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阿托伐他汀和辛伐他汀在有和无既往心血管疾病患者中的持续性:一项美国管理式医疗研究。

Persistence of atorvastatin and simvastatin among patients with and without prior cardiovascular diseases: a US managed care study.

作者信息

Foody JoAnne M, Joyce Amie T, Rudolph Amy E, Liu Larry Z, Benner Joshua S

机构信息

Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02130, USA.

出版信息

Curr Med Res Opin. 2008 Jul;24(7):1987-2000. doi: 10.1185/03007990802203279. Epub 2008 Jun 4.

Abstract

BACKGROUND

In clinical practice, persistence with statin therapy is poor. While little is known about relative persistence to specific statins, previous studies have observed greater persistence in patients who achieve greater degrees of lipid lowering. Identification of statin therapies which improve patient persistence has the potential to improve the quality of patient care and clinical outcomes. Therefore, we assessed patient persistence with atorvastatin and simvastatin in primary and secondary prevention patients enrolled in managed care.

METHODS

New statin users aged > or =18 years, both with and without prior cardiovascular (CV) events within the 12 month pre-treatment period, were identified from a large national database of managed care patients. Patients initiated atorvastatin or simvastatin therapy from January 1, 2003 to September 30, 2005 and were continuously enrolled in a covered plan for at least 12 months before and after initiation of statin therapy. Subanalyses of patients > or =65 years were also conducted. Measures of interest included demographic and clinical characteristics of the study samples and persistence of statin utilization over the 1-year follow-up period. Persistence was defined as the number of days a patient remained on treatment in the first year following their index date, measured from the date of first fill to study end or the date of discontinuation.

RESULTS

A total of 129 764 atorvastatin users and 45 558 simvastatin users without prior CV events were included in the study. For those patients with prior CV events, a total of 6888 atorvastatin users and 4443 simvastatin users were included in the study. Median persistence in patients without prior CV events was 50 days longer for patients initiating therapy with atorvastatin than simvastatin (207 vs. 157 days, p<0.0001) and after adjusting for confounding factors, those treated with atorvastatin were 15% less likely to discontinue therapy during the first year than those treated with simvastatin (HR=0.85; 95% CI 0.84, 0.86; p<0.001). In secondary prevention patients median persistence was 85 days longer in atorvastatin patients than simvastatin patients (266 vs. 181 days, p<0.0001) and atorvastatin patients were 22% less likely to discontinue therapy (HR=0.78; 95% CI 0.75, 0.82; p<0.001). Persistence was worse in the elderly patients, but the relative difference between atorvastatin and simvastatin was similar to the overall patient population.

CONCLUSIONS

In patients with and without prior CV disease, persistence is generally poor, even worse in the elderly, but significantly better for atorvastatin patients than simvastatin patients (p<0.001). Further studies are required to determine whether this is due to differences in cost, effectiveness, side-effects, or other attributes of the statins.

STUDY LIMITATIONS

Differences in persistence could be, in part, due to unmeasured confounders although all available variables were adjusted in multivariate analyses. Additionally, the claims database lacks some clinical data such as lipid levels, limiting assessments of statin efficacy, and does not include any reasons for discontinuation of therapy.

摘要

背景

在临床实践中,他汀类药物治疗的持续性较差。虽然对于特定他汀类药物的相对持续性了解较少,但先前的研究观察到,血脂降低程度更大的患者持续性更高。确定能够提高患者治疗持续性的他汀类药物治疗方法,有可能改善患者护理质量和临床结局。因此,我们评估了参与管理式医疗的一级和二级预防患者使用阿托伐他汀和辛伐他汀的治疗持续性。

方法

从一个大型全国性管理式医疗患者数据库中,识别出年龄≥18岁的新他汀类药物使用者,这些患者在治疗前12个月内有或无心血管(CV)事件。患者于2003年1月1日至2005年9月30日开始使用阿托伐他汀或辛伐他汀治疗,并在他汀类药物治疗开始前后连续参保一项涵盖计划至少12个月。还对年龄≥65岁的患者进行了亚组分析。感兴趣的指标包括研究样本的人口统计学和临床特征,以及1年随访期内他汀类药物使用的持续性。持续性定义为患者自索引日期起第一年接受治疗的天数,从首次配药日期至研究结束或停药日期进行测量。

结果

共有129764名无既往CV事件的阿托伐他汀使用者和45558名辛伐他汀使用者纳入研究。对于那些有既往CV事件的患者,共有6888名阿托伐他汀使用者和4443名辛伐他汀使用者纳入研究。在无既往CV事件的患者中,开始使用阿托伐他汀治疗的患者的中位持续性比使用辛伐他汀的患者长50天(207天对157天,p<0.0001),在调整混杂因素后,使用阿托伐他汀治疗的患者在第一年停药的可能性比使用辛伐他汀治疗的患者低15%(HR=0.85;95%CI 0.84,0.86;p<0.001)。在二级预防患者中,阿托伐他汀患者的中位持续性比辛伐他汀患者长85天(266天对181天,p<0.0001),阿托伐他汀患者停药的可能性低22%(HR=0.78;95%CI 0.75,0.82;p<0.001)。老年患者的持续性较差,但阿托伐他汀和辛伐他汀之间的相对差异与总体患者人群相似。

结论

在有和无既往CV疾病的患者中,治疗持续性总体较差,在老年人中更差,但阿托伐他汀患者的持续性明显优于辛伐他汀患者(p<0.001)。需要进一步研究以确定这是否是由于他汀类药物在成本、疗效、副作用或其他属性方面的差异所致。

研究局限性

持续性差异可能部分归因于未测量的混杂因素,尽管在多变量分析中对所有可用变量进行了调整。此外,索赔数据库缺乏一些临床数据,如血脂水平,限制了对他汀类药物疗效的评估,并且不包括任何停药原因。

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