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1. Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials

Author

Palmer, SC, Tendal, B, Mustafa, RA, Vandvik, PO, Li, S, Hao, Q, Tunnicliffe, D, Ruospo, M, Natale, P, Saglimbene, V, Nicolucci, A, Johnson, DW, Tonelli, M, Rossi, MC, Badve, S, Cho, Y, Nadeau-Fredette, A-C, Burke, M, Faruque, L, Lloyd, A, Ahmad, N, Liu, Y, Tiv, S, Millard, T, Gagliardi, L, Kolanu, N, Barmanray, RD, McMorrow, R, Cortez, AKR, White, H, Chen, X, Zhou, X, Liu, J, Rodriguez, AF, Gonzalez-Colmenero, AD, Wang, Y, Li, L, Sutanto, S, Solis, RC, Gonzalez-Colmenero, FD, Rodriguez-Gutierrez, R, Walsh, M, Guyatt, G, Strippoli, GFM, Palmer, SC, Tendal, B, Mustafa, RA, Vandvik, PO, Li, S, Hao, Q, Tunnicliffe, D, Ruospo, M, Natale, P, Saglimbene, V, Nicolucci, A, Johnson, DW, Tonelli, M, Rossi, MC, Badve, S, Cho, Y, Nadeau-Fredette, A-C, Burke, M, Faruque, L, Lloyd, A, Ahmad, N, Liu, Y, Tiv, S, Millard, T, Gagliardi, L, Kolanu, N, Barmanray, RD, McMorrow, R, Cortez, AKR, White, H, Chen, X, Zhou, X, Liu, J, Rodriguez, AF, Gonzalez-Colmenero, AD, Wang, Y, Li, L, Sutanto, S, Solis, RC, Gonzalez-Colmenero, FD, Rodriguez-Gutierrez, R, Walsh, M, Guyatt, G, and Strippoli, GFM

Abstract

OBJECTIVE: To evaluate sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists in patients with type 2 diabetes at varying cardiovascular and renal risk. DESIGN: Network meta-analysis. DATA SOURCES: Medline, Embase, and Cochrane CENTRAL up to 11 August 2020. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials comparing SGLT-2 inhibitors or GLP-1 receptor agonists with placebo, standard care, or other glucose lowering treatment in adults with type 2 diabetes with follow up of 24 weeks or longer. Studies were screened independently by two reviewers for eligibility, extracted data, and assessed risk of bias. MAIN OUTCOME MEASURES: Frequentist random effects network meta-analysis was carried out and GRADE (grading of recommendations assessment, development, and evaluation) used to assess evidence certainty. Results included estimated absolute effects of treatment per 1000 patients treated for five years for patients at very low risk (no cardiovascular risk factors), low risk (three or more cardiovascular risk factors), moderate risk (cardiovascular disease), high risk (chronic kidney disease), and very high risk (cardiovascular disease and kidney disease). A guideline panel provided oversight of the systematic review. RESULTS: 764 trials including 421 346 patients proved eligible. All results refer to the addition of SGLT-2 inhibitors and GLP-1 receptor agonists to existing diabetes treatment. Both classes of drugs lowered all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, and kidney failure (high certainty evidence). Notable differences were found between the two agents: SGLT-2 inhibitors reduced admission to hospital for heart failure more than GLP-1 receptor agonists, and GLP-1 receptor agonists reduced non-fatal stroke more than SGLT-2 inhibitors (which appeared to have no effect). SGLT-2 inhibitors caused genital infection (high certainty), whereas GLP-1 receptor agon

Published
2021

2. Efficacy of self-monitoring blood glucose as a key component of a chronic care model versus usual care in type 2 diabetes patients treated with oral agents: results of a randomized trial

Author

Musacchio, N, Ciullo, I, Scardapane, M, Giancaterini, A, Pessina, L, Maino, S, Gaiofatto, R, Nicolucci, A, Rossi, Mc, Valentini, U, Cimino, A, Agosti, B, Zarra, E, Magri, A, Pellegrini, Ma, Pellarini, L, Sciangula, L, Nappi, F, Ciucci, A, Grassa, B, De Marco, R, Olivo, Es, Trevisan, R, Frosio, I, Morlini, C, Corsi, A, Dodesini, Ar, Grassi, G, Calvi, E, Capello, E, Gramaglia, E, Ramella, V, De Rossi, C, Mengozzi, G, Orsi, E, Lunati, Me, Palmieri, E, Resi, V, Grancini, V, Giarratana, L, Ragonese, M, Slongo, R, Scoponi, C, Tonolo, G, Amadori, G, Becciu, A, Canu, L, Cherchi, S, Paciotti, V, Alfidi, P, Babini, A, Ripani, R, Cantelli, R, Rossi, P, Di Cianni, G, Russo, L, Lemmi, P, Sannino, C, Marconi, S, Di Bartolo, P, Pellicano, F, Scolozzi, P, Annese, S, Lorizzo, F, Coppolino, A, Peditto, Gc, De Feo ME, Piscopo, G, Varriale, A, De Candia, L, Ceci, A, Elia, G, Falzone, G, Schembari, R, Citro, G, Di Mauro, M, D’Urso, C, Caruso, C, on behalf of Self-Care Study Group, Musacchio, N, Ciullo, I, Scardapane, M, Giancaterini, A, Pessina, L, Maino, S, Gaiofatto, R, Nicolucci, A, Rossi, M, Valentini, U, Cimino, A, Agosti, B, Zarra, E, Magri, A, Pellegrini, M, Pellarini, L, Sciangula, L, Nappi, F, Ciucci, A, Grassa, B, De Marco, R, Olivo, E, Trevisan, R, Frosio, I, Morlini, C, Corsi, A, Dodesini, A, Grassi, G, Calvi, E, Capello, E, Gramaglia, E, Ramella, V, De Rossi, C, Mengozzi, G, Orsi, E, Lunati, M, Palmieri, E, Resi, V, Grancini, V, Giarratana, L, Ragonese, M, Slongo, R, Scoponi, C, Tonolo, G, Amadori, G, Becciu, A, Canu, L, Cherchi, S, Paciotti, V, Alfidi, P, Babini, A, Ripani, R, Cantelli, R, Rossi, P, Di Cianni, G, Russo, L, Lemmi, P, Sannino, C, Marconi, S, Di Bartolo, P, Pellicano, F, Scolozzi, P, Annese, S, Lorizzo, F, Coppolino, A, Peditto, G, De Feo, M, Piscopo, G, Varriale, A, De Candia, L, Ceci, A, Elia, G, Falzone, G, Schembari, R, Citro, G, Di Mauro, M, D'Urso, C, and Caruso, C

Subjects
medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, oral antidiabetic agent, Type 2 diabetes, law.invention, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Diabetes mellitus, Internal medicine, Internal Medicine, medicine, hemoglobin A1c lipid, 030212 general & internal medicine, Intensive care medicine, Chronic care, business.industry, Mellitus, General Medicine, medicine.disease, Management, Oral agents, Usual care, Self-monitoring, Empowerment, business
Published
2018

4. Antiretroviral genotypic resistance in plasma RNA and whole blood DNA in HIV-1 infected patients failing HAART

Author

Saracino, A, Gianotti, N, Marangi, M, Cibelli, Dc, Galli, A, Punzi, G, Monno, L, Lazzarin, A, Angarano, G, Dini, M, Del Gobbo, R, Montroni, M, Butini, L, Scalise, G, Ancarani, F, Di Cesare, S, Giacometti, A, Biglino, A, Degioanni, M, Paoloni, M, Mariani, R, Calella, G, Pastore, G, Ladisa, N, Mennea, G, Gritti, Fm, Fasullo, G, Chiodo, F, Borderi, M, Carosi, Giampiero, Castelli, Francesco, Torti, Carlo, Uccelli, C, Rizzardini, G, Visoná, R, Salvo, A, Averna, A, Russo, R, Celesia, Bm, Cosentino, S, Rinaldi, E, Pusterla, L, Carnevale, G, Mondello, P, Petrini, C, Ghinelli, F, Sighinolfi, L, Mazzotta, F, Lo Caputo, S, Pierotti, P, Leoncini, F, Sterrantino, Gk, Corsi, P, Pompei, Ag, Di Toro MT, Purificato, F, Indiveri, F, Setti, M, Murdaca, G, Iannessi, A, Cellini, A, Mariani, A, Scasso, A, De Gennaro, M, Chiodera, A, Castelli, P, Maltempo, K, Mongolo, G, Caggese, L, Schlacht, I, Cargnel, A, Atzori, C, Micheli, V, Moroni, M, Bini, T, Marcatto, I, Chiesa, E, Vigevani, G, Argenteri, B, Capetti, A, Esposito, R, Guaraldi, G, Seghetto, B, Chirianni, A, Gargiulo, M, Abrescia, N, D'Abbraccio, M, Busto, T, Marchitelli, C, Santirocchi, M, Abbadessa, V, Mancuso, S, Meneghetti, F, Pranzetti, M, Ferrari, C, Pizzaferri, P, Stagni, G, Di Candilo, F, Petrelli, E, Balducci, M, Menichetti, F, Polidori, M, Tascini, C, Di Carlo, A, Palamara, G, Antinori, A, Liuzzi, G, Aiuti, F, Mezzaroma, I, Pinter, E, Barbone, B, Vullo, V, Massetti, P, Dell'Isola, S, Mura, Ms, Mannazzu, M, Delias, R, Di Giammartino, D, Tarquini, P, Marranconi, F, Ferretto, R, Caramello, P, Orofino, Gc, Cimino, T, Bramato, C, Di Perri, G, Sinicco, A, Zeme, D, Bonora, S, Trentini, L, Soranzo, Ml, Macor, A, Salassa, B, Branz, F, Delle Foglie, P, Vaglia, A, Rossi, Mc, Ciccone, L, Panzolli, L, Grossi, P, Giola, M, Raise, E, Narne, E, Poggio, A, Demin, F, Mondino, V, Serpelloni, G, Malena, M, Bosco, O., Saracino, A, Gianotti, N, Marangi, M, Cibelli, D, Galli, A, Punzi, G, Monno, L, Lazzarin, A, Angarano, G, and Mancuso, S

Subjects
Anti-HIV Agents, DNA Mutational Analysis, Molecular Sequence Data, Proviral DNA, HIV Infections, HAART failure, medicine.disease_cause, DNA Mutational Analysi, chemistry.chemical_compound, HIV Protease, Proviruses, Antiretroviral Therapy, Highly Active, Virology, Drug Resistance, Viral, medicine, Humans, Multicenter Studies as Topic, HIV Infection, Treatment Failure, Genotyping, Randomized Controlled Trials as Topic, COLD-PCR, Mutation, Plasma RNA, biology, Proviruse, Sequence Analysis, RNA, Anti-HIV Agent, RNA, Sequence Analysis, DNA, biology.organism_classification, HIV Reverse Transcriptase, Reverse transcriptase, Antiretroviral genotypic resistance, Infectious Diseases, chemistry, DNA, Viral, Lentivirus, Immunology, HIV-1, RNA, Viral, DNA, antiretroviral genotypic resistance, haart failure, hiv-1, plasma rna, proviral dna, Human
Abstract

The extent to which HIV-1 proviral DNA mutations cause clinically relevant antiretroviral resistance is still controversial. Paired plasma HIV-1 RNA and whole blood DNA were compared in patients failing HAART to investigate if the additional knowledge of archived mutations could improve the selection of potentially active drugs. Seventy-three HIV-1-infected patients with first/second HAART failure were studied before starting a new regimen based on RNA genotyping. Follow-up data after a 12-week therapy were available. DNA genotyping was retrospectively performed on stored whole blood samples and mutational profiles were compared to those from RNA. The mean number of IAS pol mutations was significantly higher in RNA (4.45 ± 2.76) than in DNA (2.88 ± 2.47) (P < 0.001). DNA genotyping provided a 6% increase in detection of resistance-associated mutations. Among 64/73 patients showing discordant DNA/RNA profiles, 54 (84%) also differed for predicted active drugs. 16/73 (22%) patients had ≥1 mutation revealed by DNA genotyping alone, probably affecting therapy success in 2/16. However, neither RNA/DNA discordance nor detection of isolated DNA mutations were statistically associated with outcome. In conclusion, plasma RNA remains the elective choice for HIV genotyping in patients with therapy failure, even if the detection of proviral resistance-associated mutations, not simultaneously found in RNA, is a frequent event. Therefore, in some cases DNA plus RNA genotyping might assist in choosing more accurately subsequent antiretroviral regimens. © 2008 Wiley-Liss, Inc.

Published
2008
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5. IL-4-induced gene 1 maintains high Tob1 expression that contributes to TCR unresponsiveness in human T helper 17 cells

Author

Santarlasci, V, Maggi, L, Mazzoni, A, Capone, M, Querci, V, Rossi, Mc, Beltrame, L, Cavalieri, D, DE PALMA, Raffaele, Liotta, F, Cosmi, L, Maggi, E, Romagnani, S, Annunziato, F., Santarlasci, V, Maggi, L, Mazzoni, A, Capone, M, Querci, V, Rossi, Mc, Beltrame, L, Cavalieri, D, DE PALMA, Raffaele, Liotta, F, Cosmi, L, Maggi, E, Romagnani, S, and Annunziato, F.

Subjects
human diseases, human Th17, proliferation, human Th17, proliferation, human diseases
Published
2014

6. SEX DISPARITIES IN THE QUALITY OF DIABETES CARE: BIOLOGICAL AND CULTURAL FACTORS MAY PLAY A DIFFERENT ROLE FOR DIFFERENT OUTCOMES: A CROSS-SECTIONAL OBSERVATIONAL STUDY FROM THE AMD ANNALS INITIATIVE

Author

Rossi MC, Cristofaro MR, Lucisano G, Manicardi V, Mulas MF, Napoli A, Nicolucci A, Pellegrini F, Suraci C, Giorda C., GENTILE, Sandro, Rossi, Mc, Cristofaro, Mr, Gentile, Sandro, Lucisano, G, Manicardi, V, Mulas, Mf, Napoli, A, Nicolucci, A, Pellegrini, F, Suraci, C, and Giorda, C.

Subjects
quality of care, gender medicine, diabetes mellitus
Abstract

Objective: To investigate the quality of type 2 diabetes care according to sex. RESEARCH DESIGN AND METHODS: Clinical data collected during the year 2009 were extracted from electronic medical records; quality-of-care indicators were evaluated. Multilevel logistic regression analysis was applied to estimate the likelihood of women versus men to be monitored for selected parameters, to reach clinical outcomes, and to be treated with specific classes of drugs. The intercenter variability in the proportion of men and women achieving the targets was also investigated. RESULTS: Overall, 415,294 patients from 236 diabetes outpatient centers were evaluated, of whom 188,125 (45.3%) were women and 227,169 (54.7%) were men. Women were 14% more likely than men to have HbA1c>9.0% in spite of insulin treatment (odds ratio 1.14 [95% CI 1.10-1.17]), 42% more likely to have LDL cholesterol (LDL-C)≥130 mg/dL (1.42 [1.38-1.46]) in spite of lipid-lowering treatment, and 50% more likely to have BMI≥30 kg/m2 (1.50 [1.50-1.54]). Women were less likely to be monitored for foot and eye complications. In 99% of centers, the percentage of men reaching the LDL-C target was higher than in women, the proportion of patients reaching the HbA1c target was in favor of men in 80% of the centers, and no differences emerged for blood pressure. CONCLUSIONS: Women show a poorer quality of diabetes care than men. The attainment of the LDL-C target seems to be mainly related to pathophysiological factors, whereas patient and physician attitudes can play an important role in other process measures and outcomes

Published
2013

7. AMD Annals: a model of continuous monitoring and improvement of the quality of diabetes care

Author

Cimino A, de Bigontina G, Fava D, Giorda C, Meloncelli I, Nicolucci A, Pellegrini F, Rossi MC, Arcangeli A, Vespasiani G, Graziano G, Memmo R, Pellicciotta E, Pipitone A, Bodner E, Bonanome A, Testa I, Boemi M, Giansanti R, Romagnoli F, Testa R, Rabini R, Brandoni G, Paciotti V, Alfidi P, Verdecchia B, Marangoni A, Pianta A, Ferrari M, Bertone V, Capellini C, Camozzi D, Remondini E, Laffi G, Ciavarella A, Giangiulio S, Grimaldi M, Mustacchio A, Santacroce G, Marini F, Bondesan L, Valentini U, Rocca L, Girelli A, Zarra E, Agosti B, Corsini R, De Blasi G, Bergmann M, Trinchera A, Masi G, Macchitella V, Mancuso C, Trisciuzzi L, Viehweider B, Carboni L, Turco MP, Delogu A, Floris M, Murtas MG, Farris L, Manai M, Spanu F, Songini M, Piras G, Seguro R, Floris R, Corona R, Lai M, Lostia S, Piras E, Dolci M, Mori M, Baccetti F, Gregori G, Capretti L, Speroni G, Carbone A, Fugazza L, Pozzuoli G, Laudato M, Barone M, Stasio G, Grosso J, Di Nardo B, Rossi L, Sciulli A, Confortin L, Marin N, Lamonica M, Lorenti I, Starnone V, Del Buono A, Terracciano AM, Boscolo Bariga A, Ballarin G, Nogara A, De Boni S, Chiambretti A, Fornengo R, Mularoni EM, Rocca A, Rumi P, Balzarini B, Pellegrini MA, Noacco C, Tonutti L, Venturini G, Santantonio G, Baldi G, Massa L, Ghilardi G, Fiorina P, Massafra C, Lovagnini Scher A, Panebianco G, Tadiotto F, Gaiti D, Bosi EA, Chierici G, Pilla S, Copelli M, Zanichelli P, Bertelli L, Caretta P, Vezzani V, Bodecchi S, Longobucco A, Ruggeri P, Mondani A, Persico R, Rossi C, Magro G, Musacchio N, Giancaterini A, Marelli G, Placentino G, Richini D, Molinari S, Strazzeri R, D'Ambrosio M, Da Tos V, Cotti L, Garrapa G, Foglini P, Bedetta C, Tortato E, Pantanetti P, Manicotti R, Forte E, Marrocco C, Torri A, Sommariva D, Taboga C, Catone B, Ghisoni G, Fabbri F, Torresan M, Marina R, Campobasso G, D'Ugo E, Merni M, Brunato B, Rossi M, Sabbatini G, Quadri F, Sambuco L, Iannarelli R, Pupillo M, De Luca A, Antenucci D, Minnucci A, Di Florio C, Carnevale A, Angelicola G, Bosco A, Fresco R, Di Marco G, Cogo L, Meniconi R, Bertoli S, Cosimi S, Giannini F, di Carlo A, Casadidio I, Maolo G, Polenta B, Bruglia M, Vincenti C, Sciangula L, Banfi E, Ciucci A, Contartese A, Menicatti L, Tatti P, Bloise D, Di Mauro P, Masselli L, Lo Presti A, Scarpitta AM, Gambina F, Venezia A, Morea R, Lagonigro G, Saitta G, Cucinotta D, Di Benedetto A, Pata P, Mancuso T, Zocca A, Aiello B, Picca M, Testori G, Rampini P, Cerutti N, Mariani G, Ragonesi PD, Bollati P, Colapinto P, Comoglio M, Manti G, Cernigoi AM, Tortul C, Volpi A, Coracina A, Cospite AM, Manicardi V, Michelini M, Finardi L, Galliani S, Cilloni R, Iemmi M, Lombardi S, Mattarello MJ, Gatti A, Giannettina R, Gobbo M, Bonavita M, Creso E, Turco S, Turco AA, Iovine C, De Natale C, Zenari L, Bertulini L, Sorgato C, Saglietti G, Schellino A, Mastinu F, Cossu M, Madau G, Mulas MF, Zuccheddu S, Torchio G, Palumbo P, Bianchi A, Mattina G, Zavaroni I, Dei Cas I, Franzini L, Usberti E, Antonimi M, Anelli N, Poli R, Picchio E, Del Sindaco P, Spalluto A, Maggiulli L, Ricciardelli L, La Penna G, Gelisio R, Vinci C, Ianni L, Lorenzetti M, Marsocci A, Di Bartolo P, Scaramuzza A, Melandri P, Giovannini C, Rastelli E, Leotta S, Suraci C, Visalli N, Gagliardi A, Fontana L, Altomare M, Carletti S, Abbruzzese S, Chiaramonte F, Giordano R, Rossini M, Migneco G, Piergiovanni F, Simonetta A, Massimiani F, Bulzomì R, Armentano G, Restuccia MG, Genovese S, Locatelli F, Croato T, Nicoletti M, Trojan N, Li Volsi P, Zanette G, Clementi L, Galetta M, Santangelo M, Bordin P, Perale L, Zanon M, Sica V, Sturaro R, Raffa M, Lione L, Calcaterra F, Cataldi F, Miola M, Manfrini S, Rilli S, Tanganelli I, Felace G, Fumagalli I, Divizia G, Agliani M, Travaglini A, Draghi P, Acler P, Romanelli T, Inchiostro S, Candido R, Caroli E, Manca E, Petrucco A, Da Ros R, Da Col P, Tommasi E, Daris N, Cogliatti MG, Pianca A, Fragiacomo E, Vasta M, Sudano M, Pronti MG, Martinelli G, Andreani M, Ciandrini G, Lani S, Bogazzi AR, Bendinelli G, Pais M, Moro E, Cervellino F, Zampino A, Sinisi R, Mingardi R, Lora L, Stocchiero C, Basso A, Brun E, Strazzabosco M, Simoncini M, Grigoletto C, Zen F, Mesturino C.A., GENTILE, Sandro, Cimino, A, de Bigontina, G, Fava, D, Giorda, C, Meloncelli, I, Nicolucci, A, Pellegrini, F, Rossi, Mc, Gentile, Sandro, Arcangeli, A, Vespasiani, G, Graziano, G, Memmo, R, Pellicciotta, E, Pipitone, A, Bodner, E, Bonanome, A, Testa, I, Boemi, M, Giansanti, R, Romagnoli, F, Testa, R, Rabini, R, Brandoni, G, Paciotti, V, Alfidi, P, Verdecchia, B, Marangoni, A, Pianta, A, Ferrari, M, Bertone, V, Capellini, C, Camozzi, D, Remondini, E, Laffi, G, Ciavarella, A, Giangiulio, S, Grimaldi, M, Mustacchio, A, Santacroce, G, Marini, F, Bondesan, L, Valentini, U, Rocca, L, Girelli, A, Zarra, E, Agosti, B, Corsini, R, De Blasi, G, Bergmann, M, Trinchera, A, Masi, G, Macchitella, V, Mancuso, C, Trisciuzzi, L, Viehweider, B, Carboni, L, Turco, Mp, Delogu, A, Floris, M, Murtas, Mg, Farris, L, Manai, M, Spanu, F, Songini, M, Piras, G, Seguro, R, Floris, R, Corona, R, Lai, M, Lostia, S, Piras, E, Dolci, M, Mori, M, Baccetti, F, Gregori, G, Capretti, L, Speroni, G, Carbone, A, Fugazza, L, Pozzuoli, G, Laudato, M, Barone, M, Stasio, G, Grosso, J, Di Nardo, B, Rossi, L, Sciulli, A, Confortin, L, Marin, N, Lamonica, M, Lorenti, I, Starnone, V, Del Buono, A, Terracciano, Am, Boscolo Bariga, A, Ballarin, G, Nogara, A, De Boni, S, Chiambretti, A, Fornengo, R, Mularoni, Em, Rocca, A, Rumi, P, Balzarini, B, Pellegrini, Ma, Noacco, C, Tonutti, L, Venturini, G, Santantonio, G, Baldi, G, Massa, L, Ghilardi, G, Fiorina, P, Massafra, C, Lovagnini Scher, A, Panebianco, G, Tadiotto, F, Gaiti, D, Bosi, Ea, Chierici, G, Pilla, S, Copelli, M, Zanichelli, P, Bertelli, L, Caretta, P, Vezzani, V, Bodecchi, S, Longobucco, A, Ruggeri, P, Mondani, A, Persico, R, Rossi, C, Magro, G, Musacchio, N, Giancaterini, A, Marelli, G, Placentino, G, Richini, D, Molinari, S, Strazzeri, R, D'Ambrosio, M, Da Tos, V, Cotti, L, Garrapa, G, Foglini, P, Bedetta, C, Tortato, E, Pantanetti, P, Manicotti, R, Forte, E, Marrocco, C, Torri, A, Sommariva, D, Taboga, C, Catone, B, Ghisoni, G, Fabbri, F, Torresan, M, Marina, R, Campobasso, G, D'Ugo, E, Merni, M, Brunato, B, Rossi, M, Sabbatini, G, Quadri, F, Sambuco, L, Iannarelli, R, Pupillo, M, De Luca, A, Antenucci, D, Minnucci, A, Di Florio, C, Carnevale, A, Angelicola, G, Bosco, A, Fresco, R, Di Marco, G, Cogo, L, Meniconi, R, Bertoli, S, Cosimi, S, Giannini, F, di Carlo, A, Casadidio, I, Maolo, G, Polenta, B, Bruglia, M, Vincenti, C, Sciangula, L, Banfi, E, Ciucci, A, Contartese, A, Menicatti, L, Tatti, P, Bloise, D, Di Mauro, P, Masselli, L, Lo Presti, A, Scarpitta, Am, Gambina, F, Venezia, A, Morea, R, Lagonigro, G, Saitta, G, Cucinotta, D, Di Benedetto, A, Pata, P, Mancuso, T, Zocca, A, Aiello, B, Picca, M, Testori, G, Rampini, P, Cerutti, N, Mariani, G, Ragonesi, Pd, Bollati, P, Colapinto, P, Comoglio, M, Manti, G, Cernigoi, Am, Tortul, C, Volpi, A, Coracina, A, Cospite, Am, Manicardi, V, Michelini, M, Finardi, L, Galliani, S, Cilloni, R, Iemmi, M, Lombardi, S, Mattarello, Mj, Gatti, A, Giannettina, R, Gobbo, M, Bonavita, M, Creso, E, Turco, S, Turco, Aa, Iovine, C, De Natale, C, Zenari, L, Bertulini, L, Sorgato, C, Saglietti, G, Schellino, A, Mastinu, F, Cossu, M, Madau, G, Mulas, Mf, Zuccheddu, S, Torchio, G, Palumbo, P, Bianchi, A, Mattina, G, Zavaroni, I, Dei Cas, I, Franzini, L, Usberti, E, Antonimi, M, Anelli, N, Poli, R, Picchio, E, Del Sindaco, P, Spalluto, A, Maggiulli, L, Ricciardelli, L, La Penna, G, Gelisio, R, Vinci, C, Ianni, L, Lorenzetti, M, Marsocci, A, Di Bartolo, P, Scaramuzza, A, Melandri, P, Giovannini, C, Rastelli, E, Leotta, S, Suraci, C, Visalli, N, Gagliardi, A, Fontana, L, Altomare, M, Carletti, S, Abbruzzese, S, Chiaramonte, F, Giordano, R, Rossini, M, Migneco, G, Piergiovanni, F, Simonetta, A, Massimiani, F, Bulzomì, R, Armentano, G, Restuccia, Mg, Genovese, S, Locatelli, F, Croato, T, Nicoletti, M, Trojan, N, Li Volsi, P, Zanette, G, Clementi, L, Galetta, M, Santangelo, M, Bordin, P, Perale, L, Zanon, M, Sica, V, Sturaro, R, Raffa, M, Lione, L, Calcaterra, F, Cataldi, F, Miola, M, Manfrini, S, Rilli, S, Tanganelli, I, Felace, G, Fumagalli, I, Divizia, G, Agliani, M, Travaglini, A, Draghi, P, Acler, P, Romanelli, T, Inchiostro, S, Candido, R, Caroli, E, Manca, E, Petrucco, A, Da Ros, R, Da Col, P, Tommasi, E, Daris, N, Cogliatti, Mg, Pianca, A, Fragiacomo, E, Vasta, M, Sudano, M, Pronti, Mg, Martinelli, G, Andreani, M, Ciandrini, G, Lani, S, Bogazzi, Ar, Bendinelli, G, Pais, M, Moro, E, Cervellino, F, Zampino, A, Sinisi, R, Mingardi, R, Lora, L, Stocchiero, C, Basso, A, Brun, E, Strazzabosco, M, Simoncini, M, Grigoletto, C, Zen, F, and Mesturino, C. A.

Published
2011

8. Serum uric acid and risk of CKD in type 2 diabetes

Author

De Cosmo, S, Viazzi, F, Pacilli, A, Giorda, C, Ceriello, A, Gentile, S, Russo, Giuseppina, Rossi, Mc, Nicolucci, A, Guida, P, Feig, D, Johnson, Rj, Pontremoli, R, AMD Annals Study Group, Cosmo, Salvatore De, Viazzi, Francesca, Pacilli, Antonio, Giorda, Carlo, Ceriello, Antonio, Gentile, Sandro, Russo, Giuseppina, Rossi, Maria C., Nicolucci, Antonio, Guida, Pietro, Feig, Daniel, Johnson, Richard J., Pontremoli, Roberto, and Group, the AMD Annals Study

Subjects
Male, medicine.medical_specialty, Epidemiology, Renal function, Type 2 diabetes, urologic and male genital diseases, Critical Care and Intensive Care Medicine, Gastroenterology, albuminuria, Excretion, chemistry.chemical_compound, Risk Factors, Internal medicine, medicine, Humans, Hyperuricemia, Longitudinal Studies, Risk factor, Renal Insufficiency, Chronic, Aged, diabetes mellitus, glomerular filtration rate, Nephrology, Transplantation, business.industry, Original Articles, Middle Aged, medicine.disease, Uric Acid, Endocrinology, chemistry, Diabetes Mellitus, Type 2, uric acid, diabetes mellitus, chronic kidney disease, Albuminuria, Uric acid, Female, albuminuria, diabetes mellitus, glomerular filtration rate, medicine.symptom, business, Kidney disease
Abstract

BACKGROUND AND OBJECTIVE: Serum uric acid may predict the onset and progression of kidney disease, but it is unclear whether uric acid is an independent risk factor for diabetic nephropathy. Our aim was to study the relationship between uric acid levels and the development of CKD components in patients with type 2 diabetes. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Longitudinal study of a cohort of patients with type 2 diabetes from the database of the Italian Association of Clinical Diabetologists network. From a total of 62,830 patients attending the diabetes centers between January 1, 2004, and June 30, 2008, we considered those with baseline eGFR values ≥60 ml/min per 1.73 m2 and normal albumin excretion (n=20,142). Urinary albumin excretion, GFR, and serum uric acid were available in 13,964 patients. We assessed the association of serum uric acid quintiles with onset of CKD components by multinomial logistic regression model adjusting for potential confounders. We calculated the relative risk ratios (RRRs) for eGFR

Published
2015

9. Severe hypoglycemia and ketoacidosis over one year in Italian pediatric population with type 1 diabetes mellitus: a multicenter retrospective observational study

Author

Cherubini, V, Pintaudi, B, Rossi, Mc, Lucisano, G, Pellegrini, F, Chiumello, G, Frongia, Ap, Monciotti, C, Patera, Ip, Toni, S, Zucchini, S, Nicolucci, A, Lera, R, Iannilli, A, Giorgetti, C, Cesaretti, A, Paparusso, Am, Alessandrelli, Mc, Scipione, M, Balsamo, C, Gallo, F, Lo Presti, D, Passanisi, S, Tumini, S, Cipriano, P, Lazzaro, N, Vergerio, A, Banin, P, Lenzi, L, Coccioli, Ms, D'Annunzio, G, Bruzzese, M, Lombardo, F, Salzano, G, Bonfanti, R, Frontino, G, Battaglino, R, Iughetti, Lorenzo, Predieri, Barbara, Cadario, F, Savastio, S, Zabadneh, N, Zanella, C, Mozzo, E, Tiozzo, S, Benevento, D, Calcaterra, V, Larizza, D, Delvecchio, M, Trada, M, Rabbone, I, Sicignano, S, Cauvin, V, Franceschi, R, Gargantini, L, Pennati, C, Bianchi, G, Salvatoni, A, Maffeis, C, Marigliano, M, Sabbion, A, Arnaldi, C, Tosini, D, Tossi, Mc, Valentini, M, D'Alonzo, D, Pirozzoli, C, Di Nardo, B, Memmo, R, and Cianci, A.

Subjects
Male, medicine.medical_specialty, Children and adolescents, endocrine system diseases, Adolescent, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Insulin, Isophane, Medicine (miscellaneous), NPH insulin, TYPE I (INSULIN-DEPENDENT) DIABETES MELLITUS, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Insulin, Child, Retrospective Studies, Glycated Hemoglobin, Type 1 diabetes, Severe hypoglycemia, Nutrition and Dietetics, business.industry, Incidence (epidemiology), Incidence, Infant, Retrospective cohort study, Diabetes ketoacidosis, Ketosis, medicine.disease, Hypoglycemia, Ketoacidosis, Surgery, Diabetes Mellitus, Type 1, Italy, Child, Preschool, Regular insulin, Female, Cardiology and Cardiovascular Medicine, business
Abstract

Background and aims: Evaluation of incidence and correlates of severe hypoglycemia (SH) and diabetes ketoacidosis (DKA) in children and adolescents with T1DM. Methods and results: Retrospective study conducted in 29 diabetes centers from November 2011 to April 2012. The incidence of SH and DKA episodes and their correlates were assessed through a questionnaire administered to parents of patients aged 0e18 years. Incidence rates and incident rate ratios (IRRs) were estimated through multivariate Poisson regression analysis and multilevel analysis. Overall, 2025 patients were included (age 12.4 � 3.8 years; 53% males; diabetes dura- tion 5.6 � 3.5 years; HbA1c 7.9 � 1.1%). The incidence of SH and DKA were of 7.7 and 2.4 events/ 100 py, respectively. The risk of SH was higher in females (IRR Z 1.44; 95%CI 1.04e1.99), in pa- tients using rapid acting analogues as compared to regular insulin (IRR Z 1.48; 95%CI 0.97e2.26) and lower for patients using long acting analogues as compared to NPH insulin (IRR Z 0.40; 95% CI 0.19e0.85). No correlations were found between SH and HbA1c levels. The risk of DKA was higher in patients using rapid acting analogues (IRR Z 4.25; 95%CI 1.01e17.86) and increased with insulin units needed (IRR Z 7.66; 95%CI 2.83e20.74) and HbA1c levels (IRR Z 1.63; 95% CI 1.36e1.95). Mother' sa ge was inversely associated with the risk of both SH (IRRZ 0.95; 95%CI 0.92e0.98) and DKA (IRR Z 0.94; 95%CI 0.88e0.99). When accounting for center effect, the risk of SH associated with the use of rapid acting insulin analogues was attenuated (IRR Z 1.48; 95%CI 0.97e2.26); 33% and 16% of the residual variance in SH and DKA risk was ex- plained by center effect. Conclusion: The risk of SH and DKA is mainly associated with treatment modalities and strongly depends on the practice of specialist centers.

Published
2014

10. Sex disparities in the quality of diabetes care: biological and cultural factors may play a different role for different outcomes: a cross-sectional observational study from the AMD Annals initiative

Author

Rossi, Mc, Cristofaro, Mr, Gentile, S, Lucisano, G, Manicardi, V, Mulas, Mf, Napoli, Angela, Nicolucci, A, Pellegrini, F, Suraci, C, Giorda, C, and on behalf of the AMD Annals Study Group

Subjects
Male, Cholesterol, HDL, Disease Management, Blood Pressure, Cholesterol, LDL, Middle Aged, Cross-Sectional Studies, Sex Factors, Diabetes Mellitus, Type 2, Humans, Female, Epidemiology/Health Services Research, Triglycerides, Aged, Original Research
Abstract

OBJECTIVE To investigate the quality of type 2 diabetes care according to sex. RESEARCH DESIGN AND METHODS Clinical data collected during the year 2009 were extracted from electronic medical records; quality-of-care indicators were evaluated. Multilevel logistic regression analysis was applied to estimate the likelihood of women versus men to be monitored for selected parameters, to reach clinical outcomes, and to be treated with specific classes of drugs. The intercenter variability in the proportion of men and women achieving the targets was also investigated. RESULTS Overall, 415,294 patients from 236 diabetes outpatient centers were evaluated, of whom 188,125 (45.3%) were women and 227,169 (54.7%) were men. Women were 14% more likely than men to have HbA1c >9.0% in spite of insulin treatment (odds ratio 1.14 [95% CI 1.10–1.17]), 42% more likely to have LDL cholesterol (LDL-C) ≥130 mg/dL (1.42 [1.38–1.46]) in spite of lipid-lowering treatment, and 50% more likely to have BMI ≥30 kg/m2 (1.50 [1.50–1.54]). Women were less likely to be monitored for foot and eye complications. In 99% of centers, the percentage of men reaching the LDL-C target was higher than in women, the proportion of patients reaching the HbA1c target was in favor of men in 80% of the centers, and no differences emerged for blood pressure. CONCLUSIONS Women show a poorer quality of diabetes care than men. The attainment of the LDL-C target seems to be mainly related to pathophysiological factors, whereas patient and physician attitudes can play an important role in other process measures and outcomes.

Published
2013

11. [Major epidemiological changes and clinical variables in patients undergoing a program of heart rehabilitation after cardiac surgery - MEPHISTOPHELES]

Author

Baravelli, M, Picozzi, A, Rossi, A, Cattaneo, P, Imperiale, D, Rossi, Mc, Fantoni, Cecilia, Vezzaro, G, Crespi, L, Bosco, M, Borghi, S, Ballotta, A, Menicanti, L, Donatelli, F, Gronda, E, and Anzà, C.

Subjects
Male, Incidence, Heart Valve Diseases, Arrhythmias, Cardiac, Length of Stay, Middle Aged, Patient Readmission, Patient Admission, Tracheostomy, Treatment Outcome, Italy, Risk Factors, Prevalence, Humans, Female, Renal Insufficiency, Acute Coronary Syndrome, Cardiac Surgical Procedures, Coronary Artery Bypass, Respiratory Insufficiency, Aged, Heart Failure, Systolic, Retrospective Studies
Abstract

Recent observational studies show an increase of more complex and critically ill patients referred to Italian cardiac rehabilitation (CR) departments; the exact mechanisms underlying this phenomenon, however, have not been clearly identified. The aim of our study was to evaluate the epidemiological and clinical changes that occurred over the last decade in patients hospitalized in CR departments with high admittance rates.We have retrospectively evaluated all patients admitted between 2002 and 2009 to our division of CR (n = 3340, 1155 female, mean age 66.4 ± 11 years) after recent cardiac surgery. The study population was divided into two homogeneous groups: the four-year period 2002-2005, group A (n = 1614, 540 female, mean age 66.1 ± 10 years) and the four-year period 2006-2009, group B (n = 1726, 615 female, mean age 67.4 ± 11 years). Data were compared using specific indicators of clinical complexity.Patients aged75 years were more in group B compared to A (26.3 vs 19.8%, p0.0001), as well as patients with recent complex surgical interventions, such as combined coronary artery bypass grafting and heart valve surgery (16.4 vs 10.2%, p0.0001). An increased incidence of cardiovascular death (1.4 vs 0.6%, p=0.02), acute coronary syndrome (1.5 vs 0.7%, p=0.02) and persistent atrial fibrillation/flutter (13.5 vs 7.1%, p0.0001) was observed in group B, as well as an increased prevalence of systolic heart failure (18.3 vs 9.0%, p0.0001). Similarly, the incidence of acute respiratory failure episodes (1.0 vs 0.4%, p=0.05), the prevalence of patients admitted with a tracheostomy tube (2.6 vs 0.2%, p0.0001) and the incidence of acute renal failure (1.1 vs 0.5%, p=0.05) were significantly increased in group B. Postoperative infections and surgical wound complications were 4-fold higher in group B (13.9 vs 3.1%, p0.0001, and 12.8 vs 2.3%, p0.0001, respectively). Compared to group A, patients of group B showed a significantly lower physical performance, as expressed by the Rivermead motility index (3.8 ± 1.1 vs 5.2 ± 0.8, p0.001); moreover, the number of subjects able to perform an incremental training program was significantly lower in group B than group A (14.8 vs 60.6%, p0.0001). Mean hospital stay was longer in group B than group A (25.4 ± 13 vs 22.1 ± 9 days, p0.001).Our study, by collecting data from a CR division in northern Italy with high admittance rates, demonstrates a dramatic increase in clinical complexity over the last few years. This points to the need for new expertise and major resources to be allocated to CR departments.

Published
2011

13. Low-risk profile for malignant ventricular arrhythmias and sudden cardiac death after surgical ventricular reconstruction

Author

Baravelli, M, Cattaneo, P, Rossi, A, Rossi, Mc, Fantoni, Cecilia, Picozzi, A, Imperiale, D, Romano, M, Saporiti, L, Bregasi, A, Menicanti, L, and Anzà, C.

Subjects
Male, Heart Ventricles, Incidence, Middle Aged, Sensitivity and Specificity, Death, Sudden, Cardiac, Treatment Outcome, Ventricular Fibrillation, Electrocardiography, Ambulatory, Tachycardia, Ventricular, Humans, Female, Coronary Artery Bypass, Aged, Retrospective Studies
Abstract

Although it has been recently demonstrated that there was no significant difference in total survival and clinical outcomes between patients who underwent coronary artery bypass grafting (CABG) with or without surgical ventricular reconstruction (SVR), the question of whether or not SVR decreases the arrhythmic risk profile in this population has not been clarified yet.To determine the real incidence of sudden cardiac death (SCD) and sustained ventricular tachycardia/ventricular fibrillation (sustained VT/VF) in patients following CABG added to SVR and to define their clinical and echocardiographic parameters predicting in-hospital and long-term arrhythmic events (SCD + sustained VT/VF).Pre- and postoperative clinical and echocardiographic values as well as postoperative electrocardiogram Holter data of 65 patients (21 female, 63 ± 11 years) who underwent SVR + CABG were retrospectively evaluated. Mean follow-up was 1,105 ± 940 days. At 3 years, the SCD-free rate was 98% and the rate free from arrhythmic events was 88%. Multivariate logistic analysis identified a preoperative left ventricular end-systolic volume index (LVESVI)102 mL/m(2) (odds ratio [OR] 1.4, confidence interval [CI] 1.073-1.864, P = 0.02; sensitivity 100%, specificity 94%) and a postoperative pulmonary artery systolic pressure (PASP)27 mmHg (OR 2.3, CI 1.887-4.487, P = 0.01; sensitivity 100%, specificity 71%) as independent predictors of arrhythmic events.Our and previous studies report a low incidence of arrhythmic events in patients following SVR added to CABG, considering the high-risk profile of the study population. A preoperative LVESVI102 mL/m(2) and a postoperative PASP27 mmHg had a good sensitivity and specificity in predicting arrhythmic events.

Published
2010

28. Diabetes Interactive Diary: a new telemedicine system enabling flexible diet and insulin therapy while improving quality of life: an open-label, international, multicenter, randomized study.

Author

Rossi MC, Nicolucci A, Di Bartolo P, Bruttomesso D, Girelli A, Ampudia FJ, Kerr D, Ceriello A, Mayor Cde L, Pellegrini F, Horwitz D, Vespasiani G, Rossi, Maria C E, Nicolucci, Antonio, Di Bartolo, Paolo, Bruttomesso, Daniela, Girelli, Angela, Ampudia, Francisco J, Kerr, David, and Ceriello, Antonio

Abstract

Objective: Widespread use of carbohydrate counting is limited by its complex education. In this study we compared a Diabetes Interactive Diary (DID) with standard carbohydrate counting in terms of metabolic and weight control, time required for education, quality of life, and treatment satisfaction.Research Design and Methods: Adults with type 1 diabetes were randomly assigned to DID (group A, n = 67) or standard education (group B, n = 63) and followed for 6 months. A subgroup also completed the SF-36 Health Survey (SF-36) and World Health Organization-Diabetes Treatment Satisfaction Questionnaire (WHO-DTSQ) at each visit.Results: Of 130 patients (aged 35.7 +/- 9.4 years; diabetes duration 16.5 +/- 10.5 years), 11 dropped out. Time for education was 6 h (range 2-15 h) in group A and 12 h (2.5-25 h) in group B (P = 0.07). A1C reduction was similar in both groups (group A from 8.2 +/- 0.8 to 7.8 +/- 0.8% and group B from 8.4 +/- 0.7 to 7.9 +/- 1.1%; P = 0.68). Nonsignificant differences in favor of group A were documented for fasting blood glucose and body weight. No severe hypoglycemic episode occurred. WHO-DTSQ scores increased significantly more in group A (from 26.7 +/- 4.4 to 30.3 +/- 4.5) than in group B (from 27.5 +/- 4.8 to 28.6 +/- 5.1) (P = 0.04). Role Physical, General Health, Vitality, and Role Emotional SF-36 scores improved significantly more in group A than in group B.Conclusions: DID is at least as effective as traditional carbohydrate counting education, allowing dietary freedom for a larger proportion of type 1 diabetic patients. DID is safe, requires less time for education, and is associated with lower weight gain. DID significantly improved treatment satisfaction and several quality-of-life dimensions. [ABSTRACT FROM AUTHOR]

Published
2010
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29. Open, Randomized, Multicentre Italian Trial on Peg-Ifn plus Ribavirin versus Peg-Ifn Monotherapy for Chronic Hepatitis C in HIV-Coinfected Patients on Haart

Author

Cargnel, Antonietta, Angeli, Elena, Mainini, Annalisa, Gubertini, Guido, Giorgi, Riccardo, Schiavini, Monica, Duca, Piergiorgio, Scalise, G, Cesare, S Di, Chiodo, F, Verucchi, G, Farci, P, Serra, G, Sagnelli, E, Nacca, C, Ferraro, T, Scerbo, A, Santoro, D, Pusterla, L, Viganò, P, Magnani, C, Ghinelli, F, Sighinolfi, L, Vigevani, G, Pastecchia, C, Moroni, M, Milazzo, L, Esposito, R, Borghi, V, Piccinino, F, Filippini, P, Cadrobbi, P, Sattin, A, Ferrari, C, Antoni, A Degli, Stagni, G, Francisci, D, Petrelli, E, Alberici, F, Sacchini, D, Zauli, T, Donà, D De, Arlotti, M, Mori, F, Marranconi, F, Caramello, P, Lipani, F, Soranzo, ML, Macor, A, Vaglia, A, Rossi, MC, Grossi, P, Tambini, R, De Lalla, F, and Tositti, G

Abstract

Background Chronic hepatitis C is common and aggressive in HIV-positive patients, so the development of a well-tolerated HCV therapy is a priority. We evaluated the efficacy and safety of pegylated interferon a2b (PEG-IFN) plus ribavirin (RBV) versus PEG-IFN monotherapy in HIV/HCV-coinfected patients undergoing highly active antiretroviral therapy (HAART), and analysed the predictive factors of response.Methods An Italian, multicentre, open-label trial including 135 coinfected patients, randomized to PEG-IFN 1.5 µg/kg/week plus RBV 400 mg twice daily (n=69, arm A) or PEG-IFN 1.5 µg/kg/week (n=66, arm B) for 48 weeks. We assessed the predictive values of early virological response (EVR) at week 8 (HCV-RNA drop >2 log10compared with baseline or undetectable levels) on sustained virological response (SVR).Results Fifty-five patients (28 from arm A and 27 from arm B) completed 48 weeks of therapy. At the end of treatment, 20/28 patients in arm A and 11/27 in arm B had HCV-RNA <50 IU/ml. In a per-protocol analysis, SVR was reached by 54% of patients in arm A (genotype 2–3, 11/16; genotype 1–4, 4/12) and 22% in arm B (genotype 2–3, 3/15; genotype 1–4, 3/12). In an intention-to-treat analysis, the SVR was 22% in arm A (genotype 2–3, 11/32; genotype 1–4, 4/37) versus 9% in arm B (genotype 2–3, 3/32; genotype 1–4, 3/34). The best predictors of SVR were the use of combination therapy, infection with HCV genotype 3 versus genotype 1, and EVR at week 8. Thirty patients (15 from arm A and 15 from arm B) dropped out of the trial prematurely due to side effects. The positive predictive value of EVR at week 8 was 65%, the negative predictive value was 86%.Conclusions PEG-IFN plus RBV can be considered a solid option for the treatment of HIV/HCV-coinfected patients. The key to successfully improving efficacy is strong compliance through strict overall patient monitoring, in order to best manage drug toxicity. EVR assessment at week 8 may become a useful stategy in the management of therapy.

Published
2005
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30. Sex Disparities in the Quality of Diabetes Care: Biological and Cultural Factors May Play a Different Role for Different Outcomes

Author

Antonio Nicolucci, Maria Chiara Rossi, Angela Napoli, Carlo Giorda, Valeria Manicardi, Concetta Suraci, Maria Rosaria Cristofaro, Sandro Gentile, Giuseppe Lucisano, Fabio Pellegrini, Maria Franca Mulas, Rossi, Mc, Cristofaro, Mr, Gentile, Sandro, Lucisano, G, Manicardi, V, Mulas, Mf, Napoli, A, Nicolucci, A, Pellegrini, F, Suraci, C, and Giorda, C.

Subjects
Advanced and Specialized Nursing, Research design, medicine.medical_specialty, Cross-sectional study, business.industry, Endocrinology, Diabetes and Metabolism, Medical record, diabetes mellitus, gender medicine, Odds ratio, Type 2 diabetes, medicine.disease, Surgery, Diabetes mellitus, Internal Medicine, medicine, Observational study, Disease management (health), business, Demography
Abstract

OBJECTIVE To investigate the quality of type 2 diabetes care according to sex. RESEARCH DESIGN AND METHODS Clinical data collected during the year 2009 were extracted from electronic medical records; quality-of-care indicators were evaluated. Multilevel logistic regression analysis was applied to estimate the likelihood of women versus men to be monitored for selected parameters, to reach clinical outcomes, and to be treated with specific classes of drugs. The intercenter variability in the proportion of men and women achieving the targets was also investigated. RESULTS Overall, 415,294 patients from 236 diabetes outpatient centers were evaluated, of whom 188,125 (45.3%) were women and 227,169 (54.7%) were men. Women were 14% more likely than men to have HbA1c >9.0% in spite of insulin treatment (odds ratio 1.14 [95% CI 1.10–1.17]), 42% more likely to have LDL cholesterol (LDL-C) ≥130 mg/dL (1.42 [1.38–1.46]) in spite of lipid-lowering treatment, and 50% more likely to have BMI ≥30 kg/m2 (1.50 [1.50–1.54]). Women were less likely to be monitored for foot and eye complications. In 99% of centers, the percentage of men reaching the LDL-C target was higher than in women, the proportion of patients reaching the HbA1c target was in favor of men in 80% of the centers, and no differences emerged for blood pressure. CONCLUSIONS Women show a poorer quality of diabetes care than men. The attainment of the LDL-C target seems to be mainly related to pathophysiological factors, whereas patient and physician attitudes can play an important role in other process measures and outcomes.

Published
2013
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31. PrEP in Italy: The time may be ripe but who's paying the bill? A nationwide survey on physicians' attitudes towards using antiretrovirals to prevent HIV infection

Author

Teresa Bini, Maria Cristina Rossi, Giuseppe Nunnari, Niccolò Riccardi, Dario Bartolozzi, Nicoletta Ladisa, P. Colletti, Antonio Di Biagio, Stefano Bonora, Giovanni Mazzola, Marco Borderi, Alessio Signori, Andrea Gori, Annalisa Saracino, Diego Ripamonti, Filippo Castelnuovo, Sergio Lo Caputo, Giancarlo Orofino, Salvatore Martini, Caterina Sagnelli, Renato Maserati, Silvia Nozza, Benedetto Maurizio Celesia, Tiziana Quirino, Di Biagio, Antonio, Riccardi, Niccolã², Signori, Alessio, Maserati, Renato, Nozza, Silvia, Gori, Andrea, Bonora, Stefano, Borderi, Marco, Ripamonti, Diego, Rossi, Maria Cristina, Orofino, Giancarlo, Quirino, Tiziana, Nunnari, Giuseppe, Celesia, Benedetto Maurizio, Martini, Salvatore, Sagnelli, Caterina, Mazzola, Giovanni, Colletti, Pietro, Bartolozzi, Dario, Bini, Teresa, Ladisa, Nicoletta, Castelnuovo, Filippo, Saracino, Annalisa, Lo Caputo, Sergio, Nulla, nullDi Biagio, Riccardi, N, Signori, A, Maserati, R, Nozza, S, Gori, A, Bonora, S, Borderi, M, Ripamonti, D, Rossi, Mc, Orofino, G, Quirino, T, Nunnari, G, Celesia, Bm, Martini, S, Mazzola, G, Colletti, P, Bartolozzi, D, Bini, T, Ladisa, N, Castelnuovo, F, Saracino, A, and Nulls, nullLo Caputo

Subjects
Genetics and Molecular Biology (all), RNA viruses, Health Knowledge, Attitudes, Practice, Medical Doctors, Cross-sectional study, Health Care Providers, Human immunodeficiency virus (HIV), Alternative medicine, lcsh:Medicine, Social Sciences, HIV Infections, 030204 cardiovascular system & hematology, medicine.disease_cause, Nationwide survey, Pathology and Laboratory Medicine, Pre-Exposure Prophylaxi, Biochemistry, Geographical Locations, Drug Users, 0302 clinical medicine, Immunodeficiency Viruses, Surveys and Questionnaires, Health care, Agency (sociology), Medicine and Health Sciences, Ethnicities, Psychology, Surveys and Questionnaire, Public and Occupational Health, HIV Infection, 030212 general & internal medicine, lcsh:Science, Practice, Multidisciplinary, Traditional medicine, Health Knowledge, Italian People, Addicts, Europe, Professions, Italy, Medical Microbiology, Viral Pathogens, Viruses, Infectious diseases, Pathogens, Research Article, Human, Risk, medicine.medical_specialty, Anti-HIV Agents, HIV prevention, MEDLINE, Addiction, Viral diseases, Microbiology, Cross-Sectional Studies, Humans, Physicians, Pre-Exposure Prophylaxis, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), 03 medical and health sciences, Retroviruses, medicine, Microbial Pathogens, National health, Cross-Sectional Studie, business.industry, Prophylaxis, lcsh:R, Lentivirus, Organisms, Biology and Life Sciences, HIV, Anti-HIV Agent, Health Care, Physician, Attitudes, Family medicine, People and Places, lcsh:Q, Population Groupings, Preventive Medicine, business
Abstract

Several studies have demonstrated the efficacy of the oral pre-exposure prophylaxis (PrEP) with tenofovir (with or without emtricitabine) on preventing HIV-negative partners of HIV infected patients to become infected through sexual contacts. PrEP is already available in the United States and now is approved by European Medicine Agency. In this setting we would like to gauge physicians’ knowledge, acquaintance with and attitude to include PrEP in their clinical practice. A cross sectional survey was conducted among Italian physicians expert on antiretroviral therapy. Out of 146 physicians, 35% of participants declared to be familiar with PrEP but only 46% of them believed that, currently, there are not enough reasons to make it available in Italy. 51% of physicians have already been attracted to prescribe it and 63.4% have been openly asked about PrEP. The main concerns noticed were: the risk of acquire other sexual transmitted diseases (STDs) (70% of physicians feared that PrEP could favor STDs spread), the potential harmful of PrEP if not adequately implemented and, especially the risk of possible side effects if not properly used. Nevertheless, 55.9% of participants believed that Health Authorities face an ethical obligation to make PrEP available as part of the strategies to protect from HIV transmission and half of the respondents asked for further researches to better define the role for PrEP. Attitudes regarding PrEP impact on Italian National Health Organization were also very interesting: 57.5% of participants did not believe that investing in PrEP would be an appropriate use of healthcare resources, while 70.6% affirmed that PrEP’s financial coverage should not be funded by the Italian National System of Health (SSN). This survey showed a high awareness of PrEP potential among Italian physicians coupled with a great deal of skepticism about how and if implementing it in clinical practice.

Published
2017

32. Demethylation of the RORC2 and IL17A in human CD4+ T lymphocytes defines Th17 origin of nonclassic Th1 cells

Author

Maria Caterina Rossi, Veronica Santarlasci, Francesco Liotta, Lorenzo Cosmi, Manuela Capone, Andreas Thiel, Valentina Querci, Alessio Mazzoni, Enrico Maggi, Raffaele De Palma, Sergio Romagnani, Jun Dong, Rolando Cimaz, Laura Maggi, Francesco Annunziato, Hyun-Dong Chang, Andreas Radbruch, Mazzoni, A, Santarlasci, V, Maggi, L, Capone, M, Rossi, Mc, Querci, V, DE PALMA, Raffaele, Chang, Hd, Thiel, A, Cimaz, R, Liotta, F, Cosmi, L, Maggi, E, Radbruch, A, Romagnani, S, Dong, J, and Annunziato, F.

Subjects
CD4-Positive T-Lymphocytes, Immunology, Cell, Retinoic acid, C-C chemokine receptor type 6, Biology, Autoimmune Disease, Models, Biological, Autoimmune Diseases, Immunophenotyping, Nuclear Receptor Subfamily 2, Group C, Member 2, chemistry.chemical_compound, Interferon-gamma, T-Lymphocyte Subsets, medicine, Immunology and Allergy, Humans, Epigenetics, Promoter Regions, Genetic, Gene, Orphan receptor, Precursor Cells, T-Lymphoid, Interleukin-17, Methylation, DNA Methylation, Th1 Cells, Molecular biology, medicine.anatomical_structure, Phenotype, chemistry, Gene Expression Regulation, Th17, DNA methylation, CD4 Antigens, Cytokines, Th17 Cells, T-Box Domain Proteins, NK Cell Lectin-Like Receptor Subfamily B
Abstract

Th17-derived Th1 lymphocytes, termed nonclassic, differ from classic Th1 cells because of the presence of retinoic acid orphan receptor (ROR)C2 and the surface expression of CD161 and CCR6. We demonstrate in this article that nonclassic Th1 cells, like Th17 cells, have a marked RORC2 and IL17A demethylation, whereas classic Th1 cells exhibit a complete methylation of these genes. The analysis of RORC2 DNA methylation in the CD4+CD161+ and CD4+CD161− naive Th subsets from umbilical cord blood surprisingly revealed comparable hypermethylation levels. PCR analysis at the single-cell level revealed that RORC2 mRNA was expressed by none of the CD4+CD161− and present only in a minority of CD4+CD161+ naive Th cells. These findings provide two important novel observations on the physiology of human Th17 cells: 1) they confirm at the epigenetic level the origin of nonclassic Th1 cells from Th17 cells, also identifying in the RORC2 and IL17A methylation status a novel tool for their distinction from classic Th1 cells, and 2) they demonstrate that RORC2-expressing cells are only a minority in the subset of CD4+CD161+ naive Th cells, which are known to contain all Th17 cell precursors.

Published
2015

33. Differential cell architecture and microenvironmental responses of pretumoral and tumoral cellular models exposed to coverslip-induced hypoxia.

Author

Millán M, Parietti F, Lamela F, De Rossi MC, Benítez B, Levi V, Domingues M, Bologna-Molina R, Arocena M, and Hochmann J

Subjects
Humans, Cell Hypoxia, Tumor Cells, Cultured, Tumor Microenvironment
Abstract

The tumor microenvironment is an altered milieu that imposes multiple selective pressures leading to the survival and dissemination of aggressive and fit tumor cell subpopulations. How pre-tumoral and tumoral cells respond to changes in their microenvironment will determine the subsequent evolution of the tumor. In this study, we have subjected pre-tumoral and tumoral cells to coverslip-induced hypoxia, which recapitulates the intracellular hypoxia and extracellular acidification characteristic of the early tumor microenvironment, and we have used a combination of quantitative phase microscopy and epifluorescence to analyze diverse cellular responses to this altered environment. In normoxia, tumor cells showed differences in nuclear organization, as evidenced by decreased numbers of HP1 foci, and in hypoxia major changes in nuclear architecture were observed, with tumor cells significantly increasing the number of high dry mass density foci in the nucleus compared to pre-tumoral and non-tumoral cells. Conversely, compared to pre-tumoral and normal cells, mitochondrial ATP levels decayed markedly in tumor cells in hypoxia, whereas the activation of executioner caspases increased only in tumor cells in this condition. Therefore, in terms of cellular organization, metabolic changes and activation of cell death processes, tumor cells showed more dramatic responses to an altered microenvironment than their pre-tumoral and normal counterparts, responses which in turn could play fundamental roles in shaping future tumor development., Competing Interests: Declarations. Conflict of interest: The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Published
2025
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34. When Does Metabolic Memory Start? Insights From the Association of Medical Diabetologists Annals Initiative on Stringent HbA1c Targets.

Author

Russo GT, Nicolucci A, Lucisano G, Rossi MC, Ceriello A, Prattichizzo F, Manicardi V, Rocca A, Di Bartolo P, De Cosmo S, Di Cianni G, and Candido R

Subjects
Humans, Male, Female, Middle Aged, Aged, Glycemic Control, Italy epidemiology, Registries, Blood Glucose metabolism, Incidence, Glycated Hemoglobin metabolism, Diabetes Mellitus, Type 2 epidemiology, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 metabolism, Cardiovascular Diseases prevention & control, Cardiovascular Diseases epidemiology
Abstract

Early, intensive glycemic control in patients with type 2 diabetes (T2D) is associated with long-term benefits in cardiovascular disease (CVD) development. Evidence on benefits of achieving HbA1c targets close to normal values is scant. Individuals with newly diagnosed T2D, without CVD at baseline, were identified in an Italian clinical registry (n = 251,339). We adopted three definitions of early exposure periods (0-1, 0-2, and 0-3 years). Mean HbA1c was categorized into HbA1c <5.7%, 5.7-6.4%, 6.5-7.0%, 7.1-8.0%, and >8.0%. The outcome was the incidence of major cardiovascular events. After a mean follow-up of 4.6 ± 2.9 years, at multivariate Cox regression analysis, compared with mean HbA1c <5.7% during the first year after diagnosis, the increase in the risk of CVD was 24%, 42%, 49%, and 56% for patients with HbA1c of 5.7-6.4%, 6.5-7.0%, 7.1-8.0%, and >8.0%, respectively. The same trend was documented in all exposure periods. In conclusion, our data support that an early achievement of stringent targets of HbA1c <5.7% is worthy for CVD prevention., (© 2024 by the American Diabetes Association.)

Published
2025
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35. Generalizability of kidney and cardiovascular protection by finerenone to the real world in Italy: insights from Fidelio and Figaro studies.

Author

De Cosmo S, Pontremoli R, Giandalia A, Manicardi V, Rocca A, Nicolucci A, Rossi MC, Lucisano G, Graziano G, Di Bartolo P, Di Cianni G, Candido R, and Russo GT

Abstract

Background: We evaluated the proportion of Type 2 diabetes (T2D) patients with chronic kidney disease (CKD) participating in the AMD (Association of Medical Diabetologists) Annals initiative who met the eligibility criteria for phase III-studies on finerenone, showing its renal and cardiovascular benefits., Methods: This analysis involved all T2D patients seen in 2019 in 282 diabetes centers in Italy, for whom data on kidney function (estimated glomerular filtration rate and albuminuria) were available. Data are presented separately for different scenarios, covering the population with main eligibility criteria for inclusion in the FIDELIO-DKD and FIGARO-DKD trials., Results: Among 343,037 T2D patients involved in the analysis, 5.4% met the eligibility criteria of the FIDELIO-DKD study (13.3% if we consider the population with fundus data) and 22.3% met those of the FIGARO-DKD trial. Overall, 110,000 (33%) patients were eligible for treatment with finerenone, with a male prevalence, an average age of 71 years, and good control of the main risk factors (HbA1c 7.3%; BP 138/76 mmHg; LDL-c 87 mg/dl), albeit with large percentages of not well controlled patients (50% with SBP > 140 mmHg; > 30% with LDL-c > 100 mg/dl). Over 12% were on sodium/glucose cotransporter 2 inhibitors or glucagon-like peptide 1 receptor agonists. Based on the event rate from the FIDELITY pooled analysis, the number of potentially avoidable events was 21.7 per 1000 eligible patients for the cardiovascular composite outcome and 16.7 for the renal outcome., Conclusions: This analysis showed that approximately 33% of patients with T2D present the main eligibility criteria for treatment with finerenone and could therefore benefit from it in the near future., Competing Interests: Declarations. Conflict of interest: The authors have no competing interests to disclose. Ethical approval: Local ethics committees of each participating center approved the study protocol. Human and animal rights statement: All Authors declare: this research did not involve animals. The research was conducted on human subjects, following procedures in accordance with the ethical standards of the responsible Committees (this is a retrospective multicenter study) on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent: Given the anonymous nature of the study, based on the Italian regulations, informed consent is not requested., (© 2024. The Author(s) under exclusive licence to Italian Society of Nephrology.)

Published
2024
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36. Prevalence and clinical determinants of rapid eGFR decline among patients with newly diagnosed type 2 diabetes.

Author

Russo GT, Giandalia A, Lucisano G, Rossi MC, Piscitelli P, Pontremoli R, Viazzi F, Rocca A, Manicardi V, Di Cianni G, Candido R, Nicolucci A, and De Cosmo S

Subjects
Humans, Male, Female, Middle Aged, Aged, Prevalence, Risk Factors, Albuminuria epidemiology, Kidney Failure, Chronic epidemiology, Kidney Failure, Chronic physiopathology, Disease Progression, Glycated Hemoglobin analysis, Italy epidemiology, Linear Models, Diabetic Retinopathy epidemiology, Diabetic Retinopathy diagnosis, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 epidemiology, Glomerular Filtration Rate, Diabetic Nephropathies epidemiology, Diabetic Nephropathies diagnosis, Diabetic Nephropathies physiopathology
Abstract

Background: Diabetic kidney disease is the most common cause of end-stage kidney disease (ESKD) in the western world. Rapid estimated glomerular filtration rate (eGFR) decline is an independent predictor of ESKD and death in the general population and in subjects with type 2 diabetes mellitus (T2D)., Aim: We investigated in a large sample of subjects with newly diagnosed T2D the prevalence and clinical determinants of fast eGFR decline, taking advantage from the dataset of the Associazione Medici Diabetologi (AMD) Annals initiative., Methods: The eGFR trajectories were evaluated by applying a linear mixed model for repeated measures (LMMRM) and rapid eGFR decline defined as an eGFR decline greater than 5 mL/min/1.73 m2 per year at 3 years., Results: Among 105,163 (57.7% M) subjects with newly diagnosed T2D, 13,587 (12.9 %) subjects showed a rapid eGFR loss. The independent significant predictors were age, female gender, HbA1c, smoking, high baseline eGFR, albuminuria and retinopathy., Conclusion: Our study demonstrates that a significant percentage of newly diagnosed T2D subjects have a rapid eGFR decline. Given the association between dynamic changes in eGFR and the risk of ESKD or death, we suggest to include this variable in the definition of CKD., (Copyright © 2024. Published by Elsevier B.V.)

Published
2024
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37. Assessing the reliability of rapid frozen tissue sections from pre-transplant kidney biopsies in DCD donors and correlations with clinico-pathological data: a pilot study.

Author

Mansour N, Battocchio RM, Storaci A, Rossi MC, Torelli R, De Feo TM, Ferrero S, and Del Gobbo A

Subjects
Humans, Pilot Projects, Biopsy methods, Retrospective Studies, Reproducibility of Results, Male, Female, Middle Aged, Adult, Brain Death, Tissue and Organ Procurement methods, Time Factors, Creatinine blood, Warm Ischemia, Kidney Transplantation, Kidney pathology, Tissue Donors, Frozen Sections
Abstract

Compared to donations after brain death, donations after circulatory death present a series of difficulties: the acquisition of the family's consent, the need for qualified personnel and specific resources, death assessment, assessment of the organ, and graft care (pre- and post-transplant). These are all time-related factors that negatively impact the organ, resulting in increased tubular, glomerular, and vascular damage. The evaluation of the organ, as per today's standards, requires three hours for the preparation and processing of formalin-fixed paraffin-embedded (FFPE) samples. An alternative to this is the use of the extemporaneous frozen biopsy. However, frozen samples are considered a second choice in the decision-making process. This retrospective study investigates the reliability of the frozen samples in identifying a series of morphological alterations compared to the more accepted results from FFPE samples. Additionally, two important clinical data, terminal serum creatinine levels and warm ischemia time, were correlated to the presence of some morphological alterations in an attempt to find effective and fast strategies to predict the kidney transplant outcome., Competing Interests: Declarations. Conflict of interest: The authors declare no potential conflict of interest with respect to the research, authorship, and/or publication of this article. Ethical approval statement and informed consent: Not applicable., (© 2024. Italian Society of Surgery (SIC).)

Published
2024
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38. Severe Hypertriglyceridemia in Patients with Type 2 Diabetes Mellitus Participating in the AMD Annals Initiative.

Author

Russo GT, Manicardi V, Rocca A, Nicolucci A, Giandalia A, Lucisano G, Rossi MC, Graziano G, Di Bartolo P, De Cosmo S, Candido R, and Di Cianni G

Subjects
Humans, Male, Female, Middle Aged, Aged, Prevalence, Severity of Illness Index, Adult, Risk Factors, Hyperlipoproteinemia Type I blood, Hyperlipoproteinemia Type I epidemiology, Hyperlipoproteinemia Type I complications, Hyperlipoproteinemia Type I diagnosis, Glycated Hemoglobin analysis, Glycated Hemoglobin metabolism, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 epidemiology, Hypertriglyceridemia epidemiology, Hypertriglyceridemia blood, Hypertriglyceridemia complications, Triglycerides blood
Abstract

Background: Familial chylomicronemia syndrome (FCS) is a rare inherited condition due to lipoprotein lipase deficiency, characterized by hyperchylomicronemia and severe hypertriglyceridemia. Diagnosis is often delayed, thus increasing the risk of acute pancreatitis and hospitalization. Hypertriglyceridemia is a common finding in patients with type 2 diabetes (T2D), who may harbor FCS among the most severe forms. Aim of the Study: We investigated the prevalence and clinical characteristics associated with severe hypertriglyceridemia in a range indicative of FCS, in a large population of subjects with T2D. Methods: Within the large population of the AMD Annals Initiative, patients with T2D with a lipid profile suggestive of FCS [triglycerides >880 mg/dL and/or high-density lipoprotein (HDL)-cholesterol <22 mg/dL or non-HDL-cholesterol ≤70 mg/dL] and their clinical features have been identified. Results: Overall, 8592 patients had triglyceride values >880 mg/dL in a single examination, 613 in two examinations, and 34 in three or more measurements. Patients with high triglyceride levels were mostly male (80%), with a relatively young age (54 years), short duration of diabetes (6.3 years), and elevated hemoglobin A1c (HbA1c) levels (9.4%). By stratifying this group of patients according to the severity of hypertriglyceridemia, more severe hypertriglyceridemia (triglyceride levels ≥2000 mg/dL) was associated with an even younger age (52 vs. 54 years), even higher mean HbA1c values (10.0% vs. 9.4%), and significantly higher HDL-cholesterol levels (37.9 vs. 32.4 mg/dL; P < 0.0001). Patients with persistently elevated triglyceride levels ( n = 34), on three measurements, had a younger age; lower body mass index, HbA1c, and HDL-cholesterol levels; more frequent use of fibrates and insulin; and a higher prevalence of major cardiovascular events. Conclusions: Severe hypertriglyceridemia is a frequent condition in outpatients with T2D participating in the AMD Annals Initiative, and it is associated with male sex, young age, short disease duration, and a worse glycemic profile. Among patients with persistent severe hypertriglyceridemia, hidden FCS may be present.

Published
2024
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39. Mesenchymal Stem Cells and Tissue Bioengineering Applications in Sheep as Ideal Model.

Author

Muniz TDTP, Rossi MC, de Vasconcelos Machado VM, and Alves ALG

Abstract

The most common technologies in tissue engineering include growth factor therapies; metal implants, such as titanium; 3D bioprinting; nanoimprinting for ceramic/polymer scaffolds; and cell therapies, such as mesenchymal stem cells (MSCs). Cell therapy is a promising alternative to organ grafts and transplants in the treatment of numerous musculoskeletal diseases. MSCs have increasingly been used in generative medicine due to their specialized self-renewal, immunomodulation, multiplication, and differentiation properties. To further expand the potential of these cells in tissue repair, significant efforts are currently dedicated to the production of biomaterials with desirable short- and long-term biophysical properties that can aid the differentiation and expansion of MSCs. Biomaterials support MSC differentiation by modulating their characteristics, such as composition, mechanical properties, porosity, and topography. This review aimed to describe recent MSC approaches, including those associated with biomaterials, from experimental, clinical, and preclinical studies with sheep models., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Talita D'Paula Tavares Pereira Muniz et al.)

Published
2024
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40. Treatment intensification following glucagon-like peptide-1 receptor agonists in type 2 diabetes: Comparative effectiveness analyses between different basal insulins. RESTORE-G real-world study.

Author

Napoli R, Nicolucci A, Larosa M, Rossi MC, and Candido R

Subjects
Humans, Female, Male, Retrospective Studies, Middle Aged, Aged, Blood Glucose drug effects, Drug Therapy, Combination, Italy epidemiology, Treatment Outcome, Comparative Effectiveness Research, Drug Substitution, Hypoglycemia chemically induced, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 blood, Hypoglycemic Agents therapeutic use, Glycated Hemoglobin analysis, Glycated Hemoglobin drug effects, Insulin Glargine therapeutic use, Insulin Glargine administration & dosage, Insulin, Long-Acting therapeutic use, Glucagon-Like Peptide-1 Receptor Agonists
Abstract

Aim: To compare the effectiveness of different basal insulins (BI) prescribed as an add-on to or switch from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy., Materials and Methods: Retrospective, real-world data from electronic medical records of 32 Italian diabetes clinics were used, after propensity score adjustment, to compare effectiveness after 6 months of treatment with second- versus first-generation BI (2BI vs. 1BI) or glargine 300 U/ml versus degludec 100 U/ml (Gla-300 vs. Deg-100), when added to (ADD-ON) or in substitution of (SWITCH) GLP-1 RA. Only comparisons, including a minimum of 100 patients per group, were performed to ensure adequate robustness of the analyses., Results: In the ADD-ON cohort (N = 700), greater benefits of 2BI versus 1BI were found in glycated haemoglobin {HbA1c; estimated mean difference: -0.32% [95% confidence interval (CI) -0.62; -0.02]; p = .04} and fasting blood glucose [FBG; -20.73 mg/dl (95% CI -35.62; -5.84); p = .007]. In the SWITCH cohort (N = 2097), greater benefits of 2BI versus 1BI were found in HbA1c [-0.22% (95% CI -0.42; -0.02); p = .03], FBG [-10.15 mg/dl (95% CI -19.04; -1.26); p = .03], and body weight [-0.67 kg (95% CI -1.30; -0.04); p = .04]. In the SWITCH cohort starting 2BI (N = 688), marked differences in favour of Gla-300 versus Deg-100 were documented in HbA1c [-0.89% (95% CI -1.26; -0.52); p < .001] and FBG [-17.89 mg/dl (95% CI -32.45; -3.33); p = .02]. Using propensity score matching as a sensitivity analysis, the benefit on HbA1c was confirmed [-0.55% (95% CI -1.02; -0.08); p = .02]. BI titration was suboptimal in all examined cohorts., Conclusions: 2BI are a valuable option to intensify GLP-1 RA therapy. Switching to Gla-300 versus Deg-100 was associated with greater HbA1c improvement., (© 2024 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Published
2024
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41. Effectiveness of switching from first-generation basal insulin to Glargine 300 U/mL in children and adolescents with type 1 diabetes: results from the ISPED CARD database.

Author

Rossi MC, Bonfanti R, Graziano G, Larosa M, Lombardo F, Nicolucci A, Vespasiani G, Zucchini S, and Rabbone I

Subjects
Humans, Adolescent, Male, Child, Female, Retrospective Studies, Insulin administration & dosage, Insulin therapeutic use, Treatment Outcome, Databases, Factual, Drug Substitution statistics & numerical data, Diabetes Mellitus, Type 1 drug therapy, Diabetes Mellitus, Type 1 blood, Insulin Glargine administration & dosage, Insulin Glargine therapeutic use, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents therapeutic use, Glycated Hemoglobin analysis, Glycated Hemoglobin metabolism, Blood Glucose drug effects, Blood Glucose metabolism, Blood Glucose analysis
Abstract

Aims: Glargine 300 U/mL (Gla-300) has been recently approved for use in children and adolescents with type 1 diabetes (T1D). However, real-world effectiveness data are scarce, and aim of this analysis was to assess clinical outcomes in young patients with T1D switching from 1st generation basal insulin (1BI) to Gla-300., Methods: ISPED CARD is a retrospective, multicenter study, based on data anonymously extracted from Electronic Medical Records. The study involved a network of 20 pediatric diabetes centers. Data on all patients aged < 18 years with T1D switching from 1BI to Gla-300 were analyzed to assess clinical characteristics at the switch and changes after 6 and 12 months in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), and standardized body mass index (BMI/SDS). Titration of basal and short-acting insulin doses was also evaluated., Results: Overall, 200 patients were identified. The mean age at the switch to Gla-300 was 13 years, and mean duration of diabetes was 3.9 years. Average HbA1c levels at switch were 8.8%. After 6 months, HbA1c levels decreased by - 0.88% (95% CI - 1.28; - 0.48; p < 0.0001). The benefit was maintained after 12 months from the switch (mean reduction of HbA1c levels - 0.80%, 95% CI - 1.25; - 0.35, p = 0.0006). Trends of reduction in FBG levels were also evidenced both at 6 months and 12 months. No significant changes in short-acting and basal insulin doses were documented., Conclusions: The study provides the first real-world evidence of the effectiveness of Gla-300 in children and adolescents with T1D previously treated with 1BI. The benefits in terms of HbA1c levels reduction were substantial, and sustained after 12 months. Additional benefits can be expected by improving the titration of insulin doses., (© 2024. Springer-Verlag Italia S.r.l., part of Springer Nature.)

Published
2024
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42. Influence of inflammation on the expression of microRNA-140 in extracellular vesicles from 2D and 3D culture models of synovial-membrane-derived stem cells.

Author

Pfeifer JPH, Stievani FC, Fernandes CJDC, Rosa GDS, Apolonio EVP, Rossi MC, Zambuzzi WF, and Alves ALG

Abstract

Background: In osteoarthritis (OA), articular homeostasis is regulated by microRNA-140 that inhibits ADAMTS-5, an enzyme that cleaves aggrecan and stimulates the synthesis of other inflammatory mediators. This study aims to evaluate the expression of microRNA-140 in extracellular vesicles (EVs) derived from equine synovial-membrane-derived mesenchymal stem cells (eqSMMSCs) cultured in monolayer (2D) and three-dimensional (3D) culture models under an in vitro inflammatory environment., Methods: Four experimental groups of eqSMMSC cultures were defined for isolation of the EVs. The 2D and 3D control groups were cultured in a conventional cell culture medium, while the 2D-OA and 3D-OA treatment groups were exposed to an OA-like medium containing IL-1β and TNFα. The culture media samples were collected at 24 h, 72 h, and 120 h time points for EV isolation and characterization using nanoparticle tracking analysis (NTA) and transmission electron microscopy (TEM). Reverse transcription quantitative polymerase chain reaction was employed to assess the expressions of microRNA-140 in both the cells and EVs. All statistical analyses were conducted at the 5% significance level., Results: Encapsulation of the eqSMMSCs protected the cells from the inflammatory media compared to the monolayer cultures. EVs were found in higher concentrations in the 3D-OA cultures. Additionally, higher expressions of microRNA-140 were observed in the cells of the 3D-OA group at 24 and 72 h, whereas microRNA-140 expressions in the EVs were higher in the 3D group at 72 h and in the 2D-OA group at 120 h ( p < 0.001). However, the 3D-OA culture showed higher expression of the mRNA Adamts5 in the EVs at 120 h., Conclusion: The responses of the eqSMMSCs to inflammatory stimuli involve intracellular expression of microRNA-140 and its subsequent transportation via the EVs, with quicker responses observed in the 3D than 2D cultures. This study sheds light on the behaviors of stem cells in restoring homeostasis in osteoarthritic joints., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Pfeifer, Stievani, Fernandes, Rosa, Apolonio, Rossi, Zambuzzi and Alves.)

Published
2024
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43. Treatment intensification following glucagon-like peptide-1 receptor agonist in type 2 diabetes: Comparative effectiveness analyses between free vs. fixed combination of GLP-1 RA and basal insulin. RESTORE-G real-world study.

Author

Candido R, Nicolucci A, Larosa M, Rossi MC, and Napoli R

Subjects
Aged, Female, Humans, Male, Middle Aged, Biomarkers blood, Blood Glucose drug effects, Blood Glucose metabolism, Drug Combinations, Drug Substitution, Electronic Health Records, Incretins adverse effects, Incretins therapeutic use, Insulin Glargine adverse effects, Insulin Glargine therapeutic use, Insulin Glargine administration & dosage, Insulin, Long-Acting therapeutic use, Insulin, Long-Acting adverse effects, Insulin, Long-Acting administration & dosage, Italy, Liraglutide adverse effects, Liraglutide therapeutic use, Retrospective Studies, Time Factors, Treatment Outcome, Comparative Effectiveness Research, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 diagnosis, Glycated Hemoglobin metabolism, Glycemic Control adverse effects, Hypoglycemic Agents therapeutic use, Hypoglycemic Agents adverse effects, Hypoglycemic Agents administration & dosage, Glucagon-Like Peptide-1 Receptor Agonists
Abstract

Background and Aims: Add-on of basal insulin (BI) to intensify the ongoing therapy with glucagon-like peptide 1 receptor agonist (GLP-1 RA) is recommended, but it is unclear if free or fixed combination of BI and GLP-1 RA produce similar outcomes. A retrospective comparative effectiveness analysis of the add-on of glargine 300 U/mL (Gla-300) to ongoing GLP-1 RA vs. switch to fixed ratio combination of degludec and liraglutide (iDegLira) was performed., Methods and Results: Real-world data collected in electronic medical records by 32 Italian diabetes clinics. Propensity score (PS) adjustment was applied to assess changes in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), body weight, and BI dose after 6 months from Gla-300 or iDegLira initiation. Compared to iDegLira group (N = 260), Gla-300+GLP-1 RA group (N = 255) had older age and higher levels of HbA1c (9.1 vs. 8.9%). After 6 months, statistically significant greater FBG improvement [estimated mean difference and 95% confidence intervals: -24.05 mg/dl (-37.04; -11.06; p = 0.0003) and BI dose increase [+0.03 U/kg (95%CI 0.00; 0.06); p = 0.009] were found in the free vs. fixed combination group, although low doses of BI (0.2 U/kg) were reached in both groups. Trends of larger HbA1c and body weight reductions with the free combination were also found, without reaching the statistical significance., Conclusion: Although inertia in insulin initiation and titration was documented in both groups, higher benefit on FBG control was obtained with free vs. fixed combination, likely due to a better titration of BI and GLP-1 RA., Competing Interests: Declaration of competing interest Riccardo Candido has received consultancy fees from Boehringer Ingelheim, Eli-Lilly, Novo Nordisk, Astra-Zeneca, Sanofi-Aventis, Roche Diabetes Care; speaking fees from Astra Zeneca, Boehringer Ingelheim, Eli-Lilly, Novo Nordisk, Sanofi-Aventis, Mundipharma Pharmaceutical, Abbott, MSD, Neopharmed Gentili, Menarini, Essex Italia, Ascensia Diabetes. Antonio Nicolucci and Maria Chiara Rossi have received funding for research from Sanofi, NovoNordisk, Alfasigma, Artsana, AstraZeneca, Johnson&Johnson, Medtronic, Shionogi, SOBI, Meteda and Theras. Monica Larosa is an employee of Sanofi and may hold shares and/or stock options in the company. Raffaele Napoli has served on advisory board panels, received consultancy and speaker's fees or financial support for research from AstraZeneca, Boerhinger Ingelheim, Eli Lilly, Novo Nordisk, MSD, Sanofi., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2024
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44. Temporal trends in the starting of insulin therapy in type 2 diabetes in Italy: data from the AMD Annals initiative.

Author

Giandalia A, Nicolucci A, Modugno M, Lucisano G, Rossi MC, Manicardi V, Rocca A, Di Cianni G, Di Bartolo P, Candido R, Cucinotta D, and Russo GT

Subjects
Humans, Female, Male, Italy epidemiology, Middle Aged, Aged, Glycated Hemoglobin analysis, Follow-Up Studies, Time Factors, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 epidemiology, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents therapeutic use, Insulin administration & dosage, Insulin therapeutic use, Blood Glucose analysis, Blood Glucose metabolism, Blood Glucose drug effects
Abstract

Aims: Opportunities and needs for starting insulin therapy in Type 2 diabetes (T2D) have changed overtime. We evaluated clinical characteristics of T2D subjects undergoing the first insulin prescription during a 15-year-observation period in the large cohort of the AMD Annals Initiative in Italy., Methods: Data on clinical and laboratory variables, complications and concomitant therapies and the effects on glucose control after 12 months were evaluated in T2D patients starting basal insulin as add-on to oral/non-insulin injectable agents, and in those starting fast-acting in add-on to basal insulin therapy in three 5-year periods (2005-2019)., Results: We evaluated data from 171.688 T2D subjects who intensified therapy with basal insulin and 137.225 T2D patients who started fast-acting insulin. Overall, intensification with insulin occurred progressively earlier over time in subjects with shorter disease duration. Moreover, the percentage of subjects with HbA1c levels > 8% at the time of basal insulin initiation progressively decreased. The same trend was observed for fast-acting formulations. Clinical characteristics of subjects starting insulin did not change in the three study-periods, although all major risk factors improved overtime. After 12 months from the starting of basal or fast-acting insulin therapy, mean HbA1c levels decreased in all the three investigated time-periods, although mean HbA1c levels remained above the recommended target., Conclusions: In this large cohort of T2D subjects, a progressively earlier start of insulin treatment was observed during a long observation period, suggesting a more proactive prescriptive approach. However, after 12 months from insulin prescription, in many patients, HbA1c levels were still out-of-target., (© 2024. The Author(s).)

Published
2024
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45. The quality of care in type 1 and type 2 diabetes - A 2023 update of the AMD Annals initiative.

Author

Russo G, De Cosmo S, Di Bartolo P, Lucisano G, Manicardi V, Nicolucci A, Rocca A, Rossi MC, Di Cianni G, and Candido R

Subjects
Humans, Aged, Middle Aged, Female, Male, Italy epidemiology, Glycated Hemoglobin analysis, Glycated Hemoglobin metabolism, Adult, Aged, 80 and over, Diabetes Mellitus, Type 2 therapy, Diabetes Mellitus, Type 2 epidemiology, Diabetes Mellitus, Type 1 therapy, Diabetes Mellitus, Type 1 epidemiology, Quality of Health Care
Abstract

Aims: An initiative of continuous monitoring of the quality of diabetes care, promoted by the Association of Medical Diabetologists, is in place in Italy since 2006 (AMD Annals). The initiative was effective in improving quality of care indicators, assessed periodically through standardized measures. Here, we show the 2023 AMD Annals data on type 2 (T2D) and type 1 (T1D) diabetes., Methods: A network of over 1/3 of diabetes centers in Italy periodically extracts anonymous data from electronic medical records, using a standardized software. Process, treatment and outcome indicators, and a validated score of overall care, the Q-score, were evaluated., Results: 296 centers provided data on 573,164 T2D (mean age 69.7 ± 11.2 years) and 42,611 T1D subjects (mean age 48.6 ± 16.9 years). A HbA1c value ≤ 7.0 % was documented in 56.3 % of patients with T2D and 35.9 % of those with T1D. Only 6.6 % of T2D patients and 3.5 % of those with T1D reached the composite outcome of HbA1c ≤ 7.0 % + LDL-C < 70 mg/dl + BP < 130/80 mmHg. Notably, only 2.8 % and 3.2 % of T2D and T1D patients, respectively, showed a Q score < 15, which correlates with an 80 % higher risk of incident CVD events compared to scores > 25., Conclusions: We documented an overall good quality of care in both T1D and T2D subjects. However, the failure to achieve the targets of the main risk factors, especially if combined, in a still too large proportion of patients testify the difficulty to apply the more and more stringent indications recommended by guidelines in the everyday clinical practice., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)

Published
2024
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46. Continuous improvement of quality of care in pediatric diabetes: the ISPED CARD clinical registry.

Author

Nicolucci A, Graziano G, Lombardo F, Rabbone I, Rossi MC, Vespasiani G, Zucchini S, and Bonfanti R

Subjects
Humans, Child, Adolescent, Male, Female, Italy epidemiology, Glycated Hemoglobin analysis, Glycated Hemoglobin metabolism, Child, Preschool, Quality of Health Care standards, Infant, Registries statistics & numerical data, Diabetes Mellitus, Type 1 therapy, Quality Improvement
Abstract

Aim: In Italy, the ISPED CARD initiative was launched to measure and improve quality of care in children and adolescents with type 1 diabetes., Methods: Process and outcome indicators and the related information derived from electronic medical records were identified. A network of pediatric diabetes centers was created on a voluntary basis., Results: Overall, 20 centers provided data on 3284 patients aged <  = 18 years. HbA1c was monitored ≥ 2/year in 81.2% of the cases. BMI was monitored ≥ 1/year in 99.0%, lipid profile in 45.3%, and blood pressure in 91.7%. Pubertal status, albuminuria, eye examination, and screening of celiac disease and thyroiditis were underreported. From 2017 to 2021, average HbA1c levels decreased from 7.8 ± 1.2 to 7.6 ± 1.3%, while patients with LDL cholesterol > 100 mg/dl increased from 18.9 to 36.7%. Prevalence of patients with elevated blood pressure and BMI/SDS values also increased. In 2021, 44.7% of patients were treated with the newest basal insulins, while use of regular human insulin had dropped to 7.7%. Use of insulin pump remained stable (37.9%)., Conclusions: This report documents the feasibility of the ISPED CARD initiative and shows lights and shadows in the care provided. Improving care, increasing number of centers, and ameliorating data recording represent future challenges., (© 2024. The Author(s).)

Published
2024
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48. Alginate-Based Carriers Loaded with Mulberry ( Morus alba L.) Leaf Extract: A Promising Strategy for Prolonging 1-Deoxynojirimicyn (DNJ) Systemic Activity for the Nutraceutical Management of Hyperglycemic Conditions.

Author

Marchetti L, Truzzi E, Rossi MC, Benvenuti S, Cappellozza S, Saviane A, Bogataj L, Siligardi C, and Bertelli D

Subjects
1-Deoxynojirimycin chemistry, Dietary Supplements, Plant Extracts chemistry, Plant Leaves metabolism, Alginates metabolism, Morus chemistry
Abstract

The iminosugar 1-deoxynojirimicyn (DNJ) contained in mulberry leaves has displayed systemic beneficial effects against disorders of carbohydrate metabolism. Nevertheless, its effect is impaired by the short half-life. Alginate-based carriers were developed to encapsulate a DNJ-rich mulberry extract: Ca-alginate beads, obtained by external gelation, and spray-dried alginate microparticles (SDMs). Mean size and distribution, morphology, drug loading, encapsulation efficiency, experimental yield, and release characteristics were determined for the two formulations. Ca-alginate beads and SDMs exhibited an encapsulation efficiency of about 54% and 98%, respectively, and a DNJ loading in the range of 0.43-0.63 μg/mg. The in vitro release study demonstrated the carriers' capability in controlling the DNJ release in acid and basic conditions (<50% in 5 h), due to electrostatic interactions, which were demonstrated by 1H-NMR relaxometry studies. Thus, alginate-based particles proved to be promising strategies for producing food supplements containing mulberry leaf extracts for the management of hyperglycemic state.

Published
2024
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49. A readout system for highly sensitive diamond detectors for FLASH dosimetry.

Author

Pettinato S, Felici G, Galluzzo L, Rossi MC, Girolami M, and Salvatori S

Abstract

Accurate dosimetry of ultra-high dose-rate beams using diamond detectors remains challenging, primarily due to the elevated photocurrent peaks exceeding the input dynamics of precision electrometers. This work aimed at demonstrating the effectiveness of compact gated-integration electronics in conditioning the current peaks (>20 mA) generated by a highly sensitive ( S  ≃ 26 nC/Gy) custom-made diamond photoconductor under electron FLASH irradiation, as well as in real-time monitoring of beam dose and dose-rate. For the emerging FLASH technology, this study provided a new perspective on using commercially available diamond dosimeters with high sensitivity, currently employed in conventional radiotherapy., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Giuseppe Felici is a SIT S.p.A. shareholder. Lorenzo Galluzzo is an employee at SIT S.p.A., (© 2024 The Author(s).)

Published
2024
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50. Treatment intensification following glucagon-like peptide-1 receptor agonist treatment in type 2 diabetes: The RESTORE-G real-world study.

Author

Candido R, Nicolucci A, Larosa M, Rossi MC, and Napoli R

Abstract

Background and Aims: To assess intensification approaches with basal insulin (BI) following glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment in type 2 diabetes (T2D)., Methods and Results: Real-world data were collected in electronic medical records by 32 Italian diabetes clinics between 2011 and 2021. Primary endpoint was the proportion of insulin-naïve T2D patients treated with GLP-1 RA who initiated (add-on or switch) BI. Secondary endpoints were: treatment approaches, mean time to BI start, effectiveness and safety. Among 7,962 eligible patients, BI was prescribed to 3,164 (39.7%; 95%CI 38.7; 40.8): 67.6% switched to BI (22.1% also starting 1-3 injections of short-acting insulin), 22.7% added BI while maintaining GLP-1 RA, and 9.7% switched to a fixed-ratio combination of GLP-1 RA and BI (FRC). Median time since the first GLP-1 RA to BI/FRC prescription was 27.4 (IQ range 11.8-53.5) months. In this study 60.3% of patients did not start BI/FRC, among whom 15.2% intensified GLP-1 RA therapy with other oral agents. Effectiveness and safety were documented in all intensification approaches with BI/FRC, but HbA1c level at intensification time of ≥9.0% and suboptimal BI titration suggested clinical inertia. Use of second generation BI and add-on to GLP-1 RA schemes increased over time and effectiveness improved., Conclusion: Clinical inertia should be overcome using innovative insulin options. Timely combination therapy of BI and GLP-1 RA is a valuable choice., Competing Interests: Conflict of interest Riccardo Candido has received consultancy fees from Boehringer Ingelheim, Eli-Lilly, Novo Nordisk, Astra-Zeneca, Sanofi-Aventis, Roche Diabetes Care; speaking fees from Astra Zeneca, Boehringer Ingelheim, Eli-Lilly, Novo Nordisk, Sanofi-Aventis, Mundipharma Pharmaceutical, Abbott, MSD, Neopharmed Gentili, Menarini, Essex Italia, Ascensia Diabetes. Antonio Nicolucci and Maria Chiara Rossi have received funding for research from Sanofi, NovoNordisk, Alfasigma, Artsana, AstraZeneca, Johnson&Johnson, Medtronic, Shionogi, SOBI, Meteda and Theras. Monica Larosa is an employee of Sanofi and may hold shares and/or stock options in the company. Raffaele Napoli has served on advisory board panels, received consultancy and speaker's fees or financial support for research from AstraZeneca, Boerhinger Ingelheim, Eli Lilly, Novo Nordisk, MSD, Sanofi., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Published
2023
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