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1. 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

2. 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

5. Prevalence of Single and Multiple Natural NS3, NS5A and NS5B Resistance-Associated Substitutions in Hepatitis C Virus Genotypes 1-4 in Italy

Author

Bertoli, A, Sorbo, M, Aragri, M, Lenci, I, Teti, E, Polilli, E, Di Maio, V, Gianserra, L, Biliotti, E, Masetti, C, Magni, C, Babudieri, S, Nicolini, L, Milana, M, Cacciatore, P, Sarmati, L, Pellicelli, A, Paolucci, S, Craxi, A, Morisco, F, Palitti, V, Siciliano, M, Coppola, N, Iapadre, N, Puoti, M, Rizzardini, G, Taliani, G, Pasquazzi, C, Andreoni, M, Parruti, G, Angelico, M, Perno, C, Cento, V, Ceccherini-Silberstein, F, Andreone, P, Baldanti, F, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Bruzzone, B, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, D'Ambrosio, C, D'Ettorre, G, De Leonardis, F, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Gasbarrini, A, Ghisetti, V, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Landonio, S, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Melis, M, Menzaghi, B, Meregalli, E, Micheli, V, Niero, F, Paoloni, M, Pieri, A, Rendina, M, Romagnoli, D, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Zazzi, M, Bertoli A., Sorbo M. C., Aragri M., Lenci I., Teti E., Polilli E., Di Maio V. C., Gianserra L., Biliotti E., Masetti C., Magni C. F., Babudieri S., Nicolini L. A., Milana M., Cacciatore P., Sarmati L., Pellicelli A., Paolucci S., Craxi A., Morisco F., Palitti V. P., Siciliano M., Coppola N., Iapadre N., Puoti M., Rizzardini G., Taliani G., Pasquazzi C., Andreoni M., Parruti G., Angelico M., Perno C. F., Cento V., Ceccherini-Silberstein F., Andreone P., Baldanti F., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Bruzzone B., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., D'Ambrosio C., D'Ettorre G., De Leonardis F., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Gasbarrini A., Ghisetti V., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Landonio S., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Melis M., Menzaghi B., Meregalli E., Micheli V., Niero F., Paoloni M., Pieri A., Rendina M., Romagnoli D., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., Vullo V., Zazzi M., Bertoli, A, Sorbo, M, Aragri, M, Lenci, I, Teti, E, Polilli, E, Di Maio, V, Gianserra, L, Biliotti, E, Masetti, C, Magni, C, Babudieri, S, Nicolini, L, Milana, M, Cacciatore, P, Sarmati, L, Pellicelli, A, Paolucci, S, Craxi, A, Morisco, F, Palitti, V, Siciliano, M, Coppola, N, Iapadre, N, Puoti, M, Rizzardini, G, Taliani, G, Pasquazzi, C, Andreoni, M, Parruti, G, Angelico, M, Perno, C, Cento, V, Ceccherini-Silberstein, F, Andreone, P, Baldanti, F, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Bruzzone, B, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, D'Ambrosio, C, D'Ettorre, G, De Leonardis, F, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Gasbarrini, A, Ghisetti, V, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Landonio, S, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Melis, M, Menzaghi, B, Meregalli, E, Micheli, V, Niero, F, Paoloni, M, Pieri, A, Rendina, M, Romagnoli, D, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Zazzi, M, Bertoli A., Sorbo M. C., Aragri M., Lenci I., Teti E., Polilli E., Di Maio V. C., Gianserra L., Biliotti E., Masetti C., Magni C. F., Babudieri S., Nicolini L. A., Milana M., Cacciatore P., Sarmati L., Pellicelli A., Paolucci S., Craxi A., Morisco F., Palitti V. P., Siciliano M., Coppola N., Iapadre N., Puoti M., Rizzardini G., Taliani G., Pasquazzi C., Andreoni M., Parruti G., Angelico M., Perno C. F., Cento V., Ceccherini-Silberstein F., Andreone P., Baldanti F., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Bruzzone B., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., D'Ambrosio C., D'Ettorre G., De Leonardis F., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Gasbarrini A., Ghisetti V., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Landonio S., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Melis M., Menzaghi B., Meregalli E., Micheli V., Niero F., Paoloni M., Pieri A., Rendina M., Romagnoli D., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., Vullo V., and Zazzi M.

Abstract

Natural resistance-associated substitutions (RASs) are reported with highly variable prevalence across different HCV genotypes (GTs). Frequency of natural RASs in a large Italian real-life cohort of patients infected with the 4 main HCV-GTs was investigated. NS3, NS5A and NS5B sequences were analysed in 1445 HCV-infected DAA-naïve patients. Sanger-sequencing was performed by home-made protocols on 464 GT1a, 585 GT1b, 92 GT2c, 199 GT3a, 16 GT4a and 99 GT4d samples. Overall, 20.7% (301/1455) of patients showed natural RASs, and the prevalence of multiclass-resistance was 7.3% (29/372 patients analysed). NS3-RASs were particularly common in GT1a and GT1b (45.2-10.8%, respectively), mainly due to 80K presence in GT1a (17%). Almost all GTs showed high prevalence of NS5A-RASs (range: 10.2-45.4%), and especially of 93H (5.1%). NS5A-RASs with fold-change >100x were detected in 6.8% GT1a (30H/R-31M-93C/H), 10.3% GT1b (31V-93H), 28.4% GT2c (28C-31M-93H), 8.5% GT3a (30K-93H), 45.5% GT4a (28M-30R-93H) and 3.8% GT4d (28V-30S-93H). Sofosbuvir RAS 282T was never detected, while the 159F and 316N RASs were found in GT1b (13.4-19.1%, respectively). Natural RASs are common in Italian patients infected with HCV-GTs 1-4. High prevalence of clinically-relevant RASs (such as Y93H) supports the appropriateness of HCV resistance-test to properly guide DAA-based therapy.

Published
2018

6. Frequent NS5A and multiclass resistance in almost all HCV genotypes at DAA failures: What are the chances for second-line regimens?

Author

Di Maio, V, Cento, V, Aragri, M, Paolucci, S, Pollicino, T, Coppola, N, Bruzzone, B, Ghisetti, V, Zazzi, M, Brunetto, M, Bertoli, A, Barbaliscia, S, Galli, S, Gennari, W, Baldanti, F, Raimondo, G, Perno, C, Ceccherini-Silberstein, F, Andreone, P, Andreoni, M, Angelico, M, Babudieri, S, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Cacciatore, P, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, Craxi, A, D'Ambrosio, C, D'Ettorre, G, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Lenci, I, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Masetti, C, Melis, M, Meregalli, E, Micheli, V, Morisco, F, Niero, F, Nicolini, L, Palitti, V, Paoloni, M, Parruti, G, Pasquazzi, C, Pellicelli, A, Polilli, E, Ponti, M, Puoti, M, Rendina, M, Rizzardini, G, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Di Maio V. C., Cento V., Aragri M., Paolucci S., Pollicino T., Coppola N., Bruzzone B., Ghisetti V., Zazzi M., Brunetto M., Bertoli A., Barbaliscia S., Galli S., Gennari W., Baldanti F., Raimondo G., Perno C. F., Ceccherini-Silberstein F., Andreone P., Andreoni M., Angelico M., Babudieri S., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Cacciatore P., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., Craxi A., D'Ambrosio C., D'Ettorre G., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Lenci I., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Masetti C., Melis M., Meregalli E., Micheli V., Morisco F., Niero F., Nicolini L. A., Palitti V. P., Paoloni M., Parruti G., Pasquazzi C., Pellicelli A., Polilli E., Ponti M. L., Puoti M., Rendina M., Rizzardini G., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., Vullo V., Di Maio, V, Cento, V, Aragri, M, Paolucci, S, Pollicino, T, Coppola, N, Bruzzone, B, Ghisetti, V, Zazzi, M, Brunetto, M, Bertoli, A, Barbaliscia, S, Galli, S, Gennari, W, Baldanti, F, Raimondo, G, Perno, C, Ceccherini-Silberstein, F, Andreone, P, Andreoni, M, Angelico, M, Babudieri, S, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Cacciatore, P, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, Craxi, A, D'Ambrosio, C, D'Ettorre, G, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Lenci, I, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Masetti, C, Melis, M, Meregalli, E, Micheli, V, Morisco, F, Niero, F, Nicolini, L, Palitti, V, Paoloni, M, Parruti, G, Pasquazzi, C, Pellicelli, A, Polilli, E, Ponti, M, Puoti, M, Rendina, M, Rizzardini, G, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Di Maio V. C., Cento V., Aragri M., Paolucci S., Pollicino T., Coppola N., Bruzzone B., Ghisetti V., Zazzi M., Brunetto M., Bertoli A., Barbaliscia S., Galli S., Gennari W., Baldanti F., Raimondo G., Perno C. F., Ceccherini-Silberstein F., Andreone P., Andreoni M., Angelico M., Babudieri S., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Cacciatore P., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., Craxi A., D'Ambrosio C., D'Ettorre G., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Lenci I., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Masetti C., Melis M., Meregalli E., Micheli V., Morisco F., Niero F., Nicolini L. A., Palitti V. P., Paoloni M., Parruti G., Pasquazzi C., Pellicelli A., Polilli E., Ponti M. L., Puoti M., Rendina M., Rizzardini G., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., and Vullo V.

Published
2018

7. Non Insulin-Dependent Diabetes Mellitus (Type 2) Secondary Failure. Metformin-Glibenclamide Treatment

Author

Guagnano, M.T., Pace-Palitti, V., Manigrasso, M.R., Merlitti, D., Parra, H.M. Soto, and Sensi, S.

Abstract

The goal of sulphonylurea (S) treatment in Non-Insulin-Dependent Diabetes Mellitus (NIDDM - type 2 diabetes) subjects should be to obtain a satisfactory glycaemic control (fasting glycaemic levels < 140 mg%). The loss of an adequate blood glucose control after an initial variable period of S is known as secondary failure(SF). The number of SF are extremely variable among different trials for many reasons, some of which are patient-related: increased food intake, weight gain, non-compliance, poor physical activity, stress, diseases and/or impaired pancreatic beta cell function, desensitization after S chronic therapy, reduced absorption, concomitant therapies.Many therapeutic strategies have been proposed to achieve an adequate metabolic control in type 2 diabetes patients: switch to intensive insulin therapy and subsequent return to S therapy; association with insulin; association with sulphonylureas plus biguanides. The association biguanides and S, in particular glibenclamide plus metformin, is now widely used by diabetologists in SF since glibenclamide improves insulin secretion while metformin exerts its antidiabetic effect by different mechanisms.

Published
2001
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8. Weight fluctuations could increase blood pressure in android obese women

Author

GUAGNANO, M. T., PACE-PALITTI, V., CARRABS, C., MERLITTI, D., and SENSI, S.

Abstract

Recent studies have documented a relationship between increased morbidity and mortality from cardiovascular diseases and a history of weight cycling (WC) in obese subjects. We performed a cross-sectional analysis in 96 weight-cycling android obese women, matched with 96 non-weight-cycling android obese women by age, body mass index (BMI) and waist-to-hip ratio (WHR), to evaluate any increase in blood pressure (BP) levels in association with WC. The patients were all between 20 and 45 years old, were non-menopausal, did not smoke, did not take any medication, had normal glucose tolerance and were otherwise healthy. A history of WC was established on the basis of at least five weight losses in the previous 5 years due to dieting, with a weight loss of at least 4.5 kg per cycle. We documented higher levels of casual BP in the weight-cycling obese compared with the non-weight-cycling subjects: 147±12/90±8 mmHg versus 125±14/79±8 mmHg (P < 0.001). The women with WC showed a statistically significant positive correlation between BP and age, weight, BMI, waist circumference, WHR, total weight regained and weight cycling index (WCI). However, in a multiple regression model only the WHR and WCI contributed significantly to the BP variability. These findings could support the hypothesis that it is the combined exposure of central-type obesity and WC that strongly raises the prediction of hypertension.

Published
1999
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9. Transdermal Clonidine Therapy and Blood Pressure Nocturnal Fall in Mild Hypertensive Male Subjects

Author

Guagnano, M. T., Palitti, V. Pace, Merlitti, D., Carrabs, C., Santucci, E., and Sensi, S.

Abstract

Treatment of mild hypertension with an antihypertensive drug administered by means of a transdermal therapeutic system (TTS) could produce favorable results, when compared with a traditional oral regimen. Purpose: Using 24-h ambulatory blood pressure (BP) monitoring (ABPM) in mild hypertensive male subjects, to analyze three aspects which have not been completely clarified: a) whether a latency in the antihypertensive effect may be present, recording BP already from the first day of application of the patch, b) the eventual hazardous enhancement of circadian nocturnal fall in BP values in treated mild hypertensive patients and, c) the possible overlapping of antihypertensive effect between the administration of two consecutive patches. Subjects and methods: In 12 caucasian male outpatients (yrs 55 ± 3 SEM) with uncomplicated essential mild hypertension, a patch containing placebo was applied for the first week (T 0 period). At the end of the T 0 period, a 5 mg TTS-2 clonidine patch was applied for one week, and, subsequently, a new patch of 5 mg TTS-2 clonidine was kept for another week. ABPM was performed on the last day of the placebo period (T 0) and on the 1st day (T1), the 7th day (T2) and the 14th day (T3) of transdermal clonidine therapy. Results: Both systolic and diastolic BP (24 h mean, day-night-time) decreased on the 1st, 7th and 14th day, when compared with T0. However, no significant differences were documented between the BP levels on the 1st and the 7th day of treatment. The incidence of nocturnal fall in systolic and diastolic BP was evaluated and no significant differences were found, when compared with night-time reference values. Conclusions: When compared with the placebo period, TTS-2 clonidine lowers SBP and DBP within the first 24 hours of application. The antihypertensive effect persists at the end of the first week, as well as after 14 days. The lowest values of systolic-diastolic BP documented were not below the levels reported in normotensive men. Therefore, TTS-2 clonidine seems to act as an antihypertensive agent rather than a hypotensive drug since it normalizes BP without lowering it below physiological levels.

Published
1997
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10. Characterization of baseline factors associated with treatment outcome in HCV-infected patients naive to direct acting antivirals: particular focus on natural resistance.

Author

Barbaliscia, S., Di Maio, V.C., Teti, E., Aragri, M., Paolucci, S., Masetti, C., D'Ambrosio, R., Degasperi, E., Polilli, E., Palitti, V. Pace, Fiorentino, G., Foroghi, L., Cento, V., Scutari, R., Bruzzone, B., Calvaruso, V., Coppola, N., Gaeta, G.B., Morsica, G., and Ghisetti, V.

Published
2019
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11. Resistance test guided retreatment of HCV infected patients with a previous failure to a NS5A inhibitor-containing regimen: the Italian Vironet C real life experience.

Author

Di Maio, V.C., Aragri, M., Masetti, C., Paolucci, S., Bruzzone, B., Degasperi, E., Barbaliscia, S., Pollicino, T., Minichini, C., Calvaruso, V., Rendina, M., Cento, V., Teti, E., Micheli, V., Ghisetti, V., Polilli, E., Palitti, V. Pace, Landonio, S., Lenci, I., and Donnarumma, L.

Published
2019
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13. Daclatasvir/sofosbuvir and ribavirin 800 mg flat dose is highly efficacy and safe in genotype 3 compensated and decompensated cirrhotic patients: The CLEO experience.

Author

Pellicelli, A., Messina, V., Tarquini, P., Pace Palitti, V., Ceccherini Silberstein, F., Pompili, M., Gulminetti, R., Cerasari, G., D’Ambrosio, C., Villani, R., Fondacaro, L., Dell’isola, S., Babudieri, S., Iovinella, V., Di Candilo, F., Chiesara, F., Di Maio, V.C., Ponziani, F.R., Sacco, R., and Izzi, A.

Published
2017
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18. Many factors can affect the prevalence of hypertension in obese patients: role of cuff size and type of obesity.

Author

Guagnano MT, Palitti VP, Murri R, Marchione L, Merlitti D, and Sensi S

Subjects
Adult, Blood Pressure Determination instrumentation, Female, Humans, Hypertension diagnosis, Male, Middle Aged, Obesity classification, Obesity pathology, Risk Factors, Somatotypes, Hypertension etiology, Obesity complications
Abstract

Objective: To determine to what extent methodological errors, including measurements taken with inappropriate cuffs and/or inaccuracies in patient enrollment, can contribute to overestimating the prevalence of hypertension in overweight or obese women., Experimental Design: Randomized and comparative investigation in overweight or obese outpatient women of the Obesity Clinic, Internal Medicine Institute, Chieti University., Patients: In 1,791 overweight or obese women, randomly selected and stratified by age (41-60 years), blood pressure (BP) was taken with casual measurement in the morning. The entire study group was divided into two subgroups. In the first one, causal BP was measured with a standard-size cuff (RCS), while an appropriate large-size cuff was used for the second one (LCS). Patients of the latter subgroup were also divided by type of obesity (android and gynoid), based on their waist-to-hip ratio., Results: In the LCS subgroup, the hypertension prevalence rate was strikingly lower among overweight and obese women, as well as in the younger and older age groups, when compared with the corresponding RCS subgroups (p < 0.001). The hypertension prevalence rate was higher for all android obese subjects (53%), including younger (34%) and older (64%) groups, when compared with gynoid obese patients (29%, 18% and 42%, respectively)., Conclusions: A comparison of different reports on the prevalence of hypertension in obesity reveals considerable differences, due mainly to age, sex, race and income level. Nevertheless, our data seem to indicate that even after adjusting for the above-mentioned variables, two significant confounding factors, cuff hypertension and the prevalence of android obesity in the obese study population, could be responsible for over-estimating the prevalence of hypertension. It should be noted that for certain groups of overweight and obese women, the prevalence of hypertension becomes similar to the rate found among the general population, as reported in many large epidemiological surveys.

Published
1998

19. [What is the real prevalence of hypertension in obesity?].

Author

Guagnano MT, Murri R, Marchione L, Merlitti D, Palitti VP, and Sensi S

Subjects
Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Blood Pressure Monitors, Body Mass Index, Circadian Rhythm, Cross-Sectional Studies, Female, Humans, Hypertension diagnosis, Male, Middle Aged, Obesity classification, Obesity epidemiology, Sex Factors, Hypertension epidemiology, Obesity complications
Abstract

Many confounding variables (age, sex, race, income level) may contribute to an incorrect estimate of the prevalence of hypertension in the obese population. Furthermore, as far as methodology is concerned, both casual morning BP measurement and, the use, in the obese patient, of inappropriate cuffs both also contribute significantly to the overestimation with the inclusion of false positives even in relevant percentages. Different types of obesity (android or gynoid; visceral or subcutaneous) should be considered when enrolling obese patients in prevalence studies being android or visceral obesity at a higher hypertensive risk. At last and overall, universally recognized cutoff-points for obesity and hypertension should always be used when studying prevalence of hypertension among general population and/or among obese patients. When such conditions are not taken into account, inaccurate and misleading conclusions on the real prevalence of hypertension in obesity may result.

Published
1995

20. Association of body mass index and regional fat distribution with blood pressure investigated by 24-hour ambulatory blood pressure monitoring in android-type obese.

Author

Guagnano MT, Cugini P, Merlitti D, Murri R, Palitti VP, and Sensi S

Subjects
Adult, Age Factors, Blood Glucose, Circadian Rhythm, Female, Humans, Hypertension, Middle Aged, Blood Pressure, Body Mass Index, Fats, Obesity
Abstract

In 46 female outpatients with android-type obesity, body mass index (BMI) 36.6 +/- 1.0, waist to hip ratio (WHR) > 0.86, and normal glucose tolerance (NGT) who were hypertensive at entry study [blood pressure (BP) > 140/90 mm Hg] and in 10 clinically healthy, nonobese, normotensive women, we evaluated the relationship between BMI, fat mass, WHR, fasting blood glucose, sum of blood glucose levels during oral glucose tolerance test and casual BP levels, 24-h ambulatory BP monitoring (ABP) parameters as the 24-hour mean, day-time mean, night-time mean and, by using a periodic model of cosine regression, MESOR (midline estimating statistic of rhythm), amplitude, acrophase, and baric impact. In android obese women, a negative correlation between ABP levels (day-/night-time, MESOR, and baric impact of systolic BP; night-time and MESOR of diastolic BP) and BMI has been documented. A positive correlation between systolic BP (casual, night-time mean, MESOR, amplitude, and baric impact), diastolic baric impact, and the WHR has been found. No correlation has been demonstrated between ABP monitoring parameters, and BMI, body fat, and WHR in the control group. Our data could suggest that, when enrolling obese subjects, it must be taken into account that obesity is a heterogeneous disorder. There are in fact obese subjects with normal or impaired glucose tolerance, as well as diabetics with moderate to severe obesity and with gynecoid or android-type obesity. In our android obese subjects with NGT, the WHR rather than the BMI was found to be a better predictor of hypertension.(ABSTRACT TRUNCATED AT 250 WORDS)

Published
1995
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21. Ambulatory blood pressure monitoring in evaluating the relationship between obesity and blood pressure.

Author

Guagnano MT, Merlitti D, Murri R, Palitti VP, and Sensi S

Subjects
Adipose Tissue anatomy & histology, Adult, Body Constitution, Body Mass Index, Circadian Rhythm physiology, Female, Glucose Tolerance Test, Humans, Male, Middle Aged, Ambulatory Care, Blood Pressure physiology, Blood Pressure Monitors, Obesity physiopathology
Abstract

The relationship of body mass index, body fat, waist to hip ratio, fasting blood glucose and sum of blood glucose levels during oral glucose tolerance test with casual blood pressure (BP) and BP parameters obtained by 24h ambulatory BP monitoring in 97 out-patients moderately obese (66 with android type obesity), normal glucose tolerance and mild hypertension at entry study, has been evaluated. A negative correlation between body mass index and systolic ambulatory BP levels as the 24h mean, daytime and nighttime, has been documented in all of the obese subjects; no correlations between body mass index and casual BP were shown. Only in the group of android type obese was the body mass index correlated positively with the casual DBP. Systolic 24h and nighttime BP values correlated positively with waist to hip ratio; the correlation coefficients improved in the subgroup of android type obese. By using 24h ambulatory BP monitoring, it may be possible to show that waist to hip ratio is a better predictor of systolic hypertension than other parameters such as those derived from weight and height measurements and body fat percentage.

Published
1994

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