Long-term safety of ketoprofen in an elderly population of arthritic patients.

A total of 823 patients (620 women and 203 men) aged greater than or equal to 65 years (mean age: 72 years) with osteoarthritis (n = 642) or rheumatoid arthritis (n = 181) were enrolled in an international prospective study designed to assess the safety profile of ketoprofen, a propionic acid derivative, over a 12-month treatment period. The patients received a 200-mg, sustained-release tablet of ketoprofen once daily. At the end of the study, 521 patients (63.3%) remained on the drug regimen, whereas 302 patients (36.7%) had withdrawn from treatment for various reasons, including adverse reactions, inefficacy and improvement, or had been lost to follow-up. A total of 314 patients (38.2%) experienced at least one adverse event during the study. Most side effects involved the digestive system (232 patients [28.2%]), the central nervous system (33 patients [4.0%]) or the cardiovascular system (26 patients [3.2%]). Fourteen patients (1.7%) experienced gastrointestinal adverse events (e.g., ulceration and bleeding). Most of these events occurred during the first 3 months of the study. Thus, it may be concluded that sustained-release ketoprofen, 200 mg once daily, is safe for the long-term treatment of elderly arthritic patients.