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Ertugliflozin safe, effective in older adults with type 2 diabetes
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SAN FRANCISCO — Adults with type 2 diabetes aged at least 65 years assigned the SGLT2 inhibitor ertugliflozin for at least 26 weeks experienced an improvement in glycemic control, body weight and systolic blood pressure that was similar to younger adults assigned the drug, according to an analysis of seven randomized controlled trials presented during the American Diabetes Association Scientific Sessions.
“This type of research is important, as a large fraction of the patients with type 2 diabetes are elderly, yet we have very little clinical trial data to support the use of newer antihyperglycemic medications in this population,” Richard E. Pratley, MD, the Samuel E. Crockett chair in diabetes research and medical director of AdventHealth Diabetes Institute, told Endocrine Today. “The pooled analysis across multiple phase 3 trials that we performed allows us to examine the efficacy and safety of ertugliflozin in a substantial number of elderly subjects. Overall, the efficacy was comparable to what was seen in the younger population and the safety analysis did not reveal any unexpected signals.”
Pratley and colleagues analyzed data from participants from seven randomized, double-blind, phase 3 studies who received 5 mg or 15 mg ertugliflozin (Steglatro, Merck) plus sitagliptin (Januvia, Merck), or placebo or non-ertugliflozin therapy (glimepiride or sitagliptin) for up to 104 weeks, including a study of patients with moderate renal impairment. A subset of three placebo-controlled studies comprised the placebo pool, which included participants assigned 5 mg or 15 mg ertugliflozin or placebo for at least 26 weeks. The broad pool included 3,605 patients younger than 65 years and 1,354 patients aged at least 65 years. The placebo pool included 1,189 patients younger than 65 years and 355 patients aged at least 65 years.
At week 26, researchers found that ertugliflozin was associated with reductions from baseline in HbA1c for adults aged at least 65 years assigned the 5-mg (least squares [LS] mean change, –0.6; 95% CI, –0.8 to –0.4) and 15-mg doses (LS mean change, –0.8; 95% CI, –1 to –0.6). Older adults assigned ertugliflozin also experienced reductions from baseline levels of fasting plasma glucose at the 5-mg (LS mean change, –27 mg/dL; 95% CI, –35.2 to –18.8) and 15-mg dose (LS mean change, –34.9 mg/dL; 95% CI, –42.9 to –26.8) when compared with patients assigned placebo, according to researchers.
Greater reductions from baseline in body weight were observed with ertugliflozin compared with placebo in both patient subgroups. In both age categories, ertugliflozin was associated with greater reductions from baseline in systolic BP relative to placebo, the researchers wrote.
Older patients experienced more adverse events vs. patients younger than 65 years; however, there was no between-group difference when comparing ertugliflozin vs. non-ertugliflozin-treated patients in either age category, according to researchers.
Pratley noted that older patients assigned ertugliflozin experienced a higher incidence of volume depletion adverse events when compared with non-ertugliflozin-treated patients.
Researchers also observed a slight increase in the incidence of renal-related adverse events in older patients assigned ertugliflozin vs. those assigned non-ertugliflozin; however, the difference did not persist after excluding patients with an estimated glomerular filtration rate less than 60 mL/min/1.73 m² at baseline.
“Importantly, elderly patients appear to be at a slightly higher risk of volume depletion-related adverse events, a finding that has been seen with other SGLT2 inhibitors,” Pratley said. “We can conclude that ertugliflozin can be used to improve glucose control safely in patients with type 2 diabetes who are older, providing the guidance on renal function and volume is followed.” – by Regina Schaffer
Reference:
Pratley R, et al. 1210-P. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, 2019; San Francisco.
Disclosures: Merck and Pfizer funded this study. Pratley reports he has received grants, speaking and consultant fees paid to his institution from AstraZeneca, Boehringer Ingelheim, Eisai, Eli Lilly, GlaxoSmithKline, Glytec, Janssen, Lexicon, Ligand Pharmaceuticals, Merck, Mundipharma, Novo Nordisk, Pfizer, Sanofi and Takeda. Please see the study for all other authors’ relevant financial disclosures.