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June 7, 2006

High-Dose Statins and the IDEAL Study—Reply

Author Affiliations

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

JAMA. 2006;295(21):2476-2479. doi:10.1001/jama.295.21.2478

In Reply: Drs Ravnskov, Rosch, and Sutter express concern that almost all patients participating in the IDEAL study experienced adverse effects. The numbers presented in Table 4 of the article do not represent only drug-related adverse effects. In accordance with good clinical trial practice, the study protocol required that all observed or volunteered adverse events, whether or not considered drug-related, should be recorded during the trial. This included worsening or increase in severity or frequency of preexisting conditions as well as minor and serious new signs, symptoms, or laboratory findings. In a population of middle-aged or elderly coronary disease patients aged up to 80 years, it is rare that anyone does not have at least an episode of common cold or a minor musculoskeletal injury over a period of 5 years. The frequency of all adverse events in the IDEAL study was therefore as expected. Adverse events considered definitely or possibly drug-related were few, and significant differences between the 2 treatment groups were presented in the article. The frequency was not greater than in comparable trials.

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