Effect of Teneligliptin on QT Interval in Type II Diabetes Mellitus Patients: A Retrospective Evaluation
Journal Title: INTERNATIONAL JOURNAL OF SCIENTIFIC STUDY - Year 2019, Vol 6, Issue 10
Abstract
Background and Aim: According to a strict QT/QTc evaluation study and clinical studies for type 2 diabetes conducted in Japan and other countries, NO AEs related to QT prolongation were detected with 40 mg/day of teneligliptin, which is the maximal dosage used in clinical practice. So far, there are no data regarding the safety of teneligliptin in Indian type 2 diabetic patients with respect to QTc prolongation. Therefore, the study was conducted to evaluate the safety of teneligliptin in type 2 diabetic patients with respect to QT prolongation. Methods: A retrospective data were collected from type 2 diabetes mellitus patients with electrocardiogram (ECG) records who were treated with teneligliptin along with ongoing treatment. Primary endpoint was to compare the change in the ECG at 3 months from the baseline from the collected data. Mean daily dose (MDD) of antidiabetic drugs, HbA1c, fasting plasma glucose (FPG), and postprandial plasma glucose (PPG) was also analyzed. Results: A total of 49 patients’ data were collected and analyzed with a mean age of 55.5 years and mean duration of diabetes 9.3 years. Hypertension was the most common comorbid disease (63.3%) along with diabetes for a mean duration of 10.0 years. Metformin plus glimepiride were the most prescribed dual drugs (63.3%) along with teneligliptin with an overall MDD of metformin (1065.2 mg) and glimepiride (2.1 mg). From the collected data, there was significant reduction in FPG and PPG at 3 months which were 49.6 mg/dL (P < 0.0001) and 100.5 mg/dL (P < 0.0001) reduction observed from the baseline, respectively. Significant changes were observed in the HbA1c from the baseline to 3 months (0.9%, P < 0.0001). There was no significant increase in the mean QTc interval from baseline to 3 months. No serious adverse events or hypoglycemia were reported. Conclusion: Teneligliptin was well tolerated with no significant change in QTc prolongation and significantly effective in reducing the FPG, PPG, and HbA1c at 3 months from the baseline with no adverse events. There was no increase in the mean QT interval.
Authors and Affiliations
S Sengupta, Ameet Rathod, H Barkate, A Pethare
Keywords
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