Efficacies of artesunate plus either sulfadoxine–pyrimethamine or amodiaquine, for the treatment of uncomplicated,Plasmodium falciparummalaria in eastern Sudan

Abstract

Artemisinin-based combination therapy (ACT) is increasingly being adopted as the first-line treatment for malaria in sub-Saharan Africa. In September-November 2005, in New Halfa, eastern Sudan, the efficacy of artesunate-sulfadoxine-pyrimethamine (AS-SP) for the treatment of uncomplicated, Plasmodium falciparum was compared with that of artesunate-amodiaquine (AS-AQ). The artesunate was given at 4 mg/kg. day on days 0-2, with either a single dose of SP (25 mg sulfadoxine/kg) given on day 0, or AQ, at 10 mg/kg. day, given on days 0-2. Eighty-two of the patients treated (40 given AS-SP and 42 given AS-AQ) completed the 28 days of follow-up. On day 3 all the patients were afebrile and only one patient, in the AS-AQ group, was still parasitaemic. AS-SP appeared slightly more efficacious than AS-AQ but the differences were not statistically significant. Only one patient (2.5%) given AS-SP but four (9.5%) of those given AS-AQ were initially considered to be late treatment and parasitological failures, with all other patients showing an adequate treatment response. The PCR-corrected frequencies of cure were 97.5% for AS-SP and 95.2% for AS-AQ (P>0.05). No gametocytaemias were observed during the follow-up and, although mild adverse effects (nausea, vomiting, abdominal pain, dizziness and/or rash) were detected in 14 patients, they occurred at the same frequency in each treatment arm. It therefore appears that the AS-SP and AS-AQ combinations were both effective and safe for the treatment of uncomplicated, P. falciparum malaria in eastern Sudan.

Multicentre study evaluating the non-inferiority of the new paediatric formulation of artesunate/amodiaquine versus artemether/lumefantrine for the management of uncomplicated Plasmodium falciparum malaria in children in Cameroon, Ivory Coast and Senegal

“…The results obtained show that the AS+AQ association proved to be very effective with a ACPR rate adjusted by 97.2% in ITT and 98.3% in PP. Various studies conducted with artesunate/amodiaquine free combination, showed comparable efficacies with a non-inferiority to AL [13] and other formulations of ACT (artesunate/sulphadoxine-pyrimethamine, dihydroartemisinine/piperaquine, artesunate/chlorproguanil-Dapsone) [14-18]. This new paediatric formulation administered once a day, besides reducing the number of doses (usually twice a day) confirms the efficacy of this association [19].…”

Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting

“…SAEs were reported in 20 patients, of whom five were given intravenous quinine after referral to tertiary health facilities and subsequently recovered, suggesting a missed diagnosis of complicated malaria for which AL was not the appropriate treatment [20]. Rash, as reported here in 21 cases, is a recognized and frequent AE associated with artemesinin-based combination therapy [9,21-23]. There were 14 cases of AL treatment reported in pregnant women during the period described.…”

A comparative study on the efficacy of artesunate plus sulphadoxine/pyrimethamine versus artemether-lumefantrine in eastern Sudan

“…In Sudan, the current recommendation for uncomplicated malaria are AS/SP and AL as first and second-line treatment, respectively [5] with 100% efficacy in Damazin, Kosti, Malakal and New Halfa [6-9,17] and 99.3% in Kassala [7]. …”

“…There have been few studies on the efficacy of AS/SP [6-9] and only one published report on the efficacy of AL in Sudan [8]. Although these studies have reported high efficacy to both combinations, ranging from 99.8% to 100%, they did not show whether the small proportion of treatment failures was due to a recrudescence of existing parasites or acquisition of a new infection, except for one recent study which reported the PCR-corrected efficacy of AS/SP [9]. It was, therefore, decided to closely monitor patients for 28 days after treatment with AS/SP or AL, and the results were genotyped to indicate recrudescence versus new infections.…”