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已发表论文
尼可地尔用于心绞痛患者及其健康状况结局：一项前瞻性、多中心、队列研究（GREAT）
Authors Zhao X, Cheng G , Sun L, Liu Y, Du X, Xu S, Wu L, Wei Y, Liu W, Miao L, Zhang Q, Ma C, Zeng Y
Received 28 November 2024
Accepted for publication 23 August 2025
Published 15 September 2025 Volume 2025:19 Pages 8295—8308
DOI https://doi.org/10.2147/DDDT.S506108
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Yan Zhu
Xiliang Zhao,1 Guojie Cheng,2 Liling Sun,3 Yajuan Liu,4 Xin Du,1 Su’e Xu,5 Litao Wu,6 Ying Wei,7 Wei Liu,8 Lifu Miao,9 Qihua Zhang,4 Changsheng Ma,1 Yong Zeng1
1Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, People’s Republic of China; 2Department of Cardiology, Beijing Daxing District People’s Hospital, Beijing, People’s Republic of China; 3Department of Cardiology, Beijing Changping District Hospital, Beijing, People’s Republic of China; 4Department of Cardiology, Beijing Miyun District Hospital, Peking University First Hospital, Beijing, People’s Republic of China; 5Department of Cardiology, Huai’an Hospital of Traditional Chinese Medicine, Jiangsu, People’s Republic of China; 6Department of Cardiology, Ruyang People’s Hospital, Henan, People’s Republic of China; 7Rehabilitation Medicine Center, Qilu Hospital of Shandong University, Dezhou Hospital, Shandong, People’s Republic of China; 8Department of Cardiology, Beijing Jishuitan Hospital, Capital Medical University, The Fourth Clinical Medical College of Peking University, Beijing, People’s Republic of China; 9Heart Center, First Affiliated Hospital of Tsinghua University, Beijing, People’s Republic of China
Correspondence: Yong Zeng, Department of Cardiology, Beijing Anzhen Hospital, Beijing, 100029, People’s Republic of China, Tel +86 13501373114, Email yzeng_anzhen@mail.ccmu.edu.cn
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.
Keywords: angina pectoris, real-world, nicorandil, coronary artery disease, health-related outcomes, Seattle angina questionnaire
1Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, People’s Republic of China; 2Department of Cardiology, Beijing Daxing District People’s Hospital, Beijing, People’s Republic of China; 3Department of Cardiology, Beijing Changping District Hospital, Beijing, People’s Republic of China; 4Department of Cardiology, Beijing Miyun District Hospital, Peking University First Hospital, Beijing, People’s Republic of China; 5Department of Cardiology, Huai’an Hospital of Traditional Chinese Medicine, Jiangsu, People’s Republic of China; 6Department of Cardiology, Ruyang People’s Hospital, Henan, People’s Republic of China; 7Rehabilitation Medicine Center, Qilu Hospital of Shandong University, Dezhou Hospital, Shandong, People’s Republic of China; 8Department of Cardiology, Beijing Jishuitan Hospital, Capital Medical University, The Fourth Clinical Medical College of Peking University, Beijing, People’s Republic of China; 9Heart Center, First Affiliated Hospital of Tsinghua University, Beijing, People’s Republic of China
Correspondence: Yong Zeng, Department of Cardiology, Beijing Anzhen Hospital, Beijing, 100029, People’s Republic of China, Tel +86 13501373114, Email yzeng_anzhen@mail.ccmu.edu.cn
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.
Keywords: angina pectoris, real-world, nicorandil, coronary artery disease, health-related outcomes, Seattle angina questionnaire