Efficacy and safety of artemisinin-based combination therapy for uncomplicated Plasmodium falciparum malaria in Sudan: a systematic review and meta-analysis

Adam, Ishag; Ibrahim, Yassin M.; Gasim, Gasim I.

doi:10.1186/s12936-018-2265-x

Cited by 26 publications

(22 citation statements)

References 32 publications

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“…Previous meta-analysis reports in 2017 revealed similarly high e cacies of AL [67,68]. This result is also consistent with neighboring Sudan, a high treatment success rate (98%) of malaria treatment was recently reported in a meta-analysis which included 20 studies with a total of 4070 patients [69].The cure rate 98.7% (95% CI 97. 7-99.6) found in this study suggests that, in accordance with WHO parameters [28], AL is still effective as rst-line drug for uncomplicated malaria treatment in Ethiopia, but a regular monitoring is necessary.…”

Section: Discussionsupporting

confidence: 86%

“…Adverse events were judged according to their causal association with AL (unlikely, possible and probable) and severity (mild, moderate or severe) [7].In this review, mild adverse events (a headache, cough, fever, diarrhoea, vomiting, perioral ulcer, anorexia, abdominal pain, dizziness and nausea, weakness/fatigue and others) were reported and almost all were resolved soon after completion of the treatment except cough [48,53,54]. Similar mild adverse events have been associated with AL, the most common being headache, fever, vomiting followed by gastrointestinal disturbances [65,69].The observed rate of 36.1%, (550/1523)ADRs was comparable with the rate reported in the previous review in Ethiopia where 269 of 633 patients had ADRs, with a pooled event rate of 41.2% [68].…”

Section: Discussionmentioning

confidence: 75%

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Efficacy and Safety of Artemether-Lumefantrine for Treatment of Uncomplicated P. Falciparum malaria in Ethiopia: A Systematic Review and Meta-Analysis

Abamecha

Yilma

Adissu

et al. 2021

Preprint

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Background: Anti-malarial drug resistance, in particular resistance to Plasmodium falciparum, challenges the treatment and control of malaria. In Ethiopia, the first-line treatment of uncomplicated falciparum malaria has been changed from sulphadoxine-pyrimethamine (SP) to artemether-lumefantrine (AL) in 2004. To maximize efficacy of anti-malarial drugs and ensure adequate treatment outcomes; monitoring drug efficacy regularly is vital to establish rational malaria treatment guidelines. This systematic review and meta-analysis is performed to obtain an overall stronger evidence to guide management of uncomplicated falciparum malaria from the existing literature in Ethiopia after policy changes in 2004.Methods: A systematic literature search was performed using the preferred reporting items for systematic review and meta-analysis (PRISMA) from published therapeutic efficacy studies conducted in Ethiopia from 2004 to 2020. The search was performed from Pubmed, Google Scholar and Clinical trial registry databases to identify literature. Two reviewers independently assessed study eligibility and extracted data. While computing the efficacy of AL, polymerase chain reaction (PCR)-corrected cure rate (adequate clinical and parasitological response, ACPR) at 28th day was considered as the primary endpoint. Meta-analysis was computed using OpenMeta-Analysis software to calculate the pooled ACPR. Statistical heterogeneity was evaluated with the Cochran chi-square test (X2) test and inverse variance index (I2). Publication bias was analyzed using funnel plots and Egger’s test statistics. The review protocol is registered in PROSPERO, number CRD42020201859.Results: Out of studies screened, fifteen studies fulfilled the inclusion criteria, and were included in final analysis with a total number of 1523 participants. Treatment success of AL for uncomplicated falciparum malaria in all combined studies was 98.4% [(95% CI 97.6–99.1), P< 0.001]. Polymerase chain reaction (PCR)-corrected AL treatment success rate of 98.7% [(95% CI 97.7-99.6), P<0.001)]. The efficacy of AL with PCR-corrected cure rates ranging from 95.0 to 99.4% in per-protocol analysis, and 88.8 to 97.4% in intention-to-treat analysis. Based on the analysis, Cochrane chi-square test (X2) test and inverse variance index (I2) indicated that the included studies with heterogeneity (X2=20.48, (df=14), P=0.116 and I2=31.65%). The highest parasite positivity rate at day-3 was 5.7%. Adverse events ranged from mild to serious but were not directly attributed to the drug.Conclusion: The present review has shown that AL is efficacious and safe for treatment of uncomplicated malaria in Ethiopia. However, few therapeutic efficacy studies were conducted in Ethiopia after treatment guideline was revised in 2004. AL has been used more than a decade in the study population without other alternative artemisinin-based combination therapy in Ethiopia and considering that the potential evolution of drug resistance is of a great concern, regular and continuous monitoring of its efficacy is warranted.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 75%

Efficacy and Safety of Artemether-Lumefantrine for Treatment of Uncomplicated P. Falciparum malaria in Ethiopia: A Systematic Review and Meta-Analysis

Abamecha

Yilma

Adissu

et al. 2021

Preprint

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“…On the other hand, the classical drug resistance is when a parasite that normally would have been cured by a treatment regimen survives, multiplies and is transmitted to a new host [33]. Interestingly, in Africa microscopy-determined parasite clearance time is rapid following ACT, with very few patients having parasitaemia on day 3 [19,35,[40][41][42]. However, clearance slopes in infections in SSA are likely to underestimate inherent resistance of parasites due to greater host immunity in high-transmission settings [43].…”

Section: Parasite Clearance Time Following Actmentioning

confidence: 99%

Evaluation of residual submicroscopic Plasmodium falciparum parasites 3 days after initiation of treatment with artemisinin-based combination therapy

Mwaiswelo

Ngasala

2020

Malar J

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Plasmodium falciparum resistance against artemisinin has not emerged in Africa; however, there are reports of the presence of polymerase chain reaction-determined residual submicroscopic parasitaemia detected on day 3 after artemisinin-based combination therapy (ACT). These residual submicroscopic parasites are thought to represent tolerant/resistant parasites against artemisinin, the fast-acting component of the combination. This review focused on residual submicroscopic parasitaemia, what it represents, and its significance on the emergence and spread of artemisinin resistance in Africa. Presence of residual submicroscopic parasitemia on day 3 after treatment initiation leaves question on whether successful treatment is attained with ACT. Thus there is a need to determine the potential public health implication of the PCR-determined residual submicroscopic parasitaemia observed on day 3 after ACT. Robust techniques, such as in vitro cultivation, should be used to evaluate if the residual submicroscopic parasites detected on day 3 after ACT are viable asexual parasites, or gametocytes, or the DNA of the dead parasites waiting to be cleared from the circulation. Such techniques would also evaluate the transmissibility of these residual parasites.

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“…Although there is a wide range of treatment failure reports for the ACTs, they are still mainstay drugs for averting uncomplicated malaria from progressing to severe disease and death [ 5 – 12 ]. To preserve therapeutic efficacy of ACTs, WHO recommends malaria-endemic countries to perform routine antimalarial drug efficacy monitoring at sentinel sites at least once every 24 months.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of artemisinin-based combination therapies for the treatment of uncomplicated malaria in pediatrics: a systematic review and meta-analysis

et al. 2021

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Background Malaria is a major cause of morbidity and mortality in pediatrics in malaria endemic areas. Artemisinin-based combination therapies (ACTs) are the drugs of choice for malaria management particularly across malaria-endemic countries. This systematic review and meta-analysis was performed to assess efficacy and safety of ACTs for uncomplicated malaria in pediatric populations. Methods A body of evidence was searched for published ACT trials until March 06, 2020. The search was focused on efficacy and safety studies of ACTs for uncomplicated malaria in pediatrics. PubMed library was searched using best adapted search terms after multiple trials. References were exported to the endnote library and then to Covidence for screening. Data was extracted using the Covidence platform. The per-protocol analysis report for the efficacy and the intention-to-treat analysis for the safety were synthesized. Met-analysis was carried using Open Meta-Analyst software. Random effects model was applied and the heterogeneity of studies was evaluated using I2 statistic. Results Nineteen studies were included in the final analysis. Overall, crude, PCR-corrected P. falciparum malaria treatment success rate was 96.3 and 93.9% for day 28 and 42, respectively. In the subgroup analysis, PCR-corrected adequate clinical and parasitological response (ACPR) of dihydroartemisinin-piperaquine (DP) was 99.6% (95% CI: 99.1 to 100%, I2 = 0%; 4 studies) at day 28 and 99.6% (95% CI of 99 to 100%, I2 = 0%; 3 studies) at day 42. Nine studies reported ACT related adverse drug reactions (ADR) (8.3%, 356/4304). The reported drug related adverse reactions ranged from 1.8% in DP (two studies) to 23.3% in artesunate-pyronaridine (AP). Gastrointestinal symptoms were the most common ACT related adverse effects, and all ADRs were reported to resolve spontaneously. Conclusion ACTs demonstrated a high crude efficacy and tolerability against P. falciparum. The high treatment success and tolerability with low heterogeneity conferred by DP has implication for policy makers who plan the use of ACTs for uncomplicated falciparum malaria treatment in pediatrics.

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Efficacy and safety of artemisinin-based combination therapy for uncomplicated Plasmodium falciparum malaria in Sudan: a systematic review and meta-analysis

Cited by 26 publications

References 32 publications

Efficacy and Safety of Artemether-Lumefantrine for Treatment of Uncomplicated P. Falciparum malaria in Ethiopia: A Systematic Review and Meta-Analysis

Efficacy and Safety of Artemether-Lumefantrine for Treatment of Uncomplicated P. Falciparum malaria in Ethiopia: A Systematic Review and Meta-Analysis

Evaluation of residual submicroscopic Plasmodium falciparum parasites 3 days after initiation of treatment with artemisinin-based combination therapy

Efficacy and safety of artemisinin-based combination therapies for the treatment of uncomplicated malaria in pediatrics: a systematic review and meta-analysis

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