2018
DOI: 10.1007/s10792-018-1003-2
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Comparative ophthalmic assessment of patients receiving tafenoquine or chloroquine/primaquine in a randomized clinical trial for Plasmodium vivax malaria radical cure

Abstract: Purpose Ophthalmic safety observations are reported from a clinical trial comparing tafenoquine (TQ) efficacy and safety versus sequential chloroquine (CQ)/primaquine (PQ) for acute Plasmodium vivax malaria. Methods In an active-control, double-blind study, 70 adult subjects with microscopically confirmed P. vivax malaria were randomized (2:1) to receive 400 mg TQ 9 3 days or 1500 mg CQ 9 3 days then 15 mg PQ 9 14 days. Main outcome measures: clinically relevant changes at Day 28 and Day 90 versus baseline in … Show more

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Cited by 12 publications
(4 citation statements)
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“…Induced ophthalmic changes are also known from other drugs, including the 4-aminoquinoline antimalarial CQ 46,47. Results of three following studies aimed to provide further evidence of the ophthalmic effects of TQ and did not find a clinically significant effect of TQ on ophthalmic function,19,41,45 even so a mild keratopathy was also observed with TQ when given for a short course (3 days) 41. One unpublished study (NCT02658435) submitted with the dossier to FDA was a phase I study designed to investigate ophthalmic safety of the 300 mg TQ dose for radical cure.…”
Section: Methodsmentioning
confidence: 99%
“…Induced ophthalmic changes are also known from other drugs, including the 4-aminoquinoline antimalarial CQ 46,47. Results of three following studies aimed to provide further evidence of the ophthalmic effects of TQ and did not find a clinically significant effect of TQ on ophthalmic function,19,41,45 even so a mild keratopathy was also observed with TQ when given for a short course (3 days) 41. One unpublished study (NCT02658435) submitted with the dossier to FDA was a phase I study designed to investigate ophthalmic safety of the 300 mg TQ dose for radical cure.…”
Section: Methodsmentioning
confidence: 99%
“…Reassuringly, no conclusive evidence of short-term ocular toxicity of clinical significance has been found in patients who received a single therapeutic dose of 300 mg of TQ, 77 nor in individuals who took 400 mg/day for three days. 78 Some minor and temporary ophthalmic changes were recorded, 77,78 as other authors have reported too. 73 In one study, no clinically significant ocular effects were detected at a dosing regimen of 200 mg of TQ daily for three consecutive days (this being a 600 mg loading dose), followed by 200 mg once weekly for 23 weeks.…”
Section: Eyesmentioning
confidence: 82%
“…This fact means that the use of tafenoquine over chloroquine as an antimalarial drug is more favorable. 25…”
Section: Ophthalmological Effects Of Tafenoquine Usementioning
confidence: 99%