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他汀类药物治疗胆固醇水平达标:临床管理指南建议与实际临床实践管理的比较。

Cholesterol level goal attainment with statins: clinical management guideline recommendations versus management in actual clinical practice.

机构信息

PHARMO Institute, Utrecht, the Netherlands.

出版信息

Pharmacotherapy. 2012 Jul;32(7):631-41. doi: 10.1002/j.1875-9114.2011.01086.x.

DOI:10.1002/j.1875-9114.2011.01086.x
PMID:22760692
Abstract

STUDY OBJECTIVES

To compare the cholesterol level goal attainment rates in patients receiving simvastatin doses recommended in clinical practice guidelines and simvastatin doses most frequently prescribed in clinical practice versus other statins at various dose levels, and to assess statin adherence rates in patients receiving all statins.

DESIGN

Retrospective cohort study.

DATA SOURCE

PHARMO database, which contains linked prescription drug information, hospitalization records, and laboratory test results of over 1 million patients in the Netherlands.

PATIENTS

A total of 7355 new statin users with available cholesterol level measurements before and 12 months after starting statin treatment between 1999 and 2006.

MEASUREMENTS AND MAIN RESULTS

Simvastatin was chosen as the reference drug because policy makers in the Netherlands have promoted the use of generically available statins to reduce costs. Cholesterol level goal attainment rates were compared in patients receiving simvastatin 40 mg/day, which was the statin dose promoted in the 2006 Dutch cardiovascular risk management guidelines, or simvastatin 20 mg/day, which was the most frequently prescribed dose up to 2006, versus other statins at various dose levels. Relative risks (RRs) were adjusted for age, sex, year of therapy initiation, cardiovascular disease, type 2 diabetes mellitus, hypertension, baseline low-density lipoprotein cholesterol level, and adherence during the 3 months before the 12-month follow-up cholesterol measurement. Compared with simvastatin 40 mg/day, cholesterol goal attainment rates were significantly higher with atorvastatin 40 mg/day (RR 1.15, 95% confidence interval [CI] 1.04-1.28) and rosuvastatin 10 mg/day (RR 1.13, 95% CI 1.04-1.23), were similar with atorvastatin 20 mg/day (RR 1.06, 95% CI 0.97-1.16) and rosuvastatin 20 mg/day (RR 1.14, 95% CI 0.93-1.39), and were significantly lower with all other frequently used statin dose levels. Compared with simvastatin 20 mg/day, cholesterol goal attainment was significantly higher with any dose of atorvastatin and rosuvastatin, but were lower with any dose of pravastatin. Goal attainment rates were similar among patients with lower and higher cardiovascular risk. Among the 13-18% of patients who had follow-up cholesterol level measurements at 12 months in all statin groups, the proportion of adherent patients was approximately 75%; this was higher than the proportion of adherent patients in the total population (48-55%), which included patients without follow-up cholesterol levels.

CONCLUSION

A larger proportion of patients reached cholesterol lipid goals with simvastatin 40 mg/day. Cholesterol level goals were achieved by many patients using the recommended simvastatin 40 mg/day, but by fewer patients among those using the more commonly prescribed simvastatin 20 mg/day. Therefore, especially in high-risk patients, the choice of statin should be based on baseline cholesterol levels and expected reductions in these levels, and treatment should be adapted if targets are not met. Improved cholesterol level monitoring may increase adherence and cholesterol management.

摘要

研究目的

比较接受推荐的临床实践指南中的辛伐他汀剂量和临床实践中最常开的辛伐他汀剂量与其他他汀类药物在不同剂量水平下的胆固醇水平达标率,并评估所有他汀类药物使用者的他汀类药物依从率。

设计

回顾性队列研究。

数据来源

PHARMO 数据库,其中包含荷兰超过 100 万患者的处方药信息、住院记录和实验室检测结果。

患者

1999 年至 2006 年间共有 7355 名新的他汀类药物使用者,在开始他汀类药物治疗前和治疗后 12 个月内有可用的胆固醇水平测量值。

测量和主要结果

选择辛伐他汀作为参考药物,因为荷兰的政策制定者已推广使用通用的他汀类药物以降低成本。比较了接受辛伐他汀 40mg/天(这是 2006 年荷兰心血管风险管理指南中推荐的他汀类药物剂量)或辛伐他汀 20mg/天(这是 2006 年之前最常开的剂量)与其他他汀类药物在不同剂量水平下的胆固醇水平达标率。相对风险(RR)调整了年龄、性别、治疗起始年份、心血管疾病、2 型糖尿病、高血压、基线低密度脂蛋白胆固醇水平和在 12 个月随访胆固醇测量前 3 个月的依从性。与辛伐他汀 40mg/天相比,阿托伐他汀 40mg/天的胆固醇达标率显著更高(RR 1.15,95%置信区间 [CI] 1.04-1.28)和瑞舒伐他汀 10mg/天(RR 1.13,95%CI 1.04-1.23),阿托伐他汀 20mg/天(RR 1.06,95%CI 0.97-1.16)和瑞舒伐他汀 20mg/天(RR 1.14,95%CI 0.93-1.39)的达标率相似,而所有其他常用他汀类药物剂量水平的达标率均较低。与辛伐他汀 20mg/天相比,阿托伐他汀和瑞舒伐他汀的任何剂量都能显著提高胆固醇目标达标率,但普伐他汀的任何剂量都能降低胆固醇目标达标率。在所有他汀类药物组中,有 13%-18%的患者在 12 个月时进行了随访胆固醇水平测量,其中依从性患者的比例约为 75%;这高于总人群(48%-55%)中依从性患者的比例,总人群包括没有进行随访胆固醇水平测量的患者。

结论

更多患者使用辛伐他汀 40mg/天达到了胆固醇脂质目标。许多患者使用推荐的辛伐他汀 40mg/天达到了胆固醇水平目标,但使用更常开的辛伐他汀 20mg/天的患者达到目标的比例较低。因此,特别是在高危患者中,他汀类药物的选择应基于基线胆固醇水平和预计降低水平,如果未达到目标,应调整治疗方案。改善胆固醇水平监测可能会提高依从性和胆固醇管理水平。

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