Purpose: Because of the developing theoretical basis that diabetes mellitus (DM) and its complications may provoke important alterations of pharmacokinetics (PK) and pharmacodynamics (PD) of cardiovascular drugs [Diabetes Care 1999;22:982-8], we investigated the comparative PK and PD of amlodipine in hypertensive subjects with and without Type II DM. Methods: Design: Placebo wash-out, titration, and maintenance. Patients: 18 hypertensive patients with Type II DM and 10 nondiabetic hypertensive patients. AUC, Cmax, and Tmax were determined for amlodipine. Acute 24-hour PD response: blood pressure (BP) and telemetric heart rate (THR). Results: There were no significant differences between hypertensive subjects with and without DM for either amlodipine 5 or 10 mg in AUC (p=0.40 for 5 mg; p=0.59 for 10 mg), Cmax (p=0.41 for 5 mg; p=0.45 for 10 mg) and Tmax (p=0.79 for 5 mg; p=0.67 for 10 mg). The 24-hour BP and THR did not differ between diabetic and nondiabetic subjects. Conclusion: Our study provides a comprehensive data base clearly demonstrating that the diabetic milieu did not alter the pharmacokinetics or pharmacodynamics of amlodipine.
|Original language||English (US)|
|Journal||Clinical Pharmacology and Therapeutics|
|State||Published - Dec 1 2001|
ASJC Scopus subject areas
- Pharmacology (medical)