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Pharmacokinetics, Safety, and Tolerability After Single and Multiple Oral Doses of Varenicline in Elderly Smokers

From the Departments of Medical and Developmental Sciences (Dr Burstein, Dr Fullerton, Dr Clark, Dr Faessel), and Clinical Pharmacokinetics and Pharmacodynamics (Dr Faessel), Pfizer Global Research and Development, Groton, Connecticut. This study was funded by Pfizer Inc. Aaron H. Burstein, Terence Fullerton, David J. Clark, and Hélène M. Faessel are employees of Pfizer Global Research and Development.

Varenicline is a novel selective 4ß2 nicotinic acetylcholine partial agonist developed for smoking cessation. This study investigated the single- and multiple-dose pharmacokinetics, safety, and tolerability of varenicline in elderly ( 65 years) smokers. Twenty-four elderly smokers with normal renal function for their age (estimated creatinine clearance 70 mL/min) received varenicline 1 mg once daily (n = 8) or placebo (n = 4) for 7 days, or 1 mg twice daily (n = 8) or placebo (n = 4) for 6 days with a single dose on day 7 in a double-blind, parallel group and placebo-controlled design. There was no evidence of concentration- or time-dependent changes in varenicline pharmacokinetics upon repeat dosing. Once- and twice-daily dosing was associated with an approximate 2-fold and 3-fold increase, respectively, in systemic exposure to varenicline. Varenicline was well tolerated; all adverse events reported were mild to moderate in intensity. Thus, no dose adjustment is necessary based on age alone.

Key Words: Varenicline • elderly • single- and multiple-dose pharmacokinetics

Address for reprints: Aaron H. Burstein, PharmD, Pfizer Global R&D, Groton/New London Labs, Eastern Point Road, MS8260-2505, Groton, CT 06340.

This article has been cited by other articles:

				A. H. Burstein, D. J. Clark, M. O'Gorman, S. A. Willavize, T. G. Brayman, G. S. Grover, R. L. Walsky, R. S. Obach, and H. M. Faessel Lack of Pharmacokinetic and Pharmacodynamic Interactions Between a Smoking Cessation Therapy, Varenicline, and Warfarin: An In Vivo and In Vitro Study J. Clin. Pharmacol., November 1, 2007; 47(11): 1421 - 1429. [Abstract] [Full Text] [PDF]