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


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


METHODS
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.


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.


METHODS
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.


CONCLUSIONS
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.
Assistant Professor, Department of Clinical Pharmacology, JIPMER , Puducherry, India .
Selvarajan
S
Sandhiya
Professor, Department of Pharmacology, JIPMER , Puducherry, India .
Steven Aibor
SA
Dkhar
Associate Professor, Department of Cardiology, JIPMER , Puducherry, India .
Ajith Ananthakrishna
AA
Pillai
Assistant Professor, Cardiac Clinical Trials, Department of Cardiology, SRM Medical College Hospital & Research Centre , Kattankulathur, Chennai, India .
Melvin
M
George
Professor, Department of Cardiology, JIPMER , Puducherry, India .
Balachander
B
Jayaraman
Senior Professor & Head, Department of Clinical Pharmacology, JIPMER , Puducherry, India .
Adithan
A
Chandrasekaran
Glycemic status; HbA1c; QTc; Ranolazine; Trimetazidine