Efficacy and safety of combination therapy with statin and ezetimibe in patients failing to achieve target LDL levels at cardiology outpatient clinics in Turkey (COM-TR-OLDL): a real-world observational study.
Ayşe Çolak, Zeynep Kumral, Önder Öztürk, Ayşegül Ülgen Kunak, Ali Nizami Elmas, Ömer Bedir, Medeni Karaduman, Naci Babat, Umut Uyan, Nurcemal Şentürk, Sebahat Tekeli Şengül, Sefa Erdi Ömür, Şahbender Koç, Mehmet Ali Işık, Samet Uysal, Cennet Yıldız, Emre Asiltürk, Tuncay Güzel, Fahri Er, Alkım Ateşli Yazıcı, Emrah Yeşil, Fuat Bice, Cansu Öztürk, Murat Gökhan Yerlikaya, Lütfü Aşkın, Melisa Uçar, Murat Çakır, Ömer Uluuysal, Afag Özyıldız, Yusuf Demir Ozan, Tolga Kunak, Selçuk Öztürk, Özkan Karaca, Özkan Kayhan, Khayal Mirzayev, İlke Çelikkale, Emine Buket Kırdağ, Mehdi Zoghi, Asım Oktay Ergene
{"title":"Efficacy and safety of combination therapy with statin and ezetimibe in patients failing to achieve target LDL levels at cardiology outpatient clinics in Turkey (COM-TR-OLDL): a real-world observational study.","authors":"Ayşe Çolak, Zeynep Kumral, Önder Öztürk, Ayşegül Ülgen Kunak, Ali Nizami Elmas, Ömer Bedir, Medeni Karaduman, Naci Babat, Umut Uyan, Nurcemal Şentürk, Sebahat Tekeli Şengül, Sefa Erdi Ömür, Şahbender Koç, Mehmet Ali Işık, Samet Uysal, Cennet Yıldız, Emre Asiltürk, Tuncay Güzel, Fahri Er, Alkım Ateşli Yazıcı, Emrah Yeşil, Fuat Bice, Cansu Öztürk, Murat Gökhan Yerlikaya, Lütfü Aşkın, Melisa Uçar, Murat Çakır, Ömer Uluuysal, Afag Özyıldız, Yusuf Demir Ozan, Tolga Kunak, Selçuk Öztürk, Özkan Karaca, Özkan Kayhan, Khayal Mirzayev, İlke Çelikkale, Emine Buket Kırdağ, Mehdi Zoghi, Asım Oktay Ergene","doi":"10.1186/s12944-026-02950-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Achieving target low-density lipoprotein cholesterol (LDL-C) levels in patients with atherosclerotic cardiovascular disease (ASCVD) frequently requires combination lipid-lowering therapy. Single-pill combination (SPC) regimens may improve adherence compared with free-dose combinations (FDC) in real-world clinical practice.</p><p><strong>Methods: </strong>This retrospective observational study included 450 ASCVD patients with baseline LDL-C levels of 70-189 mg/dL who were followed in cardiology outpatient clinics between January 2023 and December 2024. Patients received atorvastatin-ezetimibe either as a single-pill combination (SPC, n = 392) or as a free-dose combination (FDC, n = 58). Primary endpoints were LDL-C reduction and treatment adherence (≥ 80% of prescribed doses). Secondary endpoints included LDL-C target attainment and adverse events. Non-parametric tests and chi-square/Fisher's exact tests were used for statistical analysis.</p><p><strong>Results: </strong>At 1 month, LDL-C levels were significantly lower in the SPC group compared with the FDC group (90.6 vs. 119 mg/dL; p = 0.005), and adherence was higher (89.8% vs. 70.7%; p < 0.001). At 4 months, LDL-C levels were comparable between groups, while continuous adherence remained significantly higher in the SPC group (86% vs. 69%; p = 0.001). A higher proportion of SPC-treated patients achieved LDL-C < 100 mg/dL at 1 month (81.9% vs. 67.2%; p = 0.009).</p><p><strong>Conclusions: </strong>In this real-world ASCVD cohort, SPC therapy with atorvastatin and ezetimibe was associated with superior adherence and comparable lipid-lowering efficacy despite lower statin doses. Fixed-dose combination strategies may represent an effective approach to optimize adherence and cardiovascular risk management.</p>","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":" ","pages":""},"PeriodicalIF":3.9000,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lipids in Health and Disease","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12944-026-02950-1","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Achieving target low-density lipoprotein cholesterol (LDL-C) levels in patients with atherosclerotic cardiovascular disease (ASCVD) frequently requires combination lipid-lowering therapy. Single-pill combination (SPC) regimens may improve adherence compared with free-dose combinations (FDC) in real-world clinical practice.
Methods: This retrospective observational study included 450 ASCVD patients with baseline LDL-C levels of 70-189 mg/dL who were followed in cardiology outpatient clinics between January 2023 and December 2024. Patients received atorvastatin-ezetimibe either as a single-pill combination (SPC, n = 392) or as a free-dose combination (FDC, n = 58). Primary endpoints were LDL-C reduction and treatment adherence (≥ 80% of prescribed doses). Secondary endpoints included LDL-C target attainment and adverse events. Non-parametric tests and chi-square/Fisher's exact tests were used for statistical analysis.
Results: At 1 month, LDL-C levels were significantly lower in the SPC group compared with the FDC group (90.6 vs. 119 mg/dL; p = 0.005), and adherence was higher (89.8% vs. 70.7%; p < 0.001). At 4 months, LDL-C levels were comparable between groups, while continuous adherence remained significantly higher in the SPC group (86% vs. 69%; p = 0.001). A higher proportion of SPC-treated patients achieved LDL-C < 100 mg/dL at 1 month (81.9% vs. 67.2%; p = 0.009).
Conclusions: In this real-world ASCVD cohort, SPC therapy with atorvastatin and ezetimibe was associated with superior adherence and comparable lipid-lowering efficacy despite lower statin doses. Fixed-dose combination strategies may represent an effective approach to optimize adherence and cardiovascular risk management.
背景：动脉粥样硬化性心血管疾病（ASCVD）患者要达到低密度脂蛋白胆固醇（LDL-C）的目标水平，通常需要联合降脂治疗。在现实世界的临床实践中，与自由剂量联合（FDC）相比，单丸联合（SPC）方案可以改善依从性。方法：这项回顾性观察性研究包括450例基线LDL-C水平为70-189 mg/dL的ASCVD患者，这些患者于2023年1月至2024年12月在心脏病门诊进行随访。患者接受阿托伐他汀-依zetimibe单片联合治疗（SPC, n = 392）或自由剂量联合治疗（FDC, n = 58）。主要终点是LDL-C降低和治疗依从性（≥处方剂量的80%）。次要终点包括LDL-C达标和不良事件。统计分析采用非参数检验和卡方/费雪精确检验。结果：在1个月时，SPC组的LDL-C水平明显低于FDC组（90.6 vs 119 mg/dL; p = 0.005），并且依从性更高（89.8% vs 70.7%）。结论：在这个现实世界的ASCVD队列中，尽管他汀类药物剂量较低，但SPC联合阿托伐他汀和依zetimibe治疗具有较好的依从性和相当的降脂效果。固定剂量联合策略可能是优化依从性和心血管风险管理的有效方法。
期刊介绍：
Lipids in Health and Disease is an open access, peer-reviewed, journal that publishes articles on all aspects of lipids: their biochemistry, pharmacology, toxicology, role in health and disease, and the synthesis of new lipid compounds.
Lipids in Health and Disease is aimed at all scientists, health professionals and physicians interested in the area of lipids. Lipids are defined here in their broadest sense, to include: cholesterol, essential fatty acids, saturated fatty acids, phospholipids, inositol lipids, second messenger lipids, enzymes and synthetic machinery that is involved in the metabolism of various lipids in the cells and tissues, and also various aspects of lipid transport, etc. In addition, the journal also publishes research that investigates and defines the role of lipids in various physiological processes, pathology and disease. In particular, the journal aims to bridge the gap between the bench and the clinic by publishing articles that are particularly relevant to human diseases and the role of lipids in the management of various diseases.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
