scholarly journals Safety of IL-23/17 Antagonists in Patients with Psoriasis or Other Immune-mediated Inflammatory Diseases: A Systematic Meta-Analysis.

2020 ◽  
Author(s):  
Siying Li ◽  
Suhan Zhang ◽  
Guishao Tang ◽  
Ruifang Wu ◽  
Yuwen Su
Keyword(s):  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Inflammatory Diseases ◽  
Meta Analysis ◽  
Cardiovascular Disorder ◽  
Control Group ◽  
Placebo Control ◽  
Serious Adverse Events ◽  
Immune Mediated ◽  
Increased Risk

Abstract Background: The IL-23/17 axis plays central role in the pathogenesis of several immune-mediated inflammatory diseases (IMIDs). IL-23/17 antagonists showed significant improvement in the treatment for psoriasis and other IMIDs, including psoriasis(PSO), psoriatic arthritis(PsA), rheumatoid arthritis(RA) and ankylosing spondylitis(AS).Objective: To assess the safety of IL-23/17 antagonists therapy on patients with psoriasis and other IMIDs.Methods: Pooled analysis from thirty-nine placebo-controlled randomized clinical trials (RCTs) of IL-23/17 axis antagonists for IMIDs. Incidences of adverse events (AEs), serious adverse events (SAEs) and AEs of interest were applied to evaluate the safety profile.Result: A Total of 15967 patients were exposed to IL-23/17 axis antagonists. The proportions of patients suffered at least one AE in antagonists group and placebo-control group are 67.5% and 51.1% respectively. Incidence of SAE was increased in patients treated with IL-23/17 axis antagonists compared to patients given placebo (relative risk 2.03; 95% CI, 1.62, 2.56). Incidence of AEs of interest were all increased in patients treated with IL-23/17 axis antagonists compared to patients given placebo.Conclusion: In this analysis, we found increased risk of AEs, SAEs, nervous system disorder, cardiovascular disorder and hypertension among patients with IMIDs treated with IL-23/17 axis antagonists.

scholarly journals A Meta-Analysis of the Efficacy of Panax Ginseng on Menopausal Women’s Sexual Function

2018 ◽  
Vol 7 (1) ◽  
pp. 124-133 ◽  
Author(s):  
Zahra Ghorbani ◽  
Mojgan Mirghafourvand
Keyword(s):  
Sexual Dysfunction ◽  
Adverse Events ◽  
Sexual Function ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Cochrane Library ◽  
Control Group ◽  
Placebo Control ◽  
Significant Difference

Objectives: An increase in life expectancy results in the aging population growth. This study was designed to evaluate the efficacy and adverse events of ginseng that could be used as a herbal medicine in women with sexual dysfunction. Materials and Methods: The authors of this study searched Cochrane Library, MEDLINE, Web of Science, Embase, Scopus, ProQuest, Google Scholar, and Persian databases without a time limitation until May 2018 and examined all the randomized clinical trials (RCTs) that compared the effect of different types of ginseng on sexual function of menopausal women as compared to the placebo controls. The Cochrane risk of bias tool was used to assess the methodological quality of the included studies. The heterogeneity was determined using the I2 index. In addition, standardized mean difference (SMD) was used instead of mean differences (MD) and a random effect was reported instead of fixed effect in meta-analysis. Results: The eligibility criteria were found in five RCTs. All the included studies were placebo-controlled. Two trials had a parallel design while three studies used a crossover design. Although four trials indicated that ginseng significantly improved sexual function, they didn’t report any treatment effect compared to the placebo group. Based on the results of meta-analysis obtained from five studies including 531 women, there was no statistically significant effect of ginseng on female sexual dysfunction (FSD) compared to the placebo control group (SMD: 0.26; 95% CI: -0.26 to 0.76). Nonetheless, there was a considerable heterogeneity among the studies (I2 = 81%; P < 0.0001). Moreover, all the included studies assessed adverse events, but in three of the RCTs, there was no significant difference between the placebo and ginseng groups. Conclusions: The evidence regarding ginseng as a therapeutic agent for sexual dysfunction is unjustifiable. Rigorous studies seem warranted in this respect.

scholarly journals Erenumab safety and efficacy in migraine: a systematic review and meta-analysis of randomized clinical trials

2018 ◽  
Author(s):  
Changyu Zhu ◽  
Jianmei Guan ◽  
Hua Xiao ◽  
Weinan Luo ◽  
Rongsheng Tong
Keyword(s):  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Preventive Treatment ◽  
Pooled Analysis ◽  
Cochrane Library ◽  
Serious Adverse Events ◽  
Increased Risk ◽  
Specific Medication ◽  
Mean Differences

Abstract Background: Erenumab is a new medicine approved lately in the US for the preventive treatment of migraine in adults. We aimed to conduct a meta-analysis to evaluate the efficacy and safety of erenumab in patients with migraine. Methods: The electronic database composed of PubMed, Embase and Cochrane library was independently retrieved by two reviewers. Only randomized controlled trials (RCTs) that compared between placebo and erenumab were included in this analysis. mean differences (MDs) and Pooled risk ratios (RRs) as well as their corresponding 95% confidence intervals (CIs) were calculated for continuous and dichotomous data, respectively. Results: Total five RCTs representing 2928 patients were included. Pooled analysis showed significant reductions of the 50% reduction(RR 1.55; 95%CI,1.35 to 1.77; P < 0.00001; I²=49%). In addition, the mean monthly migraine days (MMMDs) from baseline in the erenumab group compared with placebo (MD -1.32, 95%CI, -1.73 to -0.91; P < 0.00001; I²=100%) and migraine-specific medication days (MSMDs) from baseline (MD -1.41; 95%CI, -1.80 to -1.02; P＜0.00001; I²=100%) were significantly increased for the erenumab group compared with placebo. Furthermore, there was significant reduction of MSMDs from baseline in 140mg erenumab group compared to 70mg (MD=0.55; 95%CI:0.54 to 0.66; Z =10.95; P<0.00001; I²=90% ). Finally, there were no significant differences between erenumab group and placebo of any adverse events and serious adverse events. Conclusion: Among patients with migraine, both 70mg and 140mg erenumab are associated with reduction of MMMDs, MSMDs from baseline and increased rate of 50% reduction without increased risk of any adverse events and serious adverse events.

scholarly journals Safety and Efficacy of Remdesivir for the Treatment of COVID-19: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 24 ◽  
pp. 237-245
Author(s):  
Mohammad Tasavon Gholamhoseini ◽  
Vahid Yazdi-Feyzabadi ◽  
Reza Goudarzi ◽  
Mohammad Hossein Mehrolhassani
Keyword(s):  
Adverse Events ◽  
Clinical Improvement ◽  
Meta Analysis ◽  
Qualitative Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Placebo Control ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Positive Effects

Purpose: To evaluate the safety and efficacy of remdesivir in adult patients with COVID-19. Methods: PubMed, Embase, Scopus, Web of Science, Cochrane Library, ClinicalTrials.gov, and medRxiv databases were searched using a search strategy tailored to each database. The Consolidated Standards of Reporting Trials (CONSORT) and Strengthening the reporting of observational studies in epidemiology (STROBE) checklists were used for the studies' qualitative assessment. The outcomes studied were mortality, all adverse events, serious adverse events, and clinical improvement. The quantitative synthesis was conducted using fixed and random effects models in the CMA 2.2. Heterogeneity was tested using the I-squared (I2) measure. Results: In general, six studies, including five randomized controlled trials and one cohort study were found eligible. Comparison of the findings related to both groups receiving remdesivir (10-day remdesivir group) and placebo/control group showed that remdesivir treatment had no significant effect on mortality at day 14 of the treatment (RR=0.769; 95% CI :0.563-1.050; p=0.098), and all adverse events (RR= 1.078; 95% CI: 0.908-1.279; p= 0.392). However, remdesivir had a significant effect on clinical improvement at day 14 compared to placebo/control (OR= 1.447; 95% CI: 1.005-2.085; p= 0.047) and reduced serious adverse events (RR= 0.736; 95% CI: 0.611-0.887; p= 0.001). Conclusion: Remdesivir has positive effects on clinical improvement, and reduction of the risk of serious adverse events. However, it does not influence the mortality at day 14 of treatment.

scholarly journals Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis

2019 ◽  
Vol 54 (18) ◽  
pp. 1073-1080 ◽  
Author(s):  
Andre Niemeijer ◽  
Hans Lund ◽  
Signe Nilssen Stafne ◽  
Thomas Ipsen ◽  
Cathrine Luhaäär Goldschmidt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Relative Risk ◽  
Adverse Events ◽  
Exercise Therapy ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Randomised Controlled

ObjectiveTo evaluate the relative risk (RR) of serious and non-serious adverse events in patients treated with exercise therapy compared with those in a non-exercising control group.DesignSystematic review and meta-analysis.Data sourcesPrimary studies were identified based on The Cochrane Database of Systematic Reviews investigating the effect of exercise therapy.Eligibility criteriaAt least two of the authors independently evaluated all identified reviews and primary studies. Randomised controlled trials were included if they compared any exercise therapy intervention with a non-exercising control. Two authors independently extracted data. The RR of serious and non-serious adverse events was estimated separately.Results180 Cochrane reviews were included and from these, 773 primary studies were identified. Of these, 378 studies (n=38 368 participants) reported serious adverse events and 375 studies (n=38 517 participants) reported non-serious adverse events. We found no increase in risk of serious adverse events (RR=0.96 (95%CI 0.90 to 1.02, I2: 0.0%) due to exercise therapy. There was, however, an increase in non-serious adverse events (RR=1.19 (95%CI 1.09 to 1.30, I2: 0.0%). The number needed to treat for an additional harmful outcome for non-serious adverse events was 6 [95%CI 4 to 11).ConclusionParticipating in an exercise intervention increased the relative risk of non-serious adverse events, but not of serious adverse events. Exercise therapy may therefore be recommended as a relatively safe intervention.PROSPERO registration numberCRD42014014819.

scholarly journals Long-acting muscarinic antagonists vs. long-acting β 2 agonists in COPD exacerbations: a systematic review and meta-analysis

2017 ◽  
Vol 43 (4) ◽  
pp. 302-312 ◽  
Author(s):  
Israel Silva Maia ◽  
Mariângela Pimentel Pincelli ◽  
Victor Figueiredo Leite ◽  
João Amadera ◽  
Anna Maria Buehler
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Therapeutic Effects ◽  
Muscarinic Antagonists ◽  
Serious Adverse Events ◽  
Exacerbation Rate ◽  
Copd Exacerbations ◽  
Long Acting

ABSTRACT Objective: To determine whether long-acting muscarinic antagonists (LAMAs) provide superior therapeutic effects over long-acting β2 agonists (LABAs) for preventing COPD exacerbations. Methods: This was a systematic review and meta-analysis of randomized clinical trials involving patients with stable, moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria, treated with a LAMA (i.e., tiotropium bromide, aclidinium, or glycopyrronium), followed for at least 12 weeks and compared with controls using a LABA in isolation or in combination with a corticosteroid. Results: A total of 2,622 studies were analyzed for possible inclusion on the basis of their title and abstract; 9 studies (17,120 participants) were included in the analysis. In comparison with LABAs, LAMAs led to a greater decrease in the exacerbation rate ratio (relative risk [RR] = 0.88; 95% CI: 0.84-0.93]; a lower proportion of patients who experienced at least one exacerbation (RR = 0.90; 95% CI: 0.87-0.94; p < 0.00001); a lower risk of exacerbation-related hospitalizations (RR = 0.78; 95% CI: 0.69-0.87; p < 0.0001); and a lower number of serious adverse events (RR = 0.81; 95% CI: 0.67-0.96; p = 0.0002). The overall quality of evidence was moderate for all outcomes. Conclusions: The major findings of this systematic review and meta-analysis were that LAMAs significantly reduced the exacerbation rate (exacerbation episodes/year), as well as the number of exacerbation episodes, of hospitalizations, and of serious adverse events.

Effects of lipid-lowering therapy on major adverse limb events in patients with peripheral arterial disease: A meta-analysis of randomized clinical trials

Vascular ◽  
2021 ◽  
pp. 170853812110439
Author(s):  
Walter Masson ◽  
Martín Lobo ◽  
Leandro Barbagelata ◽  
Graciela Molinero ◽  
Ignacio Bluro
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Arterial Disease ◽  
Lipid Lowering ◽  
Placebo Control ◽  
Lipid Lowering Therapy ◽  
Lowering Therapy ◽  
Increased Risk ◽  
Peripheral Arterial

Objective Patients with peripheral artery disease (PAD) are at increased risk of major adverse limb events (MALE). Furthermore, MALE have several clinical implications and a poor prognosis, so prevention is a fundamental issue. The main objective of the present meta-analysis of randomized clinical trials is to evaluate the effect of different lipid-lowering therapies on MALE incidence in patients with PAD. Methods A meta-analysis of randomized studies that evaluated the use of lipid-lowering therapy in patients with PAD and reported MALE was performed, after searching the PubMed/MEDLINE, Embase, ScieLO, Google Scholar, and Cochrane Controlled Trials databases. A fixed- or random-effects model was used. Results Five randomized clinical trials including 11,603 patients were identified and considered eligible for the analyses (5903 subjects were allocated to receive lipid-lowering therapy, while 5700 subjects were allocated to the respective placebo/control arms). The present meta-analysis revealed that lipid-lowering therapy was associated with a lower incidence of MALE (OR: 0.76, 95% confidence interval: 0.66–0.87; I2: 28%) compared to placebo/control groups. The sensitivity analysis shows that the results are robust. Conclusion This study demonstrated that the use of lipid-lowering therapy compared with the placebo/control arms was associated with a marked reduction in the risk of MALE. Physicians involved in the monitoring and treatment of patients with PAD must work hard to ensure adequate lipid-lowering medication in these patients.

scholarly journals Effects of dual blockade in heart failure and renal dysfunction: Systematic review and meta-analysis

2019 ◽  
Vol 20 (4) ◽  
pp. 147032031988265
Author(s):  
Alessandra Rodrigues Silva ◽  
Alexandre Goes Martini ◽  
Graziela De Luca Canto ◽  
Eliete Neves da Silva Guerra ◽  
Francisco de Assis Rocha Neves
Keyword(s):  
Heart Failure ◽  
Systematic Review ◽  
Adverse Events ◽  
Renal Dysfunction ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Renin Angiotensin System ◽  
Ras Inhibition ◽  
Increased Risk ◽  
Dual Blockade

Objective: The effect of dual renin–angiotensin system (RAS) inhibition in heart failure (HF) is still controversial. Systematic reviews have shown that dual RAS blockade may reduce mortality and hospitalizations, yet it has been associated with the increased risk of renal dysfunction (RD). Surprisingly, although RD in patients with HF is frequent, the effect of combining RAS inhibitors in HF patients with RD has never been studied in a meta-analysis. Methods: A systematic review and meta-analysis of randomized clinical trials involving HF patients with RD who received dual blockade analyzing death, cardiovascular (CV) death or HF hospitalization, and adverse events. Results: Out of 2258 screened articles, 12 studies were included (34,131 patients). Compared with monotherapy, dual RAS inhibition reduced hazard ratio of death to 0.94 ( p=0.07) and significantly reduced CV death or HF hospitalization to 0.89 ( p=0.0006) in all individuals, and to 0.86 ( p=0.005) in patients with RD and to 0.91 ( p=0.04) without RD. Nevertheless, dual RAS blockade significantly increased the risk of renal impairment (40%), hyperkalemia (44%), and hypotension (42%), although discontinuation of treatment occurs only in 3.68% versus 2.19% ( p=0.00001). Conclusions: Dual RAS inhibition therapy reduces the risk of CV death or HF hospitalization. However, cautions monitoring for specific adverse events may be warranted.

Pre-Morbid Obesity is Associated with Increased Risk of Developing Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis

2017 ◽  
Vol 152 (5) ◽  
pp. S976-S977 ◽  
Author(s):  
Siddharth Singh ◽  
Mathurin Fumery ◽  
Katherine Shaffer ◽  
Abha G. Singh ◽  
Larry Prokop ◽  
...  
Keyword(s):  
Systematic Review ◽  
Morbid Obesity ◽  
Inflammatory Diseases ◽  
Meta Analysis ◽  
Immune Mediated ◽  
Increased Risk
Sign in / Sign up

Export Citation Format

Share Document