Fluvastatin : clinical and safety profile

Therapy with HMG-CoA reductase inhibitors (statins) has been shown to significantly reduce major coronary events and death in a wide range of individuals at risk for these events. In addition, recent observations suggest that some of the clinical benefits associated with statin therapy may be pleiotropic; that is, independent of their cholesterol-inhibiting action. It is clear that the clinical benefits associated with statin therapy far outweigh the risks; however, there may be important clinical differences among agents within the class, related to both benefits and drug safety. Evaluation of the benefit-to-risk profile for each available statin should include considering the results of randomised clinical outcome trials, the safety record of each agent, effect on lipoproteins and evidence of beneficial pleiotropic properties. Recently, data from several clinical outcome trials have shown that substantial benefits are associated with treatment with fluvastatin in diverse populations. In particular, data from two large, randomised clinical trials have demonstrated that fluvastatin is effective for secondary prevention of cardiac events in patients following coronary intervention procedures, and for primary prevention of cardiac events in renal transplant recipients. Pleiotropic benefits for fluvastatin have been shown in experimental and clinical studies as well. Fluvastatin was the first statin available as an extended-release product (fluvastatin XL 80mg); both formulations have demonstrated efficacy and safety in a wide range of patients. Taken together, these clinical outcomes and safety data suggest a strong benefit-to-risk profile for fluvastatin.