title: Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial.
abstract: OBJECTIVE
  Although non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs). As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic.
  
  
  METHODS
  Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174) or ketoprofen 100 mg IV plus placebo (n = 164). 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174) or ketoprofen 100 mg IV(n = 164) plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID) at 30 minutes by visual analog scale (VAS) (per-protocol population). An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI) for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint.
  
  
  RESULTS
  Baseline demographics were similar. The mean (SD) mPID30 min was 33.84 (24.61) and 35.16 (26.01) for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen) the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments.
  
  
  CONCLUSIONS
  Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.
authors.affiliation: Hospital Ipiranga, Sao Paulo, Brazil. glinas@terra.com.br
authors.forename: Sidney
authors.initials: S
authors.lastname: Glina
authors.forename: Ronaldo
authors.initials: R
authors.lastname: Damiao
authors.forename: Joao
authors.initials: J
authors.lastname: Afif-Abdo
authors.forename: Carlos Francisco
authors.initials: CF
authors.lastname: Santa Maria
authors.forename: Raúl
authors.initials: R
authors.lastname: Novoa
authors.forename: Carlos Eurico Dornelles
authors.initials: CE
authors.lastname: Cairoli
authors.forename: Dalia
authors.initials: D
authors.lastname: Wajsbrot
authors.forename: Gaston
authors.initials: G
authors.lastname: Araya
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000698:Analgesia / Q000379:methods; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use*; D007660:Ketoprofen / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D056844:Renal Colic / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D007555:Isoxazoles; D007660:Ketoprofen; C409945:parecoxib