每周一次度拉糖肽治疗中国老年2型糖尿病患者的疗效和安全性：AWARD-CHN研究的事后分析
Efficacy and Safety of Once-Weekly Dulaglutide in Elderly Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN Studies.
作者信息
Kuang Jian, Zhu Jiankun, Liu Siying, Li Quanmin
机构信息
Department of Endocrinology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.
出版信息
Diabetes Ther. 2020 Oct;11(10):2329-2339. doi: 10.1007/s13300-020-00910-1. Epub 2020 Aug 28.
INTRODUCTION
This analysis evaluated the efficacy and safety of dulaglutide in Chinese patients with type 2 diabetes (T2D) aged ≥ 60 and < 60 years.
METHODS
This post hoc analysis included patients with T2D enrolled in two phase 3 clinical trials AWARD-CHN1 (NCT01644500) and AWARD-CHN2 (NCT01648582) of dulaglutide 0.75 and 1.5 mg. Patients were categorized into two groups (≥ 60 and < 60 years). Efficacy outcomes (change in glycated hemoglobin [HbA1c], fasting blood glucose [FBG], and weight; percentage of patients achieving HbA1c target [< 7.0%]) and safety outcomes (incidence of hypoglycemia and gastrointestinal treatment-emergent adverse events [GI TEAEs]) at 26 weeks were evaluated for each age group in both trials.
RESULTS
A total of 766 patients (≥ 60 years, n = 222; < 60 years, n = 544) were included in the study. A similar reduction of HbA1c was observed in both age groups: AWARD-CHN1, 1.5 mg (least squares mean [LSM] 95% confidence interval [CI] ≥ 60 years: - 1.45% [- 1.69, - 1.21%] and < 60 years: - 1.43% [- 1.59, - 1.28%]) and 0.75 mg (≥ 60 years: - 1.29% [- 1.53, - 1.05%] and < 60 years: - 1.18% [- 1.33, - 1.03%]); AWARD-CHN2, 1.5 mg (≥ 60 years: - 1.60% [- 1.83, - 1.36%] and < 60 years: - 1.64% [- 1.80, - 1.49%]) and 0.75 mg (≥ 60 years: - 1.31% [- 1.55, - 1.08%] and < 60 years: - 1.33% [- 1.48, - 1.17%]). Dulaglutide showed a reduction in HbA1c as early as 4 weeks after initiation of treatment, which was maintained over 26 weeks in both age groups. The percentage of patients achieving HbA1c target < 7.0% at 26 weeks was also similar in both age groups. Incidence of hypoglycemia and GI TEAEs was low in each age group.
CONCLUSION
Treatment with once-weekly dulaglutide improved glycemic control in patients with T2D aged ≥ 60 years and < 60 years and was well tolerated in older patients, suggesting it can be considered a safe and effective treatment option for use in older patients with T2D.
TRIAL REGISTRATION
AWARD-CHN1 (NCT01644500) and AWARD-CHN2 (NCT01648582).
引言
本分析评估了度拉糖肽在≥60岁和<60岁的中国2型糖尿病（T2D）患者中的疗效和安全性。
方法
这项事后分析纳入了参加两项度拉糖肽0.75毫克和1.5毫克的3期临床试验AWARD-CHN1（NCT01644500）和AWARD-CHN2（NCT01648582）的T2D患者。患者被分为两组（≥60岁和<60岁）。对两项试验中每个年龄组在26周时的疗效结果（糖化血红蛋白[HbA1c]、空腹血糖[FBG]和体重变化；达到HbA1c目标[<7.0%]的患者百分比）和安全性结果（低血糖发生率和胃肠道治疗中出现的不良事件[GI TEAEs]）进行了评估。
结果
该研究共纳入766例患者（≥60岁，n = 222；<60岁，n = 544）。两个年龄组的HbA1c均有类似程度的降低：AWARD-CHN1，1.5毫克组（最小二乘均值[LSM] 95%置信区间[CI]≥60岁：-1.45%[-1.69，-1.21%]，<60岁：-1.43%[-1.59，-1.28%]）和0.75毫克组（≥60岁：-1.29%[-1.53，-1.05%]，<60岁：-1.18%[-1.33，-1.03%]）；AWARD-CHN2，1.5毫克组（≥60岁：-1.60%[-1.83，-1.36%]，<60岁：-1.64%[-1.80，-1.49%]）和0.75毫克组（≥60岁：-1.31%[-1.55，-1.08%]，<60岁：-1.33%[-1.48，-1.17%]）。度拉糖肽在治疗开始后4周时就显示出HbA1c降低，且在两个年龄组中均维持了26周。两个年龄组在26周时达到HbA1c目标<7.0%的患者百分比也相似。每个年龄组的低血糖和胃肠道治疗中出现的不良事件发生率都很低。
结论
每周一次使用度拉糖肽治疗可改善≥60岁和<60岁的T2D患者的血糖控制，且老年患者耐受性良好，这表明它可被视为老年T2D患者安全有效的治疗选择。
试验注册
AWARD-CHN1（NCT01644500）和AWARD-CHN2（NCT01648582）。
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