scholarly journals Randomized Controlled Trials of Remdesivir in Hospitalized COVID-19 Patients: A Systematic Review and Meta-Analysis

2020 ◽  
Author(s):  
Azza Sarfraz ◽  
Zouina Sarfraz ◽  
Marcos Sanchez-Gonzalez ◽  
Jack Michel ◽  
George Michel ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Antiviral Treatment ◽  
Intervention Group ◽  
Phase Iii ◽  
Nucleoside Triphosphate ◽  
Controlled Trials ◽  
Randomized Controlled

Background: The first cases of the coronavirus disease 2019 (COVID-19) were reported in Wuhan, China. No antiviral treatment options are currently available with proven clinical efficacy. However, preliminary findings from phase III trials suggest that remdesivir is an effective and safe treatment option for COVID-19 patients with both moderate and severe disease. Objective: The aim of the present meta-analysis was to investigate whether remdesivir was effective for treating COVID-19 including reduced in-hospital adverse events, oxygen support, and mortality rates. Methods: According to PRISMA reporting guidelines, a review was conducted from January 1 2020 until 25 August 2020 with MeSH terms including COVID-19, COVID, coronavirus, SARS-CoV-2, remdesivir, adenosine nucleoside triphosphate analog, Veklury using MEDLINE, Scopus, and CINAHL Plus. A modified Delphi process was utilized to include the studies and ensure that the objectives were addressed. Using dichotomous data for select values, the unadjusted odds ratios (ORs) were calculated applying Mantel Haenszel (M-H) random-effects method in Review Manager 5.4. Results: Randomized controlled trials pooled in 3013 participants with 46.3% (n=1,395) in the remdesivir group and 53.7% (n=1,618) in the placebo group. The placebo group had a higher risk of mortality as compared to the intervention group with significant odds ratio (OR=0.61) (95% confidence interval of 0.45-0.82; P=0.001). There was minimal heterogeneity among the studies (I2=0%). Conclusions Our findings suggest that remdesivir extends clinical benefits by reducing mortality, adverse events and oxygen support in moderate to severely ill COVID-19 patients. Concerted efforts and further randomized placebo-controlled trials are warranted to examine the potency of anti-viral drugs and immune-pathological host responses contributing to severity of COVID-19.

scholarly journals Anti-Angiogenesis Maintenance Therapy in Newly Diagnosed and Relapsed Ovarian Cancer: A Meta-analysis of Phase III Randomized Controlled Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Yizi Wang ◽  
Shitai Zhang ◽  
Zixuan Song ◽  
Ling Ouyang ◽  
Yan Li
Keyword(s):  
Ovarian Cancer ◽  
Adverse Events ◽  
Maintenance Therapy ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Phase Iii ◽  
Controlled Trials ◽  
Newly Diagnosed ◽  
Randomized Controlled ◽  
Fatal Adverse Events

Aim: Anti-angiogenesis agents have been added as maintenance therapy in ovarian cancer over the past decade. The aim of this meta-analysis was to analyze the efficacy of anti-angiogenesis therapy in newly diagnosed and relapsed ovarian cancer.Methods: PubMed, Embase, and Cochrane databases were searched for all phase III randomized controlled trials (RCTs) that assessed the efficacy and toxicity of anti-angiogenesis agents in ovarian cancer. Overall survival (OS) and progression-free survival (PFS) were used to evaluate the effectiveness of anti-angiogenesis therapy in ovarian cancer.Results: A total of 6097 patients with newly diagnosed ovarian cancer from 5 phase III RCTs and 2943 patients with relapsed ovarian cancer from 6 phase III RCTs were included in this meta-analysis. The pooled results showed that anti-angiogenesis maintenance therapy significantly improved PFS (hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.76–0.93; p = 0.001), but not OS (HR, 0.98; 95% CI, 0.91–1.05; p = 0.49) compared with placebo in patients with newly diagnosed ovarian cancer. In patients with relapsed ovarian cancer, the pooled results showed a significant improvement on OS (HR, 0.89; 95% CI, 0.82–0.98; p = 0.02) and PFS (HR, 0.61; 95% CI, 0.52–0.72; p < 0.001). The pooled results also showed that the anti-angiogenesis agents were associated with an increase in the occurrence of severe hypertension, neutropenia, diarrhea, thrombocytopenia, headache, and bleeding in ovarian cancer. However, infrequent fatal adverse events occurred in the anti-angiogenesis groups.Conclusions: Study results suggest that anti-angiogenesis agents were an effective therapy for newly diagnosed and relapsed ovarian cancer, especially for relapsed ovarian cancer. Anti-angiogenesis agents may be associated with some severe but not fatal adverse events.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/, identifier CRD42021283647

Differential side effects profile in mCRPC patients treated with abiraterone or enzalutamide: A meta-analysis of randomized controlled trials.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 73-73 ◽  
Author(s):  
Raphael Brandao Moreira ◽  
Marcio Debiasi ◽  
Fernando C. Maluf ◽  
Joaquim Bellmunt ◽  
Andre Poisl Fay ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Cardiovascular Events ◽  
Meta Analysis ◽  
Phase Iii ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Grade 3

73 Background: Abiraterone and enzalutamide are currently approved for mCRPC patients. Both drugs have distinct mechanisms of action and may have different toxicity profile. There are limited data comparing the side effects of abiraterone and enzalutamide. We performed a meta-analysis of randomized controlled trials (RCT) to better characterize the risk of adverse events associated with both drugs. Methods: We performed a literature search on MEDLINE for studies reported from January 1966 to July 31, 2015. Abstracts presented at ASCO meetings from 2004 to 2015 were selected manually. Phase III RCT were included in analysis. We assessed the risk of adverse events reported in RCT by performing two meta-analysis: abiraterone-prednisone vs. placebo-prednisone (2,283 pts) and enzalutamide vs. placebo (2,914 pts). Summary of incidence, relative-risks (RR), and 95% confidence intervals (CI) were calculated using random-effects or fixed-effects models based on the heterogeneity of included studies. Results: Overall, enzalutamide was not associated with all-grade (RR 1.06 - 95% CI 0.67-1.65) or grade ≥3 (RR 0.81 - 95% CI 0.28-2.33) cardiovascular events, but was associated with increased risk of all-grade fatigue (RR 1.29 - 95% CI 1.15-1.44). On the other hand, abiraterone was associated with increased risk of all-grade (RR 1.28 - 95% CI 1.06-1.55) and grade ≥3 (RR 1.76 - 95% CI 1.12-2.75) cardiovascular events, but was not associated with all-grade (RR 0.85 - 95% CI 0.58-1.23) or grade ≥3 (RR 1.07 - 95% CI 0.97-1.19) fatigue. No evidence of publication bias was observed. Conclusions: In this meta-analysis, abiraterone was associated with an increased risk of cardiovascular events, while enzalutamide was associated with an increased risk of fatigue.

scholarly journals A Meta-Analysis of Therapeutic Efficacy and Safety of Gabapentin in the Treatment of Postherpetic Neuralgia from Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Meng Zhang ◽  
Cun-Xiang Gao ◽  
Ke-Tao Ma ◽  
Li Li ◽  
Zhi-Gang Dai ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Postherpetic Neuralgia ◽  
Clinical Effect ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Clinical Database ◽  
Randomized Controlled

Objective. The study aims to systematically evaluate the clinical effect of gabapentin in the treatment of postherpetic neuralgia (PHN). Method. Data were retrieved electronically from PubMed, Embase, CNKI, the China Biomedical Database, and the Library of Clinical Database, beginning from the time of inception to April 2017, in order to collect data on randomized controlled trials (RCTs) of gabapentin and placebo in PHN treatment. Results. A total of 11 RCTs (2376 people) were retrieved. The gabapentin group reported significantly reduced pain intensity [MD=−0.91, 95% CI −1.32 to −0.51, P<0.00001] compared with the placebo group. Those treated with gabapentin also experienced significantly improved sleep quality [SMD=−0.44, 95% CI −0.66 to −0.23, P<0.0001], but were more likely to experience incidence of adverse events, such as somnolence, dizziness, and peripheral edema. Results of the subgroup analysis showed that the source of heterogeneity may be related to the formulations of the drug. Conclusion. Gabapentin can be used to effectively and safely treat PHN.

Effects of Teriparatide versus Salmon Calcitonin Therapy for the Treat-ment of Osteoporosis in Asia: A Meta-analysis of Randomized Controlled Trials

2020 ◽  
Vol 20 ◽  
Author(s):  
Changjun Chen ◽  
Mohammed Alqwbani ◽  
Jie Chen ◽  
Ruitong Yang ◽  
Songgang Wang ◽  
...  
Keyword(s):  
Femoral Neck ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Salmon Calcitonin ◽  
Bone Markers ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Asian Patients ◽  
Teriparatide Treatment

Objective: The objective of this meta-analysis was to compare the efficacy and safety of teriparatide versus salmon calcitonin for the treatment of osteoporosis in Asian patients and to investigate whether the results of global studies could be applicable to Asian patients. Methods: PubMed, OVID, Cochrane Central Register of Controlled Trials (CENTRAL) and EMBASE up to December 2018 were searched. Eligible randomized controlled trials (RCTs) that compared teriparatide versus salmon calcitonin in Asian osteoporosis popula-tion were included. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for data synthe-sis, and Cochrane Collaboration software Review Manager 5.3 was used to analyze the pooled data. Results: Three RCTs involving 529 patients were included (mean age 68.7 yr; 93.4% females; mean follow-up 6 months); outcome measures included bone mineral density (BMD) of the femoral neck, total hip and lumbar spine; bone markers and adverse events. We found that the period of 6-months of teriparatide treatment was helpful for the improvement of the BMD of lumbar vertebra, however, the improvement of BMD was not significant in femoral neck and total hip join. There was a positive correlation between bone-specific alka-line phosphatase (BSAP) and osteocalcin (OCN) and the response of Asian patients to subcutaneous injection of 20 micrograms per day of teriparatide. And the proportion of the occurrence of adverse effect was more obvious in teriparatide group compared with salmon calciton-in, but there was no significant difference. Conclusion: Results suggested that the use of teriparatide could improve the lumbar BMD by short-term (six months) application in Asian osteoporosis patients, which is beneficial to the patients who cannot tolerate adverse events of long-term treatment. The BSAP and OCN bone markers could be useful to monitor the responses of Asian osteoporosis patients to teriparatide treatment. Finally, both of teriparatide and salmon calcitonin were well tolerated by Asian patients.

Inhaled Levodopa (CVT-301) for the Treatment of Parkinson Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials

2021 ◽  
pp. 10.1212/CPJ.0000000000001143
Author(s):  
Glenardi Glenardi ◽  
Tutwuri Handayani ◽  
Jimmy Barus ◽  
Ghea Mangkuliguna
Keyword(s):  
Systematic Review ◽  
Placebo Group ◽  
Adverse Events ◽  
Respiratory Symptoms ◽  
Meta Analysis ◽  
Motor Fluctuation ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Improve Motor Function

ABSTRACTPurposeof Review: To investigate the efficacy and safety of CVT-301 for motor fluctuation in Parkinson’s disease (PD).Recent Findings:This study demonstrated that the CVT-301 group had a higher proportion of patients achieving an ON state than the placebo group (OR=2.68; 95% CI: 1.86-3.86; p<0.00001). Moreover, CVT-301 had also shown to improve motor function by UPDRS-III score (SMD=3.83; 95% CI: 2.44-5.23; p<0.00001) and promote an overall improvement of PD by PGIC self-rating (OR=2.95; 95% CI: 1.78-4.9; p<0.00001). The most common adverse events encountered were respiratory symptoms (OR=12.18; 95% CI: 5.01-29.62; p<0.00001) and nausea (OR=3.95; 95% CI: 1.01-15.41; p=0.05).Summary:CVT-301 had the potential to be an alternative or even a preferred treatment for motor fluctuation in PD patients.

Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

2022 ◽  
pp. 112972982110701
Author(s):  
Yunfeng Li ◽  
Zhenwei Shi ◽  
Yunyun Zhao ◽  
Zhanjiang Cao ◽  
Zhengli Tan
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Primary Patency ◽  
Controlled Trials ◽  
Technical Success ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Drug Coated Balloon

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

scholarly journals The Effectiveness and Safety of Probiotic Supplements for Psoriasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Preclinical Trials

2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Liuting Zeng ◽  
Ganpeng Yu ◽  
Yang Wu ◽  
Wensa Hao ◽  
Hua Chen
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Intestinal Flora ◽  
Controlled Trials ◽  
Skin Thickness ◽  
Randomized Controlled ◽  
Probiotic Treatment ◽  
Preclinical Trials

Background. Patients with psoriasis need long-term medication to control their condition. Recent studies suggest that changing the intestinal flora may be a potential treatment. Methods. The databases were utilized to search the randomized controlled trials (RCTs) and preclinical trials about probiotic supplement in the treatment of psoriasis. The retrieval time is from the establishment of these databases to December 2020. RevMan5.3 was used for the risk assessment of bias and meta-analysis. This systematic review was registered in PROSPERO (CRD42021232756). Results. A total of 3 RCTs involving 164 participants were included. Two RCTs showed that probiotics can improve PASI and thereby improve the condition. For inflammation-related indicators, only one RCT showed that probiotics can improve the levels of CRP and TNF-α but have no obvious improvement effect on IL6. One RCT demonstrated the total effective rate of probiotics in the treatment of psoriasis. For adverse events, one RCT showed that the incidence of adverse events of probiotic treatment was low. Preclinical studies showed that continuous intervention with oral probiotics can significantly improve the progression of psoriasis and reduce the expression of inflammatory factors. The meta-analysis showed that the PASI between two groups was of no statistical significance (SMD 1.83 [-0.41, 4.07], P = 0.11 ). Meanwhile, probiotics may improve skin thickness (SMD -5.87 [-11.34, -0.41], P = 0.04 ) in animal model. Conclusion. Prebiotics may have a positive effect on alleviating the clinical symptoms of psoriasis, but a large sample of RCTs is still needed to support its therapeutic effect in psoriasis.

scholarly journals The efficacy and safety of intrathecal bupivacaine alone versus bupivacaine combined with magnesium sulfate in adults using spinal anesthesia: a meta-analysis of randomized controlled trials

2020 ◽  
Author(s):  
Mi-Zhou Wang ◽  
Rui Dong ◽  
Li-Na Jia ◽  
Deng-Bin Ai ◽  
Jian-Hua Zhang
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Magnesium Sulfate ◽  
Motor Block ◽  
Meta Analysis ◽  
Sensory Block ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Rescue Analgesia ◽  
Randomized Controlled

Abstract Background: Several studies have investigated the effects of intrathecal magnesium sulfate as an adjuvant for bupivacaine; however, their conclusions are inconsistent. Therefore, it is necessary to conduct a meta-analysis on this topic.Methods We searched Pubmed, EMBASE (OvidSP) and Cochrane Central Register of Controlled Trials (CENTRAL) for randomized controlled trials (RCTs) comparing the effect of intrathecal bupivacaine combined with magnesium sulfate versus bupivacaine alone in adults using spinal anesthesia.Results Eighteen studies that met our inclusion criteria were included in our analysis. We found that the addition of intrathecal magnesium sulfate to bupivacaine provided a longer duration of analgesia (SMD 0.99; 95% CI [0.45, 1.52], P = 0.0003, I2 = 93%), prolonged the duration of sensory block (MD=106.69; 95% CI, 60.93-152.45; P<0.00001), delayed the onset of sensory block (SMD 1.20; 95% CI [0.65, 1.75], P =<0.0001, I2 = 91%) and motor block (SMD 1.46; 95% CI [0.23, 2.69], P =0.02, I2 = 96%), decreased the requirement for rescue analgesia (SMD -0.81; 95% CI [-1.06, -0.56], P < 0.00001, I2 = 11%). For duration of motor block, and incidence of postoperative adverse events (such as nausea and vomiting, hypotension, bradycardia, pruritus, shivering and neurological deficit), no statistically differences were observed between the 2 groups.Conclusions Our meta-analysis demonstrated that intrathecal magnesium sulfate combined with bupivacaine prolongs the dusration of analgesia, without an impact on the adverse events. However, the quality of evidence was very low when using GRADE to assess it. Given adverse effects before use, more high-quality trials with large samples are required before magnesium sulfate is routinely used as a intrathecal adjunct.

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