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DRUG INTERACTIONS

Pharmacokinetics of Oral Doses of Telmisartan and Nisoldipine, Given Alone and in Combination, in Patients With Essential Hypertension

Milica Bajcetic*, Ralf A. Benndorf*, Daniel Appel, Edzard Schwedhelm, Friedrich Schulze, Daniel Riekhof, Renke Maas and Rainer H. Böger

From the Clinical Pharmacology Unit, Institute of Experimental and Clinical Toxicology and Pharmacology, University Hospital Hamburg-Eppendorf, Germany (Bajcetic, Benndorf, Appel, Schwedhelm, Schulze, Riekhof, Maas, Böger) and the Department of Pharmacology, Clinical Pharmacology and Toxicology, School of Medicine, University of Belgrade, Serbia and Montenegro (Bajcetic).

This randomized, single-blind, parallel-group study was performed to assess pharmacokinetic interactions potentially occurring during concomitant use of telmisartan and nisoldipine. Patients with essential hypertension (n = 37) were treated with once-daily doses of telmisartan, nisoldipine, or their combination for 6 weeks. The regimen was started at low dose with an increase of dosage after 3 weeks of treatment. AUCss (132%; P < .01) of telmisartan applied in doses of 80 mg was significantly higher after concomitant application with nisoldipine (10 mg), whereas CL/fss (-54%; P < .05) and Vz/fss (-72%; P < .05) were significantly lower. Regarding pharmacokinetic parameters of nisoldipine, significant differences between treatment groups were not detected. In conclusion, the results of this study strongly suggest that concomitant treatment with nisoldipine enhances telmisartan bioavailability in hypertensive individuals. Larger crossover trials will have to establish these observations and investigate whether interaction of both drugs affects telmisartan efficacy and tolerability in clinical use.

Key Words: telmisartan • nisoldipine • hypertension • pharmacokinetic • interaction • calcium channel blockers • angiotensin receptor antagonists

Address for reprints: Address for correspondence: Dr Ralf A. Benndorf, Institute of Experimental and Clinical Pharmacology and Toxicology, Clinical Pharmacology Unit, University Hospital Hamburg-Eppendorf, Martinistrasse 521, D-20246 Hamburg; e-mail: benndorf{at}uke.uni-hamburg.de.


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