在近东国家，地特胰岛素联合口服抗糖尿病药物可改善 2 型糖尿病患者的血糖控制：来自黎巴嫩亚组的结果。

Insulin Detemir in Combination with Oral Antidiabetic Drugs Improves Glycemic Control in Persons with Type 2 Diabetes in Near East Countries: Results from the Lebanese Subgroup.

机构信息

Division of Endocrinology, Rafic Hariri University Hospital, Beer Hassan, Beirut, Lebanon.

Division of Endocrinology, Notre Dame de Secours Hospital, Byblos, Lebanon.

出版信息

Ethn Dis. 2017 Jan 19;27(1):45-54. doi: 10.18865/ed.27.1.45.

DOI:10.18865/ed.27.1.45

PMID:28115821

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5245608/

Abstract

OBJECTIVE

To evaluate the effectiveness and safety of insulin detemir treatment as add-on therapy in a real-world setting of Lebanese insulin naïve persons, with type 2 diabetes poorly controlled on oral antidiabetic drugs (OADs).

METHODS

Our study was a prospective, observational study representing the Lebanese arm of the multinational prospective and observational study involving 2,155 persons across Near East countries, Lebanon, Pakistan, Israel and Jordan. Effectiveness endpoints were changes in HbA1c, fasting and post-prandial glucose (FPG, PPG) after 24 weeks of treatment with insulin detemir in eligible persons. Safety endpoints were number of hypoglycemic events, incidence of adverse drug reactions (ADRs), serious ADRs, adverse events, and body weight change between baseline and end of treatment.

RESULTS

868 persons were included (mean age: 59.5 ± 10.4 years, men: 55.3%). Glycemic control improved with significant reduction in mean HbA1c from 9.7 ± 1.6% to 7.2 ± 1% (P<.0001). The percentage of persons who achieved the target of HbA1c<7% increased from .7% at baseline to 39% at week 24. Mean FPG decreased significantly from 213.7 ± 60.1 mg/dL to 120.3 ± 25.7 mg/dL (P<.001), and mean PPG from 271 ± 65.3 mg/dL to 158.1 ± 36.4 mg/dL (P<.0001). The rate of major hypoglycemic episodes decreased from .1498 at baseline to .0448 at week 24. Three adverse events but no ADR or serious ADR were reported. Body weight decreased from 80.4±13.2 Kg to 79.9±12.5 Kg (P<.0001).

CONCLUSIONS

Initiating insulin detemir in a clinical health care setting among Lebanese with type 2 diabetes mellitus on OADs improves glycemic control with no increase in hypoglycemia, adverse events or weight compared with baseline.

摘要

目的

评估在以口服降糖药（OAD）治疗的 2 型糖尿病患者中，作为附加疗法使用德谷胰岛素的有效性和安全性，这些患者来自真实的黎巴嫩环境，此前未使用过胰岛素。

方法

我们的研究是一项前瞻性、观察性研究，代表了涉及近东国家（黎巴嫩、巴基斯坦、以色列和约旦）的 2155 人的多国前瞻性和观察性研究的黎巴嫩部分。在符合条件的人群中，经过 24 周德谷胰岛素治疗后，有效性终点为 HbA1c、空腹和餐后血糖（FPG、PPG）的变化。安全性终点为低血糖事件、药物不良反应（ADR）发生率、严重 ADR、不良事件以及治疗前后体重变化的数量。

结果

共纳入 868 人（平均年龄：59.5 ± 10.4 岁，男性：55.3%）。血糖控制得到改善，平均 HbA1c 从 9.7 ± 1.6%显著降低至 7.2 ± 1%（P<.0001）。达到 HbA1c<7%目标的患者比例从基线时的 0.7%增加至 24 周时的 39%。FPG 均值从 213.7 ± 60.1 mg/dL 显著降低至 120.3 ± 25.7 mg/dL（P<.001），PPG 均值从 271 ± 65.3 mg/dL 降低至 158.1 ± 36.4 mg/dL（P<.0001）。严重低血糖事件的发生率从基线时的 0.1498 降至 24 周时的 0.0448。报告了 3 起不良事件，但无 ADR 或严重 ADR。体重从 80.4±13.2 Kg 降至 79.9±12.5 Kg（P<.0001）。