PMID- 22017620
OWN - NLM
STAT- MEDLINE
DCOM- 20120222
LR  - 20151119
IS  - 1365-2060 (Electronic)
IS  - 0785-3890 (Linking)
VI  - 43
IP  - 8
DP  - 2011 Dec
TI  - A fixed-dose combination of naproxen and esomeprazole magnesium has comparable 
      upper gastrointestinal tolerability to celecoxib in patients with osteoarthritis 
      of the knee: results from two randomized, parallel-group, placebo-controlled 
      trials.
PG  - 594-605
LID - 10.3109/07853890.2011.625971 [doi]
AB  - BACKGROUND. Non-steroidal anti-inflammatory drugs are associated with poor upper 
      gastrointestinal (UGI) tolerability and increased ulcer risk, but patient 
      adherence to gastroprotective co-therapy is frequently inadequate. A fixed-dose 
      combination of enteric-coated naproxen 500 mg and immediate-release esomeprazole 
      magnesium 20 mg was evaluated: efficacy is reported by Hochberg et al. (Curr Med 
      Res Opin 2011;27:1243-53); tolerability findings are reported here. PATIENTS AND 
      METHODS. In two 12-week double-blind, placebo-controlled, multicenter, phase III 
      studies (PN400-307 and PN400-309), patients aged >/= 50 years with symptomatic knee 
      osteoarthritis randomly (2:2:1) received naproxen/esomeprazole magnesium BID, 
      celecoxib 200 mg QD, or placebo. Tolerability end-points included: modified 
      Severity of Dyspepsia Assessment (mSODA); heartburn severity; and UGI adverse 
      events (AEs). RESULTS. Overall, 619 (PN400-307) and 615 (PN400-309) patients were 
      randomized; mSODA scores improved (baseline to week 12) in each group, with no 
      significant treatment differences between naproxen/esomeprazole magnesium and 
      celecoxib (95% CIs: PN400-307: -0.4, 1.9; PN400-309: -1.8, 0.6). 
      Naproxen/esomeprazole magnesium-treated patients reported significantly more 
      heartburn-free days versus celecoxib (95% CIs: PN400-307: 2.1, 12.7; PN400-309: 
      2.5, 13.4). UGI AE incidence (PN400-307: 17.3%; PN400-309: 20.3%) was similar 
      between treatment groups. UGI AEs resulted in few discontinuations (< 4%, either 
      study). CONCLUSIONS. Naproxen/esomeprazole magnesium has comparable UGI 
      tolerability to celecoxib in patients with osteoarthritis.
FAU - Cryer, Byron L
AU  - Cryer BL
AD  - University of Texas Southwestern Medical Center, Dallas, USA. 
      Byron.Cryer@UTSouthwestern.edu
FAU - Sostek, Mark B
AU  - Sostek MB
FAU - Fort, John G
AU  - Fort JG
FAU - Svensson, Ola
AU  - Svensson O
FAU - Hwang, Clara
AU  - Hwang C
FAU - Hochberg, Marc C
AU  - Hochberg MC
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111022
PL  - England
TA  - Ann Med
JT  - Annals of medicine
JID - 8906388
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Anti-Ulcer Agents)
RN  - 0 (Cyclooxygenase 2 Inhibitors)
RN  - 0 (Drug Combinations)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - 0 (Tablets, Enteric-Coated)
RN  - 57Y76R9ATQ (Naproxen)
RN  - JCX84Q7J1L (Celecoxib)
RN  - N3PA6559FT (Esomeprazole)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/adverse effects
MH  - Anti-Ulcer Agents/*administration & dosage
MH  - Celecoxib
MH  - Cyclooxygenase 2 Inhibitors/adverse effects/therapeutic use
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Dyspepsia/chemically induced
MH  - Esomeprazole/*administration & dosage
MH  - Female
MH  - Gastrointestinal Tract/*drug effects
MH  - Heartburn/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Naproxen/*administration & dosage/adverse effects
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Pyrazoles/adverse effects/therapeutic use
MH  - Sulfonamides/adverse effects/therapeutic use
MH  - Tablets, Enteric-Coated
MH  - Treatment Outcome
EDAT- 2011/10/25 06:00
MHDA- 2012/02/23 06:00
CRDT- 2011/10/25 06:00
PHST- 2011/10/25 06:00 [entrez]
PHST- 2011/10/25 06:00 [pubmed]
PHST- 2012/02/23 06:00 [medline]
AID - 10.3109/07853890.2011.625971 [doi]
PST - ppublish
SO  - Ann Med. 2011 Dec;43(8):594-605. doi: 10.3109/07853890.2011.625971. Epub 2011 Oct 
      22.