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12. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial

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Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, A, Rivellese, A, Squatrito, S, Giorda, C, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, A, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, A, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Dodesini, A, Reggiani, G, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi, M, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, M, Franzetti, I, Radin, R, Annunziata, F, Bonabello, L, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, M, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta, G, D'Andrea, S, Giuliani, A, Polidoro, W, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, M, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, M, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, P, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, G, Loi, C, Oldani, M, Bottalico, M, Pellegata, B, Bonomo, M, Menicatti, L, Resi, V, Bertuzzi, F, Disoteo, E, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, S, Turco, A, Costagliola, L, Corte, G, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, N, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, K, Penno, G, Livraga, S, Calzoni, F, Corsini, E, Tedeschi, A, Gagliano, M, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, M, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, A, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, P, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, M, Coletti, M, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, C, Agrusta, M, Vaccaro O., Masulli M., Nicolucci A., Bonora E., Del Prato S., Maggioni A. P., Rivellese A. A., Squatrito S., Giorda C. B., Sesti G., Mocarelli P., Lucisano G., Sacco M., Signorini S., Cappellini F., Perriello G., Babini A. C., Lapolla A., Gregori G., Giordano C., Corsi L., Buzzetti R., Clemente G., Di Cianni G., Iannarelli R., Cordera R., La Macchia O., Zamboni C., Scaranna C., Boemi M., Iovine C., Lauro D., Leotta S., Dall'Aglio E., Cannarsa E., Tonutti L., Pugliese G., Bossi A. C., Anichini R., Dotta F., Di Benedetto A., Citro G., Antenucci D., Ricci L., Giorgino F., Santini C., Gnasso A., De Cosmo S., Zavaroni D., Vedovato M., Consoli A., Calabrese M., di Bartolo P., Fornengo P., Riccardi G., D'Angelo F., Giansanti R., Tanase L., Lanari L., Testa I., Pancani F., Ranchelli A., Vagheggi P., Scatona A., Fontana L., Laviola L., Tarantino L., Ippolito C., Gigantelli V., Manicone M., Conte E., Trevisan R., Rota R., Dodesini A. R., Reggiani G. M., Montesi L., Mazzella N., Forlani G., Caselli C., Di Luzio R., Mazzotti A., Aiello A., Barrea A., Musto A., D'Amico F., Sinagra T., Longhitano S., Trowpea V., Sparti M., Italia S., Lisi E., Grasso G., Pezzino V., Insalaco F., Carallo C., Scicchitano C., De Franceschi M. S., Calbucci G., Ripani R., Cuneo G., Corsi S., Romeo F., Lesina A., Comoglio M., Bonetto C., Robusto A., Nada E., Asprino V., Cetraro R., Impieri M., Lucchese G., Donnarumma G., Tizio B., Lenza L., Paraggio P., Tomasi F., Dozio N., Scalambra E., Mannucci E., Lamanna C., Cignarelli M., Macchia O. L., Fariello S., Sorrentino M. R., Franzetti I., Radin R., Annunziata F., Bonabello L. A., Durante A., Dolcino M., Gallo F., Mazzucchelli C., Aleo A., Melga P., Briatore L., Maggi D., Storace D., Cecoli F., D'Ugo E., Pupillo M., Baldassarre M. P. A., Salvati F., Minnucci A., De Luca A., Zugaro A., Santarelli L., Bosco A., Petrella V., La Verghetta G. G., D'Andrea S., Giuliani A. E., Polidoro W. L., Sperandio A., Sciarretta F., Pezzella A., Carlone A., Potenziani S., Venditti C., Foffi C., Carbone S., Cipolloni L., Moretti C., Leto G., Serra R., Petrachi F., Romano I., Lacaria E., Russo L., Goretti C., Sannino C., Dolci M., Bruselli L., Mori M. L., Baccetti F., Del Freo M., Cucinotta D., Giunta L., Ruffo M. C., Cannizzaro D., Pintaudi B., Perrone G., Pata P., Ragonese F., Lettina G., Mancuso T., Coppolino A., Piatti P. M., Monti L., Stuccillo M., Lucotti P., Setola M., Crippa G. V., Loi C., Oldani M., Bottalico M. L., Pellegata B., Bonomo M., Menicatti L. S. M., Resi V., Bertuzzi F., Disoteo E. O., Pizzi G., Annuzzi G., Capaldo B., Nappo R., Auciello S. M., Turco A. A., Costagliola L., Corte G. D., Vallefuoco P., Nappi F., Vitale M., Cocozza S., Ciano O., Massimino E., Garofalo N., Avogaro A., Guarneri G., Fedele D., Sartore G., Chilelli N. C., Burlina S., Bonsembiante B., Galluzzo A., Torregrossa V., Mancastroppa G., Arsenio L., Cioni F., Caronna S., Papi M., Santeusanio F., Calagreti G., Timi A., Tantucci A., Marino C., Ginestra F., Di Biagio R., Taraborelli M., Miccoli R., Bianchi C., Garofolo M., Politi K. S., Penno G., Livraga S., Calzoni F., Mancastroppa G. L. F., Corsini E., Tedeschi A., Gagliano M. S., Ippolito G., Salutini E., Cervellino F., Natale M., Salvatore V., Zampino A., Sinisi R., Arcangeli A., Zogheri A., Guizzotti S., Longo R., Pellicano F., Scolozzi P., Termine S., Luberto A., Ballardini G., Trojani C., Mazzuca P., Bruglia M., Ciamei M., Genghini S., Zannoni C., Rangel G., Salvi L., Zappaterreno A., Cordone S., Simonelli P., Meggiorini M., Frasheri A., Di Pippo C., Maglio C., Mazzitelli G., Rinaldi M. E., Galli A., Romano M., D'Angelo P., Suraci C., Bacci S., Palena A. P., Genovese S., Mancino M., Rondinelli M., Capone F., Calabretto E., Bulgheroni M., Bucciarelli L., Ceccarelli E., Fondelli C., Santacroce C., Guarino E., Nigi L., Lalli C., Di Vizia G., Scarponi M., Montani V., Di Bernardino P., Romagni P., Dolcetti K., Forte E., Tamburo L., Perin P. C., Prinzis T., Gruden G., Bruno G., Zucco C., Perotta M., Marena S., Monsignore S., Panero F., Ponzi F., Carpinteri R., Casagrande M. L., Coletti M. F., Balini A., Filopanti M., Madaschi S., Pulcina A., Grimaldi F., Venturini G., Agus S., Pagnutti S., Guidotti F., Cavarape A., Cigolini M., Pichiri I., Brangani C., Fainelli G., Tomasetto E., Zoppini G., Galletti A., Perrone D., Capra C., Bianchini F., Ceseri M., Di Nardo B., Sasso E., Bartolomei B., Suliman I., Fabbri G., Romano G., Maturo N., Nunziata G., Capobianco G., De Simone G., Villa V., Rota G., Pentangelo C., Carbonara O., Caiazzo G., Cutolo M., Sorrentino T., Mastrilli V., Amelia U., Masi S., Corigliano G., Gaeta I., Armentano V., Calatola P., Capuano G., Angiulli B., Auletta P., Petraroli E., Iodice C. E., Agrusta M., Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, A, Rivellese, A, Squatrito, S, Giorda, C, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, A, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, A, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Dodesini, A, Reggiani, G, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi, M, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, M, Franzetti, I, Radin, R, Annunziata, F, Bonabello, L, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, M, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta, G, D'Andrea, S, Giuliani, A, Polidoro, W, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, M, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, M, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, P, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, G, Loi, C, Oldani, M, Bottalico, M, Pellegata, B, Bonomo, M, Menicatti, L, Resi, V, Bertuzzi, F, Disoteo, E, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, S, Turco, A, Costagliola, L, Corte, G, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, N, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, K, Penno, G, Livraga, S, Calzoni, F, Corsini, E, Tedeschi, A, Gagliano, M, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, M, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, A, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, P, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, M, Coletti, M, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, C, Agrusta, M, Vaccaro O., Masulli M., Nicolucci A., Bonora E., Del Prato S., Maggioni A. P., Rivellese A. A., Squatrito S., Giorda C. B., Sesti G., Mocarelli P., Lucisano G., Sacco M., Signorini S., Cappellini F., Perriello G., Babini A. C., Lapolla A., Gregori G., Giordano C., Corsi L., Buzzetti R., Clemente G., Di Cianni G., Iannarelli R., Cordera R., La Macchia O., Zamboni C., Scaranna C., Boemi M., Iovine C., Lauro D., Leotta S., Dall'Aglio E., Cannarsa E., Tonutti L., Pugliese G., Bossi A. C., Anichini R., Dotta F., Di Benedetto A., Citro G., Antenucci D., Ricci L., Giorgino F., Santini C., Gnasso A., De Cosmo S., Zavaroni D., Vedovato M., Consoli A., Calabrese M., di Bartolo P., Fornengo P., Riccardi G., D'Angelo F., Giansanti R., Tanase L., Lanari L., Testa I., Pancani F., Ranchelli A., Vagheggi P., Scatona A., Fontana L., Laviola L., Tarantino L., Ippolito C., Gigantelli V., Manicone M., Conte E., Trevisan R., Rota R., Dodesini A. R., Reggiani G. M., Montesi L., Mazzella N., Forlani G., Caselli C., Di Luzio R., Mazzotti A., Aiello A., Barrea A., Musto A., D'Amico F., Sinagra T., Longhitano S., Trowpea V., Sparti M., Italia S., Lisi E., Grasso G., Pezzino V., Insalaco F., Carallo C., Scicchitano C., De Franceschi M. S., Calbucci G., Ripani R., Cuneo G., Corsi S., Romeo F., Lesina A., Comoglio M., Bonetto C., Robusto A., Nada E., Asprino V., Cetraro R., Impieri M., Lucchese G., Donnarumma G., Tizio B., Lenza L., Paraggio P., Tomasi F., Dozio N., Scalambra E., Mannucci E., Lamanna C., Cignarelli M., Macchia O. L., Fariello S., Sorrentino M. R., Franzetti I., Radin R., Annunziata F., Bonabello L. A., Durante A., Dolcino M., Gallo F., Mazzucchelli C., Aleo A., Melga P., Briatore L., Maggi D., Storace D., Cecoli F., D'Ugo E., Pupillo M., Baldassarre M. P. A., Salvati F., Minnucci A., De Luca A., Zugaro A., Santarelli L., Bosco A., Petrella V., La Verghetta G. G., D'Andrea S., Giuliani A. E., Polidoro W. L., Sperandio A., Sciarretta F., Pezzella A., Carlone A., Potenziani S., Venditti C., Foffi C., Carbone S., Cipolloni L., Moretti C., Leto G., Serra R., Petrachi F., Romano I., Lacaria E., Russo L., Goretti C., Sannino C., Dolci M., Bruselli L., Mori M. L., Baccetti F., Del Freo M., Cucinotta D., Giunta L., Ruffo M. C., Cannizzaro D., Pintaudi B., Perrone G., Pata P., Ragonese F., Lettina G., Mancuso T., Coppolino A., Piatti P. M., Monti L., Stuccillo M., Lucotti P., Setola M., Crippa G. V., Loi C., Oldani M., Bottalico M. L., Pellegata B., Bonomo M., Menicatti L. S. M., Resi V., Bertuzzi F., Disoteo E. O., Pizzi G., Annuzzi G., Capaldo B., Nappo R., Auciello S. M., Turco A. A., Costagliola L., Corte G. D., Vallefuoco P., Nappi F., Vitale M., Cocozza S., Ciano O., Massimino E., Garofalo N., Avogaro A., Guarneri G., Fedele D., Sartore G., Chilelli N. C., Burlina S., Bonsembiante B., Galluzzo A., Torregrossa V., Mancastroppa G., Arsenio L., Cioni F., Caronna S., Papi M., Santeusanio F., Calagreti G., Timi A., Tantucci A., Marino C., Ginestra F., Di Biagio R., Taraborelli M., Miccoli R., Bianchi C., Garofolo M., Politi K. S., Penno G., Livraga S., Calzoni F., Mancastroppa G. L. F., Corsini E., Tedeschi A., Gagliano M. S., Ippolito G., Salutini E., Cervellino F., Natale M., Salvatore V., Zampino A., Sinisi R., Arcangeli A., Zogheri A., Guizzotti S., Longo R., Pellicano F., Scolozzi P., Termine S., Luberto A., Ballardini G., Trojani C., Mazzuca P., Bruglia M., Ciamei M., Genghini S., Zannoni C., Rangel G., Salvi L., Zappaterreno A., Cordone S., Simonelli P., Meggiorini M., Frasheri A., Di Pippo C., Maglio C., Mazzitelli G., Rinaldi M. E., Galli A., Romano M., D'Angelo P., Suraci C., Bacci S., Palena A. P., Genovese S., Mancino M., Rondinelli M., Capone F., Calabretto E., Bulgheroni M., Bucciarelli L., Ceccarelli E., Fondelli C., Santacroce C., Guarino E., Nigi L., Lalli C., Di Vizia G., Scarponi M., Montani V., Di Bernardino P., Romagni P., Dolcetti K., Forte E., Tamburo L., Perin P. C., Prinzis T., Gruden G., Bruno G., Zucco C., Perotta M., Marena S., Monsignore S., Panero F., Ponzi F., Carpinteri R., Casagrande M. L., Coletti M. F., Balini A., Filopanti M., Madaschi S., Pulcina A., Grimaldi F., Venturini G., Agus S., Pagnutti S., Guidotti F., Cavarape A., Cigolini M., Pichiri I., Brangani C., Fainelli G., Tomasetto E., Zoppini G., Galletti A., Perrone D., Capra C., Bianchini F., Ceseri M., Di Nardo B., Sasso E., Bartolomei B., Suliman I., Fabbri G., Romano G., Maturo N., Nunziata G., Capobianco G., De Simone G., Villa V., Rota G., Pentangelo C., Carbonara O., Caiazzo G., Cutolo M., Sorrentino T., Mastrilli V., Amelia U., Masi S., Corigliano G., Gaeta I., Armentano V., Calatola P., Capuano G., Angiulli B., Auletta P., Petraroli E., Iodice C. E., and Agrusta M.

Abstract

Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50–75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2–3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15–45 mg) or a sulfonylurea (5–15 mg glibenclamide, 2–6 mg glimepiride, or 30–120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 p

Published
2017

30. Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects

Author

James, Wp, Caterson, Id, Coutinho, W, Finer, N, VAN GAAL LF, Maggioni, Ap, TORP-PEDERSEN, C, Sharma, Am, Shepherd, Gm, Rode, Ra, Renz, Cl, Van Gaal LF, Torp-Pedersen, C, Pepine, C, Pocock, S, Drexler, H, Swedberg, K, Sleight, P, Armstrong, P, Kerr, D, Dagenais, G, Brophy, J, Avezum, A, Bogaty, P, Fabbri, G, Galli, M, Hildebrandt, P, Mann, J, Ostergren, J, Sherman, D, Zannad, F, Colquhoun, D, Hollanders, G, e Forti A, Costa, Cifkova, R, Toubro, S, Ziegler, O, Scherbaum, Wa, Jordan, J, Halmy, L, Ferrannini, E, Santini, F, Gonzalez, C, Narkiewicz, K, Hancu, N, Payer, J, Pascual, J, Wilding, J, Campbell, L, Carey, D, Gerstman, M, Karrasch, J, Lefkovits, J, Marks, J, Marks, S, Moses, R, Phillips, P, Proietto, J, Roberts, D, Roberts-Thomson, P, Shaw, J, Simpson, R, Singh, B, Singleton Jeffries, W, Stuckey, B, Boland, J, Brohet, C, Coucke, F, Dendale, P, Jouret, G, Kolanowski, J, Kutnowski, M, Martens, F, Muls, E, Peiffer, F, Penninckx, H, Scheen, A, Schoors, D, Vaerenberg, M, Van Cleemput, J, Van Crombrugge, P, Van Kuyk, M, Verhaegen, A, Wollaert, B, de Albuquerque DC, Appolinario, J, de Godoy Matos AF, Gross, Jl, Halpern, A, Kerr Saraiva JF, Milagres, R, Repetto, G, Suplicy, Hl, Zanella, Mt, Bednarova, J, Cepelak, V, Cerny, P, Hainer, V, Havranek, P, Homza, M, Jansa, P, Karlicek, M, Kolesar, J, Kotik, I, Kucera, D, Kuchar, J, Kunc, M, Kvapil, M, Linhart, A, Machova, V, Matuska, J, Oral, I, Pavlas, J, Pesatova, S, Povolny, J, Semrad, B, Smetana, K, Soucek, M, Svacina, S, Tesinsky, P, Urbanek, R, Wasserburger, B, Zachoval, R, Zahumensky, E, Zidkova, E, Astrup, A, Dominguez, H, Faber, J, Hilderbrant, P, Kober, L, Perrild, H, Richelsen, B, Sogaard, P, Svendsen, Ol, Urhammer, S, Archambeaud, F, Basdevant, A, Borys, Jm, Bringer, J, Brunetiere, C, Charpentier, G, Cocaul-André, M, Dabadie, H, Dubreuil, A, Estour, B, Gautier, Jf, Gibault, T, Halimi, S, Hespel, Jp, Issa Sayegh, M, Krempf, M, Laville, M, Lecerf, Jm, Louvet, Jp, Penfornis, A, Ritz, P, Schlienger, Jl, Schmitt, B, Valensi, P, Baar, M, Beermann, J, Bock, M, Boenner, G, Dammann, Hg, Diehm, C, Ditschuneit, H, Gadow, J, Gehlhar, S, Gessner, S, Guthersohn, A, Hamann, A, Hanefeld, M, Hasenfuss, G, Herzner, A, Heun, Kc, Heufelder, Ae, Hohensee, H, Jacob, S, Krings, P, Krätzig, B, Krosse, B, Lehmann, Rt, Mindt-Prüfert, S, Maisch, B, Pfeiffer, Af, Richard, F, Rose, B, Schmidt, E, Scholze, J, Schreckenberg, A, Stuebler, P, Walter, J, Wirth, A, Wunderlich, J, Abraham, G, Altorjay, A, Augusztin, G, Csaszar, A, Czuriga, I, Dinnyes, J, Gero, L, Gyimesi, A, Janosi, A, Kovacs, I, Liziczai, I, Majtenyi, A, Medvegy, M, Nadhazi, Z, Pados, G, Polak, G, Ronaszeki, A, Sido, Z, Simon, K, Anzà, C, Bevilacqua, M, Bosello, O, Chiariello, M, Cordera, R, Ferrari, E, Frittitta, L, Giorgino, R, Liuzzi, A, Malinverni, C, Di Mario, U, Melchionda, N, Occhi, G, Perticone, F, Pinchera, A, Pinelli, G, Rovera, G, Santeusanio, F, Urbinati, S, Alpizar-Salazar, M, Carrillo-Ortega, E, Fanghanel Salmon, G, Laviada-Molina, Ha, Madero, Ma, Rodriguez, G, Saldate, C, Sanchez-Castillo, Cp, Violante, Rm, Wacher, N, Zayas-Jaime, Fj, Zuniga-Guajardo, S, Adamiec, R, Banasiak, W, Chrusciel, P, Derlaga, B, Gebala, A, Gessek, J, Janik, K, Janion, M, Kalina, Z, Kozlowski, A, Kusnierz, B, Majcher, Z, Miekus, P, Niegowska, J, Okopien, B, Ostrowska, L, Pasowicz, M, Piepiorka, M, Pluta, W, Polaszewska-Muszynska, M, Ponikowski, P, Pupek-Musialik, D, Sawicki, A, Sobocik, H, Stankiewicz, A, Szpajer, M, Trojnar, R, Tykarski, A, Wrabec, K, Wyrzkowski, B, Zahorska-Markiewicz, B, Zalewski, M, Carrageta, M, Mendes Pedro MM, Parente Martins LM, dos Santos, L, Babes, A, Creteanu, G, Dan, Ga, Dragulescu, Si, Graur, M, Tirgoviste, Ci, Morosanu, M, Mota, M, Paveliu, Fs, Radoi, M, Ranetti, A, Totoian, I, Andre, I, Bugan, V, Cencarik, J, Csala, L, Farsky, S, Gonsorcik, J, Kamensky, G, Kmec, J, Krahulec, B, Kurian, R, Macek, V, Majercak, I, Micko, K, Mokan, M, Riecansky, I, Sojka, G, Uhliar, R, Urgeova, L, Vancik, J, Baro, Fm, Barrios Merino, A, Borras, Jl, Caixas, A, Cuatrecasas Cambra, G, Dominguez Escribano JR, Duran Garcia, S, Escobar-Jimenez, L, Esteva de Antonio, I, Formiguera Sala, X, Garcia-Luna, Pp, Garcia Robles, R, Gonzalez Albarran, O, Hernandez-Mijares, A, Martin Hidalgo, A, Masmiquel Comas, L, Morales Perez, F, Moreno Esteban, B, Pascual Izuel JM, Redon Mas, J, Ricart, W, Rubio, Ma, Ruilope, Lm, Salas-Salvado, J, Terroba Larumbe, M, Tinahones, F, de la Torre Casares ML, Vidal Cortada, J, Zuniga-Perez Lemaur, M, Abdulhakim, Ee, Adler, A, Barnett, Ah, Bodmer, C, Campbell, Iw, Chowdhury, T, Cleland, J, Cook, Rc, Dinneen, S, Donnachie, H, Haslam, Dw, Hillis, Gs, Horne, M, Howarth, Dj, Hughes, E, Jackson, S, Jones, Sc, Jones, Th, Kumar, S, Lean, M, Maroni, J, Mcinnes, G, Middleton, A, Morris, A, Newcombe, G, O'Kane, Kp, Pavel, Ic, Pawa, R, Perry, C, Pitts, C, Raja, A, Reckless, J, Robinson, J, Sarmiento, R, Soo, Sc, Taylor, S, Thomas, Ho, Thomson, Ma, and Wilkins, M.

Subjects
Male, medicine.medical_specialty, Myocardial Infarction, Blood Pressure, Kaplan-Meier Estimate, Type 2 diabetes, Klinikai orvostudományok, Placebo, law.invention, Double-Blind Method, Randomized controlled trial, Weight loss, law, Internal medicine, Appetite Depressants, medicine, Humans, Obesity, Myocardial infarction, Stroke, Aged, business.industry, Hazard ratio, Orvostudományok, General Medicine, Middle Aged, Overweight, medicine.disease, Surgery, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Cardiology, Female, Human medicine, medicine.symptom, business, Cyclobutanes, Sibutramine, medicine.drug
Abstract

Background The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established. Methods We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death). Results The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.31; P=0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P=0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P=0.03). The rates of cardiovascular death and death from any cause were not increased. Conclusions Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; ClinicalTrials.gov number, NCT00234832.)

Published
2010

31. Primary Ovarian Insufficiency due to Steroidogenic Cell Autoimmunity Is Associated with a Preserved Pool of Functioning Follicles

Author

La Marca, A., Marzotti, S., Brozzetti, A., Stabile, G., Artenisio, A. C., Bini, V., Giordano, R., De Bellis, A., Volpe, A., Falorni, A., Ambrosi, B., Angeli, A., Arnaldi, G., Arvat, E., Baccarelli, A., Barbetta, L., Beck Peccoz, P., Bellastella, A., Betterle, C., Bizzarro, A., Boscaro, M., Cavagnini, F., Celleno, R., Dal Prà, C., Dotta, Francesco, Ghigo, E., Laureti, S., Libè, R., Lorè, F., Mannelli, M., Mantero, F., Mantovani, G., Paccotti, P., Pecori Giraldi, F., Perniola, R., Santeusanio, F., Terzolo, M., Tiberti, C., Toja, P., Torlontano, M., Toscano, V., Trischitta, V., Zanchetta, R., LA MARCA, A, Marzotti, S, Brozzetti, A, Stabile, G, Artenisio, Ac, Bini, V, Giordano, R, DE BELLIS, Annamaria, Volpe, A, and Falorni, A.

Subjects
Endocrinology, Diabetes and Metabolism, Biochemistry, Endocrinology, Clinical Biochemistry, Biochemistry (medical), Adult, Anti-Mullerian Hormone, medicine.medical_specialty, Adolescent, Cell, Primary ovarian insufficiency, Radioimmunoassay, Enzyme-Linked Immunosorbent Assay, 030209 endocrinology & metabolism, Primary Ovarian Insufficiency, Biology, medicine.disease_cause, Autoimmunity, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Ovarian Follicle, Internal medicine, medicine, Humans, Inhibins, Ovarian follicle, Gonadal Steroid Hormones, Amenorrhea, Autoantibodies, Analysis of Variance, 030219 obstetrics & reproductive medicine, Estradiol, Autoantibody, Luteinizing Hormone, Middle Aged, medicine.disease, Obesity, Diabetes and Metabolism, medicine.anatomical_structure, Female, Follicle Stimulating Hormone, medicine.symptom, Hormone
Abstract

Primary ovarian insufficiency (POI) is defined as hypergonadotropic amenorrhea before the age of 40 yr. In 4-5% of patients with POI, an ovarian autoimmune process is present.Serum concentrations of antimüllerian hormone (AMH) have been determined in 26 women with POI due to steroidogenic cell autoimmunity (SCA-POI), 66 with nonautoimmune idiopathic POI (iPOI), 40 postmenopausal women (PMW), and 44 healthy fertile women (HW). SCA-POI was diagnosed according to presence of steroidogenic enzyme autoantibodies (17alpha-hydroxylase, side chain cleavage, and 21-hydroxylase autoantibodies).AMH concentrations were significantly higher in women with SCA-POI than women with iPOI (P = 0.018) or PMW (P = 0.03) but significantly lower than HW (P0.0001). AMH was detected in 11 of 26 women with SCA-POI (42%) and seven of 66 with iPOI (11%) (P = 0.002). Serum concentrations above the fifth percentile of the normal range (0.6 ng/ml) were detected in nine of 26 women with SCA-POI (35%) and four of 66 with iPOI (6%) (P = 0.001). Eight of 12 women with SCA-POI with less than 5 yr (67%) and one of 14 with longer disease duration (7%) had AMH concentrations within the normal range (P = 0.003). AMH concentrations correlated inversely with disease duration in women with SCA-POI (rho = -0.563, P = 0.003) but not women with iPOI. AMH correlated inversely with FSH serum concentrations in HW (rho = -0.584, P0.001) but not PMW or women with POI.Two thirds of women with recent-onset SCA-POI had normal AMH concentrations. Women with SCA-POI, differently from those with iPOI, present a preserved ovarian follicle pool for several years after diagnosis of ovarian insufficiency.

Published
2009

33. Levels of Adrenocortical Autoantibodies Correlate with the Degree of Adrenal Dysfunction in Subjects with Preclinical Addison's Disease

Author

LURETI S, DE BELLIS, Annamaria, MUCCITELLI IV, CALCINARO F, BIZZARRO, Antonio, ROSSI R, BELLASTELLA A, SANTEUSANIO F, FALORNI S., Lureti, S, DE BELLIS, Annamaria, Muccitelli, Iv, Calcinaro, F, Bizzarro, Antonio, Rossi, R, Bellastella, A, Santeusanio, F, and Falorni, S.

Subjects
anticorpi anti-21-idrossilasi, Endocrinology, Endocrinology, Diabetes and Metabolism, Biochemistry (medical), Clinical Biochemistry, Morbo di Addison, predizione, fattori di rischio, Biochemistry
Published
1998

34. Protein intake and urinary albumin excretion rates in the EURODIAB IDDM Complications Study

Author

Toeller, M, Buyken, A, Heitkamp, G, Brämswig, S, Mann, J, Milne, R, Gries, F. A, Keen, H, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Klischan, A, Forst, T, Schumacher, W, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Afonso, Mj, Monteiro, M, Mitchell, DAVID ROSS, Jepson, E, Mchardyyoung, S, Fuller, Jh, Betteridge, Dj, Milne, M, Thompson, T, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Djs, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Marchi, Manuel, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Standl, E, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Careddu, G, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, Sivieri, P., R, Carta, Q, Petraroli, G, Papazoglu, N, Goutzourela, M, Manes, C, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Henio, Ev, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, Vrhovac, V., Toeller, M, Buyken, A, Heitkamp, G, Bramswig, S, Mann, J, Milne, R, Gries, Fa, Keen, H, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Klischan, A, Forst, T, Schumacher, W, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Afonso, Mj, Monteiro, M, David, R, Jepson, E, Mchardyyoung, S, Fuller, Jh, Betteridge, Dj, Milne, M, Thompson, T, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Dj, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Marchi, M, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Standl, E, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Careddu, G, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglu, N, Goutzourela, M, Manes, C, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Ev, Henio, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, and Vrhovac, V

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, endocrine system diseases, Endocrinology, Diabetes and Metabolism, Urinary system, Physiology, Albuminuria, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Diabetic Nephropathies, Dietary Proteins, Europe, Female, Humans, Middle Aged, Nephropathy, Protein intake, urinary albumin, Diabetic nephropathy, Excretion, Diabetes mellitus, Internal medicine, Diabetes Mellitus, Internal Medicine, Medicine, Proteinuria, business.industry, medicine.disease, Endocrinology, Blood pressure, medicine.symptom, business, Type 1, Kidney disease
Abstract

For people with insulin-dependent diabetes mellitus (IDDM) renal disease represents a life-threatening and costly complication. The EURODIAB IDDM Complications Study, a cross-sectional, clinic-based study, was designed to determine the prevalence of renal complications and putative risk factors in stratified samples of European individuals with IDDM. The present study examined the relationship between dietary protein intake and urinary albumin excretion rate (AER). Food intake was assessed centrally by a standardized 3-day dietary record. Urinary AER was determined in a central laboratory from a timed 24-h urine collection. Complete data were available from 2696 persons with IDDM from 30 centres in 16 European countries. In individuals who reported protein consumption less than 20 % of total food energy intake, mean AER was below 20 μg/min. In those in whom protein intake constituted more than 20 %, mean AER increased, a trend particularly pronounced in individuals with hypertension and/or poor metabolic control. Trends reached statistical significance for intakes of total protein (% of energy, p = 0.01) and animal protein (% of energy, p = 0.02), while no association was seen for vegetable protein (p = 0.83). These findings support the current recommendation for people with diabetes not to exceed a protein intake of 20 % of total energy. Monitoring and adjustment of dietary protein appears particularly desirable for individuals with AER exceeding 20 μg/min (approximately 30 mg/24 h), especially when arterial pressure is raised and/or diabetic control is poor. [Diabetologia (1997) 40: 1219–1226]

Published
1997

35. Repeatability of three-day dietary records in the EURODIAB IDDM Complications Study

Author

Toeller M, Buyken A, Heitkamp G, Milne R, Klischan A, Gries FA, Fuller JH, Keen H, Krans HMJ, Navalesi R, Sjolie AK, Stephenson JM, Viberti GC, Karamanos B, Tountas C, Kofinis A, Petrou K, Katsilambros N, RoussiPenessi D, Cignarelli M, Giorgino R, DeGeco ML, Ramunni I, IonescuTirgoviste C, Strachinariu R, Nicolau A, Tamas G, Kerenyi Z, Ahmed AM, Toth J, Kempler P, Muntoni S, Songini M, Stabilini M, Fossarello M, Pintus S, Ferriss B, Cronin CC, Humphreys M, Forst T, Schumacher W, Wagener W, Venhaus A, Rottiers R, Priem H, Deschoolmeester MJ, Ebeling P, Sinisalo M, Koivisto VA, IdziorWalus B, Solnica B, SzopinskaCiba L, Solnica K, Lemkes HHPJ, Jansen JJ, EltedeWever BM, NunesCorrea J, Boavida J, Carvalho R, Afonso MJ, Monteiro M, David R, Jepson E, McHardyYoung S, Betteridge DJ, Milne M, Thompson T, Michel G, Wirion R, Paquet S, Hornick H, Boulton AJM, Ashe H, Fernando DJS, Curwell J, Pozza G, Slaviero G, Comi G, Fattor B, Marchi M, Mehnert H, Nuber A, Janka H, Nichting M, Standl E, Crepaldi G, Nosadini R, Cathelineau G, Cathelineau BV, Jellal M, Grodner N, Feiss PG, Baclet N, Santeusanio F, Rosi G, Ventura MRM, Cagini C, Marino C, Penno G, Miccoli R, Nannipieri M, Manfredi S, Bertolotto A, Ghirlanda G, Manto A, Cotroneo P, Ward JD, Tesfaye S, Mody C, Rudd C, Papazoglou N, Goutzourela M, Manes C, Molinatti GM, Vitelli F, Porta M, Pagano GF, Estivi P, Sivieri R, Carta Q, Petraroli G, BenSoussan D, Fallas MC, Fallas P, Dhanaeus C, Bourgeois MD, Muggeo M, Cacciatori V, Bellavere F, Galante P, Gemma ML, Branzi P, Irsigler K, Abrahamian H, Gurdet C, Hornlein B, Willinger C, Strohner H, Just M, Walford S, Wardle EV, Henio S, Cooke H, Roglic G, Resman Z, Metelko Z, Skrabalo Z., BANDELLO , FRANCESCO, Toeller, M, Buyken, A, Heitkamp, G, Milne, R, Klischan, A, Gries, Fa, Fuller, Jh, Keen, H, Krans, Hmj, Navalesi, R, Sjolie, Ak, Stephenson, Jm, Viberti, Gc, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Forst, T, Schumacher, W, Wagener, W, Venhaus, A, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Lemkes, Hhpj, Jansen, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Afonso, Mj, Monteiro, M, David, R, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Thompson, T, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Dj, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, Francesco, Marchi, M, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Standl, E, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Manto, A, Cotroneo, P, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Papazoglou, N, Goutzourela, M, Manes, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Bourgeois, Md, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Ev, Henio, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, and Skrabalo, Z.

Subjects
Dietary Fiber, medicine.medical_specialty, Alcohol Drinking, European community, Saturated fat, Population, Medicine (miscellaneous), the EURODIAB IDDM Study, Diabetes mellitus, Dietary Carbohydrates, medicine, Humans, education, education.field_of_study, Nutrition and Dietetics, business.industry, Reproducibility of Results, Repeatability, medicine.disease, Dietary Fats, Diet Records, Confidence interval, Surgery, Europe, three-day dietary records, Diabetes Mellitus, Type 1, Nutrition Assessment, Quartile, Cohort, Dietary Proteins, Energy Intake, business, Demography
Abstract

Objectives: Repeatability of a dietary method is important in determining the quality of nutritional data. It should be assessed in the population of interest. This study evaluated the repeatability of nutritional data from standardized three-day dietary records, from the clinic-based, cross-sectional multi-centre EURODIAB IDDM Complications Study. Design and Subjects: 15% of the total EURODIAB cohort was randomly selected to test the repeatability of nutritional intake data. Two three-day records, completed three weeks apart, were available for 216 diabetic patients (7.5%) representative of the total cohort. All records were analysed centrally, for intakes of protein (animal and vegetable), fat (saturated fat and cholesterol), carbohydrate, fibre, alcohol and energy. Repeatability was measured comparing mean intakes, determining the proportion of patients classified into the same/opposite quartile by the two three-day records and assessing mean differences with standard deviations (s.d.d). Results: There were no significant differences in mean energy and nutrient intakes between the first and second records. Classification of individuals into the opposite quartile occurred only in 0–4% of patients and overall about 50% (range 44–74%) of the subjects were classified into the same quartiles of intakes. Only small mean differences were found for energy intake (−156 (1633) kJ; 95% confidence limits −375, 63 kJ) and nutrients with s.d.ds comparable to intra-individual variations in the general population. The differences in energy intake were randomly distributed over the range of intakes. Conclusions: The present study demonstrates that standardized three day dietary records show a high degree of repeatability within a short period of time in a sample of European IDDM patients. The good repeatability strengthens the conclusions drawn from the nutritional data in the EURODIAB IDDM Complications Study. Sponsorship: Nutrition Co-ordinating Centre research funds, Diabetes Research Institute at Heinrich-Heine University, Dusseldorf. The EURODIAB IDDM Complications Study was supported by the European Community.

Published
1997

36. Predictive role of the immunostaining pattern of immunofluorescence and the titers of antipituitary antibodies at presentation for the occurrence of autoimmune hypopituitarism in patients with autoimmune polyendocrine syndromes over a five-year follow-up

Author

Bellastella, G, Rotondi, M, Pane, E, Dello Iacovo, A, Pirali, B, Dalla Mora, L, Falorni, A, Sinisi, Aa, Bizzarro, A, Colao, A, Chiovato, L, De Bellis, A, Italian Autoimmune Hypophysitis Network Study, Ambrosio, Mr, Arvat, E, Beck Peccoz, P, Betterle, C, Cannavo', Salvatore, Degli Uberti, E, Giordano, R, Ghigo, E, Lombardi, G, Maghnie, M, Mantero, F, Persani, L, Spada, A, Santeusanio, F, Delvecchio, M., Bellastella, G., Rotondi, M., Pane, E., Dello Iacovo, A., Pirali, B., Dalla Mora, L., Falorni, A., Sinisi, ANTONIO AGOSTINO, Bizzarro, Antonio, Colao, Annamaria, Chiovato, L., DE BELLIS, Annamaria, Italian AutoimmuneHypophysitis Network, S. t. u. d. y., Bellastella, G, Rotondi, M, Pane, E, DELLO IACOVO, A, Pirali, B, DALLA MORA, L, Falorni, A, Sinisi, Aa, Bizzarro, A, Colao, A, Chiovato, L, DE BELLIS, A, Ambrosio, Mr, Arvat, E, BECK-PECOZ, P, Betterle, C, Cannavò, S, DEGLI UBERTI, E, Giordano, R, Ghigo, E, Lombardi, G, Maghnie, M, Mantero, F, Persani, L, Spada, A, Santeusanio, F, and DEL VECCHIO, M.

Subjects
Adult, Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, education, Clinical Biochemistry, Fluorescent Antibody Technique, Context (language use), Hypopituitarism, Immunofluorescence, medicine.disease_cause, Biochemistry, Statistics, Nonparametric, antipituitary antibodie, NO, Autoimmunity, Endocrinology, Anterior pituitary, autoimmune hypopituitarism, Pituitary Gland, Anterior, Predictive Value of Tests, Internal medicine, mental disorders, medicine, Humans, Polyendocrinopathies, Autoimmune, Autoantibodies, medicine.diagnostic_test, biology, business.industry, polyendocrine syndrome, Biochemistry (medical), medicine.disease, antipituitary antibodies, autoimmune polyendocrine syndromes, medicine.anatomical_structure, hypopituitarism, Autoimmune polyendocrine syndrome, immunofluorescence, antipituitary antibodies, poly-endocrine syndrome, biology.protein, Regression Analysis, Female, Antibody, business, Immunostaining, psychological phenomena and processes
Abstract

CONTEXT: Antipituitary antibodies (APA) are frequently present in patients with autoimmune polyendocrine syndrome (APS). DESIGN: The aim was to evaluate the predictive value of APA for the occurrence of hypopituitarism. A total of 149 APA-positive and 50 APA-negative patients with APS and normal pituitary function were longitudinally studied for 5 yr. METHODS: APA, by indirect immunofluorescence, and anterior pituitary function were assessed yearly in all patients. The risk for developing autoimmune pituitary dysfunction was calculated using survival and multivariate analysis. RESULTS: Hypopituitarism occurred in 28 of 149 (18.8%) APA-positive patients but in none of the 50 APA-negative patients. The immunostaining pattern in APA-positive patients involved either isolated pituitary cells [type 1 pattern; n=99 (66.4%)] or all pituitary cells [type 2 pattern; n=50 (33.6%)]. All patients developing pituitary dysfunction throughout the study span had a type 1 pattern. Kaplan-Meier curves for cumulative survival showed a significantly higher rate for developing hypopituitarism in relation to positive APA tests (P

Published
2010

37. Microalbuminuria in type 1 diabetes: Rates, risk factors and glycemic threshold

Author

Chaturvedi, Nish, Bandinelli, Simona, Mangili, Ruggero, Penno, Guiseppe, Rottiers, Raoul E., Fuller, John H., Karamanos, B., Kofinis, A., Petrou, K., Giorgino, R., Giorgino, F., Picca, G., Angarano, A., De Pergola, G., Ionescu-Tirgoviste, C., Coszma, A., Songini, M., Casu, A., Pedron, M., Fossarello, M., Ferriss, J. B., Grealy, G., Keefe, D. O., White, A., Cleary, P. E., Toeller, M., Arden, C., Rottiers, R., Tuyttens, C., Priem, H., Ebeling, P., Kylliainen, M., Kyostio-Renvall, T., Idzior-Walus, B., Sieradzki, J., Cyganek, K., Lemkes, H. H. P. J., Roest, C., Nunes-Correa, J., Rogado, M. C., Gardete-Correia, L., Cardoso, M. C., Michel, G., Wirion, R., Cardillo, S., Pozza, G., Mangili, R., Asnaghi, V., Lattanzio, Rosangela, Galardi, G., Standl, E., Schaffler, B., Brand, H., Harms, A., Ben Soussan, D., Verier-Mine, O., Fuller, J. H., Holloway, J., Asbury, L., Betteridge, D. J., Cathelineau, G., Bouallouche, A., Villatte Cathelineau, B., Santeusanio, F., Rosi, G., D’ Alessandro, V., Cagini, C., Navalesi, R., Penno, G., Bandinelli, S., Miccoli, R., Ghirlanda, G., Saponara, C., Cotroneo, P., Manto, A., Minnella, A., Ward, J. D., Tesfaye, S., Eaton, S., Mody, C., Porta, M., Perin, P. Cavallo, Borra, M., Giunti, S., Papazoglou, N., Manes, Gianfranco, Muggeo, M., Iagulli, M., Irsigler, K., Abrahamian, H., Walford, S., Wardle, E. V., Sinclair, J., Hughes, S., Roglic, G., Metelko, Z., Resman, Z., Sjolie, A. -. K., Chaturvedi, N., Ferriss, B., Webb, D., Viberti, G. -. C., Swaminathan, R., Lumb, P., Collins, A., Sankaralingham, S., Aldington, S., Mortemore, T., and Lipinski, H.

Subjects
Albuminuria, Blood sugar control, Cardiovascular disease, Insulin resistance, Renal disease, Adolescent, Adult, Blood Glucose, Body Constitution, Cohort Studies, Diabetes Mellitus, Type 1, Differential Threshold, Disease Progression, Europe, Female, Follow-Up Studies, Humans, Incidence, Insulin Resistance, Male, Middle Aged, Prospective Studies, Reference Values, Risk Factors, Triglycerides, Nephrology, endocrine system diseases, urologic and male genital diseases, Gastroenterology, Waist–hip ratio, Proteinuria, Settore MED/30 - MALATTIE APPARATO VISIVO, female genital diseases and pregnancy complications, medicine.symptom, Type 1, medicine.medical_specialty, Internal medicine, Diabetes mellitus, Diabetes Mellitus, medicine, Risk factor, Glycemic, Type 1 diabetes, business.industry, nutritional and metabolic diseases, medicine.disease, Endocrinology, Microalbuminuria, business
Abstract

Microalbuminuria in type 1 diabetes: Rates, risk factors and glycemic threshold.BackgroundThe occurrence of microalbuminuria in type 1 diabetes is strongly predictive of renal and cardiovascular disease and is still likely to occur despite improvements in glycemic control. A better understanding of microalbuminuria is required to inform new interventions. We determined the incidence and risk factors for microalbuminuria [albumin excretion rate (AER) 20 to 200 μg/min] in the EURODIAB Prospective Complications Study.MethodsThis is a seven-year follow-up (between 1988 and 1991) of 1134 normoalbuminuric men and women (aged 15 to 60) with type 1 diabetes from 31 European centers. Risk factors and AER were measured centrally.ResultsThe incidence of microalbuminuria was 12.6% over 7.3 years. Independent baseline risk factors were HbA1c (7.1 vs. 6.2%, P = 0.0001) and AER (9.6 vs. 7.8 μg/min, P = 0.0001) and, independent of these, fasting triglyceride (0.99 vs. 0.88 mmol/L, P = 0.01), low-density lipoprotein cholesterol (3.5 vs. 3.2 mmol/L, P = 0.02), body mass index (24.0 vs. 23.4 kg/m2, P = 0.01), and waist to hip ratio (WHR; 0.85 vs. 0.83, P = 0.009). Triglyceride and WHR risk factors were nearly as strong as AER in predicting microalbuminuria (standardized regression effects of 1.3 for triglyceride and WHR and 1.5 for AER). Blood pressure at follow-up, but not at baseline, was also raised in those who progressed. There was no evidence of a threshold of HbA1c on microalbuminuria risk.ConclusionsThe incidence of microalbuminuria in patients with type 1 diabetes remains high, and there is no apparent glycemic threshold for it. Markers of insulin resistance, such as triglyceride and WHR, are strong risk factors. Systemic blood pressure is not raised prior to the onset of microalbuminuria.

Published
2001

38. Erratum

Author

Fanelli, C., Pampanelli, S., Epifano, L., Rambotti, A. M., Di Vincenzo, A., Modarelli, F., Ciofetta, M., Lepore, M., Annibale, B., Torlone, E., Perriello, G., De Feo, P., Santeusanio, F., Brunetti, P., and Bolli, G. B.

Published
1995
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39. Diabetes Incidence in 0- to 14-Year Age-Group in Italy

Author

CARLE F, GESUITA R, BRUNO G, COPPA GV, FALORNI A, LORINI R, MARTINUCCI ME, POZZILLI P, PRISCO F, SONGINI M, TENCONI MT, CHERUBINI V, THE RIDI STUDY GROUP, PIFFER S, FRANCHINI S, BIANCHI L, CERUTTI F, MERLETTI F, PAGANO G, COTELLESSA M, MINICUCCI L, BARBIERI P, D’ANNUNZIO G, BAZZANO S, TONI S, REALI MS, MEDICI A, IUGHETTI L, PREDIERI B, BALLI F, VISALLI N, SEBASTIANI L, MARIETTI G, SANTEUSANIO F, DE GIORGI G, SANTILLI E, IANNILLI A, PINELLI A, MASCIOLI G, ALTOBELLI E, CHIARELLI F, TUMINI S, IAFUSCO D, DE FELICE E, INGENITO N, CASU A, FRONGIA P, MARINARO A., DEVOTI, Gabriele, Carle, F, Gesuita, R, Bruno, G, Coppa, Gv, Falorni, A, Lorini, R, Martinucci, Me, Pozzilli, P, Prisco, F, Songini, M, Tenconi, Mt, Cherubini, V, THE RIDI STUDY, Group, Piffer, S, Franchini, S, Bianchi, L, Cerutti, F, Merletti, F, Pagano, G, Cotellessa, M, Minicucci, L, Barbieri, P, Devoti, Gabriele, D’Annunzio, G, Bazzano, S, Toni, S, Reali, M, Medici, A, Iughetti, L, Predieri, B, Balli, F, Visalli, N, Sebastiani, L, Marietti, G, Santeusanio, F, DE GIORGI, G, Santilli, E, Iannilli, A, Pinelli, A, Mascioli, G, Altobelli, E, Chiarelli, F, Tumini, S, Iafusco, D, DE FELICE, E, Ingenito, N, Casu, A, Frongia, P, and Marinaro, A.

Subjects
incidence, registry, Type 1 diabetes mellitu
Abstract

Objective. The Registry for Type 1 Diabetes Mellitus in Italy (RIDI) Study Group was established to coordinate the registries of type 1 diabetes in Italy. This report is based on 3,606 children younger than 15 years diagnosed with type 1 diabetes and prospectively registered during 1990-1999 by nine centers, covering > 35% of the Italian population. Research design and methods. Registries were pooled in four geographic macro-areas: north, central, south and insular. The completeness of registration was assessed by the capture-recapture method. Poisson regression analysis was used to evaluate temporal trend in incidence. Results. Large variation in incidence were confirmed not only between Sardegna and the mainland but also among peninsular areas. In Sardegna, there was an excess of boys (the boy-to-girl incidence ratio was 1.4). The overall incidence showed average increases of 3.6% (p

Published
2004

40. Randomised placebo-controlled trial of lisinopril in normotensive patients with insulin-dependent diabetes and normoalbuminuria or microalbuminuria

Author

Chaturvedi, N, Stevenson, J, Fuller, Jh, Rottiers, R, Ferriss, B, Karamanos, B, Kofinis, A, Petrou, C, Ionescutirgovisite, C, Iosif, C, Tamas, G, Bibok, G, Kerenyi, Z, Kisgombos, P, Toth, J, Grealy, G, Priem, H, Koivisto, V, Tuominen, J, Kostamo, E, Idziorwalus, B, Solnica, B, Galickalatalie, D, Michel, G, Keipes, M, Giuliani, A, Herode, A, Santeusanio, F, Bueti, A, Bistoni, S, Cagini, Navalesi, R, Penno, G, Nannipieri, Monica, Rizzo, L, Miccoli, Roberto, Ghirlanda, G, Cotroneo, P, Manto, A, Minella, A, Saponara, C, Ward, J, Plater, M, Ibrahim, S, Ibbotson, S, Mody, C, Papazoglou, N, Manes, C, Soulis, K, Voukias, M, Muggeo, M, Cacciatori, V, Gemma, Ml, Dellera, A, Castellarin, A, Irsigler, K, Abrahamian, H, Gurdet, C, Willinger, C, Nelstrop, A, Feben, C, Walford, S, Mclelland, V, Hughes, S, Metelko, Z, Roglic, G, Pepeonik, Zr, Stephenson, J, Viberti, Gc, Sjolie, Ak, Holloway, J, Milne, M, Webb, D, Bulpitt, C, Fletcher, A, Shipley, M, John, G, and Newman, Dj

Subjects
medicine.medical_specialty, Proteinuria, endocrine system diseases, business.industry, Urology, Lisinopril, Renal function, Captopril, General Medicine, urologic and male genital diseases, Placebo, medicine.disease, Endocrinology, Internal medicine, ACE inhibitor, medicine, Albuminuria, Microalbuminuria, medicine.symptom, business, medicine.drug
Abstract

Summary Background Renal disease in people with insulin-dependent diabetes (IDDM) continues to pose a major health threat. Inhibitors of angiotensin-converting enzyme (ACE) slow the decline of renal function in advanced renal disease, but their effects at earlier stages are unclear, and the degree of albuminuria at which treatment should start is not known. Methods We carried out a randomised, double-blind, placebo-controlled trial of the ACE inhibitor lisinopril in 530 men and women with IDDM aged 20–59 years with normoalbuminuria or microalbuminuria. Patients were recruited from 18 European centres, and were not on medication for hypertension. Resting blood pressure at entry was at least 75 and no more than 90 mm hg diastolic, and no more than 155 mm hg systolic. Urinary albumin excretion rate (AER) was centrally assessed by means of two overnight urine collections at baseline, 6, 12, 18, and 24 months. Findings There were no differences in baseline characteristics by treatment group; mean AER was 8.0 μg/min in both groups; and prevalence of microalbuminuria was 13% and 17% in the placebo and lisinopril groups, respectively. On intention-to-treat analysis at 2 years, AER was 2.2 μg/min lower in the lisinopril than in the placebo group, a percentage difference of 18.8% (95% CI 2·0–32·7, p=0·03), adjusted for baseline AER and centre, absolute difference 2.2 μg/min. In people with normoalbuminuria, the treatment difference was 1·0 μg/min (12·7% [−2·9 to 26·0], p=0·1). In those with microalbuminuria, however, the treatment difference was 34.2 μg/min (49·7% [−14·5 to 77·9], p=0·1; for interaction, p=0·04). For patients who completed 24 months on the trial, the final treatment difference in AER was 38·5 μg/min in those with microalbuminuria at baseline (p=0·001), and 0·23 μg/min in those with normoalbuminuria at baseline (p=0·6). There was no treatment difference in hypoglycaemic events or in metabolic control as assessed by glycated haemoglobin. Interpretation Lisinopril slows the progression of renal disease in normotensive IDDM patients with little or no albuminuria, though greatest effect was in those with microalbuminuria (AER ≥20 μg/min). Our results show that lisinopril does not increase the risk of hypoglycaemic events in IDDM.

Published
1997

41. A Multicenter Study on the Prevalence of Diabetic Neuropathy in Italy

Author

Fedele, D, Comi, G, Coscelli, C, Cucinotta, Domenico Maria, Feldman, El, Ghirlanda, G, Greene, Da, Negrin, P, Santeusanio, F, Cavazzuti, P, Iotti, A, Preti, B, Simoncini, G, Tessari, F, Viaggi, S, Corigliano, G, Zarella, A, Siletti, A, Sorrenti, G, Kuppelwiieser, U, Deblasi, G, Spogler, F, Degiuli, Gc, Demaria, G, Legati, F, Valentini, U, Colosio, W, Donati, E, Dalpa, F, Dimaggio, G, Lisi, E, Mazzeo, P, Papalia, D, Pollicina, S, Leonardi, G, Lunetta, M, Scrofani, A, Luciano, M, Piro, Ga, Teti, Diana, Basso, F, Brambilla, L, Garozzo, M, Elli, P, and R. E. Z. Z. O. N. I. .

Subjects
Advanced and Specialized Nursing, medicine.medical_specialty, Diabetic neuropathy, medicine.diagnostic_test, business.industry, Endocrinology, Diabetes and Metabolism, Concordance, Neurological examination, medicine.disease, Surgery, Peripheral neuropathy, Diabetes mellitus, Internal medicine, Epidemiology, Internal Medicine, medicine, Age of onset, Complication, business
Abstract

OBJECTIVE The prevalence of neuropathy, a common complication of diabetes, was determined in diabetic patients recruited from 109 outpatient diabetes clinics in Italy. RESEARCH DESIGN AND METHODS Neuropathy was diagnosed using the Diabetic Neuropathy Index (DNI), a standardized examination developed for use in the outpatient setting. A total of 8,757 diabetic patients were studied, 51.2% men and 48.8% women, with average and median ages of 56 and 58 years, respectively. RESULTS Of the 8,757 patients, 32.3% had neuropathy, defined as a positive score of > 2 points on the DNI. A total of 2,033 (49.6% men and 50.4% women) were administered the Diabetic Neuropathy Score (DNS), the second component of the screening program, by a neurologist. This component consists of a quantitative neurological examination and nerve conduction studies that together provide a summated score. A total of 335 patients (16.5%) were not neuropathic, and 395 (19.4%) had borderline, 453 (22.3%) mild, 592 (29.1%) moderate, and 258 (12.7%) severe neuropathy. The concordance between a positive score on the DNI and a DNS indicating neuropathy was 83.5%. The severity of neuropathy increased with both age and disease duration. Of patients with neuropathy, 64.1% had an average age between 58 and 59 years with a disease duration between 12.4 ± 8.4 years (mild neuropathy) and 15.6 ± 9.7 years (severe neuropathy). CONCLUSIONS Neuropathy is a common complication of diabetes and, in this study, was present in 32.3% of all patients. An increased awareness of the high prevalence of neuropathy can lead to early therapeutic intervention and possible prevention of later neuropathic complications, such as infection and foot ulcers.

Published
1997

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