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辛伐他汀治疗不耐受或难治患者转换为阿托伐他汀治疗:CAPISH研究

Conversion to atorvastatin in patients intolerant or refractory to simvastatin therapy: the CAPISH study.

作者信息

Krasuski Richard A, Doeppenschmidt Dennis, Henry John S, Smith P Brad, Adinaro Joseph, Beck Rachel, Thompson Christopher M

机构信息

Wilford Hall Medical Center, San Antonio, Tex, USA.

出版信息

Mayo Clin Proc. 2005 Sep;80(9):1163-8. doi: 10.4065/80.9.1163.

Abstract

OBJECTIVE

To examine the safety and efficacy of switching from simvastatin to atorvastatin in patients who had either an inadequate lipid-lowering response with, or an adverse reaction to, simvastatin.

PATIENTS AND METHODS

The Conversion to Atorvastatin in Patients Intolerant or Refractory to Simvastatin Therapy (CAPISH) study was designed in 2 parts: a retrospective cohort study of patients (group A), identified from a large pharmacy database, who converted from simvastatin to atorvastatin at a single academic military medical center (between April 1998 and March 2002) and a prospective cohort study of patients (group B) monitored in a lipid clinic at the same institution (between April 2002 and March 2003). Group A was identified by 2 or more simvastatin prescription fills and at least 1 atorvastatin prescription fill. Group B was identified by a physician-perceived need to switch from simvastatin to atorvastatin. Clinical, pharmaceutical, and laboratory records of both cohorts were reviewed.

RESULTS

Approximately 1 in 4 simvastatin-treated patients discontinued therapy during a 4-year period. The most common reason for switching to atorvastatin was inadequate low-density lipoprotein (LDL) cholesterol control, although asymptomatic creatine kinase (CK) elevation and myalgias were also common. In most cases of myositis and in nearly all cases of rhabdomyolysis, patients were taking 80 mg of simvastatin. Achievement of National Cholesterol Education Program LDL cholesterol goals increased from 25% to 63% in group A and from 13% to 78% in group B, both P<.001. Significant reductions in CK also were seen in both groups. Adherence to atorvastatin was greater than 80% in both groups after 28.1+/-13.2 months (group A, 841 patients) and 8.1+/-3.8 months (group B, 104 patients). Among patients not taking atorvastatin at follow-up, 58% were no longer taking statins.

CONCLUSION

Atorvastatin was well tolerated in patients who previously were taking simvastatin. Serum lipid panels were improved substantially and CK levels were decreased without compromise to patient safety.

摘要

目的

探讨辛伐他汀治疗期间降脂效果不佳或出现不良反应的患者换用阿托伐他汀的安全性和有效性。

患者与方法

不耐受或难治性辛伐他汀治疗患者换用阿托伐他汀(CAPISH)研究分为两部分:一项回顾性队列研究(A组),从一个大型药房数据库中识别出在一家学术性军队医疗中心(1998年4月至2002年3月)从辛伐他汀换用阿托伐他汀的患者;另一项前瞻性队列研究(B组),在同一机构的血脂门诊对患者进行监测(2002年4月至2003年3月)。A组通过2次或更多次辛伐他汀处方配药和至少1次阿托伐他汀处方配药来确定。B组通过医生认为有必要从辛伐他汀换用阿托伐他汀来确定。对两组患者的临床、药学和实验室记录进行了回顾。

结果

在4年期间,约四分之一接受辛伐他汀治疗的患者停止了治疗。换用阿托伐他汀最常见的原因是低密度脂蛋白(LDL)胆固醇控制不佳,不过无症状肌酸激酶(CK)升高和肌痛也很常见。在大多数肌炎病例和几乎所有横纹肌溶解病例中,患者服用的是80毫克辛伐他汀。A组达到国家胆固醇教育计划LDL胆固醇目标的比例从25%增至63%,B组从13%增至78%,P值均<0.001。两组的CK水平也有显著降低。在28.1±13.2个月后(A组,841例患者)和8.1±3.8个月后(B组,104例患者),两组对阿托伐他汀的依从性均大于80%。在随访时未服用阿托伐他汀的患者中,58%不再服用他汀类药物。

结论

阿托伐他汀在先前服用辛伐他汀的患者中耐受性良好。血脂水平得到显著改善,CK水平降低,且未影响患者安全。

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