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1. Antihypertensive treatment changes and related clinical outcomes in older hospitalized patients

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Cicco, S, D'Abbondanza, M, Proietti, M, Zaccone, V, Pes, C, Caradio, F, Mattioli, M, Piano, S, Marra, A, Nobili, A, Mannucci, P, Pietrangelo, A, Sesti, G, Buzzetti, E, Salzano, A, Cimellaro, A, Perticone, F, Violi, F, Corazza, G, Corrao, S, Marengoni, A, Salerno, F, Cesari, M, Tettamanti, M, Pasina, L, Franchi, C, Novella, A, Miglio, G, Galbussera, A, Ardoino, I, Prisco, D, Silvestri, E, Emmi, G, Bettiol, A, Mattioli, I, Biolo, G, Zanetti, M, Bartelloni, G, Zaccari, M, Chiuch, M, Vanoli, M, Grignani, G, Pulixi, E, Pirro, M, Lupattelli, G, Bianconi, V, Alcidi, R, Giotta, A, Mannarino, M, Girelli, D, Busti, F, Marchi, G, Barbagallo, M, Dominguez, L, Beneduce, V, Cacioppo, F, Natoli, G, Mularo, S, Raspanti, M, Argano, C, Cavallaro, F, Zoli, M, Matacena, M, Orio, G, Magnolfi, E, Serafini, G, Simili, A, Brunori, M, Lazzari, I, Cappellini, M, Fabio, G, De Amicis, M, De Luca, G, Scaramellini, N, Di Stefano, V, Leoni, S, Seghezzi, S, Di Mauro, A, Maira, D, Mancarella, M, Lucchi, T, Rossi, P, Clerici, M, Bonini, G, Conti, F, Prolo, S, Fabrizi, M, Martelengo, M, Vigani, G, Di Sabatino, A, Miceli, E, Lenti, M, Pisati, M, Pitotti, L, Padula, D, Antoci, V, Cambie, G, Pontremoli, R, Beccati, V, Nobili, G, Leoncini, G, Alberto, J, Cattaneo, F, Anastasio, L, Sofia, L, Carbone, M, Cipollone, F, Guagnano, M, Rossi, I, Valeriani, E, D'Ardes, D, Esposito, L, Sestili, S, Angelucci, E, Mancuso, G, Calipari, D, Bartone, M, Delitala, G, Berria, M, Delitala, A, Muscaritoli, M, Molfino, A, Petrillo, E, Giorgi, A, Gracin, C, Imbimbo, G, Zuccala, G, D'Aurizio, G, Romanelli, G, Volpini, A, Lucente, D, Manzoni, F, Pirozzi, A, Zucchelli, A, Picardi, A, Gentilucci, U, Gallo, P, Dell'Unto, C, Bellelli, G, Corsi, M, Antonucci, C, Sidoli, C, Principato, G, Bonfanti, A, Szabo, H, Mazzola, P, Piazzoli, A, Arturi, F, Succurro, E, Tassone, B, Giofre, F, Serra, M, Bleve, M, Brucato, A, De Falco, T, Negro, E, Brenna, M, Trotta, L, Squintani, G, Randi, M, Fabris, F, Bertozzi, I, Bogoni, G, Rabuini, M, Prandini, T, Ratti, F, Zurlo, C, Cerruti, L, Cosi, E, Manfredini, R, Fabbian, F, Boari, B, De Giorgi, A, Tiseo, R, Paolisso, G, Rizzo, M, Catalano, C, Di Meo, I, Borghi, C, Strocchi, E, Ianniello, E, Soldati, M, Schiavone, S, Bragagni, A, Leoni, F, De Sando, V, Scarduelli, S, Cammarosano, M, Pareo, I, Sabba, C, Vella, F, Suppressa, P, De Vincenzo, G, Comitangelo, A, Amoruso, E, Custodero, C, Re, G, Schilardi, A, Loparco, F, Fenoglio, L, Falcetta, A, Giraudo, A, D'Aniano, S, Fracanzani, A, Tiraboschi, S, Cespiati, A, Oberti, G, Sigon, G, Cinque, F, Peyvandi, F, Rossio, R, Colombo, G, Agosti, P, Pagliaro, E, Semproni, E, Ciro, C, Monzani, V, Savojardo, V, Ceriani, G, Folli, C, Pallini, G, Montecucco, F, Ottonello, L, Caserza, L, Vischi, G, Kassem, S, Liberale, L, Liberato, N, Tognin, T, Purrello, F, Di Pino, A, Piro, S, Rozzini, R, Falanga, L, Pisciotta, M, Bellucci, F, Buffelli, S, Ferrandina, C, Mazzeo, F, Spazzini, E, Cono, G, Cesaroni, G, Montrucchio, G, Peasso, P, Favale, E, Poletto, C, Margaria, C, Sanino, M, Perri, L, Guasti, L, Rotunno, F, Castiglioni, L, Maresca, A, Squizzato, A, Campiotti, L, Grossi, A, Diprizio, R, Dentali, F, Bertolotti, M, Mussi, C, Lancellotti, G, Libbra, M, Galassi, M, Grassi, Y, Greco, A, Bigi, E, Pellegrini, E, Orlandi, L, Dondi, G, Carulli, L, Sciacqua, A, Perticone, M, Battaglia, R, Maio, R, Scozzafava, A, Condoleo, V, Falbo, T, Colangelo, L, Filice, M, Clausi, E, Stanghellini, V, Ruggeri, E, del Vecchio, S, Benzoni, I, Salvi, A, Leonardi, R, Damiani, G, Moroncini, G, Capeci, W, Martino, G, Biondi, L, Pettinari, P, Ormas, M, Filippini, E, Benfaremo, D, Romiti, R, Ghio, R, Col, A, Minisola, S, Cilli, M, Labbadia, G, Afeltra, A, Marigliano, B, Pipita, M, Castellino, P, Zanoli, L, Gennaro, A, Gaudio, A, Pignataro, S, Mete, F, Gino, M, Moreo, G, Pina, G, Ballestrero, A, Ferrando, F, Gonella, R, Cerminara, D, Setti, P, Traversa, C, Scarsi, C, Graziella, B, Baldassarre, S, Fragapani, S, Gruden, G, Berti, F, Famularo, G, Tarsitani, P, Castello, R, Pasino, M, Maggio, M, Ceda, G, Morganti, S, Artoni, A, Grossi, M, Del Giacco, S, Firinu, D, Costanzo, G, Argiolas, G, Paoletti, G, Losa, F, Montalto, G, Licata, A, Montalto, F, Corica, F, Basile, G, Catalano, A, Bellone, F, Principato, C, Malatino, L, Stancanelli, B, Terranova, V, Di Marca, S, Di Quattro, R, La Malfa, L, Caruso, R, Mecocci, P, Ruggiero, C, Boccardi, V, Meschi, T, Ticinesi, A, Nouvenne, A, Minuz, P, Fondrieschi, L, Imperiale, G, Morellini, S, Pirisi, M, Fra, G, Sola, D, Bellan, M, Quadri, R, Larovere, E, Novelli, M, Simeone, E, Scurti, R, Tolloso, F, Tarquini, R, Valoriani, A, Dolenti, S, Vannini, G, Volpi, R, Bocchi, P, Vignali, A, Harari, S, Lonati, C, Napoli, F, Aiello, I, Salvatore, T, Monaco, L, Ricozzi, C, Pilotto, A, Indiano, I, Gandolfo, F, Pasini, F, Capecchi, P, Nuti, R, Valenti, R, Ruvio, M, Cappelli, S, Palazzuoli, A, Bernardi, M, Bassi, S, Santi, L, Zaccherini, G, Durante, V, Tirotta, D, Eusebi, G, Cattaneo, M, Amoruso, M, Fracasso, P, Fasolino, C, Tresoldi, M, Bozzolo, E, Damanti, S, Porta, M, Armentaro, G, Arnone, M, Barone, M, Bertolino, L, Bianco, S, Binello, N, Brancati, S, Buonauro, A, Cordeddu, W, Curcio, R, Dalbeni, A, D'Agnano, S, De Feo, M, Donnarumma, E, Fei, M, Gambino, C, Giorgini, P, Lombardi, R, Miceli, G, Naccarato, P, Noviello, S, Olivieri, G, Parente, R, Pignataro, F, Poma, S, Porceddu, E, Pucci, G, Ricchio, M, Sabena, A, Salice, M, Santarossa, C, Savona, A, Savrie, C, Scicali, R, Stabile, M, Talerico, G, Talia, M, Tassone, E, Teatini, T, Tombolini, E, Traversa, M, Vettore, E, Vignal, A, Vilardi, L, Villani, R, Vitale, F, Cicco S., D'Abbondanza M., Proietti M., Zaccone V., Pes C., Caradio F., Mattioli M., Piano S., Marra A. M., Nobili A., Mannucci P. M., Pietrangelo A., Sesti G., Buzzetti E., Salzano A., Cimellaro A., Perticone F., Violi F., Corazza G. R., Corrao S., Marengoni A., Salerno F., Cesari M., Tettamanti M., Pasina L., Franchi C., Novella A., Miglio G., Galbussera A. A., Ardoino I., Prisco D., Silvestri E., Emmi G., Bettiol A., Mattioli I., Biolo G., Zanetti M., Bartelloni G., Zaccari M., Chiuch M., Vanoli M., Grignani G., Pulixi E. A., Pirro M., Lupattelli G., Bianconi V., Alcidi R., Giotta A., Mannarino M. R., Girelli D., Busti F., Marchi G., Barbagallo M., Dominguez L., Beneduce V., Cacioppo F., Natoli G., Mularo S., Raspanti M., Argano C., Cavallaro F., Zoli M., Matacena M. L., Orio G., Magnolfi E., Serafini G., Simili A., Brunori M., Lazzari I., Cappellini M. D., Fabio G., De Amicis M. M., De Luca G., Scaramellini N., Di Stefano V., Leoni S., Seghezzi S., Di Mauro A. D., Maira D., Mancarella M., Lucchi T., Rossi P. D., Clerici M., Bonini G., Conti F., Prolo S., Fabrizi M., Martelengo M., Vigani G., Di Sabatino A., Miceli E., Lenti M. V., Pisati M., Pitotti L., Padula D., Antoci V., Cambie G., Pontremoli R., Beccati V., Nobili G., Leoncini G., Alberto J., Cattaneo F., Anastasio L., Sofia L., Carbone M., Cipollone F., Guagnano M. T., Rossi I., Valeriani E., D'Ardes D., Esposito L., Sestili S., Angelucci E., Mancuso G., Calipari D., Bartone M., Delitala G., Berria M., Delitala A., Muscaritoli M., Molfino A., Petrillo E., Giorgi A., Gracin C., Imbimbo G., Zuccala G., D'Aurizio G., Romanelli G., Volpini A., Lucente D., Manzoni F., Pirozzi A., Zucchelli A., Picardi A., Gentilucci U. V., Gallo P., Dell'Unto C., Bellelli G., Corsi M., Antonucci C., Sidoli C., Principato G., Bonfanti A., Szabo H., Mazzola P., Piazzoli A., Arturi F., Succurro E., Tassone B., Giofre F., Serra M. G., Bleve M. A., Brucato A., De Falco T., Negro E., Brenna M., Trotta L., Squintani G. L., Randi M. L., Fabris F., Bertozzi I., Bogoni G., Rabuini M. V., Prandini T., Ratti F., Zurlo C., Cerruti L., Cosi E., Manfredini R., Fabbian F., Boari B., De Giorgi A., Tiseo R., Paolisso G., Rizzo M. R., Catalano C., Di Meo I., Borghi C., Strocchi E., Ianniello E., Soldati M., Schiavone S., Bragagni A., Leoni F. G., De Sando V., Scarduelli S., Cammarosano M., Pareo I., Sabba C., Vella F. S., Suppressa P., De Vincenzo G. M., Comitangelo A., Amoruso E., Custodero C., Re G., Schilardi A., Loparco F., Fenoglio L., Falcetta A., Giraudo A. V., D'Aniano S., Fracanzani A. L., Tiraboschi S., Cespiati A., Oberti G., Sigon G., Cinque F., Peyvandi F., Rossio R., Colombo G., Agosti P., Pagliaro E., Semproni E., Ciro C., Monzani V., Savojardo V., Ceriani G., Folli C., Pallini G., Montecucco F., Ottonello L., Caserza L., Vischi G., Kassem S., Liberale L., Liberato N. L., Tognin T., Purrello F., Di Pino A., Piro S., Rozzini R., Falanga L., Pisciotta M. S., Bellucci F. B., Buffelli S., Ferrandina C., Mazzeo F., Spazzini E., Cono G., Cesaroni G., Montrucchio G., Peasso P., Favale E., Poletto C., Margaria C., Sanino M., Perri L., Guasti L., Rotunno F., Castiglioni L., Maresca A., Squizzato A., Campiotti L., Grossi A., Diprizio R. D., Dentali F., Bertolotti M., Mussi C., Lancellotti G., Libbra M. V., Galassi M., Grassi Y., Greco A., Bigi E., Pellegrini E., Orlandi L., Dondi G., Carulli L., Sciacqua A., Perticone M., Battaglia R., Maio R., Scozzafava A., Condoleo V., Falbo T., Colangelo L., Filice M., Clausi E., Stanghellini V., Ruggeri E., del Vecchio S., Benzoni I., Salvi A., Leonardi R., Damiani G., Moroncini G., Capeci W., Martino G. P., Biondi L., Pettinari P., Ormas M., Filippini E., Benfaremo D., Romiti R., Ghio R., Col A. D., Minisola S., Cilli M., Labbadia G., Afeltra A., Marigliano B., Pipita M. E., Castellino P., Zanoli L., Gennaro A., Gaudio A., Pignataro S., Mete F., Gino M., Moreo G., Pina G., Ballestrero A., Ferrando F., Gonella R., Cerminara D., Setti P., Traversa C., Scarsi C., Graziella B., Baldassarre S., Fragapani S., Gruden G., Berti F., Famularo G., Tarsitani P., Castello R., Pasino M., Maggio M. G., Ceda G. P., Morganti S., Artoni A., Grossi M., Del Giacco S., Firinu D., Costanzo G., Argiolas G., Paoletti G., Losa F., Montalto G., Licata A., Montalto F. A., Corica F., Basile G., Catalano A., Bellone F., Principato C., Malatino L., Stancanelli B., Terranova V., Di Marca S., Di Quattro R., La Malfa L., Caruso R., Mecocci P., Ruggiero C., Boccardi V., Meschi T., Ticinesi A., Nouvenne A., Minuz P., Fondrieschi L., Imperiale G. N., Morellini S., Pirisi M., Fra G. P., Sola D., Bellan M., Quadri R., Larovere E., Novelli M., Simeone E., Scurti R., Tolloso F., Tarquini R., Valoriani A., Dolenti S., Vannini G., Volpi R., Bocchi P., Vignali A., Harari S., Lonati C., Napoli F., Aiello I., Salvatore T., Monaco L., Ricozzi C., Pilotto A., Indiano I., Gandolfo F., Pasini F. L., Capecchi P. L., Nuti R., Valenti R., Ruvio M., Cappelli S., Palazzuoli A., Bernardi M., Bassi S. L., Santi L., Zaccherini G., Durante V., Tirotta D., Eusebi G., Cattaneo M., Amoruso M. V., Fracasso P., Fasolino C., Tresoldi M., Bozzolo E., Damanti S., Porta M., Armentaro G., Arnone M. I., Barone M., Bertolino L., Bianco S., Binello N., Brancati S., Buonauro A., Cordeddu W., Curcio R., Dalbeni A., D'Agnano S., De Feo M., Donnarumma E., Fei M., Gambino C. G., Giorgini P., Lombardi R., Miceli G., Naccarato P., Noviello S., Olivieri G., Parente R., Pignataro F. S., Poma S., Porceddu E., Pucci G., Ricchio M., Sabena A., Salice M., Santarossa C., Savona A., Savrie C., Scicali R., Stabile M., Talerico G., Talia M., Tassone E. J., Teatini T., Tombolini E., Traversa M., Vettore E., Vignal A., Vilardi L., Villani R., Vitale F., Cicco, S, D'Abbondanza, M, Proietti, M, Zaccone, V, Pes, C, Caradio, F, Mattioli, M, Piano, S, Marra, A, Nobili, A, Mannucci, P, Pietrangelo, A, Sesti, G, Buzzetti, E, Salzano, A, Cimellaro, A, Perticone, F, Violi, F, Corazza, G, Corrao, S, Marengoni, A, Salerno, F, Cesari, M, Tettamanti, M, Pasina, L, Franchi, C, Novella, A, Miglio, G, Galbussera, A, Ardoino, I, Prisco, D, Silvestri, E, Emmi, G, Bettiol, A, Mattioli, I, Biolo, G, Zanetti, M, Bartelloni, G, Zaccari, M, Chiuch, M, Vanoli, M, Grignani, G, Pulixi, E, Pirro, M, Lupattelli, G, Bianconi, V, Alcidi, R, Giotta, A, Mannarino, M, Girelli, D, Busti, F, Marchi, G, Barbagallo, M, Dominguez, L, Beneduce, V, Cacioppo, F, Natoli, G, Mularo, S, Raspanti, M, Argano, C, Cavallaro, F, Zoli, M, Matacena, M, Orio, G, Magnolfi, E, Serafini, G, Simili, A, Brunori, M, Lazzari, I, Cappellini, M, Fabio, G, De Amicis, M, De Luca, G, Scaramellini, N, Di Stefano, V, Leoni, S, Seghezzi, S, Di Mauro, A, Maira, D, Mancarella, M, Lucchi, T, Rossi, P, Clerici, M, Bonini, G, Conti, F, Prolo, S, Fabrizi, M, Martelengo, M, Vigani, G, Di Sabatino, A, Miceli, E, Lenti, M, Pisati, M, Pitotti, L, Padula, D, Antoci, V, Cambie, G, Pontremoli, R, Beccati, V, Nobili, G, Leoncini, G, Alberto, J, Cattaneo, F, Anastasio, L, Sofia, L, Carbone, M, Cipollone, F, Guagnano, M, Rossi, I, Valeriani, E, D'Ardes, D, Esposito, L, Sestili, S, Angelucci, E, Mancuso, G, Calipari, D, Bartone, M, Delitala, G, Berria, M, Delitala, A, Muscaritoli, M, Molfino, A, Petrillo, E, Giorgi, A, Gracin, C, Imbimbo, G, Zuccala, G, D'Aurizio, G, Romanelli, G, Volpini, A, Lucente, D, Manzoni, F, Pirozzi, A, Zucchelli, A, Picardi, A, Gentilucci, U, Gallo, P, Dell'Unto, C, Bellelli, G, Corsi, M, Antonucci, C, Sidoli, C, Principato, G, Bonfanti, A, Szabo, H, Mazzola, P, Piazzoli, A, Arturi, F, Succurro, E, Tassone, B, Giofre, F, Serra, M, Bleve, M, Brucato, A, De Falco, T, Negro, E, Brenna, M, Trotta, L, Squintani, G, Randi, M, Fabris, F, Bertozzi, I, Bogoni, G, Rabuini, M, Prandini, T, Ratti, F, Zurlo, C, Cerruti, L, Cosi, E, Manfredini, R, Fabbian, F, Boari, B, De Giorgi, A, Tiseo, R, Paolisso, G, Rizzo, M, Catalano, C, Di Meo, I, Borghi, C, Strocchi, E, Ianniello, E, Soldati, M, Schiavone, S, Bragagni, A, Leoni, F, De Sando, V, Scarduelli, S, Cammarosano, M, Pareo, I, Sabba, C, Vella, F, Suppressa, P, De Vincenzo, G, Comitangelo, A, Amoruso, E, Custodero, C, Re, G, Schilardi, A, Loparco, F, Fenoglio, L, Falcetta, A, Giraudo, A, D'Aniano, S, Fracanzani, A, Tiraboschi, S, Cespiati, A, Oberti, G, Sigon, G, Cinque, F, Peyvandi, F, Rossio, R, Colombo, G, Agosti, P, Pagliaro, E, Semproni, E, Ciro, C, Monzani, V, Savojardo, V, Ceriani, G, Folli, C, Pallini, G, Montecucco, F, Ottonello, L, Caserza, L, Vischi, G, Kassem, S, Liberale, L, Liberato, N, Tognin, T, Purrello, F, Di Pino, A, Piro, S, Rozzini, R, Falanga, L, Pisciotta, M, Bellucci, F, Buffelli, S, Ferrandina, C, Mazzeo, F, Spazzini, E, Cono, G, Cesaroni, G, Montrucchio, G, Peasso, P, Favale, E, Poletto, C, Margaria, C, Sanino, M, Perri, L, Guasti, L, Rotunno, F, Castiglioni, L, Maresca, A, Squizzato, A, Campiotti, L, Grossi, A, Diprizio, R, Dentali, F, Bertolotti, M, Mussi, C, Lancellotti, G, Libbra, M, Galassi, M, Grassi, Y, Greco, A, Bigi, E, Pellegrini, E, Orlandi, L, Dondi, G, Carulli, L, Sciacqua, A, Perticone, M, Battaglia, R, Maio, R, Scozzafava, A, Condoleo, V, Falbo, T, Colangelo, L, Filice, M, Clausi, E, Stanghellini, V, Ruggeri, E, del Vecchio, S, Benzoni, I, Salvi, A, Leonardi, R, Damiani, G, Moroncini, G, Capeci, W, Martino, G, Biondi, L, Pettinari, P, Ormas, M, Filippini, E, Benfaremo, D, Romiti, R, Ghio, R, Col, A, Minisola, S, Cilli, M, Labbadia, G, Afeltra, A, Marigliano, B, Pipita, M, Castellino, P, Zanoli, L, Gennaro, A, Gaudio, A, Pignataro, S, Mete, F, Gino, M, Moreo, G, Pina, G, Ballestrero, A, Ferrando, F, Gonella, R, Cerminara, D, Setti, P, Traversa, C, Scarsi, C, Graziella, B, Baldassarre, S, Fragapani, S, Gruden, G, Berti, F, Famularo, G, Tarsitani, P, Castello, R, Pasino, M, Maggio, M, Ceda, G, Morganti, S, Artoni, A, Grossi, M, Del Giacco, S, Firinu, D, Costanzo, G, Argiolas, G, Paoletti, G, Losa, F, Montalto, G, Licata, A, Montalto, F, Corica, F, Basile, G, Catalano, A, Bellone, F, Principato, C, Malatino, L, Stancanelli, B, Terranova, V, Di Marca, S, Di Quattro, R, La Malfa, L, Caruso, R, Mecocci, P, Ruggiero, C, Boccardi, V, Meschi, T, Ticinesi, A, Nouvenne, A, Minuz, P, Fondrieschi, L, Imperiale, G, Morellini, S, Pirisi, M, Fra, G, Sola, D, Bellan, M, Quadri, R, Larovere, E, Novelli, M, Simeone, E, Scurti, R, Tolloso, F, Tarquini, R, Valoriani, A, Dolenti, S, Vannini, G, Volpi, R, Bocchi, P, Vignali, A, Harari, S, Lonati, C, Napoli, F, Aiello, I, Salvatore, T, Monaco, L, Ricozzi, C, Pilotto, A, Indiano, I, Gandolfo, F, Pasini, F, Capecchi, P, Nuti, R, Valenti, R, Ruvio, M, Cappelli, S, Palazzuoli, A, Bernardi, M, Bassi, S, Santi, L, Zaccherini, G, Durante, V, Tirotta, D, Eusebi, G, Cattaneo, M, Amoruso, M, Fracasso, P, Fasolino, C, Tresoldi, M, Bozzolo, E, Damanti, S, Porta, M, Armentaro, G, Arnone, M, Barone, M, Bertolino, L, Bianco, S, Binello, N, Brancati, S, Buonauro, A, Cordeddu, W, Curcio, R, Dalbeni, A, D'Agnano, S, De Feo, M, Donnarumma, E, Fei, M, Gambino, C, Giorgini, P, Lombardi, R, Miceli, G, Naccarato, P, Noviello, S, Olivieri, G, Parente, R, Pignataro, F, Poma, S, Porceddu, E, Pucci, G, Ricchio, M, Sabena, A, Salice, M, Santarossa, C, Savona, A, Savrie, C, Scicali, R, Stabile, M, Talerico, G, Talia, M, Tassone, E, Teatini, T, Tombolini, E, Traversa, M, Vettore, E, Vignal, A, Vilardi, L, Villani, R, Vitale, F, Cicco S., D'Abbondanza M., Proietti M., Zaccone V., Pes C., Caradio F., Mattioli M., Piano S., Marra A. M., Nobili A., Mannucci P. M., Pietrangelo A., Sesti G., Buzzetti E., Salzano A., Cimellaro A., Perticone F., Violi F., Corazza G. R., Corrao S., Marengoni A., Salerno F., Cesari M., Tettamanti M., Pasina L., Franchi C., Novella A., Miglio G., Galbussera A. A., Ardoino I., Prisco D., Silvestri E., Emmi G., Bettiol A., Mattioli I., Biolo G., Zanetti M., Bartelloni G., Zaccari M., Chiuch M., Vanoli M., Grignani G., Pulixi E. A., Pirro M., Lupattelli G., Bianconi V., Alcidi R., Giotta A., Mannarino M. R., Girelli D., Busti F., Marchi G., Barbagallo M., Dominguez L., Beneduce V., Cacioppo F., Natoli G., Mularo S., Raspanti M., Argano C., Cavallaro F., Zoli M., Matacena M. L., Orio G., Magnolfi E., Serafini G., Simili A., Brunori M., Lazzari I., Cappellini M. D., Fabio G., De Amicis M. M., De Luca G., Scaramellini N., Di Stefano V., Leoni S., Seghezzi S., Di Mauro A. D., Maira D., Mancarella M., Lucchi T., Rossi P. D., Clerici M., Bonini G., Conti F., Prolo S., Fabrizi M., Martelengo M., Vigani G., Di Sabatino A., Miceli E., Lenti M. V., Pisati M., Pitotti L., Padula D., Antoci V., Cambie G., Pontremoli R., Beccati V., Nobili G., Leoncini G., Alberto J., Cattaneo F., Anastasio L., Sofia L., Carbone M., Cipollone F., Guagnano M. T., Rossi I., Valeriani E., D'Ardes D., Esposito L., Sestili S., Angelucci E., Mancuso G., Calipari D., Bartone M., Delitala G., Berria M., Delitala A., Muscaritoli M., Molfino A., Petrillo E., Giorgi A., Gracin C., Imbimbo G., Zuccala G., D'Aurizio G., Romanelli G., Volpini A., Lucente D., Manzoni F., Pirozzi A., Zucchelli A., Picardi A., Gentilucci U. V., Gallo P., Dell'Unto C., Bellelli G., Corsi M., Antonucci C., Sidoli C., Principato G., Bonfanti A., Szabo H., Mazzola P., Piazzoli A., Arturi F., Succurro E., Tassone B., Giofre F., Serra M. G., Bleve M. A., Brucato A., De Falco T., Negro E., Brenna M., Trotta L., Squintani G. L., Randi M. L., Fabris F., Bertozzi I., Bogoni G., Rabuini M. V., Prandini T., Ratti F., Zurlo C., Cerruti L., Cosi E., Manfredini R., Fabbian F., Boari B., De Giorgi A., Tiseo R., Paolisso G., Rizzo M. R., Catalano C., Di Meo I., Borghi C., Strocchi E., Ianniello E., Soldati M., Schiavone S., Bragagni A., Leoni F. G., De Sando V., Scarduelli S., Cammarosano M., Pareo I., Sabba C., Vella F. S., Suppressa P., De Vincenzo G. M., Comitangelo A., Amoruso E., Custodero C., Re G., Schilardi A., Loparco F., Fenoglio L., Falcetta A., Giraudo A. V., D'Aniano S., Fracanzani A. L., Tiraboschi S., Cespiati A., Oberti G., Sigon G., Cinque F., Peyvandi F., Rossio R., Colombo G., Agosti P., Pagliaro E., Semproni E., Ciro C., Monzani V., Savojardo V., Ceriani G., Folli C., Pallini G., Montecucco F., Ottonello L., Caserza L., Vischi G., Kassem S., Liberale L., Liberato N. L., Tognin T., Purrello F., Di Pino A., Piro S., Rozzini R., Falanga L., Pisciotta M. S., Bellucci F. B., Buffelli S., Ferrandina C., Mazzeo F., Spazzini E., Cono G., Cesaroni G., Montrucchio G., Peasso P., Favale E., Poletto C., Margaria C., Sanino M., Perri L., Guasti L., Rotunno F., Castiglioni L., Maresca A., Squizzato A., Campiotti L., Grossi A., Diprizio R. D., Dentali F., Bertolotti M., Mussi C., Lancellotti G., Libbra M. V., Galassi M., Grassi Y., Greco A., Bigi E., Pellegrini E., Orlandi L., Dondi G., Carulli L., Sciacqua A., Perticone M., Battaglia R., Maio R., Scozzafava A., Condoleo V., Falbo T., Colangelo L., Filice M., Clausi E., Stanghellini V., Ruggeri E., del Vecchio S., Benzoni I., Salvi A., Leonardi R., Damiani G., Moroncini G., Capeci W., Martino G. P., Biondi L., Pettinari P., Ormas M., Filippini E., Benfaremo D., Romiti R., Ghio R., Col A. D., Minisola S., Cilli M., Labbadia G., Afeltra A., Marigliano B., Pipita M. E., Castellino P., Zanoli L., Gennaro A., Gaudio A., Pignataro S., Mete F., Gino M., Moreo G., Pina G., Ballestrero A., Ferrando F., Gonella R., Cerminara D., Setti P., Traversa C., Scarsi C., Graziella B., Baldassarre S., Fragapani S., Gruden G., Berti F., Famularo G., Tarsitani P., Castello R., Pasino M., Maggio M. G., Ceda G. P., Morganti S., Artoni A., Grossi M., Del Giacco S., Firinu D., Costanzo G., Argiolas G., Paoletti G., Losa F., Montalto G., Licata A., Montalto F. A., Corica F., Basile G., Catalano A., Bellone F., Principato C., Malatino L., Stancanelli B., Terranova V., Di Marca S., Di Quattro R., La Malfa L., Caruso R., Mecocci P., Ruggiero C., Boccardi V., Meschi T., Ticinesi A., Nouvenne A., Minuz P., Fondrieschi L., Imperiale G. N., Morellini S., Pirisi M., Fra G. P., Sola D., Bellan M., Quadri R., Larovere E., Novelli M., Simeone E., Scurti R., Tolloso F., Tarquini R., Valoriani A., Dolenti S., Vannini G., Volpi R., Bocchi P., Vignali A., Harari S., Lonati C., Napoli F., Aiello I., Salvatore T., Monaco L., Ricozzi C., Pilotto A., Indiano I., Gandolfo F., Pasini F. L., Capecchi P. L., Nuti R., Valenti R., Ruvio M., Cappelli S., Palazzuoli A., Bernardi M., Bassi S. L., Santi L., Zaccherini G., Durante V., Tirotta D., Eusebi G., Cattaneo M., Amoruso M. V., Fracasso P., Fasolino C., Tresoldi M., Bozzolo E., Damanti S., Porta M., Armentaro G., Arnone M. I., Barone M., Bertolino L., Bianco S., Binello N., Brancati S., Buonauro A., Cordeddu W., Curcio R., Dalbeni A., D'Agnano S., De Feo M., Donnarumma E., Fei M., Gambino C. G., Giorgini P., Lombardi R., Miceli G., Naccarato P., Noviello S., Olivieri G., Parente R., Pignataro F. S., Poma S., Porceddu E., Pucci G., Ricchio M., Sabena A., Salice M., Santarossa C., Savona A., Savrie C., Scicali R., Stabile M., Talerico G., Talia M., Tassone E. J., Teatini T., Tombolini E., Traversa M., Vettore E., Vignal A., Vilardi L., Villani R., and Vitale F.

Abstract

Background: Hypertension management in older patients represents a challenge, particularly when hospitalized. Objective: The objective of this study is to investigate the determinants and related outcomes of antihypertensive drug prescription in a cohort of older hospitalized patients. Methods: A total of 5671 patients from REPOSI (a prospective multicentre observational register of older Italian in-patients from internal medicine or geriatric wards) were considered; 4377 (77.2%) were hypertensive. Minimum treatment (MT) for hypertension was defined according to the 2018 ESC guidelines [an angiotensin-converting-enzyme-inhibitor (ACE-I) or an angiotensin-receptor-blocker (ARB) with a calcium-channel-blocker (CCB) and/or a thiazide diuretic; if >80 years old, an ACE-I or ARB or CCB or thiazide diuretic]. Determinants of MT discontinuation at discharge were assessed. Study outcomes were any cause rehospitalization/all cause death, all-cause death, cardiovascular (CV) hospitalization/death, CV death, non-CV death, evaluated according to the presence of MT at discharge. Results: Hypertensive patients were older than normotensives, with a more impaired functional status, higher burden of comorbidity and polypharmacy. A total of 2233 patients were on MT at admission, 1766 were on MT at discharge. Discontinuation of MT was associated with the presence of comorbidities (lower odds for diabetes, higher odds for chronic kidney disease and dementia). An adjusted multivariable logistic regression analysis showed that MT for hypertension at discharge was associated with lower risk of all-cause death, all-cause death/hospitalization, CV death, CV death/hospitalization and non-CV death. Conclusions: Guidelines-suggested MT for hypertension at discharge is associated with a lower risk of adverse clinical outcomes. Nevertheless, changes in antihypertensive treatment still occur in a significant proportion of older hospitalized patients.

Published
2023

3. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study.

Author

Manns M., Pol S., Jacobson I.M., Marcellin P., Gordon S.C., Peng C.-Y., Chang T.-T., Everson G.T., Heo J., Gerken G., Yoffe B., Towner W.J., Bourliere M., Metivier S., Chu C.-J., Sievert W., Bronowicki J.-P., Thabut D., Lee Y.-J., Kao J.-H., McPhee F., Kopit J., Mendez P., Linaberry M., Hughes E., Noviello S., Manns M., Pol S., Jacobson I.M., Marcellin P., Gordon S.C., Peng C.-Y., Chang T.-T., Everson G.T., Heo J., Gerken G., Yoffe B., Towner W.J., Bourliere M., Metivier S., Chu C.-J., Sievert W., Bronowicki J.-P., Thabut D., Lee Y.-J., Kao J.-H., McPhee F., Kopit J., Mendez P., Linaberry M., Hughes E., and Noviello S.

Abstract

BACKGROUND: An unmet need exists for interferon-free and ribavirin-free treatments for chronic hepatitis C virus (HCV) infection. In this study, we assessed all-oral therapy with daclatasvir (NS5A replication complex inhibitor) plus asunaprevir (NS3 protease inhibitor) in patients with genotype 1b infection, including those with high unmet needs or cirrhosis, or both. METHODS: We did this phase 3, multicohort study (HALLMARK-DUAL) at 116 sites in 18 countries between May 11, 2012, and Oct 9, 2013. Patients were adults with chronic HCV genotype 1b infection who were treatment-naive; previous non-responders to peginterferon alfa plus ribavirin; or medically ineligible for, previously intolerant of, or ineligible for and intolerant of peginterferon alfa plus ribavirin. Treatment-naive patients were randomly assigned (2:1 ratio) by an interactive voice-response system with a computer-generated random allocation sequence (stratified by cirrhosis status) to receive daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily or placebo for 12 weeks. Patients and investigator sites were masked to treatment assignment and HCV RNA results to the end of week 12. The treatment-naive group assigned to daclatasvir plus asunaprevir continued open-label treatment to the end of week 24; participants assigned to placebo entered another daclatasvir plus asunaprevir study. Non-responders and ineligible, intolerant, or ineligible and intolerant patients received open-label daclatasvir plus asunaprevir for 24 weeks. The primary endpoint was sustained virological response at post-treatment week 12. Efficacy analyses were restricted to patients given daclatasvir plus asunaprevir. This trial is registered with ClinicalTrials.gov, number NCT01581203. FUNDING: Bristol-Myers Squibb. FINDINGS: This study included 307 treatment-naive patients (205 received daclatasvir plus asunaprevir and 102 received placebo; all randomly assigned patients received the intended treatment), 205 non-responde

Published
2021

5. Daclatasvir vs telaprevir in combination with peginterferon alfa/ribavirin in treatment-naive patients with HCV genotype 1: phase 3 COMMAND-3 results: O213

Author

Jacobson, I, Zeuzem, S, Flisiak, R, Knysz, B, Lueth, S, Zarebska-Michaluk, D, Janczewska, E, Ferenci, P, Diago, M, Zignego, A, Safadi, R, Baruch, Y, Abdurakhmanov, D, Shafran, S, Thabut, D, Bruck, R, Gadano, A, Thompson, A, Kopit, J, McPhee, F, Michener, T, Hughes, E, Yin, P, and Noviello, S

Published
2014
Full Text
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7. Interleukin 28B polymorphisms are the only common genetic variants associated with low-density lipoprotein cholesterol (LDL-C) in genotype-1 chronic hepatitis C and determine the association between LDL-C and treatment response

Author

Clark, P. J., Thompson, A. J., Zhu, M., Vock, D. M., Zhu, Q., Ge, D., Patel, K., Harrison, S. A., Urban, T. J., Naggie, S., Fellay, J., Tillmann, H. L., Shianna, K., Noviello, S., Pedicone, L. D., Esteban, R., Kwo, P., Sulkowski, M. S., Afdhal, N., Albrecht, J. K., Goldstein, D. B., McHutchison, J. G., and Muir, A. J.

Published
2012
Full Text
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14. Iclaprim reduces the incidence and severity of Staphylococcus aureus-induced septic arthritis in a murine model

Author

Huang, D. B., Noviello, S., and Gemmell, C.G.

Abstract

Staphylococcus aureus is the most common non-gonococcal aetiology of septic arthritis. The efficacy of iclaprim against S. aureus LS-1, a clinical strain identified from a patient with septic arthritis, was studied in MF1 mice to evaluate the activity of iclaprim, which is in clinical development, in preventing joint infections. Iclaprim (2.5–80 mg kg− 1) administered as a single dose via the tail vein reduced the incidence of S. aureus septic arthritis and mortality in an experimental murine model of septic arthritis.

Published
2019

21. New insights into classification, epidemiology and microbiology of SSTIs, including diabetic foot infections

Author

Esposito, S., Noviello, S., Caro, F., and GIOVANNI BOCCIA

Subjects
Soft Tissue Infections, Humans, Skin Diseases, Bacterial, Diabetic Foot
Abstract

Skin and soft tissue infections (SSTIs) involve a heterogeneous group of entities with different clinical presentations classified according to several specific criteria. Because of their great variability, their incidence and prevalence is difficult to accurately determine. Yet it is generally thought that the rate of SSTIs is globally increasing due to an aging population, strictly associated with the increase in the number of critical and immunocompromised patients. The aetiology of SSTIs is also extremely variable, reflecting the noteworthy heterogeneity of their clinical presentations and their epidemiology. Gram-positive are far more prevalently than Gram-negative cocci responsible for STTIs globally considered including both aerobe and anaerobe microorganisms. The emergence of multidrug-resistance bacteria represents a serious public health threat which is making antimicrobial therapy less efficacious and more challenging by the day.

Published
2018

22. Long-term follow-up of patients with chronic HCV infection treated with daclatasvir-based regimens in phase 2 and 3 studies

Author

Reddy, K. R., Pol, S., Thuluvath, P. J., Kumada, H., Toyota, J., Chayama, K., Levin, J., Lawitz, E., Gadano, A., Ghesquiere, W., Gerken, Guido, Brunetto, M. R., Peng, C. Y., Silva, M. O., Strasser, S. I., Heo, J., McPhee, F., Liu, Z. H., Yang, R., Linaberry, M., and Noviello, S.

Subjects
Medizin, ComputingMethodologies_GENERAL
Abstract

Poster Abstract

Published
2016

24. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: A pooled analysis.

Author

Bhore R., Lee Y.-J., Mendez P., Noviello S., Hughes E., Kao J.-H., Jensen D.M., Manns M.P., Jacobson I., Kumada H., Toyota J., Heo J., Yoffe B., Sievert W., Bessone F., Peng C.-Y., Roberts S.K., Bhore R., Lee Y.-J., Mendez P., Noviello S., Hughes E., Kao J.-H., Jensen D.M., Manns M.P., Jacobson I., Kumada H., Toyota J., Heo J., Yoffe B., Sievert W., Bessone F., Peng C.-Y., and Roberts S.K.

Abstract

Background & Aims: We compared outcomes by cirrhosis status across studies of the all-oral combination of daclatasvir (DCV) plus asunaprevir (ASV). Method(s): Outcomes from global and Japanese phase 2 and 3 clinical studies of DCV+ASV in patients with genotype (GT) 1b infection were assessed by cirrhosis status. Sustained virological response (SVR) was assessed in individual phase 3 studies; a pooled analysis was carried out for safety outcomes. Result(s): In the Japanese phase 3 study, SVR12 was achieved by 91% of patients with cirrhosis (n = 22) and 84% of patients without cirrhosis (n = 200); in the global phase 3 study, SVR12 was achieved by 84% of patients with cirrhosis (n = 206) and by 85% of patients without cirrhosis (n = 437). The frequency of serious adverse events, adverse events leading to treatment discontinuation and treatment-emergent grade 3/4 laboratory abnormalities was low (<10%) and similar among patients with (n = 229) or without (n = 689) compensated cirrhosis receiving DCV+ASV. Grade 3/4 reductions in platelets and neutrophils were more common among patients with cirrhosis (1.3 and 2.2%, respectively) compared with those without cirrhosis (both 0.6%). Grade 3/4 liver function test abnormalities were less common among patients with cirrhosis (1.8%) compared with those without cirrhosis (3.5-4.7%). Alanine aminotransferase elevations were not associated with hepatic decompensation. Conclusion(s): The safety and efficacy of DCV+ASV were similar in patients with or without compensated cirrhosis. This all-oral, interferon- and ribavirin-free combination is an effective and well-tolerated treatment option for patients with HCV GT1b infection and cirrhosis.Copyright © 2016 John Wiley & Sons A/S.

Published
2016

25. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.

Author

Noviello S., Manns M.P., Jacobson I., Kumada H., Toyota J., Heo J., Yoffe B., Sievert W., Peng C.-Y., Roberts S.K., Lee Y.-J., Bhore R., Mendez P., Hughes E., Bessone F., Kao J.-H., Jensen D.M., Noviello S., Manns M.P., Jacobson I., Kumada H., Toyota J., Heo J., Yoffe B., Sievert W., Peng C.-Y., Roberts S.K., Lee Y.-J., Bhore R., Mendez P., Hughes E., Bessone F., Kao J.-H., and Jensen D.M.

Abstract

Background & Aims: We compared outcomes by cirrhosis status across studies of the all-oral combination of daclatasvir (DCV) plus asunaprevir (ASV). Method(s): Outcomes from global and Japanese phase 2 and 3 clinical studies of DCV+ASV in patients with genotype (GT) 1b infection were assessed by cirrhosis status. Sustained virological response (SVR) was assessed in individual phase 3 studies; a pooled analysis was carried out for safety outcomes. Result(s): In the Japanese phase 3 study, SVR12 was achieved by 91% of patients with cirrhosis (n = 22) and 84% of patients without cirrhosis (n = 200); in the global phase 3 study, SVR12 was achieved by 84% of patients with cirrhosis (n = 206) and by 85% of patients without cirrhosis (n = 437). The frequency of serious adverse events, adverse events leading to treatment discontinuation and treatment-emergent grade 3/4 laboratory abnormalities was low (<10%) and similar among patients with (n = 229) or without (n = 689) compensated cirrhosis receiving DCV+ASV. Grade 3/4 reductions in platelets and neutrophils were more common among patients with cirrhosis (1.3 and 2.2%, respectively) compared with those without cirrhosis (both 0.6%). Grade 3/4 liver function test abnormalities were less common among patients with cirrhosis (1.8%) compared with those without cirrhosis (3.5-4.7%). Alanine aminotransferase elevations were not associated with hepatic decompensation. Conclusion(s): The safety and efficacy of DCV+ASV were similar in patients with or without compensated cirrhosis. This all-oral, interferon- and ribavirin-free combination is an effective and well-tolerated treatment option for patients with HCV GT1b infection and cirrhosis. Trial registrations numbers: Clinicaltrials.gov identifiers: NCT01012895; NCT01051414; NCT01581203; NCT01497834.Copyright © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Published
2016

32. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: A randomised study.

Author

Liu Z., Wind-Rotolo M., Noviello S., Schnittman S., Yin P.D., Hughes E.A., Hezode C., Hirschfield G.M., Ghesquiere W., Sievert W., Rodriguez-Torres M., Shafran S.D., Thuluvath P.J., Tatum H.A., Waked I., Esmat G., Lawitz E.J., Rustgi V.K., Pol S., Weis N., Pockros P.J., Bourliere M., Serfaty L., Vierling J.M., Fried M.W., Weiland O., Brunetto M.R., Everson G.T., Zeuzem S., Kwo P.Y., Sulkowski M., Brau N., Hernandez D., McPhee F., Liu Z., Wind-Rotolo M., Noviello S., Schnittman S., Yin P.D., Hughes E.A., Hezode C., Hirschfield G.M., Ghesquiere W., Sievert W., Rodriguez-Torres M., Shafran S.D., Thuluvath P.J., Tatum H.A., Waked I., Esmat G., Lawitz E.J., Rustgi V.K., Pol S., Weis N., Pockros P.J., Bourliere M., Serfaty L., Vierling J.M., Fried M.W., Weiland O., Brunetto M.R., Everson G.T., Zeuzem S., Kwo P.Y., Sulkowski M., Brau N., Hernandez D., and McPhee F.

Abstract

Objective To evaluate the safety and efficacy of daclatasvir, an HCV NS5A inhibitor with pangenotypic activity, administered with peginterferon-alfa-2a/ribavirin. Design In this Phase 2b double-blind, placebocontrolled study, treatment-naive adults with HCV genotype 1 (N=365) or 4 (N=30) infection were randomly assigned (2:2:1) to daclatasvir 20 mg or 60 mg, or placebo once daily plus weekly peginterferonalfa: 2a and twice-daily ribavirin. Daclatasvir recipients achieving protocol-defined response (PDR; HCVRNA< lower limit of quantitation at Week 4 and undetectable at Week 10) were rerandomised at Week 12 to continue daclatasvir/peginterferon-alfa: 2a/ribavirin for 24 weeks total duration or to placebo/peginterferon-alfa-2a/ribavirin for another 12 weeks. Patients without PDR and placebo patients continued peginterferon-alfa/ribavirin through Week 48. Primary efficacy endpoints were undetectable HCV-RNA at Weeks 4 and 12 (extended rapid virologic response, eRVR) and at 24 weeks post-treatment (sustained virologic response, SVR24) among genotype 1-infected patients. Results Overall, eRVR was achieved by 54.4% (80/147) of genotype 1-infected patients receiving daclatasvir 20 mg, 54.1% (79/146) receiving 60 mg versus 13.9% (10/72) receiving placebo. SVR24 was achieved among 87 (59.2%), 87 (59.6%), and 27 (37.5%) patients in these groups, respectively. Higher proportions of genotype 4-infected patients receiving daclatasvir 20 mg (66.7%; 8/12) or 60 mg (100.0%; 12/12) achieved SVR24 versus placebo (50.0%; 3/6). A majority of daclatasvir-treated patients achieved PDR and experienced less virologic failure and higher SVR24 rates with a shortened 24-week treatment duration. Adverse events occurred with similar frequency across all treatment groups. Conclusions The combination of daclatasvir/peginterferon-alfa/ribavirin was generally well tolerated and achieved higher SVR24 rates compared with placebo/peginterferon-alfa/ribavirin among patients infected with HCV genotype 1

Published
2015

33. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: A multinational, phase 3, multicohort study.

Author

Kopit J., Sievert W., Bronowicki J.-P., Thabut D., Lee Y.-J., Kao J.-H., McPhee F., Mendez P., Noviello S., Hughes E., Manns M., Linaberry M., Pol S., Jacobson I.M., Marcellin P., Gordon S.C., Peng C.-Y., Chang T.-T., Everson G.T., Heo J., Gerken G., Yoffe B., Towner W.J., Bourliere M., Metivier S., Chu C.-J., Kopit J., Sievert W., Bronowicki J.-P., Thabut D., Lee Y.-J., Kao J.-H., McPhee F., Mendez P., Noviello S., Hughes E., Manns M., Linaberry M., Pol S., Jacobson I.M., Marcellin P., Gordon S.C., Peng C.-Y., Chang T.-T., Everson G.T., Heo J., Gerken G., Yoffe B., Towner W.J., Bourliere M., Metivier S., and Chu C.-J.

Abstract

Background: An unmet need exists for interferon-free and ribavirin-free treatments for chronic hepatitis C virus (HCV) infection. In this study, we assessed all-oral therapy with daclatasvir (NS5A replication complex inhibitor) plus asunaprevir (NS3 protease inhibitor) in patients with genotype 1b infection, including those with high unmet needs or cirrhosis, or both. Method(s): We did this phase 3, multicohort study (HALLMARK-DUAL) at 116 sites in 18 countries between May 11, 2012, and Oct 9, 2013. Patients were adults with chronic HCV genotype 1b infection who were treatment-naive; previous non-responders to peginterferon alfa plus ribavirin; or medically ineligible for, previously intolerant of, or ineligible for and intolerant of peginterferon alfa plus ribavirin. Treatment-naive patients were randomly assigned (2:1 ratio) by an interactive voice-response system with a computer-generated random allocation sequence (stratified by cirrhosis status) to receive daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily or placebo for 12 weeks. Patients and investigator sites were masked to treatment assignment and HCV RNA results to the end of week 12. The treatment-naive group assigned to daclatasvir plus asunaprevir continued open-label treatment to the end of week 24; participants assigned to placebo entered another daclatasvir plus asunaprevir study. Non-responders and ineligible, intolerant, or ineligible and intolerant patients received open-label daclatasvir plus asunaprevir for 24 weeks. The primary endpoint was sustained virological response at post-treatment week 12. Efficacy analyses were restricted to patients given daclatasvir plus asunaprevir. This trial is registered with ClinicalTrials.gov, number NCT01581203. Finding(s): This study included 307 treatment-naive patients (205 received daclatasvir plus asunaprevir and 102 received placebo; all randomly assigned patients received the intended treatment), 205 non-responders, and 235 ineligible, int

Published
2015

34. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection

Author

Dore, GJ, Lawitz, E, Hézode, C, Shafran, SD, Ramji, A, Tatum, HA, Taliani, G, Tran, A, Brunetto, MR, Zaltron, S, Strasser, SI, Weis, N, Ghesquiere, W, Lee, SS, Larrey, D, Pol, S, Harley, H, George, J, Fung, SK, De Lédinghen, V, Hagens, P, McPhee, F, Hernandez, D, Cohen, D, Cooney, E, Noviello, S, Hughes, EA, Dore, GJ, Lawitz, E, Hézode, C, Shafran, SD, Ramji, A, Tatum, HA, Taliani, G, Tran, A, Brunetto, MR, Zaltron, S, Strasser, SI, Weis, N, Ghesquiere, W, Lee, SS, Larrey, D, Pol, S, Harley, H, George, J, Fung, SK, De Lédinghen, V, Hagens, P, McPhee, F, Hernandez, D, Cohen, D, Cooney, E, Noviello, S, and Hughes, EA

Abstract

Background & Aims Twenty-four weeks of treatment with peginterferon and ribavirin for chronic hepatitis C virus (HCV) genotype 2 or 3 infection produces a sustained virologic response (SVR) in 70%-80% of patients. We performed a randomized, double-blind, phase 2b study to assess whether adding daclatasvir, a nonstructural protein 5A (NS5A) inhibitor that is active against these genotypes, improves efficacy and shortens therapy. Methods Patients with HCV genotype 2 or 3 infection (n = 151), enrolled at research centers in North America, Europe, or Australia, were assigned randomly to groups given 12 or 16 weeks of daclatasvir (60 mg once daily), or 24 weeks of placebo, each combined with peginterferon alfa-2a and ribavirin. Treatment was extended to 24 weeks for recipients of daclatasvir who did not meet the criteria for early virologic response. The primary end point was SVR at 24 weeks after treatment (SVR24). Results Baseline characteristics were similar among patients within each HCV genotype group. However, the 80 patients with HCV genotype 3, compared with the 71 patients with HCV genotype 2, were younger (mean age, 45 vs 53 y, respectively), and a larger proportion had cirrhosis (23% vs 1%, respectively). Among patients with HCV genotype 2 infection, an SVR24 was achieved by 83%, 83%, and 63% of those in the daclatasvir 12-week group, the daclatasvir 16-week group, or the placebo group, respectively; among patients with HCV genotype 3 infection, an SVR24 was achieved by 69%, 67%, and 59% of patients in these groups, respectively. Differences between genotypes largely were attributable to the higher frequency of post-treatment relapse among patients infected with HCV genotype 3. In both daclatasvir arms for both HCV genotypes, the lower bound of the 80% confidence interval of the difference in SVR24 rates between the daclatasvir and placebo arms was above -20%, establishing noninferiority. Safety findings were similar among groups, and were typical of those exp

Published
2015

35. [Outpatient parenteral antibiotic therapy (OPAT) of diabetic foot infections with piperacillin/tazobactam]

Author

Marvaso A., Esposito S., Noviello S., Ianniello S., Leone S, Macello A., PETRONELLA, Pasquale, Marvaso, A., Esposito, S., Noviello, S., Ianniello, S., Leone, S, Macello, A., and Petronella, Pasquale

Subjects
Adult, Male, Piperacillin, Aged, Ambulatory Care, Anti-Bacterial Agents, Bacterial Infections, Diabetic Foot, Female, Humans, Injections, Middle Aged, Penicillanic Acid, Retrospective Studies, Piperacillin, Tazobactam Drug Combination
Abstract

Treatment of diabetic foot infections (DFIs) represents an important challenge for surgeons, especially in light of the poor results achieved by traditional therapeutic approaches. In this study, the clinical and bacteriological efficacy of TZP for treatment of DFIs in 38 outpatients was evaluated. All patients (median age 63 yrs) were affected by DFIs to different degrees of severity according to Wagner's classification: degree 0, 7 pts; degree 1, 17 pts; degree 2, 10 pts; degree 3, 4 pts. Degree 0-1 infections underwent a 10-18 day course with TZP given i.m. (2.25 g bid); degree 2-3 infections were initially treated with TZP i.v. (4.5 g bid or tid). Some patients began treatment in hospital and after early discharge continued parenteral therapy at home; others were treated exclusively at home. Some pts, after a 5-7-day course of i.v. therapy switched to i.m. route. The average duration of antibiotic therapy was 28 days. At the end of treatment with TZP, some patients underwent a new treatment with oral coamoxi-clav for 10-15 days. A bacteriological examination was done for all patients: ulcus (degree 1) and deep tissue (degree 2-3) swabs at the first surgical toilette. Clinical controls, medications, surgical toilettes and microbiological cultures were performed according to the degree of severity, extension of the lesion and response to treatment. All cultures were positive for polymicrobial infections (Staphylococcus spp, Enterococcus spp, Enterobacteriaceae, Pseudomonas spp). In 30/38 pts (79%) a complete resolution was observed; in 4 pts (10%) an improvement. DFIs require long term parenteral treatment, with wide spectrum antibiotics including Gram +, Gram - and anaerobes. OPAT represents a valid alternative to hospitalisation when the general conditions of the patient are stable, the infection is not too severe and complications are not present. TZP proved to be a good choice for treatment of diabetic foot infections that, due to its high safety, can be successfully utilized also in OPAT programmes

Published
2002

39. P0829 : On-treatment HCVRNA as a predictor of sustained virologic response in HCV genotype 3 infected patients treated with daclatasvir and sofosbuvir: analysis of phase 3 ALLY-3 study

Author

Kowdley, K., primary, Nelson, D., additional, Lalezari, J., additional, Box, T., additional, Gitlin, N., additional, Poleynard, G., additional, Rabinovitz, M., additional, Ravendhran, N., additional, Sheikh, A., additional, Siddique, A., additional, Bhore, R., additional, Yin, P.D., additional, Noviello, S., additional, and Rana, K., additional

Published
2015
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40. P0782 : All-oral 12-week combination treatment with daclatasvir (DCV) and sofosbuvir (SOF) in treatment-experienced patients infected with HCV genotype (GT) 3: A subanalysis of the ALLY-3 phase 3 study

Author

Nelson, D., primary, Bernstein, D., additional, Freilich, B., additional, Lawitz, E., additional, Hawkins, T., additional, Pockros, P., additional, Thuluvath, P., additional, Younes, Z., additional, Bennett, M., additional, Ghalib, R., additional, Ruane, P.J., additional, Tong, M., additional, Bhore, R., additional, Yin, P.D., additional, Noviello, S., additional, and Rana, K., additional

Published
2015
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42. All-oral dual therapy with daclatasvir and asunaprevir in patients with HCV genotype 1B infection: Phase 3 study results.

Author

Mendez P., McPhee F., Kopit J., Linaberry M., Noviello S., Hughes E., Manns M., Pol S., Jacobson I., Marcellin P., Gordon S., Peng C.-Y., Chang T.-T., Everson G., Heo J., Gerken G., Yoffe B., Towner W.J., Bourliere M., Metivier S., Chu C.-J., Sievert W., Bronowicki J.-P., Thabut D., Lee Y.-J., Kao J.-H., Mendez P., McPhee F., Kopit J., Linaberry M., Noviello S., Hughes E., Manns M., Pol S., Jacobson I., Marcellin P., Gordon S., Peng C.-Y., Chang T.-T., Everson G., Heo J., Gerken G., Yoffe B., Towner W.J., Bourliere M., Metivier S., Chu C.-J., Sievert W., Bronowicki J.-P., Thabut D., Lee Y.-J., and Kao J.-H.

Abstract

Background and Aims: Daclatasvir plus asunaprevir dual oral therapy (DCV+ASV) has demonstrated potent antiviral activity in HCV genotype 1b infection. This phase 3 study (AI447028) evaluated DCV+ASV in a broad range of patients, including those with cirrhosis. Method(s): Treatment-naive patients were randomly assigned (2:1; double-blinded) to receive DCV 60mg QD plus ASV 100mg BID (n = 203), or matching placebo (n = 102) for 12 weeks. The DCV+ASV group continued treatment for another 12 weeks; placebo recipients entered another DCV+ASV study. Patients with prior null/partial response to peginterferon/ribavirin (null/partial; N= 205), and those medically ineligible for, or previously intolerant of, peginterferon/ribavirin (ineligible/intolerant; N= 235) received DCV+ASV for 24 weeks. Primary endpoint was sustained virologic response at posttreatment Week 12 (SVR12). Result(s): Overall, patients were 49% male, 68% white, and 71% IL28B non-CC; 30% had cirrhosis. SVR12 rates among DCV+ASV-treated patients were 90%, 82%, and 82% in the naive, null/partial, and ineligible/intolerant groups (table). No differences in SVR12 rates were observed based on age, gender, race, or IL28B genotype; SVR12 rates were similar across all groups in noncirrhotic (85%; n = 437) and cirrhotic (84%; n = 206) patients. Serious AEs occurred in 6% and AEs leading to discontinuation (reversible elevated ALT/AST most common) in 2%, with no deaths. Grade 3/4 laboratory abnormalities were uncommon, including low incidences of ALT elevations (first 12 weeks) with DCV+ASV or placebo in naive patients (2% for both). Conclusion(s): DCV+ASV provided high SVR12 rates of 90% (treatmentnaive) and >80% (null/partial and ineligible/intolerant), including in cirrhotics, and was generally well tolerated in patients with HCV genotype 1b infection. (Table Presented).

Published
2014

43. Efficacy and safety of daclatasvir in combination with asunaprevir (DCV+ASV) in cirrhotic and non-cirrhotic patients with HCV genotype 1B: Results of the hallmark dual study.

Author

Noviello S., Kopit J., Linaberry M., Hughes E., Manns M., Kao J.-H., Heo J., Yoffe B., Sievert W., Jacobson I., Bessone F., Peng C.-Y., Roberts S., Yoon K.T., Noviello S., Kopit J., Linaberry M., Hughes E., Manns M., Kao J.-H., Heo J., Yoffe B., Sievert W., Jacobson I., Bessone F., Peng C.-Y., Roberts S., and Yoon K.T.

Abstract

Background and Aims: Current therapy of HCV infection in cirrhotic patients is complicated by poor tolerability and suboptimal sustained virologic response (SVR) rates. All-oral, direct-acting antiviral (DAA)-based regimens may improve efficacy and tolerability for cirrhotics. A phase 3 study of DCV+ASV demonstrated SVR rates of up to 90% in genotype 1b infection; efficacy/safety outcomes in cirrhotics versus non-cirrhotics were assessed. Method(s): Treatment-naive (naive) patients were randomized (2:1; double-blinded) to receive DCV 60mg QD plus ASV 100mg BID (n = 203), or matching placebo (n = 102) for 12 weeks. DCV+ASVtreated patients continued treatment through 24 weeks; placebo recipients entered another DCV+ASV study. Patients with prior null/partial response to peginterferon/ribavirin (null/partial; N= 205), and those medically ineligible for, or intolerant of, peginterferon/ribavirin (ineligible/intolerant; N= 235) received DCV+ASV for 24 weeks. The ineligible/intolerant group included a subgroup (n = 77) with advanced fibrosis/cirrhosis and thrombocytopenia (50-<90x109 cells/L). Primary endpoint was SVR at posttreatment Week 12 (SVR12). Result(s): At baseline, 32 naive (DCV+ASV), 63 null/partial, and 111 ineligible/intolerant patients had cirrhosis. Demographic/baseline characteristics were comparable in cirrhotics and non-cirrhotics. SVR12 was achieved by 172/206 (84%) cirrhotics and 370/437 (85%) non-cirrhotics (table). The ineligible/intolerant subgroup with advanced fibrosis/cirrhosis and thrombocytopenia had an SVR12 rate of 73% (56/77). No deaths occurred; no clinically meaningful differences were observed in frequencies of serious adverse events (AEs), AEs leading to discontinuation, or grade 3/4 AST/ALT elevations in patients with or without cirrhosis. Conclusion(s): All-oral DCV+ASV treatment exhibited similarly high SVR rates and no clinically relevant differences in safety/tolerability in cirrhotic and non-cirrhotic patients with HCV genotype 1b

Published
2014

45. [Catheter-associated urinary tract infections: epidemiology and prevention]

Author

Esposito, Silvano, Noviello, S, and Leone, Sebastiano

Subjects
Biocompatible, Male, Aged, Alloys, Bacteriuria, Biofilms, Coated Materials, Biocompatible, Enterobacteriaceae Infections, Equipment Contamination, Female, Humans, Hydrogels, Intensive Care, Long-Term Care, Multicenter Studies as Topic, Oxides, Randomized Controlled Trials as Topic, Risk Factors, Silver Compounds, Urethra, Urinary Catheterization, Urinary Tract Infections, Critical Care, Coated Materials
Abstract

Urinary tract infections (UTIs) represent the second most often observed infectious diseases in community, following the respiratory tract infections. In the United States, these infections account for up to 7 million/year of visits, with a mean yearly expense for the related antibiotic treatment that has been estimated in more than one billion dollars. In nosocomial setting, UTIs represent the most frequent diseases, whose incidence equates 40% of nosocomial infections overall considered; about 80% of UTIs is related to urinary catheterization. In the present review, the authors, after a brief introduction about epidemiology, pathogenesis and aetiology of urinary tract infections, consider two particular settings: long term care facilities, where UTIs represent the most often diagnosed and treated infections, and the Intensive Care Units where occurrence of urinary tract infections represents an especially frequent event as well. Patients referred to both these settings are particular, as they undergo, in most cases, to urinary catheterization. After describing the pathogenesis of UTIs related to catheterization, either short- or long term, the authors consider the different currently available catheters, focusing on silver-coated and silver alloy coated (silver, gold, and platinum). With regard to this latter issue, results presented by a number of papers in the literature are reported, where clinical experiences following the use of these urinary catheters are described. In their conclusion, authors suggest the opportunity to increase any prevention strategy able to reduce the incidence of infections related to urinary catheterization and its consequences, as a more rational length and modality of catheterization, in addition to the use of innovative catheters.

Published
2008

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