디클로페낙의 심혈관계 부작용 발생 위험 분석: 후향적 코호트
Risk of Cardiovascular Diseases due to Diclofenac use: a Retrospective Cohort Study
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Diclofenac is one of the most prescribed NSAIDs. However there have been concerns regarding its cardiovascular risk. Our study aimed to examine whether diclofenac was associated with increased risk of cardiovascular diseases (CVDs) in general population. Using the National Health Insurance database, we designed a retrospective cohort study including 8,386,076 patients aged 18 years and over, who were new users of diclofenac, ibuprofen, and naproxen, between 2011 and 2012. All study patients were monitored until their diagnosis of CVDs, their deaths, or the end of the study. We evaluated the incidence of CVDs, and the relationship between CVDs and diclofenac, using the Cox proportional model after adjusting for age, sex, history of medications and diseases. All the rates were expressed per 1,000 person-year. Compared with naproxen, the hazard ratios (HRs) of diclofenac were 1.16 (95% CI=1.14-1.17). The incidence rates of CVDs were 15.3/1,000 in users of diclofenac. Among these users, the incidence of event in the aspirin group was 51.1/1,000, hypertension 42.8/1,000, diabetes mellitus 41.8/1,000, female 16.2/1,000, and aged 65 years and older 60.8/1,000. Our results indicate an increased risk of cardiovascular events in diclofenac users. We further confirmed the association between diclofenac and CVDs reported in previous studies. Although diclofenac shows lesser gastrointestinal complications than ibuprofen or naproxen, patients with hypertension, diabetes mellitus, or the elderly, need to be careful for cardiovascular events while taking diclofenac.
Abstract
Diclofenac is one of the most prescribed NSAIDs. However there have been concerns regarding its cardiovascular risk. Our study aimed to examine whether diclofenac was associated with increased risk of cardiovascular diseases (CVDs) in general population. Using the National Health Insurance database, we designed a retrospective cohort study including 8,386,076 patients aged 18 years and over, who were new users of diclofenac, ibuprofen, and naproxen, between 2011 and 2012. All study patients were monitored until their diagnosis of CVDs, their deaths, or the end of the study. We evaluated the incidence of CVDs, and the relationship between CVDs and diclofenac, using the Cox proportional model after adjusting for age, sex, history of medications and diseases. All the rates were expressed per 1,000 person-year. Compared with naproxen, the hazard ratios (HRs) of diclofenac were 1.16 (95% CI=1.14-1.17). The incidence rates of CVDs were 15.3/1,000 in users of diclofenac. Among these users, the incidence of event in the aspirin group was 51.1/1,000, hypertension 42.8/1,000, diabetes mellitus 41.8/1,000, female 16.2/1,000, and aged 65 years and older 60.8/1,000. Our results indicate an increased risk of cardiovascular events in diclofenac users. We further confirmed the association between diclofenac and CVDs reported in previous studies. Although diclofenac shows lesser gastrointestinal complications than ibuprofen or naproxen, patients with hypertension, diabetes mellitus, or the elderly, need to be careful for cardiovascular events while taking diclofenac.
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