title: 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.
abstract: 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.
authors.affiliation: Department of Clinical Pharmacology, T. N. Medical College and B. Y. L. Nair Hospital, Mumbai, India.
authors.forename: N A
authors.initials: NA
authors.lastname: Kshirsagar
authors.forename: N J
authors.initials: NJ
authors.lastname: Gogtay
authors.forename: N S
authors.initials: NS
authors.lastname: Moorthy
authors.forename: M R
authors.initials: MR
authors.lastname: Garg
authors.forename: S S
authors.initials: SS
authors.lastname: Dalvi
authors.forename: A R
authors.initials: AR
authors.lastname: Chogle
authors.forename: J S
authors.initials: JS
authors.lastname: Sorabjee
authors.forename: S N
authors.initials: SN
authors.lastname: Marathe
authors.forename: G H
authors.initials: GH
authors.lastname: Tilve
authors.forename: A D
authors.initials: AD
authors.lastname: Bhatt
authors.forename: S P
authors.initials: SP
authors.lastname: Sane
authors.forename: R
authors.initials: R
authors.lastname: Mull
authors.forename: I
authors.initials: I
authors.lastname: Gathmann
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000962:Antimalarials / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D002738:Chloroquine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004562:Electrocardiography; D004983:Ethanolamines; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D012717:Sesquiterpenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; D012717:Sesquiterpenes; D002738:Chloroquine