Efficacy and safety of malarial prophylaxis with mefloquine during pregnancy in Kisangani, Democratic Republic of Congo: A randomized clinical trial

• Published in: British journal of clinical pharmacology 2021-08, Vol.87 (8), p.3115-3126
• Main Authors: Labama Otuli, Noël, Marini Djang'eing'a, Roland, Losimba Likwela, Joris, Bosenge Nguma, Jean‐Didier, Maindo Alongo, Mike‐Antoine, Ahuka Ona Longombe, Albert, Mbutu Mango, Bernard, M.N. Bono, Diane, L. Mokili, John, Manga Okenge, Jean‐Pascal
• Format: Article
• Language: English
• Subjects: drug safety < clinical pharmacology; parasitology < infectious diseases; pregnancy < gynaecology/obstetrics
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1111/bcp.14720

Aims Kisangani is an area with intense malaria transmission and sulfadoxine–pyrimethamine resistance. Alternative antimalaria prophylaxis medication and protocols are needed, particularly with pregnant individuals. In this study, we compare the tolerance and effectiveness of mefloquine regimen as a split dose with a meal vs. sulfadoxine–pyrimethamine for the intermittent preventive treatment in pregnant individuals in Kisangani. Methods This study was conducted from 15 May to 30 November 2019 as a single‐blind, randomized clinical trial comparing 2 regimens of intermittent preventive treatment during pregnancy. The first regimen consisted of 4 doses of sulfadoxine–pyrimethamine, and the second of 2 doses of mefloquine taken as a split dose with meal. Results The occurrence of major or minor side‐effects among patients treated with mefloquine and those treated with sulfadoxine–pyrimethamine were not statistically significant (major side effects: Fisher exact = 0.5014; minor side effects: P = .0961). Intermittent preventive treatment using mefloquine significantly reduced the risk of placental malaria (risk ratio [RR]: 0.4315, 95% confidence interval [CI]: 0.2201–0.8460), maternal peripheral parasitaemia (RR: 0.4397, 95% CI: 0.2377–0.8132) and low birth weight (RR: 0.4708, 95% CI: 0.2455–0.9029). Conclusion Splitting dose and intake with a meal increased mefloquine tolerability while keeping its efficacy higher compared to sulfadoxine–pyrimethamine. Intermittent preventive treatment during pregnancy using mefloquine reduces the risk of placental malaria, maternal peripheral parasitaemia and low birth weight, compared to sulfadoxine–pyrimethamine. Thus, mefloquine is a good alternative to intermittent preventive treatment in pregnancy.