Large Scale Safety Study of Ketoprofen 25 mg (Toprec®) in Febrile and Painful Conditions

Objective—To assess the safety, tolerability and efficacy of low‐dose ketoprofen (75–150 mg daily for 5 to 15 days) in a general practice setting. Design—Open label, non‐controlled study of ketoprofen 25 mg tablets in the treatment of pain in ENT diseases, dysmenorrhoea, and musculoskeletal disorders. Setting—General practice, 600 investigators Subjects—Four thousand and sixty‐eight patients, aged 13–93 years, mean 42.3 years, 1009 with ENT diseases (mean age 38.8 (13–83) years, 53% female), 978 with dysmenorrhoea (mean age 30.3 (13–60) years, 100% female), 2081 with musculoskeletal disorders (mean age 49.6 (16–93) years, 54% female). Main outcome measures—Occurrence of adverse events, on patient and physician evaluation; dose and duration of treatment prescribed/taken (diary); global evaluation of efficacy by patient and physician. Result—Twenty‐two patients were lost to follow‐up (