Overview on Clinical Data of Dexibuprofen

Abstract

Several clinical trials, post-marketing surveillance studies and a meta-analysis were performed to obtain information about dose finding, pharmacokinetics, special indications, tolerability and compliance. In eight clinical trials, according to GCP, 1463 patients were included. Six of the trials were double-blind studies against placebo, racemic ibuprofen and diclofenac; the pharmacokinetic study and a long-term safety study were open studies. A meta-analysis of five clinical trials compared tolerability and safety data between dexibuprofen and racemic ibuprofen. Three PMS studies collected data on 7133 outpatients. All clinical trials and PMS studies have been published. In the dosage ratio 0.5:1, dexibuprofen was found to be at least as efficacious as racemic ibuprofen; 75% of the maximum daily dose of dexibuprofen was equally efficacious as 100% of MDD of diclofenac; no influence was found of meals on bioavailability and a significant doseresponse relationship; there was clinical efficacy in rheumatoid arthritis, ankylosing spondylitis, osteoarthritis of the hip, osteoarthritis of the knee, lumbar vertebral syndrome, distortion of the ankle joint and dysmenorrhoea; there was good tolerability compared to other NSAIDs: racemic ibuprofen showed a 30% and diclofenac a 90 % higher incidence of adverse drug reactions; the longterm study stated a 15.2% adverse drug event incidence; the incidence of adverse drug reactions in the PMS studies was between 5.5% and 7.4%, and withdrawals were between 2.3% and 2.7%. In conclusion, dexibuprofen (Seractil®) has the stature of a modern NSAID, combining the high efficacy of diclofenac with the good tolerability of ibuprofen, and need not hide behind the new generation of COX-2 inhibitors.