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高血压患者中咪达普利与氨氯地平对肾脏参数影响的比较有效性研究:一项回顾性队列研究

A Comparative Effectiveness Study of Renal Parameters Between Imidapril and Amlodipine in Patients with Hypertension: A Retrospective Cohort Study.

作者信息

Nishida Yayoi, Takahashi Yasuo, Tezuka Kotoe, Takeuchi Satoshi, Nakayama Tomohiro, Asai Satoshi

机构信息

Division of Genomic Epidemiology and Clinical Trials, Clinical Trials Research Center, Nihon University School of Medicine, 30-1 Oyaguchi-Kamimachi, Itabashi-ku, Tokyo, 173-8610, Japan.

Division of Pharmacology, Department of Biomedical Sciences, Nihon University School of Medicine, 30-1 Oyaguchi-Kamimachi, Itabashi-ku, Tokyo, 173-8610, Japan.

出版信息

Cardiol Ther. 2017 Jun;6(1):69-80. doi: 10.1007/s40119-016-0080-4. Epub 2017 Jan 2.

Abstract

INTRODUCTION

Imidapril is an angiotensin converting enzyme inhibitor (ACEI) that is frequently used as an antihypertensive drug in Japan. Although ACEIs are known to have adverse effects of decreasing glomerular filtration rate (GFR) and causing hyperkalemia, there are very few clinical data on the long-term effect of imidapril on glomerular function. We conducted a retrospective cohort study using a clinical database to evaluate and compare the long-term effects of imidapril and amlodipine on renal parameters in Japanese hypertensive patients in routine clinical practice.

METHODS

We identified cohorts of new users of imidapril (n = 57) and a propensity score-matched group with an equal number of new users of amlodipine (n = 57). We used a multivariable regression model to evaluate and compare the effects of the drugs on laboratory parameters including serum levels of creatinine, potassium, sodium, blood urea nitrogen, and estimated GFR (eGFR) between imidapril users and amlodipine users up to 12 months after the initiation of study drug administration. The mean exposure of imidapril and amlodipine was 226.2 and 235.2 days, respectively.

RESULTS

We found a significant increase of serum creatinine and potassium levels and a decrease of eGFR in imidapril users from the baseline period to the exposure period. The reduction of eGFR and the increase of serum creatinine and potassium levels in imidapril users were significantly greater than those in amlodipine users.

CONCLUSIONS

Our study showed that imidapril decreased eGFR and increases the serum levels of creatinine and potassium compared with amlodipine, at least during 1 year of administration.

摘要

引言

咪达普利是一种血管紧张素转换酶抑制剂(ACEI),在日本常被用作抗高血压药物。尽管已知ACEI具有降低肾小球滤过率(GFR)和导致高钾血症的不良反应,但关于咪达普利对肾小球功能长期影响的临床数据非常少。我们使用临床数据库进行了一项回顾性队列研究,以评估和比较咪达普利和氨氯地平在日本高血压患者常规临床实践中对肾脏参数的长期影响。

方法

我们确定了咪达普利新使用者队列(n = 57)和倾向评分匹配组,其中氨氯地平新使用者数量相等(n = 57)。我们使用多变量回归模型来评估和比较在开始使用研究药物后长达12个月内,咪达普利使用者和氨氯地平使用者之间药物对实验室参数的影响,这些参数包括血清肌酐、钾、钠、血尿素氮水平以及估计的GFR(eGFR)。咪达普利和氨氯地平的平均暴露时间分别为226.2天和235.2天。

结果

我们发现从基线期到暴露期,咪达普利使用者的血清肌酐和钾水平显著升高,eGFR降低。咪达普利使用者eGFR的降低以及血清肌酐和钾水平的升高显著大于氨氯地平使用者。

结论

我们的研究表明,至少在给药1年期间,与氨氯地平相比,咪达普利会降低eGFR,并升高血清肌酐和钾水平。

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Revised equations for estimated GFR from serum creatinine in Japan.日本基于血清肌酐估算肾小球滤过率的修订方程。
Am J Kidney Dis. 2009 Jun;53(6):982-92. doi: 10.1053/j.ajkd.2008.12.034. Epub 2009 Apr 1.

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