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Therapeutic Research
Abstract
Objective:We conducted a post‒marketing surveillance to investigate the safety and efficacy of atovaquone under actual conditions of use for the treatment of patients with Pneumocystis pneumonia(PCP)or prevention of PCP. Method:All patients who received atovaquone after the start of its distribution were included in the surveillance. The duration of the observation was 21 days at a maximum for PCP treatment and one year at a maximum for PCP prevention. Safety was evaluated based on the occurrence of adverse drug reactions(ADRs), and efficacy was assessed based on the investigator’s global assessment for PCP treatment, and the development of PCP for PCP prevention.Results:The incidence of ADRs was 23.20%(29/125)for PCP treatment and 13.99%(20/143)for PCP prevention in patients with human immunodeficiency virus (HIV), and 19.25%(51/265)for PCP treatment and 18.50%(96/519)for PCP prevention in non‒HIV patients. Common ADRs were rash, drug eruption, hepatic function abnormal and diarrhea. The responder rates were 88.14%(104/118)for PCP treatment and 100.00%(134/134)for PCP prevention in the HIV patients, and 83.54%(203/243) for PCP treatment and 99.80%(492/493)for PCP prevention in the non‒HIV patients. Conclusion:The results of this surveillance revealed no new safety or efficacy concern for both PCP treatment and prevention, and suggested that atovaquone would be a useful alternative drug when the use of sulfamethoxazole‒trimethoprim combination would be difficult.
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