Safety of ketoprofen in the elderly: a prospective study on 20,000 patients.

Safety is a major concern in drug therapy in the elderly. NSAIDs are often used in the elderly and may induce side-effects. With a view to monitor the safety profile of ketoprofen, 19,880 patients greater than 60 years of age were enrolled in a large scale open study. They received a 200 mg sustained release tablet once-a-day for one month, in almost all cases for osteoarthritis. Patients mean age was 72.2 +/- 6.7 years. At the end of treatment, overall efficacy was rated as excellent or good in 70.7% of cases by patients and 74.2% by physicians. Tolerability was judged excellent: 60.8%; good: 24.0%; moderate: 8.7%; and poor: 5.1%. Side-effects related to ketoprofen occurred in 15.3% of patients and led to withdrawal in 4.5%. The most frequent side-effects were related to the G.I. tract (13.5% of total patients). Severe G.I. side-effects (ulcer, melena) occurred in 0.03%. Skin side-effects occurred in 0.7% and were always benign. No relationship was found between the incidence of side-effects and age or dosing time. In contrast, a higher incidence of side-effects was demonstrated in women, in case of associated disorders or concomitant therapy and in patients previously treated with other NSAIDs. In conclusion, in this very large population of elderly patients, ketoprofen had a good risk/benefit ratio.