Alzheimer's & Dementia: The Journal of the Alzheimer's Association
Volume 4, Issue 1 , Pages 30-37, January 2008

One-week dose titration of extended release galantamine in patients with Alzheimer’s disease

  • Douglas W. Scharre

      Affiliations

    • Division of Cognitive Neurology, Department of Neurology, Ohio State University, Columbus, OH, USA
    • ,
  • Thomas Shiovitz

      Affiliations

    • California Neuroscience Research, Sherman Oaks, CA, USA
    • ,
  • Young Zhu

      Affiliations

    • Ortho-McNeil Janssen Scientific Affairs, L.L.C., Titusville, NJ, USA
    • ,
  • Joan Amatniek

      Affiliations

    • Ortho-McNeil Janssen Scientific Affairs, L.L.C., Titusville, NJ, USA
    • Corresponding Author InformationCorresponding author. Tel.: 609-730-3438; Fax: 609-730-3406.

published online 21 December 2007.

Abstract 

Background

Our purpose was to assess the safety and tolerability of extended-release galantamine (GAL-ER), using a 1-week dose titration in Alzheimer’s patients.

Methods

An open-label, 12-week, multicenter study was performed (n = 82). Results were compared with findings from a placebo-controlled trial using a 4-week titration of GAL-ER and immediate-release galantamine. The primary analysis compared incidences of adverse events (AEs).

Results

Although not statistically significant, more patients in the 1-week titration study experienced an AE. More patients with a 1-week titration had at least one prespecified gastrointestinal (GI) AE. These findings correlated with a higher baseline incidence of GI disturbances. Four patients experienced serious AEs; no deaths occurred. Mean Mini-Mental State Examination scores improved by 1.8 and 1.9 points at weeks 4 and 12, respectively.

Conclusions

A 1-week titration of GAL-ER was generally safe and well tolerated, with a potential risk of more GI side effects. A 1-week titration may permit dosing flexibility and promote increased adherence to medication regimens.

Keywords: Alzheimer’s disease, Acetylcholinesterase inhibitors, Galantamine, Extended release, Dose titration

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 Financial disclosures: Douglas W. Scharre, M.D., serves as a consultant and speaker for Abbott Laboratories, Eisai, Inc., Forest Laboratories, Ortho-McNeil Janssen, and Pfizer, Inc. He has received research grants from Astellas Pharma, Inc., Eisai, Inc., Forest Laboratories, GlaxoSmithKline, Janssen Pharmaceutica, Myriad Genetics, Inc., Ono Pharmaceutical, Pfizer, Inc., Sanofi-Aventis Pharmaceuticals, and Voyager. Thomas Shiovitz, M.D., serves as a consultant and speaker for Pfizer, Inc. He has received research grants from Astellas Pharma, Inc., Astra-Zeneca, Corcept, Eisai, Inc., Janssen Pharmaceutica, Lilly, Merck, Pfizer, Inc., Sanofi-Aventis Pharmaceuticals, and Sention. Young Zhu, Ph.D., and Joan Amatniek, M.D., are employees of Ortho-McNeil Janssen Scientific Affairs, L.L.C.

PII: S1552-5260(07)00638-3

doi:10.1016/j.jalz.2007.10.013

Alzheimer's & Dementia: The Journal of the Alzheimer's Association
Volume 4, Issue 1 , Pages 30-37, January 2008

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