Efficacy and safety of celecoxib versus diclofenac and omeprazole in elderly arthritis patients: a subgroup analysis of the CONDOR trial

Abstract

Objective:

To compare the safety and efficacy of celecoxib versus diclofenac slow release (SR) plus omeprazole in elderly arthritis patients.

Research design and methods:

Patients aged ≥65 years, with osteoarthritis and/or rheumatoid arthritis, at high gastrointestinal (GI) risk who participated in the CONDOR trial (Celecoxib vs. Omeprazole and Diclofenac in Patients With Osteoarthritis and Rheumatoid Arthritis) were included in this subanalysis. CONDOR was a 6-month prospective, double-blind, randomized, parallel-group, multicenter, international study comparing treatment with celecoxib 200 mg twice daily (BID) versus diclofenac SR 75 mg BID plus omeprazole 20 mg daily.

Main outcome measures:

The primary end point was a composite of Clinically Significant Upper and Lower GI Events adjudicated by an independent blinded expert committee. Efficacy was determined by the Patient’s Global Assessment of Arthritis.

Results:

A total of 2446 patients aged ≥65 years were included in the intent-to-treat (ITT) population (n = 1219 celecoxib; n = 1227 diclofenac). Eight patients in the celecoxib group and 52 in the diclofenac group were adjudicated as having Clinically Significant Upper and Lower GI events (adjusted odds ratio: 6.27; p < 0.0001). Clinically significant reductions in hemoglobin (≥2 g/dL) and/or hematocrit (≥10%) were observed in 23 patients in the celecoxib group and in 76 in the diclofenac group (relative risk: 3.22 [95% confidence interval: 2.04–5.07]; p < 0.0001). Incidence of moderate-to-severe abdominal symptoms and discontinuation of treatment due to GI adverse events (AEs) were lower in the celecoxib group. The Patient’s Global Assessment of Arthritis score least squares mean change from baseline to final visit and percentage of patients rating treatment efficacy as good/very good at baseline and final visit were similar in both groups.

Limitations:

The dose of celecoxib used is consistent with the European label for the management of osteoarthritis and may not reflect what is commonly prescribed in current clinical practice in the United States. The data were obtained in a clinical trial setting where patients were enrolled based on specific inclusion and exclusion criteria; as such, the patients may not be broadly representative of the patient population in a general practice setting.

Conclusions:

Efficacy was comparable in the two treatment groups. There were fewer endpoints as well as fewer GI AEs reported in patients treated with celecoxib compared with diclofenac. These data may help physicians in their treatment decisions for elderly patients with arthritis.

Keywords::

• Arthritis
• Elderly
• GI
• NSAIDs

Transparency

Declaration of funding

This study was sponsored by Pfizer Inc.

Declaration of financial/other relationships

H.L.K. has disclosed that he is a consultant/advisor for Pfizer and is a member of Pfizer’s speakers’ bureau. C.L. and M.N.E. are full-time employees of Pfizer. CMRO peer reviewers on this manuscript have no relevant financial or other interests to disclose.

Acknowledgments

Dr Kellner was an investigator in the CONDOR trial. Editorial support was provided by L. Prevost, BSc, of PAREXEL and was funded by Pfizer Inc.

Previous presentation: Poster presented at OARSI (2011) World Congress on Osteoarthritis.