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 At the end of the study, 521 patients (63.3%) remained on the drug regimen, whereas 302 patients (36.7%) had withdrawn from treatment for various reasons, including adverse reactions, inefficacy and improvement, or had been lost to follow-up.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.
Schattenkirchner
M
M
Rheumatology Unit, Ludwig-Maximilians University, Munich, Germany.
D000367:Age Factors; D000368:Aged; D000375:Aging / Q000502:physiology*; D001168:Arthritis / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D003692:Delayed-Action Preparations; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology; D006339:Heart Rate / Q000187:drug effects / Q000502:physiology; D006801:Humans; D015994:Incidence; D007660:Ketoprofen / Q000008:administration & dosage / Q000592:standards* / Q000627:therapeutic use; D008297:Male; D010003:Osteoarthritis / Q000188:drug therapy / Q000453:epidemiology / Q000503:physiopathology; D011446:Prospective Studies; D012307:Risk Factors; D013997:Time Factors
D003692:Delayed-Action Preparations; D007660:Ketoprofen