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A large, naturalistic, community-based study of rivastigmine in mild-to-moderate AD: the EXTEND Study.
Curr Med Res Opin. 2006 Nov; 22(11):2251-65.CM

Abstract

BACKGROUND

Previous studies in Alzheimer's Disease (AD) suggest a benefit from switching from one cholinesterase (ChE) inhibitor to another in the event of treatment failure on the index agent. This observational, open-label study sought to evaluate the efficacy of the ChE inhibitor rivastigmine on cognition, functional autonomy and behavior in patients with mild-to-moderate AD previously treated with other ChE inhibitors (switched patients) as well as in those previously ChE-inhibitor-naive (de novo users).

METHODS

Patients were eligible for a switch if they experienced a lack or loss of efficacy or had experienced intolerance to prior ChE inhibitor therapy. Rivastigmine was initiated at a dose of 1.5 mg b.i.d. and titration was done as per standard medical practice. Efficacy was assessed using the mini-mental state examination (MMSE) and an abbreviated version of the Clinician's Global Impression of Change (CGI-C) at Month 3 and Month 6. Caregiver burden was also assessed at Month 6 using a self-rated scale.

RESULTS

Overall, 2633 subjects were enrolled in this study. The mean MMSE improved from 20.6 at baseline to 21.5 at Month 6. More patients improved than deteriorated on every domain of the CGI-C. Caregivers felt less burdened after the 6 month evaluation period. Efficacy parameters demonstrated favorable results for both de novo and switched patients, but more so in the first group.

LIMITATIONS

Open-label studies have an inherent potential for bias by both the caregiver and the physician. In this study, there was also a large percentage of missing patient records for each of the follow-up visits (Months 3 and 6).

CONCLUSIONS

Patients with mild-to-moderate AD switched from previous ChE inhibitor therapy to rivastigmine can obtain measurable benefits, although the treatment effect may be less than in de novo patients. Further research into switching cholinesterase inhibitors is warranted.

Authors+Show Affiliations

McGill Centre for Studies in Aging, Douglas Hospital, Montreal, Quebec, Canada. serge.gauthier@mcgill.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

17076986

Citation

Gauthier, Serge, et al. "A Large, Naturalistic, Community-based Study of Rivastigmine in Mild-to-moderate AD: the EXTEND Study." Current Medical Research and Opinion, vol. 22, no. 11, 2006, pp. 2251-65.
Gauthier S, Juby A, Morelli L, et al. A large, naturalistic, community-based study of rivastigmine in mild-to-moderate AD: the EXTEND Study. Curr Med Res Opin. 2006;22(11):2251-65.
Gauthier, S., Juby, A., Morelli, L., Rehel, B., & Schecter, R. (2006). A large, naturalistic, community-based study of rivastigmine in mild-to-moderate AD: the EXTEND Study. Current Medical Research and Opinion, 22(11), 2251-65.
Gauthier S, et al. A Large, Naturalistic, Community-based Study of Rivastigmine in Mild-to-moderate AD: the EXTEND Study. Curr Med Res Opin. 2006;22(11):2251-65. PubMed PMID: 17076986.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A large, naturalistic, community-based study of rivastigmine in mild-to-moderate AD: the EXTEND Study. AU - Gauthier,Serge, AU - Juby,Angela, AU - Morelli,Lidia, AU - Rehel,Bonita, AU - Schecter,Robyn, AU - ,, PY - 2006/11/2/pubmed PY - 2006/12/9/medline PY - 2006/11/2/entrez SP - 2251 EP - 65 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 22 IS - 11 N2 - BACKGROUND: Previous studies in Alzheimer's Disease (AD) suggest a benefit from switching from one cholinesterase (ChE) inhibitor to another in the event of treatment failure on the index agent. This observational, open-label study sought to evaluate the efficacy of the ChE inhibitor rivastigmine on cognition, functional autonomy and behavior in patients with mild-to-moderate AD previously treated with other ChE inhibitors (switched patients) as well as in those previously ChE-inhibitor-naive (de novo users). METHODS: Patients were eligible for a switch if they experienced a lack or loss of efficacy or had experienced intolerance to prior ChE inhibitor therapy. Rivastigmine was initiated at a dose of 1.5 mg b.i.d. and titration was done as per standard medical practice. Efficacy was assessed using the mini-mental state examination (MMSE) and an abbreviated version of the Clinician's Global Impression of Change (CGI-C) at Month 3 and Month 6. Caregiver burden was also assessed at Month 6 using a self-rated scale. RESULTS: Overall, 2633 subjects were enrolled in this study. The mean MMSE improved from 20.6 at baseline to 21.5 at Month 6. More patients improved than deteriorated on every domain of the CGI-C. Caregivers felt less burdened after the 6 month evaluation period. Efficacy parameters demonstrated favorable results for both de novo and switched patients, but more so in the first group. LIMITATIONS: Open-label studies have an inherent potential for bias by both the caregiver and the physician. In this study, there was also a large percentage of missing patient records for each of the follow-up visits (Months 3 and 6). CONCLUSIONS: Patients with mild-to-moderate AD switched from previous ChE inhibitor therapy to rivastigmine can obtain measurable benefits, although the treatment effect may be less than in de novo patients. Further research into switching cholinesterase inhibitors is warranted. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/17076986/A_large_naturalistic_community_based_study_of_rivastigmine_in_mild_to_moderate_AD:_the_EXTEND_Study_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079906X132749 DB - PRIME DP - Unbound Medicine ER -