Faculté de Médecine, Université de Montréal, Montréal, QC, Canada.
Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 850 rue St-Denis, Montréal, QC, H2X 0A9, Canada.
Mol Diagn Ther. 2018 Apr;22(2):241-254. doi: 10.1007/s40291-018-0323-2.
Statin (HMG-CoA reductase inhibitor) therapy is the mainstay dyslipidemia treatment and reduces the risk of a cardiovascular (CV) event (CVE) by up to 35%. However, adherence to statin therapy is poor. One reason patients discontinue statin therapy is musculoskeletal pain and the associated risk of rhabdomyolysis. Research is ongoing to develop a pharmacogenomics (PGx) test for statin-induced myopathy as an alternative to the current diagnosis method, which relies on creatine kinase levels. The potential economic value of a PGx test for statin-induced myopathy is unknown.
We developed a lifetime discrete event simulation (DES) model for patients 65 years of age initiating a statin after a first CVE consisting of either an acute myocardial infarction (AMI) or a stroke. The model evaluates the potential economic value of a hypothetical PGx test for diagnosing statin-induced myopathy. We have assessed the model over the spectrum of test sensitivity and specificity parameters.
Our model showed that a strategy with a perfect PGx test had an incremental cost-utility ratio of 4273 Canadian dollars ($Can) per quality-adjusted life year (QALY). The probabilistic sensitivity analysis shows that when the payer willingness-to-pay per QALY reaches $Can12,000, the PGx strategy is favored in 90% of the model simulations.
We found that a strategy favoring patients staying on statin therapy is cost effective even if patients maintained on statin are at risk of rhabdomyolysis. Our results are explained by the fact that statins are highly effective in reducing the CV risk in patients at high CV risk, and this benefit largely outweighs the risk of rhabdomyolysis.
他汀类药物（HMG-CoA 还原酶抑制剂）治疗是治疗血脂异常的主要方法，可将心血管事件（CVE）的风险降低多达 35%。然而，他汀类药物的治疗依从性很差。患者停止他汀类药物治疗的一个原因是肌肉骨骼疼痛和横纹肌溶解症的相关风险。目前正在研究开发一种用于他汀类药物诱导的肌病的药物基因组学（PGx）检测方法，以替代目前依赖肌酸激酶水平的诊断方法。他汀类药物诱导的肌病的 PGx 检测的潜在经济价值尚不清楚。
我们为 65 岁以上首次发生急性心肌梗死（AMI）或中风的 CVE 后开始使用他汀类药物的患者开发了一个终生离散事件模拟（DES）模型。该模型评估了用于诊断他汀类药物诱导的肌病的假设 PGx 检测的潜在经济价值。我们已经在测试灵敏度和特异性参数的范围内评估了模型。
我们的模型表明，具有完美 PGx 测试的策略的增量成本-效用比为每质量调整生命年（QALY）4273 加元（Can）。概率敏感性分析表明，当支付方每 QALY 的意愿支付达到 12,000 加元时，PGx 策略在模型模拟的 90%中是有利的。
我们发现，即使患者有发生横纹肌溶解症的风险，支持患者继续使用他汀类药物的策略也是具有成本效益的。我们的结果可以解释为，他汀类药物在降低高心血管风险患者的心血管风险方面非常有效，这种益处大大超过了横纹肌溶解症的风险。
