Efficacy and safety of Arterolane-Piperaquine in the treatment of acute uncomplicated Plasmodium Falciparum Malaria in adults: A Post Marketing Surveillance study
Abstract
Background and Objective: Arterolane maleate (150 mg) and Piperaquine phosphate (750 mg) as a fixed dose combination was approved for the ‘Treatment of acute uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in adults’. Arterolane is a synthetic trioxolane, which rapidly kills malarial parasites in
blood and provides fast relief from symptoms of malaria like fever, chills and associated symptoms. Piperaquine has a long lasting effect than Arterolane and kills the residual malarial parasites. There was a need of a post marketing surveillance study to ascertain efficacy and to identify any safety concerns with the use of Arterolane-
Piperaquine (AP) therapy in adult patients with uncomplicated P. falciparum malaria in India.
Methods: This was a prospective, open-label, single arm, multi-center, post-marketing study. Patients with acute symptomatic uncomplicated malaria confirmed positive for P.falciparum malaria by Rapid Diagnostic Test (RDT) and presence of fever (≥ 99 °F) were included. Enrolled patients were on the study drug, Arterolane-Piperaquine
therapy, one tablet once daily for 3 consecutive days. Patients with severe malaria, mixed infection, age <12 or > 65 years, known allergy, significant renal or hepatic impairment; and pregnant and lactating women were excluded from the study. Efficacy was assessed in terms of percentage of patients being ‘afebrile’ and blood smear
negative for P. falciparum at end of 3 days of treatment and at the end of day 28 of the Observation period. Safety and tolerability was evaluated by the incidence and severity of adverse events (AEs), and abnormal laboratory values through the 3 days of treatment with AP therapy and day 28 of Observation period.
Results: A total of 1681 patients were screened of which 336 patients were found to be febrile with RDT positive for P. falciparum and were enrolled in the study. Of the enrolled patients, 67.9% of patients were males and 32.1% were females, with the mean age of 33.0 years. In this study, the Primary Endpoint for the percentage of
patients being ‘afebrile’ at end of 3 days of treatment was almost 100%, confirming the efficacy of AP therapy. This was further confirmed by the absence of P. falciparum in thick blood smear examination at the end of 3 days of treatment. Regarding the Secondary Endpoint, 100% of patients were ‘aparasitemia’ on Day 28 of the observation
period on thick blood smear examination; and there was no reported case of ‘fever’ during 28 Days of the observation period. Arterolane-Piperaquine therapy was well tolerated and there was no new adverse event that was reported in this study compared to the earlier studies done with AP therapy.
Conclusion: Arterolane-Piperaquine therapy provides rapid clearance of P. falciparum parasite, relief from most
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