scholarly journals Neuropsychiatric adverse events of enzalutamide and abiraterone acetate plus prednisone treatment: Contrasting a meta-analysis of randomized clinical trials with real world reporting patterns from EUDRA

2017 ◽  
Vol 28 ◽  
pp. v289
Author(s):  
M. Sanchez Iznaola ◽  
R. Parra ◽  
G. Angela ◽  
J. Casariego ◽  
J. MuÑoz Del Toro ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Abiraterone Acetate ◽  
Prednisone Treatment

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.

scholarly journals THE RATE OF ADVERSE EVENTS OF SODIUM-GLUCOSE COTRANSPORTER 2 INHIBITORS: A META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS

2021 ◽  
Vol 77 (18) ◽  
pp. 660
Author(s):  
Mohamad B. Taha ◽  
Mohammad As Sayaideh ◽  
Omar Sajdeya ◽  
Osama Dasa ◽  
Mohammed Ruzieh
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Sodium Glucose Cotransporter

Neuropsychiatric adverse events of enzalutamide and abiraterone acetate: Meta-analysis of randomized clinical trials with real world reporting patterns from EudraVigilance.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 217-217 ◽  
Author(s):  
Maria Paola Moreno Perez ◽  
Miguel Sanchez Iznaola ◽  
Angela Garcia ◽  
Jacobo Muñoz del Toro ◽  
Joaquin Casariego ◽  
...  
Keyword(s):  
Real World ◽  
Randomized Clinical Trials ◽  
Proportional Reporting Ratio ◽  
Meta Analysis ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Increased Risk ◽  
Neuropsychiatric Adverse Effects ◽  
Reporting Pattern

217 Background: Androgen deprivation is associated with cognitive decline and mood changes. Abiraterone acetate plus prednisone (AAP) and enzalutamide (ENZ) are oral hormonal agents for the treatment of metastatic castration resistant prostate cancer (mCPRC); both target the androgen signaling pathway. Meta-analysis for individual neuropsychiatric adverse effects (NAEs) associated with these drugs has not been available in the literature. Methods: Following the methodology presented by Ruiz et al. a further meta-analysis was performed to estimate the pooled Relative Risk (RR) of NAEs for AAP and ENZ. A complementary analysis of the EudraVigilance database was performed to explore the consistency of the real world adverse drug reactions (ADR) reporting pattern with the meta-analysis. Results: The meta-analysis results indicate that patients treated with ENZ had a statistically significant higher risk of restless leg syndrome (RLS), anxiety, headache and insomnia vs control. Both AAP and ENZ showed significant increased risk for falls vs control. The Proportional Reporting Ratio (PRR) of ADRs reported in Eudra is higher with ENZ than with AAP for all the variables analyzed. Conclusions: NAEs studied are more prevalent with ENZ vs placebo than AAP vs prednisone plus placebo. Reporting trend in Eudra is consistent with this results. [Table: see text]

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.

Sign in / Sign up

Export Citation Format

Share Document