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

Byron L. Cryer, Mark B. Sostek, John G. Fort, Ola Svensson, Clara Hwang, Marc C. Hochberg

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

Abstract

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;27:124353); 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.

Original languageEnglish (US)
Pages (from-to)594-605
Number of pages12
JournalAnnals of Medicine
Volume43
Issue number8
DOIs
StatePublished - Dec 2011

Keywords

  • Celecoxib
  • Drug therapy combination
  • Dyspepsia
  • Esomeprazole
  • Heartburn
  • MSODA
  • Naproxen
  • Proton pump inhibitors
  • Tolerability
  • Upper gastrointestinal tract

ASJC Scopus subject areas

  • Medicine(all)

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