BETTER EFFICACY OF TWICE-MONTHLY THAN MONTHLY AEROSOLIZED PENTAMIDINEFOR SECONDARY PROPHYLAXIS OF PNEUMOCYSTIS-CARINII PNEUMONIA IN PATIENTS WITH AIDS - AN ITALIAN MULTICENTRIC RANDOMIZED CONTROLLED TRIAL

The aim of this multicentric randomised controlled trial was to evalua te long-term efficacy and safety of once-monthly versus twice-monthly 300 mg aerosolised pentamidine (AP) as secondary prophylaxis of Pneumo cystis carinii pneumonia (PCP). We randomised 205 patients with a prev ious confirmed episode of PCP (107 treated with 300 mg once-monthly AP , and 98 with 300 mg twice-monthly AP); the median review period was 2 32 days. Kaplan-Meier method and Cox's hazard regression model were us ed for analysis. The main outcome assessments were PCP recurrence, sur vival and incidence of drug toxicity. The two groups were balanced for prognostic predictors. In the once-monthly AP group, 14 relapses of c onfirmed PCP were observed while five occurred in the twice-monthly AP gl oup; the crude relative risk (RR) was 2.69 (95% CI 1.002-7.236, P = 0.0496) and the adjusted RR accounting for prognostic predictors was 2.62 (95% CI 0.92-7.5, P = 0071). Death occurred in 36 and 26 patient s respectively (adjusted RR 1.32, 95% CI 0.8-2.18, P = 0.28). Two pati ents interrupted the study because of intolerance to AP (one in each g roup), and severe coughing occurred in two patients (one in each group ). At the end of the study, pulmonary function tests were not changed compared with baseline and were the same between the two groups. Our s tudy suggests that 300 mg twice-monthly AP is more effective than 300 mg once-monthly AP as secondary prophylaxis of PCP.