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西班牙基层医疗环境中他汀类药物治疗高胆固醇血症的药物经济学评价

A pharmacoeconomic evaluation of statins in the treatment of hypercholesterolaemia in the primary care setting in Spain.

作者信息

Tárraga-López Pedro J, Celada-Rodríguez Angel, Cerdán-Oliver Miguel, Solera-Albero Juan, Ocaña-López José M, López-Cara Mateo A, De Miguel-Clave Jaime

机构信息

Zone 6 Primary Care Center, Albacete, Spain.

出版信息

Pharmacoeconomics. 2005;23(3):275-87. doi: 10.2165/00019053-200523030-00007.

Abstract

BACKGROUND

Cardiovascular disease is one of the leading causes of death and it has been shown that primary prevention with the HMG-CoA reductase inhibitor (statin) lipid-lowering drugs can reduce cardiovascular events. Acquisition costs vary between statins and this may be an important consideration in the overall cost effectiveness (CE) of different options.

OBJECTIVE

To perform a CE study of the main statins used in Spain for primary prevention of cardiovascular disease in patients with high cholesterol levels [corrected]

STUDY DESIGN

The CE analysis was based on an open-label, prospective, naturalistic, randomised intervention study under usual care conditions in primary care settings in patients with high cholesterol levels (total cholesterol [TC] >240 mg/dL, low-density lipoprotein cholesterol [LDL-C] >160 mg/dL) and one or more cardiovascular risk factors. The analysis was conducted from the perspective of the Spanish National Health System; the year of costing was 2001.

PATIENTS

A total of 161 patients (49.7% males), mean age 65 +/- 10.3 years, without evidence of cardiovascular disease were included in the study. Of those, 82.1% were hypertensive, 37.1% had diabetes mellitus and 17.9% were smokers.

INTERVENTIONS

Forty-eight patients received oral atorvastatin 10 mg/day, 32 received fluvastatin 40 mg/day, 44 received simvastatin 20 mg/day and 37 patients received pravastatin 20 mg/day for 6 months.

MAIN MEASUREMENTS AND RESULTS

After 6 months, the therapeutic goals of LDL-C control, according to the recommendations of the Spanish Society of Arteriosclerosis--Consensus-2000, were reached in 62.5%, 43.8%, 45.5% and 40.5% of patients treated with atorvastatin, fluvastatin, simvastatin and pravastatin, respectively. The average CE ratio, expressed as the cost in euros (euro) per patient achieving the therapeutic goals, was euros 424.3 for atorvastatin, euros 503.5 for fluvastatin, euros 527.0 for simvastatin and euros 683.4 for pravastatin. The incremental CE ratios for atorvastatin versus fluvastatin and simvastatin were euros 238.9 and euros 149.5, respectively, per additional patient reaching therapeutic goals. Atorvastatin, fluvastatin and simvastatin all dominated pravastatin.

CONCLUSIONS

All the statins studied have been shown to be effective for reducing both TC and LDL-C levels. In this study, atorvastatin was the most efficient drug, with the best CE ratio (cost per patient reaching therapeutic goals). Atorvastatin was more effective and less costly than pravastatin, and when compared with fluvastatin or simvastatin the additional cost per additional patient achieving therapeutic goals was <euros 250.

摘要

背景

心血管疾病是主要死因之一,研究表明,使用HMG-CoA还原酶抑制剂(他汀类)降脂药物进行一级预防可减少心血管事件。不同他汀类药物的购置成本有所不同,这可能是不同选择的总体成本效益(CE)的一个重要考量因素。

目的

对西班牙用于高胆固醇水平患者心血管疾病一级预防的主要他汀类药物进行成本效益研究[校正后]

研究设计

成本效益分析基于一项开放标签、前瞻性、自然主义、随机干预研究,该研究在初级保健机构的常规护理条件下,针对高胆固醇水平(总胆固醇[TC]>240mg/dL,低密度脂蛋白胆固醇[LDL-C]>160mg/dL)且有一个或多个心血管危险因素的患者进行。分析是从西班牙国家卫生系统的角度进行的;成本核算年份为2001年。

患者

共有161例患者(49.7%为男性)纳入研究,平均年龄65±10.3岁,无心血管疾病证据。其中,82.1%患有高血压,37.1%患有糖尿病,17.9%为吸烟者。

干预措施

48例患者接受口服阿托伐他汀10mg/天,32例接受氟伐他汀40mg/天,44例接受辛伐他汀20mg/天,37例患者接受普伐他汀20mg/天,为期6个月。

主要测量指标与结果

6个月后,根据西班牙动脉硬化协会——2000年共识的建议,接受阿托伐他汀、氟伐他汀、辛伐他汀和普伐他汀治疗的患者中,分别有62.5%、43.8%、45.5%和40.5%达到了LDL-C控制的治疗目标。以每位达到治疗目标的患者的欧元成本表示的平均成本效益比,阿托伐他汀为424.3欧元,氟伐他汀为503.5欧元,辛伐他汀为527.0欧元,普伐他汀为683.4欧元。阿托伐他汀与氟伐他汀和辛伐他汀相比,每多一位达到治疗目标的患者,增量成本效益比分别为238.9欧元和149.5欧元。阿托伐他汀、氟伐他汀和辛伐他汀均优于普伐他汀。

结论

所有研究的他汀类药物均已证明可有效降低TC和LDL-C水平。在本研究中,阿托伐他汀是最有效的药物,具有最佳的成本效益比(每位达到治疗目标的患者的成本)。阿托伐他汀比普伐他汀更有效且成本更低,与氟伐他汀或辛伐他汀相比,每多一位达到治疗目标的患者的额外成本<250欧元。

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