Dulaglutide Safety in Older Diabetic Patients

May 31, 2016

Researchers compared the safety and efficacy of a GLP-1 receptor agonist in patients aged 65 years or older to those under 65 years.

Use of the glucagon-like peptide (GLP)-1 receptor agonist dulaglutide in patients aged 65 years or older resulted in similar efficacy and safety as it did in patients younger than 65, according to the results of a pooled analysis published in Diabetes, Obesity and Metabolism.

“Given the increasing prevalence of type 2 diabetes in older adults, continued evaluation of diabetes medications for efficacy and safety in this population are necessary,” wrote researcher Malaz A. Boustani, MD, MPH, of Indiana University, and colleagues. “The results of this analysis show that treatment with both dulaglutide doses improves glycemic control, decreases body weight (or results in less weight gain), has a low risk of hypoglycemia, and similar incidence of gastrointestinal adverse events in patients ≥65 years of age and those <65 years of age and can be considered a safe and effective treatment option for use in older adults.”

According to the study, patients with diabetes aged older than 65 present a more challenging patient population because of the presence of comorbidities such as renal impairment, neuropathy, and cognitive dysfunction, and challenges using insulin therapy related to poor vision, arthritis, or cognitive dysfunction. In contrast, dulaglutide is administered in a single use pen.

In this study, Boustani and colleagues pooled data from six phase III AWARD studies of dulaglutide 1.5 mg and 0.75 mg and compared outcomes among patients aged 65 and older and those aged younger than 65. Among the study populations, 958 (15.7%) patients were 65 or older.

At the end of the 26-week study periods there was a similar decrease in HbA1c among both ages groups for both the 1.5-mg dose (≥65: -1.24 vs. <65: -1.29) and the 0.75-mg dose (≥65: -1.16 vs. <65: -1.10). 

“The current standards for treating type 2 diabetes recommend an HbA1c of <7% for healthy adults, but less stringent goals, such as <8-9%, are recommended for those with limited life expectancy and/or comorbid illness,” the researchers wrote. In this analysis, a similar percentage of patients in both age groups were able to achieve goal HbA1c targets:

• <7%:

♦ 1.5 mg: ≥65: 67.8% vs. <65: 65.4%

♦ 0.75 mg: ≥65: 64.0% vs. <65: 58.7%

• <8%:

♦ 1.5 mg: ≥65: 89.4% vs. <65: 87.3%

♦ 0.75 mg: ≥65: 87.4% vs. <65: 84.4%

• <9%:

♦ 1.5 mg: ≥65: 96.0% vs. <65: 96.2%

♦ 0.75 mg: ≥65: 96.8% vs. <65: 94.7%

“From a safety perspective, the incidences of documented symptomatic, asymptomatic, and nocturnal hypoglycemic (PG ≤3.9 mmol/L) events were similar across age groups, and were low when patients were not on concomitant sulfonylurea or insulin therapy,” the researchers wrote.

Similar rates of gastrointestinal adverse events were seen among patients in both age groups and severe hypoglycemia was infrequent.

This study was funded by Eli Lilly and Company.

Boustani MA, et al. Comparable efficacy and safety of once weekly dulaglutide in patients with type 2 diabetes ≥65 and <65 years of age. Diabetes Obes Metab. Epub 2016 May 10.