Efficacy and Safety of Once-Weekly Dulaglutide in Elderly Chinese Patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN Studies

Abstract

Introduction: This analysis evaluated the efficacy and safety of dulaglutide in Chinese patients with type 2 diabetes (T2D) aged C 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 Digital Features To view digital features for this article go to

Pancreatic Safety of Once-Weekly Dulaglutide in Chinese Patients with Type 2 Diabetes Mellitus: Subgroup Analysis by Potential Influencing Factors

“…However, the safety outcomes reported by these prior studies mainly included hypoglycemia and gastrointestinal adverse events, and there are limited data on the pancreatic safety of GLP-1 RAs in elderly patients. The present study addresses this knowledge gap and provides evidence that the pancreatic safety profile of dulaglutide is similar in Chinese patients with T2DM aged \ 60 and C 60 years and, together with previous reports, suggests dulaglutide is a safe and effective treatment option for elderly patients with T2DM [34,35]. The results of this analysis also showed no association between patient sex and pancreatic safety of dulaglutide.…”

“…In addition, an appreciable increase in the incidence of, and risk of mortality from, acute pancreatitis has been observed among elderly [33]. Previous studies have shown that the efficacy and safety of dulaglutide is similar across patient age groups [34,35]. Furthermore, liraglutide and exenatide have been shown to be well tolerated regardless of patient age [36,37].…”

Efficacy and safety of dulaglutide 3.0 and 4.5 mg in patients aged younger than 65 and 65 years or older: Post hoc analysis of the AWARD‐11 trial

“…Discontinuations of study drug as a result of any AE or specifically because of nausea, vomiting or diarrhoea were not significantly different among older versus younger patients, further supporting the conclusion that overall and GI tolerability of dulaglutide across the dose range studied in AWARD‐11 are similar between age groups, consistent with prior studies with lower doses of dulaglutide. 9 , 12 The dulaglutide safety profile related to SAEs was also comparable between age groups across all doses. The incidence of SAEs was not dose‐related in either age subgroup.…”

“…The incidence of total (including severe) hypoglycaemia and documented symptomatic hypoglycaemia was low, with no significant evidence of a differential treatment effect between age groups, consistent with prior studies with lower doses of dulaglutide. 9 , 12 These results are particularly reassuring in the treatment of elderly patients with T2D because of their increased risk of hypoglycaemia and complications associated with hypoglycaemia, including falls, fractures, depression, cardiac arrhythmias and other cardiac events, cognitive impairment, dementia, and an overall reduced quality of life. 27 , 28 …”

“…The safety profile for the additional dulaglutide doses was consistent with that of dulaglutide 1.5 mg and similar between age subgroups. These results were in line with the findings of previous published studies that showed similar glycaemic and BW effects and safety profiles irrespective of baseline age when treated with dulaglutide doses of 0.75 and 1.5 mg. 9 , 12 These additional dulaglutide doses may benefit elderly patients who are not achieving glycaemic targets on a lower dulaglutide dose, as they can remain on their current therapy with familiar administration and tolerability experience.…”