Comparison of the outcomes of the prolonged antianginal therapy use in stable coronary artery disease patients according to the data of randomized and observational studies

Abstract

ObjectiveTo compare the results of treatment with antianginal drug nicorandil in patients with stable coronary artery disease according to the results of the observational study (OS) «NIKEA» and randomized controlled trial (RCT) «IONA». Methods«NIKEA » observational program included 590 patients with stable angina pectoris. Subgroups in the OS were formed based on the adherence to nicorandil use. Adherence was assessed during follow-up direct questioning. «IONA » RCT included 5126 patients with stable angina pectoris. ResultsFollow-up period and mean age of patients were equal in OS and RCT. In OS the group of adherent to nicorandil use patients had fewer males, life-saving drugs were administered significantly more often than in RCT, comorbidities (arterial hypertension, peripheral atherosclerosis and diabetes mellitus) were more pronounced. Angina pectoris class III was diagnosed in 32% of the OS patients vs 11% of the RCT patients, and class I – in 4.4% and 26%, respectively (р<0.001). Both in RCT and OS, there were significantly fewer cases of all cardiovascular events in the groups of nicorandil and adherent to nicorandil use patients in comparison with the groups of placebo and nonadherent patients. Both in RCT and OS the use of nicorandil led to significant decrease in the risk of all cardiovascular events. ConclusionResults of the efficacy and effectiveness studies complement each other and give the opportunity to assess the realisation of the RCT results in real clinical practice.