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Revista médica de Chile

Print version ISSN 0034-9887

Abstract

PRIETO D, Juan Carlos. Safety profile of statins. Rev. méd. Chile [online]. 2001, vol.129, n.11, pp.1237-1240. ISSN 0034-9887.  http://dx.doi.org/10.4067/S0034-98872001001100001.

HMG-CoA reductase inhibitors (statins) are the treatment of choice for patients with hypercholesterolaemia. Several large-scale clinical trials have examined the efficacy and tolerability of statins, providing a wealth of information on their safety and adverse effect profile. Adverse hepatic effect is reflected as asymptomatic elevations in serum levels of aminotransaminases. Myopathy, occasionally leading to myoglobulinuria secondary to rhabdomyolysis, is a rare and potentially fatal complication. Cerivastatin, the last statin approved for use in humans, was voluntarily withdrawn from the market by Bayer, because fatal rhabdomyolysis was most frequently reported with cerivastatin than for other approved statins. The concomitant use of statins with drugs that inhibit CYP3A4 (cyclosporin, erythromycin, clarithromycin, itraconazole, and ketoconazole), may result in increased plasma concentrations of HMG-CoA reductase inhibitors leading occasionally to myotoxicity. Fibric acid derivatives can produce myotoxicity, and the association of both types of drugs increases the risk of this adverse event. The reason for the greater association of rhabdomyolysis with cerivastatin than with other statins is unknown. The efficiency of post marketing drug surveillance programs in different countries, was the clue for the awareness of this problem (Rev Méd Chile 2001; 129: 1237-40).

Keywords : Adverse drug reaction reporting systems; Cerivastatin; Hidroxymethylglutaryl-CoA reductase inhibitors; Rhabdomyolysis; Statins.

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