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The Treatment of Vasopressin V2-Receptor Antagonists in Cirrhosis Patients with Ascites

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The Treatment of Vasopressin V2-Receptor Antagonists in Cirrhosis Patients with Ascites Yan et al. BMC Gastroenterology (2015) 15:65 DOI 10.1186/s12876-015-0297-z RESEARCH ARTICLE Open Access The treatment of vasopressin V2-receptor antagonists in cirrhosis patients with ascites: a meta-analysis of randomized controlled trials Long Yan1†, Feng Xie1†, Jiongjiong Lu1, Qingqiang Ni1, Changying Shi1, Caixi Tang2 and Jiamei Yang1* Abstract Background: Ascites is the most common complication of cirrhosis. It may lead to the consequence of poor prognosis and the deterioration of quality of life. Asopressin V2 receptor antagonists is a kind of vaptans, and it has been proved to be effective in hyponatremia patients. We conducted a meta-analysis about treatment of vaptans in cirrhosis patients with ascites. Methods: Following our selection criteria, we collected a total of 14 studies containing 16 randomized controlled trials (2620 patients) from a series of database about the treatment with vaptans for cirrhosis with ascites patients. The included studies compared the treatment effect of lixivaptan (VPA 985), or RMJ-351647, or satavaptan, or tolvaptan with placebo. Results: The included vaptans (asopressin V2 receptor antagonists) showed significant effect of increasing the serum sodium concentration for cirrhosis patients (WMD = 2.11 mmol/L, p < 0.00001). Patients also could acquire significant improvement of ascites, as this kind of aquaretics can significantly reduce ascites patients’ weight (WMD = −1.53, p < 0.00001), abdominal girth (WMD = −2.04, p < 0.00001), and the ratio of worsening ascites (RR = 0.51, p = 0.001). Though the drug did not produce more total adverse events (RR = 1.04, p = 0.09) and the total serious events (RR = 1.04, p = 0.42), the emergence of excessive correction of serum sodium concentrations (>145 mmol/L) was more frequently noted in patients under the employment of vaptans (RR = 2.14, 95 % CI [1.45, 3.16], p = 0.0001). Whether with the administration of vaptans for short-term or long-term, no survival benefit was detected from the selected studies. Conclusions: Asopressin V2 receptor antagonists could play an effective and safe role in symptomatic treatment for cirrhosis patients with ascites, especially for refractory ascites patients who presented insufficient response to conventional diuretics. Keywords: Cirrhosis, Ascites, V2-receptor antagonist, Randomized controlled trials Background of quality of life (QOL) [2]. Besides the liver transplantation, As the most common complication of cirrhosis, ascites diuretics also play an important role on the conventional is occurred in about 60 % patients within 10 years management of ascites, such as aldosterone antagonist during the course of compensated cirrhosis [1]. Besides (spironolactone) and loop diuretic (furosemide) [3]. But the the consequence of poor prognosis, persistent ascites effect is complicated for the cirrhosis patients due to the may lead to the development of various subjective and varied response to these diuretics [4]. If we administrate objective symptoms, which could result in deterioration diuretics with high dose to achieve a higher response, complications, which are associated with diuretics, could * Correspondence: [email protected] develop more frequently, like electrolyte disturbances, † Equal contributors worsening of renal function, hepatic encephalopathy, and 1Department of Special Treatment and Liver Transplantation, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University, 225 so on [5, 6]. On account of these reasons, the development Changhai Road, Shanghai 200438, China Full list of author information is available at the end of the article © 2015 Yan et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Yan et al. BMC Gastroenterology (2015) 15:65 Page 2 of 13 of more effective drugs for the management of ascites is Methods necessary. Search strategy The orally and intravenously active non-peptide We searched the studies till February 2014 from the follow- vasopressin receptor antagonists are called vaptans. ing databases: MEDLINE, PubMed, Embase, the Cochrane Vasopressin V2 receptor antagonists are one of the Centeral Register of Controlled Trials, Cochrane Database three kinds of vaptans, and they could competitively of Systematic Reviews, http://www.ClinicalTrials.gov, and bind and block the V2-receptors of arginine vasopressin the Chinese BioMedical Literature Database. At the mean (AVP) in the renal collecting ducts. So unlike the time, we check the references of some relevant previous traditional diuretics, they could induce a highly hypotonic studies to make sure no eligible studies were missed. The diuresis without affecting the excretion of electrolytes [7]. searching language was English or Chinese, and the search Previous reports found it was effective to improve the terms were: vasopressin V2 receptor antagonist, vaptans, serum sodium concentration of hyponatremia, which was mozavaptan, OPC 31260, satavaptan, lixivaptan, VPA 985, generated from syndrome of inappropriate antidiuretic RMJ-351647, cirrhosis, liver fibrosis, ascites, hepatic edema, hormone secretion (SIADH), congestive heart failure hyponatremia. patients, and cirrhosis patients with ascites, especially [8, 9]. Some drugs have been approved for the treatment Selection criteria of hyponatremia in Europe [3]. However, some aspects In our selection process, randomized controlled trials limit the use of vasopressin V2 receptor antagonists. focusing on the treatment for ascites patients with all Excessive correction of hyponatraemia, which could kinds of of vasopressin V2-receptor antagonist were be produced by aquaretics, may cause some serious included (Fig. 1). These adopted vaptans included tolvap- consequence, like osmotic demyelination and myelinolysis; tan, conivaptan, lixivaptan (VPA-985), mozavaptan, sata- Liver injury is another serious problem people concern vaptan, RMJ-351647. Although conivaptan is antagonists with, which is regarded as an important adverse effect of vasopressin V1A and V2 receptors, it was also included. from the use of vaptans [10]. In addition to these, there All patients in the selected studies should be definitely are still some uncertainty and controversies about the diagnosed as ascites, and the disease of cirrhosis should be effectiveness of vaptans on improvement of the symptoms, the only pathogeny. Whether patients accepted conven- prognosis of the cirrhosis patients with ascites. We tional diuretics before or during the study, they would be systematically reviewed the previous randomized controlled included. trials about the treatment of vasopressin V2 receptor And the exclusion criteria were: (1) nonhuman studies; antagonists in cirrhosis patients with ascites. (2) non-randomized trials; (3) articles not containing Fig. 1 Identification process of the included studies Yan et al. BMC Gastroenterology (2015) 15:65 Page 3 of 13 primary data or not stating the data of cirrhosis patients Interventions [12]. If there were several dose groups separately; (4) patients with other diseases which also comparing with one control group, the data of interven- could cause ascites, like SIADH, liver failure, kidney tion groups would be gathered up as one to make the disease; (5) patients with other serious disease, such comparison of dichotomous variables, and the highest as neoplastic disease, the end stage of other chronic dose group would be regarded as the only drug interven- disease, and severe nervous system disease. tion group when we analyzed continuous variables. Dichotomous variables (normalized ratio of serum sodium Data extraction and quality assessment level, adverse events, and 1-year survival) were expressed Twoauthorsindependentlyextractedthedatawith as odds ratios (OR) or risk ratio (RR)with 95 % confidence the tool of Microsoft Office Excel. In this process, the interval (CI), continuous variables were presented as included articles were further checked once more and weighted mean differences (WMD) with 95 % CI. When some studies were excluded for the reason that the we pooled the data across studies, fixed-effects model was data did not meet the inclusion criteria. Following a used in most cases, and random-effects model was brief plan which was made previously, the two authors adopted when statistical heterogeneity was significant. I2 collected the publication details, study characteristics, and was calculated in the process of analysis, which was used the data of outcome assessment. Discrepancies were to assess the statistical heterogeneity [13]. We defined resolved by discussion until a consensus was made. 0-25 % as no or low-level heterogeneity, > = 50 % as The quality assessment of all eligible studies was carried significant heterogeneity. When the heterogeneity was out with the Jadad score (maximum number of points is significant, we would adopt subgroup to analyze the data 5). This evaluation criterion is based on the description of and make some explanation, except using random-effects three aspects in the study: random approach, blind model. method, the withdrawals and dropouts. And each of the first two aspects had totally 2 points and the third had just
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