patients treated with aerosolized pentamidine (28%). Among patients treated with MEPRON Suspension, there was no evidence of a dose-related increase in the incidence of adverse experiences. Treatment-limiting adverse experiences occurred less often in patients treated with aerosolized pentamidine (7%) than in patients treated with 1,500 mg MEPRON Suspension once daily (25%, P ≤0.001) or 750 mg MEPRON Suspension once daily (16%, P = 0.004). The most common adverse experiences requiring discontinuation of dosing in the group receiving 1,500 mg MEPRON Suspension once daily were rash (6%), diarrhea (4%), and nausea (3%). The most common adverse experience requiring discontinuation of dosing in the group receiving aerosolized pentamidine was bronchospasm (2%).
Table 7. Treatment-Emergent Adverse Experiences in the Aerosolized Pentamidine Comparative PCP Prevention Study
Treatment-Emergent
Adverse Experience Percentage of Patients with Treatment-Emergent Adverse Experience
MEPRON
1,500 mg/day
(n = 175)
MEPRON
750 mg/day
(n = 188)
Aerosolized
Pentamidine
(n = 186)
Diarrhea 42% 42% 35%
Rash 39% 46% 28%
Headache 28% 31% 22%
Nausea 26% 32% 23%
Cough increased 25% 25% 31%
Fever 25% 31% 18%
Rhinitis 24% 18% 17%
Asthenia 22% 31% 31%
Infection 22% 18% 19%
Abdominal pain 20% 21% 20%
Dyspnea 15% 21% 16%
Vomiting 15% 22% 11%
Patients discontinuing therapy due to an adverse experience 25% 16% 7%
Patients reporting at least 1 adverse experience 98% 96% 89%
Other events occurring in ≥10% of the patients receiving the recommended dose of MEPRON included sweating, flu syndrome, pain, sinusitis, pruritus, insomnia, depression, and myalgia. Bronchospasm occurred more frequently in patients receiving aerosolized pentamidine (11%) than in patients receiving MEPRON 1,500 mg/day (4%) and MEPRON 750 mg/day (2%).
Neither MEPRON nor aerosolized pentamidine was associated with a substantial change from baseline values in any measured laboratory parameter, nor were there any significant differences in any measured laboratory parameter between MEPRON and aerosolized pentamidine. Some patients had laboratory abnormalities considered serious by the investigator or that contributed to discontinuation of therapy.
PCP Treatment Studies
Table 8 summarizes all the clinical adverse experiences reported by ≥5% of the study population during the TMP-SMX comparative study of MEPRON (n = 408), regardless of attribution. The incidence of adverse experiences with MEPRON Suspension at the recommended dose was similar to that seen with the tablet formulation of atovaquone.
Table 8. Treatment-Emergent Adverse Experiences in the TMP-SMX Comparative PCP Treatment Study
Percentage of Patients with Treatment-Emergent Adverse Experience
Treatment-Emergent
Adverse Experience
MEPRON
(n = 203)
TMP-SMX
Rash (including maculopapular) 23% 34%
Nausea 21% 44%
Diarrhea 19% 7%
Headache 16% 22%
Vomiting 14% 35%
Fever 14% 25%
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