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多中心前瞻性观察研究西格列汀,一种选择性二肽基肽酶-4 抑制剂,在血糖控制不佳的 2 型糖尿病患者中的应用:关注血糖控制、降压作用和安全性——日本九州地区抗糖尿病试验-西格列汀(CHAT-T)。

Multicenter prospective observational study of teneligliptin, a selective dipeptidyl peptidase-4 inhibitor, in patients with poorly controlled type 2 diabetes: Focus on glycemic control, hypotensive effect, and safety Chikushi Anti-Diabetes Mellitus Trial-Teneligliptin (CHAT-T).

机构信息

Department of Cardiovascular Diseases, Fukuoka University Chikushi Hospital, Chikushino, Japan.

Department of Endocrinology and Diabetes Mellitus, Fukuoka University Chikushi Hospital, Chikushino, Japan.

出版信息

Clin Exp Hypertens. 2020;42(3):197-204. doi: 10.1080/10641963.2019.1601207. Epub 2019 Apr 11.

Abstract

: We purpose to confirm the effect of teneligliptin (Tenelia), a selective dipeptidyl peptidase-4 (DPP-4) inhibitor, on glycemic control and non-glucose risk factors for macroangiopathy, including blood pressure, lipid metabolism, and body weight.: In a prospective, multicenter, open-label, observational study, teneligliptin (20 mg/day) was administered to type 2 diabetic patients with poor glycemic control (HbA1c ≥ 6.5% to <10%) at our hospitals. The safety of teneligliptin and its impact on blood glucose, blood pressure, and the lipid profile were assessed after administration for 3 and 6 months.: One hundred and sixty-two patients were enrolled between February 2014 and August 2015. HbA1c was 7.6% at baseline and showed significant reduction to 7.1% after 3 months of treatment and to 6.9% after 6 months (both p < 0.01). Patients with poorly controlled hypertension (systolic blood pressure [SBP] ≥130 mmHg and/or diastolic blood pressure [DBP] ≥80 mmHg) at study initiation were extracted to investigate the effect of teneligliptin on blood pressure. SBP showed a significant decrease from 141.2 ± 9.8 mmHg at baseline to 131.1 ± 14.3 mmHg after 3 months and 133.9 ± 11.5 mmHg after 6 months (both p < 0.001). DBP also decreased significantly from 85.8 ± 5.7 mmHg at baseline to 78.4 ± 10.0 mmHg after 3 months and 79.7 ± 10.1 mmHg after 6 months (both p < 0.001). Adverse events were pruritus in four patients, and cerebral infarction was reported as a cerebrovascular event in one patient.: Teneligliptin therapy was safe and improved glycemic control irrespective of baseline HbA1c. Blood pressure was also improved in patients with concomitant hypertension.

摘要

我们旨在确认替格列汀(Tenelia),一种选择性二肽基肽酶-4(DPP-4)抑制剂,对血糖控制和大血管病变的非葡萄糖危险因素的影响,包括血压、脂代谢和体重。在我们医院,20 毫克/天的替格列汀用于血糖控制不佳(HbA1c≥6.5%至<10%)的 2 型糖尿病患者,进行了一项前瞻性、多中心、开放标签、观察性研究。在给药后 3 个月和 6 个月,评估了替格列汀的安全性及其对血糖、血压和血脂谱的影响。2014 年 2 月至 2015 年 8 月期间共纳入 162 例患者。基线时 HbA1c 为 7.6%,治疗 3 个月后显著降至 7.1%,6 个月后降至 6.9%(均 p<0.01)。从研究开始时血压控制不佳(收缩压[SBP]≥130mmHg 和/或舒张压[DBP]≥80mmHg)的患者中提取出来,以研究替格列汀对血压的影响。SBP 从基线时的 141.2±9.8mmHg 显著下降至 3 个月时的 131.1±14.3mmHg 和 6 个月时的 133.9±11.5mmHg(均 p<0.001)。DBP 也从基线时的 85.8±5.7mmHg 显著下降至 3 个月时的 78.4±10.0mmHg 和 6 个月时的 79.7±10.1mmHg(均 p<0.001)。不良事件为 4 例患者出现瘙痒,1 例患者报告发生脑血管事件。替格列汀治疗安全,改善了血糖控制,无论基线 HbA1c 如何。同时患有高血压的患者血压也得到改善。

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