Abstract
Background and objective
A number of reports have been published on the possible involvement of changes in brain cholesterol metabolism in the origin of Alzheimer’s disease (AD) and the potential for influencing these changes by administration of HMG-CoA reducíase inhibitors (‘statins’). The aim of this study was to evaluate a potential association between use of statins and maintenance of cognitive function in patients with AD in galantamine clinical trials.
Method
A post hoc analysis was conducted on data pooled from three double-blind, placebo-controlled, clinical trials of galantamine in patients with AD. Patients were divided into four treatment groups: statin plus galantamine (n = 42), statin alone (n = 50), galantamine alone (n = 614) or neither galantamine nor statin (n = 619).
Results
Galantamine was associated with a significant beneficial effect on cognitive status (p < 0.001). The association of use of statins with changes in cognitive status was not significant (p = 0.083). There was no significant interaction between the effects on cognition of statins and galantamine (p = 0.183) and no statistically significant changes in adverse effect rates were observed.
Conclusion
These findings suggest the need for larger long-term trials to confirm or refute possible effects of statins on cognitive function and the potential interaction of statins with acetylcholinesterase inhibitors in the treatment of AD.
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Acknowledgements
Dr Bengt Winblad is a consultant to Janssen Cilag and Johnson & Johnson, and has taken part in advisory board meetings for and/or received honoraria from Janssen Cilag, Novartis, Pfizer, Merz, Lundbeck, Sanofi, Wyeth, Merck, Sharp and Dohme, and Myriad. Drs Joan Amatniek and Paul Kershaw are employees of Johnson & Johnson. Dr Vesna Jelic has no potential conflicts of interest that are directly relevant to the content of this study.
Drs Winblad, Jelic, Amatniek and Kershaw designed the post hoc analysis. The statistical analysis was performed at Janssen Pharmaceutica. Drs Winblad, Jelic, Amatniek and Kershaw provided interpretation of the data and jointly prepared and reviewed the manuscript.
The authors thank Elane M. Gutterman, PhD, and Jeffrey S. Markowitz, DrPH, for performing the statistical analyses and providing valuable comments.
Johnson & Johnson Pharmaceutical Research & Development funded the galantamine clinical trials. Ortho McNeil Neurologics provided funding assistance for the preparation of this article.
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Winblad, B., Jelic, V., Kershaw, P. et al. Effects of Statins on Cognitive Function in Patients with Alzheimer’s Disease in Galantamine Clinical Trials. Drugs Aging 24, 57–61 (2007). https://doi.org/10.2165/00002512-200724010-00004
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DOI: https://doi.org/10.2165/00002512-200724010-00004