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Use of Composite End Points to Measure Clinical Events
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To The Editor: Dr Freemantle and colleagues1 discussed the pros and cons of composite end points in clinical trials and the difficulties in interpreting results when using them. They argued that composite end points can be used to gain statistical power or when there is uncertainty about which single end point to choose. We would like to add a third reason: to be able to define a summary measure for drug efficacy.
The marked decline in morbidity and mortality of human immunodeficiency virus (HIV) infection after the introduction of combination antiretroviral therapy2 has made morbidity or mortality unfeasible as clinical end points. Current HIV clinical trials resort to surrogate end points to evaluate drug efficacy, including virological and immunologic parameters. However, as with all treatments, efficacy of antiretroviral drugs also depends on the tolerability of drug regimens. Regimens that are poorly tolerated are more likely to lead to nonadherence and . . . [Full Text of this Article]
Frank van Leth, MD, MSc;
Joep M. A. Lange, MD, PhD
International Antiviral Therapy Evaluation Center
Amsterdam, the Netherlands
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