PMID- 19210159
OWN - NLM
STAT- MEDLINE
DCOM- 20100913
LR  - 20190911
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 25
IP  - 3
DP  - 2009 Mar
TI  - Pooled analysis of GI tolerability of 21 randomized controlled trials of 
      celecoxib and nonselective NSAIDs.
PG  - 729-40
LID - 10.1185/03007990802714382 [doi]
AB  - OBJECTIVE: To compare the gastrointestinal (GI) tolerability of celecoxib and 
      nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) at approved doses in 
      patients with common musculoskeletal conditions. RESEARCH DESIGN AND METHODS: 
      This was a retrospective, pooled analysis of studies selected from the Pfizer 
      Corporate Clinical Trials Registry. Study selection criteria were: (1) Data 
      available as of October 31, 2004; (2) Randomized, parallel-group study design and 
      planned treatment duration of >or= 2 weeks; (3) At least one nonselective NSAID 
      (naproxen, ibuprofen, or diclofenac) as a comparator; (4) At least one arm with 
      200 mg or 400 mg celecoxib per day; (5) Patients with osteoarthritis (OA), adult 
      rheumatoid arthritis (RA), or ankylosing spondylitis (AS). Data were pooled by 
      treatment and by subject from the safety analysis population of each included 
      study. Joint primary end points were the combined incidence of 
      tolerability-related GI adverse events (AEs) (abdominal pain, dyspepsia, nausea, 
      diarrhea, and flatulence), and time to study discontinuation due to any GI AE. 
      RESULTS: In all, 21 studies met the selection criteria. Across the safety 
      analysis populations of the included studies, 7797 patients received celecoxib 
      total daily dose 200 mg/day, 6653 received celecoxib total daily dose 400 mg/day, 
      2953 received naproxen, 499 received ibuprofen, and 5643 received diclofenac. 
      Tolerability-related GI AEs were reported by significantly fewer 
      celecoxib-treated patients (16.0%) than by those treated with naproxen (24.3%), 
      ibuprofen (24.2%), or diclofenac (19.9%) (p < 0.0001 vs. each comparator). Time 
      to study discontinuation due to any GI AE was significantly longer for celecoxib 
      than for naproxen (p < 0.0001), ibuprofen (p = 0.002), or diclofenac (p = 0.048). 
      In the RA subpopulation (n = 2857), there was no significant difference between 
      the celecoxib and naproxen or ibuprofen groups in incidence of 
      tolerability-related GI AEs and GI AEs. LIMITATIONS: The limitations are inherent 
      to the retrospective analysis design. CONCLUSIONS: In this pooled analysis of 
      celecoxib at approved doses in OA, RA, and AS, fewer celecoxib-treated patients 
      in the overall population had tolerability-related GI AEs than patients treated 
      with naproxen, ibuprofen, or diclofenac. In addition, celecoxib-treated patients 
      had a significantly longer time to study discontinuation due to GI AEs.
FAU - Niculescu, Liviu
AU  - Niculescu L
AD  - Pfizer Inc, New York, NY 10017, USA. Liviu.Niculescu@pfizer.com
FAU - Li, Chunming
AU  - Li C
FAU - Huang, Jim
AU  - Huang J
FAU - Mallen, Sharon
AU  - Mallen S
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - JCX84Q7J1L (Celecoxib)
SB  - IM
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Celecoxib
MH  - Female
MH  - Gastrointestinal Tract/*drug effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pyrazoles/administration & dosage/adverse effects/*therapeutic use
MH  - *Randomized Controlled Trials as Topic
MH  - Sulfonamides/administration & dosage/adverse effects/*therapeutic use
EDAT- 2009/02/13 09:00
MHDA- 2010/09/14 06:00
CRDT- 2009/02/13 09:00
PHST- 2009/02/13 09:00 [entrez]
PHST- 2009/02/13 09:00 [pubmed]
PHST- 2010/09/14 06:00 [medline]
AID - 10.1185/03007990802714382 [pii]
AID - 10.1185/03007990802714382 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2009 Mar;25(3):729-40. doi: 10.1185/03007990802714382.