{"title":"在实际临床实践中评估PCSK9抑制剂治疗患者的生化和经济结果。","authors":"Melania Dovizio, Marta Nugnes, Biagio Iacolare, Carmela Nappi, Stefania Saragoni, Margherita Andretta, Antonietta Barbieri, Fausto Bartolini, Gianmarco Chinellato, Mariarosaria Cillo, Stefania Dell'orco, Stefano Grego, Antonella Lavalle, Cataldo Procacci, Davide Re, Luca Degli Esposti","doi":"10.23736/S2724-5683.24.06626-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>PCSK9 inhibitors (PCSK9i) in combination with high-dose statins can reduce LDL-cholesterol (LDL-C) levels by 50-60% over statin monotherapy. This analysis investigated biochemical (LDL-C reduction) and economic outcomes in Italian patients treated with PCSK9i or potentially eligible but untreated.</p><p><strong>Methods: </strong>Administrative databases of healthcare institutions covering around 5 million residents were used to identify patients with PCSK9i prescriptions or potentially eligible-untreated patients between 2017 and Oct-2022. Outcomes were assessed during follow-up in cohorts balanced for baseline covariates by propensity score matching (PSM).</p><p><strong>Results: </strong>After PSM-balancing, 2649 treated and 2649 potentially eligible-untreated patients were included: mean age 64.4-64.7 years, 70-68% males, 92-93% with hypertension, 24-25% with diabetes, and 87% with previous atherosclerotic/cardiovascular events. During follow-up, PCSK9i-treated patients versus untreated/eligible showed a reduction of LDL-C levels (68.9±43.9 vs. 100.4±34.6 mg/dL, P<0.0001), hospitalization rates for heart attack (4.5% vs. 6.8%, P=0.0069), heart failure (4.5% vs. 6.6%, P=0.010), and lower all-cause mortality (3.2% vs. 9.5%, P<0.0001). The multivariate Cox model confirmed that eligible-untreated patients had a more than doubled mortality risk compared to the PCSK9i-treated ones (HR: 2.291, 95%CI: 1.651-3.178, P<0.0001). Although mean annualized total healthcare costs were higher in PCSK9i-treated versus untreated/eligible patients (€6745 vs. €4343, P<0.0001), because of the higher drug costs, PCSK9i therapy was associated with reduced expenses for hospitalizations (€1113 vs. €1687, P<0.0001) and specialist outpatient services (€386 vs. €787, P<0.0001).</p><p><strong>Conclusions: </strong>The real-world analysis suggests that therapy with PCSK9i resulted in reduced LDL-C levels, lower mortality rates and cost savings for hospitalizations and specialist services.</p>","PeriodicalId":18668,"journal":{"name":"Minerva cardiology and angiology","volume":" ","pages":""},"PeriodicalIF":1.4000,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluation of biochemical and economic outcomes in patients treated with PCSK9 inhibitors in a real clinical practice setting.\",\"authors\":\"Melania Dovizio, Marta Nugnes, Biagio Iacolare, Carmela Nappi, Stefania Saragoni, Margherita Andretta, Antonietta Barbieri, Fausto Bartolini, Gianmarco Chinellato, Mariarosaria Cillo, Stefania Dell'orco, Stefano Grego, Antonella Lavalle, Cataldo Procacci, Davide Re, Luca Degli Esposti\",\"doi\":\"10.23736/S2724-5683.24.06626-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>PCSK9 inhibitors (PCSK9i) in combination with high-dose statins can reduce LDL-cholesterol (LDL-C) levels by 50-60% over statin monotherapy. This analysis investigated biochemical (LDL-C reduction) and economic outcomes in Italian patients treated with PCSK9i or potentially eligible but untreated.</p><p><strong>Methods: </strong>Administrative databases of healthcare institutions covering around 5 million residents were used to identify patients with PCSK9i prescriptions or potentially eligible-untreated patients between 2017 and Oct-2022. Outcomes were assessed during follow-up in cohorts balanced for baseline covariates by propensity score matching (PSM).</p><p><strong>Results: </strong>After PSM-balancing, 2649 treated and 2649 potentially eligible-untreated patients were included: mean age 64.4-64.7 years, 70-68% males, 92-93% with hypertension, 24-25% with diabetes, and 87% with previous atherosclerotic/cardiovascular events. During follow-up, PCSK9i-treated patients versus untreated/eligible showed a reduction of LDL-C levels (68.9±43.9 vs. 100.4±34.6 mg/dL, P<0.0001), hospitalization rates for heart attack (4.5% vs. 6.8%, P=0.0069), heart failure (4.5% vs. 6.6%, P=0.010), and lower all-cause mortality (3.2% vs. 9.5%, P<0.0001). The multivariate Cox model confirmed that eligible-untreated patients had a more than doubled mortality risk compared to the PCSK9i-treated ones (HR: 2.291, 95%CI: 1.651-3.178, P<0.0001). Although mean annualized total healthcare costs were higher in PCSK9i-treated versus untreated/eligible patients (€6745 vs. €4343, P<0.0001), because of the higher drug costs, PCSK9i therapy was associated with reduced expenses for hospitalizations (€1113 vs. €1687, P<0.0001) and specialist outpatient services (€386 vs. €787, P<0.0001).</p><p><strong>Conclusions: </strong>The real-world analysis suggests that therapy with PCSK9i resulted in reduced LDL-C levels, lower mortality rates and cost savings for hospitalizations and specialist services.</p>\",\"PeriodicalId\":18668,\"journal\":{\"name\":\"Minerva cardiology and angiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2025-04-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Minerva cardiology and angiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.23736/S2724-5683.24.06626-2\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Minerva cardiology and angiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.23736/S2724-5683.24.06626-2","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景：PCSK9抑制剂（PCSK9i）与大剂量他汀类药物联合使用可比他汀类药物单药治疗降低ldl -胆固醇（LDL-C）水平50-60%。该分析调查了接受PCSK9i治疗或可能符合条件但未经治疗的意大利患者的生化（LDL-C降低）和经济结果。方法：使用覆盖500万居民的医疗机构管理数据库，对2017年至2022年10月期间使用PCSK9i处方的患者或可能符合条件的未治疗患者进行识别。在随访期间，通过倾向评分匹配（PSM）平衡基线协变量的队列评估结果。结果：在psm平衡后，纳入了2649例接受治疗和2649例可能符合条件的未接受治疗的患者：平均年龄64.4-64.7岁，70-68%为男性，92-93%为高血压，24-25%为糖尿病，87%为既往动脉粥样硬化/心血管事件。在随访期间，接受PCSK9i治疗的患者与未接受PCSK9i治疗的患者相比，LDL-C水平降低（68.9±43.9 vs 100.4±34.6 mg/dL）。结论：现实世界分析表明，接受PCSK9i治疗可降低LDL-C水平，降低死亡率，节省住院和专科服务费用。
Evaluation of biochemical and economic outcomes in patients treated with PCSK9 inhibitors in a real clinical practice setting.
Background: PCSK9 inhibitors (PCSK9i) in combination with high-dose statins can reduce LDL-cholesterol (LDL-C) levels by 50-60% over statin monotherapy. This analysis investigated biochemical (LDL-C reduction) and economic outcomes in Italian patients treated with PCSK9i or potentially eligible but untreated.
Methods: Administrative databases of healthcare institutions covering around 5 million residents were used to identify patients with PCSK9i prescriptions or potentially eligible-untreated patients between 2017 and Oct-2022. Outcomes were assessed during follow-up in cohorts balanced for baseline covariates by propensity score matching (PSM).
Results: After PSM-balancing, 2649 treated and 2649 potentially eligible-untreated patients were included: mean age 64.4-64.7 years, 70-68% males, 92-93% with hypertension, 24-25% with diabetes, and 87% with previous atherosclerotic/cardiovascular events. During follow-up, PCSK9i-treated patients versus untreated/eligible showed a reduction of LDL-C levels (68.9±43.9 vs. 100.4±34.6 mg/dL, P<0.0001), hospitalization rates for heart attack (4.5% vs. 6.8%, P=0.0069), heart failure (4.5% vs. 6.6%, P=0.010), and lower all-cause mortality (3.2% vs. 9.5%, P<0.0001). The multivariate Cox model confirmed that eligible-untreated patients had a more than doubled mortality risk compared to the PCSK9i-treated ones (HR: 2.291, 95%CI: 1.651-3.178, P<0.0001). Although mean annualized total healthcare costs were higher in PCSK9i-treated versus untreated/eligible patients (€6745 vs. €4343, P<0.0001), because of the higher drug costs, PCSK9i therapy was associated with reduced expenses for hospitalizations (€1113 vs. €1687, P<0.0001) and specialist outpatient services (€386 vs. €787, P<0.0001).
Conclusions: The real-world analysis suggests that therapy with PCSK9i resulted in reduced LDL-C levels, lower mortality rates and cost savings for hospitalizations and specialist services.
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