{"title":"Nicorandil Use and Health Status Outcomes in Patients with Angina Pectoris: A Prospective, Multicenter, Cohort Study (GREAT).","authors":"Xiliang Zhao, Guojie Cheng, Liling Sun, Yajuan Liu, Xin Du, Su'e Xu, Litao Wu, Ying Wei, Wei Liu, Lifu Miao, Qihua Zhang, Changsheng Ma, Yong Zeng","doi":"10.2147/DDDT.S506108","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Patients and methods: </strong>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.</p><p><strong>Results: </strong>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; <i>P</i>=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).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Registration: </strong>ClinicalTrials.gov, NCT05050773.</p>","PeriodicalId":11290,"journal":{"name":"Drug Design, Development and Therapy","volume":"19 ","pages":"8295-8308"},"PeriodicalIF":5.1000,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12447962/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Design, Development and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/DDDT.S506108","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications.
The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas.
Specific topics covered by the journal include:
Drug target identification and validation
Phenotypic screening and target deconvolution
Biochemical analyses of drug targets and their pathways
New methods or relevant applications in molecular/drug design and computer-aided drug discovery*
Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes)
Structural or molecular biological studies elucidating molecular recognition processes
Fragment-based drug discovery
Pharmaceutical/red biotechnology
Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products**
Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development
Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing)
Preclinical development studies
Translational animal models
Mechanisms of action and signalling pathways
Toxicology
Gene therapy, cell therapy and immunotherapy
Personalized medicine and pharmacogenomics
Clinical drug evaluation
Patient safety and sustained use of medicines.
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