Background To explore the effect of ivabradine on angina-related quality of life (QoL) in patients participating in the SIGNIFY Quality of Life substudy.
Methods and results QoL was evaluated in a prespecified subgroup of SIGNIFY patients with angina (Canadian Cardiovascular Society class ≥2 at baseline) using the Seattle Angina Questionnaire (SAQ) and a generic visual analogue scale (VAS) on health status. Data were available for 4187 patients (2084 ivabradine, 2103 placebo). There were improvements in QoL in both treatment groups. The primary outcome of change in physical limitation score at 12 months was 4.56 points for ivabradine versus 3.40 points for placebo (E, 0.96, 95% CI, –0.13– 2.05, p=0.085).The ivabradine-placebo difference in physical limitation score was significant at 6 months (p=0.048). At 12 months, the VAS and the other SAQ dimensions were higher among ivabradine-treated patients, notably angina frequency (p<0.001) and disease perception (p=0.006). Patients with the worst QoL at baseline (i.e. those in the lowest tertile of score) had the best improvement in QoL over 12 months, with improvements in the physical limitation and a significant reduction in angina frequency (p=0.034). The effect on QoL was maintained over the study duration, and ivabradine patients had better scores on angina frequency at every visit to 36 months.
Conclusion Treatment with ivabradine did not affect the primary outcome of change in physical limitation score at 12 months. It did produce consistent improvements in in other self-reported QoL parameters related to angina pectoris, notably in terms of angina frequency and disease perception.