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Aspirin and P2Y12 receptor antagonists are widely used across the spectrum of cardiovascular and cerebrovascular diseases. Gastrointestinal complications, including ulcer and bleeding, are relatively common during antiplatelet treatment and, therefore, concomitant proton pump inhibitor (PPI) treatment is often prescribed. However, potential increased risk of cardiovascular events has been suggested for PPIs, and, in recent years, it has been discussed whether these drugs may reduce the cardiovascular protection by aspirin and, even more so, clopidogrel. Indeed, pharmacodynamic and pharmacokinetic studies suggested an interaction through hepatic CYP2C19 between PPIs and clopidogrel, which could translate into clinical inefficacy, leading to higher rates of cardiovascular events. The FDA and the EMA sent a warning in 2010 discouraging the concomitant use of clopidogrel with omeprazole or esomeprazole. In addition, whether the use of PPIs may affect the clinical efficacy of the new P2Y12 receptor antagonists, ticagrelor and prasugrel, remains less known. According to current guidelines, PPIs in combination with antiplatelet treatment are recommended in patients with risk factors for gastrointestinal bleeding, including advanced age, concurrent use of anticoagulants, steroids or non-steroidal anti-inflammatory drugs, and Helicobacter pylori infection. Like vitamin K antagonists (VKAs), DOACs can determine gastrointestinal bleeding. Results from both randomized clinical trials and observational studies suggest that high-dose dabigatran (150 mg bid), rivaroxaban and high-dose edoxaban (60 mg daily) are associated with a higher risk of GI bleeding as compared with apixaban and warfarin. In patients taking oral anticoagulant with GI risk factor, PPI could be recommended, even if usefulness of PPIs in these patients deserves further data. Helicobacter pylori should always be searched, and treated, in patients with history of peptic ulcer disease (with or without complication). Given the large number of patients treated with antithrombotic drugs and PPIs, even a minor reduction of platelet inhibition or anticoagulant effect potentially carries a considerable clinical impact. The present joint statement by ANMCO and AIGO summarizes the current knowledge regarding the widespread use of platelet inhibitors, anticoagulants, and PPIs in combination. Moreover, it outlines evidence supporting or opposing drug interactions between these drugs and discusses consequent clinical implications.

Aspirin and P2Y12 receptor antagonists are widely used across the spectrum of cardiovascular and cerebrovascular diseases. Gastrointestinal complications, including ulcer and bleeding, are relatively common during antiplatelet treatment and, therefore, concomitant proton pump inhibitor (PPI) treatment is often prescribed. However, potential increased risk of cardiovascular events has been suggested for PPIs, and, in recent years, it has been discussed whether these drugs may reduce the cardiovascular protection by aspirin and, even more so, clopidogrel. Indeed, pharmacodynamic and pharmacokinetic studies suggested an interaction through CYP2C19 between PPIs and clopidogrel, which could translate into clinical inefficacy, leading to higher rates of cardiovascular events. The Food and Drug Administration and the European Medicines Agency sent a warning in 2010 discouraging the concomitant use of clopidogrel with omeprazole or esomeprazole. In addition, whether the use of PPIs may affect the clinical efficacy of the new P2Y12 receptor antagonists, ticagrelor and prasugrel, remains less known. According to current guidelines, PPIs in combination with antiplatelet treatment are recommended in patients with risk factors for gastrointestinal bleeding, including advanced age, concurrent use of anticoagulants, steroids or non-steroidal anti-inflammatory drugs, and Helicobacter pylori infection. Like traditional anticoagulants, novel oral anticoagulants may cause gastrointestinal bleeding. Results from both randomized clinical trials and observational studies suggest that high-dose dabigatran (150 mg bid), rivaroxaban and high-dose edoxaban (60 mg daily) are associated with a higher risk of gastrointestinal bleeding as compared with warfarin. However, the usefulness of PPIs in patients receiving these anticoagulants deserves to be further demonstrated. Given the large number of patients treated with antithrombotic drugs and PPIs, even a minor reduction of platelet inhibition or anticoagulant effect potentially carries a considerable clinical impact. The present joint statement by ANMCO and AIGO summarizes the current knowledge regarding the widespread use of platelet inhibitors, anticoagulants, and PPIs in combination. Moreover, it outlines evidence supporting or opposing drug interactions between these drugs and discusses consequent clinical implications.

The mortality from esophageal variceal hemorrhage in liver cirrhosis patients remains approximately 15-20%. Predictors of short-term outcomes, such as the hepatic venous pressure gradient, are often unavailable in the acute setting. Clinical variables seem to have a similar predictive performance, but some variables including active bleeding during endoscopy have not been reevaluated after the utilization of endoscopic banding as endoscopic procedure. In addition, patients with severe liver failure are often excluded from clinical trials. The aim of this study was to prospectively reevaluate the risk factors affecting a 5-day failure after acute variceal bleeding in unselected cirrhotic patients, managed with the current standard treatment using vasoactive drugs, band ligation, and antibiotics.One hundred and eighty five patients with liver cirrhosis and variceal bleeding admitted from January 2010 to July 2011 were evaluated.Hepatocellular carcinoma was present in 28.1% of cases and portal vein thrombosis (PVT) was present in 17.3% of cases. Band ligation was feasible in 92.4% of cases. Five-day failure occurred in 16.8% of cases; 12 patients (6.5%) experienced failure to control bleeding or early rebleeding, and 66.7% of patients died within 5 days. The overall 5-day mortality rate was 14.6%. By multivariate analysis, we determined that Child-Pugh class C, a white blood cell count over 10 × 10(9)/l, and the presence of PVT were the only independent predictors of the 5-day failure.The prognosis of a consistent group of liver cirrhosis patients with variceal bleeding remains poor. The current treatment is highly effective in controlling variceal bleeding, but mortality is related mainly to the severity of liver failure.

Background and Aim We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA. Methods Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis. Results Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23–2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03–1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00–2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76–2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24–1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44–1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD. Conclusions Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile.

To evaluate cortisolemia by using conventional electrochemiluminescence immunoassay (ECLIA) method compared to liquid chromatography-tandem mass spectrometry (LC-MS/MS) method in active ulcerative colitis (UC) patients treated with oral prednisone (PD).Twenty patients (12 males) with acute relapse of UC started oral PD at a dose of 40 mg once a day, tapered of 10 mg every 2 wk. When a stable 2-wk daily dose of 30 mg was reached, blood samples for cortisol levels' measurement were drawn in the morning in fasting conditions to determine circulating cortisol by LC-MS/MS and ECLIA assay.Median interquartile range cortisolemia with ECLIA and LC-MS/MS method was 54.1 (185.8) nmol/L and 32.1 (124.0) nmol/L, respectively (P0.001). The within-patient median differences between the two methods was 23.2 (40.6) nmol/L, with higher cortisol levels for the ECLIA method. The estimated geometric mean ratio between methods was 1.85 (95%CI: 2.39-1.43) considering all data or 1.58 (95%CI: 2.30-1.09) considering only data above the limit of quantification (n = 12). The 95%CIs of the geometric mean ratio between methods confirm a statistically significant difference.Blood cortisol levels detected with ECLIA method seems to be higher than the ones measured by LC-MS/MS, indicating a possible overestimation of them in patients treated with PD. Therefore, the cortisol suppression in patients under treatment with oral PD should not be measured using ECLIA method.

Background and study aims Ingestion of foreign bodies is a common occurrence. Few papers in the literature report experience and outcome at tertiary centers. The aim of this paper is to report the management and the outcomes in 414 patients admitted for suspected ingestion of foreign body between May 1995 and December 1999. Methods A plain radiographic film of the neck, chest or abdomen was obtained in the case of radiopaque objects, and in order to rule out suspected perforation: in such cases a computed tomography (CT) study was also performed. All patients were asked to give their informed consent, which was refused by three patients. Anesthesia was always used, either conscious sedation (86.8 %), or general anesthesia in the case of poor patient tolerance (13.2 %). All patients underwent an endoscopic procedure within six hours of admission. A flexible scope was used in all patients and a wide range of endoscopic devices was employed. Results Foreign bodies were found in 64.5 % of our patients. Almost all were found in the esophagus. The types of foreign body were very different, but they were chiefly food boluses, bones or cartilages, dental prostheses or fish bones. In three patients (1.1 %) it was impossible to endoscopically remove the foreign body, which was located in the cervical esophagus: all these three patients required surgery. No complications relating to the endoscopic procedure were observed, but 30.7 % of patients had an underlying esophageal disease, such as a stricture. Only eight patients required a second endoscopic procedure, performed by a more experienced endoscopist. Conclusion Foreign body ingestion represents a frequent reason for emergency endoscopy. The endoscopic procedure is a successful technique which allows the removal of the foreign bodies in almost all cases without significant complications. Surgery is rarely required.

The estrogenic/antiestrogenic activity and the genotoxicity/antigenotoxicity of bee pollen from Salix alba L. and Cystus incanus L. and its derivative extracts in yeast and human cells was investigated. All samples showed a marked inhibitory effect on the activity of the natural estrogen 17 beta-estradiol (higher than 90% for extracts 2) and failed to cause estrogenic activity and chromosome damage. At least one preparation from each species showed a marked antigenotoxic effect against the action of the anticancer drugs mytomicin C, bleomycin, and vincristine. Bee pollens from C. incanus and S. alba were found to be neither genotoxic nor estrogenic as well as effective estrogen inhibitors, and able to reduce the chromosome damage induced by the three cancer drugs used, thus supporting their use as a safe food supplement and future chemoprotective/chemopreventive agents.

We retrospectively evaluated the medical records of patients admitted to the U.O.C. of General and Emergency Surgery with Surgical and Polyspecialistic Observation of the Emergency Unit of A.O.R.N. A. Cardarelli of Naples for non-variceal upper gastrointestinal bleeding from 2003 to 2006. All data regarding patients submitted to surgery for non-variceal upper gastrointestinal bleeding were collected including the number of patients submitted to surgery after failure of the endoscopic procedure, the diseases most frequently requiring surgery, the endoscopic and surgical procedures most frequently used, and the reasons that prompted the surgical procedure. Of 1482 patients admitted for non-variceal upper gastrointestinal bleeding the lesions that most frequently required surgery were peptic ulcer disease complicated by bleeding in 31 patients (70.5%) and cancer in 13 (29.5%). The most frequent surgical procedure was subtotal gastrectomy (17 patients [38.6%]), followed by direct haemostasis of the ulcer (13 patients [29.5%]), total gastrectomy (11 patients [25%]), and ulcer excision (3 patients [6.9%]). Subtotal or total gastrectomy is the surgical procedure of choice in patients with non-variceal upper gastrointestinal bleeding after failure of endoscopic treatment. The indication for gastrectomy should be determined on the basis of the patient's haemodynamic condition.

Non-variceal upper gastrointestinal bleeding (NVUGIB) is recognized world-wide as a common cause of emergency hospitalization, and it often represents a life-threatening event. The purpose of this prospective study was to assess in-hospital mortality in NVUGIB Forrest 1 patients admitted to the emergency unit owing to active bleeding.We enrolled all patients consecutively admitted to the emergency unit for NVUGIB, acutely bleeding at endoscopy (spurting or oozing). Demographic characteristics, clinical and biochemical parameters, endoscopic findings and treatments were evaluated.Of a total of 142 patients (98 M (69%), mean age+/-SD=66+/-14 years), spurting (16 (11.3%)) and oozing (126 (88.7%)) were identified. All patients received endoscopic treatment within 6 h of admission and were managed according to the guidelines. Seventeen (12%) patients suffered rebleeding, 4 patients (2.8%) required surgery to stop the bleeding, and 8 (5.6%) died during hospitalization (4 within 5 days and the remainder within 24 days of admission) - 3 as a consequence of bleeding (2.1%) and 5 of non-surgical complications (3.5%). Cox regression analysis showed that the lesions in more than one segment of the esophagogastroduodenal tract (p=0.008, hazard ratio (95% CI)=7.623 (1.680-34.600)) and the number of blood units transfused during the first 48 h of hospitalization (p=0.038, 2.075 (1.041-4.135)) were predictive of in-hospital death.In Forrest 1 patients given rapid endoscopic treatment, in-hospital mortality seems to be related to the contemporaneous presence of bleeding and non-bleeding lesions in more than one segment of the esophagogastroduodenal tract and the number of blood units transfused during the first 48 h of hospitalization.

Objectives Prophylactic antibiotics are helpful in decreasing the incidence of septic complications in acute pancreatitis. The aim of this study was to compare the efficacy of meropenem, a new carbapenem antibiotic, with that of imipenem, which is the standard prophylactic treatment in patients with severe acute pancreatitis. Methods One hundred seventy-six patients with necrotizing pancreatitis were prospectively randomized to prophylactic treatment with 0.5 g meropenem t.i.d. intravenously or 0.5 g imipenem q.i.d. intravenously. The occurrence of infection of pancreatic necrosis, rate of extrapancreatic infections, systemic and local complications, need for surgery, mortality rate, and length of hospitalization were recorded for each group. When a septic complication of pancreatic necrosis was suspected, fine needle aspiration with cultures of the sample was performed. Surgery was performed in cases of verified infected necrosis. Conclusion No difference was observed between patients treated with meropenem and those treated with imipenem in terms of incidence of pancreatic infection (11.4% versus 13.6%) and extrapancreatic infections (21.6% versus 23.9%) and clinical outcome. Meropenem is as effective as imipenem in preventing septic complications of patients with severe acute pancreatitis.

Background/Aim: Aim of the present study is to assess, according to the guidelines of the Maastricht Consensus Conference, the appropriateness and diagnostic yield of upper gastrointestinal endoscopy in an open-access endoscopy system, in order to evaluate the diffusion of knowledge about Helicobacter pylori among different types of physicians. Methods: Patients undergoing endoscopy because of dyspeptic symptoms were prospectively considered in 21 endoscopy services of Campania during two different 1-week periods in 1998 and 2001. The following data were recorded: age, sex, symptoms, history of peptic ulcer with regard to previous endoscopic or radiographic examinations and treatment, endoscopic diagnosis, and H. pylori status. The indication for endoscopy was evaluated according to Maastricht guidelines and current medical knowledge. Results: In the two periods, 1998 and 2001, 706 and 520 patients were, respectively, considered. The two series were matched for demographic characteristics, symptoms, and endoscopic diagnosis. Endoscopy was considered not indicated in 398 patients (56.4%) in 1998 and in 265 patients (50.9%) in 2001 (p = NS). The majority of them, 288/398 (72.3%) in 1998 and 162/265 (61.1%) in 2001 (p = 0.001), had recently undergone endoscopy or radiology and empiric antisecretory treatment or eradication. They had been referred to endoscopy because of recurrence of symptoms or to assess healing. In 110 cases in 1998 (27.6%) and in 103 cases in 2001 (38.9%; p = 0.001) endoscopy was performed in dyspeptic patients younger than 45 years without alarm symptoms. Conclusions: 4 years after the Maastricht Conference, a large number of endoscopic examinations are not indicated and could be avoided following the Maastricht guidelines. In 2001, in comparison to 1998, a larger number of physicians are likely to investigate and treat correctly the H.-pylori-related diseases, but there are still some problems with the application of the ‘test-and-treat policy’.

AIM: To establish the prevalence of Helicobacter pylori (H. pylori) infection in patients with a bleeding peptic ulcer after consumption of non-steroidal antiinflammatory drugs (NSAIDs). METHODS: A very early upper endoscopy was performed to find the source of upper gastrointestinal bleeding and to take biopsy specimens for analysis of H. pylori infection by the rapid urease (CLO) test, histological examination, and bacterial culture. IgG anti-CagA were also sought. The gold standard for identifying H. pylori infection was positive culture of biopsy specimens or contemporary positivity of the CLO test and the presence of H. pylori on tissue sections. RESULTS: Eighty patients, 61 males (76.3%), mean age 61.2 ± 15.9 years, were consecutively enrolled. Forty-seven (58.8%) patients occasionally consumed NSAIDs, while 33 (41.3%) were on chronic treatment with low-dose aspirin (LD ASA). Forty-four (55.0%) patients were considered infected by H. pylori. The infection rate was not different between patients who occasionally or chronically consumed NSAIDs. The culture of biopsy specimens had a sensitivity of 86.4% and a specificity of 100%; corresponding figures for histological analysis were 65.9% and 77.8%, for the CLO test were 68.2% and 75%, for the combined use of histology and the CLO test were 56.8% and 100%, and for IgG anti-CagA were 90% and 98%. The highest accuracy (92.5%) was obtained with the culture of biopsy specimens. CONCLUSION: Patients with a bleeding peptic ulcer after NSAID/LD ASA consumption frequently have H. pylori infection. Biopsy specimen culture after an early upper gastrointestinal tract endoscopy seems the most efficient test to detect this infection.

H. pylori significantly improved reflux symptoms in the subjects with mild atrophy and did not aggravate in those with severe atrophy, but did not change dysmotility symptoms, regardless of the degree of atrophy. Conclusion: The reflux symptoms were improved in the subjects with mild atrophy and were not aggravated in those with severe atrophy, who had PPI-based triple therapy for cancer prevention in Japanese general population.