PMID- 17616556
OWN - NLM
STAT- MEDLINE
DCOM- 20080304
LR  - 20151119
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Linking)
VI  - 67
IP  - 3
DP  - 2008 Mar
TI  - Comparison of two different dosages of celecoxib with diclofenac for the 
      treatment of active ankylosing spondylitis: results of a 12-week randomised, 
      double-blind, controlled study.
PG  - 323-9
AB  - OBJECTIVES: To demonstrate the non-inferiority of celecoxib compared with 
      diclofenac in subjects with ankylosing spondylitis (AS). METHODS: The basis of 
      the present work was a 12-week randomised, double-blind, controlled study in 
      active AS subjects with three treatment arms: celecoxib 200 mg once a day, 
      celecoxib 200 mg twice a day, and diclofenac SR 75 mg twice a day. The primary 
      efficacy endpoint was the change from baseline in global pain intensity on a 
      visual analogue scale (VAS) at week 12. Secondary endpoints covered changes in 
      disease activity, functional and mobility capacities, and adverse events. 
      RESULTS: A total of 458 subjects were randomly assigned to either celecoxib 200 
      mg once a day (n = 153), celecoxib 200 mg twice a day (n = 150), or diclofenac (n 
      = 155). Least square (LS) mean changes from baseline at week 12 on a pain VAS 
      were clinically relevant in all treatment groups (celecoxib 200 mg once a day: 
      -29.1 mm; celecoxib 200 mg twice a day:-31.7 mm; diclofenac:-32.7 mm) and 
      non-inferior when compared to diclofenac. Ankylosing Spondylitis Assessment Study 
      group 20% (ASAS 20) response and mean improvement in Bath Ankylosing Spondylitis 
      Disease Activity Index (BASDAI) scores at week 12 were numerically better on 
      celecoxib 200 mg twice a day (59.7% and-1.32 points) and on diclofenac (60.2% 
      and-1.48 points) than on celecoxib 200 mg once a day (46.0% and-0.99 points). The 
      incidence of gastrointestinal adverse events was significantly higher on 
      diclofenac (28.4%) than on celecoxib 200 mg once a day (15.0%) or 200 mg twice a 
      day (16.7%). CONCLUSIONS: The efficacy of celecoxib 200 mg once a day and 200 mg 
      twice a day was comparable to that of diclofenac 75 mg twice a day with respect 
      to pain reduction. Celecoxib 200 mg twice a day and diclofenac reduced some 
      parameters associated with inflammation more effectively than celecoxib 200 mg 
      once a day. Treatment was well tolerated, with celecoxib (either dose) exhibiting 
      less frequent gastrointestinal adverse events than diclofenac.
FAU - Sieper, J
AU  - Sieper J
AD  - Benjamin Franklin University Berlin, Berlin, Germany. joachim.sieper@charite.de
FAU - Klopsch, T
AU  - Klopsch T
FAU - Richter, M
AU  - Richter M
FAU - Kapelle, A
AU  - Kapelle A
FAU - Rudwaleit, M
AU  - Rudwaleit M
FAU - Schwank, S
AU  - Schwank S
FAU - Regourd, E
AU  - Regourd E
FAU - May, M
AU  - May M
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20070706
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Cyclooxygenase Inhibitors)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - 144O8QL0L1 (Diclofenac)
RN  - JCX84Q7J1L (Celecoxib)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse 
      effects/therapeutic use
MH  - Celecoxib
MH  - Cyclooxygenase Inhibitors/administration & dosage/adverse effects/therapeutic use
MH  - Diclofenac/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - Pyrazoles/*administration & dosage/adverse effects/therapeutic use
MH  - Severity of Illness Index
MH  - Spondylitis, Ankylosing/*drug therapy
MH  - Sulfonamides/*administration & dosage/adverse effects/therapeutic use
MH  - Treatment Outcome
EDAT- 2007/07/10 09:00
MHDA- 2008/03/05 09:00
CRDT- 2007/07/10 09:00
PHST- 2007/07/10 09:00 [pubmed]
PHST- 2008/03/05 09:00 [medline]
PHST- 2007/07/10 09:00 [entrez]
AID - ard.2007.075309 [pii]
AID - 10.1136/ard.2007.075309 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2008 Mar;67(3):323-9. doi: 10.1136/ard.2007.075309. Epub 2007 Jul 
      6.