Treatment with the drug valsartan was not associated with a reduction in the incidence of recurrent atrial fibrillation, according to a study published in the 16 April, 2009 issue of the New England Journal of Medicine.
The large, randomised, prospective, placebo-controlled, multicentre trial was conducted to test whether the angiotensin II-receptor blocker valsartan could reduce the recurrence of atrial fibrillation.
Dr Marcello Disertori, Santa Chiara Hospital in Trento, Italy, and colleagues analysed data from 1,442 patients with recent atrial fibrillation. Patients were in sinus rhythm but had had either two or more documented episodes of atrial fibrillation in the previous six months or successful cardioversion for atrial fibrillation in the previous two weeks. To be eligible, patients also had to have underlying cardiovascular disease, diabetes, or left atrial enlargement.
The patients were randomised to receive placebo or a daily dose of valsartan that was increased over the course of a month to 320mg daily for the remainder of the year. Primary endpoints were time to first recurrence of atrial fibrillation and proportion of patients with more than one recurrence during the year. Patients could continue previous angiotensin-converting-enzyme inhibitors, amiodarone, and betablockers.
Atrial fibrillation recurred in 371 of the 722 patients (51.4%) in the valsartan group, as compared with 375 of 720 (52.1%) in the placebo group (adjusted hazard ratio, .97; 96% confidence interval [CI], .83 to 1.14; p=.73). More than one episode of atrial fibrillation occurred in 194 of 722 patients (26.9%) in the valsartan group and in 201 of 720 (27.9%) in the placebo group (adjusted odds ratio, .89; 99% CI, .64 to 1.23; p=.34). The results were similar in all predefined subgroups of patients, including those who were not receiving angiotensin-converting-enzyme inhibitors.
Novartis provided funding for the study.