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Pharmacoepidemiol Drug Saf. 2000 Jan;9(1):25-35. doi: 10.1002/(SICI)1099-1557(200001/02)9:1<25::AID-PDS469>3.0.CO;2-E.

The calcium-channel blocker controversy: historical perspective and important lessons for future pharmacotherapies. An international society of pharmacoepidemiology 'hot topic'.

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1
Department of Medicine and Cardiovascular Division, University of Pennsylvania School of Medicine, Pennsylvania, USA.

Abstract

Reports of adverse events in association with calcium-channel blockers led to heated controversy over the safety and efficacy of these drugs, as well as to panic among the general public. At the 1998 International Conference of Pharmacoepidemiology, four experts were asked to summarize, and draw lessons from, the controversy's development. We conducted our own review in order to provide a broader historical perspective on the subject and to present the discussants' views within the framework of additional published opinions. Several years after the controversy's onset, many uncertainties still remain about the merits of CCBs. Yet the media scare generated by a few studies might have been prevented had investigators placed greater emphasis, particularly in their reports to the media, on the limitations of their observational and meta-analytic designs. These studies, however, did call attention to the persistent use of CCBs for off-label indications, and the imperative to improve clinician prescribing practices. Moreover, they showed the pitfalls of reliance on surrogate endpoints, stressing the need for data on major clinical outcomes-with funding a responsibility of the pharmaceutical industry-before approving drugs destined for widespread, long-term use. Attention to these lessons will do us well as we evaluate emerging pharmacotherapies.

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