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

Table 3

Efficacy of PSR 15 mg and PSR 30 mg against relapse of P. vivax malaria.

Characteristics	P 15 mg	PSR 15 mg	PSR 30 mg	PSR 15 mg + PSR 30 mg
Number of randomized patients	120	118	120	238
Duration of follow-up (days)
Mean	142.3	149.6	149.0	149.3
Median	168	168	168	168
Total	17076	17652	17876	35528
Number of relapse, (%)	3 (2.86)	0 (0.0)	1 (0.93)	1 (0.42)
value	—	0.076	0.293	0.069
Relapses per persons-year	0.064	0.00	0.02	0.01
Reduction in incidence, % (95% CI)	NA	100 (−134 to 100)	68.2 (−29.6 to 99.4)	83.9 (−99.5 to 99.7)
value		0.059	0.176	0.057

P 15 mg: conventional primaquine 15 mg, PSR 15 mg: primaquine sustained release 15 mg, and PSR 30 mg: primaquine sustained release 30 mg.
Denominator used is the number of patients who had completed treatment period of 14 days (for P 15 mg, ; for PSR 15 mg, ; and for PSR 30 mg, ).
PSR 15 mg and PSR 30 mg compared with P 15 mg conventional using Fisher’s exact test.
Denominator used is the total duration of follow-up in years (calculated based on total number of follow-up days).
Value shown is a conditional exact 95% CI for ratio of two Poisson variables.
Percentage reduction in incidence rate of PSR 15 mg and PSR 30 mg compared with conventional P 15 mg.
NA: not applicable value.