Long-Term Benefits and Safety of Statins in Patients with Kidney Failure: A Target Trial Emulation Study.

Abstract

Background: Patients with kidney failure are at elevated risk of cardiovascular diseases. Although statins were commonly used to mitigate cardiovascular disease risk among the population with high risk, the evidence for initiating statin therapy among patients with kidney failure remains inconclusive. This study aimed to investigate the long-term benefits and risks associated with statin therapy in patients with kidney failure.

Methods: Using territory-wide public electronic health records in Hong Kong, 3,019 statin-eligible individuals with kidney failure and elevated LDL cholesterol ≥ 100 mg/dL from Jan 2008 to Dec 2015 were included for analysis. The framework of target trial emulation was adopted to investigate the risk of the major cardiovascular diseases (i.e., a composite of myocardial infarction, heart failure and stroke), all-cause mortality, as well as the major adverse events (i.e., myopathies and liver dysfunction) between statin initiators and statin non-initiators. The pooled logistic model was used to obtain the hazard ratio (HRs) for the outcomes of interest in both intention-to-treat (ITT) analysis and per-protocol (PP) analysis.

Results: Significant risk reduction associated with statin therapy (HR [95%CI]) was observed for major cardiovascular diseases (ITT: 0.78 [0.62, 0.98]; PP: 0.66 [0.50, 0.87]) and all-cause mortality (ITT: 0.80 [0.68, 0.95]; PP: 0.60 [0.48, 0.76]). The standardised 5-year and 10-year absolute risk reduction in per-protocol analysis was 7% (3%, 11%) and 11% (4%, 18%), respectively. No significant risks for the major adverse events were observed.

Conclusions: Statin therapy was associated with lower risks of cardiovascular diseases and all-cause mortality in patients with kidney failure without a higher risk of major adverse events.