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2. Predictors of serious adverse events and non-response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid

Author

De Vincentis, A, D'Amato, D, Cristoferi, L, Gerussi, A, Malinverno, F, Lleo, A, Colapietro, F, Marra, F, Galli, A, Fiorini, C, Coco, B, Brunetto, M, Niro, G, Cotugno, R, Saitta, C, Cozzolongo, R, Losito, F, Giannini, E, Labanca, S, Marzioni, M, Marconi, G, Morgando, A, Pellicano, R, Vanni, E, Cazzagon, N, Floreani, A, Chessa, L, Morelli, O, Muratori, L, Pellicelli, A, Pompili, M, Ponziani, F, Tortora, A, Rosina, F, Russello, M, Cannavo, M, Simone, L, Storato, S, Vigano, M, Abenavoli, L, D'Anto, M, De Gasperi, E, Distefano, M, Scifo, G, Zolfino, T, Calvaruso, V, Cuccorese, G, Palitti, V, Sacco, R, Bertino, G, Frazzetto, E, Alvaro, D, Mulinacci, G, Palermo, A, Scaravaglio, M, Terracciani, F, Galati, G, Ronca, V, Zuin, M, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Vespasiani-Gentilucci, U, Carbone, M, Feletti, V, Mussetto, A, Venere, R, Bernaccioni, G, Graciella Pigozzi, M, Fagiuoli, S, Terreni, N, Pozzoni, P, Baiocchi, L, Grassi, G, Vinci, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, De Vincentis A., D'Amato D., Cristoferi L., Gerussi A., Malinverno F., Lleo A., Colapietro F., Marra F., Galli A., Fiorini C., Coco B., Brunetto M., Niro G. A., Cotugno R., Saitta C., Cozzolongo R., Losito F., Giannini E. G., Labanca S., Marzioni M., Marconi G., Morgando A., Pellicano R., Vanni E., Cazzagon N., Floreani A., Chessa L., Morelli O., Muratori L., Pellicelli A., Pompili M., Ponziani F., Tortora A., Rosina F., Russello M., Cannavo M., Simone L., Storato S., Vigano M., Abenavoli L., D'Anto M., De Gasperi E., Distefano M., Scifo G., Zolfino T., Calvaruso V., Cuccorese G., Palitti V. P., Sacco R., Bertino G., Frazzetto E., Alvaro D., Mulinacci G., Palermo A., Scaravaglio M., Terracciani F., Galati G., Ronca V., Zuin M., Claar E., Izzi A., Picardi A., Invernizzi P., Vespasiani-Gentilucci U., Carbone M., Feletti V., Mussetto A., Venere R., Bernaccioni G., Graciella Pigozzi M., Fagiuoli S., Terreni N., Pozzoni P., Baiocchi L., Grassi G., Vinci M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., De Vincentis, A, D'Amato, D, Cristoferi, L, Gerussi, A, Malinverno, F, Lleo, A, Colapietro, F, Marra, F, Galli, A, Fiorini, C, Coco, B, Brunetto, M, Niro, G, Cotugno, R, Saitta, C, Cozzolongo, R, Losito, F, Giannini, E, Labanca, S, Marzioni, M, Marconi, G, Morgando, A, Pellicano, R, Vanni, E, Cazzagon, N, Floreani, A, Chessa, L, Morelli, O, Muratori, L, Pellicelli, A, Pompili, M, Ponziani, F, Tortora, A, Rosina, F, Russello, M, Cannavo, M, Simone, L, Storato, S, Vigano, M, Abenavoli, L, D'Anto, M, De Gasperi, E, Distefano, M, Scifo, G, Zolfino, T, Calvaruso, V, Cuccorese, G, Palitti, V, Sacco, R, Bertino, G, Frazzetto, E, Alvaro, D, Mulinacci, G, Palermo, A, Scaravaglio, M, Terracciani, F, Galati, G, Ronca, V, Zuin, M, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Vespasiani-Gentilucci, U, Carbone, M, Feletti, V, Mussetto, A, Venere, R, Bernaccioni, G, Graciella Pigozzi, M, Fagiuoli, S, Terreni, N, Pozzoni, P, Baiocchi, L, Grassi, G, Vinci, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, De Vincentis A., D'Amato D., Cristoferi L., Gerussi A., Malinverno F., Lleo A., Colapietro F., Marra F., Galli A., Fiorini C., Coco B., Brunetto M., Niro G. A., Cotugno R., Saitta C., Cozzolongo R., Losito F., Giannini E. G., Labanca S., Marzioni M., Marconi G., Morgando A., Pellicano R., Vanni E., Cazzagon N., Floreani A., Chessa L., Morelli O., Muratori L., Pellicelli A., Pompili M., Ponziani F., Tortora A., Rosina F., Russello M., Cannavo M., Simone L., Storato S., Vigano M., Abenavoli L., D'Anto M., De Gasperi E., Distefano M., Scifo G., Zolfino T., Calvaruso V., Cuccorese G., Palitti V. P., Sacco R., Bertino G., Frazzetto E., Alvaro D., Mulinacci G., Palermo A., Scaravaglio M., Terracciani F., Galati G., Ronca V., Zuin M., Claar E., Izzi A., Picardi A., Invernizzi P., Vespasiani-Gentilucci U., Carbone M., Feletti V., Mussetto A., Venere R., Bernaccioni G., Graciella Pigozzi M., Fagiuoli S., Terreni N., Pozzoni P., Baiocchi L., Grassi G., Vinci M., Bellia V., Boldizzoni R., Casella S., Omazzi B., and Poggi G.

Abstract

Background & Aims: Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with “advanced cirrhosis” because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non-response in cirrhotic patients undergoing OCA therapy. Methods: Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non-response were reported as risk ratios (RR) with 95% confidence intervals (CIs). Results: One hundred PBC cirrhotics were included, 97 Child-Pugh class A and 3 class B. Thirty-one had oesophageal varices and 5 had a history of ascites. Thirty-three per cent and 32% of patients achieved a biochemical response at 6 and 12 months respectively. Male sex (adjusted-RR 1.75, 95%CI 1.42–2.12), INR (1.37, 1.00–1.87), Child-Pugh score (1.79, 1.28–2.50), MELD (1.17, 1.04–1.30) and bilirubin (1.83, 1.11–3.01) were independently associated with non-response to OCA. Twenty-two patients discontinued OCA within 12 months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted-RR 1.91, 95%CI 1.10–3.36), lower albumin levels (0.18, 0.06–0.51), Child-Pugh score (2.43, 1.50–4.04), history of ascites (3.5, 1.85–6.5) and bilirubin (1.30, 1.05–1.56), were associated with hepatic SAEs. A total bilirubin≥1.4 mg/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA. Conclusions: An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level ≥1.4 mg/dl should discourage from its use.

Published
2022

3. Long-term results from the Italian real-world experience on obeticholic acid treatment in primary biliary cholangitis: The RECAPITULATE study

Author

Terracciani, F., primary, De Vincentis, A., additional, D'Amato, D., additional, Invernizzi, P., additional, Morgando, A., additional, Vanni, E., additional, Viganò, M., additional, Alvaro, D., additional, Venere, R., additional, Lleo, A., additional, Colapietro, F., additional, Degasperi, E., additional, Viganò, R., additional, Giannini, E.G., additional, Labanca, S., additional, Feletti, V., additional, Mussetto, A., additional, Cozzolongo, R., additional, Losito, F., additional, Pompili, M., additional, Ponziani, F.R., additional, Niro, G.A., additional, Cotugno, R., additional, Pozzoni, P., additional, Chessa, L., additional, Cuccorese, G., additional, Palitti, V. Pace, additional, Russello, M., additional, Cannavò, M., additional, Frazzetto, E., additional, Bertino, G., additional, Marzioni, M., additional, Terreni, N., additional, Zolfino, T., additional, Saitta, C., additional, Pellicelli, A., additional, Coco, B., additional, Brunetto, M., additional, Cazzagon, N., additional, Floreani, A., additional, Muratori, L., additional, Rosina, F., additional, Di Stefano, M., additional, Scifo, G., additional, Baiocchi, L., additional, Grassi, G., additional, Sacco, R., additional, Izzi, A., additional, Crocè, S. Lory, additional, Fiorini, C., additional, Marra, F., additional, Simone, L., additional, Morelli, O., additional, Abenavoli, L., additional, Pizzolante, F., additional, De Matthaeis, N., additional, Scaravaglio, M., additional, Gimignani, G., additional, Boano, V., additional, Manfredi, G.F., additional, Marignani, M., additional, Fanella, S., additional, Giacchetto, M., additional, Castellaneta, A., additional, Poggi, G., additional, Buzzanca, V., additional, Scivetti, P., additional, Tortora, A., additional, Casella, S., additional, Bellia, V., additional, Omazzi, B.F., additional, Alagna, G., additional, Ricci, C., additional, Poisa, P., additional, Rigamonti, C., additional, Calvaruso, V., additional, Carbone, M., additional, and Vespasiani-Gentilucci, U., additional

Published
2023
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4. Prediction of response to obeticholic acid in primary biliary cholangitis: Development and validation of the OCA response score (ORS)

Author

De Vincentis, A., primary, Terracciani, F., additional, D'Amato, D., additional, Invernizzi, P., additional, Morgando, A., additional, Vanni, E., additional, Viganò, M., additional, Alvaro, D., additional, Venere, R., additional, Lleo, A., additional, Colapietro, F., additional, Degasperi, E., additional, Viganò, R., additional, Giannini, E.G., additional, Labanca, S., additional, Feletti, V., additional, Mussetto, A., additional, Cozzolongo, R., additional, Losito, F., additional, Pompili, M., additional, Ponziani, F.R., additional, Niro, G.A., additional, Cotugno, R., additional, Pozzoni, P., additional, Chessa, L., additional, Cuccorese, G., additional, Palitti, V. Pace, additional, Russello, M., additional, Cannavò, M., additional, Frazzetto, E., additional, Bertino, G., additional, Marzioni, M., additional, Terreni, N., additional, Zolfino, T., additional, Saitta, C., additional, Pellicelli, A., additional, Coco, B., additional, Brunetto, M., additional, Cazzagon, N., additional, Floreani, A., additional, Muratori, L., additional, Rosina, F., additional, Di Stefano, M., additional, Scifo, G., additional, Baiocchi, L., additional, Grassi, G., additional, Sacco, R., additional, Izzi, A., additional, Crocè, Saveria Lory, additional, Fiorini, Cecilia, additional, Marra, Fabio, additional, Simone, Loredana, additional, Morelli, Olivia, additional, Abenavoli, L., additional, Pizzolante, F., additional, De Matthaeis, N., additional, Scaravaglio, M., additional, Gimignani, G., additional, Boano, V., additional, Manfredi, G.F., additional, Marignani, M., additional, Fanella, S., additional, Giacchetto, M., additional, Castellaneta, A., additional, Poggi, G., additional, Buzzanca, V., additional, Scivetti, P., additional, Tortora, A., additional, Casella, S., additional, Bellia, V., additional, Omazzi, B.F., additional, Alagna, G., additional, Ricci, C., additional, Poisa, P., additional, Rigamonti, C., additional, Calvaruso, V., additional, Vespasiani-Gentilucci, U., additional, and Carbone, M., additional

Published
2023
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5. Real-world experience with obeticholic acid in patients with primary biliary cholangitis

Author

D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D., De Vincentis A., Malinverno F., Vigano M., Alvaro D., Pompili M., Picciotto A., Palitti V. P., Russello M., Storato S., Pigozzi M. G., Calvaruso V., De Gasperi E., Lleo A., Castellaneta A., Pellicelli A., Cazzagon N., Floreani A., Muratori L., Fagiuoli S., Niro G. A., Feletti V., Cozzolongo R., Terreni N., Marzioni M., Pellicano R., Pozzoni P., Baiocchi L., Chessa L., Rosina F., Bertino G., Vinci M., Morgando A., Vanni E., Scifo G., Sacco R., D'Anto M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., Cristoferi L., Gerussi A., Ronca V., Venere R., Ponziani F., Cannavo M., Mussetto A., Fontana R., Losito F., Frazzetto E., Distefano M., Colapietro F., Labanca S., Marconi G., Grassi G., Galati G., O'Donnell S. E., Mancuso C., Mulinacci G., Palermo A., Claar E., Izzi A., Picardi A., Invernizzi P., Carbone M., Vespasiani-Gentilucci U., D'Amato, D, De Vincentis, A, Malinverno, F, Vigano, M, Alvaro, D, Pompili, M, Picciotto, A, Palitti, V, Russello, M, Storato, S, Pigozzi, M, Calvaruso, V, De Gasperi, E, Lleo, A, Castellaneta, A, Pellicelli, A, Cazzagon, N, Floreani, A, Muratori, L, Fagiuoli, S, Niro, G, Feletti, V, Cozzolongo, R, Terreni, N, Marzioni, M, Pellicano, R, Pozzoni, P, Baiocchi, L, Chessa, L, Rosina, F, Bertino, G, Vinci, M, Morgando, A, Vanni, E, Scifo, G, Sacco, R, D'Anto, M, Bellia, V, Boldizzoni, R, Casella, S, Omazzi, B, Poggi, G, Cristoferi, L, Gerussi, A, Ronca, V, Venere, R, Ponziani, F, Cannavo, M, Mussetto, A, Fontana, R, Losito, F, Frazzetto, E, Distefano, M, Colapietro, F, Labanca, S, Marconi, G, Grassi, G, Galati, G, O'Donnell, S, Mancuso, C, Mulinacci, G, Palermo, A, Claar, E, Izzi, A, Picardi, A, Invernizzi, P, Carbone, M, Vespasiani-Gentilucci, U, D'Amato D., De Vincentis A., Malinverno F., Vigano M., Alvaro D., Pompili M., Picciotto A., Palitti V. P., Russello M., Storato S., Pigozzi M. G., Calvaruso V., De Gasperi E., Lleo A., Castellaneta A., Pellicelli A., Cazzagon N., Floreani A., Muratori L., Fagiuoli S., Niro G. A., Feletti V., Cozzolongo R., Terreni N., Marzioni M., Pellicano R., Pozzoni P., Baiocchi L., Chessa L., Rosina F., Bertino G., Vinci M., Morgando A., Vanni E., Scifo G., Sacco R., D'Anto M., Bellia V., Boldizzoni R., Casella S., Omazzi B., Poggi G., Cristoferi L., Gerussi A., Ronca V., Venere R., Ponziani F., Cannavo M., Mussetto A., Fontana R., Losito F., Frazzetto E., Distefano M., Colapietro F., Labanca S., Marconi G., Grassi G., Galati G., O'Donnell S. E., Mancuso C., Mulinacci G., Palermo A., Claar E., Izzi A., Picardi A., Invernizzi P., Carbone M., and Vespasiani-Gentilucci U.

Abstract

Background & aims: Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods: Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed. Results: We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria, and 11% by normal range criteria. Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p = 0.004), although with similar ALP reduction (29.4% vs. 34%, p = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%). Conclusions: Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compare

Published
2021

6. Persistence of both reversible airway obstruction and higher blood eosinophils may predict lung function decline in severe asthma

Author

Sposato B., Scalese M., Ricci A., Rogliani P., Paggiaro P., Migliorini M. G., Di Tomassi M., Olivieri C., Perrella A., Camiciottoli G., Maselli R., Pelaia G., Busceti M. T., Sabato E., Cagnazzo M. G., Colombo F., Palumbo L., Ravazzi A., Bucca C., Caiaffa M. F., Berra A., Calabrese C., Stanziola A. A., Schino P., Di Gioacchino M., Cazzola M., Segreti A., Pastorello E. A., Scibilia G., Vianello A., Marchi M. R., Paladini L., Baglioni S., Abbritti M., Almerigogna F., Matucci A., Vultaggio A., Maggi E., Maestrelli P., Guarnieri G., Steinhilber G., Bonavia M., Rottoli P., Bargagli E., Senna G., Caminati M., Macchia L., Bellia V., Scichilone N., Novelli F., Latorre M., Vergura L., Masieri S., Rosati Y., Milanese M., Folletti I., Pio R., Pio A., Maccari U., Maggiorelli C., Scala R., Vignale L., Pulera N., Carpagnano G. E., Foschino Barbaro M. P., Sposato B., Scalese M., Ricci A., Rogliani P., Paggiaro P., Migliorini M.G., Di Tomassi M., Olivieri C., Perrella A., Camiciottoli G., Maselli R., Pelaia G., Busceti M.T., Sabato E., Cagnazzo M.G., Colombo F., Palumbo L., Ravazzi A., Bucca C., Caiaffa M.F., Berra A., Calabrese C., Stanziola A.A., Schino P., Di Gioacchino M., Cazzola M., Segreti A., Pastorello E.A., Scibilia G., Vianello A., Marchi M.R., Paladini L., Baglioni S., Abbritti M., Almerigogna F., Matucci A., Vultaggio A., Maggi E., Maestrelli P., Guarnieri G., Steinhilber G., Bonavia M., Rottoli P., Bargagli E., Senna G., Caminati M., Macchia L., Bellia V., Scichilone N., Novelli F., Latorre M., Vergura L., Masieri S., Rosati Y., Milanese M., Folletti I., Pio R., Pio A., Maccari U., Maggiorelli C., Scala R., Vignale L., Pulera N., Carpagnano G.E., Foschino Barbaro M.P., Sposato, B., Scalese, M., Ricci, A., Rogliani, P., Paggiaro, P., Migliorini, M. G., Di Tomassi, M., Olivieri, C., Perrella, A., Camiciottoli, G., Maselli, R., Pelaia, G., Busceti, M. T., Sabato, E., Cagnazzo, M. G., Colombo, F., Palumbo, L., Ravazzi, A., Bucca, C., Caiaffa, M. F., Berra, A., Calabrese, C., Stanziola, A. A., Schino, P., Di Gioacchino, M., Cazzola, M., Segreti, A., Pastorello, E. A., Scibilia, G., Vianello, A., Marchi, M. R., Paladini, L., Baglioni, S., Abbritti, M., Almerigogna, F., Matucci, A., Vultaggio, A., Maggi, E., Maestrelli, P., Guarnieri, G., Steinhilber, G., Bonavia, M., Rottoli, P., Bargagli, E., Senna, G., Caminati, M., Macchia, L., Bellia, V., Scichilone, N., Novelli, F., Latorre, M., Vergura, L., Masieri, S., Rosati, Y., Milanese, M., Folletti, I., Pio, R., Pio, A., Maccari, U., Maggiorelli, C., Scala, R., Vignale, L., Pulera, N., Carpagnano, G. E., Foschino Barbaro, M. P., and Et, Al

Subjects
Pulmonary and Respiratory Medicine, severe asthma, medicine.medical_specialty, medicine.drug_class, Severe asthma, Eosinophil, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Gastroenterology, Persistence (computer science), 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Bronchodilator, allergic asthma, blood eosinophil, bronchodilator reversibility, lung function decline, severe asthma, salbutamol, Forced Expiratory Volume, medicine, Settore MED/10, Immunology and Allergy, Humans, 030212 general & internal medicine, Blood eosinophil, Lung, Genetics (clinical), Lung function, Bronchodilator Agent, allergic asthma, blood eosinophil, bronchodilator reversibility, lung function decline, salbutamol, bronchodilator agents, eosinophils, forced expiratory volume, humans, lung, airway obstruction, asthma, business.industry, Airway obstruction, medicine.disease, Asthma, Bronchodilator Agents, Airway Obstruction, Eosinophils, 030228 respiratory system, Salbutamol, Blood eosinophils, business, medicine.drug, Human
Abstract

Objective: This study analysed whether the persistence of both reversible airway obstruction (RAO) and elevated BE counts was associated to reduced asthma control and accelerated lung function decline in treated severe asthmatics. Methods: About 202 severe asthmatics were studied after 12–120months of step-5 treatment associated to anti-IgE therapy. Following treatments, reversibility tests, after inhaling 400 mcg of Salbutamol, were performed. FEV1>12% or ≤12% changes differentiated RAO+ from RAO− subjects. Blood eosinophil (BE) counts after treatment were considered. Results: Pre-/post-treatment bronchodilator FEV1% and ACT were lower (61% [50–71], 74.4% [62.5–83.7] and 20[18–22]), whereas BE were higher (380 cells/µl [170–590]) in RAO+ compared to RAO− subjects (77% [64–88], p=0.0001, 81.8% [66.1–94.3], p=0.0001, 21[18–23], p=0.045 and 230 cells/µl [80–360], p=0.003). A negative relationship between SABA-induced FEV1% changes and pre-bronchodilator FEV1% (β=−0.551%; p=0.0001) and ACT (β=−0.059; p=0.038) was found. Conversely, post-treatment BE levels were positively related (β=145.565 cells/µl; p=0.003) to FEV1>12% increases. A rising trend of pre-/post-bronchodilator FEV1% in time was observed in RAO− subjects with BE300 cells/µl reaching lower values after more than 36months of step-5 treatment (59.6% [39.9–72.1] vs 74[66.5–89.2] of RAO+ individuals with BE300 cells/µl [p=0.009]). Conclusion: Persistent SABA-induced FEV1>12%, especially when associated to BE>300 cells/ml, may be a marker of accelerated lung function decline in severe asthmatics despite maximal step-5 treatment. The highest bronchodilation associated to the lowest BE levels should be the main goal of asthma treatment to prevent such decline.

Published
2020

7. Safety and efficacy of montelukast as adjunctive therapy for treatment of asthma in elderly patients

Author

Scichilone N, Battaglia S, Benfante A, and Bellia V

Subjects
Leukotriene, asthma treatment, airway inflammation, aging, Geriatrics, RC952-954.6
Abstract

Nicola Scichilone, Salvatore Battaglia, Alida Benfante, Vincenzo BelliaDipartimento Biomedico di Medicina Interna e Specialistica, University of Palermo, Palermo, ItalyAbstract: Asthma is a disease of all ages. This assumption has been challenged in the past, because of several cultural and scientific biases. A large body of evidence has accumulated in recent years to confirm that the prevalence of asthma in the most advanced ages is similar to that in younger ages. Asthma in the elderly may show similar functional and clinical characteristics to that occurring in young adults, although the frequent coexistence of comorbid conditions in older patients, together with age-associated changes in the human lung, may lead to more severe forms of the disease. Management of asthma in the elderly follows specific guidelines that apply to all ages, although most behaviors are pure extrapolation of what has been tested in young ages. In fact, age has always represented an exclusion criterion for eligibility to clinical trials. This review focuses specifically on the safety and efficacy of leukotriene modifiers, which represent a valid option in the treatment of allergic asthma, both as an alternative to first-line drugs and as add-on treatment to inhaled corticosteroids. Available studies specifically addressing the role of montelukast in the elderly are scarce; however, leukotriene modifiers have been demonstrated to be safe in this age group, even though cases of acute hepatitis and occurrence of Churg-Strauss syndrome have been described in elderly patients; whether this is associated with age is to be confirmed. Furthermore, leukotriene modifiers provide additional benefit when added to regular maintenance therapy, not differently from young asthmatics. In elderly patients, the simpler route of administration of leukotriene modifiers, compared with the inhaled agents, could represent a more effective strategy in improving the outcomes of asthma therapy, given that unintentional nonadherence with inhalation therapy represents a complex problem that may lead to significant impairment of asthma symptom control.Keywords: leukotriene antagonists, asthma, treatment, airway inflammation, aging

Published
2013

8. Early Lung Function Abnormalities in Acromegaly

Author

Benfante, A., Ciresi, A., Bellia, M., Cannizzaro, F., Bellia, V., Giordano, C., and Scichilone, N.

Subjects
Pulmonary function tests -- Methods, Acromegaly -- Complications and side effects, Lung diseases -- Risk factors -- Diagnosis, Health
Abstract

Background Acromegaly is an insidious disorder caused by a pituitary growth hormone (GH)-secreting adenoma resulting in high circulating levels of GH and insulin-like growth factor I (IGF-I). Respiratory disorders are common complications in acromegaly, and can severely impact on quality of life, eventually affecting mortality. Objectives The present study aimed to explore structural and functional lung alterations of acromegalic subjects. Methods We enrolled 10 consecutive patients (M/F: 5/5) affected by acromegaly. In all patients, magnetic resonance imaging (MRI) revealed the presence of pituitary tumor. All patients underwent clinical, lung functional, biological, and radiological assessments. Ten healthy age-matched subjects also served as controls. Results No statistically significant differences in lung function were detected between acromegalic and healthy subjects (p [greater than or equal to] 0.05 for all analyses). However, the diffusing capacity for CO (TLCO) was significantly lower in the acromegalic group than in healthy subjects (TLCO% predicted: 78.1 ± 16 vs. 90 ± 6 %, respectively, p = 0.04; KCO% predicted: 77 ± 16 vs. 93 ± 5 %, p = 0.02, respectively). None of the lung function parameters correlated with duration of the disease, or with inflammatory marker of the airways. In acromegalics, biological (exhaled NO concentrations) and imaging (total lung volume, TLV, and mean lung density, MLD) evaluations were within normal values. The TLV measured by HRCT was 3540 ± 1555 ml in acromegalics, and the MLD was -711 ± 73 HU. None of the lung functional, radiological, and biological findings correlated with GH or IGF-I levels, and no correlation was found with duration of disease. Conclusions In the current study, lung function evaluation allowed to detect early involvement of lung parenchyma, as assessed by TLCO and KCO, even in the absence of parenchymal density alterations of the lung by HRCT. These findings suggest to routinely include the carbon monoxide diffusing capacity in the lung function assessment for an early intervention in acromegaly., Author(s): A. Benfante[sup.1] , A. Ciresi[sup.2] , M. Bellia[sup.3] , F. Cannizzaro[sup.3] , V. Bellia[sup.1] , C. Giordano[sup.2] , N. Scichilone[sup.1] Author Affiliations: (1) Dipartimento Biomedico di Medicina Interna e [...]

Published
2015
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9. Lung penetration and patient adherence considerations in the management of asthma: role of extra fine formulations

Author

Scichilone N, Spatafora M, Battaglia S, Arrigo R, Benfante A, and Bellia V

Subjects
Immunologic diseases. Allergy, RC581-607
Abstract

Nicola Scichilone, Mario Spatafora, Salvatore Battaglia, Rita Arrigo, Alida Benfante, Vincenzo BelliaDipartimento di Biomedicina e Medicina Interna e Specialistica, Sezione di Pneumologia, University of Palermo, Palermo, ItalyAbstract: The mainstay of management in asthma is inhalation therapy at the target site, with direct delivery of the aerosolized drug into the airways to treat inflammation and relieve obstruction. Abundant evidence is available to support the concept that inflammatory and functional changes at the level of the most peripheral airways strongly contribute to the complexity and heterogeneous manifestations of asthma. It is now largely accepted that there is a wide range of clinical phenotypes of the disease, characterized primarily by small airways involvement. Thus, an appropriate diagnostic algorithm cannot exclude biological and functional assessment of the peripheral airways. Similarly, achievement of optimal control of the disease and appropriate management of specific phenotypes of asthma should be based on drugs (and delivery options) able to distribute uniformly along the bronchial tree and to reach the most peripheral airways. Products developed with the Modulite® technology platform have been demonstrated to meet these aims. Recent real-life studies have shown clearly that extra-fine fixed-combination inhaled therapy provides better asthma control than non-extra-fine formulations, thus translating the activity of the drugs into greater effectiveness in clinical practice. We suggest that in patients with incomplete asthma control despite good lung function, involvement of the peripheral airways should always be suspected. When this is the case, treatments targeting both the large and small airways should be used to improve asthma control. Above all, it is emphasized that patient adherence with prescribed medications can contribute to clinical success, and clinicians should always be aware of the role played by patients themselves in determining the success or failure of treatment.Keywords: asthma, small airways, inflammation, quality of life, device

Published
2013

10. Diagnosis of airway obstruction in the elderly: contribution of the SARA study

Author

Sorino C, Battaglia S, Scichilone N, Pedone C, Antonelli-Incalzi R, Sherrill D, and Bellia V

Subjects
Diseases of the respiratory system, RC705-779
Abstract

Claudio Sorino,1,2 Salvatore Battaglia,1 Nicola Scichilone,1 Claudio Pedone,3 Raffaele Antonelli-Incalzi,3 Duane Sherrill,4 Vincenzo Bellia11Biomedical Department of Internal and Specialist Medicine, Section of Pulmonology, University of Palermo, Italy; 2Division of Pulmonology, S Anna Hospital, Como, Italy; 3Chair of Geriatrics, University Campus Bio-Medico, Roma, Italy; 4Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USABackground: The choice between lower limit of normal or fixed value of forced expiratory volume in one second/forced vital capacity ratio (FEV1/FVC) < 0.70 as the criterion for confirming airway obstruction is an open issue. In this study, we compared the criteria of lower limit of normal and fixed FEV1/FVC for diagnosis of airway obstruction, with a focus on healthy elderly people.Methods: We selected 367 healthy nonsmoking subjects aged 65–93 years from 1971 participants in the population-based SARA (Salute Respiratoria nell’Anziano, Italian for “Respiratory Health in the Elderly”) study, analyzed their spirometric data, and tested the relationship between spirometric indices and anthropometric variables. The lower limit of normal for FEV1/FVC was calculated as the fifth percentile of the normal distribution for selected subjects.Results: While FEV1 and FVC decreased significantly with aging, the relationship between FEV1/FVC and age was not statistically significant in men or women. The lower limit of normal for FEV1/FVC was 0.65 in men and 0.67 in women. Fifty-five participants (15%) had FEV1/FVC < 0.70 and would have been inappropriately classified as obstructed according to the Global Initiative for Obstructive Lung Disease, American Thoracic Society/European Respiratory Society, and Canadian guidelines on chronic obstructive pulmonary disease. By applying different FEV1/FVC thresholds for the different age groups, as previously proposed in the literature, (0.70 for 80 years) the percentage of patients classified as obstructed decreased to 6%. No subjects older than 80 years had an FEV1/FVC < 0.60.Conclusion: The present results confirm the inadequacy of FEV1/FVC < 0.70 as a diagnostic criterion for airway obstruction after the age of 65 years. FEV1/FVC < 0.65 and

Published
2012

11. Anti-inflammatory effects of pre-seasonal Th1-adjuvant vaccine to Parietaria judaica in asthmatics

Author

Scichilone N, Minaldi C, Santagata R, Battaglia S, Camarda G, and Bellia V

Subjects
Immunologic diseases. Allergy, RC581-607
Abstract

Nicola Scichilone, Chiara Minaldi, Roberta Santagata, Salvatore Battaglia, Gaetana Camarda, Vincenzo Bellia Dipartimento Biomedico di Medicina Interna e Specialistica (Di.Bi.M.I.S.), Sezione di Pneumologia, University of Palermo, Palermo, ItalyBackground: The ultra-short course pre-seasonal allergy vaccine, containing appropriate allergoids with the adjuvant monophosphoryl lipid A (MPL), may be effective in treating allergic symptoms. Objective: To explore the timing of the immunological responses to the pre-seasonal allergy vaccine.Methods: Four subcutaneous injections of the active product (Pollinex Quattro) were administered to 20 Parietaria-sensitive intermittent asthmatics (M/F: 12/8; age: 48 ± 10 years; FEV1% predicted: 108% ± 12%) during the 6 weeks prior to the start of the pollen season. Exhaled breath condensate (EBC) was collected immediately before the first and immediately after the last injections (t1 and t2), during the pollen season (t3) and after (t4) the pollen season. EBC was analyzed to determine the levels of pH and 8-isoprostane. Ten Parietaria-sensitive asthmatics served as the untreated control group at t1 and t2.Results: Measured pH levels were 7.64 ± 0.33 at t1, 7.67 ± 0.23 at t2, 7.72 ± 0.34 at t3, and 7.82 ± 0.34 at t4 (P = 0.049 vs baseline). 8-isoprostane levels were significantly lower than baseline at each visit (mean difference from baseline, for t2: —0.77 pg, P = 0.031; for t3: —0.92 pg, P = 0.010; for t4: —0.70 pg, P = 0.048). In the control group, pH levels were 7.73 ± 0.26 at baseline and did not change after 6 weeks (7.79 ± 0.25, P = 0.33). Similarly, the concentrations of 8-isoprostane in the control group were not different from those of the study group at baseline (P = 0.86), and the levels remained unchanged after 6 weeks (P = 0.58).Conclusion: These findings show that the ultra-short course of vaccine adjuvated with MPL acutely reduces the degree of airway inflammation, as expressed by markers of oxidative stress, and suggest that this reduction is maintained during and after the pollen season.Keywords: allergen, asthma, immunotherapy, inflammation, pollen, exhaled breath condensate

Published
2011

13. Higher blood eosinophil levels after omalizumab treatment may be associated with poorer asthma outcomes

Author

Sposato, B, Scalese, M, Milanese, M, Masieri, S, Cavaliere, C, Latorre, M, Scichilone, N, Ricci, A, Cresti, A, Santus, P, Olivieri, C, Perrella, A, Rogliani, P, Paggiaro, P, Migliorini, M. G, Di Tomassi, M, Camiciottoli, G, Maselli, R, Pelaia, G, Busceti, M. T, Sabato, E, Cagnazzo, M. G, Colombo, F, Palumbo, L, Ravazzi, A, Bucca, C, Caiaffa, M. F, Berra, A, Calabrese, C, Stanziola, A. A, Schino, P, Di Gioacchino, M, Cazzola, M, Segreti, A, Pastorello, E. A, Scibilia, G, Vianello, A, Marchi, M. R, Paladini, L, Baglioni, S, Abbritti, M, Almerigogna, F, Matucci, A, Vultaggio, A, Maggi, E, Maestrelli, P, Guarnieri, G, Steinhilber, G, Bonavia, M, Rottoli, P, Bargagli, E, Senna, G, Caminati, M, Macchia, L, Bellia, V, Novelli, F, Vergura, L, Rosati, Y, Folletti, I, Pio, R, Pio, A, Maccari, U, Maggiorelli, C, Scala, R, Vignale, L, Pulerà, N, Carpagnano, G. E, Foschino Barbaro, M. P, The Omalizumab Italian Study Group, Sposato, B, Scalese, M, Milanese, M, Masieri, S., Cavaliere, C, Latorre, M., Scichilone, N., Ricci, A., Cresti, A., Santus, P., Olivieri, C., Perrella, A., Rogliani, P., Paggiaro, P., Sposato, B., Migliorini, M. G., Di Tomassi, M., Camiciottoli, G., Maselli, R., Pelaia, G., Busceti, M. T., Sabato, E., Cagnazzo, M. G., Colombo, F., Palumbo, L., Ravazzi, A., Bucca, C., Caiaffa, M. F., Berra, A., Calabrese, C., Stanziola, A. A., Schino, P., Di Gioacchino, M., Cazzola, M., Segreti, A., Pastorello, E. A., Scibilia, G., Vianello, A., Marchi, M. R., Paladini, L., Baglioni, S., Abbritti, M., Almerigogna, F., Matucci, A., Vultaggio, A., Maggi, E., Maestrelli, P., Guarnieri, G., Steinhilber, G., Bonavia, M., Rottoli, P., Bargagli, E., Senna, G., Caminati, M., Macchia, L., Bellia, V., Novelli, F., Vergura, L., Scalese, M., Rosati, Y., Milanese, M., Folletti, I., Pio, R., Pio, A., Maccari, U., Maggiorelli, C., Scala, R., Vignale, L., Pulera, N., Carpagnano, G. E., Foschino Barbaro, M. P., Cavaliere, C., Sposato B., Scalese M., Milanese M., Masieri S., Cavaliere C., Latorre M., Scichilone N., Ricci A., Cresti A., Santus P., Olivieri C., Perrella A., Rogliani P., Paggiaro P., Migliorini M.G., Di Tomassi M., Camiciottoli G., Maselli R., Pelaia G., Busceti M.T., Sabato E., Cagnazzo M.G., Colombo F., Palumbo L., Ravazzi A., Bucca C., Caiaffa M.F., Berra A., Calabrese C., Stanziola A.A., Schino P., Di Gioacchino M., Cazzola M., Segreti A., Pastorello E.A., Scibilia G., Vianello A., Marchi M.R., Paladini L., Baglioni S., Abbritti M., Almerigogna F., Matucci A., Vultaggio A., Maggi E., Maestrelli P., Guarnieri G., Steinhilber G., Bonavia M., Rottoli P., Bargagli E., Senna G., Caminati M., Macchia L., Bellia V., Novelli F., Vergura L., Rosati Y., Folletti I., Pio R., Pio A., Maccari U., Maggiorelli C., Scala R., Vignale L., Pulera N., Carpagnano G.E., and Foschino Barbaro M.P.

Subjects
Adult, Male, medicine.medical_specialty, Settore MED/09 - Medicina Interna, Treatment outcome, MEDLINE, Omalizumab, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Immunoglobulin E, eosinophil, Omalizumab, anti-IgE, asthma, Leukocyte Count, Text mining, Forced Expiratory Volume, Internal medicine, Eosinophilia, medicine, Humans, Immunology and Allergy, Anti-Asthmatic Agents, Blood eosinophil, Aged, Retrospective Studies, Asthma, biology, business.industry, Retrospective cohort study, Middle Aged, asthma, Prognosis, medicine.disease, Eosinophils, Treatment Outcome, inflammation, biology.protein, Female, business, medicine.drug
Published
2019

19. Higher blood eosinophil levels after omalizumab treatment may be associated with poorer asthma outcomes

Author

Sposato, B., Migliorini, M.G., Di Tomassi, M., Olivieri, C., Perrella, A., Camiciottoli, G., Maselli, R., Pelaia, G., Busceti, M.T., Sabato, E., Cagnazzo, M.G., Colombo, F., Palumbo, L., Ravazzi, A., Bucca, C., Caiaffa, M.F., Berra, A., Calabrese, C., Stanziola, A.A., Schino, P., Di Gioacchino, M., Rogliani, P., Cazzola, M., Segreti, A., Pastorello, E.A., Scibilia, G., Vianello, A., Marchi, M.R., Paladini, L., Baglioni, S., Abbritti, M., Almerigogna, F., Matucci, A., Vultaggio, A., Maggi, E., Maestrelli, P., Guarnieri, G., Steinhilber, G., Bonavia, M., Rottoli, P., Bargagli, E., Senna, G., Caminati, M., Macchia, L., Bellia, V., Scichilone, N., Paggiaro, P., Novelli, F., Latorre, M., Vergura, L., Masieri, S., Scalese, M., Rosati, Y., Milanese, M., Folletti, I., Pio, R., Pio, A., Maccari, U., Maggiorelli, C., Scala, R., Vignale, L., Pulerà, N., Carpagnano, G.E., Foschino Barbaro, M.P., Sposato, Bruno, Scalese, Marco, Milanese, Manlio, Masieri, Simonetta, Cavaliere, Carlo, Latorre, Manuela, Scichilone, Nicola, Ricci, Alberto, Cresti, Alberto, Santus, Pierachille, Olivieri, Carmela, Perrella, Antonio, Rogliani, Paola, and Paggiaro, Pierluigi

Published
2019
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21. International conference on biomedical aspects of aging research: December 10–13, 1997 Fondazione Cini, San Giorgio, Venezia, Italy

Author

Cristofalo, Vincent J., Crepaldi, Gaetano, Evans, J. Grimley, Rowe, J. W., Kahn, R. L., Kirkwood, T. B. L., Hayflick, L., Austad, S. N., De Benedictis, G., Franceschi, C., Martin, G. M., Sohal, R. S., Orr, W. C., Levine, R. L., Cristofalo, V. J., Tresini, M., Effros, R. B., Passeri, M., Motta, L., Miller, R. A., Jackson, A., Chrisp, C., Galecki, A., Burke, D., Michel, J-P., Hyman, B. T., Schneider, L. S., Sorbi, S., Nacmias, B., Forleo, P., Zaidi, M., Barrett-Connor, E., Kowal, J., Adami, S., McGowan, J. A., Dere, W. H., Blanchard, F., Papapoulos, S., Compston, J., Maggi, S., Lakatta, E. G., Lye, M., Marchionni, N., Di Bari, M., Innocenti, F., Chiarlone, M., Nardi, M., Pini, R., Masotti, G., Pedersen, T. R., Schroll, M., Zanchetti, A., Rich, M. W., Manzato, E., Brody, J. A., Grant, M. D., Frateschi, L. J., Miller, S. C., Zhang, H., Heikkinen, E., Andrews, G. R., Masoro, E. J., Bergamini, E., Cavallini, G., Cecchi, L., Donati, A., Dolfi, C., Gori, Z., Innocenti, B., Maccheroni, M., Marino, M., Masini, M., Paradiso, C., Pollera, M., Trentalance, A., Bellia, V., Tilvis, R., Johnson, B. D., Grassi, V., Cossi, S., Leonardi, R., Tantucci, C., and SARA Study Group

Published
1998
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34. Asthma control in severe asthmatics under treatment with omalizumab: A cross-sectional observational study in Italy

Author

Novelli, Federica, Latorre, Matteo, Vergura, Letizia, Caiaffa, Maria Filomena, Camiciottoli, Gianna, Guarnieri, Gabriella, Matucci, Andrea, Macchia, Luigi, Vianello, Andrea, Vultaggio, Alessandra, Celi, Alessandro, Cazzola, Mario, Paggiaro, Pierluigi, Camiciottoli, G., Maselli, R., Pelaia, G., Busceti, M. T., Sabato, E., Cagnazzo, M. G., Colombo, F., Palumbo, Laura, Ravazzi, Aldo, Bucca, C., Caiaffa, M. F., Berra, A., Calabrese, C., Stanziola, A. A., Schino, P., Di Gioacchino, M., Cazzola, M., Segreti, A., Pastorello, E. A., Scibilia, G., Vianello, A., Marchi, M. R., Paladini, L., Baglioni, S., Abbritti, M., Almerigogna, F., Matucci, A., Vultaggio, A., Maggi, E., Maestrelli, P., Guarnieri, G., Steinhilber, G., Bonavia, M., Rottoli, P., Bargagli, E., Senna, G., Caminati, M., Macchia, L., Bellia, V., Scichilone, N., Paggiaro, P., Novelli, F., Vergura, L., Novelli F., Latorre M., Vergura L., Caiaffa M.F., Camiciottoli G., Guarnieri G., Matucci A., Macchia L., Vianello A., Vultaggio A., Celi A., Cazzola M., Paggiaro P., Maselli R., Pelaia G., Busceti M.T., Sabato E., Cagnazzo M.G., Colombo F., Palumbo L., Ravazzi A., Bucca C., Berra A., Calabrese C., Stanziola A.A., Schino P., Di Gioacchino M., Segreti A., Pastorello E.A., Scibilia G., Marchi M.R., Paladini L., Baglioni S., Abbritti M., Almerigogna F., Maggi E., Maestrelli P., Steinhilber G., Bonavia M., Rottoli P., Bargagli E., Senna G., Caminati M., Bellia V., Scichilone N., Novelli, F., Latorre, M., Vergura, L., Caiaffa, M. F., Camiciottoli, G., Guarnieri, G., Matucci, A., Macchia, L., Vianello, A., Vultaggio, A., Celi, A., Cazzola, M., Paggiaro, P., Maselli, R., Pelaia, G., Busceti, M. T., Sabato, E., Cagnazzo, M. G., Colombo, F., Palumbo, L., Ravazzi, A., Bucca, C., Berra, A., Calabrese, C., Stanziola, A. A., Schino, P., Di Gioacchino, M., Segreti, A., Pastorello, E. A., Scibilia, G., Marchi, M. R., Paladini, L., Baglioni, S., Abbritti, M., Almerigogna, F., Maggi, E., Maestrelli, P., Steinhilber, G., Bonavia, M., Rottoli, P., Bargagli, E., Senna, G., Caminati, M., Bellia, V., and Scichilone, N.

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Exacerbation, Cross-sectional study, Omalizumab, Comorbidity, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Exhaled nitric oxide, Exacerbations, Comorbidities, Asthma, Control, Severity of Illness Index, Internal medicine, Severity of illness, Medicine, Anti-Asthmatic Agent, Humans, Pharmacology (medical), Anti-Asthmatic Agents, Inflammation Mediator, Respiratory Function Test, Aged, Cross-Sectional Studie, business.industry, Biochemistry (medical), Middle Aged, medicine.disease, Respiratory Function Tests, Cross-Sectional Studies, Italy, Physical therapy, Observational study, Female, Inflammation Mediators, Comorbiditie, business, medicine.drug, Human
Abstract

Few data are available on the proportion of asthmatics achieving a good asthma control (according GINA guidelines) and on the level of airway inflammation during omalizumab treatment. The aim of this cross-sectional national observational study was to assess the level of control (according to GINA guidelines) achieved in a group of asthmatics on omalizumab treatment, and to characterize the factors that influence the lack of control. We studied 306 asthmatics under omalizumab treatment for a median of 32 months (range 4-120). The level of control according to GINA was good in 25.2%, partial in 47.1% and poor in 24.5% of patients (data were missing for the remaining 3.2%). Comparison between poorly controlled and partially or well controlled asthmatics showed a statistically significant higher prevalence of some comorbidities in the first group, namely obesity, gastro-oesophageal reflux disease (GORD), aspirin intolerance and mental disorders (all p

Published
2015

38. Do GOLD stages of COPD severity really correspond to differences in health status?

Author

Antonelli Incalzi*, R., Imperiale#, C., Bellia}, V., Catalano}, F., Scichilone}, N., Pistelli*, R., Rengoz, F., the SaRA investigators, Pini, Laura, Grassi, Vittorio, Antonelli-Incalzi, R., Imperiale, C., Bellia, V., Catalano, F., Scichilone, N., Pistelli, R., and Rengo, F.

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Multivariate analysis, Pulmonary disease, Global Initiative for Chronic Obstructive Lung Disease guidelines, health status, Comorbidity, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Severity of Illness Index, elderly, Health Statu, Pulmonary Disease, Chronic Obstructive, Surveys and Questionnaires, Internal medicine, Severity of illness, Chronic obstructive pulmonary disease, medicine, Surveys and Questionnaire, Humans, Stage (cooking), Multivariate Analysi, Respiratory Function Test, Aged, COPD, business.industry, Kruskal–Wallis one-way analysis of variance, Female, Linear Models, Multivariate Analysis, Respiratory Function Tests, Health Status, medicine.disease, Obstructive lung disease, Physical therapy, Linear Model, business, Human
Abstract

The purpose of this study was to assess whether different stages of chronic obstructive pulmonary disease (COPD) severity defined according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria correlate with meaningful differences in health status. A total of 381 COPD patients, aged 73+/-6 yrs, were classified in the five GOLD stages. Disease-specific (St George Respiratory Questionnaire (SGRQ)) and generic indexes of health status were measured in all patients. Multivariate analysis of covariance or Kruskal Wallis tests were used to compare health status indexes across the spectrum of GOLD stages of COPD severity. GOLD stages of COPD severity significantly differed in SGRQ components and Barthel's index, but not in the indexes assessing cognitive and affective status and quality of sleep. The largest variation in health status was observed at the transition from stage IIa to stage IIb, while there were no other significant differences between consecutive stages. Both female sex and comorbidity were associated with a greater impact of COPD on the health status. In conclusion, the upper limit of stage IIb (forced expiratory volume in one second of 49%) marks a threshold for dramatic worsening of health status. Progression of chronic obstructive pulmonary disease severity from stage 0 to stage IIa does not correspond to any meaningful difference in health status.

Published
2003

42. Hypoxemia during Sleep

Author

Bonsignore, G., Marrone, O., Bellia, V., Cibella, F., Karczewski, W. A., editor, Grieb, P., editor, Kulesza, Joanna, editor, and Bonsignore, G., editor

Published
1988
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44. Evolving clinical landscape of chronic hepatitis B: A multicenter Italian study

Author

Stroffolini T., Almasio P. L., Sagnelli E., Mele A., Gaeta G. B., Italian Hospitals' Collaborating Group, Scuteri A., Antonucci G., Iacomi F., Babudieri S., Pintus A., Stornaiuolo G., Brancaccio G., Brunetto M., Sasso R., Caporaso N., Morisco F., Chiaramonte M., Lattanzi E., Di Marco V., Venezia G., Fagiuoli S., Boninsegna S., Fattovich G., Olivari N., Ferrari C., Giuberti T., Ferrigno L., Magnani G., Massari M., Mangano C., Caserta C., Messina V., Pastore G., Palattella S., Piccinino F., Stanzione M., Pinzello G., Vinci M., Raimondo G., Caccamo G., Roffi L., Bellia V., Rizzetto M., Smedile A., Ciancio A., ANDREONE, PIETRO, Infectious and Tropical Diseases, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Gastroenterology, Università degli studi di Palermo - University of Palermo, Public,Clinical and Preventive Medicine, University of Naples Federico II, Laboratory of Epidemiology, Clinical Epidemiology Unit, Istituto Superiore di Sanita [Rome], Infectious Diseases Dept, Stroffolini T., Almasio P.L., Sagnelli E., Mele A., Gaeta G.B., Italian Hospitals' Collaborating Group, Andreone P., Scuteri A., Antonucci G., Iacomi F., Babudieri S., Pintus A., Stornaiuolo G., Brancaccio G., Brunetto M., Sasso R., Caporaso N., Morisco F., Chiaramonte M., Lattanzi E., Di Marco V., Venezia G., Fagiuoli S., Boninsegna S., Fattovich G., Olivari N., Ferrari C., Giuberti T., Ferrigno L., Magnani G., Massari M., Mangano C., Caserta C., Messina V., Pastore G., Palattella S., Piccinino F., Stanzione M., Pinzello G., Vinci M., Raimondo G., Caccamo G., Roffi L., Bellia V., Rizzetto M., Smedile A., Ciancio A., Stroffolini, T, Almasio, P, Sagnelli, E, Mele, A, Gaeta, G, Andreone, P, Scuteri, A, Antonucci, G, Iacomi, F, Babudieri, S, Pintus, A, Stornaiuolo, G, Brancaccio, G, Brunetto, M, Sasso, R, Caporaso, N, Morisco, F, Chiaramonte, M, Lattanzi, E, Di Marco, V, Venezia, G, Fagiuoli, S, Boninsegna, S, Fattovich, G, Olivari, N, Ferrari, C, Giuberti, T, Ferrigno, L, Magnani, G, Massari, M, Mangano, C, Caserta, C, Messina, V, Pastore, G, Palattella, S, Piccinino, F, Stanzione, M, Pinzello, G, Vinci, M, Raimondo, G, Caccamo, G, Roffi, L, Bellia, V, Rizzetto, M, Smedile, A, and Ciancio, A

Subjects
Male, HBsAg, viruses, HIV Infections, Antibodies, Viral, HBeAg, Hepatitis, Liver disease, CHRONIC HEPATITIS B, epidemiology, GEOGRAPHICAL LANDSCAPE, 0302 clinical medicine, 80 and over, Prevalence, Viral, Chronic, Aged, 80 and over, 0303 health sciences, Geography, Age Factors, virus diseases, Hepatitis C, Hepatitis B, Middle Aged, Hepatitis D, 3. Good health, Infectious Diseases, Cirrhosis, Italy, Medicine, 030211 gastroenterology & hepatology, Female, Hepatitis D virus, Human, Adult, Hepatitis, Viral, Human, Adolescent, Antibodies, 03 medical and health sciences, Hepatitis B, Chronic, HDV, Virology, Cirrhosis, HBeAg, HDV, Hepatitis B, Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Antibodies, Viral, Cross-Sectional Studies, Female, Geography, HIV, HIV Infections, Hepatitis B, Chronic, Hepatitis, Viral, Human, Humans, Italy, Male, Middle Aged, Prevalence, Virology, Infectious Diseases, medicine, Aged, Cross-Sectional Studies, HIV, Humans, 030304 developmental biology, Cirrhosi, business.industry, medicine.disease, digestive system diseases, business
Abstract

The aim of the study was to evaluate the characteristics of chronic hepatitis B with special reference to the geographical origin of the patients and to the prevalence of HBeAg and viral and non-viral co-factors of liver disease. A cross-sectional multicenter survey was undertaken, which enrolled 1,386 HBsAg chronic carriers observed consecutively in 21 referral centers over a 6-month period. The prevalence of HBeAg in patients was 11%; the presence of HBeAg was associated independently with a younger age and co-infection with HIV. Anti-HDV, anti-HCV, or anti-HIV antibodies were detected in 8.1%, 6.5%, and 2%, respectively. However, among the patients first diagnosed during the study period (incident cases), 14.3% were anti-HDV positive. Seven percent of the patients were immigrants; they were younger than Italian patients and 18% were HBeAg positive; no difference was observed in the prevalence of anti-HDV, anti-HCV, or anti-HIV antibodies. The presence of cirrhosis was associated independently with an age >52 years, the presence of anti-HDV or anti-HCV, alcohol use >4 drinks/day, and a high BMI. The clinical epidemiology of chronic hepatitis B virus (HBV) infection shows a dynamic profile, with the potential for re-emergence of cases with HBeAg or anti-HDV and an emerging impact of metabolic factors on the evolution of liver disease.

Published
2009

46. Allergen sensitizations in southern Italy: a 5-year retrospective study in allergic respiratory patients

Author

Scichilone N, Sanfilippo A, Claudio Sorino, Giuliano L, Misseri M, Bellia V, Scichilone, N, Sanfilippo, A, Sorino, C, Giuliano, L, Misseri, M, and Bellia, V

Subjects
Adult, Aged, 80 and over, Adolescent, Italy, Hypersensitivity, Prevalence, Humans, Allergens, Middle Aged, Child, Allergens/immunology,Hypersensitivity/epidemiology, Aged, Retrospective Studies
Abstract

The assessment of the distribution of allergen skin test sensitizations is highly recommended for the optimal management of allergic respiratory conditions. We aimed at evaluating the distribution of allergen sensitizations in individuals with asthma and/or rhinitis in the Southern region of ltaly, and at exploring whether changes in the frequency of allergen sensitizations occurred after a 5-year period. Demographic data and skin prick test sensitizations to allergens from asthmatics and/or rhinitis attending the Division of Respiratory Diseases, University of Palermo, Italy in 2005 (Phase 1) and in 2010 (Phase 2) were extrapolated and retained for analysis. A total of 2033 allergic respiratory patients were included (1002 in Phase 1 and 1031 in Phase 2). In both investigations, the most prevalent allergen sensitization was towards Parietaria; however, a significant reduction in the rate of prevalence after 5 years was recorded (from 60% to 48% of skin test positive patients, p < 0.0001). Up to one out of two subjects showed sensitization to dust mites in both Phases. Interestingly, Cypress pollen sensitization almost doubled from Phase 1 (17%) to Phase 2 (29%; p < 0.0001). Overall, the mean number of skin test sensitizations for each patient increased from 2.7 +/- 1.6 in Phase 1 to 3.1 + 1.8 in Phase 2 (p < 0.0001). The present findings confirm the prevalent role of Parietaria sensitization in the allergic population of the Mediterranean area of Southern Italy, and document the increase of Cypress sensitization. These observations could contribute to a proper management of chronic allergic respiratory conditions in this region.

Published
2013

47. Evolving clinical landscape of chronic hepatitis B: A multicenter Italian study

Author

Stroffolini, T, Almasio, P, Sagnelli, E, Mele, A, Gaeta, G, Andreone, P, Scuteri, A, Antonucci, G, Iacomi, F, Babudieri, S, Pintus, A, Stornaiuolo, G, Brancaccio, G, Brunetto, M, Sasso, R, Caporaso, N, Morisco, F, Chiaramonte, M, Lattanzi, E, Di Marco, V, Venezia, G, Fagiuoli, S, Boninsegna, S, Fattovich, G, Olivari, N, Ferrari, C, Giuberti, T, Ferrigno, L, Magnani, G, Massari, M, Mangano, C, Caserta, C, Messina, V, Pastore, G, Palattella, S, Piccinino, F, Stanzione, M, Pinzello, G, Vinci, M, Raimondo, G, Caccamo, G, Roffi, L, Bellia, V, Rizzetto, M, Smedile, A, Ciancio, A, Stroffolini T, Almasio PL, Sagnelli E, Mele A, Gaeta GB, Andreone P, Scuteri A, Antonucci G, Iacomi F, Babudieri S, Pintus A, Stornaiuolo G, Brancaccio G, Brunetto M, Sasso R, Caporaso N, Morisco F, Chiaramonte M, Lattanzi E, Di Marco V, Venezia G, Fagiuoli S, Boninsegna S, Fattovich G, Olivari N, Ferrari C, Giuberti T, Ferrigno L, Magnani G, Massari M, Mangano C, Caserta C, Messina V, Pastore G, Palattella S, Piccinino F, Stanzione M, Pinzello G, Vinci M, Raimondo G, Caccamo G, Roffi L, Bellia V, Rizzetto M, Smedile A, Ciancio A. Italian Hospitals' Collaborating Group., Stroffolini, T, Almasio, P, Sagnelli, E, Mele, A, Gaeta, G, Andreone, P, Scuteri, A, Antonucci, G, Iacomi, F, Babudieri, S, Pintus, A, Stornaiuolo, G, Brancaccio, G, Brunetto, M, Sasso, R, Caporaso, N, Morisco, F, Chiaramonte, M, Lattanzi, E, Di Marco, V, Venezia, G, Fagiuoli, S, Boninsegna, S, Fattovich, G, Olivari, N, Ferrari, C, Giuberti, T, Ferrigno, L, Magnani, G, Massari, M, Mangano, C, Caserta, C, Messina, V, Pastore, G, Palattella, S, Piccinino, F, Stanzione, M, Pinzello, G, Vinci, M, Raimondo, G, Caccamo, G, Roffi, L, Bellia, V, Rizzetto, M, Smedile, A, Ciancio, A, Stroffolini T, Almasio PL, Sagnelli E, Mele A, Gaeta GB, Andreone P, Scuteri A, Antonucci G, Iacomi F, Babudieri S, Pintus A, Stornaiuolo G, Brancaccio G, Brunetto M, Sasso R, Caporaso N, Morisco F, Chiaramonte M, Lattanzi E, Di Marco V, Venezia G, Fagiuoli S, Boninsegna S, Fattovich G, Olivari N, Ferrari C, Giuberti T, Ferrigno L, Magnani G, Massari M, Mangano C, Caserta C, Messina V, Pastore G, Palattella S, Piccinino F, Stanzione M, Pinzello G, Vinci M, Raimondo G, Caccamo G, Roffi L, Bellia V, Rizzetto M, Smedile A, and Ciancio A. Italian Hospitals' Collaborating Group.

Abstract

The aim of the study was to evaluate the characteristics of chronic hepatitis B with special reference to the geographical origin of the patients and to the prevalence of HBeAg and viral and non-viral co-factors of liver disease. A cross-sectional multicenter survey was undertaken, which enrolled 1,386 HBsAg chronic carriers observed consecutively in 21 referral centers over a 6-month period. The prevalence of HBeAg in patients was 11%; the presence of HBeAg was associated independently with a younger age and co-infection with HIV. Anti-HDV, anti-HCV, or anti-HIV antibodies were detected in 8.1%, 6.5%, and 2%, respectively. However, among the patients first diagnosed during the study period (incident cases), 14.3% were anti-HDV positive. Seven percent of the patients were immigrants; they were younger than Italian patients and 18% were HBeAg positive; no difference was observed in the prevalence of anti-HDV, anti-HCV, or anti-HIV antibodies. The presence of cirrhosis was associated independently with an age >52 years, the presence of anti-HDV or anti-HCV, alcohol use >4 drinks/day, and a high BMI. The clinical epidemiology of chronic hepatitis B virus (HBV) infection shows a dynamic profile, with the potential for re-emergence of cases with HBeAg or anti-HDV and an emerging impact of metabolic factors on the evolution of liver disease.

Published
2009

48. Evaluation of health outcomes in elderly patients with asthma and COPD using disease-specific and generic instruments: the Salute Respiratoria nell'Anziano (Sa.R.A.) Study

Author

INCALZI RA, BELLIA V, CATALANO F, SCICHILONE N, IMPERIALE C, MAGGI S, RENGO, FRANCO, Incalzi, R., Bellia, V., Catalano, F., Scichilone, N., Imperiale, C., Maggi, S., Rengo, F., Incalzi, Ra, Bellia, V, Catalano, F, Scichilone, N, Imperiale, C, Maggi, S, and Rengo, Franco

Subjects
Cross-Sectional Studie, Male, Health Status, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Asthma, Health Statu, Cross-Sectional Studies, Quality of Life, Health Status Indicators, Humans, Female, Health Status Indicator, Lung Diseases, Obstructive, Geriatric Assessment, Human, Aged
Abstract

To compare the effects of asthma and COPD on health status (HS) in elderly patients, and to assess the correlation between disease-specific and generic instruments assessing HS.Multicenter, cross-sectional, observational study.The Salute Respiratoria nell'Anziano (respiratory health in the elderly) Study network of outpatient departments.One hundred ninety-eight asthma patients and 230 COPD patientsor = 65 years old.HS was assessed by the Saint George's Respiratory Questionnaire (SGRQ) and five generic outcomes: Barthel's index, 6-min walk test, mini mental state examination, geriatric depression scale (GDS), and quality-of-sleep index. Independent correlates of SGRQ scores were assessed by logistic regression. Patients were considered to have a "good" HS or "poor" HS according to whether they did or did not perform worse than 75% of the corresponding population of asthma or COPD patients, on at least two of the five generic outcomes.On average, COPD patients had poorer HS than asthma patients on the SGRQ. Only polypharmacy (more than three respiratory drugs) and diagnosis of COPD qualified as independent correlates of the SGRQ score. The SGRQ "Activity" and "Impacts" scores shared the following independent correlates: polypharmacy, Barthel's index92, and GDS6. Further correlates were waist/hip ratio1 for the Activity score, and age and occiput-wall distance9 cm for the Impacts score. All sections of the SGRQ except for the Symptoms score could significantly distinguish patients with good HS and poor HS.Individual dimensions of HS recognize different determinants. COPD outweighs asthma as a cause of distressing respiratory symptoms. A high degree of concordance exists between SGRQ and generic health outcomes, except for the Symptoms dimension in COPD patients.

Published
2001

49. Addition of Either Lonidamine or Granulocyte Colony-Stimulating Factor Does Not Improve Survival in Early Breast Cancer Patients Treated With High-Dose Epirubicin and Cyclophosphamide

Author

Papaldo, P., Lopez, M., Cortesi, Enrico, Cammilluzzi, E., Antimi, M., Terzoli, E., Lepidini, G., Vici, P., Barone, C., Ferretti, G., Di Cosimo, S., Nistico, C., Carlini, P., Conti, F., Di Lauro, L., Botti, C., Vitucci, C., Fabi, A., Giannarelli, D., Marolla, P., Di Maio, M., Perrone, F., Gallo, C., Iaffaioli, R. V., Manzione, L., Piantedosi, F. V., Cigolari, S., Illiano, A., Barbera, S., Robbiati, S. F., Piazza, E., Ianniello, G. P., Frontini, L., Veltri, E., Castiglione, F., Rosetti, F., De Maio, E., Maione, P., Gridelli, C., Rossi, A., Barletta, E., Barzelloni, M. L., Signoriello, G., Bilancia, D., Dinota, A., Rosati, G., Germano, D., Lamberti, A., Pontillo, V., Brancacio, L., Crispino, C., Esposito, M., Battiloro, C., Tufano, G., Cioffi, A., Guardasole, V., Angelini, V., Guidetti, G., Renda, F., Romano, F., Volpintesta, A., Sannicolo, M., Filipazzi, V., Esani, G., Gambaro, A., Ferrario, S., Tinessa, V., Caprio, M. G., Zonato, S., Cabiddu, M., Raina, A., D'Aprile, M., Pistillucci, G., Porcile, G., Ostellino, O., Vinante, O., Azzarello, G., Gebbia, V., Borsellino, N., Testa, A., Gasparini, G., Morabito, A., Gattuso, D., Romito, S., Carrozza, F., Fava, S., Calcagno, A., Grimi, E., Bertetto, O., Ciuffreda, L., Parello, G., Maiorino, L., Santoro, A., Santoro, M., Failla, G., Aiello, R. A., Bearz, A., Sorio, R., Scalone, S., Clerici, M., Bollina, R., Belloni, P., Sacco, C., Sibau, A., Adamo, V., Altavilla, G., Scimone, A., Spatafora, M., Bellia, V., Hopps, M. R., Monfardini, S., Favaretto, A., Stefani, M., Corradini, G. M., Pavia, G., Scagliotti, G., Novello, S., Selvaggi, G., Tonato, M., Darwish, S., Michetti, G., Belometti, M. O., Labianca, R., Quadri, A., De Marinis, F., Migliorino, M. R., Martelli, O., Colucci, G., Galetta, D., Giotta, F., Isa, L., Candido, P., Rossi, N., Calandriello, A., Ferrau, F., Malaponte, E., Barni, S., Cazzaniga, M., Gebbia, N., Valerio, Mr, Belli, M., Colantuoni, G., Capuano, M. A., Angiolillo, M., Sollitto, F., Ardizzoia, A., Luporini, G., Locatelli, M. C., Pari, F., Aitini, E., Pedicini, T., Febbraro, A., Zollo, C., Di Costanzo, F., Bartolucci, R., Gasperoni, S., Gaion, F., Palazzolo, G., Galligioni, E., Caffo, O., Cortesi, E., D'Auria, G., Curcio, C., Vasta, M., Bumma, C., Celano, A., Bretti, S., Nettis, G., Anselmo, A., Mattioli, R., Aschelter, A., and Foa, P.

Subjects
Adult, Cancer Research, medicine.medical_specialty, Indazoles, Filgrastim, Cyclophosphamide, medicine.medical_treatment, Breast Neoplasms, Gastroenterology, Disease-Free Survival, chemistry.chemical_compound, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, medicine, Humans, Survival rate, Aged, Epirubicin, Chemotherapy, business.industry, Lonidamine, Middle Aged, medicine.disease, Metastatic breast cancer, Recombinant Proteins, Granulocyte colony-stimulating factor, Surgery, Survival Rate, Oncology, chemistry, Female, business, Follow-Up Studies, medicine.drug
Abstract

Purpose: Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity. Patients and Methods: From October 1991 to April 1994, 506 patients with stage I/II BC were randomly assigned to four groups: (A) epirubicin 120 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients). Results: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non–G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus non-LND arms (81.3%) and in G-CSF (80.6%) versus non–G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively). Conclusion: EC is active and well tolerated in patients with early breast cancer. The addition of LND or G-CSF does not improve DFS or OS.

Published
2003

50. Assessment of large and small airways wall thickness by HRCT in asthma

Author

BELLIA, Maria, SCICHILONE, Nicola Alessandro, Figlioli, G, Cannizzaro, F, Bellia, V, MIDIRI, Massimo, Lagalla, R., Bellia, M, Scichilone, N, Figlioli, G, Cannizzaro, F, Bellia, V, Midiri, M, and Lagalla, R

Subjects
HRCT , Asthma, Thorax, Chest - Lung, Lung, Respiratory system, Airways, wall thickne
Abstract

Purpose Methods and Materials Results Conclusion References Personal Information, Purpose: As a consequence of long-standing bronchial asthma, both small and large airways undergo structural changes, currently referred to as "remodelling". The latter involves all the wall components of both large and small airways. Thickening of the...

Published
2010
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