Gender differences in gastrointestinal disturbances and plasma concentrations of tafenoquine in healthy volunteers after tafenoquine administration for post-exposure vivax malaria prophylaxis

Edstein, M.D., Nasveld, P.E., Kocisko, D.A., Kitchener, S.J., Gatton, M.L., and Rieckmann, K.H. (2007) Gender differences in gastrointestinal disturbances and plasma concentrations of tafenoquine in healthy volunteers after tafenoquine administration for post-exposure vivax malaria prophylaxis. Transactions of the Royal Society of Tropical Medicine and Hygiene, 101 (3). pp. 226-230.

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Abstract

In an open-label sequential cohort study, we compared gastrointestinal (GI) disturbances and plasma tafenoquine concentrations after administration of single-dose (400 mg daily × 3 days; n = 76 males, 11 females) and split-dose (200 mg twice daily × 3 days; n = 73 males, 13 females) tafenoquine regimens in healthy Australian Defence Force volunteers for post-exposure malaria prophylaxis. The female and male volunteers had comparable demographic characteristics (age, weight, height) in the single- and split-dose treatment groups. GI disturbances were generally mild and self-limiting for both groups. The frequency of nausea and abdominal distress was over two-fold higher in females than in males for both treatment groups. Reporting of GI disturbances in the single-dose group differed significantly between males and females, but this gender difference was not seen for the split-dose group. In those volunteers who experienced GI disturbances, the mean plasma tafenoquine concentrations 12 h after the last dose of tafenoquine were approximately 1.3-fold higher in females than in males (means ± SD: 737 ± 118 ng/ml vs. 581 ± 113 ng/ml). These preliminary findings suggest that further studies are required in a larger number of females to determine whether there is a need to reduce the dose of tafenoquine to minimise GI disturbances in females.

Item ID: 29766
Item Type: Article (Research - C1)
ISSN: 1878-3503
Keywords: malaria; Plasmodium vivax; Tafenoquine; adverse events; gender
Date Deposited: 11 Oct 2013 00:30
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1117 Public Health and Health Services > 111716 Preventive Medicine @ 100%
SEO Codes: 92 HEALTH > 9204 Public Health (excl. Specific Population Health) > 920412 Preventive Medicine @ 100%
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