reductions of 38.2% (p < 0.0005, between gender groups). Women also tended to have greater LDL-C reductions with the placebo+niacin combination, compared with men (p < 0.05). At the end of 12-15 weeks, there were HDL-C increases of 33.1% (p < 0.001) whereas triglyceride levels declined by 32.3% (p < 0.001). In conclusion, fluvastatin, both as monotherapy and in combination with niacin, proved to be an effective and well-tolerated alternative for the treatment of hypercholesterolemia. The differential response in LDL-C between men and women should be further explored in other trials of lipid-lowering therapy.