Details:

Alternative Title:
Ann Intern Med
Personal Author:
Twomey, Patrick S. ; Smith, Bryan L. ; McDermott, Cathy ; Marino, Anne ; McCarthy, William ; ... More +
Twomey, Patrick S. ; Smith, Bryan L. ; McDermott, Cathy ; Marino, Anne ; McCarthy, William ; Kachur, S. Patrick ; Ransom, Janet ; Arguin, Paul M. Less -
Description:
Background

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.

Objective

Assess the safety and clinical benefit of intravenous artesunate as a quinidine alternative

Design

Retrospective case series

Setting

United States hospitals

Patients

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.

Measurements

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.

Results

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.

Limitations

Potential late-presenting safety issues might lie outside the 7-day follow-up period.

Conclusions

Artesunate was a safe and clinically beneficial alternative to quinidine.


Subjects:
[+]
Adolescent Adult Aged Antimalarials Artemisinins Article Child Child, Preschool Drugs, Investigational Drug Therapy, Combination Female Humans Infant Injections, Intravenous Malaria Male Medication Adherence Middle Aged Parasitemia Retrospective Studies Treatment Outcome Young Adult
Source:
Ann Intern Med. 163(7):498-506.
Pubmed ID:
26301474
Pubmed Central ID:
PMC4627466
Document Type:
Journal Article
Funding:
CC999999/Intramural CDC HHS/United States
Place as Subject:
United States
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:dba62f1342909384c480ede1bae58fed713c9132090176e6daf125f778033b33
Download URL:
https://stacks.cdc.gov/view/cdc/36341/cdc_36341_DS1.pdf
File Type:

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