title: Racecadotril for childhood gastroenteritis: an individual patient data meta-analysis.
abstract: BACKGROUND
  Racecadotril is an antidiarrhoeal drug with intestinal antisecretory mechanism of action.
  
  
  OBJECTIVE
  To assess racecadotril efficacy as an adjunct to oral rehydration solution, against oral rehydration solution alone or with placebo in childhood acute gastroenteritis.
  
  
  METHODS
  Individual patient data meta-analysis following multilevel mixed models testing the significance of the treatment effect adjusted for baseline covariates.
  
  
  RESULTS
  Nine randomised clinical trials (n=1384) were identified with raw data. Baseline dehydration level and Rotavirus were found as two essential predictors influencing the outcomes. The proportion of recovered patients was higher in racecadotril groups compared with placebo, Hazard Ratio HR=2.04, 95% CI (1.85; 2.32), p<0.001. For inpatient studies, the ratio of mean stool output racecadotril/placebo was 0.59 (0.51; 0.74), p<0.001. For outpatient studies, the ratio of the mean number of diarrhoeic stools racecadotril/placebo was 0.63 (0.51; 0.74), p<0.001.
  
  
  CONCLUSIONS
  Dehydration level and Rotavirus at baseline are essential adjustments to compare treatments. As an adjunct to oral rehydration solution, racecadotril has a clinically relevant effect in reducing diarrhoea (duration, stool output and stool number), irrespective of baseline conditions (dehydration, Rotavirus or age), treatment conditions (inpatient or outpatient studies) or cultural environment.
authors.affiliation: Statistics Department, Faculty of Economics, FUCAM, Louvain Academy, Belgium. philippe.lehert@gmail.com
authors.forename: Philippe
authors.initials: P
authors.lastname: Lehert
authors.forename: Gérard
authors.initials: G
authors.lastname: Chéron
authors.forename: Guillermo Alvarez
authors.initials: GA
authors.lastname: Calatayud
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Cézard
authors.forename: Pedro Gutierrez
authors.initials: PG
authors.lastname: Castrellón
authors.forename: José-Manuel Meléndez
authors.initials: JM
authors.lastname: Garcia
authors.forename: Mar
authors.initials: M
authors.lastname: Santos
authors.forename: M R
authors.initials: MR
authors.lastname: Savitha
mesh_terms: D000293:Adolescent; D000328:Adult; D000930:Antidiarrheals / Q000627:therapeutic use*; D002648:Child; D003131:Combined Modality Therapy; D003681:Dehydration / Q000209:etiology; D003967:Diarrhea / Q000188:drug therapy* / Q000209:etiology / Q000628:therapy; D005243:Feces / Q000821:virology; D005260:Female; D005759:Gastroenteritis / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D015532:Rehydration Solutions / Q000008:administration & dosage / Q000627:therapeutic use*; D012401:Rotavirus / Q000302:isolation & purification*; D015244:Thiorphan / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000930:Antidiarrheals; D015532:Rehydration Solutions; C049331:racecadotril; D015244:Thiorphan