PMID- 19476399 OWN - NLM STAT- MEDLINE DCOM- 20090709 LR - 20220716 IS - 1170-229X (Print) IS - 1170-229X (Linking) VI - 26 IP - 4 DP - 2009 TI - Memantine in moderately-severe-to-severe Alzheimer's disease: a postmarketing surveillance study. PG - 321-32 LID - 10.2165/00002512-200926040-00003 [doi] AB - BACKGROUND: Postmarketing surveillance studies (PMS) are an important tool for evaluating a drug's effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimer's disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's 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 (mean age 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. FAU - Clerici, Francesca AU - Clerici F AD - Centre for Research and Treatment on Cognitive Dysfunctions, University of Milan, "L. Sacco" Hospital, Milan, Italy. francesca.clerici1@unimi.it FAU - Vanacore, Nicola AU - Vanacore N FAU - Elia, Antonietta AU - Elia A FAU - Spila-Alegiani, Stefania AU - Spila-Alegiani S FAU - Pomati, Simone AU - Pomati S FAU - Da Cas, Roberto AU - Da Cas R FAU - Raschetti, Roberto AU - Raschetti R FAU - Mariani, Claudio AU - Mariani C CN - Memantine Lombardy Study Group LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - New Zealand TA - Drugs Aging JT - Drugs & aging JID - 9102074 RN - 0 (Excitatory Amino Acid Antagonists) RN - W8O17SJF3T (Memantine) SB - IM MH - Aged MH - Aged, 80 and over MH - Alzheimer Disease/*drug therapy/physiopathology MH - Dementia/drug therapy/etiology MH - Excitatory Amino Acid Antagonists/adverse effects/*therapeutic use MH - Female MH - Humans MH - Italy/epidemiology MH - Male MH - Memantine/adverse effects/*therapeutic use MH - Product Surveillance, Postmarketing MH - Psychiatric Status Rating Scales MH - Severity of Illness Index MH - Treatment Outcome FIR - Altavilla, R IR - Altavilla R FIR - Appollonio, I IR - Appollonio I FIR - Isella, V IR - Isella V FIR - Avanzi, S IR - Avanzi S FIR - Bargnani, C IR - Bargnani C FIR - Bascelli, C IR - Bascelli C FIR - Bellelli, G IR - Bellelli G FIR - Guerini, F IR - Guerini F FIR - Belotti, G IR - Belotti G FIR - Bottini, G IR - Bottini G FIR - Gerini, M IR - Gerini M FIR - Cheldi, A IR - Cheldi A FIR - Bellotti, M IR - Bellotti M FIR - Chia, F IR - Chia F FIR - Cislaghi, G IR - Cislaghi G FIR - Cusi, C IR - Cusi C FIR - Mesina, M IR - Mesina M FIR - Cuzzoni, G IR - Cuzzoni G FIR - Farina, E IR - Farina E FIR - Alberoni, M IR - Alberoni M FIR - Franceschi, M IR - Franceschi M FIR - Zucchi, M IR - Zucchi M FIR - Guerini, M IR - Guerini M FIR - Iori, T IR - Iori T FIR - Lanza, E IR - Lanza E FIR - Finotti, M IR - Finotti M FIR - Lucchelli, F IR - Lucchelli F FIR - Maggiore, L IR - Maggiore L FIR - Ratti, P L IR - Ratti PL FIR - Magnani, G IR - Magnani G FIR - Schiatti, E IR - Schiatti E FIR - Marcone, A IR - Marcone A FIR - Giusti, M C IR - Giusti MC FIR - Margarito, F P IR - Margarito FP FIR - Martina, A IR - Martina A FIR - Mauri, M IR - Mauri M FIR - Merlo, P IR - Merlo P FIR - Mazza, S IR - Mazza S FIR - Moleri, M IR - Moleri M FIR - Riva, R IR - Riva R FIR - Montecalvo, G IR - Montecalvo G FIR - Chinaglia, C Negri IR - Chinaglia CN FIR - Engaddi, I IR - Engaddi I FIR - Perini, M IR - Perini M FIR - Carnicelli, A IR - Carnicelli A FIR - Petro, E IR - Petro E FIR - Pettenati, C IR - Pettenati C FIR - Perotta, D IR - Perotta D FIR - Ranzenigo, A IR - Ranzenigo A FIR - Bertozzi, B IR - Bertozzi B FIR - Redaelli, L IR - Redaelli L FIR - Reverberi, F IR - Reverberi F FIR - Salvi, G P IR - Salvi GP FIR - Manzoni, L IR - Manzoni L FIR - Saviotti, F M IR - Saviotti FM FIR - Scarpini, E IR - Scarpini E FIR - Guidi, I IR - Guidi I FIR - Sinforiani, E IR - Sinforiani E FIR - Zucchella, C IR - Zucchella C FIR - Tagliavini, F IR - Tagliavini F FIR - Marcon, G IR - Marcon G FIR - Turla, M IR - Turla M FIR - Viti, N IR - Viti N FIR - Zanetti, O IR - Zanetti O FIR - Alberici, A IR - Alberici A EDAT- 2009/05/30 09:00 MHDA- 2009/07/10 09:00 CRDT- 2009/05/30 09:00 PHST- 2009/05/30 09:00 [entrez] PHST- 2009/05/30 09:00 [pubmed] PHST- 2009/07/10 09:00 [medline] AID - 3 [pii] AID - 10.2165/00002512-200926040-00003 [doi] PST - ppublish SO - Drugs Aging. 2009;26(4):321-32. doi: 10.2165/00002512-200926040-00003.