Assessment of clinical safety and efficacy of fixed dose combination of arterolane maleate and piperaquine phosphate versus artesunate, sulfadoxine and pyrimethamine in patients of uncomplicated falciparum malaria

Anil Kumar P., Shanmukananda P.


Objective: To compare the safety and efficacy of fixed dose combination (FDC) of Arterolane maleate, Piperaquine phosphate with AS+SP (Artesunate + sulfadoxine, pyrimethamine) in uncomplicated falciparum malaria.

Methods: Study was conducted in Dr B R Ambedkar Medical College & Hospital, by randomly allocating the subjects into 2 groups (n=30 each) and by comparison of their efficacy as well as safety of two FDC of drugs at regular follow ups at 0, 2, 7, 14 and 28 days.

Results: Thirty subjects in each group completed the 28 days follow-up. On day one, total 30 patients in both the groups were febrile and parasitaemic. Three patients of those divided groups, were afebrile and aparasitaemic which was assessed by fever clearance and parasite clearance time. There was no late clinical as well as parasitological failures were found in both the groups, total 60 patients demonstrated Adequate Clinical and Parasitological Response 96.5% (APCR) with the study drugs. No gametocytemia was seen in the two groups during follow up. Adverse drug effects were detected in four patients (two patients had anaemia, and one patient shown slight elevation in hepatic transaminases,one patient shown jaundice-unconjugated hyperbili-rubinemia? Haemolytic) in AM+PIP.PO4 group (GROUP1), and three patients (anaemia in two patients and slight elevation in hepatic transaminases in one patient) in AS+SP group (Group 2).

Conclusion: The study showed that Arterolane maleate and Piperaquine phosphate combination and Artesunate, Sulfadoxine and Pyrimethamine combination are equally potent in making the patient  afebrile and aparasitemic on day 3, and achieving 96.5% APCR on day 28,  and safety profile of the  new drug (AM+PIP.PO4) is non inferior to AS+SP in the treatment of uncomplicated P. falciparum malaria.


Artesunate, Sulfadoxine, Arterolane, ACT, Falciparum malaria

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