Abstract

Objective: The kidney plays a key role in both the metabolism and excretion of vildagliptin. This study was designed to investigate the effects of varying degrees of renal impairment (RI) on the pharmacokinetics of vildagliptin. Methods: A total of 96 subjects were enrolled, and each subject received vildagliptin 50 mg dosed orally once daily for 14 days. Vildagliptin and metabolite concentrations in plasma and urine were measured on Days 1 and 14. Results: Compared to age-, gender-, BMI-matched subjects with normal renal function, the mean AUC of vildagliptin after 14 days in patients with mild, moderate, and severe RI increased by 40%, 71%, and 100%, respectively, and the C_max of vildagliptin showed similar and minimal increases of 37%, 32% and 36%, respectively. Conclusions: These pharmacokinetics results suggest that 50 mg once daily is an appropriate dose and recommended for patients with moderate and severe renal impairment.

Author Details

Authors

• Yan-Ling He¹
• Kenneth Kulmatycki¹
• Yiming Zhang²
• Wei Zhou²
• Christine Reynolds²
• Monica Ligueros-Saylan²
• Ann Taylor¹

Departments

• ¹ Novartis Institutes for BioMedical Research, Cambridge, MA, and
• ² Novartis Pharmaceuticals, East Hanover, NJ, USA

Address

Yan-Ling He, PhD, DMSci
Translational Medicine
Novartis Institutes for BioMedical Research, Inc.
220 Massachusetts Avenue
Cambridge, MA 02139, USA
Email: [email protected]

Citation