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

Abstract

AimTo compare the efficacy, tolerability and safety of celecoxib, naproxen and placebo in Asian patients with osteoarthritis (OA) of the knee.MethodPatients of Asian descent with knee OA, aged ≥ 45 years, in a flare state with a functional capacity classification of I–III, received celecoxib 200 mg once daily, naproxen 500 mg twice daily or placebo, for 6 weeks. The change in Patient's Assessment of Arthritis Pain (week 6 vs. baseline) was the primary endpoint. Secondary endpoints, including Patient's and Physician's Global Assessments of Arthritis, Western Ontario and McMaster Universities OA Index (WOMAC), use of complementary and alternative medicines, incidence of treatment‐emergent adverse events (TEAEs) and measurements of upper gastrointestinal tolerability, were also assessed.ResultsThree hundred and sixty‐seven patients were randomized: 145 to celecoxib, 144 to naproxen and 78 to placebo. Celecoxib was as effective as naproxen in reducing OA pain (least squares mean change from baseline in visual analogue scale score [standard error] −37.1 [2.0] for celecoxib and −37.5 [2.0] for naproxen). Patient's and Physician's Global Assessment of Arthritis, WOMAC scores, Pain Satisfaction Scale and Patient Health Questionnaire‐9 showed statistically significant improvement in active treatment groups versus placebo, with the exception of naproxen WOMAC scores. Treatment‐related TEAEs occurred in 19 (13%), 34 (24%) and six (8%) patients in the celecoxib, naproxen and placebo groups, respectively.ConclusionCelecoxib and naproxen were comparable in their effects to reduce the signs and symptoms of knee OA in Asian patients. Celecoxib was shown to be safe and well tolerated in this patient population.

Non-steroidal anti-inflammatory drug (NSAID) therapy in patients with hypertension, cardiovascular, renal or gastrointestinal comorbidities: joint APAGE/APLAR/APSDE/APSH/APSN/PoA recommendations

“…NSAIDs are associated with an increased risk of upper and lower GI adverse events 45 46 53 58 90 97 102 103 124 151–181. The most common GI adverse event is dyspepsia.…”

“…Use of a NSAID is associated with dyspepsia, abdominal pain and a variety of non-specific abdominal symptoms 152 165 168. However, the correlation between dyspepsia and endoscopically documented pathology is poor.…”

Efficacy and tolerability of duloxetine in patients with knee osteoarthritis: a meta‐analysis of randomised controlled trials

“…Although acetaminophen used to be the first‐line treatment for mild and moderate pain in knee OA, it has been shown to be less effective than NSAID, and it may produce hepatotoxicity when the dose exceeds 4 g/day . Nevertheless, long‐term use of oral NSAID increases the risk of adverse events (AE), including those affecting the gastrointestinal and/or cardiovascular systems . Thus, it is challenging to manage knee OA due to the limited improvement and AE associated with various pharmacological therapies.…”

“…10,11 Nevertheless, long-term use of oral NSAID increases the risk of adverse events (AE), including those affecting the gastrointestinal and/or cardiovascular systems. 12 Thus, it is challenging to manage knee OA due to the limited improvement and AE associated with various pharmacological therapies. Against this background, ideal medication for knee OA that can improve symptoms and have better tolerability has been the main focus of research.…”

Effectiveness and Safety of Manufactured Chinese Herbal Formula for Knee Osteoarthritis: Insights from a Systematic Review

“…Among these various interventions, nonsteroidal anti-inflammatory drugs and intra-articular hyaluronic acid or corticosteroids were more commonly used in clinical practice [ 11 , 12 ]. However, such treatments may be ineffective or lead to serious adverse events in some patients [ 13 ]. Under this circumstance, clinicians and patients were becoming more willing to adopt complementary and alternative medicine as a treatment option for KOA [ 14 – 16 ].…”