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Atovaquone-proguanil versus chloroquine-proguanil for malaria prophylaxis in non-immune travellers: a randomised, double-blind study. Malarone International Study Team.
Lancet. 2000 Dec 02; 356(9245):1888-94.Lct

Abstract

BACKGROUND

Chloroquine plus proguanil is widely used for malaria chemoprophylaxis despite low effectiveness in areas where multidrug-resistant malaria occurs. Studies have shown that atovaquone and proguanil hydrochloride is safe and effective for prevention of falciparum malaria in lifelong residents of malaria-endemic countries, but little is known about non-immune travellers.

METHODS

In a double-blind equivalence trial, 1083 participants travelling to a malaria-endemic area were randomly assigned to two treatment groups: atovaquone-proguanil plus placebos for chloroquine and proguanil, or chloroquine, proguanil, and placebo for atovaquone-proguanil. Follow-up was by telephone 7 and 60 days after travel and at a clinic at 28 days. Serum samples were tested for antibodies to a malaria circumsporozoite protein. Blood and serum samples of participants with a potential malaria diagnosis were tested in a reference laboratory.

FINDINGS

7 days after travel, at least one adverse event was reported by 311 (61%) of 511 participants who received atovaquone-proguanil and 329 (64%) of 511 who received chloroquine-proguanil. People receiving atovaquone-proguanil had a lower frequency of treatment-related gastrointestinal adverse events (59 [12%] vs 100 [20%], p=0.001), and of treatment-related adverse events of moderate or severe intensity (37 [7%] vs 56 [11%], p=0.05). There were fewer treatment-related adverse events that caused prophylaxis to be discontinued in the atovaquone-proguanil group than in the chloroquine-proguanil group (one [0.2%] vs ten [2%], p=0.015).

INTERPRETATION

Overall the two preparations were similarly tolerated. However, significantly fewer adverse gastrointestinal events were observed in the atovaquone-proguanil group in than in the chloroquine-proguanil group.

Authors+Show Affiliations

International Travel Vaccination Centre, Copenhagen, Denmark.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11130385

Citation

Høgh, B, et al. "Atovaquone-proguanil Versus Chloroquine-proguanil for Malaria Prophylaxis in Non-immune Travellers: a Randomised, Double-blind Study. Malarone International Study Team." Lancet (London, England), vol. 356, no. 9245, 2000, pp. 1888-94.
Høgh B, Clarke PD, Camus D, et al. Atovaquone-proguanil versus chloroquine-proguanil for malaria prophylaxis in non-immune travellers: a randomised, double-blind study. Malarone International Study Team. Lancet. 2000;356(9245):1888-94.
Høgh, B., Clarke, P. D., Camus, D., Nothdurft, H. D., Overbosch, D., Günther, M., Joubert, I., Kain, K. C., Shaw, D., Roskell, N. S., & Chulay, J. D. (2000). Atovaquone-proguanil versus chloroquine-proguanil for malaria prophylaxis in non-immune travellers: a randomised, double-blind study. Malarone International Study Team. Lancet (London, England), 356(9245), 1888-94.
Høgh B, et al. Atovaquone-proguanil Versus Chloroquine-proguanil for Malaria Prophylaxis in Non-immune Travellers: a Randomised, Double-blind Study. Malarone International Study Team. Lancet. 2000 Dec 2;356(9245):1888-94. PubMed PMID: 11130385.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Atovaquone-proguanil versus chloroquine-proguanil for malaria prophylaxis in non-immune travellers: a randomised, double-blind study. Malarone International Study Team. AU - Høgh,B, AU - Clarke,P D, AU - Camus,D, AU - Nothdurft,H D, AU - Overbosch,D, AU - Günther,M, AU - Joubert,I, AU - Kain,K C, AU - Shaw,D, AU - Roskell,N S, AU - Chulay,J D, AU - ,, PY - 2000/12/29/pubmed PY - 2001/2/28/medline PY - 2000/12/29/entrez SP - 1888 EP - 94 JF - Lancet (London, England) JO - Lancet VL - 356 IS - 9245 N2 - BACKGROUND: Chloroquine plus proguanil is widely used for malaria chemoprophylaxis despite low effectiveness in areas where multidrug-resistant malaria occurs. Studies have shown that atovaquone and proguanil hydrochloride is safe and effective for prevention of falciparum malaria in lifelong residents of malaria-endemic countries, but little is known about non-immune travellers. METHODS: In a double-blind equivalence trial, 1083 participants travelling to a malaria-endemic area were randomly assigned to two treatment groups: atovaquone-proguanil plus placebos for chloroquine and proguanil, or chloroquine, proguanil, and placebo for atovaquone-proguanil. Follow-up was by telephone 7 and 60 days after travel and at a clinic at 28 days. Serum samples were tested for antibodies to a malaria circumsporozoite protein. Blood and serum samples of participants with a potential malaria diagnosis were tested in a reference laboratory. FINDINGS: 7 days after travel, at least one adverse event was reported by 311 (61%) of 511 participants who received atovaquone-proguanil and 329 (64%) of 511 who received chloroquine-proguanil. People receiving atovaquone-proguanil had a lower frequency of treatment-related gastrointestinal adverse events (59 [12%] vs 100 [20%], p=0.001), and of treatment-related adverse events of moderate or severe intensity (37 [7%] vs 56 [11%], p=0.05). There were fewer treatment-related adverse events that caused prophylaxis to be discontinued in the atovaquone-proguanil group than in the chloroquine-proguanil group (one [0.2%] vs ten [2%], p=0.015). INTERPRETATION: Overall the two preparations were similarly tolerated. However, significantly fewer adverse gastrointestinal events were observed in the atovaquone-proguanil group in than in the chloroquine-proguanil group. SN - 0140-6736 UR - https://www.unboundmedicine.com/medline/citation/11130385/Atovaquone_proguanil_versus_chloroquine_proguanil_for_malaria_prophylaxis_in_non_immune_travellers:_a_randomised_double_blind_study__Malarone_International_Study_Team_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140673600032608 DB - PRIME DP - Unbound Medicine ER -