Pharmaceutical Outcomes Research Program, University of Colorado School of Pharmacy, Aurora, CO 80045, USA.
Curr Med Res Opin. 2010 Oct;26(10):2485-97. doi: 10.1185/03007995.2010.516994.
High-sensitivity C-reactive protein (hs-CRP) has been explored for use in predicting cardiovascular risk. The recent Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study found that statin therapy reduced cardiovascular events in those with low-density lipoprotein (LDL) cholesterol levels below current treatment thresholds (≤130 mg/dL, 3.4 = mmol/L), but with elevated hs-CRP levels (≥2.0 mg/L). This study examines the cost-effectiveness of statin treatment for individuals with elevated hs-CRP but normal LDL cholesterol.
A Markov decision-analytic model was conducted from the U.S. societal perspective. Data from JUPITER were used to estimate rates of myocardial infarction, angina and stroke. Statin costs were based on generic simvastatin 80 mg, equipotent to the rosuvastatin 20 mg dose used in JUPITER. Primary prevention was the focus and secondary prevention was not modeled explicitly. Quality-adjusted life-years (QALYs) were calculated using nationally representative preference-based utility weights. One-way sensitivity analyses and multivariate probabilistic sensitivity analysis were used to explore uncertainty in model parameters as well as estimate the likelihood of cost-effectiveness when all event rates, costs and utilities were drawn randomly from distributions reflecting uncertainty.
Statin therapy cost $10,889/QALY for vascular event prevention in this population. Results were sensitive to the cost of statin treatment. Based on 10,000 simulations, statin therapy was cost-effective in 99.5% of simulations, using a willingness-to-pay threshold of $20,000/QALY, and 100% of simulations using a threshold of $50,000/QALY.
Treatment with statins in patients with elevated hs-CRP but normal cholesterol appears to be cost-effective. Limitations of this study include the assumption that an equipotent dose of simvastatin resulted in the same risk reduction as rosuvastatin. Further, post-event states simulated the average experience of a patient. Continued statin use, subsequent events and/or heart failure were not explicitly modeled.
高敏 C 反应蛋白（hs-CRP）已被用于预测心血管风险。最近的《初级预防中使用他汀类药物的理由：评估瑞舒伐他汀的干预试验（JUPITER）》研究发现，在 LDL 胆固醇水平低于当前治疗阈值（≤130mg/dL，3.4mmol/L）但 hs-CRP 水平升高（≥2.0mg/L）的患者中，他汀类药物治疗可降低心血管事件。本研究探讨了 hs-CRP 升高但 LDL 胆固醇正常的个体使用他汀类药物治疗的成本效益。
采用 Markov 决策分析模型，从美国社会角度进行分析。使用 JUPITER 数据来估计心肌梗死、心绞痛和中风的发生率。他汀类药物的成本基于仿制药辛伐他汀 80mg，与 JUPITER 中使用的瑞舒伐他汀 20mg 剂量等效。主要预防为重点，未明确建模二级预防。使用具有全国代表性的基于偏好的效用权重计算质量调整生命年（QALY）。采用单因素敏感性分析和多变量概率敏感性分析，以探索模型参数的不确定性，并在所有事件发生率、成本和效用随机取自反映不确定性的分布时，估计成本效益的可能性。
在该人群中，他汀类药物治疗的血管事件预防费用为 10889 美元/QALY。结果对他汀类药物治疗的成本敏感。基于 10000 次模拟，在使用 20000 美元/QALY 的意愿支付阈值时，他汀类药物治疗在 99.5%的模拟中具有成本效益，在使用 50000 美元/QALY 的阈值时，100%的模拟具有成本效益。
在 hs-CRP 升高但胆固醇正常的患者中使用他汀类药物治疗似乎具有成本效益。本研究的局限性包括假设等效剂量的辛伐他汀可产生与瑞舒伐他汀相同的风险降低。此外，模拟的发病后状态是患者平均经历的情况。未明确建模他汀类药物的持续使用、后续事件和/或心力衰竭。
