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Malaria Research and Treatment
Volume 2015, Article ID 579864, 8 pages
http://dx.doi.org/10.1155/2015/579864
Clinical Study

Sustained Release Formulation of Primaquine for Prevention of Relapse of Plasmodium vivax Malaria: A Randomized, Double-Blind, Comparative, Multicentric Study

1Medical Affairs and Clinical Research, Ipca Laboratories Limited, Mumbai 400067, India
2Clinical Research & Development, Ipca Laboratories Limited, Mumbai 400067, India
3Department of Clinical Pharmacology, Seth G. S. Medical College & K. E. M. Hospital, Mumbai 400012, India
4Department of Medicine, Grant Medical College & Sir J. J. Group of Hospitals, Mumbai 400008, India
5Department of Medicine, Padmashree Dr. D. Y. Patil Medical College, Pimpri, Pune 411018, India
6Department of Medicine, B. Y. L. Nair Charitable Hospital & T. N. Medical College, Mumbai 400008, India
7Department of Medicine, IPGMER and SSKM College & Hospital, Kolkata 700020, India
8Department of Medicine, R. G. Kar Medical College & Hospital, 1 Kshudiram Bose Sarani, Kolkata 700004, India
9Department of Medicine, Dr. S. N. Medical College, Jodhpur 342003, India
10Kothari Medical and Research Institute, Bikaner 334004, India
11Kasturba Hospital for Infectious Diseases, Mumbai 400011, India

Received 4 July 2015; Accepted 3 August 2015

Academic Editor: Polrat Wilairatana

Copyright © 2015 Anil Pareek et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. Primaquine is used to eradicate latent Plasmodium vivax parasite from liver, with administration of standard dose daily up to 14 days. We studied efficacy, safety, and tolerability of sustained release (SR) formulation of primaquine in comparison with conventional primaquine in preventing relapse of P. vivax malaria. Methods. Microscopically confirmed cases of P. vivax malaria received chloroquine therapy for three days. Aparasitemic and asymptomatic patients were then randomized to receive either conventional primaquine 15 mg for 14 days or primaquine SR 15 mg for 14 days, or primaquine SR 30 mg for seven days. Results. Of the 360 patients, who received chloroquine therapy, 358 patients were randomized. Two-hundred eighty-eight patients completed six-month follow-up and four patients (three: conventional primaquine 15 mg (2.86%), one: primaquine SR 30 mg (0.93%)) showed relapse confirmed by PCR genotyping. Drug compliance was significantly better in primaquine SR 30 mg group (95.57%, ) without any serious adverse events. Conclusion. Primaquine SR 15 mg and primaquine SR 30 mg could be an effective alternative to conventional primaquine 15 mg due to their comparable cure rates and safety profile. Shorter treatment duration with primaquine SR 30 mg may increase patient compliance and may further reduce relapse rates. Clinical Trial Registration. This trial is registered with CTRI/2010/091/000245.