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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.

Dahlberg, Leif LU ; Holme, I; Høye, K and Ringertz, B (2009) In Scandinavian Journal of Rheumatology 38. p.133-143
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 >/= 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... (More)
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 >/= 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. Conclusion: 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. (Less)
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type
Contribution to journal
publication status
published
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in
Scandinavian Journal of Rheumatology
volume
38
pages
133 - 143
publisher
Taylor & Francis
external identifiers
  • wos:000263992100009
  • pmid:19165648
  • scopus:62249194020
ISSN
1502-7732
DOI
10.1080/03009740802419065
language
English
LU publication?
yes
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865cce6e-ee09-4bad-81eb-c22349dc1df7 (old id 1289327)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/19165648?dopt=Abstract
date added to LUP
2009-02-05 14:32:24
date last changed
2017-12-10 04:41:12
@article{865cce6e-ee09-4bad-81eb-c22349dc1df7,
  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 &gt;/= 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&lt;0.0001). Medication costs were higher for celecoxib than diclofenac but mean total treatment cost was slightly higher in the diclofenac group. Conclusion: 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.},
  author       = {Dahlberg, Leif and Holme, I and Høye, K and Ringertz, B},
  issn         = {1502-7732},
  language     = {eng},
  pages        = {133--143},
  publisher    = {Taylor & Francis},
  series       = {Scandinavian Journal of Rheumatology},
  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.},
  url          = {http://dx.doi.org/10.1080/03009740802419065},
  volume       = {38},
  year         = {2009},
}