Li Xuechun, Steenhuis Dennis, Bijlsma Maarten J, de Vos Stijn, Mubarik Sumaira, Bos Jens H J, Schuiling-Veninga Catharina C M, Hak Eelko
Pharmacotherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands.
Laboratory of Population Health, Max Planck Institute for Demographic Research, Rostock, Germany.
Int J Gen Med. 2024 Oct 26;17:4947-4958. doi: 10.2147/IJGM.S479120. eCollection 2024.
PURPOSE: Anti-hyperlipidemic drug treatments are effective in reducing the risk of cardiovascular disease. In a long-term retrospective inception cohort study, we aimed to assess the real-world comparative effectiveness of anti-hyperlipidemic monotherapies for primary prevention of cardiovascular events. PATIENTS AND METHODS: Patients aged 18 years and older, who initiated primary prevention with anti-hyperlipidemic monotherapy, were selected from the University of Groningen IADB.nl dispensing database. In intention-to-treat (ITT) analysis we included all patients, whereas in per-protocol (PP) analysis we included both all patients independent of adherence (PPIA) and adherent patients (PPA). Study outcome was the time to first prescription of acute cardiac drug therapy measured by valid drug proxies to identify a first major cardiovascular event. We applied inverse probability of treatment-weighted (IPTW) analysis using Cox regression and time-varying Cox regression with simvastatin as the reference category to estimate the average treatment effect hazard ratios (HR) and their corresponding 95% confidence intervals (CI). RESULTS: Atorvastatin users had significantly higher hazards compared to simvastatin users (HR range: 1.27 to 1.47, 95% CI: 1.15 to 1.69). Similarly, Pravastatin users also exhibited increased hazards compared to simvastatin users (HR range: 1.41 to 1.56, 95% CI: 1.14 to 2.04). Similar patterns were observed in patients with diabetes, rheumatoid arthritis, and asthma/COPD. No differences were found in the hazards of rosuvastatin, fluvastatin, fibrates, and simvastatin. CONCLUSION: Atorvastatin and pravastatin users had higher long-term rates of cardiovascular events compared to simvastatin monotherapy in primary prevention, the difference may be attributed to the confounding by severity, but also possibly due to differences in drug mechanisms or patient response. These findings could influence current guideline recommendations, suggesting a potential preference for simvastatin in primary prevention, underscoring the need for further research to explore long-term impacts and underlying mechanisms, especially in diverse populations.
目的：抗高血脂药物治疗在降低心血管疾病风险方面是有效的。在一项长期回顾性起始队列研究中，我们旨在评估抗高血脂单一疗法对心血管事件一级预防的真实世界比较疗效。 患者与方法：从格罗宁根大学IADB.nl配药数据库中选取开始使用抗高血脂单一疗法进行一级预防的18岁及以上患者。在意向性治疗（ITT）分析中，我们纳入了所有患者，而在符合方案（PP）分析中，我们纳入了所有与依从性无关的患者（PPIA）和依从性好的患者（PPA）。研究结局是通过有效的药物替代指标来衡量首次开具急性心脏药物治疗处方的时间，以确定首次重大心血管事件。我们使用Cox回归和时变Cox回归进行逆概率治疗加权（IPTW）分析，以辛伐他汀作为参考类别，估计平均治疗效果风险比（HR）及其相应的95%置信区间（CI）。 结果：与辛伐他汀使用者相比，阿托伐他汀使用者的风险显著更高（HR范围：1.27至1.47，95%CI：1.15至1.69）。同样，与辛伐他汀使用者相比，普伐他汀使用者的风险也有所增加（HR范围：1.41至1.56，95%CI：1.14至2.04）。在糖尿病、类风湿性关节炎和哮喘/慢性阻塞性肺疾病患者中也观察到类似模式。瑞舒伐他汀、氟伐他汀、贝特类药物和辛伐他汀的风险未发现差异。 结论：在一级预防中，与辛伐他汀单一疗法相比，阿托伐他汀和普伐他汀使用者发生心血管事件的长期发生率更高，这种差异可能归因于病情严重程度的混杂因素，但也可能是由于药物机制或患者反应的差异。这些发现可能会影响当前的指南建议，表明在一级预防中可能更倾向于使用辛伐他汀，强调需要进一步研究以探索长期影响和潜在机制，尤其是在不同人群中。
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