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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. Insulin resistance, diabetic kidney disease, and all-cause mortality in individuals with type 2 diabetes: a prospective cohort study

Author

Penno, G, Solini, A, Orsi, E, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Zerbini, G, Lamacchia, O, Nicolucci, A, Pugliese, G, Laviola, L, Penno G., Solini A., Orsi E., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Zerbini G., Lamacchia O., Nicolucci A., Pugliese G., Laviola L., Penno, G, Solini, A, Orsi, E, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Zerbini, G, Lamacchia, O, Nicolucci, A, Pugliese, G, Laviola, L, Penno G., Solini A., Orsi E., Bonora E., Fondelli C., Trevisan R., Vedovato M., Cavalot F., Zerbini G., Lamacchia O., Nicolucci A., Pugliese G., and Laviola L.

Abstract

Background: It is unclear whether insulin resistance (IR) contributes to excess mortality in patients with type 2 diabetes independent of diabetic kidney disease (DKD), which is strongly associated with IR and is a major risk factor for cardiovascular disease (CVD), the main cause of death in these individuals. We tested this hypothesis in patients with type 2 diabetes from the Renal Insufficiency And Cardiovascular Events Italian Multicentre Study. Methods: This observational, prospective, cohort study enrolled 15,773 patients with type 2 diabetes attending 19 Italian Diabetes Clinics in 2006–2008. Insulin sensitivity was assessed as estimated glucose disposal rate (eGDR), which was validated against the euglycaemic-hyperinsulinemic clamp technique. Vital status on October 31, 2015, was retrieved for 15,656 patients (99.3%). Participants were stratified by eGDR tertiles from T1 (≥ 5.35 mg/kg/min) to T3 (≤ 4.14 mg/kg/min, highest IR). Results: CVD risk profile was worse in T2 and T3 vs T1. eGDR tertiles were independently associated with micro- and macroalbuminuria and the albuminuric DKD phenotypes (albuminuria with preserved or reduced estimated glomerular filtration rate [eGFR]) as well as with eGFR categories or the nonalbuminuric DKD phenotype. Over a 7.4-year follow-up, unadjusted death rates and mortality risks increased progressively across eGDR tertiles, but remained significantly elevated after adjustment only in T3 vs T1 (age- and gender- adjusted death rate, 22.35 vs 16.74 per 1000 person-years, p < 0.0001, and hazard ratio [HR] adjusted for multiple confounders including DKD, 1.140 [95% confidence interval [CI], 1.049–1.238], p = 0.002). However, eGDR was independently associated with mortality in participants with no DKD (adjusted HR, 1.214 [95% CI, 1.072–1.375], p = 0.002) and in those with nonalbuminuric DKD (1.276 [1.034–1.575], p = 0.023), but not in those with the albuminuric DKD phenotypes. Moreover, the association was stronger in males and i

Published
2021

3. Body mass index versus surrogate measures of central adiposity as independent predictors of mortality in type 2 diabetes

Author

Orsi, E, Solini, A, Penno, G, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Lamacchia, O, Haxhi, J, Nicolucci, A, Pugliese, G, Orsi, Emanuela, Solini, Anna, Penno, Giuseppe, Bonora, Enzo, Fondelli, Cecilia, Trevisan, Roberto, Vedovato, Monica, Cavalot, Franco, Lamacchia, Olga, Haxhi, Jonida, Nicolucci, Antonio, Pugliese, Giuseppe, Orsi, E, Solini, A, Penno, G, Bonora, E, Fondelli, C, Trevisan, R, Vedovato, M, Cavalot, F, Lamacchia, O, Haxhi, J, Nicolucci, A, Pugliese, G, Orsi, Emanuela, Solini, Anna, Penno, Giuseppe, Bonora, Enzo, Fondelli, Cecilia, Trevisan, Roberto, Vedovato, Monica, Cavalot, Franco, Lamacchia, Olga, Haxhi, Jonida, Nicolucci, Antonio, and Pugliese, Giuseppe

Abstract

Background: An “obesity paradox” for mortality has been shown in chronic disorders such as diabetes, and attributed to methodological bias, including the use of body mass index (BMI) for obesity definition. This analysis investigated the independent association of BMI versus surrogate measures of central adiposity with all-cause mortality in individuals with type 2 diabetes. Methods: The Renal Insufficiency And Cardiovascular Events Italian Multicentre Study is a prospective cohort study that enrolled 15,773 patients in 19 Italian centres in 2006–2008. Exposures were BMI and the surrogate measures of central adiposity waist circumference (WC), waist-to-height ratio (WHtR), and A Body Shape Index (ABSI). Vital status was retrieved on 31 October 2015 for 15,656 patients (99.3%), Results: Age- and sex-adjusted hazard ratios and 95% confidence intervals were significantly higher in BMI-based underweight (1.729 [1.193–2.505), P = 0.004), moderately obese (1.214 [1.058–1.392), P = 0.006) and severely obese (1.703 [1.402–2.068), P < 0.0001), lower in overweight (0.842 [0.775–0.915), P < 0.0001) and similar in mildly obese (0.950 [0.864–1.045), P = 0.292), compared to normal-weight individuals. When further adjusting for smoking, physical activity (PA), and comorbidities, risk was lower also in mildly obese versus normal-weight patients. The BMI-mortality relationship did not change after sequentially excluding ever smokers, individuals with comorbidities, and those died within two years from enrollment and when analyzing separately participants below and above the median age. Conversely, a paradox relationship was observed among inactive/moderately inactive, but not moderately/highly active patients. Mortality risk adjusted for age, gender, smoking, PA and comorbidities was significantly higher in the highest tertile of WC (1.279 [1.089–1.501], P = 0.003), WHtR (1.372 [1.165–1.615], P < 0.0001), and ABSI (1.263 [1.067–1.495], P = 0.007) versus the lowest tertile.

Published
2022

4. Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

Author

Lepore, G, Bonfanti, R, Bozzetto, L, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Laviola, L, Rabbone, I, Schiaffini, R, Bruttomesso, D, Mammi, F, Bruzzese, M, Schettino, M, Nuzzo, M, Fresa, R, Lambiase, C, Zanfardino, A, Confetto, S, Annuzzi, G, Alderisio, A, Riccardi, G, Gentile, S, Marino, G, Guarino, G, Zucchini, S, Maltoni, G, Suprani, T, Graziani, V, Nizzoli, M, Acquati, S, Cavani, R, Romano, S, Michelini, M, Manicardi, E, Bonadonna, R, Dei Cas, A, Dall'Aglio, E, Papi, M, Riboni, S, Manicardi, V, Pugni, V, Lasagni, A, Street, M, Pagliani, U, Rossi, C, Assaloni, R, Brunato, B, Tortul, C, Zanette, G, Li Volsi, P, Zanatta, M, Tonutti, L, Agus, S, Pellegrini, M, Ceccano, P, Pozzilli, G, Anguissola, B, Buzzetti, R, Moretti C, C, Leto, G, Pozzilli, P, Manfrini, S, Maurizi, A, Leotta, S, Altomare, M, Abbruzzese, S, Carletti, S, Suraci, C, Filetti, S, Manca Bitti, M, Arcano, S, Cavallo, M, De Bernardinis, M, Pitocco, D, Caputo, S, Rizzi, A, Manto, A, Cappa, M, Benevento, D, Frontoni, S, Malandrucco, I, Morano, S, Filardi, T, Lauro, D, Marini, M, Castaldo, E, Sabato, D, Tuccinardi, F, Forte, E, Viterbori, P, Arnaldi, C, Minuto, N, D'Annunzio, G, Corsi, A, Rota, R, Scaranna, C, Trevisan, R, Valentini, U, Bonfadini, S, Zarra, E, Plebani, A, Prandi, E, Felappi, B, Rocca, A, Meneghini, E, Galli, P, Ruggeri, P, Carrai, E, Fugazza, L, Baggi, V, Conti, D, Bosi, E, Laurenzi, A, Caretto, A, Molinari, C, Orsi, E, Grancini, V, Resi, V, Favalli, V, Bonura, C, Rigamonti, A, Bonomo, M, Bertuzzi, F, Pintaudi, B, Disoteo, O, Perseghin, G, Perra, S, Chiovato, L, De Cata, P, Zerbini, F, Lovati, E, Laneri, M, Guerraggio, L, Bossi, A, De Mori, V, Galetta, M, Meloncelli, I, Aiello A, A, Di Vincenzo, S, Nuzzi, A, Fraticelli, E, Ansaldi, E, Battezzati, M, Lombardi, M, Balbo, M, Lera, R, Secco, A, De Donno, V, Cadario, F, Savastio, S, Ponzani, C, Aimaretti, G, Ignaccolo, G, Tinti, D, Cerutti, F, Bari, F, Giorgino, F, Piccinno, E, Zecchino, O, Cignarelli, M, Lamacchia, O, Picca, G, De Cosmo, S, Rauseo, A, Tomaselli, L, Tumminia, A, Egiziano, C, Scarpitta, A, Maggio, F, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Scorsone, A, Scatena, A, Gregori, G, Lucchesi, S, Gadducci, F, Di Cianni, S, Pancani, S, Del Prato, S, Aragona, M, Crisci, I, Calianno, A, Fattor, B, Crazzolara, D, Reinstadler, P, Longhi, S, Incelli, G, Rauch, S, Romanelli, T, Orrasch, M, Cauvin, V, Franceschi, R, Lalli, C, Pianta, A, Marangoni, A, Arico, C, Marin, N, Nogara, N, Simioni, N, Filippi, A, Gidoni Guarneri, G, Contin, M, Decata, A, Bondesan, L, Confortin, L, Coracina, A, Lombardi, S, Costa Padova, S, Cipponeri, E, Scotton, R, Galasso, S, Boscari, F, Zanon, M, Vinci, C, Lisato, G, Gottardo, L, Bonora, E, Trombetta, M, Negri, C, Brangani, C, Maffeis, C, Sabbion, A, Marigliano, M, Lepore G., Bonfanti R., Bozzetto L., Di Blasi V., Girelli A., Grassi G., Iafusco D., Laviola L., Rabbone I., Schiaffini R., Bruttomesso D., Mammi F., Bruzzese M., Schettino M., Nuzzo M. G., Fresa R., Lambiase C., Zanfardino A., Confetto S., Annuzzi G., Alderisio A., Riccardi G., Gentile S., Marino G., Guarino G., Zucchini S., Maltoni G., Suprani T., Graziani V., Nizzoli M., Acquati S., Cavani R., Romano S., Michelini M., Manicardi E., Bonadonna R., Dei Cas A., Dall'aglio E., Papi M., Riboni S., Manicardi V., Pugni V., Lasagni A., Street M. E., Pagliani U., Rossi C., Assaloni R., Brunato B., Tortul C., Zanette G., Li Volsi P., Zanatta M., Tonutti L., Agus S., Pellegrini M. A., Ceccano P., Pozzilli G., Anguissola B., Buzzetti R., Moretti C C., Leto G., Pozzilli P., Manfrini S., Maurizi A. R., Leotta S., Altomare M., Abbruzzese S., Carletti S., Suraci C., Filetti S., Manca Bitti M. L., Arcano S., Cavallo M. G., De Bernardinis M., Pitocco D., Caputo S., Rizzi A., Manto A., Cappa M., Benevento D., Frontoni S., Malandrucco I., Morano S., Filardi T., Lauro D., Marini M. A., Castaldo E., Sabato D., Tuccinardi F., Forte E., Viterbori P., Arnaldi C., Minuto N., d'Annunzio G., Corsi A., Rota R., Scaranna C., Trevisan R., Valentini U., Bonfadini S., Zarra E., Plebani A., Prandi E., Felappi B., Rocca A., Meneghini E., Galli P., Ruggeri P., Carrai E., Fugazza L., Baggi V., Conti D., Bosi E., Laurenzi A., Caretto A., Molinari C., Orsi E., Grancini V., Resi V., Favalli V., Bonura C., Rigamonti A., Bonomo M., Bertuzzi F., Pintaudi B., Disoteo O., Perseghin G., Perra S., Chiovato L., De Cata P., Zerbini F., Lovati E., Laneri M., Guerraggio L., Bossi A. C., De Mori V., Galetta M., Meloncelli I., Aiello A A., Di Vincenzo S., Nuzzi A., Fraticelli E., Ansaldi E., Battezzati M., Lombardi M., Balbo M., Lera R., Secco A., De Donno V., Cadario F., Savastio S., Ponzani C., Aimaretti G., Ignaccolo G., Tinti D., Cerutti F., Bari F., Giorgino F., Piccinno E., Zecchino O., Cignarelli M., Lamacchia O., Picca G., De Cosmo S., Rauseo A., Tomaselli L., Tumminia A., Egiziano C., Scarpitta A. M., Maggio F., Cardella F., Roppolo R., Provenzano V., Fleres M., Scorsone A., Scatena A., Gregori G., Lucchesi S., Gadducci F., Di Cianni S., Pancani S., Del Prato S., Aragona M., Crisci I., Calianno A., Fattor B., Crazzolara D., Reinstadler P., Longhi S., Incelli G., Rauch S., Romanelli T., Orrasch M., Cauvin V., Franceschi R., Lalli C., Pianta A., Marangoni A., Arico C. N., Marin N., Nogara N., Simioni N., Filippi A., Gidoni Guarneri G. L., Contin M. L M. L., Decata A. P., Bondesan L., Confortin L., Coracina A., Lombardi S., Costa Padova S., Cipponeri E., Scotton R., Galasso S., Boscari F., Zanon M. S., Vinci C., Lisato G., Gottardo L., Bonora E., Trombetta M., Negri C., Brangani C., Maffeis C., Sabbion A., Marigliano M., Lepore, G, Bonfanti, R, Bozzetto, L, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Laviola, L, Rabbone, I, Schiaffini, R, Bruttomesso, D, Mammi, F, Bruzzese, M, Schettino, M, Nuzzo, M, Fresa, R, Lambiase, C, Zanfardino, A, Confetto, S, Annuzzi, G, Alderisio, A, Riccardi, G, Gentile, S, Marino, G, Guarino, G, Zucchini, S, Maltoni, G, Suprani, T, Graziani, V, Nizzoli, M, Acquati, S, Cavani, R, Romano, S, Michelini, M, Manicardi, E, Bonadonna, R, Dei Cas, A, Dall'Aglio, E, Papi, M, Riboni, S, Manicardi, V, Pugni, V, Lasagni, A, Street, M, Pagliani, U, Rossi, C, Assaloni, R, Brunato, B, Tortul, C, Zanette, G, Li Volsi, P, Zanatta, M, Tonutti, L, Agus, S, Pellegrini, M, Ceccano, P, Pozzilli, G, Anguissola, B, Buzzetti, R, Moretti C, C, Leto, G, Pozzilli, P, Manfrini, S, Maurizi, A, Leotta, S, Altomare, M, Abbruzzese, S, Carletti, S, Suraci, C, Filetti, S, Manca Bitti, M, Arcano, S, Cavallo, M, De Bernardinis, M, Pitocco, D, Caputo, S, Rizzi, A, Manto, A, Cappa, M, Benevento, D, Frontoni, S, Malandrucco, I, Morano, S, Filardi, T, Lauro, D, Marini, M, Castaldo, E, Sabato, D, Tuccinardi, F, Forte, E, Viterbori, P, Arnaldi, C, Minuto, N, D'Annunzio, G, Corsi, A, Rota, R, Scaranna, C, Trevisan, R, Valentini, U, Bonfadini, S, Zarra, E, Plebani, A, Prandi, E, Felappi, B, Rocca, A, Meneghini, E, Galli, P, Ruggeri, P, Carrai, E, Fugazza, L, Baggi, V, Conti, D, Bosi, E, Laurenzi, A, Caretto, A, Molinari, C, Orsi, E, Grancini, V, Resi, V, Favalli, V, Bonura, C, Rigamonti, A, Bonomo, M, Bertuzzi, F, Pintaudi, B, Disoteo, O, Perseghin, G, Perra, S, Chiovato, L, De Cata, P, Zerbini, F, Lovati, E, Laneri, M, Guerraggio, L, Bossi, A, De Mori, V, Galetta, M, Meloncelli, I, Aiello A, A, Di Vincenzo, S, Nuzzi, A, Fraticelli, E, Ansaldi, E, Battezzati, M, Lombardi, M, Balbo, M, Lera, R, Secco, A, De Donno, V, Cadario, F, Savastio, S, Ponzani, C, Aimaretti, G, Ignaccolo, G, Tinti, D, Cerutti, F, Bari, F, Giorgino, F, Piccinno, E, Zecchino, O, Cignarelli, M, Lamacchia, O, Picca, G, De Cosmo, S, Rauseo, A, Tomaselli, L, Tumminia, A, Egiziano, C, Scarpitta, A, Maggio, F, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Scorsone, A, Scatena, A, Gregori, G, Lucchesi, S, Gadducci, F, Di Cianni, S, Pancani, S, Del Prato, S, Aragona, M, Crisci, I, Calianno, A, Fattor, B, Crazzolara, D, Reinstadler, P, Longhi, S, Incelli, G, Rauch, S, Romanelli, T, Orrasch, M, Cauvin, V, Franceschi, R, Lalli, C, Pianta, A, Marangoni, A, Arico, C, Marin, N, Nogara, N, Simioni, N, Filippi, A, Gidoni Guarneri, G, Contin, M, Decata, A, Bondesan, L, Confortin, L, Coracina, A, Lombardi, S, Costa Padova, S, Cipponeri, E, Scotton, R, Galasso, S, Boscari, F, Zanon, M, Vinci, C, Lisato, G, Gottardo, L, Bonora, E, Trombetta, M, Negri, C, Brangani, C, Maffeis, C, Sabbion, A, Marigliano, M, Lepore G., Bonfanti R., Bozzetto L., Di Blasi V., Girelli A., Grassi G., Iafusco D., Laviola L., Rabbone I., Schiaffini R., Bruttomesso D., Mammi F., Bruzzese M., Schettino M., Nuzzo M. G., Fresa R., Lambiase C., Zanfardino A., Confetto S., Annuzzi G., Alderisio A., Riccardi G., Gentile S., Marino G., Guarino G., Zucchini S., Maltoni G., Suprani T., Graziani V., Nizzoli M., Acquati S., Cavani R., Romano S., Michelini M., Manicardi E., Bonadonna R., Dei Cas A., Dall'aglio E., Papi M., Riboni S., Manicardi V., Pugni V., Lasagni A., Street M. E., Pagliani U., Rossi C., Assaloni R., Brunato B., Tortul C., Zanette G., Li Volsi P., Zanatta M., Tonutti L., Agus S., Pellegrini M. A., Ceccano P., Pozzilli G., Anguissola B., Buzzetti R., Moretti C C., Leto G., Pozzilli P., Manfrini S., Maurizi A. R., Leotta S., Altomare M., Abbruzzese S., Carletti S., Suraci C., Filetti S., Manca Bitti M. L., Arcano S., Cavallo M. G., De Bernardinis M., Pitocco D., Caputo S., Rizzi A., Manto A., Cappa M., Benevento D., Frontoni S., Malandrucco I., Morano S., Filardi T., Lauro D., Marini M. A., Castaldo E., Sabato D., Tuccinardi F., Forte E., Viterbori P., Arnaldi C., Minuto N., d'Annunzio G., Corsi A., Rota R., Scaranna C., Trevisan R., Valentini U., Bonfadini S., Zarra E., Plebani A., Prandi E., Felappi B., Rocca A., Meneghini E., Galli P., Ruggeri P., Carrai E., Fugazza L., Baggi V., Conti D., Bosi E., Laurenzi A., Caretto A., Molinari C., Orsi E., Grancini V., Resi V., Favalli V., Bonura C., Rigamonti A., Bonomo M., Bertuzzi F., Pintaudi B., Disoteo O., Perseghin G., Perra S., Chiovato L., De Cata P., Zerbini F., Lovati E., Laneri M., Guerraggio L., Bossi A. C., De Mori V., Galetta M., Meloncelli I., Aiello A A., Di Vincenzo S., Nuzzi A., Fraticelli E., Ansaldi E., Battezzati M., Lombardi M., Balbo M., Lera R., Secco A., De Donno V., Cadario F., Savastio S., Ponzani C., Aimaretti G., Ignaccolo G., Tinti D., Cerutti F., Bari F., Giorgino F., Piccinno E., Zecchino O., Cignarelli M., Lamacchia O., Picca G., De Cosmo S., Rauseo A., Tomaselli L., Tumminia A., Egiziano C., Scarpitta A. M., Maggio F., Cardella F., Roppolo R., Provenzano V., Fleres M., Scorsone A., Scatena A., Gregori G., Lucchesi S., Gadducci F., Di Cianni S., Pancani S., Del Prato S., Aragona M., Crisci I., Calianno A., Fattor B., Crazzolara D., Reinstadler P., Longhi S., Incelli G., Rauch S., Romanelli T., Orrasch M., Cauvin V., Franceschi R., Lalli C., Pianta A., Marangoni A., Arico C. N., Marin N., Nogara N., Simioni N., Filippi A., Gidoni Guarneri G. L., Contin M. L M. L., Decata A. P., Bondesan L., Confortin L., Coracina A., Lombardi S., Costa Padova S., Cipponeri E., Scotton R., Galasso S., Boscari F., Zanon M. S., Vinci C., Lisato G., Gottardo L., Bonora E., Trombetta M., Negri C., Brangani C., Maffeis C., Sabbion A., and Marigliano M.

Abstract

Background and aim: The objective of this cross-sectional study was to evaluate the degree of glycaemic control and the frequency of diabetic complications in Italian people with diabetes who were treated with continuous subcutaneous insulin infusion (CSII). Methods and results: Questionnaires investigating the organisation of diabetes care centres, individuals’ clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. <58 mmol/mol for age <18 years and [removed]18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels. The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis. Conclusions: Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia. Clinical trial registration number: NCT 02620917 (ClinicalTrials.gov).

Published
2018

5. Distribution of cardiovascular disease and retinopathy in patients with type 2 diabetes according to different classification systems for chronic kidney disease: a cross-sectional analysis of the renal insufficiency and cardiovascular events (RIACE) Italian multicenter study

Author

Pugliese, G, Solini, A, Bonora, E, Orsi, E, Zerbini, G, Fondelli, C, Gruden, G, Cavalot, F, Lamacchia, O, Trevisan, R, Vedovato, M, Penno, G, Pugliese G, Solini A, Bonora E, Orsi E, Zerbini G, Fondelli C, Gruden G, Cavalot F, Lamacchia O, Trevisan R, Vedovato M, Penno G, Pugliese, G, Solini, A, Bonora, E, Orsi, E, Zerbini, G, Fondelli, C, Gruden, G, Cavalot, F, Lamacchia, O, Trevisan, R, Vedovato, M, Penno, G, Pugliese G, Solini A, Bonora E, Orsi E, Zerbini G, Fondelli C, Gruden G, Cavalot F, Lamacchia O, Trevisan R, Vedovato M, and Penno G

Abstract

Background: The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF's KDOQI) staging system for chronic kidney disease (CKD) is based primarily on estimated GFR (eGFR). This study aimed at assessing whether reclassification of subjects with type 2 diabetes using two recent classifications based on both eGFR and albuminuria, the Alberta Kidney Disease Network (AKDN) and the Kidney Disease: Improving Global Outcomes (KDIGO), provides a better definition of burden from cardiovascular disease (CVD) and diabetic retinopathy (DR) than the NKF's KDOQI classification.Methods: This is a cross-sectional analysis of patients with type 2 diabetes (n = 15,773) from the Renal Insufficiency And Cardiovascular Events Italian Multicenter Study, consecutively visiting 19 Diabetes Clinics throughout Italy in years 2007-2008. Exclusion criteria were dialysis or renal transplantation. CKD was defined based on eGFR, as calculated from serum creatinine by the simplified Modification of Diet in Renal Disease Study equation, and albuminuria, as measured by immunonephelometry or immunoturbidimetry. DR was assessed by dilated fundoscopy. Prevalent CVD, total and by vascular bed, was assessed from medical history by recording previous documented major acute events.Results: Though prevalence of complications increased with increasing CKD severity with all three classifications, it differed significantly between NKF's KDOQI stages and AKDN or KDIGO risk categories. The AKDN and KDIGO systems resulted in appropriate reclassification of uncomplicated patients in the lowest risk categories and a more graded independent association with CVD and DR than the NKF's KDOQI classification. However, CVD, but not DR prevalence was higher in the lowest risk categories of the new classifications than in the lowest stages of the NKF's KDOQI, due to the inclusion of subjects with reduced eGFR without albuminuria. CVD prevalence differed also among eGFR and albuminuria categories grouped

Published
2014

6. Distribution of cardiovascular disease and retinopathy in patients with type 2 diabetes according to different classification systems for chronic kidney disease: a cross-sectional analysis of the renal insufficiency and cardiovascular events (RIACE) Italian multicenter study

Author

Pugliese, G, Solini, A, Bonora, E, Orsi, E, Zerbini, G, Fondelli, C, Gruden, G, Cavalot, F, Lamacchia, O, Trevisan, R, Vedovato, M, Penno, G, Pugliese G, Solini A, Bonora E, Orsi E, Zerbini G, Fondelli C, Gruden G, Cavalot F, Lamacchia O, Trevisan R, Vedovato M, Penno G, Pugliese, G, Solini, A, Bonora, E, Orsi, E, Zerbini, G, Fondelli, C, Gruden, G, Cavalot, F, Lamacchia, O, Trevisan, R, Vedovato, M, Penno, G, Pugliese G, Solini A, Bonora E, Orsi E, Zerbini G, Fondelli C, Gruden G, Cavalot F, Lamacchia O, Trevisan R, Vedovato M, and Penno G

Abstract

Background: The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF's KDOQI) staging system for chronic kidney disease (CKD) is based primarily on estimated GFR (eGFR). This study aimed at assessing whether reclassification of subjects with type 2 diabetes using two recent classifications based on both eGFR and albuminuria, the Alberta Kidney Disease Network (AKDN) and the Kidney Disease: Improving Global Outcomes (KDIGO), provides a better definition of burden from cardiovascular disease (CVD) and diabetic retinopathy (DR) than the NKF's KDOQI classification.Methods: This is a cross-sectional analysis of patients with type 2 diabetes (n = 15,773) from the Renal Insufficiency And Cardiovascular Events Italian Multicenter Study, consecutively visiting 19 Diabetes Clinics throughout Italy in years 2007-2008. Exclusion criteria were dialysis or renal transplantation. CKD was defined based on eGFR, as calculated from serum creatinine by the simplified Modification of Diet in Renal Disease Study equation, and albuminuria, as measured by immunonephelometry or immunoturbidimetry. DR was assessed by dilated fundoscopy. Prevalent CVD, total and by vascular bed, was assessed from medical history by recording previous documented major acute events.Results: Though prevalence of complications increased with increasing CKD severity with all three classifications, it differed significantly between NKF's KDOQI stages and AKDN or KDIGO risk categories. The AKDN and KDIGO systems resulted in appropriate reclassification of uncomplicated patients in the lowest risk categories and a more graded independent association with CVD and DR than the NKF's KDOQI classification. However, CVD, but not DR prevalence was higher in the lowest risk categories of the new classifications than in the lowest stages of the NKF's KDOQI, due to the inclusion of subjects with reduced eGFR without albuminuria. CVD prevalence differed also among eGFR and albuminuria categories grouped

Published
2014

7. Hemoglobin A(1c) variability as an independent correlate of cardiovascular disease in patients with type 2 diabetes: a cross-sectional analysis of the Renal Insufficiency and Cardiovascular Events (RIACE) Italian Multicenter Study

Author

Penno, G, Solini, A, Zoppini, G, Orsi, E, Fondelli, C, Zerbini, G, Morano, S, Cavalot, F, Lamacchia, O, Trevisan, R, Vedovato, M, Pugliese, G, Penno G, Solini A, Zoppini G, Orsi E, Fondelli C, Zerbini G, Morano S, Cavalot F, Lamacchia O, Trevisan R, Vedovato M, Pugliese G, Penno, G, Solini, A, Zoppini, G, Orsi, E, Fondelli, C, Zerbini, G, Morano, S, Cavalot, F, Lamacchia, O, Trevisan, R, Vedovato, M, Pugliese, G, Penno G, Solini A, Zoppini G, Orsi E, Fondelli C, Zerbini G, Morano S, Cavalot F, Lamacchia O, Trevisan R, Vedovato M, and Pugliese G

Abstract

Background: Previous reports have clearly indicated a significant relationship between hemoglobin (Hb) A1c change from one visit to the next and microvascular complications, especially nephropathy (albuminuria and albuminuric chronic kidney disease, CKD). In contrast, data on macrovascular disease are less clear. This study was aimed at examining the association of HbA1c variability with cardiovascular disease (CVD) in the large cohort of subjects with type 2 diabetes from the Renal Insufficiency and Cardiovascular Events (RIACE) Italian Multicenter Study.Methods: Serial (3-5) HbA1c values obtained during the 2-year period preceding recruitment, including that obtained at the enrolment, were available from 8,290 subjects from 9 centers (out of 15,773 patients from 19 centers). Average HbA1c and HbA1c variability were calculated as the intra-individual mean (HbA1c-MEAN) and standard deviation (HbA1c-SD), respectively, of 4.52±0.76 values. Prevalent CVD, total and by vascular bed, was assessed from medical history by recording previous documented major acute events. Diabetic retinopathy (DR) was assessed by dilated fundoscopy. CKD was defined based on albuminuria, as measured by immunonephelometry or immunoturbidimetry, and estimated glomerular filtration rate, as calculated from serum creatinine.Results: HbA1c-MEAN, but not HbA1c-SD, was significantly higher (P<0.0001) in subjects with history of any CVD (n. 2,133, 25.7%) than in those without CVD (n. 6,157, 74.3%). Median and interquartile range were 7.78 (7.04-8.56) and 7.49 (6.81-8.31), respectively, for HbA1c-MEAN, and 0.47 (0.29-0.75) and 0.46 (0.28-0.73), respectively, for HbA1c-SD. Logistic regression analyses showed that HbA1c-MEAN, but not HbA1c-SD (and independent of it), was a significant correlate of any CVD. Similar findings were observed in subjects with versus those without any coronary or cerebrovascular event or myocardial infarction. Conversely, none of these measures were associated with stroke

Published
2013

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