title: Comparative evaluation of efficacy and safety of artesunate-lumefantrine vs. artemether-lumefantrine fixed-dose combination in the treatment of uncomplicated Plasmodium falciparum malaria.
abstract: OBJECTIVE
  To establish efficacy and safety of artesunate/lumefantrine fixed-dose combination (FDC) in comparison with artemether/lumefantrine FDC in treatment of uncomplicated Plasmodium falciparum malaria.
  
  
  METHODS
  Confirmed cases of uncomplicated P. falciparum malaria were randomly assigned to receive artesunate (100 mg)/lumefantrine (480 mg) (ASLF FDC) or artemether (80 mg)/lumefantrine (480 mg) (AMLF FDC) tablets for 3 days. Patients were followed up on Day 7, 14, 21 and 28.
  
  
  RESULTS
  Of the 158 enrolled patients, 144 completed the study. Seventy-three patients (94.8%) from the ASLF group and 71 patients (94.7%) from the AMLF group showed parasite clearance within 48 h. The mean parasite clearance time was 25.40 ± 14.82 h in the ASLF group and 24 ± 13.32 h in the AMLF group (P = 0.542). All patients showed gametocyte clearance by Day 7 and remained gametocyte free till Day 28. Sixty-five patients (84.4%) from the ASLF group and 56 patients (74.7%) from the AMLF group were afebrile within 24 h. The mean fever clearance time was 17.38 ± 12.33 h in the ASLF group and 17.2 ± 12.01 h in the AMLF group (P = 0.929). There was one early treatment failure in the AMLF group as per WHO criteria. Improvement in haemoglobin and haematocrit was comparable in both the treatment groups. In the ASLF group, of the 25 (32.47%) patients anaemic at baseline, only seven (9.09%) reported anaemia on Day 28, while in the AMLF group, of the 14 (18.67%) patients anaemic at baseline, only four (5.33%) reported anaemia on Day 28. Both study medications were well tolerated.
  
  
  CONCLUSIONS
  Artesunate (100 mg)/lumefantrine (480 mg) fixed-dose combination could add one more option to currently available artemisinin combinations in treatment of uncomplicated P. falciparum malaria.
authors.affiliation: Medical Affairs and Clinical Research, Ipca Laboratories Limited, Kandivli, Mumbai, India.
authors.forename: Anil
authors.initials: A
authors.lastname: Pareek
authors.forename: Nitin
authors.initials: N
authors.lastname: Chandurkar
authors.forename: Vipul
authors.initials: V
authors.lastname: Srivastav
authors.forename: Jitendra
authors.initials: J
authors.lastname: Lakhani
authors.forename: Partha S
authors.initials: PS
authors.lastname: Karmakar
authors.forename: Subrata
authors.initials: S
authors.lastname: Basu
authors.forename: Arnab
authors.initials: A
authors.lastname: Ray
authors.forename: Sangeeta
authors.initials: S
authors.lastname: Pednekar
authors.forename: P B
authors.initials: PB
authors.lastname: Gupta
authors.forename: Nilay
authors.initials: N
authors.lastname: Suthar
authors.forename: Sucheta
authors.initials: S
authors.lastname: Lakhani
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects; D000077332:Artesunate; D004311:Double-Blind Method; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005334:Fever; D005449:Fluorenes / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007194:India; D000078102:Lumefantrine; D016778:Malaria, Falciparum / Q000097:blood / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D008875:Middle Aged; D059208:Parasite Load; D010963:Plasmodium falciparum / Q000302:isolation & purification; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; D000077332:Artesunate; D000078102:Lumefantrine