Ethnopharmacological relevance: SKI306X (Joins®) is an anti-inflammatory analgesic herbal medicine extract that was clinically approved for treatment of osteoarthritis in the previous trials and shown to be effective on follow-up studies. However, its potential cardiovascular risk has yet to be investigated.
Aim of the study: This retrospective cohort study investigated the cardiovascular safety of SKI306X, celecoxib and naproxen.
Materials and methods: We used the National Health Insurance Service-National Sample Cohort (NHIS-NSC) to investigate patients over 20 years old with osteoarthritis and rheumatoid arthritis who received a single prescription of SKI306X, celecoxib or naproxen at least once from January 1, 2011 through December 31, 2012. Patients who received SKI306X, celecoxib or naproxen from January 1, 2009 to December 31, 2010 were excluded. Data pertaining to the included patients were investigated to determine the risk of major cardiovascular events associated with the aforementioned prescription using the Cox proportional hazards model after being adjusted for sex, age and comorbidity.
Results: A total of 27,253 patients were selected, among which 10,983 were prescribed SKI306X, 12,311 celecoxib and 3959 naproxen. The incidence of major cardiovascular events was highest for celecoxib (15.4%), followed by SKI306X (8.6%) and naproxen (8.0%). Celecoxib had a higher cardiovascular risk than naproxen, while SKI306X did not have a higher risk of cardiovascular events than naproxen. Upon sensitivity analysis, SKI306X was associated with 1.36 times (95%CI: 1.08-1.72) more cardiovascular events than naproxen during 15-60 days of prescription, but not at less than 14 days or more than 61 days.
Conclusions: Evaluation of the cardiovascular safety of the anti-inflammatory analgesic herbal medicine SKI306X revealed that it did not differ from that of naproxen, which is known to have low cardiovascular risk.
Keywords: Cardiovascular safety; Celecoxib; Naproxen; SKI306X (Joins(®)).
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