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Abstract Number: 244

Onset, Magnitude, and Durability of Pain Relief in Patients with Knee OA Receiving a Fixed-Dose Combination Tablet of Enteric-Coated (EC) Naproxen Plus Immediate-Release (IR) Esomeprazole Magnesium Versus Celecoxib and Placebo: Pooled Results from Two Randomized Controlled Trials

John Fort1, Robert Holt2, Amy Y. Grahn3, Jana Steinmetz4, Ying Zhang5 and Jeffery Kent6, 1Pozen, Inc, Chapel Hill, NC, 2College of Pharmacy, University of Illinois-Chicago, Vernon Hill, IL, 3Horizon Pharma, Inc., Deerfield, IL, 4Statistics, Premier Research, Naperville, IL, 5Biostatistics, Pozen, Inc, Chapel Hill, NC, 6Medical Affairs, Horizon Pharma, Inc, Deerfield, IL

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: naproxen and pain, OA

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Session Information

Session Title: Pain: Basic and Clinical Aspects

Session Type: Abstract Submissions (ACR)

Background/Purpose: Over 40% of patients with OA report having significant knee pain every day. (1) Previously published data have demonstrated the overall comparable efficacy of EC naproxen/IR esomeprozole to celecoxib and superiority to placebo in the management of knee OA. (2) EC naproxen/IR esomeprazole also significantly reduced the incidence of endoscopic ulcers and improved UGI tolerability compared with EC naproxen alone in previous trials and maintained GI protective effect with low-dose aspirin (3). This new analysis characterizes time-to-first pain relief, effect size, and sustainability of naproxen/IR esomeprazole and celecoxib with placebo.

Methods: Two double-blind, double-dummy, placebo-controlled trials in patients aged ≥50 years with knee OA randomized to either EC naproxen 500mg/IR esomeprazole 20mg BID (n=487) or celecoxib 200mg/day (n=486) or placebo (n=246). Acute response endpoints assessed: 1) Time to first significant response during days 1-7 as measured by Patient Global Assessment Likert scale, 2) Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale using a visual analog scale (VAS) during days 1-7, and 3) American Pain Society Patient Outcome Questionnaire (APS-POQ) scores over the first 7 days.  Endpoints to assess sustainability of naproxen/esomeprazole included:  1) Routine Assessment of Patient Data (RAPID)-3 and 2) WOMAC Stiffness, Total and Pain VAS at 6/12 weeks. Time to first significant response was analyzed using the log-rank test and estimated using the Kaplan-Meier analysis method.  Other endpoints were analyzed using ANCOVA models with baseline values as covariates. Least square means, confidence intervals, and p-values were generated on change from baseline differences compared to placebo. Effect sizes (Cohen’s D) and correlation coefficients (Spearman, Pearson) were estimated descriptively.

Results: EC Naproxen/IR esomeprazole produced statistically significant decreases in WOMAC Pain on Days 2-7 (Figure) and at Weeks 6 and 12; APS-POQ pain assessments were significantly improved on Days 2-7. RAPID and WOMAC Total/Pain/Stiffness scores decreased significantly at Weeks 6 and 12. Responses were comparable to celecoxib. Pain relief effect sizes were moderate and median days to good-excellent response was 6 days. Total RAPID-3 to WOMAC and WOMAC to RAPID Pain were highly correlated with each other (correlation > 0.80) at 6 and 12 weeks.

Conclusion: EC naproxen/IR esomeprazole produces a moderate-large early pain response which is maintained for 12 weeks. RAPID-3 was found to be highly correlated with the typical OA measure (WOMAC) and might be a useful clinical tool for measuring NSAID response.

(1)    Jordan, et. al. J Rheumatol 2007;34(1):172-180.

(2)    Hochberg, et. al. Curr Med Res Opin 2011; 27:1243–53.

(3)    Cryer, et. a. Ann Med 2011;43:594-605.

  

 

 

 


Disclosure:

J. Fort,

Pozen, Inc,

3;

R. Holt,

Horizon Pharma, Inc,

5,

Pozen, Inc.,

5;

A. Y. Grahn,

Horizon Pharma, Inc,

3;

J. Steinmetz,

Horizon Pharma, Inc,

5;

Y. Zhang,

Pozen, Inc,

5;

J. Kent,

Horizon Pharma, Inc,

3.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/onset-magnitude-and-durability-of-pain-relief-in-patients-with-knee-oa-receiving-a-fixed-dose-combination-tablet-of-enteric-coated-ec-naproxen-plus-immediate-release-ir-esomeprazole-magnesi/

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