A cost-effectiveness analysis of fluvastatin in patients with diabetes after successful percutaneous coronary intervention
A cost-effectiveness analysis of fluvastatin in patients with diabetes after successful percutaneous coronary intervention
复制标题
DOI：
10.1016/j.clinthera.2005.09.012
复制
发表时间：
2005-09-01
影响因子：
3.2
通讯作者：
Chaplin, S
中科院分区：
文献类型：
--
作者：
Scuffham, PA;Chaplin, S
背景：Lescol 干预预防研究 (LIPS) 是一项多国随机对照试验，结果显示，与对照组相比，接受经皮冠状动脉介入治疗（PCI，定义为带或不带支架的血管成形术）的患者，常规使用氟伐他汀可使心源性死亡的相对风险降低 47%，主要不良心脏事件 (MACE) 降低 22%。在这项研究中，MACE 包括心源性死亡、非致命性心肌梗死以及随后的 PCI 和冠状动脉旁路移植术。糖尿病是 MACE 的最大危险因素。 目的：本研究评估了氟伐他汀用于糖尿病患者 PCI 术后 MACE 二级预防的成本效益。方法：对来自 LIPS 的糖尿病患者进行事后亚组分析，以评估氟伐他汀在减少心肌梗死、血运重建和心源性死亡方面的有效性。使用英国资源和成本数据开发了概率马尔可夫模型，以从英国国民医疗服务体系的角度估计 10 年来获得的额外成本和质量调整生命年 (QALY)。该模型包含 6 种健康状态，转换概率来自 LIPS 数据。包括从氟伐他汀换用其他降脂药物、退出氟伐他汀以及对照组使用降脂药物。 结果：在 LIPS 试验的 202 名糖尿病患者亚组中，120 名氟伐他汀患者中的 18 名（15.0%）和 82 名对照参与者中的 21 名（25.6%）存在胰岛素依赖（P = NS）。与对照组相比，接受氟伐他汀治疗的患者在 10 年内预计每名患者的 QALY 平均数 (SD) 会增加 0.196 (0.139) (P < 0.001)，并且卫生服务部门的平均数 (SD) 会增加 10 (E448) (P = NS)（平均 [SD] 16 美元 [689 美元]）。每 QALY 获得的额外成本为；(51（78 美元）。成本效益的关键决定因素包括重复干预的概率、心源性死亡、氟伐他汀的成本以及用于评估的时间范围。结论：氟伐他汀是一种经济有效的治疗方法，可预防接受 PCI 的糖尿病患者发生 MACE。
Background: The Lescol Intervention Prevention Study (LIPS) was a multinational randomized controlled trial that showed a 47% reduction in the relative risk of cardiac death and a 22% reduction in major adverse cardiac events (MACEs) from the routine use of fluvastatin, compared with controls, in patients undergoing percutaneous coronary intervention (PCI, defined as angioplasty with or without stents). In this study, MACEs included cardiac death, nonfatal myocardial infarction, and subsequent PCI and coronary artery bypass graft. Diabetes was the greatest risk factor for MACEs.Objective: This study estimated the cost-effectiveness of fluvastatin when used for secondary prevention of MACEs after PCI in people with diabetes.Methods: A post hoc subgroup analysis of patients with diabetes from the LIPS was used to estimate the effectiveness of fluvastatin in reducing myocardial infarction, revascularization, and cardiac death. A probabilistic Markov model was developed using United Kingdom resource and cost data to estimate the additional costs and quality-adjusted life-years (QALYs) gained over 10 years from the perspective of the British National Health Service. The model contained 6 health states, and the transition probabilities were derived from the LIPS data. Crossover from fluvastatin to other lipid-lowering drugs, withdrawal from fluvastatin, and the use of lipid-lowering drugs in the control group were included.Results: In the subgroup of 202 patients with diabetes in the LIPS trial, 18 (15.0%) of 120 fluvastatin patients and 21 (25.6%) of 82 control participants were insulin dependent (P = NS). Compared with the control group, patients treated with fluvastatin can expect to gain an additional mean (SD) of 0.196 (0.139) QALY per patient over 10 years (P < 0.001) and will cost the health service an additional mean (SD) of 10 (E448) (P = NS) (mean [SD] US $16 [$689]). The additional cost per QALY gained was;(51 (US $78). The key determinants of cost-effectiveness included the probabilities of repeat interventions, cardiac death, the cost of fluvastatin, and the time horizon used for the evaluation. Conclusion: Fluvastatin was an economically efficient treatment to prevent MACEs in these patients with diabetes undergoing PCI.