Abstract
Background: Reporting of serious adverse events (SAEs) is an essential safety procedure in randomised controlled trials. Risk factors for SAEs post-stroke and the relationship of SAEs with outcome were studied in the ENOS trial. Methods: ENOS assessed glyceryl trinitrate (GTN, 5 mg) vs no GTN for 7 days in 4,011 patients with acute stroke and high blood pressure. Information on SAEs was collected up to day 90. SAEs were adjudicated centrally with blinding to treatment assignment. Results: SAEs were reported in 1022 (25.5%) patients, 43.8% of whom died. Patients who suffered SAEs were more likely to be older (mean age 74.2 vs. 69.0 years, p<0.001) and have a history of atrial fibrillation (AF) (relative risk [RR] 1.80, p<0.001). Patients with non-oral feeding at baseline were more vulnerable to SAEs (RR 2.14, p<0.001) and fatal SAEs (RR 3.77, p<0.001) as compared with those with oral feeding. Males were at less risk than females to suffer an SAE (RR 0.83, p<0.001), as were smokers (RR 0.73, p<0.001). Smokers also suffered fewer fatal SAEs (RR 0.55, p<0.001). GTN did not increase the incidence of SAEs. The most common type of SAE was pneumonia (6% incidence) with a high risk of death (RR 9.29, p<0.001). Conclusions: SAEs are associated with a range of risk factors that should be taken into account in clinical practice. AF and non-oral feeding status were associated with increased, and smoking with reduced, risk of of SAEs. Incidence of pneumonia was a common and life threatening issue amongst patients.
Published Version
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