Abstract

Background: Postmarketing surveillance studies (PMS) are an important tool for evaluating a drugs effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimers disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke Alzheimers Disease and Related Disorders Association criteria has been conducted to date. Objective: The Lombardy Health Office, Italy, promoted this PMS to evaluate the effectiveness and safety of memantine in the treatment of moderately-severe-to-severe AD in clinical practice. Methods: A total of 451 patients with moderately-severe-to-severe AD (meanage 77 7 years; 72% female), free of cholinergic medication, received memantine (standard titration to 10 mg twice daily). After 6 months of therapy, treatment effectiveness was evaluated according to two definitions of response (no deterioration and improvement), as measured by changes in baseline scores on the Clinical Global Impression of Change, Mini-Mental State Examination, Neuropsychiatric Inventory and Activities of Daily Living scales. The safety measure was the frequency of adverse events (AEs). Results: At 6-month assessment, 26.8% of subjects showed no deterioration and 3.8% showed improvement. In those showing no deterioration, response to treatment at the 3-month assessment was associated with a greater probability of a response at 6 months (adjusted odds ratio = 8.54; 95% CI 4.54, 16.05). Seventy patients (15.5%) experienced at least one AE and 39 (8.6%) discontinued treatment prematurely because of an AE. Of those who experienced an AE, 27 (38.6%) manifested behavioural and psychological symptoms of dementia. Conclusion: The proportion of responders to memantine treatment in this PMS was similar to that reported in a previous randomized clinical trial (26.8% vs 29%, respectively). The proportion of patients who discontinued treatment prematurely because of an AE (8.6%) was similar to that reported in two previous randomized clinical trials (10% and 12.4%). This PMS provides additional evidence that both the effectiveness and the tolerability of memantine may be transferred into real world medicine, where AD patients receiving treatment are not selected according to strict criteria.

Original languageEnglish
Pages (from-to)321-332
Number of pages12
JournalDrugs and Aging
Volume26
Issue number4
DOIs
Publication statusPublished - Jan 1 2009

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Memantine
Alzheimer Disease
Safety
Therapeutics
Randomized Controlled Trials
National Institute of Neurological Disorders and Stroke
Communication Disorders
Behavioral Symptoms
Activities of Daily Living
Cholinergic Agents
Italy
Dementia
Odds Ratio
Medicine
Psychology
Equipment and Supplies
Health
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Pharmacology (medical)

Cite this

Memantine in moderately-severe-to-severe alzheimers disease : A postmarketing surveillance study. / Memantine Lombardy Study Group investigators.

In: Drugs and Aging, Vol. 26, No. 4, 01.01.2009, p. 321-332.

Research output: Contribution to journalArticle

Memantine Lombardy Study Group investigators. / Memantine in moderately-severe-to-severe alzheimers disease : A postmarketing surveillance study. In: Drugs and Aging. 2009 ; Vol. 26, No. 4. pp. 321-332.
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title = "Memantine in moderately-severe-to-severe alzheimers disease: A postmarketing surveillance study",
abstract = "Background: Postmarketing surveillance studies (PMS) are an important tool for evaluating a drugs effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimers disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke Alzheimers Disease and Related Disorders Association criteria has been conducted to date. Objective: The Lombardy Health Office, Italy, promoted this PMS to evaluate the effectiveness and safety of memantine in the treatment of moderately-severe-to-severe AD in clinical practice. Methods: A total of 451 patients with moderately-severe-to-severe AD (meanage 77 7 years; 72{\%} female), free of cholinergic medication, received memantine (standard titration to 10 mg twice daily). After 6 months of therapy, treatment effectiveness was evaluated according to two definitions of response (no deterioration and improvement), as measured by changes in baseline scores on the Clinical Global Impression of Change, Mini-Mental State Examination, Neuropsychiatric Inventory and Activities of Daily Living scales. The safety measure was the frequency of adverse events (AEs). Results: At 6-month assessment, 26.8{\%} of subjects showed no deterioration and 3.8{\%} showed improvement. In those showing no deterioration, response to treatment at the 3-month assessment was associated with a greater probability of a response at 6 months (adjusted odds ratio = 8.54; 95{\%} CI 4.54, 16.05). Seventy patients (15.5{\%}) experienced at least one AE and 39 (8.6{\%}) discontinued treatment prematurely because of an AE. Of those who experienced an AE, 27 (38.6{\%}) manifested behavioural and psychological symptoms of dementia. Conclusion: The proportion of responders to memantine treatment in this PMS was similar to that reported in a previous randomized clinical trial (26.8{\%} vs 29{\%}, respectively). The proportion of patients who discontinued treatment prematurely because of an AE (8.6{\%}) was similar to that reported in two previous randomized clinical trials (10{\%} and 12.4{\%}). This PMS provides additional evidence that both the effectiveness and the tolerability of memantine may be transferred into real world medicine, where AD patients receiving treatment are not selected according to strict criteria.",
author = "{Memantine Lombardy Study Group investigators} and Francesca Clerici and Nicola Vanacore and Antonietta Elia and Stefania Spila-Alegiani and Simone Pomati and {Da Cas}, Roberto and Roberto Raschetti and Claudio Mariani and R. Altavilla and I. Appollonio and V. Isella and S. Avanzi and C. Bargnani and C. Bascelli and G. Bellelli and F. Guerini and G. Belotti and G. Bottini and M. Gerini and A. Cheldi and M. Bellotti and F. Chia and G. Cislaghi and C. Cusi and M. Mesina and G. Cuzzoni and E. Farina and M. Alberoni and M. Franceschi and M. Zucchi and M. Guerini and T. Iori and E. Lanza and M. Finotti and F. Lucchelli and L. Maggiore and Ratti, {P. L.} and G. Magnani and E. Schiatti and A. Marcone and Giusti, {M. C.} and Margarito, {F. P.} and A. Martina and M. Mauri and S. Mazza and R. Riva and E. Scarpini and E. Sinforiani and F. Tagliavini and O. Zanetti",
year = "2009",
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journal = "Drugs and Aging",
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TY - JOUR

T1 - Memantine in moderately-severe-to-severe alzheimers disease

T2 - A postmarketing surveillance study

AU - Memantine Lombardy Study Group investigators

AU - Clerici, Francesca

AU - Vanacore, Nicola

AU - Elia, Antonietta

AU - Spila-Alegiani, Stefania

AU - Pomati, Simone

AU - Da Cas, Roberto

AU - Raschetti, Roberto

AU - Mariani, Claudio

AU - Altavilla, R.

AU - Appollonio, I.

AU - Isella, V.

AU - Avanzi, S.

AU - Bargnani, C.

AU - Bascelli, C.

AU - Bellelli, G.

AU - Guerini, F.

AU - Belotti, G.

AU - Bottini, G.

AU - Gerini, M.

AU - Cheldi, A.

AU - Bellotti, M.

AU - Chia, F.

AU - Cislaghi, G.

AU - Cusi, C.

AU - Mesina, M.

AU - Cuzzoni, G.

AU - Farina, E.

AU - Alberoni, M.

AU - Franceschi, M.

AU - Zucchi, M.

AU - Guerini, M.

AU - Iori, T.

AU - Lanza, E.

AU - Finotti, M.

AU - Lucchelli, F.

AU - Maggiore, L.

AU - Ratti, P. L.

AU - Magnani, G.

AU - Schiatti, E.

AU - Marcone, A.

AU - Giusti, M. C.

AU - Margarito, F. P.

AU - Martina, A.

AU - Mauri, M.

AU - Mazza, S.

AU - Riva, R.

AU - Scarpini, E.

AU - Sinforiani, E.

AU - Tagliavini, F.

AU - Zanetti, O.

PY - 2009/1/1

Y1 - 2009/1/1

N2 - Background: Postmarketing surveillance studies (PMS) are an important tool for evaluating a drugs effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimers disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke Alzheimers Disease and Related Disorders Association criteria has been conducted to date. Objective: The Lombardy Health Office, Italy, promoted this PMS to evaluate the effectiveness and safety of memantine in the treatment of moderately-severe-to-severe AD in clinical practice. Methods: A total of 451 patients with moderately-severe-to-severe AD (meanage 77 7 years; 72% female), free of cholinergic medication, received memantine (standard titration to 10 mg twice daily). After 6 months of therapy, treatment effectiveness was evaluated according to two definitions of response (no deterioration and improvement), as measured by changes in baseline scores on the Clinical Global Impression of Change, Mini-Mental State Examination, Neuropsychiatric Inventory and Activities of Daily Living scales. The safety measure was the frequency of adverse events (AEs). Results: At 6-month assessment, 26.8% of subjects showed no deterioration and 3.8% showed improvement. In those showing no deterioration, response to treatment at the 3-month assessment was associated with a greater probability of a response at 6 months (adjusted odds ratio = 8.54; 95% CI 4.54, 16.05). Seventy patients (15.5%) experienced at least one AE and 39 (8.6%) discontinued treatment prematurely because of an AE. Of those who experienced an AE, 27 (38.6%) manifested behavioural and psychological symptoms of dementia. Conclusion: The proportion of responders to memantine treatment in this PMS was similar to that reported in a previous randomized clinical trial (26.8% vs 29%, respectively). The proportion of patients who discontinued treatment prematurely because of an AE (8.6%) was similar to that reported in two previous randomized clinical trials (10% and 12.4%). This PMS provides additional evidence that both the effectiveness and the tolerability of memantine may be transferred into real world medicine, where AD patients receiving treatment are not selected according to strict criteria.

AB - Background: Postmarketing surveillance studies (PMS) are an important tool for evaluating a drugs effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimers disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke Alzheimers Disease and Related Disorders Association criteria has been conducted to date. Objective: The Lombardy Health Office, Italy, promoted this PMS to evaluate the effectiveness and safety of memantine in the treatment of moderately-severe-to-severe AD in clinical practice. Methods: A total of 451 patients with moderately-severe-to-severe AD (meanage 77 7 years; 72% female), free of cholinergic medication, received memantine (standard titration to 10 mg twice daily). After 6 months of therapy, treatment effectiveness was evaluated according to two definitions of response (no deterioration and improvement), as measured by changes in baseline scores on the Clinical Global Impression of Change, Mini-Mental State Examination, Neuropsychiatric Inventory and Activities of Daily Living scales. The safety measure was the frequency of adverse events (AEs). Results: At 6-month assessment, 26.8% of subjects showed no deterioration and 3.8% showed improvement. In those showing no deterioration, response to treatment at the 3-month assessment was associated with a greater probability of a response at 6 months (adjusted odds ratio = 8.54; 95% CI 4.54, 16.05). Seventy patients (15.5%) experienced at least one AE and 39 (8.6%) discontinued treatment prematurely because of an AE. Of those who experienced an AE, 27 (38.6%) manifested behavioural and psychological symptoms of dementia. Conclusion: The proportion of responders to memantine treatment in this PMS was similar to that reported in a previous randomized clinical trial (26.8% vs 29%, respectively). The proportion of patients who discontinued treatment prematurely because of an AE (8.6%) was similar to that reported in two previous randomized clinical trials (10% and 12.4%). This PMS provides additional evidence that both the effectiveness and the tolerability of memantine may be transferred into real world medicine, where AD patients receiving treatment are not selected according to strict criteria.

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DO - 10.2165/00002512-200926040-00003

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