[Effect of dapsone on survival in HIV infected patients: a meta- analysis of finished trials]

Abstract

Background: The aim of the study was to estimate the effect of dapsone on survival in HIVinfected patients.

Method: The method was a metaanalysis. Data searches used MEDLINE, AIDS TRIALS, and AIDS DRUGS databases from 1983 to January 1996, clinical trials registries of appropriate collaborative research groups, abstract books of International Conferences on AIDS and infectious diseases between 1988 and 1996, references listed within selected articles and active experts in HIV infection. Were considered as eligible: randomized clinical trials, conducted in adults, with one arm evaluating dapsone as prophylactic agent for Pneumocystis Carinii Pneumonia (PCP). Each primary investigator was asked to provide the most recent aggregated study data by completing a standardized questionnaire and to provide files of individual patient data whenever possible.

Results: Overall, 17 trials (4343 patients) were eligible for the metaanalysis. The analysis of all available aggregated data included 16 trials (4267 patients) and showed no deleterious effect of dapsone on survival: OR=1.11, 95% Confidence Interval (CI)=0.961.29. There was no evidence of heterogeneity among studies (p=0.50). The analysis of individual data included 10 trials (3115 patients) (OR for aggregated data from those trials=1.10, CI=0. 931.29) and confirmed the absence of deleterious effect of dapsone on survival: stratified Hazard Ratio=1.12, CI=0.991.27 (logrank test: p=0.08). In this subsample, there was evidence of a deleterious effect of dapsone used as secondary prophylaxis. However, this result did not remain when the trial reporting the greatest negative effect of dapsone on survival was omitted.

Conclusion: Dapsone may be used safely as a primary prophylactic regimen for PCP or toxoplasmosis. However, no definitive recommendation can be made for the use of dapsone as secondary PCP prophylaxis.