A randomized, double-blind, parallel-group, comparative safety, and efficacy trial of oral co-artemether versus oral chloroquine in the treatment of acute uncomplicated Plasmodium falciparum malaria in adults in India.

N A KshirsagarDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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N J GogtayDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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N S MoorthyDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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M R GargDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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S S DalviDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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A R ChogleDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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J S SorabjeeDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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S N MaratheDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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G H TilveDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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A D BhattDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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S P SaneDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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R MullDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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I GathmannDepartment of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.

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In India, treatment of acute, uncomplicated Plasmodium falciparum malaria is becoming increasingly difficult due to resistance to chloroquine, thus there is a need for new antimalarial drugs. CGP 56697 (co-artemether), a new drug, is a combination of artemether and lumefantrine in a single oral formulation (one tablet = 20 mg of artemether plus 120 mg of lumefantrine). In a double-blind study, 179 patients with acute uncomplicated P. falciparum malaria were randomly assigned to receive either CGP (n = 89) given as a short course of 4 x 4 tablets over a 48-hr period or chloroquine (n = 90) given as four tablets (one tablet = 150 mg of chloroquine base) initially, followed by two tablets each at 6-8, 24, and 48 hr. Due to a death in the chloroquine group and a decrease in the chloroquine cure rate to < 50% (based on the blinded overall cure rate at that time), recruitment was terminated prematurely. CGP 56697 showed a superior 28-day cure rate (95.4% versus 19.7%; P < 0.001), time to parasite clearance (median = 36 versus 60 hr; P < 0.001), and resolution of fever (median = 18 versus 27 hr; P = 0.0456). This drug provides a safe, effective, and rapid therapy for the treatment of acute uncomplicated P. falciparum malaria.

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