Long term study of ketoprofen SR in elderly patients

Elderly patients are often chronically treated with different drugs. As rheumatic conditions are very common in this population, NSAIDs are widely used on a chronic basis. To determine the safety profile of ketoprofen, an international prospective study was set up to monitor the effects of the drug over a 12-month period. Four hundred and sixty five patients were enrolled mostly for osteoarthritis (86%) and rheumatoid arthritis (14%) and received a 200 mg SR tablet o.d. Sex ratio (women/men) was 3/1 and mean age was 70.8 +/- 5.8 years (range: 62-95). The pain as evaluated by the VAS decreased from 50 +/- 2.8 mm at baseline to 20 +/- 1.7 mm at the end of the study. 33.3% of patients complained of side-effects mostly related to GI tract (18%), CNS (4%) and skin (2%). After 12 months of treatment, the maintenance rate was 71.6%. No relationship was evidenced between side-effect incidence and age or cumulative dose, even for severe GI side-effects. 13.3% patients withdrew from the study for side-effects, nearly always related to GI tract (11.2%), 60% of which occurred during the first month. Skin side-effects were always benign. In conclusion, ketoprofen, a short half-life NSAID, administered on a long-term basis in elderly patients has a favorable safety profile and displays no increase in toxicity with age.