An overview of European experience with ketoprofen, a nonsteroidal anti‐inflammatory drug (NSAID) with analgesic properties, from the time of its marketing in 1973 until the present is presented. Orally administered ketoprofen (200 mg/day) has been proven effective in treating rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Furthermore, several alternate dosage forms, including intramuscular injection for relief of acutely painful conditions, suppositories, two slow‐release forms (a sustained‐release tablet [IBP 200®] and a controlled‐release capsule [Oruvaii®]), and a topical gel for local treatment of certain superficial conditions and minor rheumatologic disease are available. The safety of ketoprofen has also been proven in several European postmarketing surveillance studies and more importantly, by French and British drug monitoring data. Ketoprofen was rated as one of the safest NSAIDs available in the United Kingdom (UK) by the Committee on the Safety of Medicine in 1986. For incidence of gastrointestinal complaints per million prescriptions, ketoprofen ranked seventh among 19 NSAIDs in its first five years of marketing in the UK. Ketoprofen has been associated with a very low incidence of serious renal, hepatic, or cutaneous reactions. Thus ketoprofen, in 15 years of marketed use in Europe, has proven to be an effective anti‐inflammatory and analgesic agent with an excellent safety profile and several convenient dosage forms.

The indirect effect of diet on the single- and multiple-dose pharmacokinetics of sustained-release ketoprofen was studied in 16 healthy male volunteers. In an open, cross-over design, 200 mg ketoprofen was administered as a gastric-juice-resistant, sustained-release tablet once daily during two periods of 5 days. A low-calorie/low-fat diet (LCFD) was given in the first period and a high-calorie/high-fat diet (HCFD) in the second period. The first meal on each day was given 4 h after drug intake. Ketoprofen plasma concentrations were measured over 24 h after the first dose on day 1 and over 36 h after the final dose on day 5 of each period. On average, plasma concentrations of ketoprofen were higher with the LCFD than with the HCFD. With the HCFD there was a tendency to longer absorption-lag times on day 5. The maximum concentration and the area under the curve over one 24-h dosage period (AUC0-24) were significantly higher with the LCFD, both on day 1 and on day 5. For AUC0-24 the differences were on average 15% (day 1) and 24% (day 5). The same tendency was observed for the amount excreted in urine over 24 h (Ae), but the difference was only significant on day 1 (14%). The elimination rate constant (K beta) and the mean residence time were similar for the two diets, both on day 1 and on day 5. From these results, we conclude that there was an acute indirect effect of diet when a meal was had 4 h after intake of the medication.(ABSTRACT TRUNCATED AT 250 WORDS)