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.

Abstract


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.

Keywords


Artesunate, Sulfadoxine, Arterolane, ACT, Falciparum malaria

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References


World malaria report 2011. [Online] Available at http://www.who.int/entity/ malaria/world_malaria_report_2011/9789241564403_eng.pdf. Accessed 15 July 2016.

Wells TN, Poll EM. When is enough enough? The need for a robust pipeline of high-quality antimalarials. Discov Med. 2010;9(48):389-98.

Elamin SB, Malik EM, Abdelgadir T. Artesunate plus sulfadoxine-pyrimethamine for treatment of uncomplicated Plasmodium falciparum malaria in Sudan. Malar J. 2005;4:41.

Valecha N, Krudsood S, Tangpukdee N. Arterolane maleate plus piperaquine phosphate for treatment of uncomplicated Plasmodium falciparum malaria: a comparative, multicenter, randomized clinical trial. Clin Infect Dis. 2012;55(5):663-71.

Biomonte MA, Wanner J, Le Roch KG. Recent advances in malaria drug discovery. Bioorg Med Chem Lett. 2013;23(10):2829-43.

Alemu A, Shiferaw Y, Ambachew A, Hamid H. Malaria helminth co-infections and their contribution for aneamia in febrile patients attending Azzezo health center, Gondar, Northwest Ethiopia: a cross sectional study. Asian Pac J Trop Med. 2012;5(10):803-9.

Hati AK, Bhattacharjee I, Mukherjee H, Bandyopadhayay B, Bandyopadhyay D, De R, et al. Concurrent dengue and malaria in an area in Kolkata. Asian Pac J Trop Med. 2012;5(4):315-7.

WHO. Iron deficiency anemia: assessment, prevention and control, a guidelines for program managers. Geneva: WHO; 2007.

Ward DIA. A case of fatal Plasmodium falciparum malaria complicated by acute dengue fever in East Timor. Am J Trop Med Hyg. 2006;75:182-5.


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