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American Journal of Epidemiology Advance Access originally published online on August 27, 2008
American Journal of Epidemiology 2008 168(8):966-973; doi:10.1093/aje/kwn191
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American Journal of Epidemiology © 2008 The Authors
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

ORIGINAL CONTRIBUTIONS

Use of a Prescribed Ephedrine/Caffeine Combination and the Risk of Serious Cardiovascular Events: A Registry-based Case-Crossover Study

Jesper Hallas, Lars Bjerrum, Henrik Støvring and Morten Andersen

Correspondence to Dr. Jesper Hallas, Department of Clinical Pharmacology, Faculty of Health Sciences, University of Southern Denmark, Winsløwsparken 19,2, DK 5000 Odense C, Denmark (e-mail: jhallas{at}health.sdu.dk).

Received for publication March 31, 2008. Accepted for publication June 9, 2008.

Ephedrine and herbal ephedra preparations have been shown to induce a small-to-moderate weight loss. Owing to reports on serious cardiovascular events, they were banned from the US market in 2004. There have been no large controlled studies on the possible association between prescribed ephedrine/caffeine and cardiovascular events in general. The authors linked data from four different sources within Statistics Denmark, using data on 257,364 users of prescribed ephedrine/caffeine for the period 1995–2002. The data were analyzed using a case-crossover technique with a composite endpoint: death outside of a hospital, myocardial infarction, or stroke. To account for effects of chronic exposure and effects in naïve users, the authors performed a secondary case-control study nested within the cohort of ephedrine/caffeine ever users. Among 2,316 case subjects, 282 (12.2%) were current users of ephedrine/caffeine. The case-crossover analysis yielded an odds ratio of 0.84 (95% confidence interval: 0.71, 1.00); after adjustment for trends in ephedrine/caffeine use, it was 0.95 (95% confidence interval: 0.79, 1.16). Subgroup analyses revealed no strata with significantly elevated risk. In the case-control substudy, there was no increased risk among naïve users or users with large cumulative doses. Prescribed ephedrine/caffeine was not associated with a substantially increased risk of adverse cardiovascular outcomes in this study.

Ephedra sinica; ephedrine; mortality; myocardial infarction; stroke

Abbreviations: CI, confidence interval; ICD, International Classification of Diseases; OR, odds ratio


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