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1. IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Author

Fadini, G, Buzzetti, R, Fittipaldi, M, D'Incau, F, Da Porto, A, Girelli, A, Simoni, L, Lastoria, G, Consoli, A, Iazzetta, N, Di Giovanni, G, Carbonara, O, Aragiusto, C, Carleo, D, Da Rosa, N, Martedi, E, Landolfi, L, Marracino, M, Tortora, A, De Morelli, G, Casarsa, V, Maddaloni, E, Siena, A, Pitocco, D, Tartaglione, L, Rizzi, A, Leonetti, F, Fasolo, M, Morsello, G, Bulzomi, R, Ruga, G, Bianconi, A, Torre, E, Rebora, A, Cecoli, F, Monti, E, Bonfadini, S, Dotti, S, Madaschi, S, Trevisan, R, Albizzi, M, Bellante, R, Corsi, A, Scaranna, C, De Cata, P, Liboa, F, Ghilotti, S, Tortato, E, Lanari, L, Turchi, F, Gabellieri, E, Lamacchia, O, Colucci, C, Mileti, G, Coluzzi, S, Carrieri, F, Rossetti, P, Anzaldi, M, Di Benedetto, A, Ruggeri, D, Scatena, A, Ranchelli, A, Ragusa, I, Gregori, G, Crisci, I, Mori, M, Baccetti, F, Anichini, R, Salutini, E, Vinci, C, Colletti, I, Zanon, M, Altomari, A, Bonora, B, Fadini G. P., Buzzetti R., Fittipaldi M. R., D'Incau F., Da Porto A., Girelli A., Simoni L., Lastoria G., Consoli A., Iazzetta N., Di Giovanni G., Carbonara O., Aragiusto C., Carleo D., Da Rosa N., Martedi E., Landolfi L., Marracino M., Tortora A., De Morelli G., Casarsa V., Maddaloni E., Siena A., Pitocco D., Tartaglione L., Rizzi A., Leonetti F., Fasolo M., Morsello G., Bulzomi R., Ruga G., Bianconi A., Torre E., Rebora A., Cecoli F., Monti E., Bonfadini S., Dotti S., Madaschi S., Trevisan R., Albizzi M., Bellante R., Corsi A., Scaranna C., De Cata P., Liboa F., Ghilotti S., Tortato E., Lanari L., Turchi F., Gabellieri E., Lamacchia O., Colucci C., Mileti G., Coluzzi S., Carrieri F., Rossetti P., Anzaldi M., Di Benedetto A., Ruggeri D., Scatena A., Ranchelli A., Ragusa I., Gregori G., Crisci I., Mori M., Baccetti F., Anichini R., Salutini E., Vinci C., Colletti I., Zanon M. S., Altomari A., Bonora B. M., Fadini, G, Buzzetti, R, Fittipaldi, M, D'Incau, F, Da Porto, A, Girelli, A, Simoni, L, Lastoria, G, Consoli, A, Iazzetta, N, Di Giovanni, G, Carbonara, O, Aragiusto, C, Carleo, D, Da Rosa, N, Martedi, E, Landolfi, L, Marracino, M, Tortora, A, De Morelli, G, Casarsa, V, Maddaloni, E, Siena, A, Pitocco, D, Tartaglione, L, Rizzi, A, Leonetti, F, Fasolo, M, Morsello, G, Bulzomi, R, Ruga, G, Bianconi, A, Torre, E, Rebora, A, Cecoli, F, Monti, E, Bonfadini, S, Dotti, S, Madaschi, S, Trevisan, R, Albizzi, M, Bellante, R, Corsi, A, Scaranna, C, De Cata, P, Liboa, F, Ghilotti, S, Tortato, E, Lanari, L, Turchi, F, Gabellieri, E, Lamacchia, O, Colucci, C, Mileti, G, Coluzzi, S, Carrieri, F, Rossetti, P, Anzaldi, M, Di Benedetto, A, Ruggeri, D, Scatena, A, Ranchelli, A, Ragusa, I, Gregori, G, Crisci, I, Mori, M, Baccetti, F, Anichini, R, Salutini, E, Vinci, C, Colletti, I, Zanon, M, Altomari, A, Bonora, B, Fadini G. P., Buzzetti R., Fittipaldi M. R., D'Incau F., Da Porto A., Girelli A., Simoni L., Lastoria G., Consoli A., Iazzetta N., Di Giovanni G., Carbonara O., Aragiusto C., Carleo D., Da Rosa N., Martedi E., Landolfi L., Marracino M., Tortora A., De Morelli G., Casarsa V., Maddaloni E., Siena A., Pitocco D., Tartaglione L., Rizzi A., Leonetti F., Fasolo M., Morsello G., Bulzomi R., Ruga G., Bianconi A., Torre E., Rebora A., Cecoli F., Monti E., Bonfadini S., Dotti S., Madaschi S., Trevisan R., Albizzi M., Bellante R., Corsi A., Scaranna C., De Cata P., Liboa F., Ghilotti S., Tortato E., Lanari L., Turchi F., Gabellieri E., Lamacchia O., Colucci C., Mileti G., Coluzzi S., Carrieri F., Rossetti P., Anzaldi M., Di Benedetto A., Ruggeri D., Scatena A., Ranchelli A., Ragusa I., Gregori G., Crisci I., Mori M., Baccetti F., Anichini R., Salutini E., Vinci C., Colletti I., Zanon M. S., Altomari A., and Bonora B. M.

Abstract

Introduction: IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). Methods: Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients’ baseline characteristics and the clinical reasons for IDegLira treatment initiation. Results: Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). Conclusions: IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients’ outcomes after IdegLira treatment under routine clinical care.

Published
2022

2. IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Author

Fadini, G. P., Buzzetti, R., Fittipaldi, M. R., D'Incau, F., Da Porto, A., Girelli, A., Simoni, L., Lastoria, G., Consoli, A., Iazzetta, N., Di Giovanni, G., Carbonara, O., Aragiusto, C., Carleo, D., Da Rosa, N., Martedi, E., Landolfi, L., Marracino, M., Tortora, Annalisa, De Morelli, G., Casarsa, V., Maddaloni, E., Siena, Annunziata, Pitocco, Dario, Tartaglione, Linda, Rizzi, A., Leonetti, F., Fasolo, M., Morsello, G., Bulzomi, R., Ruga, G., Bianconi, A., Torre, Enza, Rebora, A., Cecoli, F., Monti, E., Bonfadini, S., Dotti, S., Madaschi, S., Trevisan, R., Albizzi, M., Bellante, R., Corsi, Alessandro, Scaranna, C., De Cata, P., Liboa, F., Ghilotti, S., Tortato, E., Lanari, L., Turchi, F., Gabellieri, E., Lamacchia, O., Colucci, C., Mileti, G., Coluzzi, Simone, Carrieri, F., Rossetti, P., Anzaldi, Mauro, Di Benedetto, A., Ruggeri, D., Scatena, A., Ranchelli, A., Ragusa, I., Gregori, G., Crisci, I., Mori, Marco Ernesto, Baccetti, F., Anichini, R., Salutini, E., Vinci, C., Colletti, I., Zanon, M. S., Altomari, A., Bonora, B. M., Fadini, G, Buzzetti, R, Fittipaldi, M, D'Incau, F, Da Porto, A, Girelli, A, Simoni, L, Lastoria, G, Consoli, A, Iazzetta, N, Di Giovanni, G, Carbonara, O, Aragiusto, C, Carleo, D, Da Rosa, N, Martedi, E, Landolfi, L, Marracino, M, Tortora, A, De Morelli, G, Casarsa, V, Maddaloni, E, Siena, A, Pitocco, D, Tartaglione, L, Rizzi, A, Leonetti, F, Fasolo, M, Morsello, G, Bulzomi, R, Ruga, G, Bianconi, A, Torre, E, Rebora, A, Cecoli, F, Monti, E, Bonfadini, S, Dotti, S, Madaschi, S, Trevisan, R, Albizzi, M, Bellante, R, Corsi, A, Scaranna, C, De Cata, P, Liboa, F, Ghilotti, S, Tortato, E, Lanari, L, Turchi, F, Gabellieri, E, Lamacchia, O, Colucci, C, Mileti, G, Coluzzi, S, Carrieri, F, Rossetti, P, Anzaldi, M, Di Benedetto, A, Ruggeri, D, Scatena, A, Ranchelli, A, Ragusa, I, Gregori, G, Crisci, I, Mori, M, Baccetti, F, Anichini, R, Salutini, E, Vinci, C, Colletti, I, Zanon, M, Altomari, A, and Bonora, B

Subjects
Type&nbsp, Real-world evidence, Endocrinology, Diabetes and Metabolism, IDegLira, Basal bolus therapy (BB), Basal insulin analogue, Basal oral therapy (BOT), Glycated hemoglobin (HbA1c), Oral antidiabetic drugs (OADs), Rapid insulin analogue, Type 2 diabetes, Settore MED/13 - ENDOCRINOLOGIA, Type 2 diabete, Type 2 diabetes, Internal Medicine, 2 diabetes
Abstract

Introduction: IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). Methods: Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients’ baseline characteristics and the clinical reasons for IDegLira treatment initiation. Results: Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). Conclusions: IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients’ outcomes after IdegLira treatment under routine clinical care.

Published
2022

3. 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

Author

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

5. The Use of Dermal Substitute in the Treatment of Burns as a Complication of Type 2 Diabetes Mellitus and Diabetic Foot Syndrome.

Author

Tedeschi A, Salutini E, Cosentino C, Poggi CD, Becherini R, Fusilli D, and Anichini R

Abstract

Diabetic Foot Syndrome is a complex and challenging clinical condition associated with high risk of mortality and lower limb amputation. The distal lesions represent the epiphenomenon of this syndrome and request a multidisciplinary care and an appropriate therapeutic path to ensure their healing. This case report describes the management of burns in a patient with type 2 diabetes mellitus, end stage renal disease and Diabetic Foot Syndrome. The lesions were treated with autologous epidermal skin graft until healing. Products that stimulate or replace extracellular matrix, which has a central role in wound healing, can be consider in the treatment of burns and offer a simpler and less disabling reconstructive possibility for the patient., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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6. The Function of Bed Management in Pandemic Times-A Case Study of Reaction Time and Bed Reconversion.

Author

Barchielli C, Vainieri M, Seghieri C, Salutini E, and Zoppi P

Subjects
Humans, Hospital Bed Capacity, Pandemics, Reaction Time, Hospitals, COVID-19 epidemiology
Abstract

The last decade was characterized by the reduction in hospital beds throughout Europe. When facing the COVID pandemic, this has been an issue of major importance as hospitals were seriously overloaded with an unexpected growth in demand. The dichotomy formed by the scarcity of beds and the need for acute care was handled by the Bed Management (BM) function. This case study explores how BM was able to help the solidness of the healthcare system, managing hospital beds at best and recruiting others in different settings as intermediate care in a large Local Health Authority (LHA) in central Italy. Administrative data show how the provision of appropriate care was achieved by recruiting approximately 500 beds belonging to private healthcare facilities affiliated with the regional healthcare system and exercising the best BM function. The ability of the system to absorb the extra demand caused by COVID was made possible by using intermediate care beds, which were allowed to stretch the logistic boundaries of the hospitals, and by the promptness of Bed Management in converting beds into COVID beds and reconverting them, and by the timely management of internal patient logistics, thus creating space according to the healthcare demands.

Published
2023
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7. Photodynamic Topical Antimicrobial Therapy for Infected Diabetic Foot Ulcers in Patients With Diabetes: A Case Series.

Author

Brocco E, Curci V, Da Ros R, Miranda C, Boschetti G, Barone S, Tedeschi A, Salutini E, and Anichini R

Subjects
Administration, Topical, Anti-Bacterial Agents therapeutic use, Humans, Wound Healing, Anti-Infective Agents therapeutic use, Diabetes Mellitus, Diabetic Foot complications, Diabetic Foot diagnosis, Diabetic Foot drug therapy
Abstract

Diabetic foot ulcers (DFUs) are common, complex, costly complications, associated with frequent recurrences and increased morbidity and mortality. DFUs can be prevented and their healing can be mostly influenced by appropriately and aggressively managing any infection, but the role of antiseptic therapies in reducing healing time lacks sufficient evidence. Several therapeutic interventions have been developed based on the principles of photomedicine to overcome the issue of poor drug circulation in infected areas, with the aim of killing microbial agents while leaving the surrounding host cells unharmed. Such techniques use absorption of photons by specific chromophores. Among these, RLP068 is a tetracationic Zn(II) phthalocyanine derivative activated by exposure to red light, used as a topical treatment for superficial bacterial and fungal infections. The photoactivation of RLP068 results in the production of singlet oxygen and other reactive oxygen species, able to affect a range of cellular targets, including cell membrane and/or wall, cytoplasm, and cellular components, resulting in a rapid, broad range, bactericidal and fungicidal effect. The phase IIa study showed that photoactivated RPL068 is capable of inducing a dose-dependent reduction in total and pathogen microbial load in infected diabetic foot ulcers. In this article, a case series of 22 DFU treated with photoactivated RLP068 at 5 different centers in Italy is presented. Considering microbial agents reduction, ulcer healing facilitation, healing rate (9 DFUs out of 22), and amputation rate (only 1 case over 22), the decrease in the cost of DFU seems to be a point in favor of RLP068 and its cost-effectiveness.

Published
2022
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8. The Complexity of Diabetic Foot Management: From Common Care to Best Practice. The Italian Expert Opinion by Delphi Survey.

Author

Salutini E, Brocco E, Da Ros R, Monge L, Uccioli L, and Anichini R

Subjects
Amputation, Surgical methods, Amputation, Surgical statistics & numerical data, Consensus, Delphi Technique, Diabetes Complications diagnosis, Diabetes Complications epidemiology, Diabetes Complications prevention & control, Health Care Surveys, Humans, Italy epidemiology, Diabetic Foot diagnosis, Diabetic Foot economics, Diabetic Foot psychology, Diabetic Foot therapy, Early Diagnosis, Early Medical Intervention, Patient Care Management methods, Patient Care Management standards, Quality of Life
Abstract

Diabetic foot is a major public health issue, driven by diabetes complications (neuropathy, peripheral vascular disease, foot deformity, and abnormal leucocyte function), which may lead to leg amputation, thus resulting in severe disability, reduced quality of life, and high health costs. The prevention of diabetes complications and the early detection and proper management of diabetic foot wounds are the milestones to avoid major amputations. Unfortunately, in many areas, the prevention of diabetic foot lesions is inadequate and wounds may proceed toward infection and chronicity, with limb- and life-threatening results. Using the Delphi method, we conducted a survey on diabetic foot among Italian experts, selected across different Italian clinical centers. This method was used to achieve a consensus on current opinion and clinical leanings on the diagnosis and management of diabetic foot ulcers. Specifically, the aim of the survey was to evaluate the current management of the diabetic foot syndrome; highlight the differences in the approach among a group of experts; evaluate the role of wound bed preparation and antisepsis; and discuss any areas of disagreement in which evidences are sparse and the clinical judgment plays a crucial role in the decision-making process.

Published
2020
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9. Tapentadol Prolonged Release Reduces the Severe Chronic Ischaemic Pain and Improves the Quality of Life in Patients with Type 2 Diabetes.

Author

Tedeschi A, De Bellis A, Francia P, Bernini A, Perini M, Salutini E, and Anichini R

Subjects
Aged, Aged, 80 and over, Chronic Pain etiology, Delayed-Action Preparations, Female, Humans, Male, Middle Aged, Pain etiology, Pain Measurement, Phenols administration & dosage, Quality of Life, Tapentadol, Treatment Outcome, Analgesics therapeutic use, Chronic Pain drug therapy, Diabetes Mellitus, Type 2 complications, Diabetic Angiopathies complications, Pain drug therapy, Peripheral Arterial Disease complications, Phenols therapeutic use
Abstract

This study has been performed in diabetic type 2 patients with pain due to peripheral artery disease (PAD) in order to evaluate the efficacy and tolerability of tapentadol prolonged release (PR). Methods . 25 patients with type 2 diabetes (13 F and 12 M) were admitted in the study. The evaluation of the analgesic efficacy of tapentadol PR was based on both the assessment of the intensity of the pain (NRS scale from 0 to 10) and the nature of the pain (DN4 questionnaire) and on assessment of the patient's quality of life and state of health (SF-12 Health Survey). Study duration was 3 months: a baseline visit and follow-up included visits after 1 week, 1 month, 2 months, and 3 months. Results . At the beginning of the study, the mean intensity of the pain was 7.88 ± 1.17 on the NRS scale and at visit 2 it reduced in a statistically significant way; at the end of the treatment with tapentadol PR, the mean intensity was 2.84 points on the NRS scale. Conclusion . In type 2 diabetic patients with chronic severe pain due to PAD, tapentadol PR reduced pain intensity, improving the quality of life.

Published
2018
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10. Hospitalization for Charcot neuroarthropathy in diabetes: A population study in Italy.

Author

Anichini R, Policardo L, Lombardo FL, Salutini E, Tedeschi A, Viti S, Francia P, Brocco E, Maggini M, Seghieri G, and De Bellis A

Subjects
Aged, Aged, 80 and over, Amputation, Surgical, Arthropathy, Neurogenic epidemiology, Diabetic Foot epidemiology, Female, Hospitalization, Humans, Incidence, Italy epidemiology, Male, Middle Aged, Prevalence, Arthropathy, Neurogenic surgery, Diabetic Foot surgery
Abstract

Aims: To provide data on hospitalization and incidence rates of Charcot neuroarthropathy (CN) and its relation to lower limbs' amputations/revascularizations in population with diabetes of Italy as well as of one of its regions (Tuscany)., Methods: Hospitalizations with CN diagnosis (codes ICD-9-CM: 7130, 7135, 7138) have been recorded in people with diabetes over years 2003-2013 in Italy and 2008-2015 in Tuscany. Amputations, peripheral vascular disease, revascularizations and infections were likewise evaluated., Results: Between 2003 and 2013 CN hospitalizations were very infrequent in Italy ranging between 14×100,000 and 11×100,000 patients with diabetes. In Tuscany they declined to a minimum of 7×100,000 patients in 2015, after a previous increase to a maximum of 22×100,000 (p=NS for both). Yearly CN incidence remained constant in Italy, declining in Tuscany to a minimum of 3.4×100,000 diabetic patients in 2015 (p=0.047). CN patients were younger and with longer length of hospital stay than those with non-Charcot diabetic foot (p<0.05 for both). Amputation and infection rates were manifold higher in CN patients than in those with non-Charcot diabetic foot, while the revascularization rate was similar in both., Conclusions: Over last decade, in Italy and Tuscany yearly CN incidence and hospitalization rates concerned only a small percentage of patients, remaining constant over years and declining in Tuscany in the last couple of years. CN was significantly associated to younger age, longer hospital stay and greater risk of amputations and infections while the need of revascularization was similar to that of non-Charcot diabetic foot., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Published
2017
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11. Access to emergency room for hypoglycaemia in people with diabetes.

Author

Salutini E, Bianchi C, Santini M, Dardano A, Daniele G, Penno G, Miccoli R, and Del Prato S

Subjects
Adult, Aged, Aged, 80 and over, Ambulances, Emergency Service, Hospital, Female, Health Services Accessibility, Hospital Mortality, Humans, Hypoglycemia mortality, Italy, Length of Stay, Logistic Models, Male, Middle Aged, Diabetes Mellitus, Type 1 drug therapy, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemia chemically induced, Hypoglycemic Agents adverse effects, Insulin adverse effects, Sulfonylurea Compounds adverse effects
Abstract

Background: Hypoglycaemia is a major burden of the pharmacological therapy of diabetes and is associated with increased morbidity, mortality and treatment costs., Methods: We screened all admissions to the emergency room of the Pisa University Hospital from 1 January 2009 to 31 December 2013, selecting individuals with a discharge diagnosis of hypoglycaemia. We retrieved 500 admissions involving adult diabetic patients: age 71 ± 16 years; M/F 50.2/49.8%; 70.2% type 2 diabetes (T2DM)., Results: Among T2DM, 42.2% were on insulin, 10.8% on insulin plus oral anti-diabetes drugs and 38.2% on oral anti-diabetes drugs alone (92% sulphonylureas/glinides ± insulin-sensitizers). Glibenclamide was the most frequently used sulphonylurea (69%). Individuals treated with oral anti-diabetes drugs were older than those on insulin (79 ± 11 versus 74 ± 12 years; p < 0.0001). Among patients taking sulphonylurea, 47% had estimated glomerular filtration rate <60 mL/min/1.73 m(2) and 13.5% had <30 mL/min/1.73 m(2) . In-hospital admission occurred in 20% of cases. Hospitalized patients with T2DM were older than those discharged (80 ± 10 versus 76 ± 12 years, p < 0.01) and were on oral antidiabetic drugs in 54.8% of the cases, whereas 35.7% were on insulin (χ(2) , p < 0.0001) and 8.3% on combined therapy. Notably, 93.5% of those on oral anti-diabetic drugs were taking a secretagogue. Insulin-treated subjects were younger than those treated with oral anti-diabetic drugs alone (77 ± 12 versus 82 ± 7 years; p < 0.02). The mean in-hospital annual mortality rate was 85 deaths per 1000 patients-year., Conclusions: Our results support the recommendation that the risk associated with insulin and insulin-secretagogues should be carefully assessed, particularly when prescribed in vulnerable patients with T2DM., (Copyright © 2015 John Wiley & Sons, Ltd.)

Published
2015
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