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Vildagliptin, a Novel Dipeptidyl Peptidase IV Inhibitor, Has No Pharmacokinetic Interactions With the Antihypertensive Agents Amlodipine, Valsartan, and Ramipril in Healthy Subjects

From Novartis Institutes for Biomedical Research, Cambridge, Massachusetts (Dr He, Dr WP Dole); Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (Dr Ligueros-Saylan, Dr Sunkara, Mr Sabo, Dr Zhao, Dr Wang, Dr K Dole, Dr Howard); Novartis Pharma S.A., Rueil-Malmaison, France (Dr Campestrini, Dr Pommier); and MDS Pharma Services, Lincoln, Nebraska (Dr Marion).

We conducted 3 open-label, multiple-dose, 3-period, randomized, crossover studies in healthy subjects to assess the potential pharmacokinetic interaction between vildagliptin, a novel dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes, and representatives of 3 commonly prescribed antihypertensive drug classes: (1) the calcium channel blocker, amlodipine; (2) the angiotensin receptor blocker, valsartan; and (3) the angiotensin-converting enzyme inhibitor, ramipril. Coadministration of vildagliptin 100 mg with amlodipine 5 mg, valsartan 320 mg, or ramipril 5 mg had no clinically significant effect on the pharmacokinetics of these drugs. The 90% confidence intervals of the geometric mean ratios for area under the plasma concentration–time curve from time zero to 24 hours (AUC_0-24h) and maximum plasma concentration (C_max) for vildagliptin, amlodipine, and ramipril (and its active metabolite, ramiprilat) were contained within the acceptance range for bioequivalence (0.80-1.25). Valsartan AUC_0-24h and C_max increased by 24% and 14%, respectively, following coadministration of vildagliptin, but this was not considered clinically significant. Vildagliptin was generally well tolerated when given alone or in combination with amlodipine, valsartan, or ramipril in healthy subjects at steady state. No adjustment in dosage based on pharmacokinetic considerations is required should vildagliptin be coadministered with amlodipine, valsartan, or ramipril in patients with type 2 diabetes and hypertension.

Key Words: Dipeptidyl peptidase IV inhibitor • angiotensin converting enzyme inhibitor • angiotensin receptor blocker • calcium channel blocker • pharmacokinetics • type 2 diabetes • vildagliptin

Address for reprints: Yan-Ling He, PhD, Exploratory Development-DMPK, Novartis Institutes for Biomedical Research, 400 Technology Square, Building 605, Cambridge, MA 02139-3584.

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