A. Offianan, S. Assi, A. Coulibaly, L. T. N’Guessan, A. A. Ako, Florence Kadjo, Moïse K San, L. Penali
{"title":"Assessment of the efficacy of first-line antimalarial drugs after 5 years of deployment by the National Malaria Control Programme in Côte d'Ivoire","authors":"A. Offianan, S. Assi, A. Coulibaly, L. T. N’Guessan, A. A. Ako, Florence Kadjo, Moïse K San, L. Penali","doi":"10.2147/OAJCT.S24687","DOIUrl":null,"url":null,"abstract":"Correspondence: Andre T Offianan Malariology Department, Institut Pasteur de Cote d’Ivoire, PO Box 490, Abidjan 01, Cote d’Ivoire Tel +225 22 44 84 25 Fax +225 22 48 53 05 Email andre_offianan@yahoo.fr Background: The emergence of artemisinin resistance has raised concerns that the most potent antimalarial drug may be under threat. Artesunate + amodiaquine (ASAQ) and artemetherlumefantrine (AL) are respectively the firstand second-line treatments for uncomplicated falciparum malaria in Cote d’Ivoire. A comparison of the efficacy and safety of these two drug combinations was necessary to make evidence-based drug treatment policies. Methods: In an open-label, non inferiority, randomized, controlled clinical trial, children aged 6–59 months were randomized to receive ASAQ or AL. Both drug regimens were given for 3 days, and follow-up was for 28 days. The primary endpoint was the 28-day cure rates and was defined as proportion of patients with polymerase chain reaction (PCR)-corrected cure rate after 28 days of follow-up. Findings: A total of 251 patients who were attending the Ayame and Dabakala hospitals and presenting with symptomatic acute uncomplicated falciparum malaria were randomized to receive ASAQ (128) and AL (123). The intention-to-treat analysis showed effectiveness rates of 94.5% and 93.5% for ASAQ and AL, respectively on day 28. After adjustment for PCR results, these rates were 96.1% and 96.8%, respectively. On day 28, the per-protocol analysis showed effectiveness rates of 98.4% and 96.6% for ASAQ and AL, respectively. After adjustment by PCR for reinfection, these rates were 100% for each drug, and both regimens were well tolerated. Conclusion: ASAQ and AL remain efficacious treatments of uncomplicated falciparum malaria in Ivorian children 5 years after adoption. The efficacy of ASAQ and AL in Cote d’Ivoire requires, therefore, continuous monitoring and evaluation.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"3 1","pages":"67-76"},"PeriodicalIF":1.4000,"publicationDate":"2011-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S24687","citationCount":"6","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Open Access Journal of Clinical Trials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/OAJCT.S24687","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 6
Abstract
Correspondence: Andre T Offianan Malariology Department, Institut Pasteur de Cote d’Ivoire, PO Box 490, Abidjan 01, Cote d’Ivoire Tel +225 22 44 84 25 Fax +225 22 48 53 05 Email andre_offianan@yahoo.fr Background: The emergence of artemisinin resistance has raised concerns that the most potent antimalarial drug may be under threat. Artesunate + amodiaquine (ASAQ) and artemetherlumefantrine (AL) are respectively the firstand second-line treatments for uncomplicated falciparum malaria in Cote d’Ivoire. A comparison of the efficacy and safety of these two drug combinations was necessary to make evidence-based drug treatment policies. Methods: In an open-label, non inferiority, randomized, controlled clinical trial, children aged 6–59 months were randomized to receive ASAQ or AL. Both drug regimens were given for 3 days, and follow-up was for 28 days. The primary endpoint was the 28-day cure rates and was defined as proportion of patients with polymerase chain reaction (PCR)-corrected cure rate after 28 days of follow-up. Findings: A total of 251 patients who were attending the Ayame and Dabakala hospitals and presenting with symptomatic acute uncomplicated falciparum malaria were randomized to receive ASAQ (128) and AL (123). The intention-to-treat analysis showed effectiveness rates of 94.5% and 93.5% for ASAQ and AL, respectively on day 28. After adjustment for PCR results, these rates were 96.1% and 96.8%, respectively. On day 28, the per-protocol analysis showed effectiveness rates of 98.4% and 96.6% for ASAQ and AL, respectively. After adjustment by PCR for reinfection, these rates were 100% for each drug, and both regimens were well tolerated. Conclusion: ASAQ and AL remain efficacious treatments of uncomplicated falciparum malaria in Ivorian children 5 years after adoption. The efficacy of ASAQ and AL in Cote d’Ivoire requires, therefore, continuous monitoring and evaluation.