Safety and Efficacy of Linagliptin in Elderly Patients (≥65 years) with Type 2 Diabetes (T2D)

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SUN 839-872-Diabetes & Obesity Management
Clinical
Sunday, June 16, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SUN-855
Sanjay Patel1, Guntram Schernthaner2, Anthony Barnett3, Angela Emser4, Maximilian von Eynatten*5 and Hans-Juergen Woerle4
1Boehringer Ingelheim, Bracknell, United Kingdom, 2Rudolfstiftung Hospital, Vienna, Austria, 3University of Birmingham and Heart of England NHS Foundation Trust, Birmingham, United Kingdom, 4Boehringer Ingelheim, Ingelheim, Germany, 5Boehringer Ingelheim, Ridgefield, CT
Objective:Treating T2D in the elderly can be complicated by associated co-morbidities and high risk of treatment-related issues, including hypoglycemia and gastrointestinal (GI) side-effects. Using pooled Phase 3 trial data, we assessed safety and efficacy of linagliptin in these patients.

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.

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

Sources of Research Support: This study was sponsored by Boehringer Ingelheim