COMBINATION THERAPY WITH FLUVASTATIN AND NIACIN IN HYPERCHOLESTEROLEMIA - A PRELIMINARY-REPORT ON SAFETY

A double-blind, randomized study was undertaken to evaluate the effica cy and safety of fluvastatin as monotherapy and as combination therapy with niacin in the treatment of hypercholesterolemia refractory to di et. Seventy-four patients with plasma low-density lipoprotein choleste rol (LDL-C) levels greater than or equal to 160 mg/dL were treated wit h flwastatin, 20 mg/d, or placebo for 6 weeks. Thereafter, immediate-r elease niacsn, at a dosage titrated to a maximum of 3 g/d, was added t o both regimens for another 9 weeks. All adverse events were monitored , with particular attention to the evaluation of liver and muscle enzy mes. Initial analysis of the data shows that fluvastatin and its combi nation with niacin was well tolerated and was not associated with any serious adverse events. Small, transient, asymptomatic rises In aspart ate aminotransferase (AST) occurred in 28.9% of fluvastatin-niacin tre ated patients compared to 8.3% in the niacin-placebo control arm (p < 0.05). These were considered clinically insignificant in that no trans aminase elevations > 3 times the upper limit of normal occurred. No ev idence of myopathy, creatine kinase levels exceeding 10 times the uppe r limit of normal, myositis, or rhabdomyolysis were demonstrated in th is short-term trial. The majority of adverse events resulting in patie nt withdrawls were ascribed to niacin therapy and Included cutaneous v asodilatation, flushing, itching, and rash. These preliminary results suggest that fluvastatin, both alone and combined with niacin, is an e ffective, safe, and well-tolerated treatment for hypercholesterolemia.