Abstract
Thirty-eight investigators in Belgium, Finland, Germany, Italy and The Netherlands participated in a long-term follow-up of 154 patients who had shown adequate response without toleration problems in a short-term multicentre trial in osteoarthrosis.
Patients were from 37 to 85 years of age (mean 63) and 68% were female. They received piroxicam from 92 to 344 days (mean 182). The starting dose of 20 mg once daily was maintained throughout for 69% of patients; for 12% the final dose was 30 mg, for 16% it was 10 mg, and for 3% it was 40 mg. Forty-seven per cent of patients reported they were taking concurrent anti-inflammatory/analgesic medication at baseline but by the end of therapy only 18% were.
Most patients had moderate or severe involvement in one or more of the knee, hip, spine, shoulder, and finger joints. By the final visit, between 84% and 94% showed marked or moderate improvement in the physician's assessment of joint tenderness and limitation of motion. These results were in good agreement with patient self assessment: 83% to 90% reported marked or moderate improvement in ability to move and use joints and in their general overall feeling (‘quality of life’ measurement). Furthermore, steady improvement was observed throughout therapy in patient self-assessment of pain and stiffness relative to baseline. The 50% to 60% pain reduction recorded over the short-term (6 to 12 weeks) reached 70% at the end of therapy. The figures for stiffness were 50% to 55% short-term and 61% long-term. Onset of morning pain which occurred on the average within 1 hour of waking at baseline had risen to 8.4 hours (740% increase) by the end of therapy.
The drug was well tolerated with sixteen patients (10%) reporting side-effects attributed to piroxicam. Nearly all were mild or moderate and occurred without disruption of therapy during the first 1 or 2 months of treatment. Most adverse reactions were upper gastro-intestinal but there were no reports of ulceration. One patient, with gastro-intestinal pain after 99 days on drug, was discontinued.
In their global evaluation, physicians judged the efficacy of piroxicam as marked in 71%, moderate in 24%, slight in 4%, and not effective in 1% of patients. Toleration was considered excellent in 83%, good in 14 %, fair in 2%, and poor in only 1%. Compared to prior therapy, piroxicam was rated by the investigators as better in 90% of the 114 assessable cases.
The results suggest that patients with osteoarthrosis who respond well to piroxicam during a short course of treatment are likely to continue their good response and possibly obtain increased relief of symptoms during longer treatment periods.
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