title: Surveillance for the safety and effectiveness of artemether-lumefantrine in patients with uncomplicated Plasmodium falciparum malaria in the USA: a descriptive analysis.
abstract: BACKGROUND
  Data from clinical studies show that artemether-lumefantrine (AL) is effective and well tolerated in adults and children with uncomplicated Plasmodium falciparum malaria. However, data on effectiveness and safety of AL in patients in non-endemic settings are limited.
  
  
  METHODS
  A 5-year surveillance plan included all AL-treated adult and paediatric patients with confirmed or suspected P. falciparum malaria in the USA, as reported to the National Malaria Surveillance System at the Centers for Disease Control and Prevention. Descriptive analyses included demographics, baseline characteristics, clinical effectiveness, and safety. From May 2010 to April 2015, demographics and baseline characteristics were collected for 203 patients and safety data for 108 patients. Treatment effectiveness data at day 7 were collected for 117 patients and at day 28 for 98 patients.
  
  
  RESULTS
  The majority of patients were male (58.6 %), Black (62.6 %), non-Hispanic (92.6 %), and likely malaria non-immune (80.8 %). The median age was 32 (range 1-88) years and the median body mass index was 25.5 (range 13.8-42.4) kg/m(2). All patients with effectiveness data had confirmed (n = 116) or suspected (n = 1) malaria. The overall cure rate for patients treated with AL was 91.5 % (95 % CI 84.8-95.8 %) at day 7 and 96.9 % (95 % CI 91.3-99.4 %) at day 28. Adverse events were reported in four (3.7 %) patients, and there were no new or unexpected safety signals.
  
  
  CONCLUSIONS
  AL was effective and well tolerated in the treatment of likely non-immune patients with P. falciparum malaria.
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop A06, Atlanta, GA, 30329-4027, USA. itt1@cdc.gov.
authors.forename: Alyson M
authors.initials: AM
authors.lastname: Gray
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop A06, Atlanta, GA, 30329-4027, USA. parguin@cdc.gov.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Arguin
authors.affiliation: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936-1080, USA. kamal.hamed@novartis.com.
authors.forename: Kamal
authors.initials: K
authors.lastname: Hamed
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000962:Antimalarials / Q000009:adverse effects* / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D004983:Ethanolamines / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010963:Plasmodium falciparum; D012189:Retrospective Studies; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes