Adverse events in clinical trials: is a new approach needed?

摘要

The use of combined endpoints in clinical trials is common, but such endpoints seldom include the incidence of adverse events. The ACUITY trial was an exception. ACUITY compared different treatment strategies in patients with acute coronary syndrome, and the primary composite endpoint included not only death, myocardial infarction, or unplanned revascularisation for ischaemia, but also major bleeding. Interestingly, bivalirudin was superior to the other alternatives mainly because of a lower incidence of bleeding. Clearly a decrease in the probability of a major side-effect such as this will translate into a better prognosis, irrespective of the effects of the drugs on cardiovascular disease, since it will be associated with better adherence to treatment.