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雷诺嗪与曲美他嗪对冠心病糖尿病患者血糖状态影响的比较——一项随机对照试验

Comparison of ranolazine and trimetazidine on glycemic status in diabetic patients with coronary artery disease - a randomized controlled trial.

作者信息

Sandhiya Selvarajan, Dkhar Steven Aibor, Pillai Ajith Ananthakrishna, George Melvin, Jayaraman Balachander, Chandrasekaran Adithan

机构信息

Assistant Professor, Department of Clinical Pharmacology, JIPMER , Puducherry, India .

Professor, Department of Pharmacology, JIPMER , Puducherry, India .

出版信息

J Clin Diagn Res. 2015 Jan;9(1):OC01-5. doi: 10.7860/JCDR/2015/10594.5448. Epub 2015 Jan 1.

DOI:10.7860/JCDR/2015/10594.5448
PMID:25738014
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4347105/
Abstract

INTRODUCTION

Cardiovascular diseases have become the leading cause of death around the globe and diabetes mellitus (DM) is considered to be a coronary artery disease (CAD) risk equivalent. Ranolazine, an anti anginal drug has been found to reduce Glycated haemoglobin (HbA1c) in diabetes patients with chronic angina. However the effect of another antianginal drug trimetazidine, on glycemic status is not clear.

AIM

To compare the effect of ranolazine and trimetazidine on glycemic status in diabetic patients with CAD.

SETTINGS AND DESIGN

Patients diagnosed with CAD and diabetes mellitus attending Cardiology Out Patient Department (OPD), Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry, India were recruited for this randomized open label parallel arm trial.

MATERIALS AND METHODS

The study conducted from January-2012 to April-2013 had 47 eligible patients diagnosed with CAD and diabetes mellitus. They were randomized to receive either ranolazine 500 mg BD or trimetazidine 35 mg BD for 12 weeks. HbA1c levels, fasting blood glucose (FBG), lipid profile, QT and QTc intervals were measured at baseline and after 12 weeks.

STATISTICAL ANALYSIS

Unpaired t-test was used to compare the baseline characteristics of between the groups while comparison within the groups were done using Paired t-test. Wilcoxon and Mann Whitney U-tests were used for non parametric data. Graph pad instat version-3 was used for statistical analysis. Values were expressed as mean ± SD. A p < 0.05 was considered statistically significant.

RESULTS

The study could not find any change in HbA1c levels in both ranolazine and trimetazidine groups. The adverse effects reported from patients on ranolazine include angina, constipation, postural hypotension, headache, dizziness, nausea and weakness while patients on trimetazidine complained of constipation, weakness, palpitations, angina, dizziness, nausea, dyspepsia, headache, gastric discomfort, joint pain, etc.

CONCLUSION

In patients with chronic angina and diabetes mellitus Ranolazine 500mg BD and Trimetazidine 35mg BD did not show any effect on HbA1c and fasting blood glucose lebel.

摘要

引言

心血管疾病已成为全球主要的死亡原因,而糖尿病(DM)被认为是冠状动脉疾病(CAD)的风险等同因素。雷诺嗪,一种抗心绞痛药物,已被发现可降低慢性心绞痛糖尿病患者的糖化血红蛋白(HbA1c)。然而,另一种抗心绞痛药物曲美他嗪对血糖状态的影响尚不清楚。

目的

比较雷诺嗪和曲美他嗪对CAD糖尿病患者血糖状态的影响。

设置与设计

在印度本地治里市贾瓦哈拉尔研究生医学教育与研究学院(JIPMER)心脏病科门诊就诊的被诊断为CAD和糖尿病的患者被纳入这项随机开放标签平行组试验。

材料与方法

该研究于2012年1月至2013年4月进行,有47例符合条件的被诊断为CAD和糖尿病的患者。他们被随机分为接受雷诺嗪500mg每日两次或曲美他嗪35mg每日两次,为期12周。在基线和12周后测量HbA1c水平、空腹血糖(FBG)、血脂谱、QT和QTc间期。

统计分析

使用未配对t检验比较组间的基线特征,而组内比较使用配对t检验。Wilcoxon和Mann Whitney U检验用于非参数数据。使用Graph pad instat 3版本进行统计分析。数值以均值±标准差表示。p<0.05被认为具有统计学意义。

结果

该研究未发现雷诺嗪组和曲美他嗪组的HbA1c水平有任何变化。服用雷诺嗪的患者报告的不良反应包括心绞痛、便秘、体位性低血压、头痛、头晕、恶心和虚弱,而服用曲美他嗪的患者抱怨便秘、虚弱、心悸、心绞痛、头晕、恶心、消化不良、头痛、胃部不适、关节疼痛等。

结论

在慢性心绞痛和糖尿病患者中,雷诺嗪500mg每日两次和曲美他嗪35mg每日两次对HbA1c和空腹血糖水平均无影响。

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Evaluation of the glycometabolic effects of ranolazine in patients with and without diabetes mellitus in the MERLIN-TIMI 36 randomized controlled trial.在MERLIN-TIMI 36随机对照试验中对雷诺嗪在糖尿病患者和非糖尿病患者中的糖代谢效应进行评估。
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