Efficacy and tolerability of celecoxib and naproxen versus placebo in Hispanic patients with knee osteoarthritis

Abstract

BackgroundCelecoxib is an effective treatment for osteoarthritis (OA). However, information on its efficacy and safety profile in different racial/ethnic groups is limited. Noticeable differences among racial groups are found in other disease states, but a thorough investigation of OA is lacking. The objective of this study was to determine if celecoxib 200 mg once daily is as effective as naproxen 500 mg twice daily in the treatment of OA of the knee in Hispanic patients.MethodsHispanic patients aged ≥45 years with knee OA were randomized to receive celecoxib 200 mg once daily, naproxen 500 mg twice daily, or placebo for 6 weeks. The primary efficacy variable was the change in Patient’s Assessment of Arthritis Pain at 6 weeks compared with baseline. Secondary variables were change in Patient’s and Physician’s Global Assessments of Arthritis from baseline to week 6/early termination, change in Western Ontario and McMaster Universities OA Index (WOMAC) from baseline to week 6/early termination, change in American Pain Society pain score, Pain Satisfaction Scale, Patient Health Questionnaire (PHQ-9), and measurements of upper gastrointestinal tolerability.ResultsIn total, 239 patients completed the trial (96 celecoxib, 96 naproxen, 47 placebo). Celecoxib was as effective as naproxen in reducing OA pain (least squares mean change from baseline [standard error] −39.7 [2.7] for celecoxib and −36.9 [2.6] for naproxen). Patient’s and Physician’s Global Assessments of Arthritis, WOMAC scores, upper gastrointestinal tolerability, Pain Satisfaction Scale, and PHQ-9 showed no statistically significant differences between the celecoxib and naproxen groups. The incidence of adverse events and treatment-related adverse events were similar among the treatment groups.ConclusionCelecoxib 200 mg once daily was as effective as naproxen 500 mg twice daily in the treatment of signs and symptoms of knee OA in Hispanic patients. Celecoxib was shown to be safe and well tolerated in this patient population.

Efficacy and safety of nonsteroidal anti‐inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo‐controlled study

“…However, it must be noted that the LSM change in arthritis pain (VAS) score was also high in the placebo group (−33.6 mm) compared with celecoxib (−37.1 mm) and naproxen (−37.5 mm) treatment. A similar finding was noted in the study of these treatments when carried out in Africa American patients12 and, to a lesser degree, Hispanic patients 13. A previous meta‐analysis has reported that the placebo effect in OA studies is high, and can be influenced by a number of factors, including sample size and baseline disease severity 22.…”

“…In addition, similar improvements from baseline to week 6 in the Patient's Assessment of Arthritis Pain VAS were noted for the active treatment groups in Asian patients, when compared to the studies carried out in patients of different ethnicities 12, 13…”

“…Aside from ethnicity, baseline characteristics of patients in this study (sex, age, duration of OA, pain assessments, functional capacity, VAS and WOMAC scores) were similar to those observed in the African American12 and Hispanic13 cohorts. In addition, similar improvements from baseline to week 6 in the Patient's Assessment of Arthritis Pain VAS were noted for the active treatment groups in Asian patients, when compared to the studies carried out in patients of different ethnicities 12, 13…”

“…The results from the study that was carried out in an African American population12 and Hispanic population13 have been published previously.…”

“…We have previously reported the results from studies that investigated the efficacy and safety of two NSAIDs in patients of African American12 and Hispanic13 descent. The aim of this report is to summarize the results from a study that evaluated the efficacy and safety of celecoxib (a cyclooxygenase [COX]‐2 selective NSAID) and naproxen (a widely used NSAID) in patients of Asian descent.…”