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1.
Therap Adv Gastroenterol ; 17: 17562848241249570, 2024.
Article in English | MEDLINE | ID: mdl-38812705

ABSTRACT

Background: Eosinophilic esophagitis (EoE) is recognized as a chronic type 2 inflammatory disease characterized by the eosinophilic infiltration of the esophageal tissue, posing a significant disease burden and highlighting the necessity for novel management strategies to address unmet clinical needs. Objectives: To critically evaluate the existing literature on the epidemiology and management of EoE, identify evidence gaps, and assess the efficacy of current and emerging treatment modalities. Design: An extensive literature review was conducted, focusing on the epidemiological trends, diagnostic challenges, and therapeutic interventions for EoE. This was complemented by a survey among physicians and consultations with a scientific expert panel, including a patient's association (ESEO Italia), to enrich the study findings. Data sources and methods: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, scrutinizing epidemiological studies and management research to compile comprehensive insights into the disease's landscape. The physician survey and expert panel discussions aimed to bridge identified evidence gaps. Results: The review included 59 epidemiological and 51 management studies, uncovering variable incidence and prevalence rates of EoE globally, with an estimated diagnosed prevalence of 41 per 100,000 in Italy. Diagnostic challenges were identified, including nonspecific symptoms and the lack of definitive biomarkers, which complicate the use of endoscopy. Treatment options such as elimination diets, proton-pump inhibitors, and swallowed corticosteroids were found to have varying success rates, while Dupilumab, an emerging therapy targeting interleukin (IL)-4 and IL-13, shows promise. Conclusion: Despite advancements in understanding and managing EoE, significant unmet clinical needs remain, particularly in biomarker identification, therapy personalization, and cost-effectiveness evaluation. A comprehensive, multidimensional approach to patient management is required, emphasizing the importance of early symptom recognition, accurate diagnosis, and tailored treatment strategies. Dupilumab offers potential as a novel treatment, underscoring the need for future research to explore the economic and social dimensions of EoE care pathways.


Understanding and improving care for eosinophilic esophagitis: bridging gaps in diagnosis and treatment Eosinophilic esophagitis (EoE) is a chronic inflammatory condition affecting the esophagus. We reviewed studies on how common EoE is and how it's managed. In Italy, about 41 out of 100,000 people may have it. Diagnosis can be tricky due to vague symptoms, and current treatments vary in effectiveness. We found a need for better ways to diagnose and treat EoE, including exploring new therapies. A promising development is a biologic called Dupilumab. Future research should also consider the costs and social aspects of caring for people with EoE.

2.
Dig Liver Dis ; 56(6): 1014-1020, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38105149

ABSTRACT

Gastrointestinal manifestations are common across all hereditary transthyretin amyloidosis (ATTRv) genotypes. However, they are poorly specific, and their recognition as part of ATTRv is difficult, resulting in misdiagnosis with more common conditions. Moreover, delays in diagnosis occur because of fragmented knowledge, a shortage of centers of excellence and specialists dedicated to ATTRv management, and the scarce involvement of gastroenterologists in multidisciplinary teams. A group of Italian gastroenterologists with experience in the management of ATTRv took part in a project aimed at assessing the awareness of ATTRv among the community of Italian gastroenterologists through an online survey and providing education about practical aspects of ATTRv management. Survey results reported low participation, and very few patients with ATTRv were cared for by gastroenterologists. This highlights the need for greater attention to rare diseases in gastroenterology and emphasizes increasing awareness of ATTRv and diagnostic suspicion. Based on the experts' recommendations, a diagnosis of ATTRv should be suspected when at least one of the 'red flags' is detected. Subsequently, it is suggested to promptly ask for genetic testing and exclude a serum and urinary monoclonal protein, even before the detection of amyloid in biopsy samples, particularly in non-endemic areas.


Subject(s)
Amyloid Neuropathies, Familial , Gastrointestinal Diseases , Humans , Amyloid Neuropathies, Familial/diagnosis , Amyloid Neuropathies, Familial/therapy , Amyloid Neuropathies, Familial/genetics , Italy , Gastrointestinal Diseases/diagnosis , Gastrointestinal Diseases/therapy , Genetic Testing , Surveys and Questionnaires , Gastroenterology
3.
Liver Int ; 42(11): 2453-2465, 2022 11.
Article in English | MEDLINE | ID: mdl-35932095

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.


Subject(s)
Liver Cirrhosis, Biliary , Albumins/therapeutic use , Ascites/drug therapy , Ascites/etiology , Bilirubin , Chenodeoxycholic Acid/analogs & derivatives , Humans , Liver Cirrhosis/complications , Liver Cirrhosis/drug therapy , Liver Cirrhosis, Biliary/complications , Liver Cirrhosis, Biliary/drug therapy , Male
4.
J Clin Med ; 11(4)2022 Feb 09.
Article in English | MEDLINE | ID: mdl-35207172

ABSTRACT

BACKGROUND AND AIM OF THE STUDY: Polyposis syndromes such as Peutz-Jeghers (PJ) and familial adenomatous polyposis (FAP) are associated with the growth of small bowel polyps; the risk is approximately 60-90% for PJ and 40-70% for FAP. The primary aim of this study was to evaluate the efficacy of device-assisted enteroscopy (DAE) in the detection and treatment of small bowel polyps to reduce the risk of surgery. The secondary objective was to study complications and mortality. METHODS: We conducted a retrospective cohort study by analyzing a structured database. Between September 2006 and October 2019, we observed and followed 42 consecutive patients with polyposis syndromes; they underwent device-assisted enteroscopy and three were excluded from elective surgery after the exam. The endoscopic exams were performed for diagnostic and therapeutic purposes. RESULTS: Thirty-nine patients were evaluated with a mean follow up of 6.7 years (±SD 2.7), 79.5% were female with a mean age of 43.8 years (±SD 15.02), and 68 enteroscopies were performed with the removal of 64 polypoid lesions. One bleeding episode occurred after operative enteroscopy, and the need for subsequent surgery occurred in six patients with PJ and in five patients with FAP. The surgical indications in PJ patients were the presence of large polyps (three patients) and three cases of intussusception, one of which was a patient with a polyp in the proximal ileum, not reachable with the scope. One patient with PJ died from pancreatic cancer during follow up. The surgical indications in patients with FAP were the presence of four large polyps with high-grade dysplasia and one ampullary neoplasia recurrence. CONCLUSIONS: In PJ patients, the endoscopic treatment of small bowel polyps was safe. During the follow-up period, the patients with successful endoscopic treatment did not need surgery. In FAP patients treated with DAE, none developed cancer.

5.
Gastrointest Endosc ; 94(3): 589-597.e1, 2021 09.
Article in English | MEDLINE | ID: mdl-33848508

ABSTRACT

BACKGROUND AND AIMS: Little is known about small-bowel (SB) capsule endoscopy (CE) in patients with a history of gastric surgery. This study aims to evaluate the feasibility and diagnostic yield (DY) of orally ingested SB-CE in patients with surgically altered gastric anatomy. METHODS: Twenty-four European centers retrospectively identified patients who had SB-CE after total or subtotal gastrectomy. The primary outcome was the DY of SB-CE (intermediate P1 to highly P2 relevant findings). Secondary outcomes were gastric and SB transit times, completion, cleanliness, and adverse event rates. RESULTS: Studied were 248 procedures from 243 patients (mean age, 62 years) with a history of partial gastrectomy (Billroth I, 13.1%; Billroth II, 34.6%), total gastrectomy (7.4%), Whipple procedure (12.8%), sleeve gastrectomy (7.2%), or gastric bypass surgery (24.7%). Obscure GI bleeding was the most frequent indication (85.1%). SB completion rate was 84.3%. One capsule retention in the SB was noted (adverse event rate, .4%). Median SB transit time was 286 minutes (interquartile range [235; 387]). Cleanliness was rated as adequate in 92.1% of procedures. After exclusion of abnormalities found at the upper anastomotic site, the DY was 43.6%, with inflammatory/ulcerated lesions observed more frequently (23.4%) than vascular lesions (21.0%). CONCLUSIONS: SB-CE seems to be feasible and safe in selected patients with a history of major gastric surgery and comes with a high DY. The spectrum of abnormal SB findings in these patients may be different from what is known from the literature in nonoperated patients.


Subject(s)
Capsule Endoscopy , Feasibility Studies , Gastrointestinal Hemorrhage/etiology , Humans , Intestine, Small , Middle Aged , Retrospective Studies
6.
J Viral Hepat ; 28(4): 651-656, 2021 04.
Article in English | MEDLINE | ID: mdl-33421220

ABSTRACT

Italy is one of the countries on track with the WHO's agenda to eliminate hepatitis C virus (HCV) by 2030. Healthcare facilities play a crucial role in seeking patients who are infected but have not yet been treated. We assessed the effectiveness of a recall strategy, named 'Telepass' project, for patients exposed to HCV infection who have not yet been linked to care in a large tertiary care centre. The 'Telepass' project was structured in two phases: (a) a retrospective analysis first identified all anti-HCV-positive subjects among patients who underwent pre-operative assessment in the facility in the course of one year; (b) a following prospective phase, aimed to recall patients in need either of further diagnostic tests (ie HCV-RNA) or treatment. A total of 12246 records of patients tested for HCV antibodies were reviewed. The overall prevalence of anti-HCV-positive subjects was 1.83% (224/12246) with a male/female ratio of 2.07. Out of the 224 anti-HCV-positive patients, 123 (54.91%) did not have documented HCV-RNA tests and were therefore selected for recall. Of these, 123 were reachable and 26 (21.13%) were successfully linked to care. Ten patients (38.46%) tested HCV-RNA positive and initiated treatment with direct-acting antivirals (DAAs). The Telepass study highlights that a recall strategy starting from internal hospital databases can help identify patients with chronic HCV infection who have not yet been linked to care, and provides an epidemiological insight into the prevalence of HCV infection in Italy in the late DAAs era.


Subject(s)
Hepatitis C, Chronic , Hepatitis C , Antiviral Agents/therapeutic use , Delivery of Health Care , Female , Hepacivirus/genetics , Hepatitis C/diagnosis , Hepatitis C/drug therapy , Hepatitis C/epidemiology , Hepatitis C, Chronic/diagnosis , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/epidemiology , Humans , Male , Prospective Studies , Retrospective Studies , Tertiary Care Centers , World Health Organization
7.
J Gastrointestin Liver Dis ; 29(3): 339-343, 2020 Sep 09.
Article in English | MEDLINE | ID: mdl-32919418

ABSTRACT

BACKGROUND AND AIMS: Hereditary transthyretin (ATTRv) amyloidosis represents a diagnostic challenge considering the great variability in clinical presentation and multiorgan involvement. In this study we report the prevalence of gastrointestinal (GI) involvement of patients with hereditary ATTRv amyloidosis from one single center of Italy, a non-endemic area. METHODS: We retrospectively analyzed a cohort of 39 patients with hereditary ATTRv amyloidosis followed at the Neurology Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy. All patients had a documented mutation in the gene encoding the thansthyretin. Neurological, cardiological and gastrointestinal manifestations were systematically collected at every monitoring visit. RESULTS: 82% reported at least one GI symptom. Unintentional weight loss was the most frequently reported. Lower GI symptoms were more frequent than upper GI symptoms (66.7% vs. 35.9%, p=0.0122). The first GI symptom was always reported within 5 years since disease onset. Gastrointestinal symptoms were almost always present in patients with Val30Met mutation (93.8%, 15/16), and in more than half of the cases with Phe64Leu mutation (66.7%, 8/12). All cases with a non-Val30Met mutation disclosed almost all GI symptoms within 5 years since disease onset; conversely, patients with Val30Met mutation continued to develop further GI manifestations during the disease course. CONCLUSIONS: Prevalence of GI symptoms in our cohort was 82%, resulting in a higher prevalence than reported in the THAOS registry. Gastroenterologists, therefore, play an important role for the management of the disease, and their expertise should be valued for an effective multidisciplinary approach to this condition.


Subject(s)
Amyloid Neuropathies, Familial/epidemiology , Gastrointestinal Diseases/epidemiology , Age of Onset , Amyloid Neuropathies, Familial/diagnosis , Amyloid Neuropathies, Familial/genetics , Female , Gastrointestinal Diseases/diagnosis , Genetic Predisposition to Disease , Humans , Male , Middle Aged , Mutation , Prealbumin/genetics , Prevalence , Retrospective Studies , Risk Assessment , Risk Factors , Rome/epidemiology
8.
Rev Recent Clin Trials ; 15(4): 321-327, 2020.
Article in English | MEDLINE | ID: mdl-32493201

ABSTRACT

BACKGROUND: Hereditary hemorrhagic telangiectasia (HHT, or Rendu-Osler-Weber disease) is a rare inherited syndrome, characterized by artero-venous malformations (AVMs or telangiectasia) with autosomal dominant transmission. AVMs can occur in any organ of the body but most commonly it occurs in the nose, pulmonary, hepatic and cerebral circulations. In patients with HHT, we report teleangectasia of mucosa of the gastrointestinal tract. METHODS: Research and online content related to HHT online activity is reviewed, and DOC writing excerpts are used to illustrate key themes. RESULTS: Patients with HHT have a high rate of complications related to bleeding; of them gastrointestinal bleeding accounts for 10.8%. Several therapies, both medical and endoscopic, were utilized to reduce the need for transfusions and hospitalization. CONCLUSION: A combination of medical and endoscopic therapy is probably the best option.


Subject(s)
Telangiectasia, Hereditary Hemorrhagic , Endoscopy , Gastrointestinal Hemorrhage/etiology , Gastrointestinal Hemorrhage/therapy , Humans , Telangiectasia, Hereditary Hemorrhagic/complications , Telangiectasia, Hereditary Hemorrhagic/diagnosis , Telangiectasia, Hereditary Hemorrhagic/therapy
10.
Orphanet J Rare Dis ; 14(1): 298, 2019 12 26.
Article in English | MEDLINE | ID: mdl-31878955

ABSTRACT

Subjects with the rare autosomal dominant disease Hereditary Hemorrhagic Telangiectasia (HHT) may develop medical conditions that require antithrombotic therapy (AT). However, safety of AT is uncertain in these patients and the only data currently available derive from retrospective analyses of registries and/or databases. At the HHT Centre of the 'Fondazione Policlinico Universitario A. Gemelli IRCCS' (Rome, Italy), a prospective study is currently ongoing to evaluate the safety of AT in subjects affected by HHT. The study is enrolling subjects with a definite diagnosis of HHT who receive an AT prescription by one of the physicians of the HHT Centre. The primary outcome is the number of hemorrhagic events, distinguished in major, clinically relevant non-major (CRNM), and minor bleedings, according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH). Another primary outcome is worsening of epistaxis upon initiation of AT, assessed using the internationally accepted Epistaxis Severity Score (ESS). Additional outcomes are changes in hemoglobin levels and changes in the need of blood transfusion after initiation of AT. Here, we present the results of an interim analysis, conducted on the 12 HHT subjects that have been enrolled so far. After a mean follow-up of 6.5 ± 0.8 months, no major bleedings, no CRNM bleedings, and no minor bleedings different from epistaxis were recorded. Worsening of epistaxis upon initiation of AT was documented only in one patient, but did not require discontinuation of AT. There were no significant changes in the mean ESS measured before and after initiation of AT. There were no significant changes in hemoglobin levels and need for blood transfusion after initiation of AT. Although preliminary, these are the first prospective data on the safety of AT in HHT patients. Our interim analysis suggests that, when prescribed by experienced physicians in a multidisciplinary setting, AT is well tolerated by HHT patients. More patients and a longer follow-up are needed to confirm these findings.


Subject(s)
Fibrinolytic Agents/adverse effects , Fibrinolytic Agents/therapeutic use , Telangiectasia, Hereditary Hemorrhagic/drug therapy , Aged , Female , Hemoglobins/metabolism , Humans , Interdisciplinary Research , Male , Middle Aged , Prospective Studies
11.
Orphanet J Rare Dis ; 14(1): 130, 2019 06 07.
Article in English | MEDLINE | ID: mdl-31174568

ABSTRACT

Hereditary hemorrhagic teleangectasia (HHT, or Rendu-Osler-Weber disease) is a rare inherited syndrome, characterized by arterio-venous malformations (AVMs or Telangiectasia). The most important and common manifestation is nose bleeds (epistaxis). The telangiectasias (small AVMs) are most evident on the lips, tongue, buccal mucosa, face, chest, and fingers, however; large arterio-venous malformations can also occur in the lungs, liver, pancreas, or brain. Telangiectasias in the upper gastrointestinal tract are known to occur, however data regarding possible small-bowel involvement is limited due to technical difficulties in visualizing the entire gastrointestinal tract. The occurrence of AVMs in the stomach and small bowel can result in chronic bleeding and anaemia. Less frequently, this may occur due to bleeding from oesophageal varices, as patients with HHT can develop hepatic parenchymal AVMs or vascular shunts which cause hepatic cirrhosis and portal hypertension. Gastroenterologists have a crucial role in the management of these patients, however difficulties remain in the detection and management of complications of HHT in the gastrointestinal tract.


Subject(s)
Telangiectasia, Hereditary Hemorrhagic/pathology , Arteriovenous Malformations/pathology , Female , Gastroenterologists , Humans , Male
12.
Expert Opin Pharmacother ; 19(17): 1941-1948, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30345837

ABSTRACT

Introduction: Hepatocellular carcinoma (HCC) is one of the most frequent malignant tumors with 854,000 new cases per year and represents the second most frequent cause of cancer-death. Despite surveillance, the number of patients that are diagnosed at a stage in which they are eligible for curative treatments ranges from 30% to 60%. Advanced HCC (BCLC-C) is characterized by a median survival of 6 months. Sorafenib, the first systemic drug proven to be effective in prolonging survival of unresectable HCC, was approved by the FDA in 2007 but no second-line treatment was available for a decade for patients progressing on sorafenib. Finally, in 2016, the RESORCE trial demonstrated regorafenib as an effective second-line treatment. Areas covered: In this manuscript, the authors review the principal preclinical and clinical trials on regorafenib used in the treatment of unresectable HCC patients progressing on sorafenib and highlight both the advantages and the limitations of this drug. Expert opinion: Regorafenib is the only second-line treatment available for patients progressing on sorafenib. Despite its promising clinical application, many doubts still remain, necessitating further investigation to explore the tolerability of this drug in Child-Pugh B and sorafenib-intolerant patients, while its scarce cost-effectiveness must also be improved.


Subject(s)
Carcinoma, Hepatocellular/drug therapy , Liver Neoplasms/drug therapy , Phenylurea Compounds/therapeutic use , Pyridines/therapeutic use , Animals , Antineoplastic Agents/chemistry , Antineoplastic Agents/pharmacokinetics , Antineoplastic Agents/pharmacology , Antineoplastic Agents/therapeutic use , Carcinoma, Hepatocellular/metabolism , Drug Screening Assays, Antitumor , Humans , Liver Neoplasms/metabolism , Phenylurea Compounds/chemistry , Phenylurea Compounds/pharmacokinetics , Phenylurea Compounds/pharmacology , Pyridines/chemistry , Pyridines/pharmacokinetics , Pyridines/pharmacology , Sorafenib/therapeutic use
13.
Scand J Gastroenterol ; 53(8): 925-929, 2018 Aug.
Article in English | MEDLINE | ID: mdl-29966446

ABSTRACT

OBJECTIVES: Single balloon enteroscopy (SBE) is an effective and safe modality for the diagnosis and therapeutic intervention of small bowel disorders. Its use in patients with Crohn's disease (CD) and particularly its effect on management changes in CD have not yet been determined. MATERIALS AND METHODS: We performed a retrospective review of the endoscopic and clinical data available on a cohort of patients with small bowel CD who had undergone SBE to determine the diagnostic and therapeutic yield of the procedure and the initial and longer-term impact it had on clinical management. RESULTS: About 52 patients have undergone SBE in our unit for the investigation of known (n = 39) or suspected (n = 13) small bowel CD with a diagnostic yield of 77% and 39%, respectively. SBE had an immediate clinical impact in 69% (n = 33) of patients, including dilatation of a stricture in 27% (n = 13), initiation or adjustment of dose of medications in 48% (n = 23), referral for surgical resection in 6% (n = 3). Moreover, the procedure permitted determining a new diagnosis of CD in 8% of the patients (n = 4), and excluding it in 8% (n = 4). Longer term follow-up was available in 34 patients (65%) which showed a significant difference in mean HBI score from 6.6 before the procedure to 4.2 after it (p < .0001). CONCLUSIONS: SBE has a high diagnostic and therapeutic yield in CD and significantly impacts disease management. Careful patient selection is a key factor in optimizing its use in CD.


Subject(s)
Crohn Disease/diagnosis , Patient Selection , Single-Balloon Enteroscopy/standards , Adolescent , Adult , Aged , Crohn Disease/therapy , Databases, Factual , Disease Management , Female , Humans , Italy , Male , Middle Aged , Retrospective Studies , Young Adult
14.
Lancet ; 391(10138): 2417-2429, 2018 06 16.
Article in English | MEDLINE | ID: mdl-29861076

ABSTRACT

BACKGROUND: Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue. METHODS: We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008-000625-19, and ClinicalTrials.gov, number NCT01288794. FINDINGS: From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40-0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3-4 non-liver related adverse events. INTERPRETATION: In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. FUNDING: Italian Medicine Agency.


Subject(s)
Albumins/therapeutic use , Ascites/therapy , Liver Cirrhosis/drug therapy , Aged , Ascites/etiology , Diuretics/administration & dosage , Diuretics/adverse effects , Drug Therapy, Combination , Female , Furosemide/administration & dosage , Furosemide/adverse effects , Humans , Hyperkalemia/chemically induced , Hyponatremia/chemically induced , Kaplan-Meier Estimate , Liver Cirrhosis/complications , Liver Cirrhosis/physiopathology , Male , Middle Aged , Mineralocorticoid Receptor Antagonists/therapeutic use , Paracentesis , Quality of Life , Quality-Adjusted Life Years , Survival Rate , Time Factors
15.
Expert Rev Clin Pharmacol ; 11(5): 519-524, 2018 May.
Article in English | MEDLINE | ID: mdl-29498556

ABSTRACT

INTRODUCTION: Treatment of Hepatitis C Virus (HCV) with direct acting antivirals (DAAs) is able to achieve the cure of infection in almost the totality of patients, independently of the characteristics of the individual and the virus, using short treatment schedules, and without the need of ribavirin. The high cost of DAAs is the main limiting factor for universal treatment of HCV. However, there is a strong evidence that treatment of infection at the early stage of disease may be the most rewarding approach. Areas covered: This review evaluates the aspects underlying the benefit of treating chronic HCV infection at the early stage of disease. It outlines the considerations that have to be taken into account when planning treatment in patients with HCV and minimal liver disease, assessing the positive reflex of viral eradication on several HCV-associated extra-hepatic conditions such as the risk of lymphoma, insulin-resistance and glycaemic control, and renal function. Lastly, it also covers the improvement of patients' quality of life and the pharmaco-economic aspects associated with early treatment. Expert commentary: Treatment of patients with HCV and minimal liver disease is associated with a beneficial, pleiotropic effect of viral eradication that goes beyond the simplistic consideration of the improvement in liver disease-related outcomes.


Subject(s)
Antiviral Agents/administration & dosage , Hepatitis C, Chronic/drug therapy , Quality of Life , Antiviral Agents/economics , Drug Costs , Economics, Pharmaceutical , Hepatitis C, Chronic/virology , Humans , Time Factors , Treatment Outcome
16.
United European Gastroenterol J ; 5(7): 974-981, 2017 Nov.
Article in English | MEDLINE | ID: mdl-29163963

ABSTRACT

BACKGROUND: Recent data imply young patients (age ≤50 years) undergoing small-bowel (SB) capsule endoscopy (CE) for iron deficiency anaemia (IDA) show higher diagnostic yield (DY) for sinister pathology. We aimed to investigate DY of CE in a large cohort of young IDA patients, and evaluate factors predicting significant SB pathology. MATERIALS AND METHODS: This was a retrospective, multicentre study (2010-2015) in consecutive, young patients (≤50 years) from 18 centres/12 countries, with negative bidirectional gastrointestinal (GI) endoscopy undergoing SBCE for IDA. Exclusion criteria: previous/ongoing obscure-overt GI bleeding; age <19 or >50 years; comorbidities associated with IDA. Data retrieved: SBCE indications; prior investigations; medications; SBCE findings; final diagnosis. Clinical and laboratory data were analysed by multivariate logistic regression. RESULTS: Data on 389 young IDA patients were retrieved. In total, 169 (43.4%) were excluded due to incomplete clinical data; data from 220 (122F/98M; mean age 40.5 ± 8.6 years) patients were analysed. Some 71 patients had at least one clinically significant SBCE finding (DY: 32.3%). They were divided into two groups: neoplastic pathology (10/220; 4.5%), and non-neoplastic but clinically significant pathology (61/220; 27.7%). The most common significant but non-neoplastic pathologies were angioectasias (22/61) and Crohn's disease (15/61). On multivariate analysis, weight loss and lower mean corpuscular volume(MCV) were associated with significant SB pathology (OR: 3.87; 95%CI: 1.3-11.3; p = 0.01; and OR: 0.96; 95%CI: 0.92-0.99; p = 0.03; respectively). Our model also demonstrates association between use of antiplatelets and significant SB pathology, although due to the small number of patients, definitive conclusions cannot be drawn. CONCLUSION: In IDA patients ≤50 years with negative bidirectional GI endoscopy, overall DY of SBCE for clinically significant findings was 32.3%. Some 5% of our cohort was diagnosed with SB neoplasia; lower MCV or weight loss were associated with higher DY for SB pathology.

17.
Dig Liver Dis ; 2017 May 25.
Article in English | MEDLINE | ID: mdl-28619257

ABSTRACT

This article has been withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.

18.
Diabetes Technol Ther ; 18(7): 444-5, 2016 07.
Article in English | MEDLINE | ID: mdl-27333334

ABSTRACT

Video capsule endoscopy (VCE) is a noninvasive diagnostic tool used to observe the small intestinal mucosa. We report a case of a 57-year-old woman with T2DM, treated with continuous subcutaneous insulin infusion using second-generation OmniPod patch pump, undergoing VCE (Given M2A; VCE Ltd, Yoqneam, Israel) for melena and anemia. During VCE, an abnormal interruption of communication between video capsule and its receiver occurred. Two hours after capsule ingestion, the patient activated the insulin pump infusion through the Personal Diabetes Manager (PDM) because she drank a sugary beverage for the first time after ingestion. Due to this, we decided to repeat VCE after the removal of the insulin pump and PDM: at this time, the capsule recorded for more than 10 h without any interruption. The video capsule and second-generation OmniPod patch pump use the same radio frequency and this may cause interference between these two devices. In patients using second-generation OmniPod patch pump undergoing VCE, we suggest to switch to intravenous insulin infusion or multiple daily injection or to use a different model of VCE, as MiRoCam (Intromedic, Seoul, Korea).


Subject(s)
Capsule Endoscopes/adverse effects , Capsule Endoscopy/methods , Insulin Infusion Systems/adverse effects , Radio Waves , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Equipment Failure , Female , Humans , Middle Aged
19.
J Gastrointestin Liver Dis ; 23(4): 387-91, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25531996

ABSTRACT

BACKGROUND AND AIMS: There is a growing interest for the use of probiotics for chronic constipation. A recent randomized controlled trial (RCT) showed a positive effect of Lactobacillus reuteri (L. reuteri) on bowel movement frequency in infants with chronic constipation. The aim of the present study was to evaluate the effects of L. reuteri in adult patients with functional constipation. METHODS: A double-blind, placebo RCT was conducted in 40 adults (18M/22F, 35+/-15 years) affected by functional constipation according to the Rome III criteria. Patients were randomly assigned to receive a supplementation of L. reuteri (DSM 17938), or matching placebo for 4 weeks. The increase of bowel movements/week was the primary outcome, while the improvement of stool consistency was the secondary outcome. RESULTS: At week 4, the mean increase in bowel movements/week was 2.6 (SD +/-1.14, 95% CI:1.6-3.6) in the L. reuteri group and 1.0 (SD+/-1. 95% CI:0.12-1.88) in the placebo group (p=0.046). At the end of the treatment, the mean bowel movements/week was 5.28+/-1.93 in the L. reuteri group and 3.89+/-1.79 in the placebo group. There was a not significant difference in the stool consistency between the two groups. CONCLUSIONS: L. reuteri is more effective than the placebo in improving bowel movement frequency in adult patients with functional constipation as previously demonstrated in children, even if it seems to have no effect on stool consistency.


Subject(s)
Constipation/therapy , Intestines/microbiology , Limosilactobacillus reuteri/growth & development , Probiotics/therapeutic use , Adult , Chronic Disease , Constipation/diagnosis , Constipation/microbiology , Constipation/physiopathology , Defecation , Double-Blind Method , Female , Humans , Intestines/physiopathology , Male , Middle Aged , Prospective Studies , Recovery of Function , Rome , Time Factors , Treatment Outcome , Young Adult
20.
Helicobacter ; 19 Suppl 1: 52-8, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25167946

ABSTRACT

While Helicobacter pylori infection was initially revealed to be associated only with some gastroduodenal diseases, further studies have shown its possible role in several extragastric diseases. For idiopathic thrombocytopenic purpura, sideropenic anemia, and vitamin B12 deficiency, the diagnosis of H. pylori infection is recommended, and there are many other conditions such as cardiovascular, neurological, dermatological, and respiratory diseases in which H. pylori may possibly play a role. Interestingly, a potential role has also been described for GI neoplastic diseases, including colorectal and pancreatic cancer. Different mechanisms of action have been proposed, ranging from the induction of a low grade inflammatory state to the occurrence of molecular mimicry mechanisms. This review summarizes the results of the most relevant studies published on this topic over the last year.


Subject(s)
Helicobacter Infections/microbiology , Helicobacter pylori/physiology , Anemia/etiology , Anemia/microbiology , Helicobacter Infections/complications , Helicobacter pylori/isolation & purification , Humans , Vitamin B 12 Deficiency/etiology , Vitamin B 12 Deficiency/microbiology
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