John E. Conte Jr., MD; David Chernoff, MD; David W. Feigal Jr., MD, MPH; Pat Joseph, MD; Charles McDonald, MD; Jeffrey A. Golden, MD
Objective: To evaluate the efficacy and toxicity of aerosolized pentamidine and of reduced-dose intravenous pentamidine for the treatment of mild to moderate Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome (AIDS).
Design: Randomized open study with serial pulmonary function testing and measurement of pentamidine concentrations in plasma and bronchoalveolar lavage fluid.
Patients: Of 44 men and 1 woman with a mild to moderate first episode of P. carinii pneumonia (PaO2 ≥ 7.3 kPa [55 mm Hg]), 23 received aerosolized pentamidine and 22, intravenous pentamidine.
Interventions: Pentamidine isethionate, 600 mg by inhalation using a Respirgard II nebulizer (Marquest Medical Products, Inc., Englewood, Colorado) or 3 mg/kg body weight intravenously, administered once daily for 2 to 3 weeks.
Measurements and Main Results: The planned 60-patient study was stopped after 45 patients had been enrolled. The rates (aerosolized compared with intravenous pentamidine) of initial failure, early recrudescence of symptoms, and relapse were 12% and 19% (difference, 7%; 99% confidence interval [CI], -23% to 37%; P = 0.67), 35% and 0% (difference, 35%; CI, 13% to 58%; P = 0.02), and 24% and 0% (difference, 24%; CI, 4% to 49%; P = 0.03). The rates (aerosolized compared with intravenous pentamidine) of major toxicity were 0% (0 of 17 patients) and 10% (2 of 21 patients) (difference 10%; CI, -1% to 29%; P = 0.24). The mean (±SD) pentamidine concentration in bronchoalveolar lavage fluid for patients receiving aerosolized pentamidine was 96.6 ± 65.1 ng/mL compared with 14.4 ± 17.7 ng/mL for patients receiving intravenous treatment. Trough concentrations of pentamidine in plasma increased from 0 to 25.4 ± 16.4, 56.5 ± 26.1, and 61.1 ± 56.0 ng/mL at the end of weeks 1, 2, and 3 of intravenous therapy, respectively.
Conclusions: The data suggest that reduced-dose intravenous pentamidine was more effective than aerosolized pentamidine for treating mild to moderate P. carinii pneumonia. Systemic absorption during aerosolized therapy was minimal; daily doses of intravenous pentamidine resulted in increased accumulation of pentamidine in plasma.
Conte JE, Chernoff D, Feigal DW, Joseph P, McDonald C, Golden JA. Intravenous or Inhaled Pentamidine for Treating
Pneumocystis carinii Pneumonia in AIDS: A Randomized Trial. Ann Intern Med. ;113:203–209. doi: 10.7326/0003-4819-113-3-203
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Published: Ann Intern Med. 1990;113(3):203-209.
Infectious Disease, Pulmonary/Critical Care.
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