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Safety and efficacy of risedronate for patients with esophageal varices and liver cirrhosis: a non-randomized clinical trial.

ABSTRACT: Despite the high prevalence of osteoporosis in liver cirrhosis, the indication of bisphosphonates for patients with esophageal varices has been avoided due to risk of digestive mucosal damage. Therefore, this study aimed to evaluate the safety profile of risedronate treatment for patients with osteoporosis, liver cirrhosis and esophageal varices with low risk of bleeding. A total of 120 patients were allocated into two groups according to their bone mineral density measured by dual-energy X-ray absorptiometry. In the intervention group, 57 subjects with osteoporosis received oral risedronate at 35?mg weekly plus daily calcium and vitamin D supplementation. In the control group, 63 subjects with osteopenia received only calcium and vitamin D. The groups received the treatment for one year and underwent surveillance endoscopies at six and 12 months, as well as a control dual-energy X-ray absorptiometry after a 12-month follow-up. The study received Institutional Review Board approval. The groups had not only comparable Model for End-stage Liver Disease score and esophageal varices degree, but also similar incidence of digestive adverse effects. A significant improvement was achieved in the intervention group in the lumbar spine T score (p?

SUBMITTER: Lima TB

PROVIDER: S-EPMC6908659 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Safety and efficacy of risedronate for patients with esophageal varices and liver cirrhosis: a non-randomized clinical trial.

Lima Talles Bazeia TB Santos Lívia Alves Amaral LAA Nunes Hélio Rubens de Carvalho HRC Silva Giovanni Faria GF Caramori Carlos Antonio CA Qi Xingshun X Romeiro Fernando Gomes FG

Scientific reports 20191212 1

Despite the high prevalence of osteoporosis in liver cirrhosis, the indication of bisphosphonates for patients with esophageal varices has been avoided due to risk of digestive mucosal damage. Therefore, this study aimed to evaluate the safety profile of risedronate treatment for patients with osteoporosis, liver cirrhosis and esophageal varices with low risk of bleeding. A total of 120 patients were allocated into two groups according to their bone mineral density measured by dual-energy X-ray ...[more]

PMID: 31831865

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Project description:Introduction: Liver cirrhosis is caused by the development of various acute and chronic liver diseases. Esophageal varices is a common and serious complication of liver cirrhosis during decompensation. Despite the development of various treatments, the prognosis for liver cirrhosis with esophageal varices (LCEV) remains poor. We aimed to establish and validate a nomogram for predicting in-hospital death in LCEV patients. Methods: Data on LCEV patients were extracted from the Medical Information Mart for Intensive Care III and IV (MIMIC-III and MIMIC-IV) database. The patients from MIMIC-III were randomly divided into training and validation cohorts. Training cohort was used for establishing the model, validation and MIMIC-IV cohorts were used for validation. The independent prognostic factors for LCEV patients were determined using the least absolute shrinkage and selection operator (LASSO) method and forward stepwise logistic regression. We then constructed a nomogram to predict the in-hospital death of LCEV patients. Multiple indicators were used to validate the nomogram, including the area under the receiver operating characteristic curve (AUC), calibration curve, Hosmer-Lemeshow test, integrated discrimination improvement (IDI), net reclassification index (NRI), and decision curve analysis (DCA). Results: Nine independent prognostic factors were identified by using LASSO and stepwise regressions: age, Elixhauser score, anion gap, sodium, albumin, bilirubin, international normalized ratio, vasopressor use, and bleeding. The nomogram was then constructed and validated. The AUC value of the nomogram was 0.867 (95% CI = 0.832-0.904) in the training cohort, 0.846 (95% CI = 0.790-0.896) in the validation cohort and 0.840 (95% CI = 0.807-0.872) in the MIMIC-IV cohort. High AUC values indicated the good discriminative ability of the nomogram, while the calibration curves and the Hosmer-Lemeshow test results demonstrated that the nomogram was well-calibrated. Improvements in NRI and IDI values suggested that our nomogram was superior to MELD-Na, CAGIB, and OASIS scoring system. DCA curves indicated that the nomogram had good value in clinical applications. Conclusion: We have established the first prognostic nomogram for predicting the in-hospital death of LCEV patients. The nomogram is easy to use, performs well, and can be used to guide clinical practice, but further external prospective validation is still required.

Project description:BackgroundEmergency treatment of bleeding esophageal varices (BEV) in cirrhotic patients is of prime importance because of the high mortality rate surrounding the episode of acute bleeding. Nevertheless, there is a paucity of randomized controlled trials of emergency surgical therapy and no reports of the costs of any of the widely used forms of emergency treatment. The important issue of direct costs of care was examined in a randomized controlled trial that compared endoscopic sclerotherapy (EST) to emergency portacaval shunt (EPCS).MethodsTwo hundred eleven unselected consecutive patients with ultimately biopsy-proven cirrhosis and endoscopically proven acute BEV were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic workup was completed, and EST or EPCS was initiated within 8 h. Criteria for failure of EST or EPCS were clearly defined, and crossover rescue treatment was applied, when primary therapy failed. Ninety-six percent of patients underwent more than 10 years follow-up, or until death. Complete charges for all aspects of care were obtained continuously for more than 10 years.ResultsDirect charges for all aspects of care were significantly lower in patients treated by EPCS than in patients treated by emergency EST followed by long-term repetitive sclerotherapy. Charges per patient, per year of treatment, and per year in each child's risk class were significantly lower in patients randomized to EPCS. Charges in patients who failed endoscopic sclerotherapy and underwent a rescue portacaval shunt were significantly higher than the charges in both the unshunted sclerotherapy patients and the patients randomized to EPCS. This result was particularly noteworthy given the widespread practice of using surgical portacaval shunt as rescue treatment only when all other forms of therapy have failed.ConclusionsIn this randomized controlled trial of emergency treatment of acute BEV, EPCS was significantly superior to EST with regard to direct costs of care as reflected in charges for care as well as in survival rate, control of bleeding, and incidence of portal-systemic encephalopathy. These results provide support for the use of EPCS as a first line of emergency treatment of BEV in cirrhosis.

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Safety and efficacy of risedronate for patients with esophageal varices and liver cirrhosis: a non-randomized clinical trial.

Publications

Safety and efficacy of risedronate for patients with esophageal varices and liver cirrhosis: a non-randomized clinical trial.

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