Session: SUN 839-872-Diabetes & Obesity Management
Poster Board SUN-855
Methods: This post-hoc analysis identified all patients ≥65 years from 7 randomized, double-blind, placebo-controlled trials of linagliptin 5mg/day as monotherapy or add-on to various glucose-lowering therapies. All 7 trials were at least 24 weeks; safety and efficacy in this analysis were assessed up to week 24.
Results: Of 1331 patients ≥65 years, 841 patients received linagliptin and 490 placebo. Mean ±SD baseline characteristics were similar in linagliptin and placebo groups: age, 71.1 ±4.5 v 70.9 ±4.7 years; BMI, 29.5 ±5.0 v 30.0 ±4.9 kg/m2; HbA1c, 8.0% ±0.8 v 8.1% ±0.8. Overall, 21% of patients had moderate or severe renal impairment (eGFR <60mL/min), more than 80% had diabetes for >5 years and more than 60% were receiving ≥2 glucose-lowering drugs. Median exposure to linagliptin and placebo was 173.0 and 176.5 days, respectively. The linagliptin group had significantly greater reductions from baseline to week 24 in HbA1c (placebo-adjusted mean change [95% CI]: −0.62% [−0.73, −0.51]; P<0.0001) and fasting plasma glucose (placebo-adjusted mean change [95% CI]: −14.8mg/dL [−20.7, −8.9]; P<0.0001). Adverse events (AEs) occurred in 71.3% and 73.3% of the linagliptin and placebo groups, respectively. Fewer patients receiving linagliptin had drug-related AEs (18.1% v 19.8% with placebo). The incidence of hypoglycemia was slightly lower in patients receiving linagliptin (21.4%) compared with placebo (25.7%), and severe hypoglycemic events requiring assistance were rare in both groups (1.0% and 1.8%, respectively). Reporting of GI AEs was comparable between groups (14.1% and 15.5%, respectively). At least one adjudicated major adverse cardiac event occurred in 0.7% and 1.0% of linagliptin- and placebo-treated patients respectively.
Discussion: In this group of elderly patients with T2D, linagliptin 5 mg/day was associated with significant improvements in measures of hyperglycemia and was well-tolerated with an AE profile similar to placebo.
Conclusion: Elderly patients often have renal impairment and a high hypoglycemia risk; however, linagliptin is well tolerated, efficacious and does not need dose adjustment in this patient group.
Disclosure: SP: Employee, Boehringer Ingelheim. GS: Speaker, Amgen, Speaker, Astra Zeneca, Speaker, Bristol-Myers Squibb, Speaker, Boehringer Ingelheim, Speaker, Eli Lilly & Company, Speaker, GlaxoSmithKline, Speaker, Merck Sharp & Dohme, Speaker, Novartis Pharmaceuticals, Speaker, Novo Nordisk, Speaker, Servier & Takeda, Speaker, Sanofi Aventis. AB: Advisory Group Member, Novo Nordisk, Advisory Group Member, Eli Lilly & Company, Advisory Group Member, Takeda, Advisory Group Member, Astra Zeneca, Advisory Group Member, Bristol-Myers Squibb, Advisory Group Member, Novartis Pharmaceuticals, Advisory Group Member, Merck Sharp & Dohme, Advisory Group Member, Boehringer Ingelheim, Advisory Group Member, Sanofi-Aventis. AE: Employee, Boehringer Ingelheim. MV: Employee, Boehringer Ingelheim. HJW: Employee, Boehringer Ingelheim.
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