Department of Public Health, Ghent University, Ghent, Belgium.
Clin Drug Investig. 2010;30(2):133-42. doi: 10.2165/11531910-000000000-00000.
Patients with type 2 diabetes mellitus have a high risk of developing cardiovascular (CV) disease. The clinical benefit of use of statins in patients with type 2 diabetes has been demonstrated in several randomized, controlled trials, including the CARDS clinical trial. Based on the clinical CARDS data, the favourable cost effectiveness of atorvastatin 10 mg in patients with type 2 diabetes has been demonstrated in countries such as the UK and France. This study aimed to estimate the cost effectiveness in the Belgian setting of atorvastatin 10 mg compared with no treatment for the primary prevention of CV events in type 2 diabetes patients without a history of CV disease.
A Markov model with 1-year cycles was developed to simulate the CV event and death risk according to the therapeutic approach initiated. The transition probabilities for CV events in the 'no statin treatment' group were derived from the risk equations reported from the large UKPDS. Risk reductions from the CARDS clinical trial were used to adjust these CV event probabilities in the atorvastatin 10 mg treatment group. The characteristics of type 2 diabetes patients without a CV history were derived from the Belgian OCAPI survey. The public healthcare payers' perspective was taken into account for costing. The direct medical costs of CV events were based on the Public Health Authorities' hospital database for acute care costs and on the literature for the follow-up costs. The impact on the reimbursement system of generic entry to the market was considered in the drug cost. Costs were valued as at year 2009; costs and outcomes were discounted at 3% and 1.5%, respectively.
Based on a 5-year time horizon, atorvastatin was demonstrated to be cost effective with an incremental cost/quality-adjusted life-year (QALY) of euro 16,681. Over a lifetime horizon (25 years), atorvastatin was demonstrated to be a cost-saving therapeutic intervention. At a threshold of euro 30,000/QALY, atorvastatin had a 98.8% probability of being cost effective.
Compared with 'no treatment', use of atorvastatin 10 mg as a primary prevention intervention in Belgian type 2 diabetes patients not only improves CV outcomes, but also appears to be cost saving over a lifetime horizon.
2 型糖尿病患者发生心血管（CV）疾病的风险较高。几项随机对照试验，包括 CARDS 临床试验，已经证实了他汀类药物在 2 型糖尿病患者中的临床获益。基于 CARDS 临床数据，阿托伐他汀 10mg 在英国和法国等国家已经显示出在 2 型糖尿病患者中具有良好的成本效益。本研究旨在评估阿托伐他汀 10mg 在比利时用于 2 型糖尿病患者一级预防 CV 事件的成本效益，这些患者无 CV 病史。
采用 1 年周期的 Markov 模型，根据所采用的治疗方法，模拟 CV 事件和死亡风险。“无他汀类药物治疗”组的 CV 事件的转移概率来自于大型 UKPDS 报道的风险方程。CARDS 临床试验的风险降低被用于调整阿托伐他汀 10mg 治疗组的这些 CV 事件概率。无 CV 病史的 2 型糖尿病患者的特征来自于比利时 OCAPI 调查。考虑了从公共医疗支付者的角度进行成本核算。CV 事件的直接医疗费用基于公共卫生当局的医院急性护理费用数据库，并参考文献中的随访费用。考虑了仿制药进入市场对报销系统的影响。以 2009 年为计价年；成本和结果分别按 3%和 1.5%贴现。
基于 5 年时间范围，阿托伐他汀具有成本效益，增量成本/质量调整生命年（QALY）为 16681 欧元。在终身时间范围内（25 年），阿托伐他汀被证明是一种节省成本的治疗干预措施。在 30000 欧元/QALY 的阈值下，阿托伐他汀有 98.8%的可能性具有成本效益。
与“无治疗”相比，阿托伐他汀 10mg 作为 2 型糖尿病患者的一级预防干预措施，不仅改善了 CV 结局，而且在终身时间范围内也具有成本效益。
