8th International AIDS Conference Amsterdam, Netherlands — July 19-24, 1992

Int Conf AIDS 1992 Jul 19-24; 8:We48 (abstract no. WeB 1016)
Quieffin J, Montaner JS, Guillemi SA, Lawson LM, Levitt N, Le TN, Ruedy J, Schechter MT; St. Paul's Hospital/UBC.

OBJECTIVES: To evaluate the effect of the early introduction of oral corticosteroids (CS) in patients with mild AIDS-related pneumocystis carinii pneumonia (PCP).

METHODS: We conducted a subgroup analysis of a double blind, placebo controlled, randomized trial, restricted to patients whose baseline oxygen saturation by pulse oximetry (O2 SAT) was greater than or equal to 90% at rest. This subgroup analysis was based on a pre-specified subgroup and was not data driven. All patients were having their first episode of PCP, had exercise desaturation and had no other known active pulmonary pathology. Subjects received either prednisone, 60 mg/day for 7 days, followed by a progressive tapering over 14 days or identical placebo (PCB). All patients had O2 SAT, exercise testing and LDH measured at days 0,3,7,14 and 28. Early deterioration, the pre-defined end-point of the trial, was defined as a 10% decrease in baseline O2 SAT at rest after day 2. The full trial was terminated after the 37th patient based on a sequential analysis.

RESULTS: At termination, there were 12 and 11 subjects in the PCB and CS groups respectively. Baseline characteristics were similar in the groups. Early deterioration developed in 7 and 1 patients in the PCB and CS groups respectively (P = 0.027). By day 3, a number of parameters were less favorable in the PCB group relative to the CS group including median O2 SAT (85 vs 97%; P = 0.003), LDH (1514 vs 763 U/L; P = 0.013), respiratory rate (30 vs 22 bpm; P = 0.003), heart rate (100 vs 81 bpm; P = 0.002), and temperature (39 vs 37 degrees C; P = 0.024). Even though patients suffering early deterioration in the PCB group were treated with CS on an open label basis, significant differences between the groups persisted to day 30 with regard to exercise tolerance. On day 30, more than half of patients initially assigned to PCB could not exercise whereas the CS group exercised for a median of 6.5 minutes (P = 0.017).

CONCLUSION: It is known that corticosteroids are of benefit in patients with moderate to severe PCP. The present subgroup analysis would suggest that early introduction of adjunctive corticosteroids prevent deterioration and increase exercise tolerance even in patients with mild AIDS-related PCP. Early return of exercise capability has obvious implications for the functional capacity and quality of life of persons with mild PCP.

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