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1. Adolescent Vulnerability to Heightened Emotional Reactivity and Anxiety After Brief Exposure to an Obesogenic Diet

Author

Johnny D. Figueroa, Matine Azadian, Julio David Vega-Torres, Arsenio L. Reyes-Rivera, Perla Ontiveros-Angel, and Raul Rios-Orsini

Subjects
diet-induced obesity, Physiology, Affect (psychology), Fear-potentiated startle, lcsh:RC321-571, fear-potentiated startle, 03 medical and health sciences, 0302 clinical medicine, Medicine, Fear conditioning, Prefrontal cortex, Reactivity (psychology), lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry, 030304 developmental biology, Original Research, 0303 health sciences, business.industry, General Neuroscience, PTSD, Extinction (psychology), CRHR1, medicine.disease, anxiety, Obesity, Anxiety, adolescence, medicine.symptom, business, 030217 neurology & neurosurgery, Neuroscience
Abstract

Background Emerging evidence demonstrates that diet-induced obesity disrupts corticolimbic circuits underlying emotional regulation. Studies directed at understanding how obesity alters brain and behavior are easily confounded by a myriad of complications related to obesity. This study investigated the early neurobiological stress response triggered by an obesogenic diet. Furthermore, this study directly determined the combined impact of a short-term obesogenic diet and adolescence on critical behavioral and molecular substrates implicated in emotion regulation and stress. Methods Adolescent (postnatal day 31) or adult (postnatal day 81) Lewis rats were fed for 1 week with an experimental Western-like high-saturated fat diet (WD, 41% kcal from fat) or a matched control diet (CD, 13% kcal from fat). We used the acoustic fear-potentiated startle (FPS) paradigm to determine the effects of the WD on cued fear conditioning and fear extinction. We used c-Fos mapping to determine the functional influence of the diet and stress on corticolimbic circuits. Results We report that 1-week WD consumption was sufficient to induce fear extinction deficits in adolescent rats, but not in adult rats. We identify fear-induced alterations in corticolimbic neuronal activation and demonstrate increased prefrontal cortex CRHR1 messenger RNA (mRNA) levels in the rats that consumed the WD. Conclusion Our findings demonstrate that short-term consumption of an obesogenic diet during adolescence heightens behavioral and molecular vulnerabilities associated with risk for anxiety and stress-related disorders. Given that fear extinction promotes resilience and that fear extinction principles are the foundation of psychological treatments for posttraumatic stress disorder (PTSD), understanding how obesogenic environments interact with the adolescent period to affect the acquisition and expression of fear extinction memories is of tremendous clinical relevance.

Published
2020
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2. Early maturational emergence of adult-like emotional reactivity and anxiety after brief exposure to an obesogenic diet

Author

Matine Azadian, Julio David Vega-Torres, Arsenio L. Reyes-Rivera, Johnny D. Figueroa, Perla Ontiveros-Angel, and Raul Rios-Orsini

Subjects
medicine.medical_specialty, business.industry, Extinction (psychology), Affect (psychology), medicine.disease, Obesity, Amygdala, Basal (phylogenetics), Endocrinology, medicine.anatomical_structure, Internal medicine, medicine, Anxiety, Fear conditioning, medicine.symptom, Prefrontal cortex, business
Abstract

BackgroundEmerging evidence demonstrates that diet-induced obesity disrupts corticolimbic circuits underlying emotional regulation. Studies directed at understanding how obesity alters brain and behavior are easily confounded by a myriad of complications related to obesity. This study investigated the early neurobiological stress response triggered by an obesogenic diet. Furthermore, this study directly determined the combined impact of a short-term obesogenic diet and adolescence on critical behavioral and molecular substrates implicated in emotion regulation and stress.MethodsAdolescent (postnatal day 31) or adult (postnatal day 81) Lewis rats were fed for one week with an experimental Western-like high-saturated fat diet (WD, 41% kcal from fat) or a matched control diet (CD, 13% kcal from fat). We used the acoustic fear-potentiated startle (FPS) paradigm to determine the effects of the WD on cued fear conditioning and fear extinction. We used c-Fos mapping to determine the functional influence of the diet and stress on corticolimbic circuits.ResultsWe report that one-week WD consumption was sufficient to induce fear extinction deficits in adolescent rats, but not in adult rats. We identify fear-induced alterations in corticolimbic neuronal activation and demonstrate increased prefrontal cortex CRHR1 mRNA levels in the rats that consumed the WD.ConclusionsOur findings demonstrate that short-term consumption of an obesogenic diet during adolescence heightens behavioral and molecular vulnerabilities associated with risk for anxiety and stress-related disorders. Given that fear extinction promotes resilience, and that fear extinction principles are the foundation of psychological treatments for PTSD, understanding how obesogenic environments interact with the adolescent period to affect the acquisition and expression of fear extinction memories is of tremendous clinical relevance.HIGHLIGHTSShort-term WD consumption during adolescence impairs cued fear extinction memory retention in a fear-potentiated startle paradigm.Short-term WD consumption during adolescence attenuates neuronal activation to electric footshock stress in the basomedial nuclei of the amygdala.Short-term WD consumption increases CRHR1 mRNA levels in the medial prefrontal cortex.Adult LEW rats exhibit increased basal HPA axis tone and heightened emotional reactivity to footshock stress relative to adolescent rats.

Published
2020
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3. Developmental regulation of fear memories by an obesogenic high-saturated fat/high-sugar diet

Author

Arsenio L. Reyes-Rivera, Julio David Vega-Torres, and Johnny D. Figueroa

Subjects
medicine.medical_specialty, business.industry, Saturated fat, Extinction (psychology), Affect (psychology), Endocrinology, Dopamine receptor D1, Dopamine receptor, Internal medicine, Medicine, Anxiety, Fear conditioning, medicine.symptom, business, Prefrontal cortex
Abstract

BackgroundAnxiety and stress-related disorders are strongly linked with obesity and the consumption of obesogenic diets. Paralleling clinical findings, we showed that the consumption of an obesogenic diet during adolescence disrupts the structural integrity of amygdalar and prefrontal cortex circuits underlying emotional responses to stress. These abnormalities were associated with a PTSD-like phenotype, including heightened stress reactivity to predator odor trauma, anxiety-like behaviors, and profound learning deficits. The present follow-up study investigates how an obesogenic diet alters aversion-related associative memories across adolescence.MethodsAdolescent Lewis rats were fed for eight weeks with an experimental Western-like high-saturated fat/high-sugar diet (WD, 41% kcal from fat) or a matched control diet (CD, 13% kcal from fat). Acoustic fear-potentiated startle (FPS) responses were assessed longitudinally at weeks 1, 4, and 8 after commencing the diets to determine the effects of the WD on cued fear conditioning, fear extinction learning, and fear extinction retention.ResultsWe found that the rats that consumed the WD exhibited substantial attenuation of fear extinction and fear extinction retention when remote memory was tested. One-week WD consumption was sufficient to induce impairments in fear extinction learning. This phenotype was associated with reduced dopamine receptor 1 mRNA levels in the prefrontal cortex. Interestingly, our reconditioning paradigm revealed that early-acquired fear memories were resistant to the disruptive effects of chronic WD consumption on cued fear learning.ConclusionsOur findings demonstrate that consumption of an obesogenic WD during adolescence heightens behavioral vulnerabilities associated with risk for anxiety and stress-related disorders. Given that fear extinction promotes resilience and that fear extinction principles are the foundation of psychological treatments for PTSD, understanding how obesity and obesogenic diets affect the acquisition and expression of fear extinction memories is of tremendous clinical relevance.HIGHLIGHTSAcute WD consumption impairs cued fear extinction learning in a fear-potentiated startle paradigm.WD consumption attenuates fear extinction memory retentionWD consumption during adolescence increases acoustic startle responsivity over timeChronic WD consumption decreases dopamine receptor D1 mRNA levels in the prefrontal cortex.

Published
2019
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5. A Case Series of Tessier 3, 4, 7 and Combined 4,7 Craniofacial Clefts

Author

Jomar S. Tinaza, Emmanuel Tadeus S. Cruz, Arsenio L. Pascual, and Karen Adiel D. Rances

Subjects
Orthodontics, Series (mathematics), Tessier Clefts No. 3, 4 and 7, oculoplasty, commisuroplasty, alar transpositional flap, canthopexy, business.industry, Medicine, Craniofacial, lcsh:Otorhinolaryngology, business, lcsh:RF1-547
Abstract

Objective: To report a case series of Tessier 3, 4, 7 and combined 4,7 craniofacial clefts, their clinical presentations, surgical approaches and outcomes in light of the current literature. Methods: Study Design: Case series Setting: Tertiary Government Hospital Subjects: 5 patients Results: Five patients aged 3 to 14-years-old with Tessier 3, 4 (2 cases), 7 and combined 4,7 were included in this study: Tessier 3 – medial orbitomaxillary cleft extending through the bony skeleton traversing obliquely across the lacrimal groove, Tessier 4 – median orbitomaxillary cleft traversing vertically thru the inferior eyelid, infraorbital rim and orbital floor extending to the lip between the philtral crest and the oral commissure (2 cases), Tessier 7 - macrostomia and cleft oral commissure, and combined Tessier 4 and 7, combining features described above. Four underwent 2- or 3-stage surgeries while 1 declined. Conclusion: Five craniofacial clefts were presented. Because of the varying patterns of craniofacial deformities, a series of surgical procedures, tailor-made for each individual were performed on four. Otolaryngologists who perform maxillofacial and cosmetic surgery should have good background knowledge about craniofacial defects and be familiar with the surgical approaches at their disposal to yield favorable results that are appropriate to their local contexts. Keywords: Tessier Clefts No. 3, 4 and 7, oculoplasty, commisuroplasty, alar transpositional flap, canthopexy

Published
2015
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6. 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, Ap, Rivellese, Aa, Squatrito, S, Giorda, Cb, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, Ac, 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, Ac, 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, IT) study group, Thiazolidinediones Or Sulfonylureas Cardiovascular Accidents Intervention Trial (TOSCA., Collaborators: Vaccaro O, Italian Diabetes Society., 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, Corsi, A, Dodesini, Ar, Reggiani, Gm, 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 MS, 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, Mr, Franzetti, I, Radin, R, Annunziata, F, Bonabello, La, 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, Mpa, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta GG, De Gregorio, A, D'Andrea, S, Giuliani, Ae, Polidoro, Wl, 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, Ml, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, Mc, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, Pm, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, Gv, Loi, C, Oldani, M, Bottalico, Ml, Pellegata, B, Bonomo, M, Menicatti, Lsm, Resi, V, Bertuzzi, F, Disoteo, Eo, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, Sm, Turco, Aa, Costagliola, L, Corte, Gd, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, Nc, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Babini, 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, Ks, Penno, G, Livraga, S, Calzoni, F, Mancastroppa, Glf, Corsini, E, Tedeschi, A, Gaglianò, Ms, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Di Bartolo, P, 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, Me, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, Ap, 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, Pc, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, Ml, Coletti, Mf, 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, Ce, Agrusta, M., Vaccaro, Olga, Masulli, Maria, Nicolucci, Antonio, Bonora, Enzo, Del Prato, Stefano, Maggioni, Aldo P, Rivellese, Angela A, Squatrito, Sebastiano, Giorda, Carlo B, Sesti, Giorgio, Mocarelli, Paolo, Lucisano, Giuseppe, Sacco, Michele, Signorini, Stefano, Cappellini, Fabrizio, Perriello, Gabriele, Babini, Anna Carla, Lapolla, Annunziata, Gregori, Giovanna, Giordano, Carla, Corsi, Laura, Buzzetti, Raffaella, Clemente, Gennaro, Di Cianni, Graziano, Iannarelli, Rossella, Cordera, Renzo, La Macchia, Olga, Zamboni, Chiara, Scaranna, Cristiana, Boemi, Massimo, Iovine, Ciro, Lauro, Davide, Leotta, Sergio, Dall'Aglio, Elisabetta, Cannarsa, Emanuela, Tonutti, Laura, Pugliese, Giuseppe, Bossi, Antonio C, Anichini, Roberto, Dotta, Francesco, Di Benedetto, Antonino, Citro, Giuseppe, Antenucci, Daniela, Ricci, Lucia, Giorgino, Francesco, Santini, Costanza, Gnasso, Agostino, De Cosmo, Salvatore, Zavaroni, Donatella, Vedovato, Monica, Consoli, Agostino, Calabrese, Maria, Di Bartolo, Paolo, Fornengo, Paolo, Riccardi, Gabriele, Maggioni, Aldo Pietro, D'Angelo, Federica, Giansanti, Roberto, Tanase, Laura, Lanari, Luigi, Testa, Ivano, Pancani, Francesca, Ranchelli, Anna, Vagheggi, Paolo, Scatona, Alessia, Fontana, Lucia, Laviola, Luigi, Tarantino, Lucia, Ippolito, Claudia, Gigantelli, Vittoria, Manicone, Mariangela, Conte, Eleonora, Trevisan, Roberto, Rota, Rossella, Corsi, Anna, Dodesini, Alessandro R., Reggiani, Giulio Marchesini, Montesi, Luca, Mazzella, Natalia, Forlani, Gabriele, Caselli, Chiara, Di Luzio, Raffaella, Mazzotti, Arianna, Aiello, Antimo, Barrea, Angelina, Musto, Antonio, D'Amico, Fiorentina, Sinagra, Tiziana, Longhitano, Sara, Trowpea, Vanessa, Sparti, Maria, Italia, Salvatore, Lisi, Enrico, Grasso, Giuseppe, Pezzino, Vincenzo, Insalaco, Federica, Carallo, Claudio, Scicchitano, Caterina, De Franceschi, Maria Serena, Calbucci, Giovanni, Ripani, Raffaella, Cuneo, Giacomo, Corsi, Simona, Giorda, Carlo B., Romeo, Francesco, Lesina, Annalisa, Comoglio, Marco, Bonetto, Caterina, Robusto, Anna, Nada, Elisa, Asprino, Vincenzo, Cetraro, Rosa, Impieri, Michelina, Lucchese, Giuseppe, Donnarumma, Giovanna, Tizio, Biagio, Lenza, Lazzaro, Paraggio, Pia, Tomasi, Franco, Dozio, Nicoletta, Scalambra, Egle, Mannucci, Edoardo, Lamanna, Caterina, Cignarelli, Mauro, Macchia, Olga La, Fariello, Stefania, Sorrentino, Maria Rosaria, Franzetti, Ivano, Radin, Raffaella, Annunziata, Francesca, Bonabello, Laura Affinito, Durante, Arianna, Dolcino, Mara, Gallo, Fiorenza, Mazzucchelli, Chiara, Aleo, Anna, Melga, Pierluigi, Briatore, Lucia, Maggi, Davide, Storace, Daniela, Cecoli, Francesca, D'Ugo, Ercole, Pupillo, Mario, Baldassarre, Maria Pompea Antonia, Salvati, Filippo, Minnucci, Anita, De Luca, Angelo, Zugaro, Antonella, Santarelli, Livia, Bosco, Angela, Petrella, Vittorio, La Verghetta, Grazia Giovanna, De Gregorio, Antonella, D'Andrea, Settimio, Giuliani, Anna Elisa, Polidoro, W. Lorella, Sperandio, Alessandra, Sciarretta, Filomena, Pezzella, Alfonso, Carlone, Angela, Potenziani, Stella, Venditti, Chiara, Foffi, Chiara, Carbone, Salvatore, Cipolloni, Laura, Moretti, Chiara, Leto, Gaetano, Serra, Rosalia, Petrachi, Francesca, Romano, Isabella, Lacaria, Emilia, Russo, Laura, Goretti, Chiara, Sannino, Claudia, Dolci, Maria, Bruselli, Laura, Mori, Mary L., Baccetti, Fabio, Del Freo, Maria, Cucinotta, Domenico, Giunta, Loretta, Ruffo, Maria Concetta, Cannizzaro, Desiree, Pintaudi, Basilio, Perrone, Giovanni, Pata, Pietro, Ragonese, Francesco, Lettina, Gabriele, Mancuso, Teresa, Coppolino, Aldo, Piatti, Pier Marco, Monti, Lucilla, Stuccillo, Michela, Lucotti, Pietro, Setola, Manuela, Crippa, Giulia Valentina, Loi, Cinzia, Oldani, Matteo, Bottalico, Maria Luisa, Pellegata, Beatrice, Bonomo, Matteo, Menicatti, Laura Silvia Maria, Resi, Veronica, Bertuzzi, Federico, Disoteo, Eugenia Olga, Pizzi, Gianluigi, Rivellese, Angela Albarosa, Annuzzi, Giovanni, Capaldo, Brunella, Nappo, Rossella, Auciello, Stefania Michela, Turco, Anna Amelia, Costagliola, Lucia, Corte, Giuseppina Della, Vallefuoco, Pasquale, Nappi, Francesca, Vitale, Marilena, Cocozza, Sara, Ciano, Ornella, Massimino, Elena, Garofalo, Nadia, Avogaro, Angelo, Guarneri, Gabriella, Fedele, Domenico, Sartor, Giovanni, Chilelli, Nino Cristiano, Burlina, Silvia, Bonsembiante, Barbara, Galluzzo, Aldo, Torregrossa, Vittoria, Mancastroppa, Giovanni, Arsenio, Leone, Cioni, Federico, Caronna, Silvana, Papi, Matteo, Babini, Massimiliano, Santeusanio, Fausto, Calagreti, Gioia, Timi, Alessia, Tantucci, Alice, Marino, Cecilia, Ginestra, Federica, Di Biagio, Rosamaria, Taraborelli, Merilda, Miccoli, Roberto, Bianchi, Cristina, Garofolo, Monia, Politi, Konstantina Savina, Penno, Giuseppe, Livraga, Stefania, Calzoni, Fabio, Mancastroppa, Giovanni Luigi Francesco, Corsini, Elisa, Tedeschi, Anna, Gaglianã², Maria Sole, Ippolito, Giulio, Salutini, Elisabetta, Cervellino, Francesco, Natale, Maria, Salvatore, Vita, Zampino, Armando, Sinisi, Rosa, Arcangeli, Adolfo, Zogheri, Alessia, Guizzotti, Sandra, Longo, Rossella, Pellicano, Francesca, Scolozzi, Patrizia, Termine, Simona, Luberto, Alessandra, Ballardini, Giorgio, Trojani, Cristina, Mazzuca, Paolo, Bruglia, Matteo, Ciamei, Monica, Genghini, Silvia, Zannoni, Chiara, Vitale, Martina, Rangel, Graziela, Salvi, Laura, Zappaterreno, Alessandra, Cordone, Samantha, Simonelli, Paola, Meggiorini, Marilla, Frasheri, Aurora, Di Pippo, Clelia, Maglio, Cristina, Mazzitelli, Giulia, Rinaldi, Maria Elena, Galli, Angelica, Romano, Maria, D'Angelo, Paola, Suraci, Concetta, Bacci, Simonetta, Palena, Antonio Pio, Genovese, Stefano, Mancino, Monica, Rondinelli, Maurizio, Capone, Filippo, Calabretto, Elisabetta, Bulgheroni, Monica, Bucciarelli, Loredana, Ceccarelli, Elena, Fondelli, Cecilia, Santacroce, Clorinda, Guarino, Elisa, Nigi, Laura, Lalli, Carlo, Di Vizia, Giovanni, Scarponi, Maura, Montani, Valeria, Di Bernardino, Paolo, Romagni, Paola, Dolcetti, Katia, Forte, Elisa, Tamburo, Lucilla, Perin, Paolo Cavallo, Prinzis, Tania, Gruden, Gabriella, Bruno, Graziella, Zucco, Chiara, Perotta, Massimo, Marena, Saverio, Monsignore, Simona, Panero, Francesco, Ponzi, Fulvia, Bossi, Antonio Carlo, Carpinteri, Rita, Casagrande, Maria Linda, Coletti, Maria Francesca, Balini, Annalisa, Filopanti, Marcello, Madaschi, Sara, Pulcina, Anna, Grimaldi, Franco, Venturini, Giorgio, Agus, Sandra, Pagnutti, Stefania, Guidotti, Francesca, Cavarape, Alessandro, Cigolini, Massimo, Pichiri, Isabella, Brangani, Corinna, Fainelli, Giulia, Tomasetto, Elena, Zoppini, Giacomo, Galletti, Anna, Perrone, Dominica, Capra, Claudio, Bianchini, Francesca, Ceseri, Martina, Di Nardo, Barbara, Sasso, Elisa, Bartolomei, Barbara, Suliman, Irina, Fabbri, Gianna, Romano, Geremia, Maturo, Nicola, Nunziata, Giuseppe, Capobianco, Giuseppe, De Simone, Giuseppina, Villa, Valeria, Rota, Giuseppe, Pentangelo, Carmine, Carbonara, Ornella, Caiazzo, Gennaro, Cutolo, Michele, Sorrentino, Tommasina, Mastrilli, Valeria, Amelia, Umberto, Masi, Stefano, Corigliano, Gerardo, Gaeta, Iole, Armentano, Vincenzo, Calatola, Pasqualino, Capuano, Gelsomina, Angiulli, Bruno, Auletta, Pasquale, Petraroli, Ettore, Iodice, Cinzia E., Agrusta, Mariano, 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, di Bartolo, Paolo, Polidoro, w Lorella, Sartore, Giovanni, and Gaglianò, Maria Sole

Subjects
Male, Diabetes and Metabolism, ipoglycemic drugs, cardiovascualr event, Settore MED/09 - Medicina Interna, endocrine system diseases, IMPACT, pioglitazone versus sulfonylureas, Endocrinology, Diabetes and Metabolism, GLIMEPIRIDE, Diabetes, cardiovascular events, metformin, pioglitazone, sulphonylureas, Type 2 diabetes, 030204 cardiovascular system & hematology, Internal Medicine, Endocrinology, law.invention, Settore MED/13 - Endocrinologia, Glibenclamide, 0302 clinical medicine, Randomized controlled trial, law, GLYCEMIC CONTROL, Gliclazide, Internal medicine, diabetes and metabolism, RISK, education.field_of_study, diabetes, Incidence, endocrinology, diabetes and metabolism, endocrinology, Middle Aged, INSULIN, Metformin, Treatment Outcome, Editorial, sulphonylureas, Cardiovascular Diseases, Combination, Drug Therapy, Combination, Female, Type 2, medicine.drug, medicine.medical_specialty, Population, 030209 endocrinology & metabolism, Aged, Diabetes Mellitus, Type 2, Humans, Hypoglycemic Agents, Pioglitazone, Sulfonylurea Compounds, Thiazolidinediones, Cardiovascular events, 03 medical and health sciences, GLUCOSE-LOWERING DRUGS, Drug Therapy, Diabetes Mellitus, medicine, sulfonylureas, education, TOSCA.IT, business.industry, MORTALITY, nutritional and metabolic diseases, Insulin resistance, medicine.disease, Surgery, Glimepiride, business, FOLLOW-UP
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 per 100 person-years) who were given sulfonylureas (hazard ratio 0·96, 95% CI 0·74–1·26, p=0·79). Fewer patients had hypoglycaemias in the pioglitazone group than in the sulfonylureas group (148 [10%] vs 508 [34%], p

Published
2017
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7. Addition of either pioglitazone or a sulfonylurea in type 2 diabetic patients inadequately controlled with metformin alone: impact on cardiovascular events. A randomized controlled trial

Author

Vaccaro, O, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, IT study group, T. O. S. C. A., Sud, Cm, Imbaro, S, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, S, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, G, Rizzo, Mr, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, Francesco, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini, M., Vaccaro, O1, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, Collaborators Riccardi G, T. O. S. C. A. IT study g. r. o. u. p., Sud, Cm, Imbaro, S, Vaccaro, O, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, Sandro, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, Giuseppe, Rizzo, Maria Rosaria, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, F, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini M., Author information, Vaccaro, Olga, Masulli, Maria, Rivellese, ANGELA ALBAROSA, Riccardi, Gabriele, Giorda, C, Maggioni, A, Rivellese, A, Giorda, CB, Maggioni, AP, and Rivellese, AA

Subjects
Blood Glucose, Male, BIO/12 - BIOCHIMICA CLINICA E BIOLOGIA MOLECOLARE CLINICA, Endocrinology, Diabetes and Metabolism, pioglitazone, sulfonylurea, type 2 diabetes, metformin, cardiovascular events, Medicine (miscellaneous), Type 2 diabetes, Settore MED/13 - Endocrinologia, Body Mass Index, law.invention, Randomized controlled trial, Risk Factors, law, Surveys and Questionnaires, Cardiovascular Disease, pioglitazone, piogllitazone, Stroke, Diabetes, Therapy, Pioglitazone, Nutrition and Dietetics, Diabetes, Thiazolidinedione, cardiovascular events, Type 2 Diabetes Mellitus, sulphonylureas, Middle Aged, Metformin, Sulfonylurea Compound, Treatment Outcome, Tolerability, Cardiovascular Diseases, Drug Therapy, Combination, Female, type 2 diabetes, Cardiology and Cardiovascular Medicine, Human, medicine.drug, medicine.medical_specialty, Endpoint Determination, sulfonylurea, cardiovascualr event, Sudden death, Follow-Up Studie, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, sulfonylureas, interventio trial, randomized controlled trial, Aged, Hypoglycemic Agent, Questionnaire, business.industry, Risk Factor, medicine.disease, Surgery, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, Quality of Life, Thiazolidinediones, Therapy, business, metformin, Pioglitazone, Follow-Up Studies
Abstract

Background and aims Metformin is the first-line therapy in type 2 diabetes. In patients inadequately controlled with metformin, the addition of a sulfonylurea or pioglitazone are equally plausible options to improve glycemic control. However, these drugs have profound differences in their mechanism of action, side effects, and impact on cardiovascular risk factors. A formal comparison of these two therapies in terms of cardiovascular morbidity and mortality is lacking. The TOSCA.IT study was designed to explore the effects of adding pioglitazone or a sulfonylurea on cardiovascular events in type 2 diabetic patients inadequately controlled with metformin. Methods Multicentre, randomized, open label, parallel group trial of 48 month duration. Type 2 diabetic subjects, 50–75 years, BMI 20–45 Kg/m 2 , on secondary failure to metformin monotherapy will be randomized to add-on a sulfonylurea or pioglitazone. The primary efficacy outcome is a composite endpoint of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned coronary revascularization. Principal secondary outcome is a composite ischemic endpoint of sudden death, fatal and non-fatal myocardial infarction and stroke, endovascular or surgical intervention on the coronary, leg or carotid arteries, major amputations. Side effects, quality of life and economic costs will also be evaluated. Efficacy, safety, tolerability, and study conduct will be monitored by an independent Data Safety Monitoring Board. End points will be adjudicated by an independent external committee. Conclusions TOSCA.IT is the first on-going study investigating the head-to-head comparison of adding a sulfonylurea or pioglitazone to existing metformin treatment in terms of hard cardiovascular outcomes. Registration: Clinicaltrials.gov ID NCT00700856.

Published
2012

8. Omitting side-holes in biliary stents does not improve drainage of the obstructed biliary system: A prospective randomized trial

Author

S.C.Sydney Chung, Arsenio L. Co, Arthur K.C. Li, Chi-Ping Tsui, and Joseph J.Y. Sung

Subjects
Male, medicine.medical_specialty, Surface Properties, Common Bile Duct Diseases, medicine.medical_treatment, Lumen (anatomy), Hepatic Duct, Common, System a, law.invention, Randomized controlled trial, Recurrence, law, medicine, Humans, Radiology, Nuclear Medicine and imaging, Prospective Studies, cardiovascular diseases, Clinical efficacy, Aged, Cholestasis, business.industry, Gastroenterology, Stent, Bilirubin, Equipment Design, Cholestasis, Extrahepatic, Alkaline Phosphatase, equipment and supplies, Surgery, surgical procedures, operative, medicine.anatomical_structure, Biliary tract, Duodenum, Drainage, Biliary stent, Female, Stents, Polyethylenes, business, Follow-Up Studies
Abstract

Sludge, which occludes biliary stents, forms mainly around the side-holes of such stents. It has been reported that omitting the side-holes results in less sludge formation and theoretically improves drainage. To compare the clinical efficacy of biliary stents with and without side-holes, we randomized patients with malignant or benign strictures to receive 10FG polyethylene stents either with side-holes (SH) or without side-holes (NSH). The patients were seen at 4, 12, 20, and 28 weeks after stenting for symptom evaluation and serum liver enzyme and bilirubin assays. The stents were replaced only when clinical symptoms of cholangitis developed. Each group included 35 patients. The mean age of patients in the SH group was 68 years, and the ratio of men to women was 1:1.3. In the NSH group, the mean age of patients was 67 years, and the ratio of men to women was 1:1.4. Eight patients with SH stents and eight with NSH stents died before the stents were removed; two NSH stents migrated into the duodenum. During a mean follow-up period of 8.1 weeks (range, 1.1 to 28 weeks for the SH group and 0.6 to 28 weeks for the NSH group), 18 stents were found to be occluded in the SH group and 17 in the NSH group. The median time before total occlusion was 7.8 weeks (range, 2.6 to 28) for SH stents and 7.9 weeks (range, 0.6 to 28) for NSH stents ( p > 0.1, NS). The occluded stents removed from these patients were freeze-dried and weighed to quantitate the sludge blocking the stent lumen. The mean (± SD) weight gain for SH stents was 4.0 ± 1.7 mg/cm and for NSH stents 4.3 ± 2.2 mg/cm ( p > 0.1, NS). In conclusion, the benefits of omitting side-holes in polyethylene stents used in the treatment of obstructive jaundice cannot be substantiated. (Gastrointest Endosc 1994;40:321-5.)

Published
1994
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10. Web-based learning: a complementary approach to standard teachnig schemes

Author

Martins, L., Arsenio, L., and Ruano, Antonio

Subjects
Internet, Neural Networks, Teaching, WWW
Abstract

Web Based Learning is increasingly attracting the interest of several teaching Institutions. It provides mechanisms for improving the conventional learning process, and also allows the opportunity for reaching new students, throughout the world, by just using an Internet connection. This paper describes the objectives of an Europeanfunded project in this area, the features found in current Web-design tools, and our own first experiences within this new teaching scheme.

Published
1998

11. Intravenous ciprofloxacin as treatment for patients with acute suppurative cholangitis: a randomized, controlled clinical trial

Author

Augustine F. B. Cheng, Arsenio L. Co, Arthur K.C. Li, Joseph J.Y. Sung, S.C.Sydney Chung, Donald J. Lyon, Joseph Leung, and R. Suen

Subjects
Microbiology (medical), Male, medicine.medical_specialty, medicine.drug_class, Cholangitis, medicine.medical_treatment, Antibiotics, Microbial Sensitivity Tests, Gastroenterology, Double-Blind Method, Ciprofloxacin, Internal medicine, medicine, Bile, Humans, Pharmacology (medical), Prospective Studies, Biliary Tract, Antibacterial agent, Aged, Pharmacology, Chemotherapy, Bacteria, business.industry, Suppurative cholangitis, medicine.disease, Surgery, Metronidazole, Infectious Diseases, Biliary tract, Bacteremia, Acute Disease, Injections, Intravenous, Drainage, Female, business, medicine.drug
Abstract

One hundred consecutive patients with acute suppurative cholangitis were randomized in a prospective, controlled clinical trial to receive either ciprofloxacin (200 mg bd iv) or triple therapy comprising ceftazidime (1 g bd iv), ampicillin (500 mg qds iv) and metronidazole (500 mg tds iv) ; 46 and 44 patients in the ciprofloxacin and triple therapy groups respectively were suitable for inclusion in the analysis of efficacy. In two-thirds of the patients biliary obstruction was caused by ductal calculi and in one-third by malignant or benign strictures of the biliary tract. Bacteraemia was documented in 38% of patients in the ciprofloxacin group and in 34% of patients in the triple therapy group, while bile cultures were positive in 87% and 92% of patients in the ciprofloxacin and triple therapy groups respectively. Escherichia coli, Klebsiella spp. and Enterococcus spp. were the most common biliary isolates. Eighty-five per cent of evaluable patients in the ciprofloxacin group and 77% of those in the triple therapy group responded to therapy. The mean durations of fever, septicaemic shock and hospitalization were also similar in the two treatment groups. Six (13%) patients in the ciprofloxacin group and seven (16%) in the triple therapy group required urgent endoscopy or surgery for uncontrolled infection. Recurrence of fever after an initial response was documented in one (2%) patient receiving ciprofloxacin and in three (7%) patients receiving triple therapy. The incidences of mortality were 4% in the ciprofloxacin group and 2% in the triple therapy group. The results of this study suggest that ciprofloxacin alone is adequate empirical therapy for patients with cholangitis.

Published
1995

12. The future and prospect of the Association of Southeast Asian Nations

Author

Tecson, Arsenio L., Olsen, Edward A., Buss, Claude A., Naval Postgraduate School, and International Resource Planning and Management

Subjects
International Resource Planning and Management
Abstract

The Association of Southeast Asian Nations (ASEAN) has been in existence for more than 25 years. Its member nations, (Brunei, Indonesia, Malaysia, the Philippines, Singapore, and Thailand) have emphasized the role of the association as a neutral organization based on cooperation among members in the spirit of equality and partnership that would bring mutual benefits and stimulate solidarity which can contribute to building the foundation of peace, stability, and prosperity in the ASEAN region in particular and the world in general. With the end of the Cold War and the collapse of the. Soviet Union, this thesis will try to examine the relevance of ASEAN's original intention in the formation of the organization. With the 2uncertainty of the US military presence in the region, Japan's growing military capabilities, China's continuous military modernization, and other developments in the region, is it necessary for the ASEAN to be transformed into a defense and security alliance? Is the ASEAN capable of forming a military defense pact? Finally, this thesis will examine the future and prospect of the ASEAN as a regional organization http://archive.org/details/thefuturendprosp1094528242 Colonel, Philippine Army Approved for public release; distribution is unlimited.

Published
1994

13. Effect of iodine administration on thyroid function in diabetic patients

Author

Elio Roti, Strata A, Angelo Gnudi, G. Robuschi, Cavalli Sforza Lt, Arsenio L, and Emanuele R

Subjects
Male, endocrine system, medicine.medical_specialty, endocrine system diseases, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Tolbutamide, Thyroid Gland, chemistry.chemical_element, Thyrotropin, Iodine, Endocrinology, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Humans, Insulin, Drug Interactions, Aged, business.industry, Potassium Iodide, General Medicine, medicine.disease, Thyroxine, Diabetes Mellitus, Type 1, chemistry, Basal (medicine), Diabetes Mellitus, Type 2, Triiodothyronine, Female, Thyroid function, business, Antithyroid Effect, Hormone, medicine.drug
Abstract

Iodide-induced hypothyroidism has been observed in subjects treated with compounds with mild antithyroid activity. The hypoglycemic agent tolbutamide belongs to the aminoheterocyclic group, a class of compounds with antithyroid effect. Thus it was thought interesting to study the effect of large doses of iodide on thyroid function in diabetics chronically treated with tolbutamide. Basal thyroid function as assessed by clinical examination and iodothyronine and TSH concentrations was normal in all patients. Furthermore, in diabetics treated with tolbutamide, hormone concentrations were not different from those of patients treated with insulin or diet. Serum T4, T3 and TSH did not show any significant variation throughout the investigation period. Our results suggest that thyroid function is not affected by chronic treatment with tolbutamide even when large doses of iodide are administered.

Published
1984

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