Descriptive study on the efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Sudan

Elamin, Sakina B.; Awad, Abdelmoneim; Eltayeb, I. B.; Elmardi, Khalid A; Hassan, Asma Hashim Al; Mohamed, AbedlRahim Osman; Malik, Elfatih M.; Mohamad, Tarig Abedelgadir

doi:10.1007/s00228-009-0750-4

Cited by 14 publications

(10 citation statements)

References 29 publications

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“…In the present study, the majority of the children had parasite clearance within 48 hours with AL and DP and the parasite clearance rate reported here was similar to previously reported rates [30,31]. This demonstrates that the P. falciparum parasites in this region are still sensitive to artemisinin derivatives, unlike in some regions of Southeast Asia where delayed response to ACT has been reported [32,33].…”

Section: Discussionsupporting

confidence: 91%

Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children aged less than five years: results of an open-label, randomized, single-centre study

Ogutu

Onyango

Koskei

et al. 2014

Malar J

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BackgroundThis open-label, randomized study evaluated efficacy and safety of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) in treatment of uncomplicated falciparum malaria in children below five years of age, to build evidence on use of AL as first-line treatment and DP as second-line treatment in Kenya.MethodsA total of 454 children aged six to 59 months with uncomplicated falciparum malaria were randomized (1:1) to receive AL dispersible or DP paediatric tablets and followed up for 42 days. Primary efficacy variable was corrected adequate clinical and parasitological response (ACPR) rate on day 28. Secondary variables included corrected (day 14, 28 and 42), uncorrected (day 3, 14, 28 and 42) cure rates, parasitological failure at days 3, 14 and 42. Acceptability and tolerability of both drugs were assessed by caregiver questionnaire.ResultsOn day 28, corrected ACPR rates for AL dispersible and DP paediatric were 97.8% (95% CI: 94.9-99.3) and 99.1% (95% CI: 96.8-99.9), respectively, in intention-to-treat population, with no significant treatment differences noted between AL dispersible and DP paediatric arms. Additionally, no significant differences were observed for PCR corrected cure rates on days 14 and ACPR on day 42 for AL dispersible (100%; 96.8%) and DP paediatric (100%; 98.7%). Similarly, for PCR uncorrected cure rates, no significant differences were seen on days 3, 14, 28, and 42 for AL dispersible (99.1%; 98.7%; 81.1%; 67.8%) and DP paediatric (100%; 100%; 87.7%; 70.5%). Parasite clearance was rapid, with approximately 90% clearance achieved in 40 hours in both treatment arms. Incidence of adverse events was related to underlying disease; malaria being reported in both treatment arms. One serious adverse event was noted in AL dispersible (0.42%) arm, not related to study drug. Adherence to treatment regimen was higher for children treated with AL dispersible (93.6%) compared to DP paediatric (85.6%). Acceptability of AL dispersible regimen was assessed as being significantly better than DP paediatric.ConclusionsAL and DP were both efficacious and well tolerated, and had similar effects at day 42 on risk of recurrent malaria. No signs of Plasmodium falciparum tolerance to artemisinins were noted.Trial registrationPACTR201111000316370.

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Section: Discussionsupporting

confidence: 91%

Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children aged less than five years: results of an open-label, randomized, single-centre study

Ogutu

Onyango

Koskei

et al. 2014

Malar J

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“…In Sudan, a 6-dose course of AL is currently recommended as a second-line treatment for uncomplicated falciparum malaria (18) and has reported in vivo efficacy of over 90% (9,20,22). In the present study, we analyzed the sequence of pfatpase6 and pfmdr1 alleles and tested for CNV at pfmdr1 in parasites before and after AL treatment for uncomplicated falciparum malaria in eastern Sudan.…”

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confidence: 99%

Increased pfmdr1 Copy Number and Sequence Polymorphisms in Plasmodium falciparum Isolates from Sudanese Malaria Patients Treated with Artemether-Lumefantrine

Gadalla

Adam

El-zaki

et al. 2011

Antimicrob Agents Chemother

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Molecular markers for surveillance of Plasmodium falciparum resistance to current antimalarials are sorely needed. A 28-day efficacy study of artemether-lumefantrine in eastern Sudan identified 5 treatment failures among 100 evaluable patients; 9 further individuals were parasite positive by PCR during follow-up. Polymorphisms in pfatpase6 and pfmdr1 were evaluated by DNA sequencing. One individual carried parasites with a novel pfmdr1 polymorphism (F1044L). pfmdr1 gene amplification in parasites prior to treatment occurred in three individuals who had recurrent infection during follow-up.

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“…1), 9 , 17–22 rapidly clearing parasitemia and fever, even in areas of widespread parasite resistance to other antimalarial agents. In addition to the six published Novartis‐sponsored clinical studies, 9 , 17–21 over 50 independent trials have produced data supporting the efficacy of AL 23–42 . Efficacy appears to be maintained across different populations and regions.…”

Section: Efficacy and Safety Of Almentioning

confidence: 99%

“…In addition to the six published Novartis-sponsored clinical studies, 9,17-21 over 50 independent trials have produced data supporting the efficacy of AL. [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42] Efficacy appears to be maintained across different populations and regions. In studies conducted in Africa and Southeast Asia, AL appeared to be at least as effective as most other ACTs in the treatment of P. falciparum malaria, with high parasitological cure rates and rapid clearance of fever and parasitemia, and was typically more effective than other, non-ACT comparators.…”

Section: Efficacy and Safety Of Almentioning

confidence: 99%

Novartis Malaria Initiative: best practice example of pharmaceutical industry's engagement in the fight against malaria

Lefèvre¹,

Marrast²,

Grueninger³

2011

Annals of the New York Academy of Sciences

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Despite considerable advances in the treatment and prevention of malaria, Plasmodium falciparum is still a threat to millions of people across the world, particularly in sub-Saharan Africa, with infants and young children bearing the greatest burden in terms of morbidity and mortality. Since 1999, the artemisinin-based combination therapy artemether-lumefantrine (AL; Coartem) has been made available. A wealth of evidence supports consistently high efficacy of AL, and a favorable safety and tolerability profile has been demonstrated. The child-friendly dispersible formulation of AL has proven to be as effective and well tolerated as the standard tablets, and will encourage ease of administration and improved adherence to the drug regimen. This article reviews the significant impact made by AL on the progress in malaria control and describes the way forward for the Novartis Malaria Initiative in leading the fight against malaria.

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Descriptive study on the efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Sudan

Abstract: Our findings showed that artemether-lumefantrine was an effective and safe drug for treating uncomplicated P. falciparum malaria in northern and southern Sudan.

Cited by 14 publications

References 29 publications

Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children aged less than five years: results of an open-label, randomized, single-centre study

Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children aged less than five years: results of an open-label, randomized, single-centre study

Increased pfmdr1 Copy Number and Sequence Polymorphisms in Plasmodium falciparum Isolates from Sudanese Malaria Patients Treated with Artemether-Lumefantrine

Novartis Malaria Initiative: best practice example of pharmaceutical industry's engagement in the fight against malaria

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