Ghosh Sujoy, Tiwaskar Mangesh, Chawla Rajiv, Jaggi Shalini, Asirvatham Arthur, Panikar Vijay
Department of Endocrinology and Metabolism, Institute of Post Graduate Medical Education and Research, Kolkata, India.
Shilpa Medical Research Centre, Mumbai, India.
Diabetes Ther. 2020 Oct;11(10):2257-2268. doi: 10.1007/s13300-020-00880-4. Epub 2020 Aug 11.
Teneligliptin is an antidiabetic medication that has been approved for the management of type 2 diabetes mellitus (T2DM) in Japan, South Korea and India. It is one of the most commonly prescribed antihyperglycaemic agents. The aim of this study was to assess the effectiveness of teneligliptin in improving glycemic control amongst Indian patients with T2DM in a real-world setting.
This was a retrospective observational study in which a predesigned structured proforma was used to collect information from hospital records of 18 medical centres across India. All participating centres were established primary care hospitals with adequate record keeping, a pre-determined condition in the study design. Data were collected during the period of January 2019 to June 2019. Data extracted from patient records, including glycaemic parameters, concomitant drugs, drug dosage and duration, were collated. The effectiveness of teneligliptin was assessed by analyzing the mean change in glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) at 12 weeks after initiation of teneligliptin.
Data from 10,623 patients were available for analysis. The mean age of the enrolled patients was 51.86 ± 11.76 years. At 12 weeks after initiation of teneligliptin as monotherapy or add-on to other medications (combination therapy), the patients showed a signficant decrease from baseline in mean HbA1c, FPG and PPG. Mean HbA1c dropped from 8.66 ± 1.15% at baseline to 7.67 ± 1.28% at 12 weeks (71 ± 12.6 to 60 ± 14 mmol/mol), with a difference of - 0.99% (95% confidence interval [CI] 0.96-1.02) or - 10.8 (95% CI 10.5-11.1) mmol/mol (p < 0.0001). The mean reductions in FPG and PPG were 43.12 mg/dL (2.39 mmol/L) and 87.73 mg/dL (4.87 mmol/L) (both p < 0.0001) respectively. HbA1c (%) reductions with teneligliptin when used as add-on to metformin, add-on to metformin + sulfonylurea combination and add-on to metformin + sulfonylurea + alpha glucosidase inhibitor combination were 0.76% (8.3 mmol/mol), 1.24% (13.6 mmol/mol) and 1.04% (11.4 mmol/mol), respectively. Teneligliptin also significantly reduced HbA1c (1.13% or 12.4 mmol/mol, p < 0.0001) in patients with impaired renal function, without worsening the estimated glomerular filtration rate. Teneligliptin consistently reduced HbA1c across all three age categories tested-by 1% (10.9 mmol/mol) in patients aged < 60 years, by 1.15% (12.6 mmol/mol) in patients aged 60-75 years and by 0.88% (9.6 mmol/mol) in patients aged > 75 years.
Teneligliptin significantly improved glycaemic parameters in Indian patients with T2DM when prescribed either as monotherapy or as an add-on to one or more other commonly prescribed antihyperglycaemic agents.
替奈利肽是一种抗糖尿病药物，已在日本、韩国和印度获批用于治疗2型糖尿病（T2DM）。它是最常用的降血糖药物之一。本研究的目的是评估替奈利肽在真实世界环境中改善印度T2DM患者血糖控制的有效性。
这是一项回顾性观察研究，使用预先设计的结构化表格从印度18个医疗中心的医院记录中收集信息。所有参与中心均为建立了完善记录保存的基层医院，这是研究设计中的一个预先确定的条件。数据收集于2019年1月至2019年6月期间。从患者记录中提取的数据，包括血糖参数、伴随用药、药物剂量和疗程，进行了整理。通过分析替奈利肽开始使用12周后糖化血红蛋白（HbA1c）、空腹血糖（FPG）和餐后血糖（PPG）的平均变化来评估替奈利肽的有效性。
有10623例患者的数据可供分析。入组患者的平均年龄为51.86±11.76岁。在替奈利肽作为单药治疗或添加到其他药物（联合治疗）开始使用12周后，患者的HbA1c、FPG和PPG较基线均有显著下降。平均HbA1c从基线时的8.66±1.15%降至12周时的7.67±1.28%（71±12.6至60±14 mmol/mol），差值为-0.99%（95%置信区间[CI] 0.96 - 1.02）或-10.8（95% CI 10.5 - 11.1）mmol/mol（p < 0.0001）。FPG和PPG的平均降幅分别为43.12 mg/dL（2.39 mmol/L）和87.73 mg/dL（4.87 mmol/L）（均p < 0.0001）。替奈利肽添加到二甲双胍、二甲双胍 + 磺脲类药物联合治疗、二甲双胍 + 磺脲类药物 + α-葡萄糖苷酶抑制剂联合治疗时，HbA1c（%）的降幅分别为0.76%（8.3 mmol/mol）、1.24%（13.6 mmol/mol）和1.04%（11.4 mmol/mol）。替奈利肽在肾功能受损患者中也显著降低了HbA1c（1.13%或12.4 mmol/mol，p < 0.0001），且未使估计肾小球滤过率恶化。在所有测试的三个年龄组中，替奈利肽均持续降低HbA1c——<60岁患者降低1%（10.9 mmol/mol），60 - 75岁患者降低1.15%（12. mmol/mol），>75岁患者降低0.88%（9.6 mmol/mol）。
替奈利肽作为单药治疗或添加到一种或多种其他常用降血糖药物时，能显著改善印度T2DM患者的血糖参数。
