Scuffham Paul A, Chaplin Stephen
York Health Economics Consortium Ltd, University of York, York, UK.
Pharmacoeconomics. 2004;22(8):525-35. doi: 10.2165/00019053-200422080-00004.
To estimate the costs, benefits and cost effectiveness, from the UK NHS perspective, of fluvastatin (relative to no HMG-CoA reductase inhibitor [statin]) for the secondary prevention of major adverse cardiac events following a successful first percutaneous coronary intervention (PCI).
A cost-effectiveness analysis was undertaken using efficacy data from the Lescol Intervention Prevention Study (LIPS). LIPS was a randomised, double-blind, placebo-controlled trial undertaken in 77 centres (predominantly in Europe). Patients included in the trial had moderate hypercholesterolaemia and had successfully undergone their first PCI. Fluvastatin (Lescol) 40 mg twice daily plus dietary counselling was given to the intervention group for up to 4 years; the control group received dietary counselling only. A Markov model was used to estimate the incremental costs per QALY gained over a 10-year period, with cost data drawn from the UK NHS (2002 values). Monte Carlo simulations and multivariate analysis were used to assess uncertainty. Costs were discounted at 6% per annum, and health outcomes at 1.5% per annum.
On average, treatment with fluvastatin cost an additional pound 300 (SD pound 303) [euro 423; SD euro 428] per patient and resulted in an additional 0.092 (SD 0.06) QALYs per patient over 10 years compared with controls. The incremental cost per QALY gained with fluvastatin versus the control group was pound 3207 (SD pound 5,497) [euro 4,527; SD euro 7,759]. Fluvastatin was dominant (better outcomes and lower costs) in 15.9% of the simulations and was dominated in 2.9%. The key determinants of cost effectiveness were: the effectiveness of fluvastatin in reducing acute myocardial infarction, subsequent PCI, coronary artery bypass graft and cardiac deaths; the utility weight associated with a subsequent post-PCI state; the cost of fluvastatin; and the time horizon evaluated.
Fluvastatin is the only statin which has proven effective in preventing major coronary adverse events in new PCI patients; other statins lack this evidence. This Markov model, with its underlying assumptions and data, suggests that fluvastatin is a viable and economically efficient pharmaceutical (relative to no statin) to reduce heart disease in the UK when given routinely to all patients following PCI.
从英国国民医疗服务体系（NHS）的角度，评估氟伐他汀（相对于不使用HMG-CoA还原酶抑制剂[他汀类药物]）在首次经皮冠状动脉介入治疗（PCI）成功后二级预防主要不良心脏事件中的成本、效益及成本效益。
使用来适可干预预防研究（LIPS）的疗效数据进行成本效益分析。LIPS是一项在77个中心（主要在欧洲）进行的随机、双盲、安慰剂对照试验。纳入试验的患者患有中度高胆固醇血症且首次PCI手术成功。干预组给予氟伐他汀（来适可）40mg每日两次加饮食咨询，持续4年；对照组仅接受饮食咨询。采用马尔可夫模型估计10年期内每获得一个质量调整生命年（QALY）的增量成本，成本数据取自英国NHS（2002年数值）。使用蒙特卡罗模拟和多变量分析评估不确定性。成本按每年6%贴现，健康结果按每年1.5%贴现。
平均而言，与对照组相比，氟伐他汀治疗每位患者在10年内额外花费300英镑（标准差303英镑）[423欧元；标准差428欧元]，且每位患者额外获得0.092（标准差0.06）个QALY。与对照组相比，氟伐他汀每获得一个QALY的增量成本为3207英镑（标准差5497英镑）[4527欧元；标准差7759欧元]。在15.9%的模拟中，氟伐他汀占优（效果更好且成本更低），在2.9%的模拟中处于劣势。成本效益的关键决定因素为：氟伐他汀在降低急性心肌梗死、后续PCI、冠状动脉搭桥术及心脏死亡方面的有效性；与PCI后状态相关的效用权重；氟伐他汀的成本；以及评估的时间范围。
氟伐他汀是唯一已被证明对新PCI患者预防主要冠状动脉不良事件有效的他汀类药物；其他他汀类药物缺乏此证据。该马尔可夫模型及其基本假设和数据表明，在英国，对所有PCI术后患者常规给予氟伐他汀是一种可行且经济有效的降低心脏病风险的药物（相对于不使用他汀类药物）。
