Vasoactive Agents for the Management of Variceal Bleeding: A Mixed Treatment Comparison Network Meta-analysis and Trial Sequential Analysis of Randomized Clinical Trials

Drug Research ◽  
2019 ◽  
Vol 69 (09) ◽  
pp. 487-495 ◽  
Author(s):  
Kannan Sridharan ◽  
Gowri Sivaramakrishnan
Keyword(s):  
Clinical Trials ◽  
Blood Transfusion ◽  
Adverse Events ◽  
Variceal Bleeding ◽  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Vasoactive Agents ◽  
Bleeding Rate

Abstract Background Vasoactives such as terlipressin, somatostatin, vasopressin, octreotide and nitrates are commonly used to treat variceal bleeding. The present study is a network meta-analysis comparing the efficacy and safety of the above vasoactive agents for treating variceal bleeding. Methods Electronic databases were searched for appropriate randomized clinical trials evaluating vasoactives in cirrhotic patients with variceal bleeding. Random-effects model was used to generate the pooled estimates. Mortality was the primary outcome and bleeding control, re-bleeding rate, hospital stay, blood transfusion requirements and adverse events were the secondary outcome measures. Results Fifty randomized clinical trials were included of which 37 were included for the primary outcome. The overall analysis did not reveal any significant difference in the mortality risk between any of the vaso-active drugs except for terlipressin that had statistically significant benefits from direct pooled estimates. Somatostatin and terlipressin showed significant reduction in the mortality risks at 24 h. Terlipressin significantly reduced re-bleeding rate; somatostatin and vasopressin were associated with better hemostasis; and terlipressin and vasopressin significantly reduced the requirement for blood transfusion. Terlipressin, vasopressin and glyceryltrinitrate/vasopressin were also associated with increased risk of adverse events. Conclusion Terlipressin could be the best agent in the vasoconstrictor category for managing variceal bleeding. Somatostatin and vasopressin can serve as alternatives.

scholarly journals Vasoactive Agents for the Management of Acute Variceal Bleeding: A Systematic Review and Meta-analysis

2021 ◽  
Vol 30 (1) ◽  
pp. 110-121
Author(s):  
Jorge Huaringa-Marcelo ◽  
Mariella R Huaman ◽  
Ana Brañez-Condorena ◽  
Pamela Villacorta-Landeo ◽  
Diego F Pinto-Ruiz ◽  
...  
Keyword(s):  
Blood Transfusion ◽  
Adverse Events ◽  
Hospital Stay ◽  
Variceal Bleeding ◽  
Meta Analysis ◽  
Bleeding Control ◽  
Vasoactive Agents ◽  
Acute Variceal Bleeding ◽  
Increased Risk ◽  
Grade Methodology

Background and Aims: Vasoactive agents with endoscopic therapy are used to treat acute variceal bleeding (AVB). There are two main groups of vasoactive agents: terlipressin and vasopressin (T-V), and octreotide and somatostatin (O-S). However, the benefit/harm balance is unclear. Our aim was to assess the efficacy and safety of T-V versus O-S for the management of AVB. Methods: We performed a systematic search for randomized controlled trials (RCTs) in PubMed, Scopus, and CENTRAL. Our main outcomes were mortality and adverse events. Secondary outcomes were bleeding control, rebleeding, blood transfusion, hospital stay. We evaluated the certainty of evidence using GRADE methodology. Results: We included 21 RCTs. The risk of mortality (RR: 1.01; 95%CI: 0.83-1.22), bleeding control (RR: 0.96; 95%CI: 0.91-1.02; I 2 =53%), early rebleeding (RR: 0.91; 95%CI: 0.66-1.24: I 2 =0%), late rebleeding (RR: 0.94; 95 CI: 0.56-1.60; I 2 =0%), blood transfusion (MD: 0.04; 95%CI: -0.31-0.39; I 2 =68%) and hospital stay (MD: -1.06; 95%CI: -2.80-0.69; I 2 =0%) were similar between T-V and O-S groups. Only 15 studies reported adverse events, which were significantly higher in the T-V compared to the O-S group (RR 2.39; 95%CI: 1.58-3.63; I 2 =57%). The certainty of evidence was moderate for the main outcomes, and low or very low for others. Conclusions: In cirrhotic patients with AVB, those treated with T-V had similar mortality risk compared to O-S. However, the use of T-V showed an increased risk of adverse events compared to O-S.

675 FUNDOPLICATION VERSUS ORAL PROTON PUMP INHIBITORS FOR GASTROESOPHAGEAL REFLUX DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Luca Schiliró Tristão ◽  
Francisco Tustumi ◽  
Guilherme Tavares ◽  
Letícia Nogueira Datrino ◽  
Maria Carolina Andrade Serafim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Adverse Events ◽  
Proton Pump ◽  
Reflux Disease ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Oral Intake

Abstract   Gastroesophageal reflux disease (GERD) is a widely studied and highly prevalent condition. However, few is reported about the exact efficacy and safety of fundoplication (FPT) compared to oral intake proton-pump inhibitors (PPI). This systematic review and meta-analysis of randomized clinical trials (RCT) aims to compare PPI and FPT in relation to the efficacy, as well as the adverse events associated with these therapies. Methods This systematic review was guided by PRISMA statement. Search carried out in June 2020 was conducted on Medline, Cochrane, EMBASE and LILACS. The inclusion criteria were (I) patients with GERD; (II) Randomized clinical trials, comparing oral intake PPI with FPT; (III) relevant outcomes for this review. The exclusion criteria were (I) reviews, case reports, editorials and letters (II) transoral or endoscopic FPT (III) studies with no full text. No restrictions were set for language or period. Certainty of evidence and risk of bias were assessed with GRADE Pro and with Review Manager Version 5.4 bias assessment tool. Results Ten RCT were included. Meta-analysis showed that heartburn (RD = −0.19; 95% CI = −0.29, −0.09) was less frequently reported by patients that underwent FPT. Furthermore, patients undergoing surgery had greater pressure on the lower esophageal sphincter than those who used PPI (MD = 7.81; 95% CI 4.79, 10.83). There was no significant difference between groups in the percentage of time with pH less than 4 in 24 hours, sustained remission and Gastrointestinal Symptom Rating Scale. Finally, FPT did not increase significantly the risk for adverse events such as postoperative dysphagia and impaired belching. Conclusion FPT is a more effective therapy than PPI treatment for GERD, without significantly increasing the risk for adverse events. However, before indicating a possible surgical approach, it is extremely important to correctly assess and select the patients who would benefit from FPT, such as those with severe erosive esophagitis, severe respiratory symptoms, low adherence to continuous drug treatment and patients with non-acid reflux, to ensure better results.

Novel oral anticoagulats for the treatment of left ventricle thrombosis: a systematic review and meta-analysis

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Serenelli ◽  
F Vitali ◽  
R Pavasini ◽  
E Tonet ◽  
G Pompei ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Left Ventricular ◽  
Left Ventricular Thrombus ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Ventricular Thrombus

Abstract Funding Acknowledgements Type of funding sources: None. Background novel oral anticoagulants (NOACs) are not guideline-recommanded treatment for left ventricular thrombus.  Purpose: the aim of this meta-analysis is to compare NOACs versus vitamin-K atagonsits (VKAs) efficacy in treating left ventricular thrombus (LVT). Methods: we systematically searched MEDLINE, Cochrane Library, Biomed Central, and Web of Science for trials comparing NOACs versus VKAs in the setting of LVT. Five studies, out of the 74 initially selected after first screening, were included in the meta-analysis. For the development of this meta-analysis, the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines were followed. The shortlisted studies were retrieved as full articles and appraised independently by two unblinded reviewers. The Mantel-Haensel method with a random effect model was used for the pooled analysis. The primary outcome was the occurrence of stroke and systemic embolism. Secondary outcome was occurrence of left ventricular thrombosis resolution during treatment.  Results: 707 patients were included in the analysis for the primary outcome. Of these, 230 were treated with NOACs and 477 with VKAs. The pooled OR for the primary outcome was 0.71 (95% CI 0.18-2.86, I2 67%), thus showing similar effect in term of ischaemic protection. A total of 698 patients, 228 on NOACs and 470 on VKAs were included in the analysis of the secondary outcome. The pooled OR for the secondary outcome pooled OR 0.97, 95% CI 0.56-1.68, I2 46%. Conclusions and Relevance: NOACs seem to have a similar efficacy profile compare to VKAs and so they should be considered as an alternative treatment for left ventricular thrombosis. Large prospective randomized clinical trials are needed to confirm this exploratory finding. Abstract Figure 1

scholarly journals The Efficacy and Safety of Acellular Matrix Therapy for Diabetic Foot Ulcers: A Meta-Analysis of Randomized Clinical Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-12 ◽  
Author(s):  
Wentao Huang ◽  
Yongsong Chen ◽  
Nasui Wang ◽  
Guoshu Yin ◽  
Chiju Wei ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Healing Rate ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Complete Healing ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Efficacy And Safety ◽  
Acellular Matrix

Background. Acellular matrix (AM) therapy has shown promise in the treatment of diabetic foot ulcers (DFUs) in several studies. The clinical effects of AM therapy were not well established. Therefore, we conducted a meta-analysis of randomized clinical trials (RCTs) to examine the efficacy and safety of AM therapy for patients with DFUs. Methods. A literature search of 5 databases was performed to identify RCTs comparing AM therapy to standard therapy (ST) in patients with DFUs. The primary outcome was the complete healing rate and the secondary outcomes mainly included time to complete healing and adverse events. Results. Nine RCTs involving 897 patients were included. Compared with ST group, patients allocated to AM group had a higher complete healing rate both at 12 weeks (risk ratio RR=1.73, 95% confidence interval (CI): 1.31 to 2.30) and 16 weeks (RR=1.56, 95% CI: 1.28 to 1.91), a shorter time to complete healing (mean difference MD=−2.41; 95% CI: -3.49 to -1.32), and fewer adverse events (RR=0.64, 95% CI: 0.44 to 0.93). Conclusion. The present study suggests that AM therapy as an adjuvant treatment could further promote the healing of full-thickness, noninfected, and nonischemia DFUs. AM therapy also has a safety profile. More large well-designed randomized clinical trials with long follow-up duration are needed to further explore the efficacy and safety of AM therapy for DFUs.

scholarly journals Comparison Outcomes of Discover Total Disk Arthroplasty and Anterior Cervical Discectomy with Fusion in Surgical Treatment of Cervical Disk Degenerative Disease: a Meta-Analysis of Randomized Trials

2018 ◽  
Vol 24 (4) ◽  
pp. 137-147
Author(s):  
V. A. Byvaltsev ◽  
I. A. Stepanov ◽  
M. A. Aliyev ◽  
B M. Avakov ◽  
B. R. Yussupov ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cervical Spine ◽  
Surgical Treatment ◽  
Adverse Events ◽  
Confidence Interval ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Degenerative Disease ◽  
Upper Limbs ◽  
Cervical Disk

The purpose —to compare the effectiveness of Discover cervical disk arthroplasty (CDA) and anterior cervical discectomy with fusion (ACDF) in the surgical treatment of cervical intervertebral disk (IVD) degenerative disease.Study design —a meta-analysis of randomized clinical trials.Material and Methods.Randomized clinical trials were conducted in the Pubmed, EMBASE, ELibrary and Cochrane Library databases published from 2008 to October 2018, which compared the results of Discover CDA and ACDF techniques in the surgical treatment of cervical IVD degenerative disease. For dichotomous variables, the relative risk and 95% confidence interval were calculated, standardized difference of mean values and their 95% confidence interval were used for continuous variables using the random effects model.Results.This meta-analysis included 9 randomized controlled clinical trials, including the results of surgical treatment of 513 patients with degenerative disease of the cervical IVD. In the CDA group, the operation time was significantly shorter, in contrast to the group of patients who underwent ACDF (p<0.0001). The values of blood loss (p = 0.89), levels of quality of life for patients according to the Neck Disability Index (NDI) (p = 0.22), severity of pain in the cervical spine (p = 0.50) and upper limbs on a visual analogue scale (VAS) (p = 0.16), as well as the prevalence of secondary surgical procedures (p = 0.68) and adverse events (p = 0.40) between the compared groups did not have significant differences. At the same time, significantly large values of the range of motion at the operated level were noted in the CDA group (p<0.00001).Conclusion.Discover CDA in comparison with ACDF has a significantly large values of range of motion at the operated level. At the same time, there were no statistically significant differences in the NDI scores, VAS pain scores in cervical spine and upper limbs, and the prevalence of secondary surgical procedures and adverse events between the compared groups of respondents were not identified.

scholarly journals Ozanimod for Treatment of Relapsing-Remitting Multiple Sclerosis in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 11 ◽  
Author(s):  
Yue Sun ◽  
Yanbo Yang ◽  
Zilan Wang ◽  
Fan Jiang ◽  
Zhouqing Chen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Adverse Events ◽  
Treatment Period ◽  
Relapse Rate ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
T2 Lesions ◽  
Relapsing Remitting ◽  
Annualized Relapse Rate

Background: Ozanimod has been approved for use in the treatment of relapsing forms of multiple sclerosis by the United States FDA. As a novel, orally available sphingosine 1-phosphate receptor modulator, ozanimod selectively binds to S1P1 and S1P5 receptor with high affinity, minimizing safety concerns caused by S1P3 receptor activation.Methods: e systematically searched PUBMED, EMBASE database, and Cochrane Library database to identify randomized controlled trials (RCTs) from inception to June 28, 2020. Trials were considered eligible if they 1) were randomized clinical trials (RCTs); 2) enrolled adult participants diagnosed with Relapsing-remitting MS; 3) compared ozanimod with placebo or any other approved DMDs that evaluated in phase III or phase II clinical trials; 4) enrolled over 100 participants; 5) provided any available information for predefined primary or secondary outcomes.Results: 2917 participants from three high-quality, multi-centered randomized clinical trials were pooled in our analysis. We found that using ozanimod was significantly associated with the reduction of the annualized relapse rate during the treatment period (RR, −0.10 [95% CI, −0.15, −0.06]). Also, the decreased number of gadolinium-enhancing lesions at the end of the trial was relative to the treatment of ozanimod (ozanimod, 0.29; control, 0.65; RR, −0.20 [95% CI, −0.34, −0.06]). Compared with patients in the control group, the number of new or enlarging T2 lesions over the treatment period decreased in patients treated with ozanimod (ozanimod, 1.82; control, 3.55; RR, −1.12 [95% CI, −1.52, −0.71]). As to the safety endpoints, patients in the ozanimod group reported a lower rate of adverse events (ozanimod, 66.03%; control, 77.07%; RR, 0.64 [95% CI, 0.43, 0.95]). Similar incidence of infection-related TEAEs was found across treatment groups (nasopharyngitis: ozanimod, 11.19%; control, 9.83%; RR, 1.10 [95% CI, 0.77–1.57]; urinary-tract infection: ozanimod, 3.81%; control, 2.97%; RR, 1.29 [95% CI, 0.83–2.00]). No case of macular edema was noted as well as second-degree, type 2, or third-degree atrioventricular block. As for the subgroup analysis, compared with 0.5 mg ozanimod, 1 mg ozanimod is related with a significant reduction of the annualized relapse rate during the treatment period (1 mg ozanimod, 0.18; 0.5 mg ozanimod, 0.24; RR, 0.05 [95% CI, 0.01, 0.09])and a decreased number of new or enlarging T2 lesions over the treatment period (1 mg ozanimod,1.58; 0.5 mg ozanimod, 2.05; RR, 0.49 [95% CI, 0.19, 0.79]). No significant difference in causing adverse events between 1 and 0.5 mg was found.Conclusions: Our meta-analysis found that, with favorable safety performance, the use of ozanimod as a treatment of relapsing-remitting multiple sclerosis in adults was associated with a significant reduction of the annualized relapse rate during the treatment period, decreased number of gadolinium-enhancing lesions at the end of the trial, and lowered number of new or enlarging T2 lesions over the treatment period. Ozanimod 1 mg outperformed 0.5 mg dose in efficacy without increasing the risk of adverse events.

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