Risk factors of adverse drug reaction caused by nimesulide in Shanghai patients with osteoarthropathy.

Abstract

The aim of this study was to investigate the risk factors for adverse drug reactions (ADRs) to nimesulide in patients from Shanghai with osteoarthropathy. A retrospective epidemiological study was performed to obtain information (observational variables) on demographics, primary disease, family history of disease, quality of life, dietary habits, lifestyle, use of nonsteroidal anti-inflammatory drugs (NSAIDs) and ADR history of NSAIDs. Univariate and multivariate analyses were performed to establish the relationship between these observational variables and the occurrence of ADRs caused by nimesulide. Among the 726 variables, five risk factors for ADRs to nimesulide were identified. The study showed an increased risk for ADR occurrence with increased scoring of the following four factors: (i) "Concomitant drug therapy" (odds ratio [OR]: 4.66, 95% confidence intervals [CI]: 1.26-17.26, p < 0.05); (ii) "Compared with six months ago, how would you rate your health in general now?" (OR: 1.38, 95% CI: 1.03-1.84, p < 0.05); (iii) "General feeling of health status" (OR: 1.27, 95% CI: 1.03-1.56, p < 0.05) and (iv) "1 expect my health to get worse" (OR: 2.05, 95% CI: 1.22-3.44, p < 0.01). There was a decreased risk for ADR occurrence with increased scoring of the factor "Have you ever suffered from depression that impacted on your life?" (OR: 0.15, 95% CI: 0.03-0.66, p < 0.05). The predictive model for the overall incidence rate of ADRs caused by nimesulide was then established. In conclusion, the predictive model helps to indicate the risk of ADRs to nimesulide and provides clinicians with an alternative method for decision making when prescribing this drug.