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1. Continuous Subcutaneous Insulin Infusion in Italy: Third National Survey

Author

Bruttomesso D., Laviola L., Lepore G., Bonfanti R., Bozzetto L., Corsi A., Di Blasi V., Girelli A., Grassi G., Iafusco D., Rabbone I., Schiaffini R., Montani V., Colleluori P., Paciotti V., Alfidi P., Grosso J., Tumini S., Cipriano P., Vitacolonna E., Di Vieste G., Minnucci A., Antenucci D., La Penna G., Taraborrelli M., Macerala B., Citro G., De Morelli G., Gnasso A., Irace C., Citriniti F., Lazzaro N., Bruzzese M., Mammi F., De Berardinis F., Santoro E., Corigliano G., Corigliano M., Parillo M., Schettino M., Fresa R., Annuzzi G., Bassi V., Santinelli C., Buono P., Mozzillo E., De Feo E., Esposito K., Petrizzo M., Foglia A., Gatti A., Gentile S., Guarino G., Zanfardino A., Lambiase C., Vitale A., Zucchini S., Maltoni G., Forlani G., Moscatiello S., Suprani T., Bensa M., Tomasi F., Monesi M., Nizzoli M., Acquati S., Chierici G., Milli B., Iughetti L., Predieri B., Cavani R., Romano S., Manicardi V., Michelini M., Cimicchi M. C., Ugolotti D., Zavaroni I., Dei Cas A., Dall'Aglio E., Papi M., Tardio S. M., Calderini M. C., Riboni S., D'Amato L., Zavaroni D., Gastaldi L., Di Bartolo P., Pellicano F., Cirillo A., Graziani V., Di Secli C., Amarri S., Lasagni A., Marsciani A., Pedini A., Pagliani U., Rossi C., Tortul C., Brunato B., Assaloni R., Zanette G., Livolsi P., Petrucco A., Tercelj K., Manca E., Candido R., Tommasi E., Tornese G., Faleschini E., Tonutti L., Agus S., Zanatta M., Rosolen A., Comici A., Graziano F. M., Misischi I., Pozzilli P., Maurizi A. R., Falasca P., Tuccinardi F., Ricciardi G. P., Di Masa P., Ragonese M., Cipolloni L., Buzzetti R., Moretti C., Leto G., Crino A., Bocchini S., Di Perna P., Giuliano M., Frontoni S., Malandrucco I., Pitocco D., Scalpone R., Toscanella F., Cappa M., Ventura C., Bonato V., De Bernardinis M., Cavallo M. G., Leonetti F., Morano S., Mandosi E., Cicconetti E., Ciampittiello G., Marini M. A., Sabato D., Napoli A., Giraudo F., Toscano V., Massimiani F., Fava D., Gargiulo P., Mecca N., Tubili C., Nardone M. R., Morviducci L., Manca-Bitti M. L., Arcano S., Leotta S., Suraci C., Chiaramonte F., Visalli N., Forte E., Palmacci C., Arnaldi C., Tosini D., Querci F., Trevisan R., Bonfadini S., Prandi E., Felappi B., Locatelli F., Fuso V., Rocca A., Meneghini E., Massafra C., Terni T., Elli P., Ruggeri P., Carrai E., Musacchio N., Lovagnini Scher C. A., Marelli G., Vilei V., Richini D., Inversini C., Franzetti I., Bonacina M., Ciucci A., Sciangula L., Duratorre E., Bonomo M., Bertuzzi F., Chebat E., Muratori M., Scaramuzza A., Zuccotti G. V., Bollati P. M., Colapinto P., Orsi E., Palmieri E., Laurenzi A., Molinari C., Frontino G., Veronelli A., Zecchini B., Bianchi A., Torchio G., Lovati E., Ghilardi G., Dagani R., Carugo D., Berra C., Favacchio G., Fochesato E., Pissarelli A., Bucciarelli L., Bulgheroni M., Guerraggio L., Zonca S., Bossi A. C., Berzi D., Mangone I., Cazzaniga E., Rabini R. A., Boemi M., Faloia E., Boscaro M., Sternari G., Iannilli A., Cherubini V., Busciantella Ricci N., Cartechini M. G., Tesei A. M., Maolo G., Galetta M., Vespasiani G., Tinti G., Manfrini S., Aiello A., Di Vincenzo S., Vitale C., Di Caro P., Lera R., Secco A., Lesina A., Romeo F., Origlia C., Giorda C., Chiambretti A. M., Fornengo R., De Donno V., Gallarotti F., Manti R., Marafetti L., Cadario F., Savastio S., Barbieri P., Massucco P., Ali A., Gottero C., Degiovanni M., Bertaina S., Maghenzani G., Tinti D., Fontana F., Giorgino F., Stefanelli G., Cavallo L., Zecchino C., Piccinno E., Ortolani F., Gallo F., Moramarco F., Marino A., Sparasci G., Mileti G., Lamacchia O., Picca G., Coccioli M. S., Micale F., Serra R., Romano I., Savino T., De Cosmo S., Rauseo A., Delvecchio M., Lapolla R., Braione A. F., Papagno G., Baroni M., Melis M., Cossu E., Songini M., Cambuli V. M., Lo Presti D., Timpanaro T. A., Chiavetta A., Garofalo M. R., Tommaselli L., Tumminia A., Scarpitta A. M., Di Benedetto A., Giunta L., Lombardo F., Salzano G., Cardella F., Roppolo R., Provenzano V., Fleres M., Migliorini S., De Luca A., Leopardi A., Beltrami C., Toni S., Guasti G., Lenzi L., Lamanna C., Mannucci E., Lucchesi S., Dicianni G., Aragona M., Del Prato S., Fattor B., Eisath J., Pasquino B., Reinstadler P., Kaufmann P., Incelli G., Rauch S., Romanelli T., Cauvin V., Franceschi R., Soldani C., Scattoni R., Norgiolini R., Celleno R., Torlone E., Bolli G. B., Lalli C., Scarponi M., Bobbio A., Bechaz M., Pianta A., Marangoni A., Arico C. N., Alagona C., Confortin L., Rossi E., Boscolo Bariga A., Nogara A., Bettio M., Frison V., Guidoni G. L., Fongher C., Contin M. L., Cosma A., Vianello S., Bondesan L., Morea A., Volpi A., Coracina A., Panebianco G., Lombardi S., Costa S., Cipponeri E., Vedovato M., Scotton R., Monciotti C. M., Galderisi A., Dalfra M. G., Lapolla A., Zanon M., Lisato G., Mollo F., Calcaterra F., Miola M., Paccagnella A., Sambataro M., Moro E., Trombetta M., Negri C., Sabbion A., Maffeis C., Strazzabosco M., Mesturino C. A., Mingardi R., Bruttomesso, D., Laviola, L., Lepore, G., Bonfanti, R., Bozzetto, L., Corsi, A., Di Blasi, V., Girelli, A., Grassi, G., Iafusco, D., Rabbone, I., Schiaffini, R., Montani, V., Colleluori, P., Paciotti, V., Alfidi, P., Grosso, J., Tumini, S., Cipriano, P., Vitacolonna, E., Di Vieste, G., Minnucci, A., Antenucci, D., La Penna, G., Taraborrelli, M., Macerala, B., Citro, G., De Morelli, G., Gnasso, A., Irace, C., Citriniti, F., Lazzaro, N., Bruzzese, M., Mammi, F., De Berardinis, F., Santoro, E., Corigliano, G., Corigliano, M., Parillo, M., Schettino, M., Fresa, R., Annuzzi, G., Bassi, V., Santinelli, C., Buono, P., Mozzillo, E., De Feo, E., Esposito, K., Petrizzo, M., Foglia, A., Gatti, A., Gentile, S., Guarino, G., Zanfardino, A., Lambiase, C., Vitale, A., Zucchini, S., Maltoni, G., Forlani, G., Moscatiello, S., Suprani, T., Bensa, M., Tomasi, F., Monesi, M., Nizzoli, M., Acquati, S., Chierici, G., Milli, B., Iughetti, L., Predieri, B., Cavani, R., Romano, S., Manicardi, V., Michelini, M., Cimicchi, M. C., Ugolotti, D., Zavaroni, I., Dei Cas, A., Dall'Aglio, E., Papi, M., Tardio, S. M., Calderini, M. C., Riboni, S., D'Amato, L., Zavaroni, D., Gastaldi, L., Di Bartolo, P., Pellicano, F., Cirillo, A., Graziani, V., Di Secli, C., Amarri, S., Lasagni, A., Marsciani, A., Pedini, A., Pagliani, U., Rossi, C., Tortul, C., Brunato, B., Assaloni, R., Zanette, G., Livolsi, P., Petrucco, A., Tercelj, K., Manca, E., Candido, R., Tommasi, E., Tornese, G., Faleschini, E., Tonutti, L., Agus, S., Zanatta, M., Rosolen, A., Comici, A., Graziano, F. M., Misischi, I., Pozzilli, P., Maurizi, A. R., Falasca, P., Tuccinardi, F., Ricciardi, G. P., Di Masa, P., Ragonese, M., Cipolloni, L., Buzzetti, R., Moretti, C., Leto, G., Crino, A., Bocchini, S., Di Perna, P., Giuliano, M., Frontoni, S., Malandrucco, I., Pitocco, D., Scalpone, R., Toscanella, F., Cappa, M., Ventura, C., Bonato, V., De Bernardinis, M., Cavallo, M. G., Leonetti, F., Morano, S., Mandosi, E., Cicconetti, E., Ciampittiello, G., Marini, M. A., Sabato, D., Napoli, A., Giraudo, F., Toscano, V., Massimiani, F., Fava, D., Gargiulo, P., Mecca, N., Tubili, C., Nardone, M. R., Morviducci, L., Manca-Bitti, M. L., Arcano, S., Leotta, S., Suraci, C., Chiaramonte, F., Visalli, N., Forte, E., Palmacci, C., Arnaldi, C., Tosini, D., Querci, F., Trevisan, R., Bonfadini, S., Prandi, E., Felappi, B., Locatelli, F., Fuso, V., Rocca, A., Meneghini, E., Massafra, C., Terni, T., Elli, P., Ruggeri, P., Carrai, E., Musacchio, N., Lovagnini Scher, C. A., Marelli, G., Vilei, V., Richini, D., Inversini, C., Franzetti, I., Bonacina, M., Ciucci, A., Sciangula, L., Duratorre, E., Bonomo, M., Bertuzzi, F., Chebat, E., Muratori, M., Scaramuzza, A., Zuccotti, G. V., Bollati, P. M., Colapinto, P., Orsi, E., Palmieri, E., Laurenzi, A., Molinari, C., Frontino, G., Veronelli, A., Zecchini, B., Bianchi, A., Torchio, G., Lovati, E., Ghilardi, G., Dagani, R., Carugo, D., Berra, C., Favacchio, G., Fochesato, E., Pissarelli, A., Bucciarelli, L., Bulgheroni, M., Guerraggio, L., Zonca, S., Bossi, A. C., Berzi, D., Mangone, I., Cazzaniga, E., Rabini, R. A., Boemi, M., Faloia, E., Boscaro, M., Sternari, G., Iannilli, A., Cherubini, V., Busciantella Ricci, N., Cartechini, M. G., Tesei, A. M., Maolo, G., Galetta, M., Vespasiani, G., Tinti, G., Manfrini, S., Aiello, A., Di Vincenzo, S., Vitale, C., Di Caro, P., Lera, R., Secco, A., Lesina, A., Romeo, F., Origlia, C., Giorda, C., Chiambretti, A. M., Fornengo, R., De Donno, V., Gallarotti, F., Manti, R., Marafetti, L., Cadario, F., Savastio, S., Barbieri, P., Massucco, P., Ali, A., Gottero, C., Degiovanni, M., Bertaina, S., Maghenzani, G., Tinti, D., Fontana, F., Giorgino, F., Stefanelli, G., Cavallo, L., Zecchino, C., Piccinno, E., Ortolani, F., Gallo, F., Moramarco, F., Marino, A., Sparasci, G., Mileti, G., Lamacchia, O., Picca, G., Coccioli, M. S., Micale, F., Serra, R., Romano, I., Savino, T., De Cosmo, S., Rauseo, A., Delvecchio, M., Lapolla, R., Braione, A. F., Papagno, G., Baroni, M., Melis, M., Cossu, E., Songini, M., Cambuli, V. M., Lo Presti, D., Timpanaro, T. A., Chiavetta, A., Garofalo, M. R., Tommaselli, L., Tumminia, A., Scarpitta, A. M., Di Benedetto, A., Giunta, L., Lombardo, F., Salzano, G., Cardella, F., Roppolo, R., Provenzano, V., Fleres, M., Migliorini, S., De Luca, A., Leopardi, A., Beltrami, C., Toni, S., Guasti, G., Lenzi, L., Lamanna, C., Mannucci, E., Lucchesi, S., Dicianni, G., Aragona, M., Del Prato, S., Fattor, B., Eisath, J., Pasquino, B., Reinstadler, P., Kaufmann, P., Incelli, G., Rauch, S., Romanelli, T., Cauvin, V., Franceschi, R., Soldani, C., Scattoni, R., Norgiolini, R., Celleno, R., Torlone, E., Bolli, G. B., Lalli, C., Scarponi, M., Bobbio, A., Bechaz, M., Pianta, A., Marangoni, A., Arico, C. N., Alagona, C., Confortin, L., Rossi, E., Boscolo Bariga, A., Nogara, A., Bettio, M., Frison, V., Guidoni, G. L., Fongher, C., Contin, M. L., Cosma, A., Vianello, S., Bondesan, L., Morea, A., Volpi, A., Coracina, A., Panebianco, G., Lombardi, S., Costa, S., Cipponeri, E., Vedovato, M., Scotton, R., Monciotti, C. M., Galderisi, A., Dalfra, M. G., Lapolla, A., Zanon, M., Lisato, G., Mollo, F., Calcaterra, F., Miola, M., Paccagnella, A., Sambataro, M., Moro, E., Trombetta, M., Negri, C., Sabbion, A., Maffeis, C., Strazzabosco, M., Mesturino, C. A., Mingardi, R., Bruttomesso, D, Laviola, L, Lepore, G, Bonfanti, R, Bozzetto, L, Corsi, A, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Rabbone, I, Schiaffini, R, Montani, V, Colleluori, P, Paciotti, V, Alfidi, P, Grosso, J, Tumini, S, Cipriano, P, Vitacolonna, E, Di Vieste, G, Minnucci, A, Antenucci, D, La Penna, G, Taraborrelli, M, Macerala, B, Citro, G, De Morelli, G, Gnasso, A, Irace, C, Citriniti, F, Lazzaro, N, Bruzzese, M, Mammi, F, De Berardinis, F, Santoro, E, Corigliano, G, Corigliano, M, Parillo, M, Schettino, M, Fresa, R, Annuzzi, G, Bassi, V, Santinelli, C, Buono, P, Mozzillo, E, De Feo, E, Esposito, K, Petrizzo, M, Foglia, A, Gatti, A, Gentile, S, Guarino, G, Zanfardino, A, Lambiase, C, Vitale, A, Zucchini, S, Maltoni, G, Forlani, G, Moscatiello, S, Suprani, T, Bensa, M, Tomasi, F, Monesi, M, Nizzoli, M, Acquati, S, Chierici, G, Milli, B, Iughetti, L, Predieri, B, Cavani, R, Romano, S, Manicardi, V, Michelini, M, Cimicchi, M, Ugolotti, D, Zavaroni, I, Dei Cas, A, Dall'Aglio, E, Papi, M, Tardio, S, Calderini, M, Riboni, S, D'Amato, L, Zavaroni, D, Gastaldi, L, Di Bartolo, P, Pellicano, F, Cirillo, A, Graziani, V, Di Secli, C, Amarri, S, Lasagni, A, Marsciani, A, Pedini, A, Pagliani, U, Rossi, C, Tortul, C, Brunato, B, Assaloni, R, Zanette, G, Livolsi, P, Petrucco, A, Tercelj, K, Manca, E, Candido, R, Tommasi, E, Tornese, G, Faleschini, E, Tonutti, L, Agus, S, Zanatta, M, Rosolen, A, Comici, A, Graziano, F, Misischi, I, Pozzilli, P, Maurizi, A, Falasca, P, Tuccinardi, F, Ricciardi, G, Di Masa, P, Ragonese, M, Cipolloni, L, Buzzetti, R, Moretti, C, Leto, G, Crino, A, Bocchini, S, Di Perna, P, Giuliano, M, Frontoni, S, Malandrucco, I, Pitocco, D, Scalpone, R, Toscanella, F, Cappa, M, Ventura, C, Bonato, V, De Bernardinis, M, Cavallo, M, Leonetti, F, Morano, S, Mandosi, E, Cicconetti, E, Ciampittiello, G, Marini, M, Sabato, D, Napoli, A, Giraudo, F, Toscano, V, Massimiani, F, Fava, D, Gargiulo, P, Mecca, N, Tubili, C, Nardone, M, Morviducci, L, Manca-Bitti, M, Arcano, S, Leotta, S, Suraci, C, Chiaramonte, F, Visalli, N, Forte, E, Palmacci, C, Arnaldi, C, Tosini, D, Querci, F, Trevisan, R, Bonfadini, S, Prandi, E, Felappi, B, Locatelli, F, Fuso, V, Rocca, A, Meneghini, E, Massafra, C, Terni, T, Elli, P, Ruggeri, P, Carrai, E, Musacchio, N, Lovagnini Scher, C, Marelli, G, Vilei, V, Richini, D, Inversini, C, Franzetti, I, Bonacina, M, Ciucci, A, Sciangula, L, Duratorre, E, Bonomo, M, Bertuzzi, F, Chebat, E, Muratori, M, Scaramuzza, A, Zuccotti, G, Bollati, P, Colapinto, P, Orsi, E, Palmieri, E, Laurenzi, A, Molinari, C, Frontino, G, Veronelli, A, Zecchini, B, Bianchi, A, Torchio, G, Lovati, E, Ghilardi, G, Dagani, R, Carugo, D, Berra, C, Favacchio, G, Fochesato, E, Pissarelli, A, Bucciarelli, L, Bulgheroni, M, Guerraggio, L, Zonca, S, Bossi, A, Berzi, D, Mangone, I, Cazzaniga, E, Rabini, R, Boemi, M, Faloia, E, Boscaro, M, Sternari, G, Iannilli, A, Cherubini, V, Busciantella Ricci, N, Cartechini, M, Tesei, A, Maolo, G, Galetta, M, Vespasiani, G, Tinti, G, Manfrini, S, Aiello, A, Di Vincenzo, S, Vitale, C, Di Caro, P, Lera, R, Secco, A, Lesina, A, Romeo, F, Origlia, C, Giorda, C, Chiambretti, A, Fornengo, R, De Donno, V, Gallarotti, F, Manti, R, Marafetti, L, Cadario, F, Savastio, S, Barbieri, P, Massucco, P, Ali, A, Gottero, C, Degiovanni, M, Bertaina, S, Maghenzani, G, Tinti, D, Fontana, F, Giorgino, F, Stefanelli, G, Cavallo, L, Zecchino, C, Piccinno, E, Ortolani, F, Gallo, F, Moramarco, F, Marino, A, Sparasci, G, Mileti, G, Lamacchia, O, Picca, G, Coccioli, M, Micale, F, Serra, R, Romano, I, Savino, T, De Cosmo, S, Rauseo, A, Delvecchio, M, Lapolla, R, Braione, A, Papagno, G, Baroni, M, Melis, M, Cossu, E, Songini, M, Cambuli, V, Lo Presti, D, Timpanaro, T, Chiavetta, A, Garofalo, M, Tommaselli, L, Tumminia, A, Scarpitta, A, Di Benedetto, A, Giunta, L, Lombardo, F, Salzano, G, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Migliorini, S, De Luca, A, Leopardi, A, Beltrami, C, Toni, S, Guasti, G, Lenzi, L, Lamanna, C, Mannucci, E, Lucchesi, S, Dicianni, G, Aragona, M, Del Prato, S, Fattor, B, Eisath, J, Pasquino, B, Reinstadler, P, Kaufmann, P, Incelli, G, Rauch, S, Romanelli, T, Cauvin, V, Franceschi, R, Soldani, C, Scattoni, R, Norgiolini, R, Celleno, R, Torlone, E, Bolli, G, Lalli, C, Scarponi, M, Bobbio, A, Bechaz, M, Pianta, A, Marangoni, A, Arico, C, Alagona, C, Confortin, L, Rossi, E, Boscolo Bariga, A, Nogara, A, Bettio, M, Frison, V, Guidoni, G, Fongher, C, Contin, M, Cosma, A, Vianello, S, Bondesan, L, Morea, A, Volpi, A, Coracina, A, Panebianco, G, Lombardi, S, Costa, S, Cipponeri, E, Vedovato, M, Scotton, R, Monciotti, C, Galderisi, A, Dalfra, M, Lapolla, A, Zanon, M, Lisato, G, Mollo, F, Calcaterra, F, Miola, M, Paccagnella, A, Sambataro, M, Moro, E, Trombetta, M, Negri, C, Sabbion, A, Maffeis, C, Strazzabosco, M, Mesturino, C, Mingardi, R, Bruttomesso, Daniela, Laviola, Luigi, Lepore, Giuseppe, Bonfanti, Riccardo, Bozzetto, Lutgarda, Corsi, Andrea, Di Blasi, Vincenzo, Girelli, Angela, Grassi, Giorgio, Iafusco, Dario, Rabbone, Ivana, Schiaffini, Riccardo, and Tornese, Gianluca

Subjects
Blood Glucose, Male, Pediatrics, Glucose control, IMPACT, Cost-Benefit Analysis, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, CHILDREN, Practice Patterns, Infusions, Subcutaneous, law.invention, Settore MED/13, Endocrinology, Randomized controlled trial, law, Surveys and Questionnaires, Insulin, Practice Patterns, Physicians', Child, Adult, Diabetes Mellitus, Type 1, Female, Guideline Adherence, Health Care Surveys, Humans, Hypoglycemic Agents, Italy, Medical Laboratory Technology, Medicine (all), PUMP THERAPY, Subcutaneous, Diabetes, Diabetes and Metabolism, TERM METABOLIC-CONTROL, Human, Type 1, Infusions, medicine.medical_specialty, Keywords KeyWords Plus:TERM METABOLIC-CONTROL, BOLUS CALCULATOR, PEDIATRIC-PATIENTS, CONTROLLED-TRIAL, CSII, Diabetes mellitus, Diabetes Mellitus, medicine, term metabolic-control, bolus calculator, pump therapy, pediatric-patients, controlled-trial, children, impact CSII, Glucose sensors, Cost-Benefit Analysi, Intensive care medicine, Type 1 diabetes, Physicians', Hypoglycemic Agent, business.industry, medicine.disease, Subcutaneous insulin, Infusions, Subcutaneou, Multicenter study, Health Care Survey, business
Abstract

Background: Continuous subcutaneous insulin infusion (CSII) is increasing worldwide, mostly because of improved technology. The aim of this study was to evaluate the current status of CSII in Italy. Materials and Methods: Physicians from 272 diabetes centers received a questionnaire investigating clinical features, pump technology, and management of patients on CSII. Results: Two hundred seventeen centers (79.8%) joined the study and, by the end of April 2013, gave information about 10,152 patients treated with CSII: 98.2% with type 1 diabetes mellitus, 81.4% adults, 57% female, and 61% with a conventional pump versus 39% with a sensor-augmented pump. CSII advanced functions were used by 68% of patients, and glucose sensors were used 12 days per month on average. Fifty-eight percent of diabetes centers had more than 20 patients on CSII, but there were differences among centers and among regions. The main indication for CSII was poor glucose control. Dropout was mainly due to pump wearability or nonoptimal glycemic control. Twenty-four hour assistance was guaranteed in 81% of centers. A full diabetes team (physician+ nurse + dietician + psychologist) was available in 23% of adult-care diabetes centers and in 53%of pediatric diabetes units. Conclusions: CSII keeps increasing in Italy. More work is needed to ensure uniform treatment strategies throughout the country and to improve pump use.

Published
2015

4. Subcutaneous insulin infusion (CSII) in italy: The third national survey,La terapia insulinica sottocutanea continua (CSII) in Italia. Terza indagine nazionale

Author

Bruttomesso, D., Laviola, L., Lepore, G., Bonfanti, R., Bozzetto, L., Corsi, A., Di Blasi, V., Girelli, A., Grassi, G., Iafusco, D., Rabbone, I., Schiaffini, R., Montani, V., Colleluori, P., Paciotti, V., Alfidi, P., Grosso, J., Tumini, S., Cipriano, P., Vitacolonna, E., Di Vieste, G., Minnucci, A., Antenucci, D., La Penna, G., Taraborrelli, M., Macerala, B., Citro, G., Morelli, G., Gnasso, A., Irace, C., Citriniti, F., Lazzaro, N., Bruzzese, M., Mammì, F., Berardinis, F., Santoro, E., Corigliano, G., Corigliano, M., Parillo, M., Schettino, M., Fresa, R., Annuzzi, G., Bassi, V., Santinelli, C., Buono, P., Mozzillo, E., Russo, V., Feo, E., Esposito, K., Petrizzo, M., Foglia, A., Gatti, A., Gentile, S., Guarino, G., Zanfardino, A., Lambiase, C., Vitale, A., Zucchini, S., Maltoni, G., Forlani, G., Moscatiello, S., Suprani, T., Bensa, M., Tomasi, F., Monesi, M., Nizzoli, M., Acquati, S., Chierici, G., Milli, B., Iughetti, L., Predieri, B., Cavani, R., Romano, S., Manicardi, V., Michelini, M., Cimicchi, M. C., Ugolotti, D., Zavaroni, I., Dei Cas, A., Dall’aglio, E., Papi, M., Tardio, S. M., Calderini, M. C., Riboni, S., D’amato, L., Zavaroni, D., Gastaldi, L., Cirillo, A., Di Bartolo, P., Pellicano, F., Di Seclì, C., Amarri, S., Lasagni, A., Marsciani, A., Pedini, A., Pagliani, U., Rossi, C., Tortul, C., Brunato, B., Assaloni, R., Zanette, G., Livolsi, P., Petrucco, A., Tercelj, K., Manca, E., Candido, R., Tommasi, E., Tornese, G., Faleschini, E., Tonutti, L., Agus, S., Zanatta, M., Rosolen, A., Comici, A., Falasca, P., Graziano, F. M., Misischi, I., Forte, E., Palmacci, C., Tuccinardi, F., Ricciardi, G. P., Di Masa, P., Ragonese, M., Cipolloni, L., Buzzetti, R., Moretti, C., Leto, G., Crinò, A., Bocchini, S., Pozzilli, P., Maurizi, A. R., Di Perna, P., Giuliano, M., Frontoni, S., Malandrucco, I., Pitocco, D., Scalpone, R., Toscanella, F., Cappa, M., Ventura, C., Bonato, V., Bernardinis, M., Cavallo, M. G., Leonetti, F., Morano, S., Mandosi, E., Cicconetti, E., Ciampittiello, G., Marini, M. A., Sabato, D., Lauro, D., Napoli, A., Giraudo, F., Toscano, V., Pugliese, G., Massimiani, F., Fava, D., Gargiulo, P., Mecca, N., Tubili, C., Nardone, M. R., Morviducci, L., Manca-Bitti, M. L., Arcano, S., Leotta, S., Suraci, C., Chiaramonte, F., Visalli, N., Strollo, F., Arnaldi, C., Tosini, D., Ponzani, P., Patrone, M., Guido, R., Aglialoro, A., Ghisoni, G., Fabbri, F., Bordone, C., Maggi, D., Cordera, R., Minuto, N., Rotondo, E., Speranza, D., Siri, M., Carro, S., Zappa, A., Parmigiani, S., Nieri, S., Briatore, L., Calvo, G., Querci, F., Trevisan, R., Bonfadini, S., Prandi, E., Felappi, B., Locatelli, F., Fuso, V., Rocca, A., Meneghini, E., Massafra, C., Terni, T., Elli, P., Ruggeri, P., Carrai, E., Musacchio, N., Marelli, G., Vilei, V., Richini, D., Inversini, C., Franzetti, I., Bonacina, M., Ciucci, A., Sciangula, L., Duratorre, E., Bonomo, M., Bertuzzi, F., Chebat, E., Muratori, M., Scaramuzza, A., Zuccotti, G. V., Bollati, P. M., Colapinto, P., Orsi, E., Palmieri, E., Laurenzi, A., Molinari, C., Frontino, G., Veronelli, A., Zecchini, B., Bianchi, A., Torchio, G., Lovati, E., Ghilardi, G., Dagani, R., Berra, C., Fochesato, E., Pissarelli, A., Bucciarelli, L., Bulgheroni, M., Guerraggio, L., Zonca, S., Bossi, A. C., Berzi, D., Mangone, I., Cazzaniga, E., Rabini, R. A., Boemi, M., Faloia, E., Boscaro, M., Sternari, G., Iannilli, A., Cherubini, V., Tinti, G., Manfrini, S., Tesei, A. M., Maolo, G., Galetta, M., Vespasiani, G., Busciantella Ricci, N., Cartechini, M. G., Aiello, A., Di Vincenzo, S., Vitale, C., Di Caro, P., Lera, R., Secco, A., Lesina, A., Romeo, F., Origlia, C., carlo giorda, Chiambretti, A. M., Fornengo, R., Donno, V., Gallarotti, F., Manti, R., Marafetti, L., Cadario, F., Savastio, S., Barbieri, P., Massucco, P., Alì, A., Gottero, C., Degiovanni, M., Bertaina, S., Maghenzani, G., Tinti, D., Fontana, F., Giorgino, F., Stefanelli, G., Cavallo, L., Zecchino, C., Piccinno, E., Ortolani, F., Gallo, F., Moramarco, F., Marino, A., Sparasci, G., Mileti, G., Lamacchia, O., Picca, G., Coccioli, M. S., Micale, F., Serra, R., Romano, I., Savino, T., Giovanni, S., Cosmo, S., Rauseo, A., Delvecchio, M., Lapolla, R., Braione, A. F., Papagno, G., Baroni, M., Melis, M., Cossu, E., Songini, M., Cambuli, V. M., Lo Presti, D., Timpanaro, T. A., Chiavetta, A., Garofalo, M. R., Tommaselli, L., Tumminia, A., Scarpitta, A. M., Di Benedetto, A., Giunta, L., Lombardo, F., Salzano, G., Cardella, F., Roppolo, R., Provenzano, V., Fleres, M., Migliorini, S., Luca, A., Leopardi, A., Beltrami, C., Toni, S., Guasti, G., Lenzi, L., Lamanna, C., Mannucci, E., Lucchesi, S., Di Cianni, G., Aragona, M., Del Prato, S., Fattor, B., Eisath, J., Pasquino, B., Reinstadler, P., Kaufmann, P., Incelli, G., Rauch, S., Romanelli, T., Cauvin, V., Franceschi, R., Ospedale, S. C., Soldani, C., Scattoni, R., Norgiolini, R., Celleno, R., Torlone, E., Bolli, G. B., Lalli, C., Scarponi, M., Bobbio, A., Bechaz, M., Pianta, A., Marangoni, A., Aricò, C. N., Alagona, C., Confortin, L., Rossi, E., Boscolo, B. A., Nogara, A., Bettio, M., Frison, V., Guidoni, G. L., Fongher, C., Contin, M. L., Cosma, A., Vianello, S., Bondesan, L., Morea, A., Volpi, A., Coracina, A., Panebianco, G., Lombardi, S., Costa, S., Cipponeri, E., Vedovato, M., Scotton, R., Monciotti, C. M., Galderisi, A., Dalfrà, M. G., Lapolla, A., Portogruaro, S., Zanon, M., Lisato, G., Mollo, F., Calcaterra, F., Miola, M., Paccagnella, A., Sambataro, M., Moro, E., Trombetta, M., Negri, C., Sabbion, A., Maffeis, C., Strazzabosco, M., Mesturino, C. A., Mingardi, R., Bruttomesso, D, Laviola, L, Lepore, G, Bonfanti, R, Bozzetto, L, Corsi, A, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Rabbone, I, Schiaffini, R, Montani, V, Colleluori, P, Paciotti, V, Alfidi, P, Grosso, J, Tumini, S, Cipriano, P, Vitacolonna, E, Di Vieste, G, Minnucci, A, Antenucci, D, La Penna, G, Taraborrelli, M, Macerala, B, Citro, G, De Morelli, G, Gnasso, A, Irace, C, Citriniti, F, Lazzaro, N, Bruzzese, M, Mammi, F, De Berardinis, F, Santoro, E, Corigliano, G, Corigliano, M, Parillo, M, Schettino, M, Fresa, R, Annuzzi, G, Bassi, V, Santinelli, C, Buono, P, Mozzillo, E, Russo, V, De Feo, E, Esposito, K, Petrizzo, M, Foglia, A, Gatti, A, Gentile, S, Guarino, G, Zanfardino, A, Lambiase, C, Vitale, A, Zucchini, S, Maltoni, G, Forlani, G, Moscatiello, S, Suprani, T, Bensa, M, Tomasi, F, Monesi, M, Nizzoli, M, Acquati, S, Chierici, G, Milli, B, Iughetti, L, Predieri, B, Cavani, R, Romano, S, Manicardi, V, Michelini, M, Cimicchi, M, Ugolotti, D, Zavaroni, I, Dei Cas, A, Dall'Aglio, E, Papi, M, Tardio, S, Calderini, M, Riboni, S, D'Amato, L, Zavaroni, D, Gastaldi, L, Cirillo, A, Di Bartolo, P, Pellicano, F, Di Secli, C, Amarri, S, Lasagni, A, Marsciani, A, Pedini, A, Pagliani, U, Rossi, C, Tortul, C, Brunato, B, Assaloni, R, Zanette, G, Livolsi, P, Petrucco, A, Tercelj, K, Manca, E, Candido, R, Tommasi, E, Tornese, G, Faleschini, E, Tonutti, L, Agus, S, Zanatta, M, Rosolen, A, Comici, A, Falasca, P, Graziano, F, Misischi, I, Forte, E, Palmacci, C, Tuccinardi, F, Ricciardi, G, Di Masa, P, Ragonese, M, Cipolloni, L, Buzzetti, R, Moretti, C, Leto, G, Crino, A, Bocchini, S, Pozzilli, P, Maurizi, A, Di Perna, P, Giuliano, M, Frontoni, S, Malandrucco, I, Pitocco, D, Scalpone, R, Toscanella, F, Cappa, M, Ventura, C, Bonato, V, De Bernardinis, M, Cavallo, M, Leonetti, F, Morano, S, Mandosi, E, Cicconetti, E, Ciampittiello, G, Marini, M, Sabato, D, Lauro, D, Napoli, A, Giraudo, F, Toscano, V, Pugliese, G, Massimiani, F, Fava, D, Gargiulo, P, Mecca, N, Tubili, C, Nardone, M, Morviducci, L, Manca-Bitti, M, Arcano, S, Leotta, S, Suraci, C, Chiaramonte, F, Visalli, N, Strollo, F, Arnaldi, C, Tosini, D, Ponzani, P, Patrone, M, Guido, R, Aglialoro, A, Ghisoni, G, Fabbri, F, Bordone, C, Maggi, D, Cordera, R, Minuto, N, Rotondo, E, Speranza, D, Siri, M, Carro, S, Zappa, A, Parmigiani, S, Nieri, S, Briatore, L, Calvo, G, Querci, F, Trevisan, R, Bonfadini, S, Prandi, E, Felappi, B, Locatelli, F, Fuso, V, Rocca, A, Meneghini, E, Massafra, C, Terni, T, Elli, P, Ruggeri, P, Carrai, E, Musacchio, N, Marelli, G, Vilei, V, Richini, D, Inversini, C, Franzetti, I, Bonacina, M, Ciucci, A, Sciangula, L, Duratorre, E, Bonomo, M, Bertuzzi, F, Chebat, E, Muratori, M, Scaramuzza, A, Zuccotti, G, Bollati, P, Colapinto, P, Orsi, E, Palmieri, E, Laurenzi, A, Molinari, C, Frontino, G, Veronelli, A, Zecchini, B, Bianchi, A, Torchio, G, Lovati, E, Ghilardi, G, Dagani, R, Berra, C, Fochesato, E, Pissarelli, A, Bucciarelli, L, Bulgheroni, M, Guerraggio, L, Zonca, S, Bossi, A, Berzi, D, Mangone, I, Cazzaniga, E, Rabini, R, Boemi, M, Faloia, E, Boscaro, M, Sternari, G, Iannilli, A, Cherubini, V, Tinti, G, Manfrini, S, Tesei, A, Maolo, G, Galetta, M, Vespasiani, G, Busciantella Ricci, N, Cartechini, M, Aiello, A, Di Vincenzo, S, Vitale, C, Di Caro, P, Lera, R, Secco, A, Lesina, A, Romeo, F, Origlia, C, Giorda, C, Chiambretti, A, Fornengo, R, De Donno, V, Gallarotti, F, Manti, R, Marafetti, L, Cadario, F, Savastio, S, Barbieri, P, Massucco, P, Ali, A, Gottero, C, Degiovanni, M, Bertaina, S, Maghenzani, G, Tinti, D, Fontana, F, Giorgino, F, Stefanelli, G, Cavallo, L, Zecchino, C, Piccinno, E, Ortolani, F, Gallo, F, Moramarco, F, Marino, A, Sparasci, G, Mileti, G, Lamacchia, O, Picca, G, Coccioli, M, Micale, F, Serra, R, Romano, I, Savino, T, Giovanni, S, De Cosmo, S, Rauseo, A, Delvecchio, M, Lapolla, R, Braione, A, Papagno, G, Baroni, M, Melis, M, Cossu, E, Songini, M, Cambuli, V, Lo Presti, D, Timpanaro, T, Chiavetta, A, Garofalo, M, Tommaselli, L, Tumminia, A, Scarpitta, A, Di Benedetto, A, Giunta, L, Lombardo, F, Salzano, G, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Migliorini, S, De Luca, A, Leopardi, A, Beltrami, C, Toni, S, Guasti, G, Lenzi, L, Lamanna, C, Mannucci, E, Lucchesi, S, Di Cianni, G, Aragona, M, Del Prato, S, Fattor, B, Eisath, J, Pasquino, B, Reinstadler, P, Kaufmann, P, Incelli, G, Rauch, S, Romanelli, T, Cauvin, V, Franceschi, R, Ospedale, S, Soldani, C, Scattoni, R, Norgiolini, R, Celleno, R, Torlone, E, Bolli, G, Lalli, C, Scarponi, M, Bobbio, A, Bechaz, M, Pianta, A, Marangoni, A, Arico, C, Alagona, C, Confortin, L, Rossi, E, Boscolo, B, Nogara, A, Bettio, M, Frison, V, Guidoni, G, Fongher, C, Contin, M, Cosma, A, Vianello, S, Bondesan, L, Morea, A, Volpi, A, Coracina, A, Panebianco, G, Lombardi, S, Costa, S, Cipponeri, E, Vedovato, M, Scotton, R, Monciotti, C, Galderisi, A, Dalfra, M, Lapolla, A, Portogruaro, S, Zanon, M, Lisato, G, Mollo, F, Calcaterra, F, Miola, M, Paccagnella, A, Sambataro, M, Moro, E, Trombetta, M, Negri, C, Sabbion, A, Maffeis, C, Strazzabosco, M, Mesturino, C, and Mingardi, R

Subjects
Continuous subcutaneous insulin infusion, Diabetes mellitus, Insulin pump
Abstract

Continuous subcutaneous insulin infusion (CSII) is increasingly being used worldwide, mostly thanks to technical improvements. This study examined the current status of CSII in Italy. Physicians in charge of 272 diabetes centers caring for patients using CSII were sent a questionnaire investigating clinical features, pump technology and management of these patients; a large proportion (217 centers, 79.8%) joined the study. By end-April 2013, data had been collected on 10152 patients treated with CSII; 98.2% had type 1 diabetes, 82.4% were adults, 57% female. Only just over half the centers (59%) managed more than 20 CSII patients each. The distribution of patients varied widely both among and within different regions. The main indication for CSII was the de- sire to improve glycemic control. Dropouts (8.65%) were mainly due to difficulties with pump wearability or non-optimal glycemic control. Among CSII patients 61% used a traditional pump, 39% a sensor augmented pump. Only 68% used the CSII advanced functions and glucose sensors were used twelve days per month on average. Round-the-clock assistance was guaranteed in 81% of centers; a full diabetes team followed patients in only 40% of adult-care centers and 50% of pediatric units. CSII is increasingly used in Italy, by adults and pediatric patients. However, further work is needed to unify treatment strategies throughout the country and to encourage optimal pump use and applications.

6. Autonomic failure in a case of Chiari malformation type I

Author

Alessandra Lugaresi, Zucconi M, Gerardi R, Sforza E, Contin M, Cortelli P, and Cirignotta F

Subjects
Male, Hypotension, Orthostatic, Sleep Apnea Syndromes, Cardiovascular Diseases, Sensation, Humans, Middle Aged, Nervous System Diseases, Autonomic Nervous System, Vocal Cord Paralysis, Arnold-Chiari Malformation
Abstract

A case of Chiari malformation type I with orthostatic hypotension and sleep apnea leading to convulsive attacks is presented.

Published
1987

8. Levodopa pharmacodynamics

Author

Contin, M., Riva, R., Martinelli, P., Pietro Cortelli, Albani, F., and Baruzzi, B.

Subjects
Neurology (clinical)

16. Subcutaneous insulin infusion (CSII) in italy: The third nationa survey | La terapia insulinica sottocutanea continua (CSII) in Italia. Terza indagine nazionale

Author

Bruttomesso, D., Laviola, L., Lepore, G., Bonfanti, R., Bozzetto, L., Corsi, A., Di Blasi, V., Girelli, A., Grassi, G., Iafusco, D., Rabbone, I., Schiaffini, R., Montani, V., Colleluori, P., Paciotti, V., Alfidi, P., Grosso, J., Tumini, S., Cipriano, P., Ester VITACOLONNA, Di Vieste, G., Minnucci, A., Antenucci, D., La Penna, G., Taraborrelli, M., Macerala, B., Citro, G., Morelli, G., Gnasso, A., Irace, C., Citriniti, F., Lazzaro, N., Bruzzese, M., Mammì, F., Berardinis, F., Santoro, E., Corigliano, G., Corigliano, M., Parillo, M., Schettino, M., Fresa, R., Annuzzi, G., Bassi, V., Santinelli, C., Buono, P., Mozzillo, E., Russo, V., Feo, E., Esposito, K., Petrizzo, M., Foglia, A., Gatti, A., Gentile, S., Guarino, G., Zanfardino, A., Lambiase, C., Vitale, A., Zucchini, S., Maltoni, G., Forlani, G., Moscatiello, S., Suprani, T., Bensa, M., Tomasi, F., Monesi, M., Nizzoli, M., Acquati, S., Chierici, G., Milli, B., Iughetti, L., Predieri, B., Cavani, R., Romano, S., Manicardi, V., Michelini, M., Cimicchi, M. C., Ugolotti, D., Zavaroni, I., Dei Cas, A., Dall’aglio, E., Papi, M., Tardio, S. M., Calderini, M. C., Riboni, S., D’amato, L., Zavaroni, D., Gastaldi, L., Cirillo, A., Di Bartolo, P., Pellicano, F., Di Seclì, C., Amarri, S., Lasagni, A., Marsciani, A., Pedini, A., Pagliani, U., Rossi, C., Tortul, C., Brunato, B., Assaloni, R., Zanette, G., Livolsi, P., Petrucco, A., Tercelj, K., Manca, E., Candido, R., Tommasi, E., Tornese, G., Faleschini, E., Tonutti, L., Agus, S., Zanatta, M., Rosolen, A., Comici, A., Falasca, P., Graziano, F. M., Misischi, I., Forte, E., Palmacci, C., Tuccinardi, F., Ricciardi, G. P., Di Masa, P., Ragonese, M., Cipolloni, L., Buzzetti, R., Moretti, C., Leto, G., Crinò, A., Bocchini, S., Pozzilli, P., Maurizi, A. R., Di Perna, P., Giuliano, M., Frontoni, S., Malandrucco, I., Pitocco, D., Scalpone, R., Toscanella, F., Cappa, M., Ventura, C., Bonato, V., Bernardinis, M., Cavallo, M. G., Leonetti, F., Morano, S., Mandosi, E., Cicconetti, E., Ciampittiello, G., Marini, M. A., Sabato, D., Lauro, D., Napoli, A., Giraudo, F., Toscano, V., Pugliese, G., Massimiani, F., Fava, D., Gargiulo, P., Mecca, N., Tubili, C., Nardone, M. R., Morviducci, L., Manca-Bitti, M. L., Arcano, S., Leotta, S., Suraci, C., Chiaramonte, F., Visalli, N., Strollo, F., Arnaldi, C., Tosini, D., Ponzani, P., Patrone, M., Guido, R., Aglialoro, A., Ghisoni, G., Fabbri, F., Bordone, C., Maggi, D., Cordera, R., Minuto, N., Rotondo, E., Speranza, D., Siri, M., Carro, S., Zappa, A., Parmigiani, S., Nieri, S., Briatore, L., Calvo, G., Querci, F., Trevisan, R., Bonfadini, S., Prandi, E., Felappi, B., Locatelli, F., Fuso, V., Rocca, A., Meneghini, E., Massafra, C., Terni, T., Elli, P., Ruggeri, P., Carrai, E., Musacchio, N., Marelli, G., Vilei, V., Richini, D., Inversini, C., Franzetti, I., Bonacina, M., Ciucci, A., Sciangula, L., Duratorre, E., Bonomo, M., Bertuzzi, F., Chebat, E., Muratori, M., Scaramuzza, A., Zuccotti, G. V., Bollati, P. M., Colapinto, P., Orsi, E., Palmieri, E., Laurenzi, A., Molinari, C., Frontino, G., Veronelli, A., Zecchini, B., Bianchi, A., Torchio, G., Lovati, E., Ghilardi, G., Dagani, R., Berra, C., Fochesato, E., Pissarelli, A., Bucciarelli, L., Bulgheroni, M., Guerraggio, L., Zonca, S., Bossi, A. C., Berzi, D., Mangone, I., Cazzaniga, E., Rabini, R. A., Boemi, M., Faloia, E., Boscaro, M., Sternari, G., Iannilli, A., Cherubini, V., Tinti, G., Manfrini, S., Tesei, A. M., Maolo, G., Galetta, M., Vespasiani, G., Busciantella Ricci, N., Cartechini, M. G., Aiello, A., Di Vincenzo, S., Vitale, C., Di Caro, P., Lera, R., Secco, A., Lesina, A., Romeo, F., Origlia, C., Giorda, C., Chiambretti, A. M., Fornengo, R., Donno, V., Gallarotti, F., Manti, R., Marafetti, L., Cadario, F., Savastio, S., Barbieri, P., Massucco, P., Alì, A., Gottero, C., Degiovanni, M., Bertaina, S., Maghenzani, G., Tinti, D., Fontana, F., Giorgino, F., Stefanelli, G., Cavallo, L., Zecchino, C., Piccinno, E., Ortolani, F., Gallo, F., Moramarco, F., Marino, A., Sparasci, G., Mileti, G., Lamacchia, O., Picca, G., Coccioli, M. S., Micale, F., Serra, R., Romano, I., Savino, T., Giovanni, S., Cosmo, S., Rauseo, A., Delvecchio, M., Lapolla, R., Braione, A. F., Papagno, G., Baroni, M., Melis, M., Cossu, E., Songini, M., Cambuli, V. M., Lo Presti, D., Timpanaro, T. A., Chiavetta, A., Garofalo, M. R., Tommaselli, L., Tumminia, A., Scarpitta, A. M., Di Benedetto, A., Giunta, L., Lombardo, F., Salzano, G., Cardella, F., Roppolo, R., Provenzano, V., Fleres, M., Migliorini, S., Luca, A., Leopardi, A., Beltrami, C., Toni, S., Guasti, G., Lenzi, L., Lamanna, C., Mannucci, E., Lucchesi, S., Di Cianni, G., Aragona, M., Del Prato, S., Fattor, B., Eisath, J., Pasquino, B., Reinstadler, P., Kaufmann, P., Incelli, G., Rauch, S., Romanelli, T., Cauvin, V., Franceschi, R., Ospedale, S. C., Soldani, C., Scattoni, R., Norgiolini, R., Celleno, R., Torlone, E., Bolli, G. B., Lalli, C., Scarponi, M., Bobbio, A., Bechaz, M., Pianta, A., Marangoni, A., Aricò, C. N., Alagona, C., Confortin, L., Rossi, E., Boscolo, B. A., Nogara, A., Bettio, M., Frison, V., Guidoni, G. L., Fongher, C., Contin, M. L., Cosma, A., Vianello, S., Bondesan, L., Morea, A., Volpi, A., Coracina, A., Panebianco, G., Lombardi, S., Costa, S., Cipponeri, E., Vedovato, M., Scotton, R., Monciotti, C. M., Galderisi, A., Dalfrà, M. G., Lapolla, A., Portogruaro, S., Zanon, M., Lisato, G., Mollo, F., Calcaterra, F., Miola, M., Paccagnella, A., Sambataro, M., Moro, E., Trombetta, M., Negri, C., Sabbion, A., Maffeis, C., Strazzabosco, M., Mesturino, C. A., and Mingardi, R.

20. Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices

Author

Francesco Pappalardo, John Wilkinson, Francois Busquet, Antoine Bril, Mark Palmer, Barry Walker, Cristina Curreli, Giulia Russo, Thierry Marchal, Elena Toschi, Rossana Alessandrello, Vincenzo Costignola, Ingrid Klingmann, Martina Contin, Bernard Staumont, Matthias Woiczinski, Christian Kaddick, Valentina Di Salvatore, Alessandra Aldieri, Liesbet Geris, Marco Viceconti, Pappalardo F., Wilkinson J., Busquet F., Bril A., Palmer M., Walker B., Curreli C., Russo G., Marchal T., Toschi E., Alessandrello R., Costignola V., Klingmann I., Contin M., Staumont B., Woiczinski M., Kaddick C., Salvatore V.D., Aldieri A., Geris L., and Viceconti M.

Subjects
notified bodies, Technology, Regulatory System, Notified Bodies, Health Informatics, Medical devices, In Silico Trials, Regulatory System, Notified Bodies, Health Information Management, Animals, Electrical and Electronic Engineering, In Silico Trials, in Silico Trials, Science & Technology, Computer Science, Information Systems, Biological system modeling, Drugs, Computational modeling, regulatory system, Europe, Medical devices, Safety, Computer Science Applications, Computer Science, Computer Science, Interdisciplinary Applications, Mathematical & Computational Biology, Life Sciences & Biomedicine, Medical Informatics
Abstract

In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. While the regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, it is more complex for In Silico Trials solutions, and therefore deserves a deeper analysis. In this position paper, we investigate the current state of the art towards the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic. We suggest that the European regulatory system should start a process of innovation: in principle to limit distorted quality by different internal processes within notified bodies, hence avoiding that the more innovative and competitive companies focus their attention on the needs of other large markets, like the USA, where the use of such radical innovations is already rapidly developing. ispartof: IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS vol:26 issue:11 pages:5282-5286 ispartof: location:United States status: published

Published
2022

21. How resistant are levodopa‐resistant axial symptoms? Response of freezing, posture, and voice to increasing levodopa intestinal infusion rates in Parkinson disease

Author

Gabriele Imbalzano, Domiziana Rinaldi, Giovanna Calandra‐Buonaura, Manuela Contin, Federica Amato, Giulia Giannini, Luisa Sambati, Claudia Ledda, Alberto Romagnolo, Gabriella Olmo, Pietro Cortelli, Maurizio Zibetti, Leonardo Lopiano, Carlo Alberto Artusi, Imbalzano G., Rinaldi D., Calandra Buonaura G., Contin M., Amato F., Giannini G., Sambati L., Ledda C., Romagnolo A., Olmo G., Cortelli P., Zibetti M., Lopiano L., and Artusi C.A.

Subjects
Parkinson disease, axial symptoms, freezing of gait, levodopa, posture, parkinson’s disease, Neurology, axial symptom, Neurology (clinical)
Abstract

Background and purpose: Treatment of freezing of gait (FoG) and other Parkinson disease (PD) axial symptoms is challenging. Systematic assessments of axial symptoms at progressively increasing levodopa doses are lacking. We sought to analyze the resistance to high levodopa doses of FoG, posture, speech, and altered gait features presenting in daily-ON therapeutic condition. Methods: We performed a pre-/postinterventional study including patients treated with levodopa/carbidopa intestinal gel infusion (LCIG) with disabling FoG in daily-ON condition. Patients were evaluated at their usual LCIG infusion rate (T1), and 1 h after 1.5× (T2) and 2× (T3) increase of the LCIG infusion rate by quantitative outcome measures. The number of FoG episodes (primary outcome), posture, speech, and gait features were objectively quantified during a standardized test by a blinded rater. Changes in motor symptoms, dyskinesia, and plasma levodopa concentrations were also analyzed. Results: We evaluated 16 patients with a mean age of 69 ± 9.4 years and treated with LCIG for a mean of 2.2± 2.1 years. FoG improved in 83.3% of patients by increasing the levodopa doses. The number of FoG episodes significantly decreased (mean=2.3 at T1, 1.7 at T2, 1.2 at T3; p= 0.013). Posture and speech features did not show significant changes, whereas stride length (p= 0.049), turn duration (p= 0.001), and turn velocity (p= 0.024) significantly improved on doubling the levodopa infusion rate. Conclusions: In a short-term evaluation, the increase of LCIG dose can improve "dopa-resistant" FoG and gait issues in most advanced PD patients with overall good control of motor symptoms in the absence of clinically significant dyskinesia.

Published
2022

22. Impulsive conditions in Parkinson's disease: A pharmacosurveillance-supported list

Author

Michele Fusaroli, Marco Menchetti, Manuela Contin, Elisabetta Poluzzi, Emanuel Raschi, Angelo Fioritti, Luisa Sambati, Fusaroli M., Raschi E., Contin M., Sambati L., Menchetti M., Fioritti A., and Poluzzi E.

Subjects
medicine.medical_specialty, Parkinson's disease, Social stigma, Impulsivity, Antiparkinson Agents, Pharmacovigilance, Punding, Obsessive-compulsive disorder, medicine, Humans, Psychiatry, Dopamine dysregulation syndrome, Dopamine agonist, business.industry, Paraphilic disorder, medicine.disease, Impulse control, Disruptive, Impulse Control, and Conduct Disorders, Aggression, Parkinson disease, Substance abuse, Neurology, Dopamine Agonists, Gambling, Impulsive behavior, Hypersexuality, Neurology (clinical), Geriatrics and Gerontology, medicine.symptom, business
Abstract

Background “Impulse Control Disorders” are behavioral conditions (e.g., gambling, hypersexuality), which are increasingly reported as reactions to dopamine agonists in Parkinson's disease. The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease focuses only on 6 behaviors. Nonetheless, impulsivity could affect the entire range of human practices. Because of their heterogeneity and undefined boundaries, it is not clear what conditions should be considered as Impulse Control Disorders. This results in poorly standardized scientific literature and underdiagnosis. Objective We aimed to create a comprehensive list of possible manifestations of drug-induced Impulse Control Disorders in Parkinson's disease and test it on pharmacosurveillance data. Methods PubMed was used to identify reviews in English about Impulse Control Disorders in Parkinson's disease. Mentioned conditions were charted and translated to the lexicon of MedDRA, ICD-11, and DSM-5. The relevant MedDRA terms were used to test potential association with dopamine agonists on the FDA Adverse Event Reporting System. Results 50 reviews published between 2001 and 2020 were identified. 66 conditions were collected as possible Impulse Control Disorders. Pathological gambling, shopping, eating and sexuality, dopamine dysregulation syndrome, hobbyism and punding were the most frequently mentioned, together with leisure activities, body-focused compulsivity, disruptive, impulse control and conduct disorders, and substance abuse. All these conditions were disproportionately reported with dopamine agonists, except for substance abuse. Conclusions We defined a potential extended list of ICDs, which, along with its conversion to international taxonomies, can support the identification of drug-induced conditions in pharmacovigilance archives, as well as monitoring processes in clinical practice.

Published
2021

23. Liver transplantation in mitochondrial neurogastrointestinal encephalomyopathy (MNGIE): clinical long-term follow-up and pathogenic implications

Author

Giulia Amore, Luca Vizioli, Luca Fasano, Caterina Tonon, Rita Rinaldi, Manuela Contin, Maria Teresa Dotti, Elisa Boschetti, Valentina Papa, Mauro Scarpelli, Alessia Pugliese, Susan Mohamed, Matteo Cescon, Roberto De Giorgio, Antonio Daniele Pinna, Leonardo Caporali, Lara Pisani, Massimiliano Filosto, Laura Ludovica Gramegna, Raffaele Lodi, Mariantonietta Capristo, Carlo Casali, Giovanna Cenacchi, Loris Pironi, Valerio Carelli, Maria Cristina Morelli, Francesco Sicurelli, Roberto D'Angelo, Roberta Costa, D'Angelo R., Boschetti E., Amore G., Costa R., Pugliese A., Caporali L., Gramegna L.L., Papa V., Vizioli L., Capristo M., Contin M., Mohamed S., Cenacchi G., Lodi R., Morelli M.C., Fasano L., Pisani L., Cescon M., Tonon C., Pinna A.D., Dotti M.T., Sicurelli F., Scarpelli M., Filosto M., Casali C., Pironi L., Carelli V., De Giorgio R., and Rinaldi R.

Subjects
Adult, medicine.medical_specialty, Neurology, medicine.medical_treatment, Hematopoietic stem cell transplantation, Liver transplantation, Gastroenterology, Ophthalmoparesis, Leukoencephalopathy, 03 medical and health sciences, 0302 clinical medicine, Mitochondrial Encephalomyopathies, Internal medicine, medicine, Humans, 030212 general & internal medicine, Thymidine phosphorylase, Gastrointestinal dysmotility, Ophthalmoplegia, business.industry, medicine.disease, Allogenic hematopoietic stem cell transplantation, Mitochondrial neurogastrointestinal encephalomyopathy, Neurology (clinical), medicine.symptom, business, Nucleoside, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

We report the longest follow-up of clinical and biochemical features of two previously reported adult mitochondrial neurogastrointestinal encephalomyopathy (MNGIE) patients treated with liver transplantation (LT), adding information on a third, recently transplanted, patient. All three patients overcame the early post-operative period and tolerated immunosuppressive therapy. Plasma nucleoside levels dramatically decreased, with evidence of clinical improvement of ambulation and neuropathy. Conversely, other features of MNGIE, as gastrointestinal dysmotility, low weight, ophthalmoparesis, and leukoencephalopathy were essentially unchanged. A similar picture characterized two patients treated with allogenic hematopoietic stem cell transplantation (AHSCT). In conclusion, LT promptly and stably normalizes nucleoside imbalance in MNGIE, stabilizing or improving some clinical parameters with marginal periprocedural mortality rate as compared to AHSCT. Nevertheless, restoring thymidine phosphorylase (TP) activity, achieved by both LT and AHSCT, does not allow a full clinical recovery, probably due to consolidated cellular damage and/or incomplete enzymatic tissue replacement.

Published
2020

24. Supervised versus unsupervised technology-based levodopa monitoring in Parkinson’s disease: an intrasubject comparison

Author

Giovanna Lopane, Sabato Mellone, Mattia Corzani, Pietro Cortelli, Lorenzo Chiari, Giovanna Calandra-Buonaura, Manuela Contin, Lopane G., Mellone S., Corzani M., Chiari L., Cortelli P., Calandra-Buonaura G., and Contin M.

Subjects
Male, 0301 basic medicine, medicine.medical_specialty, Neurology, Pilot Projects, Timed Up and Go test, Motor Activity, Therapeutic drug monitoring, Antiparkinson Agents, Levodopa, 03 medical and health sciences, 0302 clinical medicine, Patient satisfaction, Physical medicine and rehabilitation, Physicians, Humans, Medicine, Dosing, Aged, Protocol (science), medicine.diagnostic_test, business.industry, Self-Management, Reproducibility of Results, Parkinson Disease, Middle Aged, Sphygmomanometers, Telemedicine, Alternate finger tapping test, 030104 developmental biology, Health Communication, Patient Satisfaction, Computers, Handheld, Ambulatory, Finger tapping, Parkinson’s disease, Female, Smartphone, Neurology (clinical), Drug Monitoring, business, 030217 neurology & neurosurgery, Information and communication technology
Abstract

We aimed to assess the intrasubject reproducibility of a technology-based levodopa (LD) therapeutic monitoring protocol administered in supervised versus unsupervised conditions in patients with Parkinson's disease (PD). The study design was pilot, intrasubject, single center, open and prospective. Twenty patients were recruited. Patients performed a standardized monitoring protocol instrumented by an ad hoc embedded platform after their usual first morning LD dose in two different randomized ambulatory sessions: one under a physician's supervision, the other self-administered. The protocol is made up of serial motor and non-motor tests, including alternate finger tapping, Timed Up and Go test, and measurement of blood pressure. Primary motor outcomes included comparisons of intrasubject LD subacute motor response patterns over the 3-h test in the two experimental conditions. Secondary outcomes were the number of intrasession serial test repetitions due to technical or handling errors and patients' satisfaction with the unsupervised LD monitoring protocol. Intrasubject LD motor response patterns were concordant between the two study sessions in all patients but one. Platform handling problems averaged 4% of total planned serial tests for both sessions. Ninety-five percent of patients were satisfied with the self-administered LD monitoring protocol. To our knowledge, this study is the first to explore the potential of unsupervised technology-based objective motor and non-motor tasks to monitor subacute LD dosing effects in PD patients. The results are promising for future telemedicine applications.

Published
2018

25. Relationship between plasma concentrations and clinical effects of perampanel: A prospective observational study

Author

Angelo Russo, Tullio Messana, Federica Pondrelli, Margherita Santucci, Lorenzo Muccioli, Paolo Tinuper, Roberto Michelucci, Susan Mohamed, Irene Ambrosetti, Lilia Volpi, Antonia Parmeggiani, Barbara Mostacci, D. Passarelli, Lorenzo Ferri, Manuela Contin, R. Rizzi, Antonella Boni, Laura Licchetta, Francesca Bisulli, Contin M., Pondrelli F., Muccioli L., Mohamed S., Santucci M., Ferri L., Licchetta L., Tinuper P., Bisulli F., Ambrosetti I., Boni A., Messana T., Michelucci R., Mostacci B., Parmeggiani A., Passarelli D., Rizzi R., Russo A., and Volpi L.

Subjects
Adult, Male, medicine.medical_specialty, Efficacy, Pyridones, Physical examination, Perampanel, Gastroenterology, Bedtime, Plasma, Young Adult, 03 medical and health sciences, Behavioral Neuroscience, chemistry.chemical_compound, Epilepsy, 0302 clinical medicine, Internal medicine, Nitriles, medicine, Humans, Prospective Studies, 030212 general & internal medicine, Adverse effect, Plasma concentration, Morning, Antiseizure medication, Dose-Response Relationship, Drug, medicine.diagnostic_test, business.industry, Middle Aged, Tolerability, medicine.disease, Treatment Outcome, Neurology, chemistry, Anticonvulsants, Female, Observational study, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Purpose The purpose of the study was to investigate the potential correlation between plasma concentration of the newer antiseizure medication (ASM) perampanel (PMP) and both tolerability and seizure control in patients with epilepsy. Methods The study design was multicenter, open, and prospective. Plasma samples were collected in the morning 12 h apart from once-a-day bedtime PMP dose. Perampanel tolerability was assessed on the day of drug monitoring by clinical examination and patients' interview. Response to PMP was defined as ≥ 50% reduction from baseline seizure frequency (pretreatment). The main outcomes were the comparisons of PMP plasma concentration-to-weight-adjusted dose ratio (C/D) [(μg/mL)/(mg/kg/day)] between patients with and without PMP-related adverse effects (AEs) and between responders and nonresponders. Results Ninety-seven patients (54% men), mean ± SD age 36 ± 14 years were enrolled in the study. The mean PMP dose was 6.7 ± 2.3 mg, drug treatment averaged 46 ± 34 weeks. The mean plasma concentration was 360 ± 268 ng/mL (range: 37–1213 ng/mL). Forty patients (41%) reported at least one AE, mainly dizziness and behavioral changes. No significant difference was found in median PMP C/Ds between patients with (2.94) and without (2.76) AEs, otherwise comparable for clinical variables. Forty-four patients (45%) were responders, at a median PMP C/D of 3.10, similar to the value of 2.76 found in nonresponders. These two groups also overlapped for clinical characteristics. Conclusion This is the first prospective real-life study to evaluate the relationship between PMP plasma concentrations, seizure control, and AEs. In line with the few real-world available data, we did not find any significant correlation between PMP plasma concentrations and both tolerability and seizure control.

Published
2020

26. Temozolomide treatment does not affect topiramate and oxcarbazepine plasma concentrations in chronically treated patients with brain tumor-related epilepsy

Author

Bruno Jandolo, Marta Maschio, Manuela Contin, Loredana Dinapoli, Alessia Zarabla, Andrea Pace, Agostino Baruzzi, Alessandra Fabi, Fiorenzo Albani, Maschio M., Albani F., Jandolo B., Zarabla A., Contin M., Dinapoli L., Fabi A., Pace A., and Baruzzi A.

Subjects
Adult, Male, Topiramate, Cancer Research, medicine.medical_specialty, Neurology, Urology, Brain tumor, Oxcarbazepine, Fructose, Pharmacology, Young Adult, Epilepsy, Temozolomide, medicine, Humans, Antineoplastic Agents, Alkylating, Brain Neoplasms, business.industry, Small sample, Middle Aged, medicine.disease, Dacarbazine, Carbamazepine, Oncology, Plasma concentration, Anticonvulsants, Female, Neurology (clinical), business, Follow-Up Studies, medicine.drug
Abstract

Objective Medical management of brain tumor-related epilepsy is complicated by interactions between antiepileptic and chemotherapeutic drugs. We studied the effect of temozolomide therapy on the disposition of the new antiepileptic drugs topiramate (TPM) or oxcarbazepine (OXC). Methods Fifteen patients chronically treated with TPM or OXC in monotherapy starting a chemotherapeutic treatment with temozolomide were enrolled in the study, of which ten were available for the final analyses. Blood samples were collected before temozolomide treatment (T0), at its end (T7) and after further 1–3 weeks (T14–T28). For each patient, more than one treatment cycle was studied. Topiramate and OXC mono-10-hydroxy derivative (MHD) plasma concentrations were determined by hplc coupled with ion spray mass spectrometer (TPM) or ultraviolet (MHD) detection. Results Mean TPM concentrations were 5.4 ± 2.4 μg/ml at T0 vs. 5.5 ± 2.4 μg/ml at T7 (n = 14), and 5.4 ± 2.4 μg/ml at T0 vs. 5.6 ± 2.8 μg/ml at T14–T28 (n = 14). Mean MHD concentrations were 16.4 ± 7.6 μg at T0 vs. 18.5 ± 9.0 μg/ml at T7 (n = 5), and 16.8 ± 7.0 μg/ml at T0 vs. 18.0 ± 8.7 μg/ml at T14–T28 (n = 8) (all comparisons not statistically significant; Student’s t-test for paired samples). Conclusion Temozolomide treatment did not affect TPM plasma concentrations in chronically treated patients. Data for MHD in OXC-treated patients were similar, but, due to the small sample size, results should be interpreted cautiously.These findings confirm that TPM (and possibly OXC) are a reasonable choice of antiepileptic drug in patients with brain tumor-related epilepsy.

Published
2008

27. Dopamine Transporter Gene Polymorphism, SPECT Imaging, and Levodopa Response in Patients with Parkinson Disease

Author

Roberto Riva, Fiorenzo Albani, Manuela Contin, M. Mochi, Maurizio Dondi, Paolo Martinelli, Agostino Baruzzi, Cinzia Pettinato, Cesa Scaglione, Stefano Fanti, CONTIN M, MARTINELLI P, MOCHI M, ALBANI F, RIVA R, SCAGLIONE C, DONDI M, FANTI S, PETTINATO C, and BARUZZI A.

Subjects
Male, medicine.medical_specialty, Levodopa, Nerve Tissue Proteins, Motor Activity, Pharmacology, Gastroenterology, Functional Laterality, Antiparkinson Agents, Iodine Radioisotopes, Polymorphism (computer science), Internal medicine, Spect imaging, mental disorders, Reaction Time, medicine, Humans, Pharmacology (medical), Aged, Dopamine transporter, Tomography, Emission-Computed, Single-Photon, Dopamine Plasma Membrane Transport Proteins, Membrane Glycoproteins, Polymorphism, Genetic, biology, Putamen, Dopaminergic, Membrane Transport Proteins, Parkinson Disease, Middle Aged, Dyskinesia, biology.protein, Female, Neurology (clinical), Gene polymorphism, medicine.symptom, Psychology, Tropanes, medicine.drug
Abstract

Objectives: To assess the potential association between dopamine transporter (DAT) genotype, single photon emission CT (SPECT) measures using [ 1 2 3 I]-N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-iodophenyl)nortropane ([ 1 2 3 I]-FP-CIT) of striatal dopaminergic function, and oral levodopa response pattern in a cohort of patients with Parkinson disease. Methods: Thirty-six patients at different disease stages enrolled in the study. Each patient was examined by [ 1 2 3 I]-FP-CIT SPECT and a standardized oral levodopa test on 2 separate days in a randomized order within 3 weeks. The main outcome variables were the specific-to-nonspecific tracer uptake ratio in the contralateral putamen for SPECT analysis; latency, duration, and magnitude of the motor effect; and presence of dyskinesias for the levodopa test. The variable number of tandem repeat (VNTR) polymorphisms of the gene coding for DAT were detected for each patient by standard methods. Results: Contralateral putamen [ 1 2 3 I]-FP-CIT uptake ratios were similar in the patients carrying the 9-copy allele (n = 20) of the DAT VNTR compared with 10-repeat homozygotes (n = 16). No significant difference was found in levodopa main outcome variables and dyskinesia incidence between the two groups of patients stratified by DAT VNTR polymorphism. Conclusions: The study did not identify clinically relevant in vivo DAT neurochemical function phenotypes or levodopa response patterns associated with the DAT polymorphism.

Published
2004

28. The Effect of a Clinically Practical Exercise on Levodopa Bioavailability and Motor Response in Patients With Parkinson Disease

Author

Manuela Contin, Giovanna Lopane, Paolo Martinelli, Fiorenzo Albani, Agostino Baruzzi, Cesa Scaglione, Lopane G., Contin M., Scaglione C., Albani F., Baruzzi A., and Martinelli P.

Subjects
Male, Levodopa, Motor Activity, Pharmacology, Severity of Illness Index, FARMACOCINETICA, Antiparkinson Agents, Benserazide, Pharmacokinetics, Heart Rate, Heart rate, FARMACODINAMICA, medicine, ESERCIZIO FISICO, Humans, Pharmacology (medical), Enzyme Inhibitors, Exercise, Morning, Cross-Over Studies, Dyskinesias, Parkinson Disease, Middle Aged, Bioavailability, Drug Combinations, Treatment Outcome, Dyskinesia, Anesthesia, Pharmacodynamics, Finger tapping, Exercise Test, Female, Neurology (clinical), medicine.symptom, Psychology, medicine.drug
Abstract

Objective: The aim of the study was to investigate the potential effect of short, moderate intensity (e70% maximum heart rate) cyclette exercise on levodopa (LD)/dopa decarboxylase inhibitor bioavailability and motor response in a subgroup of Parkinson disease (PD) patients presenting a moderate-to-severe delay in fasting morning LD dose absorption and matched motor response. Methods: Ten patients underwent an oral LD instrumental kinetic-dynamic test based on simultaneous serial measurements of plasma LD concentrations, finger tapping motor effects, dyskinesia ratings plus Unified Parkinson Disease Rating Scale Motor Section (section III) evaluation after ingestion of their usual fasting first morning LD dose, on 2 occasions, 2 weeks apart, according to an intrasubject randomized cross-over design: once receiving their oral LD test dose immediately before a 15-minute cycling and once at seated rest. The main LD pharmacokinetic variables were time to peak, peak plasma concentration, and the area under the 4-hour plasma concentration-time curve. The main LD pharmacodynamic variables were the latency, duration of the motor effect elicited by the LD test dose, and the area under the 4-hour tapping effect-time curve. Results: The LD pharmacokinetics and pharmacodynamics did not differ between the 2 sessions. Conclusions: We found no significant effect of a moderate, clinically practical exercise on LD rate and extent of absorption and matched motor response in a subgroup of patients with delayed LD kinetic-dynamic effect.

Published
2010

29. Variation in Lamotrigine Plasma Concentrations with Hormonal Contraceptive Monthly Cycles in Patients with Epilepsy

Author

Alassane Dicko, Edgard Brice Ngoungou, Michel Druet-Cabanac, Maryse Tuillas, Maryvonne Kombila, Abdoulaye Traoré, Pierre-Marie Preux, Belco Poudiougou, Ogobara K. Doumbo, Olivier Dulac, Guy Farnarier, Marouf M. Keita, Drissa Coulibaly, Contin M., Albani F., Ambrosetto G., Avoni P., Bisulli F., Riva R., Tinuper P., and Baruzzi A.

Subjects
Adult, Periodicity, medicine.medical_specialty, Pediatrics, Adolescent, Population, Lamotrigine, Drug Administration Schedule, Contraceptives, Oral, Hormonal, CONTRACCETTIVI ORMONALI, 03 medical and health sciences, Epilepsy, 0302 clinical medicine, medicine, Humans, Drug Interactions, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, education, Mass screening, education.field_of_study, Triazines, business.industry, Environmental exposure, Middle Aged, medicine.disease, 3. Good health, Surgery, LAMOTRIGINA, Neurology, Relative risk, Cohort, Anticonvulsants, Female, Neurology (clinical), Drug Monitoring, business, 030217 neurology & neurosurgery, Cohort study
Abstract

Summary: Purpose: Cerebral malaria (CM) is suspected to be a potential cause of epilepsy in tropical areas, but little information is available. The purpose of this study was to evaluate the role of CM in epilepsy among children in Mali. Methods: An exposed–nonexposed study was performed to identify children who had epilepsy after malaria in the 0- to 15-year age group. The exposure factor was CM defined according to World Health Organization (WHO) criteria, and the nonexposure factor was symptomatic malaria without the characteristics of CM (NCM). All the children underwent a screening questionnaire and were examined by a medical physician. After the screening phase, a specialist in neuropediatrics examined the children suspected to have epilepsy. EEG and computed tomography (CT) scans were performed in some of these patients. Results: In total, 101 subjects who had had CM and 222 who had had NCM were included. Fifty-four children (CM, 34; NCM, 20) were suspected to have epilepsy, and six were confirmed (CM, five; NCM, one). The incidence rate was 17.0 per 1000 person-years in the CM group and 1.8 per 1000 person-year in the NCM group; thus the relative risk (RR) was 9.4 [95% confidence interval (CI), 1.3–80.3; p = 0.02]. After adjustment on age and duration of follow-up, the RR was 14.3 (95% CI, 1.6–132.0; p = 0.01). Conclusions: The risk of sequelar epilepsy is significantly higher in the CM group compared with the NCM group. A reevaluation of this cohort should be carried out later to search for temporal epilepsy that appeared after age 10 years.

Published
2006

30. Levetiracetam clinical pharmacokinetics in elderly and very elderly patients with epilepsy

Author

Agostino Baruzzi, Fiorenzo Albani, Roberto Riva, Susan Mohamed, Manuela Contin, Contin M., Mohamed S., Albani F., Riva R., and Baruzzi A.

Subjects
Adult, Male, medicine.medical_specialty, Elderly and very elderly patient, Levetiracetam, health care facilities, manpower, and services, Pharmacokinetic, Therapeutic drug monitoring, Epilepsy, Pharmacokinetics, medicine, Humans, Prospective Studies, Prospective cohort study, Aged, Retrospective Studies, Geriatrics, Aged, 80 and over, medicine.diagnostic_test, business.industry, Age Factors, Piracetam, Oral clearance, Retrospective cohort study, social sciences, Middle Aged, medicine.disease, humanities, Neurology, Anesthesia, Anticonvulsants, Female, Neurology (clinical), business, medicine.drug
Abstract

We aimed to compare apparent steady-state oral clearance (CL/F) of the antiepileptic drug levetiracetam (LEV) in elderly (66-80 years, n=105) and very elderly (81-96 years, n=70) vs nonelderly (30-65 years, n=97) patients with epilepsy. Median weight-normalized CL/F (mLmin(-1)kg(-1)) decreased from 1.23 (nonelderly) to 0.83 (elderly) and 0.59 (very elderly) (p

Published
2011

31. Isolated noradrenergic failure in adult-onset autosomal dominant leukodystrophy

Author

Vincenzo Donadio, Manuela Contin, Maria Chiara Casadio, Sabina Capellari, Pasquale Montagna, Pietro Cortelli, Pietro Guaraldi, Rocco Liguori, Guaraldi P., Donadio V., Capellari S., Contin M., Casadio M.C., Montagna P., Liguori R., and Cortelli P.

Subjects
Male, medicine.medical_specialty, Vasoactive intestinal peptide, Noradrenergic failure, Biology, Adult-onset autosomal dominant leukodystrophy (ADLD), Cellular and Molecular Neuroscience, Norepinephrine, Internal medicine, Gene duplication, medicine, Humans, Genes, Dominant, integumentary system, Orthostatic hypotension, Endocrine and Autonomic Systems, Leukodystrophy, Microneurography, Leukodystrophy, Metachromatic, Middle Aged, medicine.disease, Autonomic nervous system, Endocrinology, Autonomic Nervous System Diseases, Cholinergic, Neurology (clinical), Lamin, medicine.drug
Abstract

We evaluated the autonomic control of the cardiovascular system and the skin innervation of a patient from a new Italian family with a genetically proven diagnosis of adult-onset autosomal dominant leukodystrophy (ADLD) due to lamin B1 gene duplication. Cardiovascular reflexes and pharmacological assessment indicated a selective sympathetic failure, sparing cardiovagal function. Microneurography revealed absent sympathetic activity. The evaluation of autonomic innervation of skin annexes showed severely depleted and morphologically abnormal noradrenergic dopamine-β-hydroxylase (DβH) immunoreactive fibres with preserved cholinergic vasoactive intestinal polypeptide (VIP) immunoreactive fibres. This peculiar autonomic dysfunction may represent a hallmark for ADLD.

Published
2010

32. Simultaneous HPLC-UV analysis of rufinamide, zonisamide, lamotrigine, oxcarbazepine monohydroxy derivative and felbamate in deproteinized plasma of patients with epilepsy

Author

Roberto Riva, Manuela Contin, Carmina Candela, Fiorenzo Albani, Susan Mohamed, Agostino Baruzzi, Contin M., Mohamed S., Candela C., Albani F., Riva R., and Baruzzi A.

Subjects
Ultraviolet Rays, medicine.medical_treatment, Clinical Biochemistry, Phenylcarbamates, Oxcarbazepine, FARMACI ANTIEPILETTICI, Rufinamide, HIGH PERFORMANCE LIQUID CHROMATOGRAPHY, Lamotrigine, Biochemistry, High-performance liquid chromatography, DEPROTEINIZZAZIONE, Analytical Chemistry, Felbamate, medicine, Humans, RUFINAMIDE, Active metabolite, Chromatography, High Pressure Liquid, Detection limit, Chromatography, Epilepsy, medicine.diagnostic_test, Chemistry, Triazines, Cell Biology, General Medicine, Isoxazoles, Triazoles, Anticonvulsant, Carbamazepine, Therapeutic drug monitoring, Propylene Glycols, Zonisamide, Anticonvulsants, medicine.drug
Abstract

We present an implementation of a method we previously reported allowing the newer antiepileptic drugs (AEDs) rufinamide (RFN) and zonisamide (ZNS) to be simultaneously determined with lamotrigine (LTG), oxcarbazepine's (OXC) main active metabolite monohydroxycarbamazepine (MHD) and felbamate (FBM) in plasma of patients with epilepsy using high performance liquid chromatography (HPLC) with UV detection. Plasma samples (250 microL) were deproteinized by 1 mL acetonitrile spiked with citalopram as internal standard (I.S.). HPLC analysis was carried out on a Synergi 4 microm Hydro-RP, 250 mm x 4.6 mm I.D. column. The mobile phase was a mixture of potassium dihydrogen phosphate buffer (50 mM, pH 4.5), acetonitrile and methanol (65:26.2:8.8, v/v/v) at an isocratic flow rate of 0.8 mL/min. The UV detector was set at 210 nm. The chromatographic run lasted 19 min. Commonly coprescribed AEDs did not interfere with the assay. Calibration curves were linear for both AEDs over a range of 2-40 microg/mL for RFN and 2-80 microg/mL for ZNS. The limit of quantitation was 2 microg/mL for both analytes and the absolute recovery ranged from 97% to 103% for RFN, ZNS and the I.S. Intra- and interassay precision and accuracy were lower than 10% at all tested concentrations. The present study describes the first simple and validated method for RFN determination in plasma of patients with epilepsy. By grouping different new AEDs in the same assay the method can be advantageous for therapeutic drug monitoring (TDM).

Published
2009

33. Simple and validated HPLC-UV analysis of levetiracetam in deproteinized plasma of patients with epilepsy

Author

Manuela Contin, Agostino Baruzzi, Roberto Riva, Fiorenzo Albani, Susan Mohamed, Contin M., Mohamed S., Albani F., Riva R., and Baruzzi A.

Subjects
Accuracy and precision, Levetiracetam, Correlation coefficient, Calibration curve, Clinical Biochemistry, Biochemistry, High-performance liquid chromatography, Sensitivity and Specificity, Analytical Chemistry, chemistry.chemical_compound, medicine, Humans, Chromatography, High Pressure Liquid, Chromatography, Epilepsy, medicine.diagnostic_test, Extraction (chemistry), Reproducibility of Results, Cell Biology, General Medicine, Piracetam, chemistry, Therapeutic drug monitoring, Methanol, medicine.drug
Abstract

We present a simple, fast and validated method for the determination of the new generation antiepileptic drug (AED) levetiracetam (LEV) in plasma of patients with epilepsy using high performance liquid chromatography (HPLC) with UV detection. Plasma sample (500 microL) pretreatment was based on simple deproteinization by methanol spiked with the internal standard (I.S.). HPLC analysis was carried out on a Synergi 4-microm Hydro-RP, 150 mm x 4 mm I.D. column. The mobile phase was a mixture of potassium dihydrogen phosphate buffer (50 mM, pH 4.5) and acetonitrile (94:6, v/v) at an isocratic flow rate of 1.5 mL/min. The UV detector was set at 205 nm. Calibration curves were linear (mean correlation coefficient=0.999) over a range of 4-80 microg/mL. The quantitation limit was 2 microg/mL and the absolute recovery was >90% for LEV and the I.S. Both intra and interassay precision and accuracy were lower than 7.5%. The chromatographic run lasted 13 min. The present procedure omitting expensive solid phase or time-consuming liquid-liquid extraction and drying steps is cheaper, faster and simpler than mostly published analytical methods for levetiracetam. Applied to a large population of patients with epilepsy this assay proved very practical in our therapeutic drug monitoring setting (TDM).

Published
2008

34. Daytime sympathetic hyperactivity in OSAS is related to excessive daytime sleepiness

Author

Manuela Contin, Enrico Bugiardini, Vincenzo Donadio, Agostino Baruzzi, Tomas Karlsson, Roberto Vetrugno, B. Gunnar Wallin, Mikael Elam, Rocco Liguori, Pasquale Montagna, Donadio V., Liguori R., Vetrugno R., Contin M., Elam M., Wallin B.G., Karlsson T., Bugiardini E., Baruzzi A., and Montagna P.

Subjects
Male, Daytime, Ambulatory blood pressure, Sympathetic Nervous System, Cognitive Neuroscience, medicine.medical_treatment, Polysomnography, Excessive daytime sleepiness, Disorders of Excessive Somnolence, Hyperkinesis, Behavioral Neuroscience, Medicine, Animals, Humans, Continuous positive airway pressure, Muscle, Skeletal, Oxygen saturation (medicine), Sleep Stages, Sleep Apnea, Obstructive, medicine.diagnostic_test, Continuous Positive Airway Pressure, business.industry, General Medicine, Microneurography, Middle Aged, respiratory tract diseases, Treatment Outcome, Anesthesia, Hypertension, Female, Rabbits, medicine.symptom, business
Abstract

SUMMARY The aim of this study was to investigate the relationships among sympathetichyperactivity, excessive daytime sleepiness (EDS) and hypertension in obstructive sleepapnoea syndrome (OSAS). Ten newly diagnosed OSAS patients with untreated EDSand daytime hypertension underwent polysomnography (PSG) and daytime measure-ments of plasma noradrenaline (NA), ambulatory blood pressure (BP), musclesympathetic nerve activity (MSNA) by microneurography and objective assessmentof EDS before and during 6 months of compliance-monitored continuous positiveairway pressure (CPAP) treatment. One month after the start of CPAP, BP, MSNAand NA were significantly lowered, remaining lower than baseline also after 3 and6 months of treatment. CPAP use caused a significant improvement of sleep structures,and reduced EDS. A statistical correlation analysis demonstrated that EDS was notcorrelated with sleep measures obtained from baseline PSG (% sleep stages, apnoea andarousal index, mean oxygen saturation value), whereas daytime sleepiness wassignificantly correlated with MSNA. Furthermore, MSNA and BP showed nocorrelation. Our data obtained from selected patients suggest that the mechanismsinducing EDS in OSAS are related to the degree of daytime sympathetic hyperactivity.Additionally, resting MSNA was unrelated to BP suggesting that factors other thanadrenergic neural tone make a major contribution to OSAS-related hypertension. Theresults obtained in this pilot study need, however, to be confirmed in a larger studyinvolving more patients.keywords continuous positive airway pressure, hypertension, muscle sympatheticnerve activity, obstructive sleep apnoea syndrome, sleepiness

Published
2007

35. Ab interno trabeculectomy: Ultrastructural evidence and early tissue response in a human eye

Author

Francesco Bandello, Maurizio Marchini, E. Ferrari, Fulvia Ortolani, Lucia Petrelli, Magali Contin, Derri Roman Pognuz, Ferrari, E, Ortolani, F, Petrelli, L, Contin, M, Pognuz, Dr, Marchini, M, and Bandello, Francesco

Subjects
Choroidal melanoma, medicine.medical_specialty, Anterior Chamber, medicine.medical_treatment, Enucleation, Glaucoma, Lumen (anatomy), Trabeculectomy, Cataract, Eye Enucleation, Trabecular Meshwork, Ophthalmology, medicine, Humans, Melanoma, Intraocular Pressure, Phacoemulsification, business.industry, Choroid Neoplasms, Middle Aged, medicine.disease, Sensory Systems, Treatment Outcome, medicine.anatomical_structure, Ultrastructure, Female, Surgery, Human eye, sense organs, business
Abstract

Purpose To report the results of ultrastructural analysis of the postoperative effects of ab interno trabeculectomy in a human eye. Setting Department of Ophthalmology, Palmanova Hospital, Palmanova, Udine, Italy. Methods A 60-year-old woman with cataract and glaucoma had enucleation for a choroidal melanoma 10 days after ab interno trabeculectomy combined with phacoemulsification. A second ab interno trabeculectomy was performed after enucleation to evaluate the outcomes of the previous trabeculectomy. Light and transmission electron microscopy analyses were performed on samples excised from areas (1) not subjected to a procedure (control samples), (2) that had ab interno trabeculectomy before enucleation, and (3) that had ab interno trabeculectomy immediately after enucleation. Results Control samples showed normal trabecular features. Semithin sections of all ab interno trabeculectomy samples showed full-thickness removal of trabeculum segments, with Schlemm's canal lumen opening into the anterior chamber and apparent preservation of the adjacent structures. On ultrathin sections of samples that had ab interno trabeculectomy before enucleation, the endothelium lining the outer wall of Schlemm's canal and other angle components showed intact ultrastructural features. In trabecular beams that were not removed, the extracellular matrix appeared to have maintained its fine texture and was free of activated fibroblasts or leucocyte infiltrates. Conclusions Observations confirm that ab interno trabeculectomy causes direct communication between Schlemm's canal lumen and the anterior chamber in vivo and immediately after enucleation during the early postoperative period. The absence of an evident inflammatory reaction in the examined case should be considered with caution because of possible tumor-induced immune suppression.

Published
2007

36. Genetic polymorphism of catechol-O-methyltransferase and levodopa pharmacokinetic-pharmacodynamic pattern in patients with Parkinson's disease

Author

M. Mochi, Manuela Contin, Fiorenzo Albani, Agostino Baruzzi, Roberto Riva, Paolo Martinelli, Contin M, Martinelli P, Mochi M, Riva R, Albani F, and Baruzzi A.

Subjects
Male, Levodopa, Parkinson's disease, Genotype, Population, Pharmacology, Motor Activity, Catechol O-Methyltransferase, Antiparkinson Agents, Benserazide, Pharmacokinetics, mental disorders, Reaction Time, Medicine, Humans, Drug Interactions, education, Aged, education.field_of_study, Analysis of Variance, Catechol-O-methyl transferase, Polymorphism, Genetic, business.industry, Parkinson Disease, Middle Aged, medicine.disease, nervous system diseases, Neurology, Dyskinesia, Pharmacogenetics, Pharmacodynamics, Area Under Curve, Female, Neurology (clinical), medicine.symptom, business, medicine.drug
Abstract

We explored the potential effect of catechol-O-methyltransferase (COMT) genetic polymorphism on the pharmacokinetics and pharmacodynamics of a standard oral dose of levodopa in patients with Parkinson's disease (PD). We prospectively collected blood samples for COMT genotyping from a population of 104 PD patients. Each patient was examined by a standard oral levodopa/benserazide test, based on simultaneous serial measurements of plasma levodopa concentrations, finger-tapping motor effects and dyskinesia ratings, up to 4 hours after dosing. The main levodopa pharmacokinetic outcome variables were time to peak and peak plasma concentration, plasma elimination half-life, and the area under the plasma concentration-time curve. The main outcome levodopa pharmacodynamic variables were latency, duration, and magnitude of the motor effect elicited by the levodopa test dose, the area under the tapping effect-time curve, and the presence of dyskinesias. Nineteen patients (18%) harbored the low-activity homozygous COMT genotype (A/A), 63 patients (61%) carried the intermediate-activity heterozygous COMT genotype (A/G) and 22 patients (21%) had the high-activity homozygous COMT genotype (G/G). The three groups were comparable for vital and clinical characteristics. No significant difference was found in levodopa main pharmacokinetic-pharmacodynamic variables and dyskinesia incidence among the three subgroups of patients. We failed to identify clinically relevant levodopa pharmacokinetic-pharmacodynamic response patterns associated with the COMT polymorphism in PD patients.

Published
2005

37. Levetiracetam therapeutic monitoring in patients with epilepsy: effect of concomitant antiepileptic drugs

Author

Manuela Contin, Fiorenzo Albani, Roberto Riva, Agostino Baruzzi, CONTIN M, ALBANI F, RIVA R, and BARUZZI A.

Subjects
Pharmacology, Adult, Male, Epilepsy, Levetiracetam, Dose-Response Relationship, Drug, Piracetam, Cytochrome P-450 Enzyme System, Humans, Pharmacology (medical), Anticonvulsants, Drug Interactions, Drug Therapy, Combination, Female, Prospective Studies, Drug Monitoring, Chromatography, High Pressure Liquid
Abstract

The authors assessed the effect of concomitant antiepileptic therapy on steady-state plasma concentrations of the new anti-epileptic drug (AED) levetiracetam in a cohort of 100 adult patients with epilepsy. On the basis of concomitant AEDs, patients were divided into two groups, otherwise comparable for age, gender, weight-adjusted daily dose of levetiracetam, and dosing frequency: group A (n = 65), receiving levetiracetam plus AED inducers of cytochrome P450 (CYP) metabolism, such as carbamazepine, phenobarbital, and phenytoin; group B (n = 35), receiving levetiracetam plus AEDs without inducing properties of CYP metabolism, namely valproic acid and lamotrigine. Plasma levetiracetam concentrations were measured by HPLC with spectrophotometric detection. Median morning trough levetiracetam plasma concentrations were significantly lower in patients of group A than in patients of group B (10.4 microg/mL versus 14.7 microg/mL, P0.001). Median weight-normalized levetiracetam apparent oral clearance (CL/F) was 1.3-fold in patients receiving AED inducers compared with patients on AED noninducers (1.93 versus 1.45 mL x min(-1) x kg, P0.001). No gender-related difference was observed in CL/F values. Levetiracetam plasma concentrations were linearly related to daily drug doses, regardless of concomitant AED therapy, over a dose range from 500 to 5000 mg/d, although at a given daily dose an appreciable interpatient variability was observed in matched plasma drug concentrations. Concomitant AED inducers can contribute to variability in levetiracetam disposition in patients with epilepsy. The observed differences were moderate and possibly of minor clinical significance.

Published
2004

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