SAFETY PROFILE OF FLUVASTATIN

Statins are regarded as a well-tolerated class of drugs, particularly when compared with some of the older lipid-modifying agents, which hav e poor rates of compliance. Despite some early concern, the incidence of lens opacities observed in clinical studies involving statin use is no different from that in a normal ageing population. Similarly, the occurrence of insomnia with lipophilic agents appears to have been ove remphasised and is not a clinically significant problem, irrespective of the statin under study.(1) Fluvastatin is the newest representative of this class of agents; it has already been evaluated in thousands o f patients who have hyperlipidaemia with and without additional risk f actors. In controlled clinical studies, the incidence of the majority of adverse events observed with fluvastatin therapy is no higher than that seen with placebo, with the exception of gastrointestinal disturb ances (known to be common to all statins). Nonetheless, the incidence of these effects seen with fluvastatin treatment is noted to be lower than that associated with cholestyramine or fibrate use. Elevations in levels of liver transaminases (aspartate aminotransferase and alanine aminotransferase) have been reported with fluvastatin therapy but hav e led to discontinuation of treatment with the same frequency as place bo. Elevations in creatine kinase levels as a cause of discontinuing f luvastatin are not more frequent than with placebo, Myopathy and rhabd omyolysis have not been reported with fluvastatin therapy, and myalgia does not occur more frequently than with placebo, In terms of drug in teractions, fluvastatin does not interfere with the efficacy of antihy pertensive agents. In controlled clinical trials, the overall reported discontinuation rate due to adverse events noted with fluvastatin the rapy is 3.3%, which is not significantly distinguishable from the rate associated with placebo (3.5%).(2)