Tamoxifen in treatment of hepatocellular carcinoma: a randomised controlled trial

Background Results from small randomised trials on tamoxifen in the treatment of hepatocellular carcinoma (HCC) are conflicting, We studied whether the addition of tamoxifen to best supportive care prolongs survival of patients with HCC. Methods Patients with any stage of HCC were eligible, irrespective of locoregional treatment. Randomisation was centralised, with a minimisation procedure accounting for centre, evidence of disease, and time from diagnosis. Patients were randomly allocated best supportive care alone or in addition to tamoxifen, Tamoxifen was given orally, 40 mg per day, from randomisation until death. Results 496 patients from 30 institutions were randomly allocated treatment from January, 1995, to January, 1997. Information was available for 477 patients. By Sept 15, 1997, 119 (50%) of 240 and 130 (55%) of 237 patients had died in the control and tamoxifen arms, respectively. Median survival was 16 months and 15 months (p=0.54), respectively, No differences were found within subgroups defined by prognostic variables. Relative hazard of death for patients receiving tamoxifen was 1.07 (95% CI 0.83-1.39). Interpretation Our findings show that tamoxifen is not effective in prolonging survival of patients with HCC

Prevalence and symptoms overlap between dyspepsia and gastroesophageal reflux disease: a study in a rural population

Background and aim. Symptoms overlap has been reported in patients suffering from both dyspepsia and gastroesophageal reflux disease (GERD). Although this aspect represents a confounding factor for both diagnosis and treatment ofGERDand dyspepsia, there are no data about their prevalence in Italy. Our aimwas to investigate the prevalence and overlap of uninvestigated dyspepsia and GERD symptoms and their overlap in a large population from a rural area in Southern Italy. Material and methods. Data were collected using standardised questionnaires administered directly to 1300 subjects by the investigators. The sample population was extracted from an age- and sex-stratified randomised group of 64370 subjects (aged 18–82 years) living in a rural area of Southern Italy. Subjects were questioned about the presence of acid regurgitation and burning sensation/discomfort rising from the stomach up to the throat. Symptom frequency was calculated based on the occurrence in the previous year (absent; mild: £1/month; moderate: £1/week; severe: >£1/week). Presence and severity (absent, mild, moderate and disabling) of eight dyspeptic symptoms (epigastric pain, postprandial fullness, bloating, early satiety, nausea, vomiting, belching, epigastric burning) were explored. Dyspepsia was then defined according to Rome II criteria. The data were assembled in an Access© database (Microsoft) and analysed with SSPS 11.0. Results. Overall prevalence of GERD symptoms was 22.3%. Patients with GERD symptoms, scored as moderate/severe, were 164 (12.6%), with 111 subjects (8.5%) having burning or discomfort rising from the stomach to the throat and 53 (4.1%) with acid regurgitation. Both symptoms were present in 5.7% of total population. Three hundred seven (23.6%) subjects had dyspeptic symptoms. Based on Rome II criteria, 76 (5.8%) were found to have dyspepsia and 69 of them had also reflux symptoms (23.7% of allGERDsubjects). Furthermore, symptoms association between dyspepsia and GERD was stronger in subjects with moderate/severe GERD symptoms (49/120 versus 20/101, p < 0.01). Conclusions. Our study showed a high prevalence of GERD and dyspepsia symptoms in Italy. Severe GERD and dyspepsia symptoms were present in at least 13 and 6% of patients, respectively, and they overlapped in at least 6% of the subjects. Our data suggest that these patients should be considered as having functional disorders rather than simple GERD

Prevalence of irritable bowel syndrome in Italian rural and urban areas

Background/aims: No comparative studies are available, as yet, in Italy, concerning the prevalence of irritable bowel syndrome (IBS) in urban and rural areas. The aim is to compare the prevalence of IBS in Italian urban and rural areas. Methods: 950 subjects were randomly selected from each area and completed a questionnaire regarding demographic data and the Rome II questionnaire. Results: The prevalence of IBS was significantly (pb0.05) higher in the urban (9.9%), than in the rural area (4.4%). In the urban area, a significantly higher prevalence of IBSwas observed in females than inmales, 67/490 (13.7%) vs 27/460 (5.9%) (pb0.05), while no gender differences were present in the rural population. Conclusion: In the urban area, we found a higher prevalence of IBS, and a significantly higher prevalence of IBS in females than in males, while no gender differences were present in the rural populati

Management of aspirin intolerance in patients undergoing percutaneous coronary intervention. The role of mono-antiplatelet therapy: A retrospective, multicenter, study

BACKGROUND: The optimal management of patients with aspirin intolerance undergoing stent implantation represents a challenge for physicians. The aim of this study was to assess the overall number of patients discharged with mono antiplatelet therapy after percutaneous coronary intervention (PCI). The most frequent aspirin intolerance symptoms in this population and the overall incidence of patient-oriented composite endpoints (POCE). METHODS: From January 2006 to June 2016 all patients discharged with mono-antiplatelet therapy because of aspirin intolerance/hypersensitivity/allergy and treated by means of PCI were included. Data about percutaneous treatments and aspirin intolerance were collected. POCE were evaluated at a twelve-month clinical follow-up comparing safety and efficacy of clopidogrel monotherapy versus new P2Y12 inhibitors. RESULTS: We collected 70 patients, that is 0.3% of the total amount of PCI in the considered period, 25 (35%) of them were women and the remaining 45 (65%) were men. An acute coronary syndrome (ACS) was the clinical presentation in 47 (67.1%) patients, with NSTEMI in 19 (27.1%) of them. Forty-six patients (65.7%) were treated with clopidogrel and 24 (34.3%) with new P2Y12 inhibitors. At one-year follow-up, 18 (25.7%) patients suffered a new clinically relevant adverse event, 5 (7.1%) died, 3 (4.3%) required a target vessel revascularization and 10 (14.3%) patients a target lesion revascularization. CONCLUSIONS: Our study evaluated patients with ACS or stable coronary artery disease undergoing PCI and treated with mono-antiplatelet therapy with P2Y12 inhibitors due to aspirin intolerance shows a 25% incidence of POCE at one year. Further studies with adequate sample size are required to evaluate the efficacy and safety of mono antiplatelet therapy in this clinical scenario

Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience.

AIM:To check the safety and efficacy of boceprevir/telaprevir with peginterferon/ribavirin for hepatitis C virus (HCV) genotype 1 in the real-world settings. METHODS: This study was a non-randomized, observational, prospective, multicenter. This study involved 47 centers in Italy. A database was prepared for the homogenous collection of the data, was used by all of the centers for data collection, and was updated continuously. All of the patients enrolled in this study were older than 18 years of age and were diagnosed with chronic infection due to HCV genotype 1. The HCV RNA testing was performed using COBAS-TaqMan2.0 (Roche, LLQ 25 IU/mL). RESULTS: All consecutively treated patients were included. Forty-seven centers enrolled 834 patients as follows: Male 64%; median age 57 (range 18-78), of whom 18.3% were over 65; mean body mass index 25.6 (range 16-39); genotype 1b (79.4%); diagnosis of cirrhosis (38.2%); and fibrosis F3/4 (71.2%). The following drugs were used: Telaprevir (66.2%) and PEG-IFN-alpha2a (67.6%). Patients were naïve (24.4%), relapsers (30.5%), partial responders (14.8%) and null responders (30.3%). Overall, adverse events (AEs) occurred in 617 patients (73.9%) during the treatment. Anemia was the most frequent AE (52.9% of cases), especially in cirrhotic. The therapy was stopped for 14.6% of the patients because of adverse events or virological failure (15%). Sustained virological response was achieved in 62.7% of the cases, but was 43.8% in cirrhotic patients over 65 years of age. CONCLUSION: In everyday practice, triple therapy is safe but has moderate efficacy, especially for patients over 65 years of age, with advanced fibrosis, non-responders to peginterferon + ribavirin