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Atorvastatin

A Safety and Tolerability Profile

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Abstract

Extensive data are available on the safety of atorvastatin from randomised clinical trials, postmarketing analyses and reports to regulatory agencies. Atorvastatin is generally well tolerated across the range of therapeutic dosages, with the exception of a slightly higher rate of liver enzyme elevations with atorvastatin 80 mg/day which does not appear to confer an increased risk of clinically important adverse events. Unlike simvastatin, atorvastatin is associated with a low incidence of muscular toxicity. It is not associated with neurological, cognitive or renal adverse effects and does not require dosage adjustment in patients with renal dysfunction, due to its favourable pharmacokinetic profile, which is unique among the statins. In patients aged >65 years, atorvastatin is well tolerated with no dose-dependent increase in adverse events up to the maximum daily dosage of 80 mg/day. Thus, atorvastatin is a safe and well tolerated statin for use in a wide range of patients.

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Table I

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Acknowledgements

The preparation of this manuscript has been sponsored by Pfizer Italia, who proposed the initial idea of the review. Prof. Marcello Arca has the responsibility of reported data as well as of their interpretation. The sponsor had no role in the approval of the final manuscript. Prof. Marcello Arca served as consultant and/or received speaker honoraria from Merck Sharp & Dhome, AstraZeneca, Simesa, Sanofi Aventis, Pfizer, Guidotti and Neopharmed. The author wishes to thank Dr Michelangelo Barone from the Medical Department of Pfizer Italia for his technical support in collecting part of the material used for this paper. Editorial support for the preparation of the manuscript was provided by Wolters Kluwer Health Medical Communications.

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  1. Department of Clinical and Therapeutic Medicine, La Sapienza University of Rome, Policlinico Umberto I, Viale del Policlinico 155, 00161, Rome, Italy

    Marcello Arca

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Correspondence to Marcello Arca.

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Arca, M. Atorvastatin. Drugs 67 (Suppl 1), 63–69 (2007). https://doi.org/10.2165/00003495-200767001-00007

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