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June 7, 2006

High-Dose Statins and the IDEAL Study

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2006;295(21):2476-2479. doi:10.1001/jama.295.21.2476-c

To the Editor: In the IDEAL study, Dr Pedersen and colleagues1 conclude that intensive cholesterol reduction in patients with prior myocardial infarction can provide benefit without increasing serious adverse effects. However, the incidence of adverse events necessitating permanent discontinuation of high-dose atorvastatin treatment (9.6%) was more than twice that of withdrawal from standard-dose simvastatin (4.2%). In the TNT study, there was also an increase in treatment-related adverse events in patients taking atorvastatin, 80 mg/d, compared with the 10-mg/d regimen (8.1% vs 5.8%; P<.001).2 In that study, the number needed to harm of 43 to produce 1 treatment-induced adverse event was similar to the number needed to treat of 45 to produce a reduction in the first cardiovascular event. In the A to Z trial, there was a significantly higher incidence of myopathy with high-dose simvastatin compared with standard therapy.3 Similarly, the incidence of alanine aminotransferase elevation to higher than 3 times the upper limit of normal was significantly increased with high-dose atorvastatin compared with standard-dose pravastatin in the PROVE IT–TIMI 22 trial (3.3% vs 1.1%; P<.001).4

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