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1. Long‐term (48 weeks) effectiveness, safety, and tolerability of erenumab in the prevention of high‐frequency episodic and chronic migraine in a real world: Results of the EARLY 2 study

Author

Barbanti P., Aurilia C., Cevoli S., Egeo G., Fofi L., Messina R., Salerno A., Torelli P., Albanese M., Carnevale A., Bono F., D'Amico D., Filippi M., Altamura C., Vernieri F., Colombo B., Frediani F., Mercuri B., D'Onofrio F., Grazzi L., Aguggia M., Pierangeli G., Favoni V., Finocchi C., Di Fiore P., Costa C. M., Brunelli N., Fallacara A., Bertuzzo D., Zucco M., Di Clemente L., Trimboli M., Pascarella A., Manzo L., Barbanti P., Aurilia C., Cevoli S., Egeo G., Fofi L., Messina R., Salerno A., Torelli P., Albanese M., Carnevale A., Bono F., D'Amico D., Filippi M., Altamura C., Vernieri F., Colombo B., Frediani F., Mercuri B., D'Onofrio F., Grazzi L., Aguggia M., Pierangeli G., Favoni V., Finocchi C., Di Fiore P., Costa C.M., Brunelli N., Fallacara A., Bertuzzo D., Zucco M., Di Clemente L., Trimboli M., Pascarella A., Manzo L., Barbanti, Piero, Aurilia, Cinzia, Cevoli, Sabina, Egeo, Gabriella, Fofi, Luisa, Messina, Roberta, Salerno, Antonio, Torelli, Paola, Albanese, Maria, Carnevale, Antonio, Bono, Francesco, D'Amico, Domenico, Filippi, Massimo, Altamura, Claudia, and Vernieri, Fabrizio

Subjects
Adult, Male, Calcitonin Gene-Related Peptide Receptor Antagonist, medicine.medical_specialty, Visual analogue scale, Migraine Disorders, Population, Analgesic, Longitudinal Studie, Sex Factor, Calcitonin gene-related peptide, Antibodies, Monoclonal, Humanized, calcitonin gene-related peptide, Sex Factors, Chronic Migraine, Migraine Disorder, Calcitonin Gene-Related Peptide Receptor Antagonists, Interquartile range, Internal medicine, Outcome Assessment, Health Care, sex, Humans, Medicine, long-term treatment, migraine, Longitudinal Studies, education, allodynia, education.field_of_study, business.industry, Middle Aged, medicine.disease, Italy, Neurology, Tolerability, Migraine, erenumab, Hyperalgesia, Chronic Disease, Female, Neurology (clinical), business, Human
Abstract

Objective: To evaluate the long-term effectiveness, safety, and tolerability of erenumab in a real-world migraine population, looking for putative predictors of responsiveness. Background: Erenumab proved to be effective, safe, and well tolerated in the prevention of episodic migraine (EM) and chronic migraine (CM) in long-term extension studies of double-blind, placebo-controlled trials in patients with no more than two (EM) or three (CM) prior preventive treatment failures. Methods: A 48-week, multicenter, longitudinal cohort real-life study was conducted at 15headache centers across eight Italian regions between December 20, 2018 and July 31, 2020. We considered all consecutive patients with high-frequency episodic migraine (HFEM) or CM aged 18–65years. Each patient was treated with erenumab 70mg, administered monthly. The dose was switched to 140mg in nonresponders and in responders who had become nonresponders for at least 4weeks. Change in monthly migraine days (MMDs) or monthly headache days (MHDs) at Weeks 45–48 compared with baseline was the primary efficacy endpoint. Secondary endpoints encompassed variation in monthly analgesic intake, achievement of a ≥50%, ≥75%, or 100% reduction in migraine or headache days, and any change in the Visual Analogue Scale (VAS) and Headache Impact Test-6 scores (HIT-6) during the same time interval. Results: A total of 242 patients with migraine received at least one dose of erenumab 70mg and were considered for safety analysis, whereas 221 received a monthly erenumab dose for ≥48weeks and were included in the effectiveness and safety analysis set. All patients had previously been treated unsuccessfully with ≥3migraine-preventive medication classes. From baseline to Weeks 45–48, erenumab treatment reduced MMD by 4.3±5.3(mean±SD) in patients with HFEM, and MHD by 12.8±8.9 (mean±SD) in subjects with CM. VAS and HIT-6scores were decreased by 1.8±1.9 (mean±SD) and 12.3±11 (mean±SD) in HFEM, and by 3.0±2.2 (mean±SD) and 13.1±11.2 (mean±SD) in CM. Median monthly analgesic intake passed from 11.0 (interquartile range [IQR] 10.0–13.0) to 5 (IQR 2.0–8.0) in HFEM and from 20.0 (IQR 15.0–30.0) to 6.0 (IQR 3.8–10.0) in CM. The ≥50% responders were 56.1% (32/57) in HFEM and 75.6% (124/164) in CM; ≥75% responders were 31.6% (18/57) and 44.5% (73/164); and 100% responders were 8.8% (5/57) and 1.2% (2/164), respectively. At Week 48, 83.6% (137/164) of patients with CM had reverted to EM. Erenumab was safe and well tolerated. Responsiveness to erenumab was positively associated with cutaneous allodynia (OR: 5.44, 95% CI: 1.52–19.41; p=0.009) in HFEM. In patients with CM, ≥50% responsiveness was positively associated with male sex (OR: 2.99, 95% CI: 1.03–8.7; p=0.044) and baseline migraine frequency (OR: 1.12, 95% CI: 1.05–1.20; p=0.001) and negatively associated with psychiatric comorbidities (OR: 0.37, 95% CI: 0.15–0.87; p=0.023) and prior treatment failures (OR: 0.77, 95% CI: 0.64–0.92; p=0.004). Conclusions: Long-term (48-week) erenumab treatment provides sustained effectiveness, safety, and tolerability in real-life patients with HFEM or CM with ≥3 prior preventive treatment failures. The dose of 140mg was required in most patients along the study and should be taken into consideration as the starting dose. Allodynia (in HFEM), male sex, and baseline migraine frequency (in CM) might represent positive responsiveness predictors. Conversely, psychiatric comorbidities and multiple prior preventive treatment failures could be negative predictors in patients with CM.

Published
2021
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2. How radical prostatectomy procedures have changed over the last 10 years in Italy: a comparative analysis based on more than 1500 patients participating in the MIRROR-SIU/LUNA and the Pros-IT CNR study

Author

Gacci, M., Artibani, W., Bassi, P., Bertoni, F., Bracarda, S., Briganti, A., Carmignani, G., Carmignani, L., Conti, G., Corvo, R., De Nunzio, C., Fusco, F., Graziotti, P., Greco, I., Maggi, S., Magrini, S. M., Mirone, V., Montironi, R., Morgia, G., Muto, G., Noale, M., Pecoraro, S., Porreca, A., Ricardi, U., Russi, E., Russo, G., Salonia, A., Simonato, A., Serni, S., Tomasini, D., Tubaro, A., Zagonel, V., Crepaldi, G., Conti, G. N., Alitto, A. R., Ambrosi, E., Antonelli, A., Aristei, C., Bardari, F., Bardoscia, L., Barra, S., Bartoncini, S., Basso, U., Becherini, C., Bellavita, R., Bergamaschi, F., Berlingheri, S., Berruti, A., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Brausi, M., Bruni, A., Bruno, G., Brunocilla, E., Buffoli, A., Buglione, M., Buttigliero, C., Cacciamani, G., Caldiroli, M., Cardo, G., Carrieri, G., Castelli, E., Castrezzati, E., Catalano, G., Cattarino, S., Catucci, F., Cavallini Francolini, D., Ceccarini, O., Celia, A., Chiancone, F., Chini, T., Cianci, C., Cisternino, A., Collura, D., Corbella, F., Corinti, M., Corsi, P., Cortese, F., Corti, L., Decosimo, N., Cristiano, O., Rolando, D. A., Da Pozzo, L., D'Agostino, D., D'Elia, C., Dandrea, M., De Angelis, M., De Angelis, P., De Cobelli, O., De Concilio, B., De Lisa, A., De Luca, S., De Stefani, A., Deantoni, C. L., Degli Esposti, C., Destito, A., Detti, B., Di Muzio, N., Di Stasio, A., Di Stefano, C., Di Trapani, D., Difino, G., Falivene, S., Farullo, G., Fedelini, P., Ferrari, I., Ferrau, F., Ferro, M., Fodor, A., Fontana, F., Francesca, F., Francolini, G., Frata, P., Frezza, G., Gabriele, P., Galeandro, M., Garibaldi, E., Gennari, P. G., Gentilucci, A., Giacobbe, A., Giussani, L., Giusti, G., Gontero, P., Guarneri, A., Guida, C., Gurioli, A., Huqi, D., Imbimbo, C., Ingrosso, G., Iotti, C., Italia, C., La Mattina, P., La Rocca, R., Lamanna, E., Lastrucci, L., Lazzari, G., Liberale, F., Liguori, G., Lisi, R., Lohr, F., Lombardo, R., Lovisolo, J. A., Ludovico, G. M., Macchione, N., Maggio, F., Malizia, M., Manasse, G., Mandoliti, G., Mantini, G., Marafioti, L., Marciello, L., Marconi, A. M., Martilotta, A., Marzano, S., Masciullo, S., Maso, G., Massenzo, A., Mazzeo, E., Mearini, L., Medoro, S., Mole, R., Monesi, G., Montanari, E., Montefiore, F., Montesi, G., Moro, G., Muscas, G., Musio, D., Muto, P., Muzzonigro, G., Napodano, G., Negro, C. L. A., Nidini, M., Ntreta, M., Orsatti, M., Palazzolo, C., Palumbo, I., Parisi, A., Parma, P., Pavan, N., Pericolini, M., Pinto, F., Pistone, A., Pizzuti, V., Platania, A., Polli, C., Pomara, G., Ponti, E., Porcaro, A. B., Porpiglia, F., Pugliese, D., Pycha, A., Raguso, G., Rampini, A., Randone, D. F., Roboldi, V., Roscigno, M., Ruggieri, M. P., Ruoppo, G., Sanseverino, R., Santacaterina, A., Santarsieri, M., Santoni, R., Scagliarini, S., Scagliotti, G. V., Scanzi, M., Scarcia, M., Schiavina, R., Sciarra, A., Sciorio, C., Scolaro, T., Scuzzarella, S., Selvaggio, O., Serao, A., Signor, M. A., Silvani, M., Silvano, G., Silvestris, F., Simeone, C., Simone, V., Spagnoletti, G., Spinelli, M. G., Squillace, L., Tombolini, V., Toninelli, M., Triggiani, L., Trinchieri, A., Trodella, L., Luca, E., Trombetta, C., Tronnolone, L., Tucci, M., Urzi, D., Valdagni, R., Valeriani, M., Vanoli, M., Vitali, E., Volpe, A., Zaramella, S., Zeccolini, G., Zini, G., Acanfora, F., Aiello, E., Alchiede, S., Altieri, V., Anceschi, C., Aragona, F., Balloni, F., Barasolo, E., Barba, G., Bartoletti, R., Bigazzi, B., Belgrano, E., Salvatore, S., Battaglia, M., Bellei, L., Bettin, A., Bianchi, G., Bombieri, L., Brancato, T., Breda, G., Caggiano, S., Calabro, A., Caldironi, M., Campo, B., Capobianco, S., Capparelli, F., Carbone, A., Carlo, D., Catanzaro, F., Ciaraldi, F., Cicalese, V., Corbu, C., Cosciani Cunico, S., Cosentino, V., Crimi, A., Cucchiarale, G., Cuscuna, D., Damiano, R., D'Armiento, M., De Dominicis, C., De Grande, G., Del Boca, C., D'Elia, A., De Mayo, E., De Martin, M., Di Clemente, L., Di Meo, S., Di Monaco, G., Di Nicola, G., Di Silverio, A., Di Silverio, F., Fabri, F., Falsaperla, M., Fanciullacci, F., Ferrari, G., Fiaccavento, G., Filoni, A., Fontana, D., Fontana, G., Ghabin, H., Frea, B., Gaboardi, F., Gentile, V., Giandotti, M., Grasso, M., Grosso, G., Guazzieri, S., Isaia, A., Landi, G., Landolfi, R., Larcher, P., Laurenti, C., Lavelli, D., Leidi, G. L., Lembo, A., Leoni, S., Maffei, N., Maffezzini, M., Martinengo, C., Manieri, C., Martorana, G., Mazza, R., Medica, M., Melloni, D., Miano, L., Micheli, E., Milesi, R., Minervini, M. S., Minocci, D., Molon, A., Morello, P., Motta, M., Narcisi, F., Nicita, G., Palermo, S., Paoluzzi, M., Pompa, P., Porena, M., Raciti, G., Rizzotto, A., Rocco, F., Romano, M., Rossini, L., Russo, G. R., Salvioni, R., Sandri, S., Savoca, G., Selli, C., Selvaggi, F. P., Sercia, F., Tallarigo, C., Tanello, M., Tasca, A., Tenaglia, R., Tensi, M., Terrone, C., Tralce, L., Vagge, A., Valenti, P., Varaldo, M., Vespasiani, G., Vicentini, C., Vicirca, F., Vigano, P., Zaccone, V., Zartar, C., Gacci, M., Artibani, W., Bassi, P., Bertoni, F., Bracarda, S., Briganti, A., Carmignani, G., Carmignani, L., Conti, G., Corvo, R., De Nunzio, C., Fusco, F., Graziotti, P., Greco, I., Maggi, S., Magrini, S. M., Mirone, V., Montironi, R., Morgia, G., Muto, G., Noale, M., Pecoraro, S., Porreca, A., Ricardi, U., Russi, E., Russo, G., Salonia, A., Simonato, A., Serni, S., Tomasini, D., Tubaro, A., Zagonel, V., Crepaldi, G., Conti, G. N., Alitto, A. R., Ambrosi, E., Antonelli, A., Aristei, C., Bardari, F., Bardoscia, L., Barra, S., Bartoncini, S., Basso, U., Becherini, C., Bellavita, R., Bergamaschi, F., Berlingheri, S., Berruti, A., Borghesi, M., Bortolus, R., Borzillo, V., Bosetti, D., Bove, G., Bove, P., Brausi, M., Bruni, A., Bruno, G., Brunocilla, E., Buffoli, A., Buglione, M., Buttigliero, C., Cacciamani, G., Caldiroli, M., Cardo, G., Carrieri, G., Castelli, E., Castrezzati, E., Catalano, G., Cattarino, S., Catucci, F., Cavallini Francolini, D., Ceccarini, O., Celia, A., Chiancone, F., Chini, T., Cianci, C., Cisternino, A., Collura, D., Corbella, F., Corinti, M., Corsi, P., Cortese, F., Corti, L., Decosimo, N., Cristiano, O., Rolando, D. A., Da Pozzo, L., D'Agostino, D., D'Elia, C., Dandrea, M., De Angelis, M., De Angelis, P., De Cobelli, O., De Concilio, B., De Lisa, A., De Luca, S., De Stefani, A., Deantoni, C. L., Degli Esposti, C., Destito, A., Detti, B., Di Muzio, N., Di Stasio, A., Di Stefano, C., Di Trapani, D., Difino, G., Falivene, S., Farullo, G., Fedelini, P., Ferrari, I., Ferrau, F., Ferro, M., Fodor, A., Fontana, F., Francesca, F., Francolini, G., Frata, P., Frezza, G., Gabriele, P., Galeandro, M., Garibaldi, E., Gennari, P. G., Gentilucci, A., Giacobbe, A., Giussani, L., Giusti, G., Gontero, P., Guarneri, A., Guida, C., Gurioli, A., Huqi, D., Imbimbo, C., Ingrosso, G., Iotti, C., Italia, C., La Mattina, P., La Rocca, R., Lamanna, E., Lastrucci, L., Lazzari, G., Liberale, F., Liguori, G., Lisi, R., Lohr, F., Lombardo, R., Lovisolo, J. A., Ludovico, G. M., Macchione, N., Maggio, F., Malizia, M., Manasse, G., Mandoliti, G., Mantini, G., Marafioti, L., Marciello, L., Marconi, A. M., Martilotta, A., Marzano, S., Masciullo, S., Maso, G., Massenzo, A., Mazzeo, E., Mearini, L., Medoro, S., Mole, R., Monesi, G., Montanari, E., Montefiore, F., Montesi, G., Moro, G., Muscas, G., Musio, D., Muto, P., Muzzonigro, G., Napodano, G., Negro, C. L. A., Nidini, M., Ntreta, M., Orsatti, M., Palazzolo, C., Palumbo, I., Parisi, A., Parma, P., Pavan, N., Pericolini, M., Pinto, F., Pistone, A., Pizzuti, V., Platania, A., Polli, C., Pomara, G., Ponti, E., Porcaro, A. B., Porpiglia, F., Pugliese, D., Pycha, A., Raguso, G., Rampini, A., Randone, D. F., Roboldi, V., Roscigno, M., Ruggieri, M. P., Ruoppo, G., Sanseverino, R., Santacaterina, A., Santarsieri, M., Santoni, R., Scagliarini, S., Scagliotti, G. V., Scanzi, M., Scarcia, M., Schiavina, R., Sciarra, A., Sciorio, C., Scolaro, T., Scuzzarella, S., Selvaggio, O., Serao, A., Signor, M. A., Silvani, M., Silvano, G., Silvestris, F., Simeone, C., Simone, V., Spagnoletti, G., Spinelli, M. G., Squillace, L., Tombolini, V., Toninelli, M., Triggiani, L., Trinchieri, A., Trodella, L., Luca, E., Trombetta, C., Tronnolone, L., Tucci, M., Urzi, D., Valdagni, R., Valeriani, M., Vanoli, M., Vitali, E., Volpe, A., Zaramella, S., Zeccolini, G., Zini, G., Acanfora, F., Aiello, E., Alchiede, S., Altieri, V., Anceschi, C., Aragona, F., Balloni, F., Barasolo, E., Barba, G., Bartoletti, R., Bigazzi, B., Belgrano, E., Salvatore, S., Battaglia, M., Bellei, L., Bettin, A., Bianchi, G., Bombieri, L., Brancato, T., Breda, G., Caggiano, S., Calabro, A., Caldironi, M., Campo, B., Capobianco, S., Capparelli, F., Carbone, A., Carlo, D., Catanzaro, F., Ciaraldi, F., Cicalese, V., Corbu, C., Cosciani Cunico, S., Cosentino, V., Crimi, A., Cucchiarale, G., Cuscuna, D., Damiano, R., D'Armiento, M., De Dominicis, C., De Grande, G., Del Boca, C., D'Elia, A., De Mayo, E., De Martin, M., Di Clemente, L., Di Meo, S., Di Monaco, G., Di Nicola, G., Di Silverio, A., Di Silverio, F., Fabri, F., Falsaperla, M., Fanciullacci, F., Ferrari, G., Fiaccavento, G., Filoni, A., Fontana, D., Fontana, G., Ghabin, H., Frea, B., Gaboardi, F., Gentile, V., Giandotti, M., Grasso, M., Grosso, G., Guazzieri, S., Isaia, A., Landi, G., Landolfi, R., Larcher, P., Laurenti, C., Lavelli, D., Leidi, G. L., Lembo, A., Leoni, S., Maffei, N., Maffezzini, M., Martinengo, C., Manieri, C., Martorana, G., Mazza, R., Medica, M., Melloni, D., Miano, L., Micheli, E., Milesi, R., Minervini, M. S., Minocci, D., Molon, A., Morello, P., Motta, M., Narcisi, F., Nicita, G., Palermo, S., Paoluzzi, M., Pompa, P., Porena, M., Raciti, G., Rizzotto, A., Rocco, F., Romano, M., Rossini, L., Russo, G. R., Salvioni, R., Sandri, S., Savoca, G., Selli, C., Selvaggi, F. P., Sercia, F., Tallarigo, C., Tanello, M., Tasca, A., Tenaglia, R., Tensi, M., Terrone, C., Tralce, L., Vagge, A., Valenti, P., Varaldo, M., Vespasiani, G., Vicentini, C., Vicirca, F., Vigano, P., Zaccone, V., Zartar, C., Gacci M., Artibani W., Bassi P., Bertoni F., Bracarda S., Briganti A., Carmignani G., Carmignani L., Conti G., Corvo R., De Nunzio C., Fusco F., Graziotti P., Greco I., Maggi S., Magrini S.M., Mirone V., Montironi R., Morgia G., Muto G., Noale M., Pecoraro S., Porreca A., Ricardi U., Russi E., Russo G., Salonia A., Simonato A., Serni S., Tomasini D., Tubaro A., Zagonel V., Crepaldi G., Conti G.N., Alitto A.R., Ambrosi E., Antonelli A., Aristei C., Bardari F., Bardoscia L., Barra S., Bartoncini S., Basso U., Becherini C., Bellavita R., Bergamaschi F., Berlingheri S., Berruti A., Borghesi M., Bortolus R., Borzillo V., Bosetti D., Bove G., Bove P., Brausi M., Bruni A., Bruno G., Brunocilla E., Buffoli A., Buglione M., Buttigliero C., Cacciamani G., Caldiroli M., Cardo G., Carrieri G., Castelli E., Castrezzati E., Catalano G., Cattarino S., Catucci F., Cavallini Francolini D., Ceccarini O., Celia A., Chiancone F., Chini T., Cianci C., Cisternino A., Collura D., Corbella F., Corinti M., Corsi P., Cortese F., Corti L., deCosimo N., Cristiano O., Rolando D.A., Da Pozzo L., D'Agostino D., D'Elia C., Dandrea M., De Angelis M., De Angelis P., De Cobelli O., De Concilio B., De Lisa A., De Luca S., De Stefani A., Deantoni C.L., Degli Esposti C., Destito A., Detti B., Di Muzio N., Di Stasio A., Di Stefano C., Di Trapani D., Difino G., Falivene S., Farullo G., Fedelini P., Ferrari I., Ferrau F., Ferro M., Fodor A., Fontana F., Francesca F., Francolini G., Frata P., Frezza G., Gabriele P., Galeandro M., Garibaldi E., Gennari P.G., Gentilucci A., Giacobbe A., Giussani L., Giusti G., Gontero P., Guarneri A., Guida C., Gurioli A., Huqi D., Imbimbo C., Ingrosso G., Iotti C., Italia C., La Mattina P., La Rocca R., Lamanna E., Lastrucci L., Lazzari G., Liberale F., Liguori G., Lisi R., Lohr F., Lombardo R., Lovisolo J.A., Ludovico G.M., Macchione N., Maggio F., Malizia M., Manasse G., Mandoliti G., Mantini G., Marafioti L., Marciello L., Marconi A.M., Martilotta A., Marzano S., Masciullo S., Maso G., Massenzo A., Mazzeo E., Mearini L., Medoro S., Mole R., Monesi G., Montanari E., Montefiore F., Montesi G., Moro G., Muscas G., Musio D., Muto P., Muzzonigro G., Napodano G., Negro C.L.A., Nidini M., Ntreta M., Orsatti M., Palazzolo C., Palumbo I., Parisi A., Parma P., Pavan N., Pericolini M., Pinto F., Pistone A., Pizzuti V., Platania A., Polli C., Pomara G., Ponti E., Porcaro A.B., Porpiglia F., Pugliese D., Pycha A., Raguso G., Rampini A., Randone D.F., Roboldi V., Roscigno M., Ruggieri M.P., Ruoppo G., Sanseverino R., Santacaterina A., Santarsieri M., Santoni R., Scagliarini S., Scagliotti G.V., Scanzi M., Scarcia M., Schiavina R., Sciarra A., Sciorio C., Scolaro T., Scuzzarella S., Selvaggio O., Serao A., Signor M.A., Silvani M., Silvano G., Silvestris F., Simeone C., Simone V., Spagnoletti G., Spinelli M.G., Squillace L., Tombolini V., Toninelli M., Triggiani L., Trinchieri A., Trodella L., Luca E., Trombetta C., Tronnolone L., Tucci M., Urzi D., Valdagni R., Valeriani M., Vanoli M., Vitali E., Volpe A., Zaramella S., Zeccolini G., Zini G., Acanfora F., Aiello E., Alchiede S., Altieri V., Anceschi C., Aragona F., Balloni F., Barasolo E., Barba G., Bartoletti R., Bigazzi B., Belgrano E., Salvatore S., Battaglia M., Bellei L., Bettin A., Bianchi G., Bombieri L., Brancato T., Breda G., Caggiano S., Calabro A., Caldironi M., Campo B., Capobianco S., Capparelli F., Carbone A., Carlo D., Catanzaro F., Ciaraldi F., Cicalese V., Corbu C., Cosciani Cunico S., Cosentino V., Crimi A., Cucchiarale G., Cuscuna D., Damiano R., D'Armiento M., De Dominicis C., De Grande G., Del Boca C., D'Elia A., De Mayo E., De Martin M., Di Clemente L., Di Meo S., Di Monaco G., Di Nicola G., Di Silverio A., Di Silverio F., Fabri F., Falsaperla M., Fanciullacci F., Ferrari G., Fiaccavento G., Filoni A., Fontana D., Fontana G., Ghabin H., Frea B., Gaboardi F., Gentile V., Giandotti M., Grasso M., Grosso G., Guazzieri S., Isaia A., Landi G., Landolfi R., Larcher P., Laurenti C., Lavelli D., Leidi G.L., Lembo A., Leoni S., Maffei N., Maffezzini M., Martinengo C., Manieri C., Martorana G., Mazza R., Medica M., Melloni D., Miano L., Micheli E., Milesi R., Minervini M.S., Minocci D., Molon A., Morello P., Motta M., Narcisi F., Nicita G., Palermo S., Paoluzzi M., Pompa P., Porena M., Raciti G., Rizzotto A., Rocco F., Romano M., Rossini L., Russo G.R., Salvioni R., Sandri S., Savoca G., Selli C., Selvaggi F.P., Sercia F., Tallarigo C., Tanello M., Tasca A., Tenaglia R., Tensi M., Terrone C., Tralce L., Vagge A., Valenti P., Varaldo M., Vespasiani G., Vicentini C., Vicirca F., Vigano P., Zaccone V., Zartar C., Gacci, Mauro, Artibani, Walter, Bassi, Pierfrancesco, Bertoni, Filippo, Bracarda, Sergio, Briganti, Alberto, Carmignani, Giorgio, Carmignani, Luca, Conti, Giario, Corvò, Renzo, De Nunzio, Cosimo, Fusco, Ferdinando, Graziotti, Pierpaolo, Greco, Isabella, Maggi, Stefania, Magrini, Stefano Maria, Mirone, Vincenzo, Montironi, Rodolfo, Morgia, Giuseppe, Muto, Giovanni, Noale, Marianna, Pecoraro, Stefano, Porreca, Angelo, Ricardi, Umberto, Russi, Elvio, Russo, Giorgio, Salonia, Andrea, Simonato, Alchiede, Serni, Sergio, Tomasini, Davide, Tubaro, Andrea, Zagonel, Vittorina, and Crepaldi, Gaetano

Subjects
Male, Nephrology, medicine.medical_specialty, Time Factors, Urology, medicine.medical_treatment, 030232 urology & nephrology, Lymph node dissection, Logistic regression, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Internal medicine, LUNA study, Biopsy, Humans, Medicine, Prospective Studies, Nerve sparing, Lymph node, Aged, Prostatectomy, medicine.diagnostic_test, business.industry, MIRROR SIU/LUNA study, Lymph node dissection, MIRROR SIU/LUNA study, Nerve sparing, Pros-IT CNR study, Prostate cancer, Robotic procedures, Prostatic Neoplasms, Cancer, Pros-IT CNR study, Middle Aged, medicine.disease, MIRROR SIU, Dissection, Robotic procedures, Logistic Models, medicine.anatomical_structure, Italy, 030220 oncology & carcinogenesis, business
Abstract

Purpose Therapeutic strategies for prostate cancer (PCa) have been evolving dramatically worldwide. The current article reports on the evolution of surgical management strategies for PCa in Italy. Methods The data from two independent Italian multicenter projects, the MIRROR-SIU/LUNA (started in 2007, holding data of 890 patients) and the Pros-IT-CNR project (started in 2014, with data of 692 patients), were compared. Differences in patients' characteristics were evaluated. Multivariable logistic regression models were used to identify characteristics associated with robot-assisted (RA) procedure, nerve sparing (NS) approach, and lymph node dissection (LND). Results The two cohorts did not differ in terms of age and prostate-specific antigen (PSA) levels at biopsy. Patients enrolled in the Pros-IT-CNR project more frequently were submitted to RA (58.8% vs 27.6%,p < 0.001) and NS prostatectomy (58.4% vs. 52.9%,p = 0.04), but received LND less frequently (47.7% vs. 76.7%,p < 0.001), as compared to the MIRROR-SIU/LUNA patients. At multivariate logistic models, Lower Gleason Scores (GS) and PSA levels were significantly associated with RA prostatectomy in both cohorts. As for the MIRROR-SIU/LUNA data, clinical T-stage was a predictor for NS (OR = 0.07 for T3, T4) and LND (OR = 2.41 for T2) procedures. As for Pros-IT CNR data, GS >= (4 + 3) and positive cancer cores >= 50% were decisive factors both for NS (OR 0.29 and 0.30) and LND (OR 7.53 and 2.31) strategies. Conclusions PCa management has changed over the last decade in Italian centers: RA and NS procedures without LND have become the methods of choice to treat newly medium-high risk diagnosed PCa.

Published
2021

4. Carotid artery stenting during endovascular thrombectomy for acute ischemic stroke with tandem occlusion: the Italian Registry of Endovascular Treatment in Acute Stroke

Author

Sallustio, Fabrizio, Pracucci, Giovanni, Cappellari, Manuel, Saia, Valentina, Mascolo, Alfredo Paolo, Marrama, Federico, Gandini, Roberto, Koch, Giacomo, Diomedi, Marina, D’Agostino, Federica, Rocco, Alessandro, Da Ros, Valerio, Wlderk, Andrea, Nezzo, Marco, Argirò, Renato, Morosetti, Daniele, Renieri, Leonardo, Nencini, Patrizia, Vallone, Stefano, Zini, Andrea, Bigliardi, Guido, Pitrone, Antonio, Grillo, Francesco, Bracco, Sandra, Tassi, Rossana, Bergui, Mauro, Naldi, Andrea, Carità, Giuseppe, Casetta, Ilaria, Gasparotti, Roberto, Magoni, Mauro, Simonetti, Luigi, Haznedari, Nicolò, Paolucci, Matteo, Mavilio, Nicola, Malfatto, Laura, Menozzi, Roberto, Genovese, Antonio, Cosottini, Mirco, Orlandi, Giovanni, Comai, Alessio, Franchini, Enrica, Pedicelli, Alessandro, Frisullo, Giovanni, Puglielli, Edoardo, Casalena, Alfonsina, Cester, Giacomo, Baracchini, Claudio, Castellano, Davide, Di Liberto, Alessandra, Ricciardi, Giuseppe Kenneth, Chiumarulo, Luigi, Petruzzellis, Marco, Lafe, Elvis, Persico, Alessandra, Cavasin, Nicola, Critelli, Adriana, Semeraro, Vittorio, Tinelli, Angelica, Giorgianni, Andrea, Carimati, Federico, Auteri, William, Rizzuto, Stefano, Biraschi, Francesco, Nicolini, Ettore, Ferrari, Antonio, Melis, Maurizio, Calia, Stefano, Tassinari, Tiziana, Nuzzi, Nunzio Paolo, Corato, Manuel, Sacco, Simona, Squassina, Guido, Invernizzi, Paolo, Gallesio, Ivan, Ruiz, Luigi, Dui, Giovanni, Carboni, Nicola, Amistà, Pietro, Russo, Monia, Maiore, Mario, Zanda, Bastianina, Craparo, Giuseppe, Mannino, Marina, Inzitari, Domenico, Toni, Danilo, Mangiafico, Salvatore, Gasparotti, R., Inzitari, D., Mangiafico, S., Toni, D., Vallone, S., Zini, A., Bergui, M., Causin, F., Ciccone, A., Nencini, P., Saletti, A., Sallustio, F., Tassi, R., Thyrion, F. Zappoli, Pracucci, G., Saia, V., Gandini, R., Da Ros, V., Greco, L., Morosetti, D., Diomedi, M., Nappini, S., Limbucci, N., Renieri, L., Fainardi, E., Verganti, L., Sacchetti, F., Zelent, G., Bigliardi, G., Dell’Acqua, M. L., Picchetto, L., Vandelli, L., Pentore, R., Maffei, S., Nichelli, P., Longo, M., Pitrone, A., Vinci, S. L., Velo, M., Caragliano, A., Tessitore, A., Bonomo, O., Musolino, R., La Spina, P., Casella, C., Fazio, M. C., Grillo, F., Cotroneo, M., Dell’Aera, C., Francalanza, I., Bracco, S., Cioni, S., Gennari, P., Vallone, I. M., Cerase, A., Martini, G., Stura, G., Daniele, D., Cerrato, P., Naldi, A., Onofrio, M., De Vito, A., Azzini, C., Casetta, I., Mardighian, D., Frigerio, M., Magoni, M., Costa, A., Simonetti, L., Cirillo, L., Taglialatela, F., Isceri, S., Princiotta, C., Dall’Olio, M., Cellerini, M., Gentile, M., Piccolo, L., Migliaccio, L., Brancaleoni, L., Naldi, F., Romoli, M., Zaniboni, A., Ruggiero, M., Sanna, A., Haznedari, N., Commodaro, C., Longoni, M., Biguzzi, S., Cordici, F., Malatesta, E., Castellan, L., Mavilio, N., Salsano, G., Malfatto, L., Finocchi, C., Menozzi, R., Piazza, P., Epifani, E., Andreone, A., Scoditti, U., Castellini, P., Latte, L., Grisendi, I., Cosottini, M., Puglioli, M., Lazzarotti, G., Lauretti, D., Mancuso, M., Giannini, N., Maccarone, M., Orlandi, G., Comai, A., Bonatti, G., Nano, G., Ferro, F., Bonatti, M., Dall’Ora, E., Dossi, R. Currò, Turri, E., Turri, M., Colosimo, C., Pedicelli, A., D’Argento, F., Alexandre, A., Frisullo, G., Di Egidio, V., Puglielli, E. G., Ruggero, L., Assetta, M., Casalena, A., Cester, G., Baracchini, C., Viaro, F., Pieroni, A., Vaudano, G., Comelli, C., Di Maggio, L., Castellano, D., Cavallo, R., Duc, E., Chianale, G., Ciceri, E. F. M., Plebani, M., Augelli, R., Zampieri, P., Grazioli, A., Cappellari, M., Forlivesi, S., Tomelleri, G., Micheletti, N., Chiumarulo, L., Zimatore, D. S., Federico, F., Petruzzelli, M., Zappoli, F., Lafe, E., Sanfilippo, G., Sgreccia, A., Martignoni, A., Cavallini, A., Denaro, F., Persico, A., Cagliari, E., Cavasin, N., Quatrale, R., Critelli, A., Burdi, N., Semeraro, V., Lucarelli, N., Ganimede, M. P., Internò, S., Tinelli, A., Prontera, M. P., Pesare, A., Cotroneo, E., Pampana, E., Ricciardi, F., Gigli, R., Pezzella, F. R., Corsi, F., Giorgianni, A., Baruzzi, F., Pellegrino, C., Terrana, A., Versino, M., Delodovici, M. L., Carimati, F., Cariddi, L. Princiotta, Auteri, W., Di Benedetto, O., Silvagni, U., Perrotta, P., Crispino, E., Petrone, A., Stancati, F., Rizzuto, S., Pugliese, P., Pisani, E., Siniscalchi, A., Gaudiano, C., Pirritano, D., Del Giudice, F., Piano, M., Agostoni, E., Motto, C., Gatti, A., Guccione, A., Tortorella, R., Stecco, A., Guzzardi, G., Del Sette, B., Coppo, L., Baldan, J., Romano, D., Siani, A., Locatelli, G., Saponiero, R., Napolitano, R., De Gregorio, M., Volpe, G., Tenuta, M., Guidetti, G., Biraschi, F., Wulbek, A., Falcou, A., Anzini, A., Mancini, A., De Michele, M., Fausti, S., Di Mascio, M. T., Durastanti, L., Sbardella, E., Mellina, V., Nicolini, E., Comelli, S., Ganau, C., Corraine, S., Fusaro, F., Ferrari, A., Schirru, F., Ledda, V., Secci, S., Melis, M., Piras, V., Moller, J., Padolecchia, R., Allegretti, L., Caldiera, V., Calia, S., Ganci, G., Tassinari, T., Sugo, A., De Nicola, M., Giannoni, M., Bruni, S., Gambelli, E., Provinciali, L., Nuzzi, N. P., Marcheselli, S., Corato, M., Scomazzoni, F., Simionato, F., Roveri, L., Filauri, P., Sacco, S., Orlandi, B., De Santis, F., Tiseo, C., Notturno, F., Ornello, R., Pavia, M., Squassina, G., Cobelli, M., Morassi, M., Magni, E., Invernizzi, P., Pepe, F., Bigni, B., Costa, P., Crabbio, M., Griffini, S., Palmerini, F., Piras, M. P., Gallesio, I., Barbero, S., Ferrandi, D., Dui, G., Fancello, M. C., Zedda, S., Ticca, A., Saddi, M. V., Deiana, G., Rossi, R., Carboni, N., Mela, A., Amistà, P., Russo, M., Iannucci, G., Pinna, V., Di Clemente, L., Santi, M., De Boni, A., De Luca, C., Natrella, M., Fanelli, G., Cristoferi, M., Bottacchi, E., Corso, G., Tosi, P., Sessa, M., Giossi, A., Baietti, Null, Romano, G., Meineri, P., Armentano, A., Versace, P., Arcudi, L., Galvano, G., Petralia, B., Feraco, P., Luppi, G., Giometto, B., Bignamini, V., Piffer, S., Meloni, G. B., Fabio, C., Maiore, M., Pintus, F., Pischedda, A., Manca, A., Mongili, C., Zanda, B., Baule, A., Florio, F., Ciccarese, G., Leone, M., Di Viesti, P., Pappalardo, M. P., Craparo, G., Gallo, C., Monaco, S., Mannino, M., Muto, M., Guarnieri, Gl., Andreone, V., Passalacqua, G., Allegritti, M., Caproni, S., Filizzolo, M., Salmaggi, A., Giordano, A., Marini, C., Frattale, I., Lucente, G., Nozzoli, C., and Lupo, F. A.

Subjects
Stent, Acute stroke, Settore MED/37 - Neuroradiologia, Acute stroke Internal carotid artery diseases Stent Thrombectomy, Neurology (clinical), General Medicine, Settore MED/26, Internal carotid artery diseases, Thrombectomy
Abstract

The management of tandem extracranial internal carotid artery and intracranial large vessel occlusion during endovascular thrombectomy (EVT) for acute ischemic stroke (AIS) has been under-investigated. We sought to investigate outcomes of AIS patients with tandem occlusion (TO) treated with carotid artery stenting (CAS) compared to those not treated with CAS (no-CAS) during EVT.We performed a cohort study using data from AIS patients enrolled in the Italian Registry of Endovascular Treatment in Acute Stroke. Outcomes were 3 months' mortality, functional outcome, complete and successful recanalization, any intracranial hemorrhage, parenchymal hematoma and symptomatic intracerebral hemorrhage.Among 466 AIS patients with TO, CAS patients were 122 and no-CAS patients were 226 (118 excluded). After adjustment for unbalanced variables, CAS was associated with a lower rate of 3 months' mortality (OR 0.407, 95% CI 0.171-0.969, p = 0.042). After adjustment for pre-defined variables, CAS was associated with a lower rate of 3 months' mortality (aOR 0.430, 95% CI 0.187-0.989, p = 0.047) and a higher rate of complete recanalization (aOR 1.986, 95% CI 1.121-3.518, p = 0.019), successful recanalization (aOR 2.433, 95% CI 1.263-4.686, p = 0.008) and parenchymal hematoma (aOR 2.876, 95% CI 1.173-7.050, p = 0.021). CAS was associated with lower 3 months mortality (OR 0.373, 95% CI 0.141-0.982, p = 0.046) and higher rates of successful recanalization (OR 2.082, 95% CI 1.099-3.942, p = 0.024) after adjustment for variables associated with 3 months' mortality and successful recanalization, respectively.Among AIS patients with TO, CAS during EVT was associated with a higher rate of successful reperfusion and a lower rate of 3 months' mortality.

Published
2022

6. Cerebral vasoreactivity in silent brain infarcts: O7

Author

Maestrini, I., Vicenzini, E., Altieri, M., Coppola, C., Di Clemente, L., Federico, F., Mazzapesa, D. M., Pantano, P., Paolino, I., Provinciali, L., Ricciardi, M. C., Silvestrini, M., Tinelli, E., Vigano’, A., and Di Piero, V.

Published
2014

21. IER-SICH Nomogram to Predict Symptomatic Intracerebral Hemorrhage After Thrombectomy for Stroke

Author

Cappellari, M., Mangiafico, S., Saia, V., Pracucci, G., Nappini, S., Nencini, P., Konda, D., Sallustio, F., Vallone, S., Zini, A., Bracco, S., Tassi, R., Bergui, M., Cerrato, P., Pitrone, A., Grillo, F., Saletti, A., De Vito, A., Gasparotti, Roberto, Magoni, M., Puglielli, E., Casalena, A., Causin, F., Baracchini, C., Castellan, L., Malfatto, L., Menozzi, R., Scoditti, U., Comelli, C., Duc, E., Comai, A., Franchini, E., Cosottini, M., Mancuso, M., Peschillo, S., De Michele, M., Giorgianni, A., Delodovici, M. L., Lafe, E., Denaro, M. F., Burdi, N., Interno, S., Cavasin, N., Critelli, A., Chiumarulo, L., Petruzzellis, M., Doddi, M., Carolei, A., Auteri, W., Petrone, A., Padolecchia, R., Tassinari, T., Pavia, M., Invernizzi, P., Turcato, G., Forlivesi, S., Ciceri, E. F. M., Bonetti, B., Inzitari, D., Toni D., Limbucci N, Consoli, A, Renieri, L, Fainardi, E, Gandini, R, Pampana, E, Diomedi, M, Koch, G, Verganti, L, Sacchetti, F, Zelent, G, Bigliardi, G, Picchetto, L, Vandelli, L, Romano, Dg, Cioni, S, Gennari, P, Cerase, A, Martini, G, Stura, G, Daniele, D, Naldi, A, Papa, R, Vinci, Sl, Bernava, G, Velo, M, Caragliano, A, Tessitore, A, Buonomo, O, Musolino, R, La Spina, P, Casella, C, Carolina Fazio, M, Cotroneo, M, Onofrio, M, Azzini, C, Casetta, I, Mardighian, D, Frigerio, M, Costa, A, Di Egidio, V, Lattanzi, R, Assetta, M, Cester, G, Mavilio, N, Serrati, C, Piazza, P, Epifani, E, Andreone, A, Castellini, P, Latte, L, Grisendi, I, Vaudano, G, Comelli, S, Cavallo, R, Chianale, G, Simonetti, L, Taglialatela, F, Isceri, S, Procaccianti, G, Zaniboni, A, Borghi, A, Bonatti, G, Ferro, F, Bonatti, M, Dall'Ora, E, Currò Dossi, R, Turri, E, Turri, M, Puglioli, M, Lazzarotti, G, Lauretti, D, Giannini, N, Maccarone, M, Orlandi, G, Chiti, A, Guidetti, G, Biraschi, F, Falcou, A, Anzini, A, Mancini, A, Fausti, S, Di Mascio, Mt, Durastanti, L, Sbardella, E, Mellina, V, Baruzzi, F, Pellegrino, C, Terrana, A, Carimati, F, Ruggiero, M, Sanna, A, Passarin, Mg, Colosimo, C, Pedicelli, A, D'Argento, F, Alexandre, A, Frisullo, G, Zappoli, F, Martignoni, A, Cavallini, A, Persico, A, Valvassori, L, Piano, M, Agostoni, E, Motto, C, Gatti, A, Longoni, M, Guccione, A, Tortorella, R, Zampieri, P, Zimatore, D, Grazioli, A, Ricciardi, Gk, Augelli, R, Bovi, P, Tomelleri, G, Micheletti, N, Semeraro, V, Lucarelli, N, Ganimede, M, Tinelli, A, Pia Prontera, M, Pesare, A, Cagliari, E, Quatrale, R, Federico, F, Passalacqua, G, Filauri, P, Orlandi, B, De Santis, F, Gabriele, A, Tiseo, C, Armentano, A, Di Benedetto, O, Silvagni, U, Perrotta, P, Crispino, E, Stancati, F, Rizzuto, S, Pugliese, P, Pisani, E, Siniscalchi, A, Gaudiano, C, Pirritano, D, Del Giudice, F, Calia, S, Ganci, G, Sugo, A, Scomazzoni, F, Simionato, F, Roveri, L, De Nicola, M, Giannoni, M, Bruni, S, Gambelli, E, Provinciali, L, Carriero, A, Coppo, L, Baldan, J, Paolo Nuzzi, N, Marcheselli, S, Corato, M, Cotroneo, E, Ricciardi, F, Gigli, R, Pozzessere, C, Pezzella, Fr, Corsi, F, Squassina, G, Cobelli, M, Morassi, M, Magni, Eugenio, Pepe, F, Bigni, B, Costa, P, Crabbio, M, Griffini, S, Palmerini, F, Piras, Mp, Natrella, M, Fanelli, G, Cristoferi, M, Bottacchi, E, Corso, G, Tosi, P, Amistà, P, Russo, M, Tettoni, S, Gallesio, I, Mascolo, Mc, Meloni, Gb, Fabio, C, Maiore, M, Pintus, F, Pischedda, A, Manca, A, Mongili, C, Zanda, B, Baule, A, Pappalardo, Mp, Craparo, G, Gallo, C, Monaco, S, Mannino, M, Terruso, V, Muto, M, Guarnieri, G, Andreone, V, Dui, G, Ticca, A, Salmaggi, A, Iannucci, G, Pinna, V, Di Clemente, L, Perini, F, De Boni, A, De Luca, C, De Giorgi, F, Corraine, S, Enne, P, Ganau, C, Piras, V., Gasparotti R., Magni E (ORCID:0000-0002-2235-2280), Cappellari, M., Mangiafico, S., Saia, V., Pracucci, G., Nappini, S., Nencini, P., Konda, D., Sallustio, F., Vallone, S., Zini, A., Bracco, S., Tassi, R., Bergui, M., Cerrato, P., Pitrone, A., Grillo, F., Saletti, A., De Vito, A., Gasparotti, Roberto, Magoni, M., Puglielli, E., Casalena, A., Causin, F., Baracchini, C., Castellan, L., Malfatto, L., Menozzi, R., Scoditti, U., Comelli, C., Duc, E., Comai, A., Franchini, E., Cosottini, M., Mancuso, M., Peschillo, S., De Michele, M., Giorgianni, A., Delodovici, M. L., Lafe, E., Denaro, M. F., Burdi, N., Interno, S., Cavasin, N., Critelli, A., Chiumarulo, L., Petruzzellis, M., Doddi, M., Carolei, A., Auteri, W., Petrone, A., Padolecchia, R., Tassinari, T., Pavia, M., Invernizzi, P., Turcato, G., Forlivesi, S., Ciceri, E. F. M., Bonetti, B., Inzitari, D., Toni D., Limbucci N, Consoli, A, Renieri, L, Fainardi, E, Gandini, R, Pampana, E, Diomedi, M, Koch, G, Verganti, L, Sacchetti, F, Zelent, G, Bigliardi, G, Picchetto, L, Vandelli, L, Romano, Dg, Cioni, S, Gennari, P, Cerase, A, Martini, G, Stura, G, Daniele, D, Naldi, A, Papa, R, Vinci, Sl, Bernava, G, Velo, M, Caragliano, A, Tessitore, A, Buonomo, O, Musolino, R, La Spina, P, Casella, C, Carolina Fazio, M, Cotroneo, M, Onofrio, M, Azzini, C, Casetta, I, Mardighian, D, Frigerio, M, Costa, A, Di Egidio, V, Lattanzi, R, Assetta, M, Cester, G, Mavilio, N, Serrati, C, Piazza, P, Epifani, E, Andreone, A, Castellini, P, Latte, L, Grisendi, I, Vaudano, G, Comelli, S, Cavallo, R, Chianale, G, Simonetti, L, Taglialatela, F, Isceri, S, Procaccianti, G, Zaniboni, A, Borghi, A, Bonatti, G, Ferro, F, Bonatti, M, Dall'Ora, E, Currò Dossi, R, Turri, E, Turri, M, Puglioli, M, Lazzarotti, G, Lauretti, D, Giannini, N, Maccarone, M, Orlandi, G, Chiti, A, Guidetti, G, Biraschi, F, Falcou, A, Anzini, A, Mancini, A, Fausti, S, Di Mascio, Mt, Durastanti, L, Sbardella, E, Mellina, V, Baruzzi, F, Pellegrino, C, Terrana, A, Carimati, F, Ruggiero, M, Sanna, A, Passarin, Mg, Colosimo, C, Pedicelli, A, D'Argento, F, Alexandre, A, Frisullo, G, Zappoli, F, Martignoni, A, Cavallini, A, Persico, A, Valvassori, L, Piano, M, Agostoni, E, Motto, C, Gatti, A, Longoni, M, Guccione, A, Tortorella, R, Zampieri, P, Zimatore, D, Grazioli, A, Ricciardi, Gk, Augelli, R, Bovi, P, Tomelleri, G, Micheletti, N, Semeraro, V, Lucarelli, N, Ganimede, M, Tinelli, A, Pia Prontera, M, Pesare, A, Cagliari, E, Quatrale, R, Federico, F, Passalacqua, G, Filauri, P, Orlandi, B, De Santis, F, Gabriele, A, Tiseo, C, Armentano, A, Di Benedetto, O, Silvagni, U, Perrotta, P, Crispino, E, Stancati, F, Rizzuto, S, Pugliese, P, Pisani, E, Siniscalchi, A, Gaudiano, C, Pirritano, D, Del Giudice, F, Calia, S, Ganci, G, Sugo, A, Scomazzoni, F, Simionato, F, Roveri, L, De Nicola, M, Giannoni, M, Bruni, S, Gambelli, E, Provinciali, L, Carriero, A, Coppo, L, Baldan, J, Paolo Nuzzi, N, Marcheselli, S, Corato, M, Cotroneo, E, Ricciardi, F, Gigli, R, Pozzessere, C, Pezzella, Fr, Corsi, F, Squassina, G, Cobelli, M, Morassi, M, Magni, Eugenio, Pepe, F, Bigni, B, Costa, P, Crabbio, M, Griffini, S, Palmerini, F, Piras, Mp, Natrella, M, Fanelli, G, Cristoferi, M, Bottacchi, E, Corso, G, Tosi, P, Amistà, P, Russo, M, Tettoni, S, Gallesio, I, Mascolo, Mc, Meloni, Gb, Fabio, C, Maiore, M, Pintus, F, Pischedda, A, Manca, A, Mongili, C, Zanda, B, Baule, A, Pappalardo, Mp, Craparo, G, Gallo, C, Monaco, S, Mannino, M, Terruso, V, Muto, M, Guarnieri, G, Andreone, V, Dui, G, Ticca, A, Salmaggi, A, Iannucci, G, Pinna, V, Di Clemente, L, Perini, F, De Boni, A, De Luca, C, De Giorgi, F, Corraine, S, Enne, P, Ganau, C, Piras, V., Gasparotti R., and Magni E (ORCID:0000-0002-2235-2280)

Abstract

Background and Purpose - As a reliable scoring system to detect the risk of symptomatic intracerebral hemorrhage after thrombectomy for ischemic stroke is not yet available, we developed a nomogram for predicting symptomatic intracerebral hemorrhage in patients with large vessel occlusion in the anterior circulation who received bridging of thrombectomy with intravenous thrombolysis (training set), and to validate the model by using a cohort of patients treated with direct thrombectomy (test set). Methods - We conducted a cohort study on prospectively collected data from 3714 patients enrolled in the IER (Italian Registry of Endovascular Stroke Treatment in Acute Stroke). Symptomatic intracerebral hemorrhage was defined as any type of intracerebral hemorrhage with increase of ≥4 National Institutes of Health Stroke Scale score points from baseline ≤24 hours or death. Based on multivariate logistic models, the nomogram was generated. We assessed the discriminative performance by using the area under the receiver operating characteristic curve. Results - National Institutes of Health Stroke Scale score, onset-to-end procedure time, age, unsuccessful recanalization, and Careggi collateral score composed the IER-SICH nomogram. After removing Careggi collateral score from the first model, a second model including Alberta Stroke Program Early CT Score was developed. The area under the receiver operating characteristic curve of the IER-SICH nomogram was 0.778 in the training set (n=492) and 0.709 in the test set (n=399). The area under the receiver operating characteristic curve of the second model was 0.733 in the training set (n=988) and 0.685 in the test set (n=779). Conclusions - The IER-SICH nomogram is the first model developed and validated for predicting symptomatic intracerebral hemorrhage after thrombectomy. It may provide indications on early identification of patients for more or less postprocedural intensive management.

Published
2019

22. Postoperative treatment with phytotheraphy Graminex G63 (CERNILEN-Flogo®) after greenlight laser XPS (180W) photovaporization of the prostate (PVP), can affect patient's quality of life?

Author

DI PASQUALE, A. B., CASSANI, A., MASCIOVECCHIO, S., ZASA, G., RANIERI, G., ROMANO, G., and DI CLEMENTE, L.

Abstract

OBJECTIVE: Phytotherapic treatment as Cernilen-flogo® is commonly used to treat chronic pelvic pain, chronic prostatitis, and BPE (benign prostatic enlargement). In our study, for the first time, we aim to evaluate postoperatively Cernilen-flogo® therapy in patients with BPE/LUTS (lower urinary tract symptoms) previously treated with Greenlight laser XPS (180W) photovaporization of prostate (PVP) to improve surgical outcomes. MATERIALS AND METHODS: We collected data from patients treated with PVP for BPE/ LUTS international prostate symptom score (IPSS) >20 unresponding to conventional treatment. Two groups of patients were analyzed: Group A including 15 patients (50%) treated postoperatively with Cernilen-flogo® vs. no treatment Group B. One expert surgeon performed all the procedures. RESULTS: 30 patients included with BPE/LUTs previously treated with PVP. There was no difference between patients' demographic, median age, prostate volume and PSA (prostate specific antigen) level. All patients had a postoperative evaluation after 30-45 days. Patients with postoperative complications (acute urinary retention, postoperative hematuria) were excluded from our study. All patients had a preoperative and postoperative evaluation of IPSS, bother score (BS) and pelvic discomfort (visual analogic scale VAS). Preoperatively there was no significative difference in IPSS, BS and VAS. IPSS Group A was postoperatively 7.13 (SD 1.64) and Group B was 7.33 (SD 1.58) (p=0.67); BS Group A was postoperatively 1.33 (SD 0.81), Group B was 1.73 (SD 1.09) (p=0.30), and VAS Group A was 2.73 (SD 1.9) and Group B was 4.33 (SD 1.58) (p=0.004) showing a statistically significative difference between the two groups in pelvic discomfort with a better outcome in patients treated with Cernilen-flogo®. CONCLUSIONS: O ur s tudy s howed t hat C ernilen- flogo® treatment after PVP is effective and minimize patient's pelvic discomfort showed by lower VAS level resulting in better postoperatively patient's quality of life (QOL). [ABSTRACT FROM AUTHOR]

Published
2020

24. Migraine-specific quality of life questionnaire and relapse on medication overuse headache

Author

Caproni, S., Bianchi, E., Cupini, L. M., Corbelli, I., Beghi, E., Calabresi, P., Sarchielli, P., Pupillo, E., Pini, L. A., Iani, C., Livrea, P., Prudenzano, M. P., Bernardi, G., Diomedi, M., Tedeschi, G., Russo, A., Pisani, F., Pisani, L. R., Bono, G., Misaggi, G., Di Piero, V., Di Clemente, L., Sandrini, G., and Allena, M.

Subjects
Adult, Male, medicine.medical_specialty, Migraine Disorders, Clinical Neurology, Placebo, Severity of Illness Index, law.invention, Randomized controlled trial, Quality of life, law, Recurrence, Surveys and Questionnaires, Severity of illness, Outcome Assessment, Health Care, medicine, Headache Disorders, Secondary, Humans, Multicenter Studies as Topic, MOH, Relapse, Randomized Controlled Trials as Topic, business.industry, MSQ, Migraine Specific Quality of Life, Ancillary Study, General Medicine, Middle Aged, medicine.disease, moh msq relapse, Settore MED/26 - NEUROLOGIA, Migraine, Physical therapy, Quality of Life, Female, Neurology (clinical), Neurosurgery, business, Research Article
Abstract

Background The management of Medication overuse headache (MOH) represents a difficult challenge for clinicians and headache experts, particularly for the responder rate after a successful withdrawal treatment. The purpose of this study was to investigate the role of demographic and clinical characteristics as well as the score of Migraine-Specific Quality of Life Questionnaire (MSQ), Migraine Disability Questionnaire and Leeds Dependence Questionnaire in predicting a response after a successful withdrawal treatment in patients with MOH. Methods This ancillary study is part of a randomized trial that demonstrated the safety and the efficacy of a 3-month treatment with sodium valproate (VPA) (800 mg/day vs placebo) in MOH. Demographic and clinical characteristics and questionnaire results were obtained from the entire sample. Results A significant correlation was found only between MOH relapse and the total MSQ score, the Role Preventive sub-scale and the Emotional Function sub-scale, suggesting a poorer quality of life in non responders. Conclusion A high MSQ score could be associated with a poor short-term outcome in MOH patients after a successful treatment with detoxification followed by a new treatment.

Published
2015

28. Role of silodosin in patients with LUTS/BPE non responding to medical treatment with tamsulosin: a prospective, open-label, pilot study.

Author

MASCIOVECCHIO, S., DI PASQUALE, A. B., RANIERI, G., ROMANO, G., and DI CLEMENTE, L.

Abstract

OBJECTIVE: Lower urinary tract symptoms (LUTS) are frequently experienced in association with benign prostatic enlargement (BPE). Current guidelines state that alpha-blockers should be considered the first-line therapy of LUTS associated with BPE in most patients. However, in clinical practice treatment efficacy differs among individuals and, therefore, intra- class switch from one alpha-blocker to another, is frequently applied. In particular, switching to silodosin in clinical practice appears an intriguing therapeutic strategy due to the peculiar pharmacological properties of this molecule. This study evaluates the efficacy of silodosin in patients with LUTS associated with BPE who were not-responders to tamsulosin. PATIENTS AND METHODS: This was a prospective, open-label, single-center study. Patients treated with tamsulosin 0.4 mg once daily for BPE/LUTS for at least 12 months and not responding to therapy were switched to silodosin 8 mg once daily. The co-primary endpoints for evaluation of efficacy were the change in IPSS and quality of life (QoL) from the beginning of silodosin therapy to week 8. RESULTS: In total, 96 patients were enrolled. Mean International Prostatic Symptoms Score (IPSS) score at baseline was 20.0 ± 4.4, and it significantly decreased to 18.6 ± 4.5 at week 8 (mean change: -1.3 ± 1.4; 95% CI -1.6 - -1.0; p < 0.03). A decrease was also observed for the two IPSS subscores; in particular, the IPSS subscore for storage symptoms was significantly reduced at week 8, compared with baseline. A significant improvement in QoL was observed after switching to silodosin, as compared with baseline (-0.8 ± 1.0; 95% CI -1.0 - -0.6; p < 0.001). CONCLUSIONS: Silodosin improves IPSS symptoms score and QoL in patients with LUTS associated with BPE who were not-responders to tamsulosin therapy. [ABSTRACT FROM AUTHOR]

Published
2017

35. Urolitiasi in gravidanza

Author

Robimarga, C, Iorio, B, Di Clemente, L, Goldoni, S, PARADISO GALATIOTO, Giuseppe, and Miano, L.

Published
1986

41. Magnetic resonance imaging of the cerebellopontine angle: comparison between constructive interference steady-state and small field-of-view technique turbo spin echo sequences.

Author

Vitale V, Varotto A, Cracco I, Mansour M, Di Clemente L, Raneri FA, Tecchio A, and Iannucci G

Subjects
Humans, Female, Male, Middle Aged, Adult, Aged, Signal-To-Noise Ratio, Young Adult, Image Enhancement methods, Cerebellopontine Angle diagnostic imaging, Magnetic Resonance Imaging methods, Imaging, Three-Dimensional methods
Abstract

Background: The aim of this work was to optimize a three-dimensional (3D) turbo-spin-echo (TSE) sequence using a small field-of-view (FOV) technique for the study of the cerebellopontine angle and to compare it with a constructive interference steady-state (CISS) sequence., Methods: A total of 30 consecutive patients underwent magnetic resonance imaging with a 3Tesla (T) scanner, including 3D CISS and the optimized 3D small FOV technique turbo spin echo (3D SFT-TSE) T2-weighted sequences for the study of the cerebellopontine angle. The 3D SFT-TSE sequence was optimized after three different steps, and a quantitative evaluation of the signal-to-noise ratio (SNR) was obtained according to the National Electrical Manufacturers Association (NEMA) method. Three neuroradiologists made a blind comparative qualitative evaluation of the images between the 3D CISS and the 3D SFT-TSE obtained after the third optimization step, based on spatial resolution, contrast resolution, and presence of artifacts and noise., Results: The calculation of SNR using the NEMA method confirmed the superiority of the third optimization step over the others. For both spatial and contrast resolution, the optimized SFT-TSE was considered better (p < 0.001) than the CISS, while image artifacts and noise were considered worse in the CISS sequence (p < 0.001). Intraobserver analysis showed that all neuroradiologists preferred the 3D SFT-TSE sequence in terms of both spatial resolution and contrast resolution and found more noise and artifact disruption in the CISS sequence., Conclusions: The use of the 2D radiofrequency pulse technique with a 3D SFT-TSE T2 sequence was significantly more efficient than the 3D CISS sequence for the study of the cerebellopontine angle and inner ear structures., Competing Interests: Declarations. Conflict of interest: V. Vitale, A. Varotto, I. Cracco, M. Mansour, L. Di Clemente, F.A. Raneri, A. Tecchio and G. Iannucci declare that they have no competing interests. All procedures performed in studies involving human participants or on human tissue were in accordance with the ethical standards of the institutional and/or national research committee and with the 1975 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. The supplement containing this article is not sponsored by industry, (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Published
2024
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42. Correction to: Assessing the Long-Term (48-Week) Effectiveness, Safety, and Tolerability of Fremanezumab in Migraine in Real Life: Insights from the Multicenter, Prospective, FRIEND3 Study.

Author

Barbanti P, Egeo G, Proietti S, d'Onofrio F, Aurilia C, Finocchi C, Di Clemente L, Zucco M, Doretti A, Messina S, Autunno M, Ranieri A, Carnevale A, Colombo B, Filippi M, Tasillo M, Rinalduzzi S, Querzani P, Sette G, Forino L, Zoroddu F, Robotti M, Valenza A, Camarda C, Borrello L, Aguggia M, Viticchi G, Tomino C, Fiorentini G, Orlando B, Bonassi S, and Torelli P

Published
2024
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43. Oreoch-1: A broad-spectrum virus and host-targeting peptide against animal infections.

Author

Nastri BM, Chianese A, Giugliano R, Di Clemente L, Capasso C, Monti A, Doti N, Iovane V, Montagnaro S, Pagnini U, Iovane G, Zannella C, De Filippis A, and Galdiero M

Subjects
Animals, Antimicrobial Peptides pharmacology, Antimicrobial Peptides chemistry, Humans, Microbial Sensitivity Tests, Chlorocebus aethiops, Virus Internalization drug effects, Antiviral Agents pharmacology, Antiviral Agents chemistry
Abstract

In recent decades, the global rise of viral emerging infectious diseases has posed a substantial threat to both human and animal health worldwide. The rapid spread and accumulation of mutations into viruses, and the limited availability of antiviral drugs and vaccines, stress the urgent need for alternative therapeutic strategies. Antimicrobial peptides (AMPs) derived from natural sources present a promising avenue due to their specificity and effectiveness against a broad spectrum of pathogens. The present study focuses on investigating the antiviral potential of oreochromicin-1 (oreoch-1), a fish-derived AMP obtained from Nile tilapia, against a wide panel of animal viruses including canine distemper virus (CDV), Schmallenberg virus (SBV), caprine herpesvirus 1 (CpHV-1), and bovine herpesvirus 1 (BoHV-1). Oreoch-1 exhibited a strong antiviral effect, demonstrating an inhibition of infection at concentrations in the micromolar range. The mechanism of action involves the interference with viral entry into host cells and a direct interaction between oreoch-1 and the viral envelope. In addition, we observed that the peptide could also interact with the cell during the CDV infection. These findings not only highlight the efficacy of oreoch-1 in inhibiting viral infection but also emphasize the potential of fish-derived peptides, specifically oreoch-1, as effective antiviral agents against viral infections affecting animals, whose potential to spill into humans is high. This research contributes valuable insights to the ongoing quest for novel antiviral drugs with the potential to mitigate the impact of infectious diseases on a global scale., (© 2024 European Peptide Society and John Wiley & Sons Ltd.)

Published
2024
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44. Assessing the Long-Term (48-Week) Effectiveness, Safety, and Tolerability of Fremanezumab in Migraine in Real Life: Insights from the Multicenter, Prospective, FRIEND3 Study.

Author

Barbanti P, Egeo G, Proietti S, d'Onofrio F, Aurilia C, Finocchi C, Di Clemente L, Zucco M, Doretti A, Messina S, Autunno M, Ranieri A, Carnevale A, Colombo B, Filippi M, Tasillo M, Rinalduzzi S, Querzani P, Sette G, Forino L, Zoroddu F, Robotti M, Valenza A, Camarda C, Borrello L, Aguggia M, Viticchi G, Tomino C, Fiorentini G, Orlando B, Bonassi S, and Torelli P

Abstract

Introduction: Long-term (1-year) fremanezumab treatment proved to be effective, safe, and well tolerated in individuals with migraine and < 2 medication clusters in a randomized controlled trial (RCT). We aimed to assess real-world evidence (RWE), long-term effectiveness, tolerability, and safety of fremanezumab in people with high-frequency episodic migraine (HFEM) or chronic migraine (CM) with > 3 treatment failures and various comorbidities., Methods: A 48-week, prospective, multicenter (n = 26), cohort study assessed fremanezumab's effectiveness, safety, and tolerability in consecutive adults with HFEM or CM with > 3 treatment failures. Primary endpoint was variation from baseline in monthly migraine days (MMD) in HFEM and monthly headache days (MHD) in CM at weeks 45-48. Secondary endpoints were changes in monthly analgesic medications, Numerical Rating Scale (NRS), Headache Impact Test (HIT-6), and the Migraine Disability Assessment Scale (MIDAS) scores and ≥ 50%, ≥ 75%, and 100% responder rates., Results: Of 533 participants who had received ≥ 1 fremanezumab dose, 130 were treated for ≥ 48 weeks and considered for effectiveness analysis. No participant missed any treatment dosage every other consecutive month during the 12-month period., Primary Endpoint: fremanezumab significantly (p < 0.001) reduced both MMD (- 6.4) in HFEM and MHD (- 14.5) in CM. Secondary endpoints: a significant reduction (p < 0.001) was observed in monthly analgesic medications (HFEM - 6.0; CM -16.5), NRS (HFEM - 3.4; CM - 3.4), HIT-6 (HFEM - 16.9; CM - 17.9) and MIDAS score (HFEM - 50.4; CM - 76.6). The ≥ 50%, ≥ 75%, and 100% response rates to fremanezumab were 75.5%, 36.7%, and 2% in HFEM and 71.6%, 44.4%, and 3.7% in CM. Corresponding response rates were 60.5%, 37.2%, and 2.3% in individuals with psychiatric comorbidities, 74.2%, 50%, and 4.8% in CM with medication overuse, and 60.9%, 39.1%, and 4.3% in CM with medication overuse and psychiatric comorbidities. Mild and transient treatment-emergent adverse events occurred in 7.8% of the participants. No subject discontinued the treatment for any reason., Conclusion: This RWE study documents that long-term fremanezumab treatment is highly effective and remarkably well tolerated in subjects with HFEM or CM with multiple (> 3) therapeutic failures, even in the presence of concomitant medication overuse, psychiatric comorbidities, or both. The effectiveness-to-tolerability ratio appears to be better in RWE than in RCTs., (© 2024. The Author(s).)

Published
2024
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45. Ultra-late response (> 24 weeks) to anti-CGRP monoclonal antibodies in migraine: a multicenter, prospective, observational study.

Author

Barbanti P, Aurilia C, Egeo G, Proietti S, D'Onofrio F, Torelli P, Aguggia M, Bertuzzo D, Finocchi C, Trimboli M, Cevoli S, Fiorentini G, Orlando B, Zucco M, Di Clemente L, Cetta I, Colombo B, di Poggio MLB, Favoni V, Grazzi L, Salerno A, Carnevale A, Robotti M, Frediani F, Altamura C, Filippi M, Vernieri F, and Bonassi S

Subjects
Humans, Male, Female, Adult, Middle Aged, Prospective Studies, Treatment Outcome, Time Factors, Migraine Disorders immunology, Migraine Disorders drug therapy, Antibodies, Monoclonal administration & dosage, Calcitonin Gene-Related Peptide immunology
Abstract

Objective: Nearly 60% of migraine patients treated with monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway experience a ≥ 50% reduction in monthly migraine days (MMD) at 12 weeks compared to baseline (responders). However, approximately half of the patients not responding to anti-CGRP mAbs ≤ 12 weeks do respond ≤ 24 weeks (late responders). We assessed frequency and characteristics of patients responding to anti-CGRP mAbs only > 24 weeks (ultra-late responders)., Methods: In this multicenter (n = 16), prospective, observational, real-life study, we enrolled all consecutive adults affected by high-frequency episodic migraine (HFEM: ≥ 8 days/month) or chronic migraine (CM), with ≥ 3 prior therapeutic failures, treated with any anti-CGRP mAbs for ≥ 48 weeks. We defined responders patients with a ≥ 50% response rate ≤ 12 weeks, late responders those with a ≥ 50% response rate ≤ 24 weeks, and ultra-late responders those achieving a ≥ 50% response only > 24 weeks., Results: A total of 572 migraine patients completed ≥ 48 weeks of anti-CGRP mAbs treatment. Responders accounted for 60.5% (346/572), late responders for 15% (86/572), and ultra-late responders for 15.7% (90/572). Among ultra-late responders, 7.3% (42/572) maintained the ≥ 50% response rate across all subsequent time intervals (weeks 28, 32, 36, 40, 44, and 48) and were considered persistent ultra-late responders, while 8.4% (48/572) missed the ≥ 50% response rate at ≥ 1 subsequent time interval and were classified as fluctuating ultra-late responders. Fifty patients (8.7%) did not respond at any time interval ≤ 48 weeks. Ultra-late responders differed from responders for higher BMI (p = 0.033), longer duration of medication overuse (p < 0.001), lower NRS (p = 0.017) and HIT-6 scores (p = 0.002), higher frequency of dopaminergic symptoms (p = 0.002), less common unilateral pain-either alone (p = 0.010) or in combination with UAS (p = 0.023), allodynia (p = 0.043), or UAS and allodynia (p = 0.012)-a higher number of comorbidities (p = 0.012), psychiatric comorbidities (p = 0.010) and a higher proportion of patients with ≥ 1 comorbidity (p = 0.020)., Conclusion: Two-thirds of patients not responding to anti-CGRP mAbs ≤ 24 weeks do respond later, while non-responders ≤ 48 weeks are quite rare (8.7%). These findings suggest to rethink the duration of migraine prophylaxis and the definition of resistant and refractory migraine, currently based on the response after 2-3 months of treatment., (© 2024. The Author(s).)

Published
2024
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46. Correction to: Ultra-late response (> 24 weeks) to anti-CGRP monoclonal antibodies in migraine: a multicenter, prospective, observational study.

Author

Barbanti P, Aurilia C, Egeo G, Proietti S, D'Onofrio F, Torelli P, Aguggia M, Bertuzzo D, Finocchi C, Trimboli M, Cevoli S, Fiorentini G, Orlando B, Zucco M, Di Clemente L, Cetta I, Colombo B, di Poggio MLB, Favoni V, Grazzi L, Salerno A, Carnevale A, Robotti M, Frediani F, Altamura C, Filippi M, Vernieri F, and Bonassi S

Published
2024
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47. Melittin-Related Peptides Interfere with Sandfly Fever Naples Virus Infection by Interacting with Heparan Sulphate.

Author

Chianese A, Zannella C, Palma F, Di Clemente L, Monti A, Doti N, De Filippis A, and Galdiero M

Abstract

Emerging viruses pose an important global public health challenge, and early action is needed to control their spread. The Bunyaviridae family contains a great number of arboviruses which are potentially pathogenic for humans. For example, phleboviruses affect a large range of hosts, including humans and animals. Some infections usually have an asymptomatic course, but others lead to severe complications, such as Toscana virus, which is able to cause meningitis and encephalitis. Unfortunately, to date, no vaccines or antiviral treatments have been found. In the present study, we evaluated the effect of melittin-related peptides, namely the frog-derived RV-23 and AR-23, on sandfly fever Naples virus infection in vitro. Both peptides exhibited a strong antiviral activity by targeting the viral particles and blocking the virus-cell interaction. Their action was directed to an early phase of SFNV infection, in particular at viral adsorption on host cells, by interfering with the binding of common glycosaminoglycan receptors. Given the better antimicrobial behavior of AR-23 and RV-23 compared to melittin in terms of selectivity, our studies expand our understanding of the potential of these peptides as antimicrobials and stimulate further investigations in the direction of novel antiviral strategies against phlebovirus infection.

Published
2023
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48. The effect of different brain lesions on the reorganization of language functions within the dominant hemisphere assessed with task-based BOLD-fMRI.

Author

Piccirilli E, Sestieri C, Di Clemente L, Delli Pizzi A, Colasurdo M, Panara V, and Caulo M

Subjects
Humans, Magnetic Resonance Imaging methods, Language, Brain pathology, Brain Mapping, Epilepsy, Temporal Lobe pathology, Epilepsy, Temporal Lobe surgery, Glioma
Abstract

Background and Purpose: Language reorganization has been described in brain lesions with respect to their location and timing, but little is known with respect to their etiology. We used fMRI to investigate the effects of different types of left hemisphere lesions (GL = gliomas, TLE = temporal lobe epilepsy and CA = cavernous angioma) on the topographic intra-hemispheric language plasticity, also considering their location., Methods: Forty-seven right-handed patients with 3 different left hemisphere lesions (16 GL, 15 TLE and 16 CA) and 17 healthy controls underwent BOLD fMRI with a verb-generation task. Euclidean distance was used to measure activation peak shifts among groups with respect to reference Tailarach coordinates of Inferior Frontal Gyrus, Superior Temporal Sulcus and Temporo-Parietal Junction. Mixed-model ANOVAs were used to test for differences in activation peak shifts., Results: Significant activation peak shifts were found in GL patients with respect both to HC and other groups (TLA and CA). In addition, in the same group of patients a significant effect of tumor location (anterior or posterior) was detected., Conclusions: We demonstrated that intra-hemispheric language plasticity is influenced by the type of lesion affecting the left hemisphere and that fMRI is especially valuable in the preoperative assessment of such reorganization in glioma patients., (© 2023. Italian Society of Medical Radiology.)

Published
2023
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49. Early and sustained efficacy of fremanezumab over 24-weeks in migraine patients with multiple preventive treatment failures: the multicenter, prospective, real-life FRIEND2 study.

Author

Barbanti P, Egeo G, Aurilia C, Torelli P, Finocchi C, d'Onofrio F, d'Onofrio L, Rao R, Messina S, Di Clemente L, Ranieri A, Autunno M, Sette G, Colombo B, Carnevale A, Aguggia M, Tasillo M, Zoroddu F, Frediani F, Filippi M, Tomino C, Proietti S, and Bonassi S

Subjects
Humans, Prospective Studies, Treatment Outcome, Double-Blind Method, Headache, Treatment Failure, Migraine Disorders drug therapy, Migraine Disorders prevention & control
Abstract

Background: To verify the long-term (24-week) efficacy, safety, and tolerability of fremanezumab in real-life patients with high-frequency episodic migraine (HFEM: ≥ 8 days/month) or chronic migraine (CM: ≥ 15 days/month), and multiple preventive treatment failures., Methods: This is a prospective, cohort, real-life study at 28 headache centers on consecutive patients affected by HFEM or CM with multiple preventive treatment failures who were prescribed subcutaneous fremanezumab (225 mg monthly/675 mg quarterly) for ≥ 24 weeks. Primary endpoint was the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM at weeks 21-24 compared to baseline. Secondary endpoints encompassed changes in monthly analgesic medications, ≥ 50%, ≥ 75%, and 100% responder rates, and variation in NRS, HIT-6 and MIDAS scores at the same time interval. Changes in MMDs/MHDs, monthly analgesic medications, ≥ 50%, ≥ 75%, and 100% responder rates, and variation in NRS and HIT-6 scores at week 4 were also monitored., Results: Four hundred ten patients who had received ≥ 1 dose of fremanezumab were considered for safety analysis while 148 patients treated for ≥ 24 weeks were included in the efficacy analysis. At weeks 21-24, fremanezumab significantly (p < 0.001) reduced MMDs, MHDs, monthly analgesic medications and NRS, HIT-6, and MIDAS scores in both HFEM and CM compared to baseline. The proportions of ≥ 50%, ≥ 75% and 100% responders at weeks 21-24were 75.0%, 30.8%, 9.6% (HFEM), and 72.9, 44.8 and 1% (CM). A significant (p < 0.001) decrease in MMDs, MHDs, monthly analgesic medications and NRS, HIT-6, and MIDAS scores in both HFEM and CM was already present at week 4. The proportions of ≥ 50%, ≥ 75%, and 100% responders at week 4 were 67.6%, 32.4%, 11.8% (HFEM) and 67.3%, 40%, 1.8% (CM). CM remitted to episodic migraine and medication overuse to no-medication overuse in 83.3 and 75% of patients at week 24, and in 80 and 72.4% at week 4. Adverse events were rare (2.4%), mild and transient. No patient discontinued treatment for any reason., Conclusions: Fremanezumab is characterized by an early and sustained efficacy in HFEM and CM patients with multiple preventive treatment failures in real-life, revealing an optimal safety and tolerability profile., (© 2023. The Author(s).)

Published
2023
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50. Successful treatment of ruptured multiple fusiform middle cerebral artery aneurysms with Silk Vista Baby flow diverter in a 10-month-old infant.

Author

Barchetti G, Di Clemente L, Mazzetto M, Zanusso M, Ferrarese P, and Iannucci G

Subjects
Cerebral Angiography, Female, Humans, Infant, Middle Cerebral Artery diagnostic imaging, Middle Cerebral Artery surgery, Treatment Outcome, Aneurysm, Ruptured diagnostic imaging, Aneurysm, Ruptured surgery, Endovascular Procedures, Intracranial Aneurysm diagnostic imaging, Intracranial Aneurysm surgery, Subarachnoid Hemorrhage diagnostic imaging, Subarachnoid Hemorrhage surgery
Abstract

We report the successful treatment of multiple ruptured fusiform middle cerebral artery (MCA) aneurysms in a 10-month-old girl. This previously healthy infant presented with subarachnoid hemorrhage and was found to have multiple irregular dilatations of the superior division branch of the right MCA. Cerebral angiography was performed and confirmed the presence of multiple fusiform aneurysms of the MCA. After discussion with the multidisciplinary team, it was decided to treat the aneurysms with a endovascular approach, using a flow diverter. Microsurgical clipping was deemed risky because of the high likelihood of parent artery occlusion, and expectant management was also considered inappropriate because of the risk of rebleeding. Dual antiplatelet therapy was started, and a flow diverter was successfully delivered in the superior division branch of the right MCA. The postoperative course was uneventful, MRI at 12 months did not show any sign of recurrence, and at 3 years of age the patient had a normal neurological examination., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2022
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