Montgomery AB, Edison RE, Sattler F, Hopewell P, Mason G, Feigal DW; International Conference on AIDS.
Int Conf AIDS. 1990 Jun 20-23; 6: 220 (abstract no. Th.B.395).
Univ of Calif., San Francisco, CA, USA
OBJECTIVE: To assess the efficacy and safety of aerosolized pentamidine (AP) compared to Trimethoprim/Sulfamethoxazole (TMP/SMX) for acute treatment of PCP. METHODS: 379 patients at 27 centers were randomized to AP or TMP/SMX if their room air Aa gradient was less than 55. 284 had PCP microscopically confirmed after induced sputum or bronchoscopy. The AP group received 600 mg of pentamidine in 6 mls sterile water delivered by the respirgard II nebulizer on a daily basis. The TMP/SMX group received 15 mg/Kg/day in four divided doses. Patients could be switched to oral TMP/SMX after five days of IV and could be discharged from the hospital when clinically stable to complete their 21 day total treatment as an outpatient. Placebo aerosol, IV solution, and tablets were used to blind the study. If the patient needed to have medications switched due to adverse reactions or slow clinical response intravenous pentamidine 4 mg/Kg/day was given unless the clinical investigator felt that another agent would be more appropriate. RESULTS: Mean duration of treatment for TMP/SMX was 19.5 days vs. 23.1 days for AP. (p less than .001). Five patients in the AP group and 11 patients in the TMP/SMX group died during the acute episode of PCP. (p=.09) The most common adverse experiences attributed to study drugs were (TMP/SMX vs. AP):rash (23% vs. 1%), elevated transaminases (15% vs. 3%), drug fever (15% vs. 0%), neutropenia (15% vs. 1%), and nausea (14% vs. 2%). The probability of discontinuing study drug for adverse reactions was 20% vs. 51% for AP vs. TMP/SMX by the 14th day and 33% vs. 59% by the 21st day. (p.=001). The probability of discontinuing study drug for slow clinical response was 18% vs. 13% for AP vs. TMP/SMX by the 7th day and 39% vs. 18% by the 21st day. (p=.01). CONCLUSION: AP is effective for the treatment of acute PCP and is more likely to be tolerated for a full course of treatment than TMP/SMX. Slow clinical response was seen more often with AP which may be best suited for patients with less severe Aa gradient abnormalities.
Publication Types:
Keywords:
- Aerosols
- Blindness
- Clinical Trials as Topic
- Double-Blind Method
- Humans
- Nebulizers and Vaporizers
- Pentamidine
- Pneumonia
- Pneumonia, Pneumocystis
- Trimethoprim-Sulfamethoxazole Combination
Other ID:
UI: 102181962
From Meeting Abstracts