The Assessment of Nicorandil Effect on the Quality of Life in Patients with Stable Angina in the "KVAZAR" Study
Aim. To assess the effect of nicorandil added to the standard therapy of patients with stable ischemic heart disease (IHD) on the quality of life (QoL). Material and methods. Patients with verified IHD (stable angina; n=120) were included into double-blind, placebo-controlled, parallel group study. All patients in the study received metoprolol tartrate (100 mg daily). Nicorandil was added (10 mg BID, and then after 2 weeks - 20 mg BID) to the treatment of patients of the main group. Placebo was added to treatment of patients in the control group. The study duration was 6 weeks. QoL was assessed by the Seattle questionnaire (SAQ) and visual analogue scale (VAS) at baseline and at the end of the study. Results. A significant decrease in the number of angina attacks was found in the nicorandil group compared to baseline [from 3.0 (2.0, 5.0) to 1.2 (0.7, 2.0); p<0.01] and compared to the placebo group [2.0 (1.0, 3.0); p=0.02]. The positive dynamics of QoL and functionality of patients with IHD was observed in the nicorandil group at the end of the study. It was demonstrated by significant improvement in all SAQ scales compared to baseline. Positive dynamics in the control group was found only in three scales (limitation of physical activity, frequency of angina attacks and patient attitude to the disease). VAS data revealed a significant increase in the integral index in patients of the main group (from 65.0±14.5 to 69.3±1 5.1; p=0.07), that was significantly higher than this in control group (64.6±15.1; p=0.02) at the end of the study. Conclusion. Nicorandil addition to the standard therapy of patients with IHD (stable angina) demonstrated improvement in the QoL, assessed by SAQ questionnaire and VAS.