PMID- 27737664
OWN - NLM
STAT- MEDLINE
DCOM- 20171101
LR  - 20220408
IS  - 1471-2474 (Electronic)
IS  - 1471-2474 (Linking)
VI  - 17
IP  - 1
DP  - 2016 Oct 13
TI  - A randomized, clinical trial to assess the relative efficacy and tolerability of 
      two doses of etoricoxib versus naproxen in patients with ankylosing spondylitis.
PG  - 426
LID - 426
AB  - BACKGROUND: This study evaluated two doses of etoricoxib (60 and 90 mg) vs. 
      naproxen 1000 mg in subjects with ankylosing spondylitis (AS). METHODS: This was 
      a 2-part, double-blind, active comparator-controlled non-inferiority study in 
      subjects >/=18 years of age with AS. In Part I, subjects were randomized to 
      naproxen 1000 mg; etoricoxib 60 mg, and 90 mg. In Part II, naproxen and 
      etoricoxib 90 mg subjects continued on the same treatment; subjects on etoricoxib 
      60 mg either continued on 60 mg or escalated to 90 mg. Part I (6 weeks) assessed 
      the efficacy of A) etoricoxib 60 mg vs. naproxen and B) 90 mg vs. naproxen 
      according to the time-weighted average change from baseline in Spinal Pain 
      Intensity (SPI; 0-100 mm VAS) (primary endpoint). The non-inferiority margin was 
      set at 8 mm for SPI. In Part II (20 weeks) we evaluated the potential benefit of 
      increasing from 60 to 90 mg (predefined minimum clinically important 
      difference = 6 mm in SPI) for inadequate responders (<50 % improvement from 
      baseline in SPI) on etoricoxib 60 mg in Part I. RESULTS: In total, 1015 subjects 
      were randomized to receive etoricoxib 60 mg (N = 702), etoricoxib 90 mg 
      (N = 156), and naproxen 1000 mg (N = 157); 70.9 % were male and the mean age was 
      45.2 years. There were 919 subjects who completed Part I and all continued to 
      Part II. In Part I, SPI change was non-inferior for both etoricoxib doses vs. 
      naproxen. In both Part I and II, the incidence of adverse events (AEs), 
      drug-related AEs, and serious adverse events (SAEs) were similar between the 3 
      treatment groups. CONCLUSION: Both doses of etoricoxib were non-inferior to 
      naproxen. All treatments were well tolerated. Etoricoxib 60 and 90 mg effectively 
      control pain in patients with AS, with 60 mg once daily as the lowest effective 
      dose for most patients. TRIAL REGISTRATION: Clinical Trials Registry # 
      NCT01208207 . Registered on 22 September 2010.
FAU - Balazcs, Eva
AU  - Balazcs E
AD  - Department of Neuromusculoskeletal Rehabilitation, Dr. Bugyi Istvan Korhaz, Sima 
      Ferenc, Szentes, Hungary.
FAU - Sieper, Joachim
AU  - Sieper J
AD  - Charite Universitatsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.
FAU - Bickham, Kara
AU  - Bickham K
AD  - Merck & Co., Inc, Kenilworth, NJ, USA. kara.bickham@merck.com.
FAU - Mehta, Anish
AU  - Mehta A
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
FAU - Frontera, Nancy
AU  - Frontera N
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
FAU - Stryszak, Paul
AU  - Stryszak P
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
FAU - Popmihajlov, Zoran
AU  - Popmihajlov Z
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
FAU - Peloso, Paul M
AU  - Peloso PM
AD  - Merck & Co., Inc, Kenilworth, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01208207
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20161013
PL  - England
TA  - BMC Musculoskelet Disord
JT  - BMC musculoskeletal disorders
JID - 100968565
RN  - 0 (Cyclooxygenase 2 Inhibitors)
RN  - 0 (Pyridines)
RN  - 0 (Sulfones)
RN  - 57Y76R9ATQ (Naproxen)
RN  - WRX4NFY03R (Etoricoxib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Cyclooxygenase 2 Inhibitors/administration & dosage/adverse effects/*therapeutic 
      use
MH  - Double-Blind Method
MH  - Etoricoxib
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Naproxen/administration & dosage/adverse effects/*therapeutic use
MH  - Pain/*drug therapy
MH  - Pain Measurement
MH  - Pyridines/administration & dosage/adverse effects/*therapeutic use
MH  - Spondylitis, Ankylosing/*drug therapy
MH  - Sulfones/administration & dosage/adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5062857
OTO - NOTNLM
OT  - Ankylosing spondylitis
OT  - Etoricoxib
OT  - NSAIDs
OT  - Naproxen
OT  - Spinal pain
EDAT- 2016/10/16 06:00
MHDA- 2017/11/02 06:00
PMCR- 2016/10/13
CRDT- 2016/10/15 06:00
PHST- 2016/01/08 00:00 [received]
PHST- 2016/09/29 00:00 [accepted]
PHST- 2016/10/15 06:00 [entrez]
PHST- 2016/10/16 06:00 [pubmed]
PHST- 2017/11/02 06:00 [medline]
PHST- 2016/10/13 00:00 [pmc-release]
AID - 10.1186/s12891-016-1275-5 [pii]
AID - 1275 [pii]
AID - 10.1186/s12891-016-1275-5 [doi]
PST - epublish
SO  - BMC Musculoskelet Disord. 2016 Oct 13;17(1):426. doi: 10.1186/s12891-016-1275-5.