Efficacité et innocuité de la prophylaxie palustique par méfloquine pendant la grossesse à Kisangani, République démocratique du Congo : un essai clinique randomisé

Labama Otuli, Noël; Marini Djang'Eing'A, Roland; Losimba Likwela, Joris; Bosenge Nguma, Jean-Didier; Maido Alongo, Mike-Antoine; Ahuka Ona Longombe, Albert; Mbutu Mango, Bernard; Bono M.N., Diane; Mokili L., John; Manga Okenge, Pascal

doi:10.1111/bcp.14720

Article (Scientific journals)

Efficacité et innocuité de la prophylaxie palustique par méfloquine pendant la grossesse à Kisangani, République démocratique du Congo : un essai clinique randomisé

Labama Otuli, Noël; Marini Djang'Eing'A, Roland; Losimba Likwela, Joris et al.

2021 • In British Journal of Clinical Pharmacology

Peer Reviewed verified by ORBi

Permalink
https://hdl.handle.net/2268/258661

DOI
10.1111/bcp.14720

PubMed
33398890

Files (1)Send to Details Statistics Bibliography Similar publications

Files

Full Text

Labama, Marini et al_Brit_Clin_Pharm_2021.pdf

Publisher postprint (1.52 MB)

Request a copy

All documents in ORBi are protected by a user license.

Send to

RIS BibTex APA Chicago Permalink X Linkedin

Details

Keywords :

drug safety; clinical pharmacology, parasitology; infectious diseases, pregnancy; gynaecology/obstetrics

Abstract :

[en] 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 singleblind, 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 = 0.0961). 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.

Research Center/Unit :

CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège

Disciplines :

Pharmacy, pharmacology & toxicology

Author, co-author :

Labama Otuli, Noël; Université de Kisangani > Gynécologie Obstétrique

Marini Djang'Eing'A, Roland ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Losimba Likwela, Joris; Université de Kisangani > Santé Publique

Bosenge Nguma, Jean-Didier; Université de Kisangani > Gynécologie Obstétrique

Maido Alongo, Mike-Antoine; Université de Kisangani > Gynécologie Obsétrique

Ahuka Ona Longombe, Albert; Université de Kisangani > Chirurgie

Mbutu Mango, Bernard; Université de Kisangani > Chirurgie

Bono M.N., Diane

Mokili L., John

Manga Okenge, Pascal; Université de Kisangani > Gynécologie Obstétrique

Language :

English

Title :

Efficacité et innocuité de la prophylaxie palustique par méfloquine pendant la grossesse à Kisangani, République démocratique du Congo : un essai clinique randomisé

Alternative titles :

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

Publication date :

04 January 2021

Journal title :

British Journal of Clinical Pharmacology

ISSN :

0306-5251

eISSN :

1365-2125

Publisher :

Blackwell, Oxford, United Kingdom

Peer reviewed :

Peer Reviewed verified by ORBi

Additional URL :

https://bpspubs.onlinelibrary.wiley.com/action/doSearch?AllField=Marini+Djang%27eing%27a%2C+Roland&SeriesKey=13652125

Name of the research project :

DREPAKIS

Available on ORBi :

since 06 April 2021

Statistics

Number of views

169 (2 by ULiège)

Number of downloads

2 (1 by ULiège)

More statistics

Scopus citations^®

Scopus citations^®
without self-citations

OpenCitations

OpenAlex citations

Bibliography

World Health Organization. World Malaria Report 2017. Geneva: WHO; 2018. https://www.who.int/malaria/publications/world-malaria-report-2017/en/
Alexander SPH, Kelly E, Mathie A, et al. In The Concise Guide to PHARMACOLOGY 2019/20: Antimalarial targets and ligands. Br J Pharmacol. 2019;176(S1:i-iv):S1-S493. https://www.guidetomalariapharmacology.org/malaria/index.jsp. Accessed December 15, 2020
World Health Organization. World Malaria Report 2018. Genève: WHO; 2019. https://www.who.int/malaria/publications/world-malaria-report-2018/en/
Labama ON, Bosenge NJ-D, Maindo AM-A, et al. Prevalence of Gestational Malaria in Kisangani, Democratic Republic of Congo. Open J Obstet Gynecol. 2018;8:854-866. http://www.scirp.org/journal/ojog. Accessed December 21, 2019
Maiga OM, Kayentao K, Traoré BT, et al. Superiority of 3 Over 2 Doses of Intermittent Preventive Treatment With SulfadoxinePyrimethamine for the prevention of malaria during pregnancy in Mali: A Randomized Controlled Trial. Cid. 2011;53(3):215-223.
Gies S, Oumar CS, Tiemegna OF, D'Alessandro U. Individual efficacy of intermittent preventive treatment with Sulfadoxine–Pyrimethamine in primi- and secundigravidae in rural Burkina Faso: impact on parasitaemia, anaemia and birth weight. Trop Med Int Health. 2009;14(2):174-182. https://doi.org/10.1111/j.1365-3156.2008.02215.x
Losimba LJ, d'Alessandro U, Labama LB, et al. Effet du traitement préventif intermittent (TPI) de la femme enceinte à la Sulfadoxine-Pyriméthamine (SP) sur le poids de naissance des enfants dans un milieu à résistance élevée du Plasmodium falciparum à la SP à l'Est de la République Démocratique du Congo (RDC). Rwanda Med J. 2010;68(4):10-15.
Brabin L, Stokes E, Dumbaya I, Owens S. Rural Gambian women's reliance on health workers to deliver sulphadoxine – pyrimethamine as recommended intermittent preventive treatment for malaria in pregnancy. Malar J. 2009;8(25):25. https://doi.org/10.1186/1475-2875-8-25
Tinto H, Ouédraogo JB, Zongo I, et al. Sulfadoxine–Pyrimethamine efficacy and selection of plasmodium falciparum dhfr mutations in burkina faso before its introduction as intermittent preventive treatment for pregnant women. Am J Trop Med Hyg. 2007;76(4):608-613.
Ruizendaal E, Tahita CM, Geskus BR, et al. Increase in the prevalence of mutations associated with sulfadoxine–pyrimethamine resistance in Plasmodium falciparum isolates collected from early to late pregnancy in Nanoro, Burkina Faso. Malar J. 2017;16(179):179. https://doi.org/10.1186/s12936-017-1831-y
Cisse M, Awandare GA, Soulama A, Tinto H, Hayette M-P, Guiguemdé RT. Recent uptake of intermittent preventive treatment during pregnancy with sulfadoxine–pyrimethamine is associated with increased prevalence of Pfdhfr mutations in Bobo-Dioulasso, Burkina Faso. Malar J. 2017;16(1:38):38. https://doi.org/10.1186/s12936-017-1695-1
Ngondi MJ, Ishengoma SD, Doctor MS, et al. Surveillance for sulfadoxine–pyrimethamine resistant malaria parasites in the Lake and Southern Zones, Tanzania, using pooling and next-generation Sequencing. Malar J. 2017;16(1):236. https://doi.org/10.1186/s12936-017-1886-9
Bertin G, Briand V, Bonaventure D, et al. Molecular markers of resistance to sulphadoxinepyrimethamine during intermittent preventive treatment of pregnant women in Benin. Malar J. 2011;10(10):196. https://doi.org/10.1186/1475-2875-10-196. Accessed December 21, 2019
Jiang T, Chen J, Fu H, et al. High prevalence of Pfdhfr–Pfdhps quadruple mutations associated with sulfadoxine–pyrimethamine resistance in Plasmodium falciparum isolates from Bioko Island, Equatorial Guinea. Malar J. 2019;18(1:101):101. https://doi.org/10.1186/s12936-019-2734-x
Ravenhall M, Diez BE, Mipando M, et al. Characterizing the impact of sustained sulfadoxine/pyrimethamine use upon the Plasmodium falciparum population in Malawi. Malar J. 2016;15(1:575):575. https://doi.org/10.1186/s12936-016-1634-6
Braun V, Rempis E, Schnack A, et al. Lack of effect of intermittent preventive treatment for malaria in pregnancy and intense drug resistance in western Uganda. Malar J. 2015;14(372):372. https://doi.org/10.1186/s12936-015-0909-7
Nosten F, McGready R. Intermittent presumptive treatment in pregnancy with sulfadoxine–pyrimethamine: a counter perspective. Malar J. 2015;14(248):248. https://doi.org/10.1186/s12936-015-0765-5
Ruh E, Bateko JP, Imir T, Taylan-Ozkan A. Molecular identification of sulfadoxine–pyrimethamine resistance in malaria infected women who received intermittent preventive treatment in the Democratic Republic of Congo. Malar J. 2018;17(1:17):17. https://doi.org/10.1186/s12936-017-2160-x
Losimba LJ, Umberto D'Alessandro U, Labama LB, Meuris S, Wembodinga DM. Sulfadoxine–pyrimethamine resistance and intermittent preventive treatment during pregnancy: a retrospective analysis of birth weight data in the Democratic Republic of Congo (DRC). Trop Med Int Health. 2012;17(3):322-329. https://doi.org/10.1111/j.1365-3156.2011.02935.x
Labama ON, Bosenge NJ-D, Maindo AM-A, Losimba LJ, Manga OJ-P. Intermittent Preventive Treatment in Pregnancy with Sulphadoxine-Pyrimethamine Does Not Have Effect on Maternal Hemoglobin at Delivery and Birth Weight in Kisangani, Democratic Republic of Congo. J Biosci Med. 2019;7(12):168-180. https://doi.org/10.4236/jbm.2019.712014
Gosling RD, Cairns ME, Chico RM, Chandramohan D. Intermittent preventive treatment against malaria: an update. Expert Rev Anti Infect Ther. 2010;8(5):589-606. https://doi.org/10.1586/eri.10.36
Briand V, Bottero J, Noel H, et al. Intermittent treatment for the prevention of malaria during pregnancy in Benin: a randomized, open-label equivalence trial comparing sulfadoxine–pyrimethamine with mefloquine. JID. 2009;200(6):991-1001. https://doi.org/10.1086/605474
Sagara I, Oduro RA, Mulenga M, et al. Efficacy and safety of a combination of Azithromycine and chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in two multi-country randomized clinical trials in African adults. Malar J. 2014;13(458). https://doi.org/10.1186/1475-2875-13-458. Accessed August 25, 2019
Kalilani L, Mofolo I, Chaponda M, et al. A Randomized Controlled Pilot Trial of Azithromycin or Artesunate Added to Sulfadoxine-Pyriméthamine as Treatment for Malaria in Pregnant Women. PLoS ONE. 2007;2(11:e1166). https://doi.org/10.1371/journal.pone.0001166
Gosling RD, Gesase S, Mosha JF, et al. Protective efficacy and safety of three antimalarial regimens for intermittent preventive treatment for malaria in infants: a randomized, double-blind, placebo-controlled trial. Lancet. 2009;374(9700):1521-1532.
González R, Pons-Duran C, Piqueras M, Aponte JJ, ter Kuile FO, Menéndez C. Mefloquine for preventing malaria in pregnant women. Cochrane Database Syst Rev. 2018;11(11):CD011444. https://doi.org/10.1002/14651858.CD011444.pub3
Centre belge d'Information Pharmacothérapeutique. Répertoire commente des médicaments 2019. 32ème édition. www.cbip.be. Accessed August 25, 2019.
Ocan M, Akena D, Nsobya S, et al. Persistence of chloroquine resistance alleles in malaria endemic countries: a systematic review of burden and risk factors. Malar J. 2019;18(1:76):76. https://doi.org/10.1186/s12936-019-2716-z
Juliao CP, Sosa S, Gonzalez DL, et al. Importation of chloroquine-resistant Plasmodium falciparum by Guatemalan peacekeepers returning from the Democratic Republic of the Congo. Malar J. 2013;12(344). https://doi.org/10.1186/1475-2875-12-344. Accessed October 17, 2019
Mvumbi MD, Boreux R, Sacheli R, et al. Assessment of pfcrt 72-76 haplotypes eight years after chloroquine withdrawal in Kinshasa. Democratic Republic of Congo Malar J. 2013;12(459). https://doi.org/10.1186/1475-2875-12-459. Accessed October 17, 2019
Hoffmann - La Roche. Lariam: Monographie 2011. https://pdf.hres.ca/dpd_pm/00013337.PDF. Accessed May 9, 2020.
González R, Mombo-Ngoma G, Ouédraogo S, et al. Intermittent Preventive Treatment of Malaria in Pregnancy with mefloquine in HIV-Negative Women: A Multicentre Randomized Controlled Trial. PLoS Med. 2014;11(9:e1001733):e1001733. https://doi.org/10.1371/journal.pmed.1001733
Portnov A. Papaverine in Pregnancy: mechanism of action and methods of application of suppositories with papaverine during pregnancy. https://iliveok.com/family/papaverine-pregnancy_106949i15828.html. Accessed December 1, 2020.
Cerner Multum. Papaverine, medically reviewed by Drugs.com on April 22, 2020. https://www.drugs.com/mtm/papaverine.html. Accessed December 7, 2020.
Direction de la Pharmacie et du Médicament. Lignes Directrices des Bonnes Pratiques de Distribution (BPD) applicables en RDC. Ministère de la Santé Publique, RDC, September 2015.
Steketee RW, Wirima JJ, Hightower AW, Slutsker L, Heymann DL, Breman JG. The effect of malaria and malaria prevention in pregnancy on offspring birthweight, prematurity, and intrauterine growth retardation in rural Malawi. Am J Trop Med Hyg. 1996;55(1_Suppl):33-41.
Briand V, Escolano S, Journot V, Massougbodji A, Cot M, Tubert-Bitter P. Mefloquine versus Sulfadoxine–Pyrimethamine for Intermittent Preventive Treatment in Pregnancy: A Joint Analysis on Efficacy and Tolerability. Am J Trop Med Hyg. 2015;93(2):300-304.
González R, Hellgren U, Greenwood B, Menéndez C. Mefloquine safety and tolerability in pregnancy: a systematic literature review. Malar J. 2014;13(75). https://doi.org/10.1186/1475-2875-13-75. Accessed May 9, 2020
Denoeud-Ndam L, Zannou D-J, Fourcade C, et al. Cotrimoxazole Prophylaxis Versus mefloquine Intermittent Preventive Treatment to Prevent Malaria in HIV-Infected Pregnant Women: Two Randomized Controlled Trials. J Acquir Immune Defic Syndr. 2014;65(2):198-206.
Lee SJ, ter Kuile FO, Price RN, Luxemburger C, Nosten F. Adverse effects of mefloquine for the treatment of uncomplicated malaria in Thailand: A pooled analysis of 19, 850 individual patients. PLoS ONE. 2017;12(2:e0168780):e0168780. https://doi.org/10.1371/journal.pone.0168780
Association Francophone des pharmaciens hospitaliers de Belgique. Interactions des médicaments anti-infectieux avec l'alimentation. www.afphb.be. Accessed December 22, 2019.
Garner P, Brabin B. A review of randomized controlled trials of routine antimalarial drug prophylaxis during pregnancy in endemic malarious areas. Bull World Health Organ. 1994;72(1):89-99.
Likilo OJ, Alworonga O, Batina A, Katenga B, Komanda L. Risk factors associated with anemia among pregnant women in Kisangani in D.R.Congo. Int J Recent Scientif Res. 2018;9(4(G)):26015-26021.