The Efficacy and Adverse Effects of Favipiravir on COVID-19 Patients: A Systematic Review and Meta-Analysis of Published Clinical Trials and Observational Studies

2021 ◽  
Author(s):  
Dang The Hung ◽  
Suhaib Ghula ◽  
Jeza Abdul Aziz ◽  
Abdelrahman M. Makram ◽  
Gehad Mohamed Tawfik ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Observational Studies ◽  
Meta Analysis

scholarly journals P556 Safety and efficacy of ustekinumab in the treatment of Crohn’s Disease: A systematic review and meta-analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S521-S521
Author(s):  
M Khorshid Fasge ◽  
A Cordie ◽  
S Abd-Elsalam
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Crohn’S Disease ◽  
Adverse Effects ◽  
Cohort Studies ◽  
Clinical Response ◽  
Observational Studies ◽  
Response Rate ◽  
Meta Analysis ◽  
Clinical Response Rate

Abstract Background This systematic review and meta-analysis was designed to estimate the safety and effectiveness of ustekinumab in the treatment for Crohn’s disease (CD) in clinical trials and observational studies. Methods We retrieved all the related publications from PubMed, Cochrane, EBSCO, Google Scholar and EMBASE using a systematic search strategy. We only included the clinical trials and observational studies that were published in English. Results Only 31 studies that met the eligibility criteria out of the 733 identified studies were included. Twenty-one studies reported the clinical response rate; three of these were clinical trials, and the other 18 were cohort studies. The overall clinical response rate in the cohort studies was 0.539, 95% CI (0.419–0.659) with significant heterogeneity (I2 = 96.22%, P < 0.001) and that in the clinical trials was 0.428, 95% CI (0.356–0.501). The pooled clinical remission rate was 0.399, 95% CI (0.295–0.503) in randomised control trials (RCTs) and 0.440, 95% CI (0.339–0.542) in cohort studies. Twenty-one studies reported the incidence of adverse effects. The rate of adverse effects was 0.158, 95% CI (0.109–0.207) in cohort studies and 0.690, 95% CI (0.633–0.748) in RCTs. Three RCTs had an infection rate of 0.275, 95% CI (0.245–0.295), while the 18 cohort studies had a rate of 0.076, 95% CI (0.047–0.105). Only ten studies reported the incidence of injection or infusion reaction; it was 0.035, 95% CI (0.027–0.043) for RCTs and 0.012, 95% CI (0.002–0.022) for cohort studies. Conclusion Ustekinumab is effective in the treatment of CD. However, more research is required on the safety profiles because there was considerable variation among the included studies.

scholarly journals Cardiovascular Toxicities Secondary to Biotherapy and Molecular Targeted Therapies in Neuroendocrine Neoplasms: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials

Cancers ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2159
Author(s):  
Charalampos Aktypis ◽  
Maria-Eleni Spei ◽  
Maria Yavropoulou ◽  
Göran Wallin ◽  
Anna Koumarianou ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Targeted Therapies ◽  
Safety Profile ◽  
Meta Analysis ◽  
Mtor Inhibitors ◽  
Risk Of Bias ◽  
Neuroendocrine Neoplasms ◽  
Controlled Trials

A broad spectrum of novel targeted therapies with prime antitumor activity and/or ample control of hormonal symptoms together with an overall acceptable safety profile have emerged for patients with metastatic neuroendocrine neoplasms (NENs). In this systematic review and quantitative meta-analysis, the PubMed, EMBASE, Cochrane Central Register of Controlled Trials and clinicaltrials.gov databases were searched to assess and compare the safety profile of NEN treatments with special focus on the cardiovascular adverse effects of biotherapy and molecular targeted therapies (MTTs). Quality/risk of bias were assessed using GRADE criteria. Placebo-controlled randomized clinical trials (RCTs) in patients with metastatic NENs, including medullary thyroid cancer (MTC) were included. A total of 3695 articles and 122 clinical trials registered in clinicaltrials.gov were screened. We included sixteen relevant RCTs comprising 3408 unique patients assigned to different treatments compared with placebo. All the included studies had a low risk of bias. We identified four drug therapies for NENs with eligible placebo-controlled RCTs: somatostatin analogs (SSAs), tryptophan hydroxylase (TPH) inhibitors, mTOR inhibitors and tyrosine kinase inhibitors (TKI). Grade 3 and 4 adverse effects (AE) were more often encountered in patients treated with mTOR inhibitors and TKI (odds ratio [OR]: 2.42, 95% CI: 1.87–3.12 and OR: 3.41, 95% CI: 1.46–7.96, respectively) as compared to SSAs (OR:0.77, 95% CI: 0.47–1.27) and TPH inhibitors (OR:0.77, 95% CI: 0.35–1.69). MTOR inhibitors had the highest risk for serious cardiac AE (OR:3.28, 95% CI: 1.66–6.48) followed by TKIs (OR:1.51, 95% CI: 0.59–3.83). Serious vascular AE were more often encountered in NEN patients treated with mTOR inhibitors (OR: 1.72, 95% CI: 0.64–4.64) and TKIs (OR:1.64, 95% CI: 0.35–7.78). Finally, patients on TKIs were at higher risk for new-onset or exacerbation of pre-existing hypertension (OR:3.31, 95% CI: 1.87–5.86). In conclusion, SSAs and TPH inhibitors appear to be safer as compared to mTOR inhibitors and TKIs with regards to their overall toxicity profile, and cardiovascular toxicities in particular. Special consideration should be given to a patient-tailored approach with anticipated toxicities of targeted NEN treatments together with assessment of cardiovascular comorbidities, assisting clinicians in treatment selection and early recognition/management of cardiovascular toxicities. This approach could improve patient compliance and preserve cardiovascular health and overall quality of life.

Low Glycemic Load or Index Diet in Association with Acne Vulgaris: A Systematic Review and Meta-analysis

2020 ◽  
Author(s):  
Roya Sakhaei ◽  
Mohammad Ali Mohsenpour
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Social Life ◽  
Observational Studies ◽  
Meta Analysis ◽  
Acne Vulgaris ◽  
Glycemic Load ◽  
Dietary Factors ◽  
Dietary Habit ◽  
The Mean

Background: Social life can be affected by skin condition. Acne Vulgaris (AV) is a multi-factorial skin disorder that affects many people. Several dietary factors are associated with AV. Objectives: Different findings on glycemic indices led us to investigate the effect of the dietary glycemic index (GI) and glycemic load (GL) on AV by a systematic review and meta-analysis. Methods: Observational studies and clinical trials were extracted from PubMed, EMBASE, Scopus, and Google Scholar. The mean ± Standard division (SD) for acne grading in clinical trials and the mean ± SD GI or GL of the diet for observational studies were used for meta-analysis. Results: We found that nine out of 15 studies were eligible for systematic review clinical trials (N = 3) and observational studies (N = 6) designs. The meta-analysis of three studies clinically assessed the effect of GI/GL on acne and showed that a diet with lower GI/GL reduced the acne severity (Hedges’g = -0.91, 95% CI: -1.57, -0.25, P = 0.007). The analysis of six observational studies showed that dietary habit with higher GI might not affect the acne severity in patients with AV (Hedges’g = 0.07, 95%CI: -0.23, 0.38, P = 0.636), but individuals with higher acne severity had a diet with higher GL (Hedges’g = 0.64, 95%CI: 0.01, 1.26, P = 0.045). Conclusions: Diet, as a part of life style, is associated with AV. Adherence to lower GL diet may reduce the severity of AV. Further well-designed clinical trials are required to confirm these results.

scholarly journals Short-Term Effectiveness and Safety of Biologics and Small Molecule Drugs for Moderate to Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis

Life ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. 927
Author(s):  
José-Juan Pereyra-Rodriguez ◽  
Sara Alcantara-Luna ◽  
Javier Domínguez-Cruz ◽  
Manuel Galán-Gutiérrez ◽  
Ricardo Ruiz-Villaverde ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Atopic Dermatitis ◽  
Adverse Effects ◽  
Small Molecules ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Severe Atopic Dermatitis ◽  
Cochrane Central Register ◽  
Number Of Patients

Background: Some Network Meta-analysis (NMA) has been published regarding atopic dermatitis (AD). These studies have considered drugs under investigation both in monotheraphy or in combination with topical corticosteroids, as well as systemic immunosuppressant therapies. The objective of this study is to evaluate the efficacy and safety of biological agents and small molecules in AD. Methods: A systematic review and NMA of biologics agents and small molecules in AD was performed. A literature search was performed using MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials for clinical trials and systematic reviews between January 2000 and 19 December 2020. Only randomized clinical trials (RCTs) were included. It was limited to English language and adult human subjects. Two networks were evaluated: monotherapy and combination with TCS. The two primary outcomes were Eczema Area and Severity Index (EASI) 75 and EASI 90 change from baseline to week 12–16, depending on source study cut-off. The Cochrane’s Risk of Bias tool 2011 update was used to analyze the risk of bias, focused on the primary objectives. Results: 30 RCTs (included in 26 publications) were included in the systematic review. Finally, 23 RCTs were included in the quantitative analysis (14 RCTs including 3582 patients in monotherapy; and 9 RCTs including 3686 patients with TCS). In monotherapy, a higher percentage of patients achieving EASI-75 was obtained with Upadacitinib 30 mg [OR: 18.90 (13.94; 25.62)] followed by Abrocitinib 200 mg [OR = 11.26 (7.02; 18.05)] and Upadacitinib 15 mg [OR: 10.89 (8.13; 14.59)]. These results were also observed in studies where the use of topical corticosteroid (TCS) was allowed (OR Upadacitinib 30 mg = 9.43; OR Abrocitinib 200 mg = 6.12; OR Upadacitinib 15 mg = 5.20). Regarding IGA, the percentage of patients achieving IGA0/1 was higher with both doses of Upadacitinib 30 mg [OR: 19.13 (13.14; 27.85)] and 15 mg [OR = 10.95 (7.52; 15.94). In studies where the use of TCS were allowed, however, the dose of Abrocitinib 200 mg [OR = 6.10 (3.94; 9.44)] showed higher efficacy than Upadacitinib 15 mg [OR = 5.47 (3.57; 8.41)]. Regarding safety, the drugs with the highest probability of presenting adverse effects were the Janus kinases (JAK) inhibitors, Upadacitinib and Abrocitinib in monotherapy and Baricitinib in combination with TCS. Discussion: Some risks of bias have been found, which must be taken into account when interpreting the results. The funnel plot shows a possible publication bias that may underestimate the efficacy of drugs. Upadacitinib and Abrocitinib are the drugs with the highest efficacy, both in monotherapy and in association with TCS. However, they were also those associated with the highest risk of adverse effects, showing monoclonal antibodies better safety profile. Limitations: We have included molecules still in the development phase as well studies completed and presented at conferences and with data available in Trialsgov® but not published yet. Several molecules’ development had included a small number of patients from 12 to 17 years of age, without being able to differentiate the results from the adult population. Other: Founding: None. PROSPERO database registration number CRD42021225793.

Abstract 15722: Proton Pump Inhibitors and Risk of Myocardial Infarction: A Systematic Review and Meta-analysis

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Ahmed Ullah Mishuk ◽  
Shahariar Mohammed Fahim ◽  
Richard Hansen ◽  
Li Chen ◽  
Philippe Gaillard ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Systematic Review ◽  
Clinical Trials ◽  
Quality Assessment ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Observational Studies ◽  
Meta Analysis ◽  
Pharmacovigilance System ◽  
Increased Risk

Introduction: Proton Pump Inhibitors (PPIs) are generally considered safe, but recent evidence suggests otherwise. Objective: This systematic review and meta-analysis assessed the association between PPIs and the risk of myocardial infarction (MI), using both clinical trials and observational studies. Methods: A systematic search was performed in December 2019 to retrieve all potential studies using PubMed, PsycInfo, International Pharmaceutical Abstracts, Web of Science, and Clinicaltrials.gov. This search initially identified any published studies describing any adverse event (AE) or outcomes related to PPI. Records were included in this study if 1) studies were published in English, 2) study design was clinical trials or observational studies, 3) PPI use was the exposure or treatment, and 4) study outcome was the incidence of MI. Two researchers independently reviewed all identified records, performed full article review, extracted data into structured evidence table, and conducted quality assessment using Newcastle-Ottawa Scale and Quality Assessment Tool for Quantitative Studies. Meta-analysis was performed using the RStudio software to assess the risk of MI with PPI use. Results: A total of 4,507 abstracts meeting the inclusion criteria were identified, and 20 full articles were included in this study, among which 10 were cohort, 3 were case-control, 3 were RCT post-hoc analysis, and 4 were RCT studies. The pooled Odds Ratio (OR)=1.40 with 95% CI=1.20-1.63 for all studies indicated the presence of an association between PPI use and increased risk of MI compared to PPI non-users. Meta-analysis found a similar association between PPI use and increased risk of MI in observational studies (OR=1.40; 95% CI=1.20, 1.64) but no association (OR=0.90; 95% CI=0.47, 1.73) in RCT-studies. Heterogeneity was high (I 2 > 75%) for all analyses except for RCTs (I 2 =0%). Conclusion: Although our meta-analysis identified the association between PPI use and increased risk of MI, results from RCTs did not agree with observational studies. Due to the mixed findings by study designs and high variation of heterogeneity among studies, the pharmacovigilance system should evaluate different levels of evidence to support decision making in safety of drug products.

scholarly journals Efficacy of Adjunctive Treatments Added to Olanzapine or Clozapine for Weight Control in Patients with Schizophrenia: A Systematic Review and Meta-Analysis

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Yun-Jung Choi
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Weight Reduction ◽  
Weight Control ◽  
Randomized Clinical Trials ◽  
Psychiatric Symptoms ◽  
Meta Analysis ◽  
Cochrane Central Register ◽  
Meta Analyses

Objectives. This study was conducted to review systematically adjunctive treatments for weight reduction in patients with schizophrenia and compare efficacies of clinical trials through meta-analysis, so as to provide effective clinical guideline regarding weight control for patients taking atypical antipsychotics.Methods. Candidate clinical trials were identified through searching the Cochrane Central Register of Controlled Trials, PubMed, and PsycINFO. Fourteen randomized clinical trials were included for systematic review and meta-analysis from 132 potential trials. The Comprehensive Meta-Analysis version 2 was used for meta-analysis.Results. Difference in means and significances from meta-analyses regarding weight control by adjunctive treatments showed that topiramate, aripiprazole, or sibutramine was more effective than metformin or reboxetine. Psychiatric evaluations did not show statistically significant changes between treatment groups and placebo groups except topiramate adjunctive treatments. Adverse effects regarding adjunctive therapies were tolerable and showed statistically no significances compared to control groups.Conclusion. Though having several reports related to exacerbation of psychiatric symptoms, topiramate and aripiprazole are more efficacious than other medications in regard to weight reduction and less burden of critical adverse effects as well as being beneficial for clinical improvement.

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