Cardiovascular Safety of Long-term Topical Application of a New Non-steroidal Anti-inflammatory Drug, S-flurbiprofen, in Patients with Osteoarthritis

Background S-flurbiprofen plaster (SFPP) is a newly developed tape-type patch of nonsteroidal anti-inflammatory drugs (NSAIDs), containing S-flurbiprofen (SFP) as an active ingredient. SFPP exhibits a significant clinical efficacy owing to the dramatically improved penetration of the active ingredient into deep tissues via good percutaneous absorption. The cardiovascular (CV) effects can be one of the class effects and they are worthy of attention. Therefore, we exploratory investigated the CV effect of SFPP, which results in comparable systemic exposure to that of oral flurbiprofen after long-term application in elderly patients with osteoarthritis. Methods A total of 201 patients with osteoarthritis (mean age, 66.3 years; 151 females) were treated with SFPP at 40 or 80 mg for 52 weeks. CV events observed after the application of SFPP were investigated. Results CV adverse events were observed in 4.5% (9/201 patients); however, none of them was classified as severe. Eight of the nine patients, who showed CV events, had CV diseases and/or hypertension at baseline. Any causal relationship between SFPP and CV events was denied by investigators on the basis of the patients' clinical courses. There was no relationship between CV events and plasma concentration of SFP in these patients. Conclusions Although CV events were observed in 4.5% of the patients after the application of SFPP, no apparent causal relationship between SFPP and CV events was observed on the basis of the clinical course and plasma SFP concentration.