title: A randomized, multicentre, double-blind, parallel-group study to assess the adverse event-related discontinuation rate with celecoxib and diclofenac in elderly patients with osteoarthritis.
abstract: OBJECTIVE
  To compare the adverse event (AE)-related discontinuation rate with celecoxib vs. diclofenac when given to reduce joint pain associated with knee or hip osteoarthritis (OA) in elderly patients.
  
  
  METHODS
  This was a double-blind, randomized, multicentre, parallel-group, 1-year comparison of celecoxib 200 mg once daily and diclofenac 50 mg twice daily in 925 patients with OA aged > or = 60 years. Study visits were at baseline and at 4, 13, 26, 39, and 52 weeks. At each visit, the Patient's and Physician's Global Assessment of Arthritis (PaGAA, PhGAA), the Patient's Assessment of Arthritis Pain--Visual Analogue Scale (PAAP-VAS), and AEs were assessed. A concomitant health economic analysis was conducted throughout.
  
  
  RESULTS
  The rate of study discontinuation due to AEs, laboratory abnormalities, and deaths was 27% for celecoxib and 31% for diclofenac (p = 0.22). The results of the arthritis/pain efficacy assessments were similar for celecoxib and diclofenac. Significantly fewer patients in the celecoxib group than the diclofenac group experienced cardiovascular/renal AEs (70/458 vs. 95/458, p = 0.039) or hepatic AEs (10/458 vs. 39/458, p<0.0001). Medication costs were higher for celecoxib than diclofenac but mean total treatment cost was slightly higher in the diclofenac group.
  
  
  CONCLUSIONS
  Treatment with celecoxib 200 mg once daily and diclofenac 50 mg twice daily resulted in similar rates of AE-related study discontinuation in elderly patients with OA. Celecoxib and diclofenac demonstrated comparable efficacy in relieving the signs and symptoms of OA. However, the proportion of patients with cardiorenal and hepatic AEs was significantly lower in the celecoxib group than the diclofenac group.
authors.affiliation: Department of Orthopaedics, Lund University, Malmö University Hospital, Malmö, Sweden. leif.dahlberg@med.lu.se
authors.forename: L E
authors.initials: LE
authors.lastname: Dahlberg
authors.forename: I
authors.initials: I
authors.lastname: Holme
authors.forename: K
authors.initials: K
authors.lastname: Høye
authors.forename: B
authors.initials: B
authors.lastname: Ringertz
mesh_terms: D000368:Aged; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects* / Q000191:economics; D004008:Diclofenac / Q000009:adverse effects* / Q000191:economics; D004311:Double-Blind Method; D016527:Drug Costs; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D015207:Osteoarthritis, Hip / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D010146:Pain / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D010147:Pain Measurement; D017060:Patient Satisfaction; D011720:Pyrazoles / Q000009:adverse effects* / Q000191:economics; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000009:adverse effects* / Q000191:economics; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D016861:Cyclooxygenase Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D004008:Diclofenac; D000068579:Celecoxib