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1. A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial

Author

Abbruzzese, G., Kulisevsky, J., Bergmans, B., Gomez-Esteban, J. C., Kagi, G., Raw, J., Stefani, A., Warnecke, T., Jost, W. H., Bourgeois, P., Cras, P., de Klippel, N., Dethy, S., Franco, G., Garraux, G., Geens, K., Jacquerye, P., Jeanjean, A., Santens, P., Supiot, F., van der Linden, C., Blersch, W. K., Delf, M., Hellwig, B., Herbst, H. P., Kupsch, A., Lang, M., Muhlack, S., Nastos, I., Oehlwein, C., Schlegel, E., Schwarz, J., Woitalla, D., Aguggia, M., Avarello, T., Barone, P., Baruffaldi, R., Belgrado, E., Bentivoglio, A. R., Bosco, D., Calabresi, P., Callegarini, C., Cannas, A., Centonze, D., Ceravolo, R., Colosimo, C., Comi, C., Contardi, S., Cortelli, P., Cossu, G., D'Amelio, M., de Pandis, M. F., Denaro, A., Di Lazzaro, V., Fabbrini, G., Gasparoli, E., Guidi, M., Iliceto, G., Lopiano, L., Manganotti, P., Marconi, R., Marini, C., Marsala, S. Z., Mauri, M., Moleri, M., Monge, A., Morgante, F., Negrotti, A., Nordera, G., Onofrj, M., Pacchetti, C., Padovani, A., Pontieri, F. E., Priori, A., Quatrale, R., Sensi, M., Tamma, F., Tessitore, A., Tinazzi, M., Vitale, C., Volonte, M. A., Zappia, M., Zecchinelli, A. L., Arbelo Gonzalez, J. M., Bayes, A., Blazquez, M., Calopa Garriga, M., Callen, A., Campos Arillo, V., Cubo, E., de Fabregues, O., Escalante Arroyo, S., Espinosa Rosso, R., Esquivel Lopez, A., Freire, E., Garcia Cobos, E., Garcia Moreno, J. M., Gonzalez-Ardura, J., Grandas Perez, F., Kurtis, M., Juni, J., Legarda, I., Leiva, C., Lopez Aristegui, N., Lopez Manzanares, L., Lozano, J. J., Luquin, M. R., Martinez Castrillo, J. C., Marti Domenech, M. J., Martinez, I., Mata, M., Mir Rivera, P., Pascual Sedano, B., Rodriguez Oroz, M. C., Rodriguez Uranga, J. J., Sanchez, S., Santos Garcia, D., Solano, B., Vaamonde Gamo, J., Accolla, E., Bohlhalter, S., Kalin, A., Michelis, J., Carrol, C., Henderson, E., Raha, S., Silva, N., Silverdale, M., Universidad de Sevilla. Departamento de Medicina, Abbruzzese G., Kulisevsky J., Bergmans B., Gomez-Esteban J.C., Kagi G., Raw J., Stefani A., Warnecke T., Jost W.H., Bourgeois P., Cras P., de Klippel N., Dethy S., Franco G., Garraux G., Geens K., Jacquerye P., Jeanjean A., Santens P., Supiot F., van der Linden C., Blersch W.K., Delf M., Hellwig B., Herbst H.P., Kupsch A., Lang M., Muhlack S., Nastos I., Oehlwein C., Schlegel E., Schwarz J., Woitalla D., Aguggia M., Avarello T., Barone P., Baruffaldi R., Belgrado E., Bentivoglio A.R., Bosco D., Calabresi P., Callegarini C., Cannas A., Centonze D., Ceravolo R., Colosimo C., Comi C., Contardi S., Cortelli P., Cossu G., D'Amelio M., de Pandis M.F., Denaro A., Di Lazzaro V., Fabbrini G., Gasparoli E., Guidi M., Iliceto G., Lopiano L., Manganotti P., Marconi R., Marini C., Marsala S.Z., Mauri M., Moleri M., Monge A., Morgante F., Negrotti A., Nordera G., Onofrj M., Pacchetti C., Padovani A., Pontieri F.E., Priori A., Quatrale R., Sensi M., Tamma F., Tessitore A., Tinazzi M., Vitale C., Volonte M.A., Zappia M., Zecchinelli A.L., Arbelo Gonzalez J.M., Bayes A., Blazquez M., Calopa Garriga M., Callen A., Campos Arillo V., Cubo E., de Fabregues O., Escalante Arroyo S., Espinosa Rosso R., Esquivel Lopez A., Freire E., Garcia Cobos E., Garcia Moreno J.M., Gonzalez-Ardura J., Grandas Perez F., Kurtis M., Juni J., Legarda I., Leiva C., Lopez Aristegui N., Lopez Manzanares L., Lozano J.J., Luquin M.R., Martinez Castrillo J.C., Marti Domenech M.J., Martinez I., Mata M., Mir Rivera P., Pascual Sedano B., Rodriguez Oroz M.C., Rodriguez Uranga J.J., Sanchez S., Santos Garcia D., Solano B., Vaamonde Gamo J., Accolla E., Bohlhalter S., Kalin A., Michelis J., Carrol C., Henderson E., Raha S., Silva N., and Silverdale M.

Subjects
Research Report, Male, 0301 basic medicine, Benzylamines, Parkinson's disease, Outcome Assessment, Comorbidity, Disease, Real-life evaluation, chemistry.chemical_compound, 0302 clinical medicine, Outcome Assessment, Health Care, 80 and over, MAO-B inhibitor, Aged, 80 and over, Safinamide, education.field_of_study, Alanine, Mental Disorders, Parkinson Disease, Middle Aged, Aged, Drug-Related Side Effects and Adverse Reactions, Europe, Female, Follow-Up Studies, Humans, Monoamine Oxidase Inhibitors, Retrospective Studies, Settore MED/26 - NEUROLOGIA, Erratum, Cohort study, medicine.medical_specialty, Population, MEDLINE, 03 medical and health sciences, Cellular and Molecular Neuroscience, Internal medicine, medicine, Adverse effect, education, business.industry, medicine.disease, Health Care, 030104 developmental biology, chemistry, Parkinson’s disease, Observational study, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Background: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson's disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency. Objective: To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. Methods: The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions. Results: Of the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events were those already described in the patients' information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in >= 40% of patients, according to the criteria developed by Shulman et al. Conclusion: The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term.

Published
2022
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2. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: The SynapSES trial

Author

Abbruzzese, G., Kulisevsky, J., Bergmans, B., Gomez-Esteban, J. C., Kagi, G., Raw, J., Stefani, A., Warnecke, T., Jost, W. H., Bourgeois, P., Cras, P., de Klippel, N., Dethy, S., Franco, G., Garraux, G., Geens, K., Jacquerye, P., Jeanjean, A., Santens, P., Supiot, F., van der Linden, C., Blersch, W. K., Delf, M., Hellwig, B., Herbst, H. P., Kupsch, A., Lang, M., Muhlack, S., Nastos, I., Oehlwein, C., Schlegel, E., Schwarz, J., Woitalla, D., Aguggia, M., Avarello, T., Barone, P., Baruffaldi, R., Belgrado, E., Bentivoglio, Anna Rita, Bosco, D., Calabresi, Paolo, Callegarini, C., Cannas, A., Centonze, D., Ceravolo, R., Colosimo, C., Comi, C., Contardi, S., Cortelli, P., Cossu, G., D'Amelio, M., de Pandis, M. F., Denaro, A., Di Lazzaro, V., Fabbrini, G., Gasparoli, E., Guidi, M., Iliceto, G., Lopiano, L., Manganotti, P., Marconi, R., Marini, C., Marsala, S. Z., Mauri, M., Moleri, M., Monge, A., Morgante, F., Negrotti, A., Nordera, G., Onofrj, M., Pacchetti, C., Padovani, A., Pontieri, F. E., Priori, A., Quatrale, R., Sensi, M., Tamma, F., Tessitore, A., Tinazzi, M., Vitale, C., Volonte, M. A., Zappia, M., Zecchinelli, A. L., Arbelo Gonzalez, J. M., Bayes, A., Blazquez, M., Calopa Garriga, M., Callen, A., Campos Arillo, V., Cubo, E., de Fabregues, O., Escalante Arroyo, S., Espinosa Rosso, R., Esquivel Lopez, A., Freire, E., Garcia Cobos, E., Garcia Moreno, J. M., Gonzalez-Ardura, J., Grandas Perez, F., Kurtis, M., Juni, J., Legarda, I., Leiva, C., Lopez Aristegui, N., Lopez Manzanares, L., Lozano, J. J., Luquin, M. R., Martinez Castrillo, J. C., Marti Domenech, M. J., Martinez, I., Mata, M., Mir Rivera, P., Pascual Sedano, B., Rodriguez Oroz, M. C., Rodriguez Uranga, J. J., Sanchez, S., Santos Garcia, D., Solano, B., Vaamonde Gamo, J., Accolla, E., Bohlhalter, S., Kalin, A., Michelis, J., Carrol, C., Henderson, E., Raha, S., Silva, N., Silverdale, M., Bentivoglio A. R. (ORCID:0000-0002-9663-095X), Calabresi P. (ORCID:0000-0003-0326-5509), Abbruzzese, G., Kulisevsky, J., Bergmans, B., Gomez-Esteban, J. C., Kagi, G., Raw, J., Stefani, A., Warnecke, T., Jost, W. H., Bourgeois, P., Cras, P., de Klippel, N., Dethy, S., Franco, G., Garraux, G., Geens, K., Jacquerye, P., Jeanjean, A., Santens, P., Supiot, F., van der Linden, C., Blersch, W. K., Delf, M., Hellwig, B., Herbst, H. P., Kupsch, A., Lang, M., Muhlack, S., Nastos, I., Oehlwein, C., Schlegel, E., Schwarz, J., Woitalla, D., Aguggia, M., Avarello, T., Barone, P., Baruffaldi, R., Belgrado, E., Bentivoglio, Anna Rita, Bosco, D., Calabresi, Paolo, Callegarini, C., Cannas, A., Centonze, D., Ceravolo, R., Colosimo, C., Comi, C., Contardi, S., Cortelli, P., Cossu, G., D'Amelio, M., de Pandis, M. F., Denaro, A., Di Lazzaro, V., Fabbrini, G., Gasparoli, E., Guidi, M., Iliceto, G., Lopiano, L., Manganotti, P., Marconi, R., Marini, C., Marsala, S. Z., Mauri, M., Moleri, M., Monge, A., Morgante, F., Negrotti, A., Nordera, G., Onofrj, M., Pacchetti, C., Padovani, A., Pontieri, F. E., Priori, A., Quatrale, R., Sensi, M., Tamma, F., Tessitore, A., Tinazzi, M., Vitale, C., Volonte, M. A., Zappia, M., Zecchinelli, A. L., Arbelo Gonzalez, J. M., Bayes, A., Blazquez, M., Calopa Garriga, M., Callen, A., Campos Arillo, V., Cubo, E., de Fabregues, O., Escalante Arroyo, S., Espinosa Rosso, R., Esquivel Lopez, A., Freire, E., Garcia Cobos, E., Garcia Moreno, J. M., Gonzalez-Ardura, J., Grandas Perez, F., Kurtis, M., Juni, J., Legarda, I., Leiva, C., Lopez Aristegui, N., Lopez Manzanares, L., Lozano, J. J., Luquin, M. R., Martinez Castrillo, J. C., Marti Domenech, M. J., Martinez, I., Mata, M., Mir Rivera, P., Pascual Sedano, B., Rodriguez Oroz, M. C., Rodriguez Uranga, J. J., Sanchez, S., Santos Garcia, D., Solano, B., Vaamonde Gamo, J., Accolla, E., Bohlhalter, S., Kalin, A., Michelis, J., Carrol, C., Henderson, E., Raha, S., Silva, N., Silverdale, M., Bentivoglio A. R. (ORCID:0000-0002-9663-095X), and Calabresi P. (ORCID:0000-0003-0326-5509)

Abstract

Background: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson's disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency. Objective: To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. Methods: The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions. Results: Of the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events were those already described in the patients' information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in ≥40% of patients, according to the criteria developed by Shulman et al. Conclusion: The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term.

Published
2021

3. Multicentre, cross-cultural, population-based, case-control study of physical activity as risk factor for amyotrophic lateral sclerosis

Author

Visser, A, Rooney, J, D'Ovidio, F, Westeneng, H, Vermeulen, R, Beghi, E, Chio, A, Logroscino, G, Hardiman, O, Veldink, J, Van Den Berg, L, Tomasoni, A, Arnaboldi, M, Valsecchi, M, Moleri, M, Poloni, M, Alimonti, D, Tagliavini, F, Redaelli, V, Fede, B, Bizzozero, I, Prioni, S, Van der Kooi, A, Raaphorst, J, Calvo, A, Moglia, C, Casale, F, Canosa, A, Manera, U, Bertuzzo, D, Mazzini, L, Bersano, E, Heverin, M, Vadja, A, Pupillo, E, Comi, G, Lunetta, C, Gerardi, F, Filosto, M, Cotelli, M, Rinaldi, F, Chiveri, L, Guaita, M, Perrone, P, Mauro, C, Diamanti, L, Ferrarese, C, Tremolizzo, L, Delodovici, M, Bono, G, Zecca, C, Tortelli, R, Riva, N, Visser A. E., Rooney J. P. K., D'ovidio F., Westeneng H. -J., Vermeulen R. C. H., Beghi E., Chio A., Logroscino G., Hardiman O., Veldink J. H., Van Den Berg L. H., Tomasoni A., Arnaboldi M., Valsecchi M., Moleri M., Poloni M., Alimonti D., Tagliavini F., Redaelli V., Fede B. D., Bizzozero I., Prioni S., Van der Kooi A. J., Raaphorst J., Calvo A., Moglia C., Casale F., Canosa A., Manera U., Bertuzzo D., Mazzini L., Bersano E., Heverin M., Vadja A., Pupillo E., Comi G., Lunetta C., Gerardi F., Filosto M., Cotelli M. S., Rinaldi F., Chiveri L., Guaita M. C., Perrone P., Mauro C., Diamanti L., Ferrarese C., Tremolizzo L., Delodovici M. L., Bono G., Zecca C., Tortelli R., Riva N., Visser, A, Rooney, J, D'Ovidio, F, Westeneng, H, Vermeulen, R, Beghi, E, Chio, A, Logroscino, G, Hardiman, O, Veldink, J, Van Den Berg, L, Tomasoni, A, Arnaboldi, M, Valsecchi, M, Moleri, M, Poloni, M, Alimonti, D, Tagliavini, F, Redaelli, V, Fede, B, Bizzozero, I, Prioni, S, Van der Kooi, A, Raaphorst, J, Calvo, A, Moglia, C, Casale, F, Canosa, A, Manera, U, Bertuzzo, D, Mazzini, L, Bersano, E, Heverin, M, Vadja, A, Pupillo, E, Comi, G, Lunetta, C, Gerardi, F, Filosto, M, Cotelli, M, Rinaldi, F, Chiveri, L, Guaita, M, Perrone, P, Mauro, C, Diamanti, L, Ferrarese, C, Tremolizzo, L, Delodovici, M, Bono, G, Zecca, C, Tortelli, R, Riva, N, Visser A. E., Rooney J. P. K., D'ovidio F., Westeneng H. -J., Vermeulen R. C. H., Beghi E., Chio A., Logroscino G., Hardiman O., Veldink J. H., Van Den Berg L. H., Tomasoni A., Arnaboldi M., Valsecchi M., Moleri M., Poloni M., Alimonti D., Tagliavini F., Redaelli V., Fede B. D., Bizzozero I., Prioni S., Van der Kooi A. J., Raaphorst J., Calvo A., Moglia C., Casale F., Canosa A., Manera U., Bertuzzo D., Mazzini L., Bersano E., Heverin M., Vadja A., Pupillo E., Comi G., Lunetta C., Gerardi F., Filosto M., Cotelli M. S., Rinaldi F., Chiveri L., Guaita M. C., Perrone P., Mauro C., Diamanti L., Ferrarese C., Tremolizzo L., Delodovici M. L., Bono G., Zecca C., Tortelli R., and Riva N.

Abstract

Objective To investigate the association between physical activity (PA) and amyotrophic lateral sclerosis (ALS) in population-based case-control studies in three European countries using a validated and harmonised questionnaire. Methods Patients with incident ALS and controls were recruited from five population-based registers in The Netherlands, Ireland and Italy. Demographic and data regarding educational level, smoking, alcohol habits and lifetime PA levels in both leisure and work time were gathered by questionnaire, and quantified using metabolic equivalent of task scores. Logistic regression models adjusting for PA-related factors were used to determine the association between PA and ALS risk, and forest plots were used to visualise heterogeneity between regions. Results 1557 patients and 2922 controls were included. We found a linear association between ALS and PA in leisure time (OR 1.07, P=0.01) and occupational activities (OR 1.06, P<0.001), and all activities combined (OR 1.06, P<0.001), with some heterogeneity between regions: the most evident association was seen in the Irish and Italian cohorts. After adjustment for other occupational exposures or exclusion of patients with a C9orf72 mutation, the ORs remained similar. Conclusion We provide new class I evidence for a positive association between PA and risk of ALS in a large multicentre study using harmonised methodology to objectively quantify PA levels, with some suggestions for population differences

Published
2018

4. Memantine in moderately-severe-to-severe Alzheimer's disease: a postmarketing surveillance study

Author

Clerici F, Vanacore N, Elia A, Spila Alegiani S, Pomati S, Da Cas R, Raschetti R, Mariani C, Memantine Lombardy Study Group, Altavilla, R, APPOLLONIO, ILDEBRANDO, ISELLA, VALERIA, Avanzi, S, Bargnani, C, Bascelli, C, BELLELLI, GIUSEPPE, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, PL, Magnani, G, Schiatti, E, Marcone, A, Giusti, MC, Margarito, FP, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, CN, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, GP, Manzoni, L, Saviotti, FM, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati S, D, Raschetti, R, Mariani, C, Memantine Lombardy Study, G, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, and Alberici, A

Subjects
Male, medicine.medical_specialty, Postmarketing surveillance, Severity of Illness Index, law.invention, Demenza, malattia di Alzheimer, Randomized controlled trial, law, Alzheimer Disease, Memantine, Internal medicine, medicine, Product Surveillance, Postmarketing, Dementia, Humans, Pharmacology (medical), Adverse effect, Aged, MED/26 - NEUROLOGIA, Aged, 80 and over, Psychiatric Status Rating Scales, business.industry, Odds ratio, medicine.disease, Surgery, Treatment Outcome, Tolerability, Italy, Clinical Global Impression, Female, Geriatrics and Gerontology, business, Excitatory Amino Acid Antagonists, memantina, medicine.drug
Abstract

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.

Published
2009

5. Memantine effects on behaviour in moderately severe to severe Alzheimer's disease: a post-marketing surveillance study

Author

Clerici, F, Vanacore, N, Elia, A, Spila-Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, Pl, Magnani, G, Schiatti, E, Marcone, A, Giusti, Mc, Margarito, Fp, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Negri Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petrò, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, Gp, Manzoni, L, Saviotti, Fm, Scarpini, E, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Marcon, Gabriella, and Appollonio, I

Subjects
Male, medicine.medical_specialty, Psychosis, Hallucinations, Behavioural and psychological symptoms of dementia, Apathy, Dopamine Agents, Postmarketing surveillance, Dermatology, Anxiety, Neuropsychological Tests, Logistic regression, Disease cluster, Severity of Illness Index, Alzheimer's disease, Memantine, Post-marketing surveillance study, Alzheimer Disease, Internal medicine, Severity of illness, Product Surveillance, Postmarketing, medicine, Humans, Dementia, Psychiatry, BIO/14 - FARMACOLOGIA, Aged, Aged, 80 and over, MED/26 - NEUROLOGIA, treatment, Depression, Feeding Behavior, General Medicine, medicine.disease, Psychiatry and Mental health, Treatment Outcome, Hypomania, Female, Neurology (clinical), medicine.symptom, Psychology, Follow-Up Studies, dementia, medicine.drug
Abstract

The aim of this study is to evaluate memantine effectiveness on behavioural and psychological symptoms of dementia (BPSD) in clinical practice and to identify variables that may predict the therapy effects. The effects of memantine on behaviour were analysed in the database of a post-marketing surveillance study promoted by the Lombardy Region Health Office and involving 43 Alzheimer's disease (AD) Units. From July to December 2005, 399 moderately severe-to-severe AD patients free of cholinergic medications were enrolled, treated with memantine and followed-up for 6 months. BPSD were assessed in a subgroup of 297 patients [mean age 77 ± 8 years; 73% females; mean neuropsychiatric inventory (NPI) score 28 ± 24] for whom the 12-item NPI subscores at baseline, and at 3 and 6 months were available. The 12 BPSD were clustered as follows: affect, physical behaviour, psychosis and hypomania. The main outcome measure was the proportion of individual cluster responders at 6 months of therapy. The proportion of individual cluster responders was 30% affect, 24% physical behaviour, 29% psychosis, 27% hypomania. Patients taking 20 mg memantine daily during the study period had a statistically significant higher probability to experience behavioural improvement than those who discontinued treatment or did not complete memantine titration (affect OR 9.0; 95% CI 3.8-21.6; physical behaviour OR 17.8; 95% CI 5.9-53.6; psychosis OR 23.6; 95% CI 5.1-110.8). The logistic regression analysis was not applicable to the hypomania subsyndrome because of the low cluster prevalence. The standard 20 mg daily memantine treatment regimen was found to be associated with a modest 6-month behavioural improvement in the affect, physical behaviour and psychosis domains in 24-30% of patients.

Published
2012

6. Memantine in moderately-severe-to-severe Alzheimer's disease: a postmarketing surveillance study

Author

Clerici, F, Vanacore, N, Elia, A, Spila-Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Negri Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petrò, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, and Alberici, A

Published
2009

7. Memantine in moderately-severe-to-severe Alzheimer's disease: a post-marketing surveillance study

Author

Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati S, D, Raschetti, R, Mariani, C, Memantine Lombardy Study, G, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A, Clerici F, Vanacore N, Elia A, Spila Alegiani S, Pomati S, Da Cas R, Raschetti R, Mariani C, Memantine Lombardy Study Group, APPOLLONIO, ILDEBRANDO, ISELLA, VALERIA, BELLELLI, GIUSEPPE, Ratti, PL, Giusti, MC, Margarito, FP, Chinaglia, CN, Salvi, GP, Saviotti, FM, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati S, D, Raschetti, R, Mariani, C, Memantine Lombardy Study, G, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A, Clerici F, Vanacore N, Elia A, Spila Alegiani S, Pomati S, Da Cas R, Raschetti R, Mariani C, Memantine Lombardy Study Group, APPOLLONIO, ILDEBRANDO, ISELLA, VALERIA, BELLELLI, GIUSEPPE, Ratti, PL, Giusti, MC, Margarito, FP, Chinaglia, CN, Salvi, GP, Saviotti, FM, and Alberici, A.

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%) w

Published
2009

8. Italian Neurological Society guidelines for the diagnosis of dementia: Revision l

Author

Musico, M., Caltagirone, C., Sorbi, S., Bonavita, V., Alberoni, M., Alfieri, P., Altavista, M. C., Amici, S., Antana, D., ILDEBRANDO APPOLLONIO, Avanzi, S., Bartolini, M., Bergamasco, B., Blundo, C., Bonavia, V., Bonuccelli, U., Cipriani, G., Bracco, L., Bruni, A. C., Bugiani, O., Caffara, P., Perri, R., Camarda, R., Canal, N., Cannatà, A., Cantone, G., Carabelli, E., Cardei, A., Carlomagno, S., Casini, A. R., Cheldi, A., Cannnella, L., Citterio, A., Daniele, A., D Anna, S., Del Curatolo, G., Del Pesce, M., Aversana, R., Farina, E., Fasanaro, A. M., Franceschi, M., Gabriele, P., Gainotti, G., Galante, E., Gallai, V., Gallasi, R., Bambina, S., Gasparini, M., Giaccone, G., Giubilei, F., Grassi, M. P., Grimaldi, L., Grioli, S., Bianca, S. G., Guarnirei, M., Batoli, A., Jandolo, B., Temolo, F., La Stilla, M., Latino, R. R., Lenzi, G. L., Lorusso, S., Magnani, G., Malaga, S., Manfredi, L., Marcon, G., Marcore, A., Mariani, C., Mearelli, S., Minore, A., Moleri, M., Morante, M., Morbin, M., Moretti, P., Murri, L., Rognoni, G., Musicco, M., Nichelli, P., Paciello, M., Padovani, A., Paganini, M., Pantieri, R., Parisen, P., Parnetti, L., Partitico, D., Pasquale, S., Passerella, B., Perini, M., Pettinati, C., Piacentini, S., Piccoli, F., Piccolini, C., Pinardi, G., Piras, M. R., Cerchi, R., Principe, M., Provinciali, L., Pugliese, N., Musicco M., Caltagirone C., Sorbi S., Bonavita V., and Gallassi R.

Subjects
Neurologic Examination, medicine.medical_specialty, business.industry, Linee guida, Malattia di Alzheimer, Diagnosi, Demenza, Dermatology, General Medicine, medicine.disease, Psychiatry and Mental health, Italy, Neurology, Medical, mental disorders, medicine, Dementia, Humans, Settore MED/26 - Neurologia, Neurology (clinical), Psychiatry, business, Societies, Societies, Medical
Abstract

The objective of this study was to verify the adherence of Italian family physicians and neurologists to the Guidelines on Diagnosis of Dementia of the Italian Society of Neurology. A multicentre survey was carried out, in 72 neurological centres. The centres included at least 15 consecutive subjects suspected of having a dementia. The adherence of family physicians to the guidelines was poor. Neurologists performed a complete neuropsychological evaluation in a minority of the cases. Patients who had a decrease of Mini Mental Status Examination scores after six months higher than or equal to 4 were more represented among those patients for whom one or more recommendations were not respected. In Italy the adherence to the Guidelines on Diagnosis of Dementia and AlzheimerValidation studys Disease of the Italian Society of Neurology is very poor for family physicians (GPs) and satisfactory, albeit improvable, on the part of neurologists. Respect for the guidelines might improve the outcome of patients with dementia.

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