Healthy Skepticism Library item: 8190

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Psaty BM, Weiss NS.
NSAID Trials and the Choice of Comparators — Questions of Public Health Importance
NEJM 2007 Jan 25; 356:(4):328-330
http://content.nejm.org/cgi/content/full/356/4/328

Abstract:

Under ideal conditions, large clinical trials would be designed so that they satisfied the marketing needs of the pharmaceutical manufacturers that generally sponsor them and, at the same time, answered important clinical questions that may have a major influence on public health. In practice, however, alternative choices in trial design often favor one of these two goals. The choice of the reference treatment in active-comparator studies is an excellent example.

For nonsteroidal antiinflammatory drugs (NSAIDs), which all relieve arthritis pain, the question of greatest interest in randomized trials involves the incidence of adverse events. The more selective cyclooxygenase-2 (COX-2) inhibitors were developed in the hope that they would pose a lower risk of gastrointestinal bleeding than traditional NSAIDs. Although an early trial of the COX-2 inhibitor rofecoxib showed a relative gastrointestinal benefit, it also suggested that the risk of myocardial infarction was about five times as high with rofecoxib as with naproxen. Subsequently, placebo-controlled trials of rofecoxib, celecoxib, and valdecoxib documented an increased risk of cardiovascular disease…

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