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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 . . . [Full Text of this Article]

Terje R. Pedersen, MD, PhD
t.r.pedersen@medisin.uio.no
Center of Preventive Medicine
Ullevål University Hospital
Oslo, Norway

Ole Faergeman, MD, DMSc
Department of Medicine–Cardiology A
Århus University Hospital
Århus, Denmark

John J. P. Kastelein, MD, PhD
Academic Hospital Amsterdam
Amsterdam, the Netherlands

Anders G. Olsson, MD, PhD
Department of Internal Medicine
University Hospital
Linköping, Sweden

Matti J. Tikkanen, MD, PhD
Medical Clinic
Helsinki University Hospital
Helsinki, Finland

Ingar Holme, PhD
Center of Preventive Medicine
Ullevål University Hospital
Oslo, Norway

Mogens Lytken Larsen, MD, DMSc
Department of Medicine–Cardiology A
Århus University Hospital,
Århus, Denmark

Fredrik S. Bendiksen, MD
Hamar, Norway

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