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Donepezil treatment and Alzheimer disease: can the results of randomized clinical trials be applied to Alzheimer disease patients in clinical practice?
Am J Geriatr Psychiatry 2007; 15(11):953-60AJ

Abstract

OBJECTIVE

To determine if results from randomized clinical trials of donepezil in Alzheimer disease (AD) patients can be applied to AD patients in clinical practice by comparing the findings from a Nordic one-year randomized AD donepezil trial with data from a one-year prospective, observational study of AD patients.

METHODS

AD patients from a consortium of California sites were systematically followed for at least one year. Their treatment regimens, including prescription of donepezil, were determined by their individual physician according to his or her usual criteria.

RESULTS

The 148 California patients treated with donepezil had a one-year decline of 1.3 (3.5 SD) points on the Mini-Mental State Exam compared to a decline of 3.3 (4.4 SD) in the 158 AD patients who received no anti-Alzheimer drugs. The Mini-Mental State Exam decline in Nordic sample was approximately 0.25 points for the 91 patients receiving donepezil and approximately 2.2 for the 98 placebo patients. The overall effect sizes were estimated at about 0.49 in both studies. The California data were further analyzed using propensity methods; after taking into account differences that could bias prescribing decisions, benefits associated with taking donepezil remained.

CONCLUSION

A comparison of a randomized clinical trial of donepezil in AD patients and this observational study indicates that if appropriate methodological and statistical precautions are undertaken, then results from randomized clinical trials can be predictive with AD patients in clinical practice. This California study supports the modest effectiveness of donepezil in AD patients having clinical characteristics similar to those of the Nordic study.

Authors+Show Affiliations

Sierra Pacific Mental Illness, Research, Education and Clinical Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA. jerytink@stanford.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

17974866

Citation

Tinklenberg, Jared R., et al. "Donepezil Treatment and Alzheimer Disease: Can the Results of Randomized Clinical Trials Be Applied to Alzheimer Disease Patients in Clinical Practice?" The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry, vol. 15, no. 11, 2007, pp. 953-60.
Tinklenberg JR, Kraemer HC, Yaffe K, et al. Donepezil treatment and Alzheimer disease: can the results of randomized clinical trials be applied to Alzheimer disease patients in clinical practice? Am J Geriatr Psychiatry. 2007;15(11):953-60.
Tinklenberg, J. R., Kraemer, H. C., Yaffe, K., Ross, L., Sheikh, J., Ashford, J. W., ... Taylor, J. L. (2007). Donepezil treatment and Alzheimer disease: can the results of randomized clinical trials be applied to Alzheimer disease patients in clinical practice? The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry, 15(11), pp. 953-60.
Tinklenberg JR, et al. Donepezil Treatment and Alzheimer Disease: Can the Results of Randomized Clinical Trials Be Applied to Alzheimer Disease Patients in Clinical Practice. Am J Geriatr Psychiatry. 2007;15(11):953-60. PubMed PMID: 17974866.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Donepezil treatment and Alzheimer disease: can the results of randomized clinical trials be applied to Alzheimer disease patients in clinical practice? AU - Tinklenberg,Jared R, AU - Kraemer,Helena C, AU - Yaffe,Kristine, AU - Ross,Leslie, AU - Sheikh,Javaid, AU - Ashford,John W, AU - Yesavage,Jerome A, AU - Taylor,Joy L, PY - 2007/11/3/pubmed PY - 2008/1/3/medline PY - 2007/11/3/entrez SP - 953 EP - 60 JF - The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry JO - Am J Geriatr Psychiatry VL - 15 IS - 11 N2 - OBJECTIVE: To determine if results from randomized clinical trials of donepezil in Alzheimer disease (AD) patients can be applied to AD patients in clinical practice by comparing the findings from a Nordic one-year randomized AD donepezil trial with data from a one-year prospective, observational study of AD patients. METHODS: AD patients from a consortium of California sites were systematically followed for at least one year. Their treatment regimens, including prescription of donepezil, were determined by their individual physician according to his or her usual criteria. RESULTS: The 148 California patients treated with donepezil had a one-year decline of 1.3 (3.5 SD) points on the Mini-Mental State Exam compared to a decline of 3.3 (4.4 SD) in the 158 AD patients who received no anti-Alzheimer drugs. The Mini-Mental State Exam decline in Nordic sample was approximately 0.25 points for the 91 patients receiving donepezil and approximately 2.2 for the 98 placebo patients. The overall effect sizes were estimated at about 0.49 in both studies. The California data were further analyzed using propensity methods; after taking into account differences that could bias prescribing decisions, benefits associated with taking donepezil remained. CONCLUSION: A comparison of a randomized clinical trial of donepezil in AD patients and this observational study indicates that if appropriate methodological and statistical precautions are undertaken, then results from randomized clinical trials can be predictive with AD patients in clinical practice. This California study supports the modest effectiveness of donepezil in AD patients having clinical characteristics similar to those of the Nordic study. SN - 1064-7481 UR - https://www.unboundmedicine.com/medline/citation/17974866/Donepezil_treatment_and_Alzheimer_disease:_can_the_results_of_randomized_clinical_trials_be_applied_to_Alzheimer_disease_patients_in_clinical_practice L2 - https://linkinghub.elsevier.com/retrieve/pii/15/11/953 DB - PRIME DP - Unbound Medicine ER -