A double-masked comparison of the efficacy of once-daily sustained-release ibuprofen and once-daily piroxicam for 24-hour control of arthralgia due to osteoarthritis in the elderly

The efficacy and safety of a novel, once-daily, sustained-release (SR) tablet formulation of ibuprofen (2 x 800 mg) and once-daily piroxicam (2 x 10 mg) were compared in 59 elderly patients (age range, 55 to 92 years) with osteoarthritis of the hip and/or knee, in a randomized, double-masked, double-dummy, parallel-group trial over a period of 4 weeks, Approximately twice as many patients were randomized to receive SR ibuprofen (n = 38) as piroxicam (n = 21), Dosing took place daily in the early evening, Goniometric assessment of joint restriction was performed at baseline and at weeks 1, 2, and 4, Patients assessed their joint pain on a visual analog scale (VAS) in the early and late morning, early evening, and at bedtime at baseline and weekly thereafter, No significant differences were identified between treatments in terms of goniometrically assessed joint restriction, and both treatments were equally effective in alleviating arthralgia, Of the patients receiving SR ibuprofen, 76% (29 of 38) judged it to be-effective in reducing joint pain, compared with 71% (15 of 21) receiving piroxicam, a nonsignificant difference, Early and late morning VAS pain scores at each of weeks 1 through 4 for the SR ibuprofen-treated group were significantly lower than at baseline, whereas for the piroxicam group, only the early morning pain scores at weeks 3 and 4 were significantly improved, Early evening (predosing) pain scores were significantly reduced versus baseline at week 4 with SR ibuprofen but at none of the early evening assessments in the piroxicam group, This indicated a tendency toward better 24-hour control of pain by SR ibuprofen than by piroxicam, The difference between the incidence of gastrointestinal-related symptoms in patients receiving SR ibuprofen (2 of 38; 5%) versus piroxicam (3 of 21; 14%) was not statistically significant, It was concluded that once-daily SR ibuprofen was at least as effective in relieving arthralgia as piroxicam over a 24-hour period but with a propensity for producing a lower incidence of gastrointestinal disturbances in elderly patients, Ibuprofen SR tablets combined effective control of painful arthralgia attributable to osteoarthritis of the hip and knee, with the acknowledged excellent safety profile of this nonsteroidal anti-inflammatory drug.