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Dose effects associated with rivastigmine transdermal patch in patients with mild-to-moderate Alzheimer’s disease

Authors


  • Disclosures George Grossberg has received personal compensation for consulting and research funding to his academic institute and department from Novartis Pharmaceuticals Corporation. Monique Somogyi and Xiangyi Meng are employees of Novartis Pharmaceutical Corporation. Jason Olin was an employee of Novartis Pharmaceuticals Corporation during the development of this manuscript. Jason Olin is now an employee of Valeant Pharmaceuticals International. This study was supported by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Medical writing and editorial assistance were provided by Alpha-Plus Medical Communications Ltd (UK) and this service was supported by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

G. T. Grossberg, Department of Neurology & Psychiatry, St Louis University School of Medicine, 1438 South Grand Boulevard, St. Louis, MO 63104, USA
Tel.: + 1 314 977 4829
Fax: + 1 314 977 4878
Email: Grossbgt@aol.com

Summary

Aim:  The cholinesterase inhibitor rivastigmine is available in both oral and transdermal forms. The efficacy of oral rivastigmine appears to be dose-dependent. The current analysis investigates the effect of dose on the efficacy of the rivastigmine transdermal patch.

Methods:  This was a retrospective analysis of a large, international, 24-week, randomised, placebo- and active-controlled trial (IDEAL, CENA713D2320) of rivastigmine in patients with mild-to-moderate Alzheimer’s disease (AD). Patients received the 9.5 mg/24 h rivastigmine patch, the 17.4 mg/24 h rivastigmine patch, 12 mg/day rivastigmine capsules or placebo. Changes from baseline at week 24 on the AD Assessment Scale–cognitive subscale (ADAS-cog), AD Cooperative Study–Clinical Global Impression of Change (ADCS-CGIC) and the AD Cooperative Study–Activities of Daily Living (ADCS-ADL) scale were calculated based on the patient’s mode and last prescribed patch dose. The analysis included the 4.6 mg/24 h and 13.3 mg/24 h patch doses, for which efficacy data have not previously been reported.

Results:  Significant differences (p < 0.05 vs. placebo) were seen on the ADAS-cog and ADCS-ADL for all mode rivastigmine patch doses (except 4.6 mg/24 h) and all last prescribed rivastigmine patch doses (except 4.6 mg/24 h and 13.3 mg/24 h). Patients with a last prescribed/mode patch dose of 9.5 mg/24 h and 13.3 mg/24 h showed significant improvements (p < 0.05 vs. placebo) on the ADCS-CGIC.

Conclusion:  Rivastigmine patch doses higher than 9.5 mg/24 h may offer additional benefits. The 13.3 mg/24 h patch is worthy of further investigation.

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