Artemether-lumefantrine versus artesunate plus amodiaquine for treating uncomplicated childhood malaria in Nigeria: randomized controlled trial

Meremikwu, Martin; Alaribe, A. A. A.; Ejemot, Regina I.; Oyo‐Ita, Angela; Ekenjoku, John A.; Nwachukwu, Chukwuemeka E; Ordu, Donald; Ezedinachi, E. N. U.

doi:10.1186/1475-2875-5-43

Cited by 43 publications

(13 citation statements)

References 12 publications

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“…After risk of bias assessment, 7 studies were of high risk [23-25,34-37]. The age of the patients ranged between six weeks and 18 years (Table 1).…”

Section: Resultsmentioning

confidence: 99%

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Comparative safety of artemether-lumefantrine and other artemisinin-based combinations in children: a systematic review

Egunsola

Oshikoya

2013

Malar J

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BackgroundThe purpose of the study was to compare the safety of artemether-lumefantrine (AL) with other artemisinin-based combinations in children.MethodsA search of EMBASE (from 1974 to April 2013), MEDLINE (from 1946 to April 2013) and the Cochrane library of registered controlled trials for randomized controlled trials (RCTs) which compared AL with other artemisinin-based combinations was done. Only studies involving children ≤ 17 years old in which safety of AL was an outcome measure were included.ResultsFour thousand, seven hundred and twenty six adverse events (AEs) were recorded in 6,000 patients receiving AL. Common AEs (≥1/100 and <1/10) included: coryza, vomiting, anaemia, diarrhoea, vomiting and abdominal pain; while cough was the only very commonly reported AE (≥1/10). AL-treated children have a higher risk of body weakness (64.9%) than those on artesunate-mefloquine (58.2%) (p = 0.004, RR: 1.12 95% CI: 1.04-1.21). The risk of vomiting was significantly lower in patients on AL (8.8%) than artesunate-amodiaquine (10.6%) (p = 0.002, RR: 0.76, 95% CI: 0.63-0.90). Similarly, children on AL had a lower risk of vomiting (1.2%) than chlorproguanil-dapsone-artesunate (ACD) treated children (5.2%) (p = 0.002, RR: 0.63, 95% CI: 0.47-0.85). The risk of serious adverse events was significantly lower for AL (1.3%) than ACD (5.2%) (p = 0.002, RR: 0.45, 95% CI: 0.27-0.74).ConclusionArtemether-lumefantrine combination is as safe as ASAQ and DP for use in children. Common adverse events are cough and gastrointestinal symptoms. More studies comparing AL with artesunate-mefloquine and artesunate-azithromycin are needed to determine the comparative safety of these drugs.

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“…After risk of bias assessment, 7 studies were of high risk [23-25,34-37]. The age of the patients ranged between six weeks and 18 years (Table 1).…”

Section: Resultsmentioning

confidence: 99%

“…Thirteen studies involving 6018 children comparing AL with ASAQ were included and analysed [20,26-37]. The risk of SAEs was not significantly different for both treatment groups (p = 0.07 RR: 0.54, 95% CI: 0.27-1.05).…”

Section: Resultsmentioning

confidence: 99%

Comparative safety of artemether-lumefantrine and other artemisinin-based combinations in children: a systematic review

Egunsola

Oshikoya

2013

Malar J

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“…Soluplus shows exceptional solubilizing properties for BCS class II and class IV drugs and also offers the possibility of producing solid dispersions by hot-melt extrusion [13]. The dissolution of poorly soluble drugs in aqueous media can be highly improved by the use of solid dispersions with Soluplus [14].…”

Section: Introductionmentioning

confidence: 99%

Artemether-Soluplus Hot-Melt Extrudate Solid Dispersion Systems for Solubility and Dissolution Rate Enhancement with Amorphous State Characteristics

Fule

Ali

Sav

et al. 2013

Journal of Pharmaceutics

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This work studied artemether (ARTM) solid dispersion (SD) formulation using mixture of polymer excipient Soluplus, PEG 400, Lutrol F127, and Lutrol F68 melts at temperatures lower than the melting point of ARTM using a laboratory-size, single-screw rotating batch extruder. The effects of three surfactants PEG 400, Lutrol F127, and Lutrol F68 and parameters like mixing temperature, screw rotating speed, and residence time were systematically studied. SEM, XRD, and FT-IR were employed to investigate the evolution of ARTM's dissolution into the molten excipient. Differential scanning calorimetry (DSC) was used to quantitatively study the melting enthalpy evolution of the drug. The results showed that the dissolution rate increased with increasing the ratio of polymer and surfactant to that of drug. It was concluded that the dissolution of the drug in the polymer melt is a convective diffusion process and that laminar distributive mixing can significantly enhance the dissolution rate. The aqueous solubility and dissolution rate of prepared solid dispersion were significantly enhanced. In vitro antimalarial studies revealed marked improvement in IC50 values. Thus hot-melt extrusion (HME) is a promising technology for improving solubility and dissolution profile of ARTM.

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“…This study did not compare artemisinin- naphthoquine with another ACT, but an earlier study in the same locality showed comparable cure rates for artemether-lumefantrine (87.0%) and artesunate/amodiaquine (82.5%) [18]. The rapid decrease in the number of persons with parasitaemia by Day 2 of follow-up is indicative of the high therapeutic efficacy characteristic of other forms of ACT already in use.…”

Section: Discussionmentioning

confidence: 93%

Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria

Meremikwu

Odey

Oringanje

et al. 2012

Malar J

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BackgroundThe use of anti-malarial drug combinations with artemisinin, or with one of its derivatives, is now widely recommended to overcome drug resistance in falciparum malaria. Fixed-dose combination of artemisinin and naphthoquine is a new generation artemisinin combination therapy (ACT) offered as a single dose therapy. The aim of the study was to assess the therapeutic efficacy, safety and tolerability of three dosage schedules of fixed-dose combination of artemisinin (125 mg) and naphthoquine (50 mg) for treating uncomplicated Plasmodium falciparum malaria among adolescents and adults in Calabar, South-east Nigeria.MethodA total of 121 patients aged ≥15 years with uncomplicated P. falciparum malaria were enrolled and randomly assigned to three dosage schedules: (A) 700 mg (four tablets) single dose; (B) 700 mg 12-hourly x two doses; and (C) 1,400 mg (eight tablets) single dose. Patients were observed for 28 days, with clinical, parasitological, and haematological assessments.ResultsA total of 108 patients completed the study. The overall 28-day cure rate was 88.9%. Day 28-cure rates of the three dosage schedules were 85.3%, 93.1% and 88.9% for Group A, B and C respectively. Adverse events were few and mild, the commonest being weakness and headache; there was no serious adverse event.ConclusionConcerns for emergence of parasite resistance due to the use of artemisinin-naphthoquine as single dose regimen is likely to compromise the usefulness of this potentially important combination treatment. A robust multi-centre trial is recommended to evaluate a three-day regimen with potentials to achieve high cure rates while minimizing the risk of emergence of resistant parasite strains.

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Artemether-lumefantrine versus artesunate plus amodiaquine for treating uncomplicated childhood malaria in Nigeria: randomized controlled trial

Abstract: Background: The therapeutic efficacy of artesunate plus amodiaquine and artemether/ lumefantrine were assessed in an area of Nigeria with high levels of Plasmodium falciparum resistance to chloroquine and sulphadoxine-pyrimethamine.

Cited by 43 publications

References 12 publications

Comparative safety of artemether-lumefantrine and other artemisinin-based combinations in children: a systematic review

Comparative safety of artemether-lumefantrine and other artemisinin-based combinations in children: a systematic review

Artemether-Soluplus Hot-Melt Extrudate Solid Dispersion Systems for Solubility and Dissolution Rate Enhancement with Amorphous State Characteristics

Open-label trial of three dosage regimens of fixed-dose combination of artemisinin and naphthoquine for treating uncomplicated falciparum malaria in calabar, Nigeria

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