Efficacy and safety of the six-dose regimen of artemether–lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in adolescents and adults: A pooled analysis of individual patient data from randomized clinical trials

Mueller, Edgar A.; Vugt, Michèle van; Kirch, Wilhelm; Andriano, Kim; Hunt, Phillip R.; Palacios, Patricia

doi:10.1016/j.actatropica.2006.09.007

Cited by 34 publications

(29 citation statements)

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“…Similar fi ndings have been previously reported in both adults and children, and were judged as not relevant cardiac risks for patients treated with artemetherlumefantrine. 7,8,31 In this context, we point out that recovery from malaria is associated with a consistent reduction in heart rate and lengthening of the QT interval as a result of decreased autonomic tone, which seems to be independent of antimalarial treatment. 10 Overall, our safety data did not show any increased risk of adverse events in the treatment with the dispersible formulation.…”

Section: Discussionmentioning

confidence: 99%

“…A tablet consists of 20 mg artemether and 120 mg lumefantrine. A 3-day, six-dose regimen of artemether-lumefantrine is effi cacious and safe in both adults and children, 7,8 and is recommended for infants and children weighing 5-35 kg, and adults weighing more than 35 kg. Many countries in sub-Saharan Africa have already adopted artemether-lumefantrine as fi rst-line treatment for uncomplicated malaria, or have initiated the implementation process.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial

et al. 2008

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial

et al. 2008

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“…12 Patients without paired PCR results or ambiguous results were classified as treatment failures. Malaria cure was defined as clearance of asexual parasitemia within 7 days of initiation of trial treatment, without subsequent recrudescence (i.e., by Day 14,28,or 42).…”

Section: Study Populationmentioning

confidence: 99%

Randomized, Prospective, Three-Arm Study to Confirm the Auditory Safety and Efficacy of Artemether-Lumefantrine in Colombian Patients with Uncomplicated Plasmodium falciparum Malaria

Carrasquilla

Barón

Monsell³

et al. 2012

The American Society of Tropical Medicine and Hygiene

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Abstract. The safety of artemether-lumefantrine in patients with acute, uncomplicated Plasmodium falciparum malaria was investigated prospectively using the auditory brainstem response (ABR) and pure-tone thresholds. Secondary outcomes included polymerase chain reaction-corrected cure rates. Patients were randomly assigned in a 3:1:1 ratio to either artemether-lumefantrine ( N = 159), atovaquone-proguanil ( N = 53), or artesunate-mefloquine ( N = 53). The null hypothesis (primary outcome), claiming that the percentage of patients with a baseline to Day-7 ABR Wave III latency increase of > 0.30 msec is ≥ 15% after administration of artemether-lumefantrine, was rejected; 2.6% of patients (95% confidence interval: 0.7-6.6) exceeded 0.30 msec, i.e., significantly below 15% ( P < 0.0001). A model-based analysis found no apparent relationship between drug exposure and ABR change. In all three groups, average improvements (2-4 dB) in pure-tone thresholds were observed, and polymerase chain reaction-corrected cure rates were > 95% to Day 42. The results support the continued safe and efficacious use of artemether-lumefantrine in uncomplicated falciparum malaria.

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“…More than 90% of these reported adverse effects, many of which are typical of the clinical symptomatology of acute malaria, were rated mild to moderate in severity. 9,12,[15][16][17][18][19] The 6-dose regimen of AL was better tolerated than, and as effective as, artesunate-mefloquine against multi-drugresistant falciparum malaria. 8,20 Furthermore, AL was better tolerated than the comparator drugs used in some trials.…”

Section: Introductionmentioning

confidence: 99%

“…It is reported as one of the most successful malaria treatment regimen, highly effective, and well tolerated, providing cure rates of up to 97%, even in areas of multi-drug resistance. 14,15 Most common adverse effects of AL include gastrointestinal (abdominal pain, anorexia, nausea, vomiting and diarrhea) and central nervous system (headache, dizziness) effects. Others include vertigo, asthenia, myalgia and arthralgia, pruritus and rash.…”

Section: Introductionmentioning

confidence: 99%

Assessment of the Sub-Acute and Delayed Toxicity of Artemether-Lumefantrine Combination in Rats

Ukekwe¹,

Ezike²,

Akah³

et al. 2013

Int. J. Res. Ayurveda Pharm.

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Considering the current surge in the use of artemether-lumefantrine combination (AL), as a treatment regimen for malaria infection, this research elucidated its sub-acute and delayed toxicity profile. Adult albino wistar rats were randomly placed in 7 groups (n=8). Groups 1-3 received oral AL 14, 28 and 56 mg/kg and were used for the sub-acute toxicity study. Groups 4-6 equally received oral AL 14, 28 and 56 mg/kg and were used for the delayed toxicity study. Animals in group 7 served as control. Treatment was given for 7 days; animals for the sub-acute tests were sacrificed on day 8, while animals for the delayed toxicity test were sacrificed on day 15. Parameters evaluated include random blood sugar levels, alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin, cholesterol, serum electrolytes and hematological indices. The liver, kidney and heart were also subjected to histopathological evaluation. The random blood sugar level was only significantly (P<0.05) elevated in the sub-acute phase but not in the delayed phase. The AL treated rats had a marginal but non-significant increments in Na + , serum cholesterol, urea and liver enzymes in both the sub-acute and delayed phases. The AL had no effect on total and conjugated bilirubin, but reduced K + , Cl -and HCO3 -. There was mild increase in hemoglobin, packed cell volume, reticulocyte, total white blood cell and lymphocyte, and a decrease in neutrophil counts. Histology sections showed dose-related increase in severity of hepatic congestion and inflammation. Renal sections showed no significant changes. However, about 25% of animals that received 14, 28 and 56 mg/kg of AL respectively had granular and eosinophilic hyaline casts in renal tubules. There were no remarkable histopathologic changes in the heart in both sub-acute and delayed phases. However, one animal that received 56 mg/kg in the sub-acute phase had organizing fibrinous pericarditis, with intense lymphocytic infiltration and tubular coagulative necrosis. Though oral administration of normal to quadruple strength of AL affected vital organs and clinical parameters, no significant deleterious toxic effect was observed.

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Efficacy and safety of the six-dose regimen of artemether–lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in adolescents and adults: A pooled analysis of individual patient data from randomized clinical trials

Cited by 34 publications

References 29 publications

Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial

Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial

Randomized, Prospective, Three-Arm Study to Confirm the Auditory Safety and Efficacy of Artemether-Lumefantrine in Colombian Patients with Uncomplicated Plasmodium falciparum Malaria

Assessment of the Sub-Acute and Delayed Toxicity of Artemether-Lumefantrine Combination in Rats

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