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Tegaserod Pharmacokinetics Are Similar in Patients with Severe Renal Insufficiency and in Healthy Subjects

From the Department of Clinical Pharmacology, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, (Dr. Zhou, Dr. Horowitz, Dr. McLeod, Dr. Alladina); Department of Drug Metabolism and Pharmacokinetics, Novartis Pharma Ltd., Rueil-Malmaison, France (Dr. Hubert); Department of Clinical Pharmacology, Novartis Pharma AG, Basel, Switzerland (Dr. Appel-Dingemanse); Department of Biostatistics, Novartis Pharma AG, Basel, Switzerland (Mr. Osborne); and Hennepin County Medical Center and Total Renal Research, Inc., Minneapolis, Minnesota (Dr. Lambrecht, Dr. Swan).

Tegaserod (HTF 919), a selective 5-HT₄ receptor partial agonist with promotile activity throughout the gastrointestinal tract, is in development for the treatment of irritable bowel syndrome. In an open-label, parallel-group study, the pharmacokinetics of a single 12-mg oral dose of tegaserod in patients with severe renal insufficiency requiring hemodialysis were compared with data obtained from healthy subjects matched for age, weight, height, and gender (n = 10, both). The pharmacokinetics of tegaserod were similar in both groups (AUC_(0h-tz), ng•h/ml: 14.6 ± 8.5 vs. 14.3 ± 7.1; C_max, ng/ml: 4.6 ± 2.3 vs. 5.1 ± 2.2; t_max, h: 1.0, for both). Tegaserod had similar tolerability in renally impaired patients and healthy volunteers, with adverse events largely related to the gastrointestinal pharmacological actions of the drug. Therefore, no dose adjustment of tegaserod is necessary for patients with renal insufficiency.

Key Words: Pharmacokinetics • pharmacodynamics • tegaserod • GI disorders • renal insufficiency

Address for reprints: James F. McLeod, MD, Department of Clinical Pharmacology, Novartis Pharmaceutical Corporation, 59 Route 10, East Hanover, NJ 07936-1080.

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