Intravenous Artesunate for the Treatment of Severe and Complicated Malaria in the United States: Clinical Use under an Investigational New Drug Protocol
Published Date:Aug 25 2015
Source:Ann Intern Med. 163(7):498-506.
Pubmed Central ID:PMC4627466
Funding:CC999999/Intramural CDC HHS/United States
Quinidine gluconate, the only FDA-approved treatment for life-threatening malaria in the United States, has a problematic safety profile and is often unavailable in hospitals.
Assess the safety and clinical benefit of intravenous artesunate as a quinidine alternative
Retrospective case series
United States hospitals
Patients with severe and complicated malaria received 4 doses of intravenous artesunate 2.4 mg/kg under a treatment protocol implemented by the Centers for Disease Control and Prevention (CDC). Protocol eligibility required the presence of microscopically confirmed malaria, the need for intravenous treatment, and an impediment to quinidine. From January 2007 through December 2010, 102 patients received artesunate. Age range was 1-72 years, with 90% adults and 61% males. At baseline, 35% had evidence of cerebral malaria and 17% had severe hepatic impairment.
Clinical and laboratory data from each patient’s hospital records were abstracted retrospectively, including information from baseline through a maximum 7-day follow-up. The abstracted data were presented before a physician committee for the evaluation of safety and clinical benefit outcomes.
Seven deaths occurred (mortality 6.9%), with the most frequent adverse events being anemia (65% of patients) and elevated hepatic enzymes (49%). All deaths and most adverse events were attributed to the severity of malaria. Patients’ symptoms generally improved or resolved within 3 days, and the median time to discharge from the Intensive Care Unit was 4 days, even for patients who had presented with severe liver disease or cerebral malaria. Over 100 concomitant medications were used, with no documented drug-drug interactions.
Potential late-presenting safety issues might lie outside the 7-day follow-up period.
Artesunate was a safe and clinically beneficial alternative to quinidine.
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