Document Detail

The safety and tolerance of atovaquone/proguanil for the long-term prophylaxis of plasmodium falciparum malaria in non-immune travelers and expatriates [corrected]
MedLine Citation:
PMID:  17367478     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: In Europe, atovaquone/proguanil (A/P) is only licensed for malaria prophylaxis for 28 days of travel. Data on the long-term safety and tolerance in nonimmune travelers are scarce. METHODS: We initiated a prospective observational study on ailments reported by travelers using A/P on a long-term basis. Ailments were recorded on a regular questionnaire. Travelers rated their ailments as (1) mild, not interfering with their daily activities; (2) moderate, causing interference with daily activities; or (3) severe, resulting in a visit to a doctor or clinic. RESULTS: One hundred sixty-nine subjects used A/P for a total of 2.974 weeks. One hundred fifty-three (90.5%) traveled to malaria-endemic regions in Africa. Seventy-five (44%) travelers, who used A/P for 1.140 weeks, reported no ailments. Ninety-four (56%) subjects who used A/P for 1.834 weeks reported a total of 363 ailments. Diarrhea was the most common ailment (13.5%; graded as mild in 7.2%, moderate in 4.7%, severe in 1.7%). Further complaints were headache (7.4%), malaise (6.1%), insomnia (5.2%), abdominal pain (5.0%), nausea (5.0%), and oral ulcers (4.1%). Four (2.4%) subjects discontinued prophylaxis due to complaints. No patient was admitted. Five (3.0%) cases of malaria were reported. CONCLUSIONS: In our observational study encompassing more than 57 person-years of follow-up, A/P was tolerated well when taken longer than the current recommendation of 28 days of travel. Treatment-limiting ailments resulting in discontinuation of chemoprophylaxis were observed in 4 of 169 (2.4%) participants, whereas none of them was admitted. There were five (3.0%) cases of self-reported malaria. These observations suggest that A/P is also a safe and efficacious drug for the long-term chemoprophylaxis of falciparum malaria.
Perry J J van Genderen; Henk R A Koene; Kimberly Spong; David Overbosch
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of travel medicine     Volume:  14     ISSN:  1195-1982     ISO Abbreviation:  J Travel Med     Publication Date:    2007 Mar-Apr
Date Detail:
Created Date:  2007-03-19     Completed Date:  2007-05-11     Revised Date:  2009-07-07    
Medline Journal Info:
Nlm Unique ID:  9434456     Medline TA:  J Travel Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  92-5     Citation Subset:  IM    
Department of Internal Medicine, Havenziekenhuis and Institute for Tropical Diseases, The Netherlands.
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MeSH Terms
Antimalarials / adverse effects*
Atovaquone / adverse effects*
Chloroguanide / adverse effects*
Double-Blind Method
Drug Combinations
Drug Tolerance
Malaria, Falciparum / prevention & control*
Mefloquine / therapeutic use*
Middle Aged
Patient Compliance
Prospective Studies
Reg. No./Substance:
0/Antimalarials; 0/Drug Combinations; 0/malarone; 500-92-5/Chloroguanide; 53230-10-7/Mefloquine; 94015-53-9/Atovaquone
Erratum In:
J Travel Med. 2007 May-Jun;14(3):203

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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