Efficacy, safety and tolerability study of artemisinin-piperaquine combination (ArtequickR) versus artemeter-lumefantrine (Co-ArtemR) for the treatment of uncomplicated plasmodium falciparum T Malaria in Ijebu ode local government health services in Nigeria

Abstract

August 2015 e9(acute on chronic liver failure). Twelve ADRs were considered due to a single drug, 10 to multiple drugs, and 5 to traditional medicines. In one patient a metabolic drug interaction with fluconazole was implicated. In 6 cases, drugs considered exacerbated prior disease. Conclusions: We were effective in improving ADR reporting, identifying important contributions of ADRs to serious morbidity, and identifying preventable patterns of ADRs. Prior similar ADRs, drugdisease interactions, and traditional medicine use, often unrecognized, were common causes of hospital admissions. Background: Artemisinin-based combination therapy (ACT) has become the standard of care for the treatment of uncomplicated Plasmodium falciparum malaria in the world. Data guiding optimal choices of ACTs are limited. Artemisinin-based combination therapy of artemether-lumefantrine (Coartem R ) is currently used for the first line treatment of uncomplicated Plasmodium falciparum malaria. However, limited efficacy and tolerability data are available on alternative forms of ACT. This study was conducted to compare the efficacy and tolerability of two fixed-dose formulation of ACT, artemisinin-piperaquine (Artequick R ) and (Coartem), for the treatment of P. falciparum in Nigeria. Methods/Materials: A randomized, open-label trial was conducted comparing the efficacy of a one-day regimen of Artequick (2.8 mg/ kg artemisinin plus 17.1 mg/kg of piperaquine per day for 24 hours) and Coartem (24 tablets, total dosage of 3360 mg, eight tablets over three days) for the treatment of adults with uncomplicated falciparum malaria. The primary end point was a day 42, PCR-corrected, parasitological cure rate; secondary end points were parasites and fever clearance time. Of 64 patients enrolled, 31 were administered with Artequick and 33 with Coartem. Result: Of the patients who completed the test, 28 were on Artequick and 29 were on Coartem. Recrudescence parasitemia was PCR confirmed for all patient in each treatment group, with cure rates at day 42 of 97% (96% CL: 90-100) for both forms of ACT. Conclusion: The median parasite clearance time was significantly slower in the Coartem group compared with the Artequick group (48 h vs 36 h, P < 0.05), and fever clearance times were shorter in the Artequick group (12 h vs 24 h, P < 0.05). The two forms of ACT were well tolerated with no serious adverse events. The polymorphic cytochrome P450 enzymes CYP2D6, CYP2C19, and CYP2C9 catalyze the oxidative metabolism of numerouscommonly prescribed drugs, such as antipsychotics, antiepileptics, antidepressants, and some cardiovascular drugs (eg, warfarin, flecainide, propafenone, and metoprolol). Evaluation of the metabolic capacity of an individual by genotyping may help the clinicians to select the right dose (in order to avoid toxic or subtherapeutic plasma concentrations) and/or the best drug for an individual patient, thereby minimizing the risk of side effects or therapeutic failure. In the period 2009 to 2014 a total of 529 genotyping analyses were perf...

Efficacy and Safety of Artemisinin-Piperaquine for the Treatment of Uncomplicated Malaria: A Systematic Review

“…Our initial search found 45 relevant articles published between 2000 and 2020, of which 9 reported repetitive data. After screening for titles, 38 abstracts, and 15 full-text reviewed, 5 studies reporting RCTs ( Krudsood et al., 2007 ; Trung et al., 2009 ; Song et al., 2011 ; Thanh et al., 2012 ; Onasanya et al., 2015 ), and 2 reporting a noncomparative single-arm studies ( Deng et al., 2008 ; Wang et al., 2020 ) were included for the analysis ( Figure 1 ).…”

“…Among the included studies, one was published in the Chinese language ( Deng et al., 2008 ) and others in the English language ( Krudsood et al., 2007 ; Trung et al., 2009 ; Song et al., 2011 ; Thanh et al., 2012 ; Onasanya et al., 2015 ; Wang et al., 2020 ). Four of the five RCTs ( Krudsood et al., 2007 ; Trung et al., 2009 ; Song et al., 2011 ; Thanh et al., 2012 ) and the two single-arm studies ( Deng et al., 2008 ; Wang et al., 2020 ) reported PCR-confirmed cure rate on day 28, while one trial reported the same on day 42 ( Onasanya et al., 2015 ). A total of 917 participants were included in the experiment, including 145 in the single-arm study, 335 in the AP group, 188 in the DHP group, 25 in the ASAM group, 59 in the ASAQ group, and 165 in the AL group.…”

“…As shown in Table 2 , half of the studies reported a low risk of bias, which was defined as meeting five of the seven domains ( Trung et al., 2009 ; Thanh et al., 2012 ). All RCTs included in this review were blinded studies ( Trung et al., 2009 ; Thanh et al., 2012 ) or open-labeled ( Krudsood et al., 2007 ; Song et al., 2011 ; Onasanya et al., 2015 ), which indicates that both the patients and the research investigator may have realized the difference in the treatment of the participants ( Table 2 ).…”

“…Author, publication year Onasanya et al, 2015Trung et al, 2009Song et al, 2011Thanh et al, 2012Krudsood et al, 2007 Random uncomplicated malarial patients. We found similar efficacy and safety of AP relative to other antimalarial drugs available for the treatment of clinical malaria patients living in the endemic regions and countries, including Nigeria, Vietnam, and Cambodia-Thailand border area.…”

“…Therefore, there is a concern regarding confidence in the treatment effect estimates. Moreover, the risk of performance bias is a concern due to the default blinding in some of the included RCTs (Song et al, 2011;Onasanya et al, 2015).…”