Wagner M, Lindgren P, Merikle E, Goetghebeur M, Jönsson B
BioMedCom Consultants Inc., 1405 TransCanada Highway, Suite 310, Montreal, Quebec H9P 2V9.
Can J Cardiol. 2009 Nov;25(11):e362-9. doi: 10.1016/s0828-282x(09)70159-x.
The Incremental Decrease in End-Points Through Aggressive Lipid-Lowering (IDEAL) trial demonstrated incremental cardiovascular benefit of treatment with high-dose atorvastatin (80 mg/ day) versus standard-dose simvastatin (20 mg/day to 40 mg/day) in 8888 patients with a previous myocardial infarction (MI) over a median follow-up period of 4.8 years.
To assess the cost-effectiveness of high-dose atorvastatin versus standard-dose simvastatin treatment in patients with a history of MI from a Canadian societal perspective.
In a within-trial analysis, end point-related events, resources used and productivity losses occurring during the IDEAL trial were aggregated by treatment arm on an intention-to-treat basis to calculate the incremental cost per event avoided. Additionally, quality-adjusted survival was projected using a lifetime Markov model. Transition probabilities, workdays lost, use of study medication and cardiovascular hospitalization rates were based on IDEAL trial data. Hospitalization, study medication and productivity costs were included. Probabilistic and deterministic sensitivity analyses were performed.
Compared with standard-dose simvastatin, atorvastatin 80 mg led to 0.099 fewer events per patient and cost savings over 4.8 years of treatment. Over a lifetime horizon, atorvastatin 80 mg led to 0.023 qualityadjusted life years (QALYs) gained per patient at an incremental cost of $26,795/QALY gained. The incremental cost-effectiveness ratio remained below $50,000/QALY in 78% of 1000 simulations. Exclusion of indirect costs resulted in an incremental cost-effectiveness ratio of $38,834/QALY. Results were relatively sensitive to baseline age, but robust with respect to sex, baseline low-density lipoprotein cholesterol levels, diabetes status and hospitalization costs.
From a Canadian societal perspective, high-dose atorvastatin is cost-effective compared with standard-dose simvastatin in patients with a previous MI.
通过积极降脂实现终点事件逐步减少(IDEAL)试验表明,在8888例既往有心肌梗死(MI)的患者中,与标准剂量辛伐他汀(20毫克/天至40毫克/天)相比,高剂量阿托伐他汀(80毫克/天)治疗在中位随访期4.8年期间具有额外的心血管益处。
从加拿大社会角度评估高剂量阿托伐他汀与标准剂量辛伐他汀治疗MI病史患者的成本效益。
在一项试验内分析中,根据意向性治疗原则,按治疗组汇总IDEAL试验期间发生的终点相关事件、所使用的资源和生产力损失,以计算避免每一事件的增量成本。此外,使用终身马尔可夫模型预测质量调整生存。转移概率、工作日损失、研究药物使用和心血管住院率基于IDEAL试验数据。纳入了住院、研究药物和生产力成本。进行了概率性和确定性敏感性分析。
与标准剂量辛伐他汀相比,80毫克阿托伐他汀使每位患者的事件减少0.099起,且在4.8年治疗期间节省成本。在终身范围内,80毫克阿托伐他汀使每位患者获得0.023个质量调整生命年(QALY),增量成本为每获得一个QALY 26,795美元。在1000次模拟中,78%的增量成本效益比保持在50,000美元/QALY以下。排除间接成本后,增量成本效益比为38,834美元/QALY。结果对基线年龄相对敏感,但在性别、基线低密度脂蛋白胆固醇水平、糖尿病状态和住院成本方面具有稳健性。
从加拿大社会角度来看,对于既往有MI的患者,高剂量阿托伐他汀与标准剂量辛伐他汀相比具有成本效益。