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Data From Post-Hoc Analyses Presented at EASD Examine Safety Profile of Linagliptin in Adults with Type 2 Diabetes
Date:9/24/2013

tes, as different populations often may have drug contraindications and require dose adjustments to help manage their disease," said Prof. Nikolaus Marx, Professor of Medicine and Cardiology, University Hospital of Aachen, Germany. "The results presented today examine the safety profile of linagliptin."

Renal safety data in the elderly 
Results from another post-hoc analysis2 evaluated pooled data from seven randomized, placebo-controlled phase III clinical trials including 1,293 adults with T2D who were 65 years or older showed:

  • Overall renal function, as assessed by estimated glomerular filtration rate (eGFR), was not significantly altered by treatment with linagliptin from baseline to week 24, compared with placebo (adjusted mean ± SE eGFR of −1.8 ± 0.7 mL/min for linagliptin vs. −1.1 ± 0.9 mL/min for placebo). The majority of patients in the linagliptin group had mild renal impairment with similar proportions of mild, moderate and severe renal impairment found in the placebo group.
  • Renal and urinary AEs were experienced by 5.5 percent and 4.3 percent of linagliptin and placebo patients, respectively
  • Incidence of investigator-defined hypoglycemia was lower in patients who received linagliptin compared with placebo (21.3 percent versus 24.7 percent), with most events occurring in trials that included a sulfonylurea or basal insulin as background therapy
  • Acute renal failure occurred in 0.5 percent and 0.2 percent of linagliptin and placebo patients, respectively

"The results from these pooled analyses continued to demonstrate that linagliptin is a treatment option for a wide range of adults with type 2 diabetes, including the elderly and those with renal impairment," said Christophe Arbet-Engels, MD, PhD, vice president, metabol
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SOURCE Eli Lilly and Company; Boehringer Ingelheim
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