PMID- 16368055
OWN - NLM
STAT- MEDLINE
DCOM- 20060203
LR  - 20181203
IS  - 0300-7995 (Print)
IS  - 0300-7995 (Linking)
VI  - 21
IP  - 12
DP  - 2005 Dec
TI  - Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain 
      and disability in patients with chronic low back pain: results of a 4-week, 
      multinational, randomized, double-blind study.
PG  - 2037-49
AB  - BACKGROUND AND METHODS: The efficacy and safety of etoricoxib 60 mg/day in 
      patients with established chronic low back pain (CLBP) were compared with those 
      of diclofenac 150 mg/day in a 4-week, multicentre, randomized, double-blind, 
      parallel-group trial. Four hundred and forty-six adult patients with CLBP (Quebec 
      Task Force on Spinal Disorders Class 1 or 2) and with worsening pain upon 
      discontinuation of pre-study analgesic medication were enrolled in the study. The 
      study primary efficacy endpoint was change from baseline in Low Back Pain 
      Intensity Scale (LBP-IS) score over the 4-week treatment period. Secondary and 
      other efficacy endpoints included: changes in Roland and Morris Disability 
      Questionnaire (RMDQ), Patient Global Assessment of Response to Therapy (PGART) 
      and Low Back Pain Bothersomeness Scale (LBP-BS) scores. Early efficacy was 
      assessed using PGART and LBP-IS scores 4 h after the first dose on the mornings 
      of Days 1, 2 and 3. The overall safety and tolerability of etoricoxib 60 mg/day 
      during 4 weeks of treatment were also assessed. RESULTS: The least-squares mean 
      time-weighted change from baseline LBP-IS score over 4 weeks was -32.94 mm (95% 
      CI -36.25, -29.63) for etoricoxib, indicating substantial efficacy in relief of 
      pain. The treatment difference for the primary outcome was 2.51 mm (95% CI -1.50, 
      6.51), fulfilling the prespecified equivalence criterion of 95% confidence 
      interval wholly within +/- 10 mm. Etoricoxib improved all secondary and other 
      efficacy outcomes. There were no statistically significant between-group 
      differences in the proportion of patients with one or more clinical adverse 
      events (AEs) (etoricoxib 35%, diclofenac 39%), or the proportion of patients who 
      discontinued due to AEs (etoricoxib 7%, diclofenac 5%). CONCLUSIONS: The results 
      of this study confirm that, for adult patients with CLBP, etoricoxib 60 mg once 
      daily over 4 weeks is effective for relief of pain and improvement of physical 
      function and comparable to high-dose diclofenac 150 mg daily.
FAU - Zerbini, C
AU  - Zerbini C
AD  - Hospital Heliopolis, Rheumatology Department, Sao Paolo, Brazil.
FAU - Ozturk, Z E
AU  - Ozturk ZE
FAU - Grifka, J
AU  - Grifka J
FAU - Maini, M
AU  - Maini M
FAU - Nilganuwong, S
AU  - Nilganuwong S
FAU - Morales, R
AU  - Morales R
FAU - Hupli, M
AU  - Hupli M
FAU - Shivaprakash, M
AU  - Shivaprakash M
FAU - Giezek, H
AU  - Giezek H
CN  - Etoricoxib CLBP Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
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 (Pyridines)
RN  - 0 (Sulfones)
RN  - 144O8QL0L1 (Diclofenac)
RN  - WRX4NFY03R (Etoricoxib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Chronic Disease
MH  - Diclofenac/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Etoricoxib
MH  - Female
MH  - Humans
MH  - Low Back Pain/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Pyridines/adverse effects/*therapeutic use
MH  - Sulfones/adverse effects/*therapeutic use
EDAT- 2005/12/22 09:00
MHDA- 2006/02/04 09:00
CRDT- 2005/12/22 09:00
PHST- 2005/12/22 09:00 [pubmed]
PHST- 2006/02/04 09:00 [medline]
PHST- 2005/12/22 09:00 [entrez]
AID - 10.1185/030079905X75069 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2005 Dec;21(12):2037-49. doi: 10.1185/030079905X75069.