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Fansimef for prophylaxis of malaria: a double-blind randomized placebo controlled trial
D Bunnag1, S Malikul, S Chittamas
1Bangkok Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
The Southeast Asian Journal of Tropical Medicine and Public Health
|December 1, 1992
Summary
This study found that Fansimef and Lariam offered similar protection against falciparum malaria, with no significant differences in adverse events compared to other treatments. Both were effective in preventing malaria in a high-risk area.
Area of Science:
- Tropical Medicine
- Infectious Diseases
- Pharmacology
Background:
- Fansimef, a fixed combination of mefloquine, sulfadoxine, and pyrimethamine, was being considered for malaria prophylaxis.
- Multiresistant Plasmodium falciparum malaria is endemic in Thailand, necessitating effective prophylactic strategies.
Purpose of the Study:
- To compare the efficacy and tolerability of Fansimef against Lariam, Fansidar, chloroquine, and placebo for malaria prophylaxis.
- To evaluate the effectiveness of Fansimef in a region with multiresistant P. falciparum.
Main Methods:
- A randomized, double-blind study involving 602 adult males in Thailand.
- Weekly administration of treatments (Fansimef, Lariam, Fansidar, chloroquine, placebo) for 24 weeks.
- Monitoring of acute Plasmodium falciparum episodes and clinical adverse events.
Main Results:
- Incidence of P. falciparum episodes was 0.17 per 100 person-months for both Fansimef and Lariam.
- No statistically significant differences in the incidence of malaria or adverse events were observed between Fansimef and Lariam.
- Headache, sleepiness, dizziness, and weakness were the most common adverse events across all groups.
Conclusions:
- Fansimef demonstrated comparable efficacy and tolerability to Lariam for malaria prophylaxis.
- Both Fansimef and Lariam showed promising results in preventing falciparum malaria in a high-risk area.
- Further research may be warranted to assess long-term effects and broader applicability.