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Nicorandil Use and Health Status Outcomes in Patients with Angina Pectoris: A Prospective, Multicenter, Cohort Study
Xiliang Zhao1, Guojie Cheng2, Liling Sun3
1Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, People's Republic of China.
Insights
Nicorandil significantly improved health status in coronary artery disease patients with angina pectoris. This study found nicorandil use led to greater Seattle Angina Questionnaire summary score improvements compared to control groups.
Area of Science:
- Cardiology
- Pharmacology
- Health Outcomes Research
Background:
- Coronary artery disease (CAD) is a significant health burden, with angina pectoris being its most common symptom.
- Nicorandil is frequently prescribed for angina management, but its impact on patient health status remains incompletely understood.
Purpose of the Study:
- To evaluate the effect of nicorandil on health status outcomes in patients with coronary artery disease and angina pectoris.
- To compare the changes in the Seattle Angina Questionnaire summary score (SAQ-SS) between nicorandil users and a control group over 12 months.
Main Methods:
- A multicenter, prospective cohort study (GREAT) involving 1556 adult CAD patients with angina pectoris in China.
- Patients were divided into nicorandil and control groups, with propensity score matching (PSM) applied to 450 pairs for bias reduction.
- The primary outcome was the change in SAQ-SS from baseline to 12 months; secondary outcomes included changes at 3, 6, and 9 months.
Main Results:
- After PSM, the nicorandil group showed a significantly greater mean improvement in SAQ-SS at 12 months (17.6 vs 15.1, P=0.003), with a clinically significant difference of 2.50 points.
- Nicorandil use was associated with greater improvements in SAQ physical limitation and quality of life domains.
- A higher proportion of nicorandil patients (42.5%) achieved large improvements (≥20 points) in SAQ-SS compared to the control group (32.9%).
Conclusions:
- Anti-anginal treatment, including nicorandil, improves health status in the majority of angina pectoris patients.
- Nicorandil-based regimens demonstrated superior health status improvements compared to non-nicorandil treatments in CAD patients with angina.
- A substantial number of patients on nicorandil experienced significant health status improvements one year after treatment initiation.
Purpose:
Coronary artery disease represents a major clinical burden, and angina pectoris is the most frequent manifestation of coronary artery disease. Nicorandil is commonly used for the management of angina pectoris; however, its effects on health status outcomes are unclear.
Patients And Methods:
This multicenter, prospective, cohort study (GREAT) enrolled 1556 adult coronary artery disease patients with angina pectoris from nine hospitals in China. Patients were classified into nicorandil and control groups. The primary outcome was the change in the Seattle Angina Questionnaire summary score (SAQ-SS) from baseline to 12 months. Secondary outcomes included changes in SAQ-SS at 3, 6, and 9 months. Propensity score matching (PSM) was used to reduce bias and control for confounding factors.
Results:
We analyzed 1528 patients with baseline and 12-month health status data. After PSM, 450 matched pairs of patients were identified. A difference of ≥5 points for SAQ-SS is considered clinically significant. Patients in the nicorandil group reported greater mean improvement in SAQ-SS (17.6 ± 14.0, difference: 2.50, 95% CI: 0.74-4.27; P=0.003) at 12 months compared with the control group (15.1 ± 13.0; P=0.003). Similar trends were noted in SAQ-SS at 3, 6, and 9 months. Additionally, nicorandil users exhibited significantly greater improvements in the SAQ physical limitation (11.7 ± 16.9 vs 8.4 ± 16.9; difference: 3.27, 95% CI, 1.05-5.48; P =0.001) and SAQ-QoL domain (18.9 ± 21.4 vs 16.3 ± 20.4; difference: 2.62, 95% CI, -0.12 to 5.35; P=0.042) at 12 months. Most patients in the entire cohort (78.4%) reported a clinical improvement in SAQ-SS. The nicorandil group had a higher proportion of patients with at least large improvements (≥20 points) in SAQ-SS (42.5% vs 32.9%; difference: 9.7%, 95% CI: 3.3-16.0; P= 0.004).
Conclusion:
Among patients with angina pectoris, anti-angina treatment improved the majority of patients' health status. Nicorandil-based regimens were associated with a greater health status outcome improvement compared to those not using nicorandil in coronary artery disease patients with angina pectoris. A substantial proportion of patients using nicorandil exhibited noteworthy improvements in health status outcomes at one year.
Registration:
ClinicalTrials.gov, NCT05050773.
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