Original ArticlesSafety and Tolerability of the Rivastigmine Patch: Results of a 28-week Open-label ExtensionGrossberg, George MD*; Sadowsky, Carl MD†; Förstl, Hans MD‡; Frölich, Lutz MD, PhD§; Nagel, Jennifer PhD∥; Tekin, Sibel MD¶; Zechner, Stefanie PhD∥; Ros, Jacqueline PhD∥; Orgogozo, Jean-Marc MD♯Author Information *Department of Neurology and Psychiatry, St. Louis University School of Medicine, St. Louis, MO †Division of Neurology, Nova Southeastern University, Fort Lauderdale, FL ¶Novartis Pharmaceuticals Corp, East Hanover, NJ ‡Clinic of Psychiatry and Psychotherapy, Technical University of Munich, Munich §Division of Geriatric Psychiatry, Central Institute for Mental Health, Ruprecht-Karls-University of Heidelberg, Germany ∥Novartis Pharma AG, Basel, Switzerland ♯Department of Neurology, Université de Bordeaux, CHU Pellegrin and CRI INSERM 897, Bordeaux, France Supported by Novartis Pharma AG, Basel, Switzerland. Alpha-Plus Medical Communications Ltd (UK) provided editorial assistance with the production of the manuscript. Reprints: George T. Grossberg, MD, Department of Neurology and Psychiatry, St Louis University School of Medicine, 1438 South Grand Boulevard, St. Louis, MO 63104 (e-mail: Grossbgt@aol.com). Received for publication December 12, 2007; accepted July 12, 2008 Alzheimer Disease & Associated Disorders: April-June 2009 - Volume 23 - Issue 2 - p 158-164 doi: 10.1097/WAD.0b013e31818b1c2c Buy Metrics Abstract The primary objective of the open-label extension was to evaluate the long-term safety and tolerability of a transdermal rivastigmine patch up to 1 year, as a novel approach to treatment in Alzheimer disease. This was a 28-week extension to a 24-week, double-blind, double-dummy, placebo-controlled, and active-controlled study evaluating rivastigmine patches [9.5 mg/24 h (10 cm2) and 17.4 mg/24 h (20 cm2)] and oral capsules (3 to 6 mg twice-daily). Patients entering the extension were switched directly to 9.5 mg/24 h rivastigmine patch and increased to 17.4 mg/24 h patch, irrespective of their double-blind study treatment. Primary measures included safety and tolerability assessments, including adverse events and serious adverse events. Of 1195 patients randomized to treatment, 870 (72.8%) completed the double-blind study and entered the open-label extension. During weeks 1 to 4 of the extension, 9.5 mg/24 h rivastigmine patch was well tolerated overall by patients formerly randomized to rivastigmine capsule or patch groups: ≤2.5% reported nausea and ≤1.9% reported vomiting. No unexpected safety issues arose, and skin tolerability was good; similar to the double-blind study. During the 28-week, open-label extension phase, the patch seemed to be well tolerated with a favorable safety profile. © 2009 Lippincott Williams & Wilkins, Inc.