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Effectiveness of open-label donepezil treatment in patients with Alzheimer's disease discontinuing memantine monotherapy.
Curr Med Res Opin 2007; 23(12):3153-65CM

Abstract

OBJECTIVE

To evaluate the efficacy and safety of donepezil in patients with Alzheimer's disease (AD) who discontinue memantine due to a lack of efficacy or not being well tolerated.

METHODS

This study enrolled patients with moderate-to-severe AD (Mini-Mental State Examination [MMSE] score 5-17) who had a history of treatment with memantine monotherapy (10 mg/BID) for > or = 3 months prior to screening and maintained until study baseline. For inclusion in this study, the patient's memantine treatment had to have been judged as lacking efficacy or not well tolerated at the screening visit. Information on previous memantine use was also obtained with regard to dose and duration of treatment. At the baseline visit, patients were switched to open-label donepezil 5 mg/day for 4 weeks, and 10 mg/day thereafter. The primary efficacy measure was a change in MMSE at week 12 using a last observation carried forward (LOCF) analysis. Secondary measures included Physician and Caregiver Satisfaction Questionnaires (PSQ, CSQ), the Clinical Global Impression-Improvement (CGI-I), Neuropsychiatric Inventory (NPI), and a Caregiver Diary (CD).

RESULTS

At week 12-LOCF, MMSE scores increased by a mean of 1.55 points from baseline (p < 0.0001). At end point, the PSQ and CSQ indicated consistent improvements in satisfaction/ease of use with donepezil; 60.2% of patients improved on the CGI-I; and 44.4-55.6% improved on each of three components of the CD. Improvements on the MMSE, CSQ, and CGI-I were apparent, irrespective of previous cholinesterase (ChE) inhibitor use. No significant effects were seen for the total score on the NPI. Withdrawal rates (8.7% due to adverse events [AEs]) and AEs were consistent with the known donepezil safety profile.

CONCLUSION

Donepezil was effective and well tolerated in moderate-to-severe AD patients who discontinued memantine monotherapy, including those with previous exposure to ChE inhibitors.

Authors+Show Affiliations

HYGEIA Diagnostic & Therapeutic Center of Athens, Athens, Greece. vsakka@ath.forthnet.grNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17988434

Citation

Sakka, Paraskevi, et al. "Effectiveness of Open-label Donepezil Treatment in Patients With Alzheimer's Disease Discontinuing Memantine Monotherapy." Current Medical Research and Opinion, vol. 23, no. 12, 2007, pp. 3153-65.
Sakka P, Tsolaki M, Hort J, et al. Effectiveness of open-label donepezil treatment in patients with Alzheimer's disease discontinuing memantine monotherapy. Curr Med Res Opin. 2007;23(12):3153-65.
Sakka, P., Tsolaki, M., Hort, J., Hager, K., Soininen, H., López Pousa, S., ... Schwam, E. (2007). Effectiveness of open-label donepezil treatment in patients with Alzheimer's disease discontinuing memantine monotherapy. Current Medical Research and Opinion, 23(12), pp. 3153-65.
Sakka P, et al. Effectiveness of Open-label Donepezil Treatment in Patients With Alzheimer's Disease Discontinuing Memantine Monotherapy. Curr Med Res Opin. 2007;23(12):3153-65. PubMed PMID: 17988434.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of open-label donepezil treatment in patients with Alzheimer's disease discontinuing memantine monotherapy. AU - Sakka,Paraskevi, AU - Tsolaki,Magda, AU - Hort,Jakub, AU - Hager,Klaus, AU - Soininen,Hilkka, AU - López Pousa,Secundino, AU - Li,Chunming, AU - Schwam,Elias, PY - 2007/11/9/pubmed PY - 2008/2/23/medline PY - 2007/11/9/entrez SP - 3153 EP - 65 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 23 IS - 12 N2 - OBJECTIVE: To evaluate the efficacy and safety of donepezil in patients with Alzheimer's disease (AD) who discontinue memantine due to a lack of efficacy or not being well tolerated. METHODS: This study enrolled patients with moderate-to-severe AD (Mini-Mental State Examination [MMSE] score 5-17) who had a history of treatment with memantine monotherapy (10 mg/BID) for > or = 3 months prior to screening and maintained until study baseline. For inclusion in this study, the patient's memantine treatment had to have been judged as lacking efficacy or not well tolerated at the screening visit. Information on previous memantine use was also obtained with regard to dose and duration of treatment. At the baseline visit, patients were switched to open-label donepezil 5 mg/day for 4 weeks, and 10 mg/day thereafter. The primary efficacy measure was a change in MMSE at week 12 using a last observation carried forward (LOCF) analysis. Secondary measures included Physician and Caregiver Satisfaction Questionnaires (PSQ, CSQ), the Clinical Global Impression-Improvement (CGI-I), Neuropsychiatric Inventory (NPI), and a Caregiver Diary (CD). RESULTS: At week 12-LOCF, MMSE scores increased by a mean of 1.55 points from baseline (p < 0.0001). At end point, the PSQ and CSQ indicated consistent improvements in satisfaction/ease of use with donepezil; 60.2% of patients improved on the CGI-I; and 44.4-55.6% improved on each of three components of the CD. Improvements on the MMSE, CSQ, and CGI-I were apparent, irrespective of previous cholinesterase (ChE) inhibitor use. No significant effects were seen for the total score on the NPI. Withdrawal rates (8.7% due to adverse events [AEs]) and AEs were consistent with the known donepezil safety profile. CONCLUSION: Donepezil was effective and well tolerated in moderate-to-severe AD patients who discontinued memantine monotherapy, including those with previous exposure to ChE inhibitors. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/17988434/Effectiveness_of_open_label_donepezil_treatment_in_patients_with_Alzheimer's_disease_discontinuing_memantine_monotherapy_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079907X242773 DB - PRIME DP - Unbound Medicine ER -