To evaluate the effectiveness and tolerability of etoricoxib in patients with osteoarthritis (OA) with suboptimal response to existing pain regimens.
A multicenter, prospective, open-label, single-arm study. OA patients (n = 500) taking nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics who had inadequate response as determined by their physicians (>or= 40 mm on a 0-100 mm pain scale) were switched directly to etoricoxib 60 mg once daily for 4 weeks without prior medication washout. The primary endpoint was the percentage of patients with >or= 30% improvement in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain walking on a flat surface after 4 weeks of treatment. Other endpoints included WOMAC Pain, Stiffness, and Physical Function subscales, Brief Pain Inventory (BPI), investigator's global assessment of response to therapy (IGART), the Treatment Satisfaction Questionnaire for Medication (TSQM) and Short Form 36 (SF36). Safety and tolerability were assessed by collecting adverse events.
After switching to etoricoxib, 52% (95% confidence interval: 47%, 57%) of patients reported a clinically meaningful reduction (>or= 30%) for WOMAC pain walking on a flat surface. Disability in daily activities and pain interference were significantly improved (P < 0.0001). IGART scores improved after the switch to etoricoxib (P < 0.05). Results from TSQM demonstrated that patient perceptions of effectiveness, convenience and overall satisfaction increased. Etoricoxib was generally well tolerated in most patients. The most commonly reported adverse event was edema (4.2%).
In OA patients experiencing inadequate relief from a wide variety of analgesics, pain, function, quality of life, and treatment satisfaction significantly improved when switched to etoricoxib.