Bloodletting Therapy for Patients with Chronic Urticaria: A Systematic Review and Meta-Analysis

Background. Many trials have reported that bloodletting therapy is effective when treating chronic urticaria. There are currently no systematic reviews of bloodletting therapy for chronic urticaria. Objective. The aim of this review is to assess the effectiveness and safety of bloodletting therapy for chronic urticaria. Methods. A systematic review and meta-analysis of randomized controlled trials were performed. Disease activity control was assessed as the primary outcome. Response rate, recurrence rate, and adverse events were assessed as secondary outcomes. Results. Seven studies with 512 participants were included. One trial showed a significant difference between bloodletting therapy plus medicine and medicine alone in disease activity control (MD 0.67; 95% CI 0.03 to 1.31; p=0.04). Six trials (372 participants) showed a significant difference between bloodletting therapy and pharmacological medication in response rate (RR 1.10; 95% CI 0.97-1.26; P =0.15). Two studies (170 participants) showed a significant difference between bloodletting therapy plus pharmacological medication and pharmacological medication in response rate (RR 1.34; 95% CI 1.10-1.63; p=0.003). Two studies (126 participants) reported a statistically significant difference between bloodletting therapy and pharmacological medication in recurrence rate. No serious adverse events related to bloodletting therapy were reported. Conclusions. Bloodletting therapy might be an effective and safe treatment for chronic urticaria, but the evidence is scarce. More high quality trials are needed in the future.

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Racecadotril for acute diarrhoea in children: systematic review and meta-analyses

Archives of Disease in Childhood ◽

10.1136/archdischild-2015-309676 ◽

2015 ◽

Vol 101 (3) ◽

pp. 234-240 ◽

Cited By ~ 14

Author(s):

Morris Gordon ◽

Anthony Akobeng

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Methodological Quality ◽

Data Extraction ◽

Meta Analysis ◽

Acute Diarrhoea ◽

Risk Of Bias ◽

Duration Of Symptoms ◽

Duration Of Illness ◽

Significant Difference

ObjectiveRacecadotril is an antisecretory agent that can prevent fluid/electrolyte depletion from the bowel as a result of acute diarrhoea without affecting intestinal motility. An up-to-date systematic review is indicated to summarise the evidence on racecadotril for the treatment of acute diarrhoea in children.DesignA Cochrane format systematic review of randomised controlled trials (RCTs). Data extraction and assessment of methodological quality were performed independently by two reviewers. Methodological quality was assessed using the Cochrane risk of bias tool.PatientsChildren with acute diarrhoea, as defined by the primary studies.InterventionsRCTs comparing racecadotril with placebo or other interventions.Main outcome measursDuration of illness, stool output/volume and adverse events.ResultsSeven RCTs were included, five comparing racecadotril with placebo or no intervention, one with pectin/kaolin and one with loperamide. Moderate to high risk of bias was present in all studies. There was no significant difference in efficacy or adverse events between racecadotril and loperamide. A meta-analysis of three studies with 642 participants showed significantly shorter duration of symptoms with racecadotril compared with placebo (mean difference −53.48 h, 95% CI −65.64 to −41.33). A meta-analysis of five studies with 949 participants showed no significant difference in adverse events between racecadotril and placebo (risk ratio 0.99, 95% CI 0.73 to 1.34).ConclusionsThere is some evidence that racecadotril is more effective than placebo or no intervention in reducing the duration of illness and stool output in children with acute diarrhoea. However, the overall quality of the evidence is limited due to sparse data, heterogeneity and risk of bias. Racecadotril appears to be safe and well tolerated.

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Perioperative outcomes and adverse events of minimally invasive versus open posterior lumbar fusion: meta-analysis and systematic review

Journal of Neurosurgery Spine ◽

10.3171/2015.2.spine14973 ◽

2016 ◽

Vol 24 (3) ◽

pp. 416-427 ◽

Cited By ~ 87

Author(s):

Christina L. Goldstein ◽

Kevin Macwan ◽

Kala Sundararajan ◽

Y. Raja Rampersaud

Keyword(s):

Systematic Review ◽

Adverse Event ◽

Adverse Events ◽

Minimally Invasive ◽

Comparative Effectiveness ◽

Meta Analysis ◽

Perioperative Outcomes ◽

Estimated Blood Loss ◽

Significant Difference ◽

Patient Reported

OBJECT The objective of this study was to determine the clinical comparative effectiveness and adverse event rates of posterior minimally invasive surgery (MIS) compared with open transforaminal or posterior lumbar interbody fusion (TLIF/PLIF). METHODS A systematic review of the Medline, EMBASE, PubMed, Web of Science, and Cochrane databases was performed. A hand search of reference lists was conducted. Studies were reviewed by 2 independent assessors to identify randomized controlled trials (RCTs) or comparative cohort studies including at least 10 patients undergoing MIS or open TLIF/PLIF for degenerative lumbar spinal disorders and reporting at least 1 of the following: clinical outcome measure, perioperative clinical or process measure, radiographic outcome, or adverse events. Study quality was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) protocol. When appropriate, a meta-analysis of outcomes data was conducted. RESULTS The systematic review and reference list search identified 3301 articles, with 26 meeting study inclusion criteria. All studies, including 1 RCT, were of low or very low quality. No significant difference regarding age, sex, surgical levels, or diagnosis was identified between the 2 cohorts (856 patients in the MIS cohort, 806 patients in the open cohort). The meta-analysis revealed changes in the perioperative outcomes of mean estimated blood loss, time to ambulation, and length of stay favoring an MIS approach by 260 ml (p < 0.00001), 3.5 days (p = 0.0006), and 2.9 days (p < 0.00001), respectively. Operative time was not significantly different between the surgical techniques (p = 0.78). There was no significant difference in surgical adverse events (p = 0.97), but MIS cases were significantly less likely to experience medical adverse events (risk ratio [MIS vs open] = 0.39, 95% confidence interval 0.23–0.69, p = 0.001). No difference in nonunion (p = 0.97) or reoperation rates (p = 0.97) was observed. Mean Oswestry Disability Index scores were slightly better in the patients undergoing MIS (n = 346) versus open TLIF/PLIF (n = 346) at a median follow-up time of 24 months (mean difference [MIS – open] = 3.32, p = 0.001). CONCLUSIONS The result of this quantitative systematic review of clinical comparative effectiveness research examining MIS versus open TLIF/PLIF for degenerative lumbar pathology suggests equipoise in patient-reported clinical outcomes. Furthermore, a meta-analysis of adverse event data suggests equivalent rates of surgical complications with lower rates of medical complications in patients undergoing minimally invasive TLIF/PLIF compared with open surgery. The quality of the current comparative evidence is low to very low, with significant inherent bias.

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The Effectiveness and Safety of Acupuncture for Patients with Chronic Urticaria: A Systematic Review

BioMed Research International ◽

10.1155/2016/5191729 ◽

2016 ◽

Vol 2016 ◽

pp. 1-7 ◽

Cited By ~ 5

Author(s):

Qin Yao ◽

Shanshan Li ◽

Xiaoxu Liu ◽

Zongshi Qin ◽

Zhishun Liu

Keyword(s):

Systematic Review ◽

Relative Risk ◽

Chronic Urticaria ◽

Primary Outcome ◽

Meta Analysis ◽

Symptom Improvement ◽

Control Groups ◽

Level Of Evidence ◽

Randomized Controlled ◽

Significant Difference

Background. Acupuncture might have effectiveness in relieving the symptoms of chronic urticaria. There are currently no systematic reviews of acupuncture for chronic urticaria published in English.Objective. We conducted a systematic review to assess the effectiveness and safety of acupuncture for chronic urticaria.Methods. A systematic review and meta-analysis of randomized, controlled trials were performed. The primary outcome was global symptom improvement.Results. We included 6 studies with 406 participants. Three trials showed significant difference between acupuncture and drugs in global symptom improvement (relative risk 1.37; 95% CI 1.11–1.70;P=0.003). As an adjuvant to medication, acupuncture was also beneficial for global symptom improvement (relative risk 1.77; 95% CI 1.41–2.22;P<0.01). There were no severe adverse events related to acupuncture.Limitations. Some methodological limitations were observed. The overall risk of bias in the 6 included trials was high and all included RCTs were conducted in China and published in Chinese. Besides, the lack of proper control groups and the use of different rating methods and cut-offs in the included trials also made the evidence of this review limited.Conclusions. Acupuncture might be effective and safe for chronic urticaria in relieving symptoms, based on a low level of evidence. To draw a reliable conclusion, more high quality trials are needed in the future. This trial is registered with PROSPEROCRD42015015702.

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Repurposing of drugs for Covid-19: a systematic review and meta-analysis

10.1101/2020.06.07.20124677 ◽

2020 ◽

Cited By ~ 1

Author(s):

Pinky Kotecha ◽

Alexander Light ◽

Enrico Checcucci ◽

Daniele Amparore ◽

Cristian Fiori ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Adverse Events ◽

Clinical Improvement ◽

Case Reports ◽

Meta Analysis ◽

Case Series ◽

Cochrane Library ◽

Control Group ◽

Significant Difference

AbstractObjectiveThe aim of this systematic review is to evaluate the data currently available regarding the repurposing of different drugs for Covid-19 treatment. Participants with suspected or diagnosed Covid-19 will be included. The interventions being considered are drugs being repurposed, and comparators will include standard of care treatment or placebo.MethodsWe searched Ovid-MEDLINE, EMBASE, Cochrane library, clinical trial registration site in the UK(NIHR), Europe (clinicaltrialsregister.eu), US (ClinicalTrials.gov) and internationally (isrctn.com), and reviewed the reference lists of articles for eligible articles published up to April 22, 2020. All studies in English that evaluated the efficacy of the listed drugs were included. Cochrane RoB 2.0 and ROBINS-I tool were used to assess study quality. This systematic review adheres to the PRISMA guidelines. The protocol is available at PROSPERO (CRD42020180915).ResultsFrom 708 identified studies or clinical trials, 16 studies and 16 case reports met our eligibility criteria. Of these, 6 were randomized controlled trials (763 patients), 7 cohort studies (321 patients) and 3 case series (191 patients). Chloroquine (CQ) had a 100% discharge rate compared to 50% with lopinavir-ritonavir at day 14, however a trial has recommended against a high dosage due to cardiotoxic events. Hydroxychloroquine (HCQ) has shown no significant improvement in negative seroconversion rate which is also seen in our meta-analysis (p=0.68). Adverse events with HCQ have a significant difference compared to the control group (p=0.001). Lopinavir-ritonavir has shown no improvement in time to clinical improvement which is seen in our meta-analyses (p=0.1). Remdesivir has shown no significant improvement in time to clinical improvement but this trial had insufficient power.DiscussionDue to the paucity in evidence, it is difficult to establish the efficacy of these drugs in the treatment of Covid-19 as currently there is no significant clinical effectiveness of the repurposed drugs. Further large clinical trials are required to achieve more reliable findings. A risk-benefit analysis is required on an individual basis to weigh out the potential improvement in clinical outcome and viral load reduction compared to the risks of the adverse events. (1-16)

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Pectoral block versus paravertebral block: a systematic review, meta-analysis and trial sequential analysis

Regional Anesthesia and Pain Medicine ◽

10.1136/rapm-2020-101512 ◽

2020 ◽

Vol 45 (9) ◽

pp. 727-732

Author(s):

Zhaosheng Jin ◽

Thomas Durrands ◽

Ru Li ◽

Tong Joo Gan ◽

Jun Lin

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Postoperative Analgesia ◽

Meta Analysis ◽

Analgesic Efficacy ◽

Opioid Consumption ◽

Paravertebral Block ◽

Trial Sequential Analysis ◽

Rescue Analgesia ◽

Significant Difference

BackgroundPectoral (PECs) block was first described by Blanco et al for postoperative analgesia in breast surgery. It was proposed to be an easier and safer alternative to thoracic epidural or paravertebral block (PVB). In this systematic review and meta-analysis, we compare the perioperative analgesic efficacy and adverse events of PECs block and PVB.MethodsWe systematically searched PubMed, Central, EMBASE, CINAHL, Google Scholar, Web of Science citation index, US clinical trials register, Wanfang database, as well as recent conference abstracts, for clinical studies comparing the two techniques. Analgesic efficacy was assessed according to the time to first rescue analgesia and 24 hours opioid consumption. Adverse events from the trials were recorded and reported descriptively.ResultsThe literature search was last updated on 20 February 2020. We identified a total of 10 randomized controlled trials (RCTs) comparing PECs to PVB with 252 and 250 patients, respectively. There was no difference in 24 hours opioid consumption between PECs and PVB. There was no significant difference in the time to rescue analgesia between the two cohorts. The most common adverse event noted was postoperative nausea and vomiting). Trial sequence analysis indicate that further studies are unlikely to alter the conclusion regarding opioid requirement.ConclusionOur systematic review suggests that PECs and PVB are comparable in postoperative analgesia efficacy for mastectomy, and further studies are unlikely to alter the conclusion. The choice of technique should, therefore, be based on practitioner skill and institutional guidelines.PROSPERO registration numberCRD42020165137.

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Efficacy and safety of pharmacological cachexia interventions: systematic review and network meta-analysis

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2020-002601 ◽

2020 ◽

pp. bmjspcare-2020-002601

Author(s):

Manit Saeteaw ◽

Phitjira Sanguanboonyaphong ◽

Jukapun Yoodee ◽

Kaitlyn Craft ◽

Ratree Sawangjit ◽

...

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Meta Analysis ◽

Total Body Weight ◽

Megestrol Acetate ◽

High Dose ◽

Efficacy And Safety ◽

Pharmacological Interventions ◽

Serious Adverse Events ◽

Significant Difference

AimsRandomised controlled trials (RCTs) demonstrated benefits of pharmacological interventions for cachexia in improving weight and appetite. However, comparative efficacy and safety are not available. We conducted a systematic review and network meta-analysis (NMA) to evaluate the relative efficacy and safety of pharmacological interventions for cachexia.MethodsPubMed, EmBase, Cochrane, and ClinicalTrials.gov were searched for RCTs until October 2019. Key outcomes were total body weight (TBW) improvement, appetite (APP) score and serious adverse events. Two reviewers independently extracted data and assessed risk of bias. NMA was performed to estimate weight gain and APP score increase at 8 weeks, presented as mean difference (MD) or standardised MD with 95% CI.Results80 RCTs (10 579 patients) with 12 treatments were included. Majority is patients with cancer (7220). Compared with placebo, corticosteroids, high-dose megestrol acetate combination (Megace_H_Com) (≥400 mg/day), medroxyprogesterone, high-dose megestrol acetate (Megace_H) (≥400 mg/day), ghrelin mimetic and androgen analogues (Androgen) were significantly associated with MD of TBW of 6.45 (95% CI 2.45 to 10.45), 4.29 (95% CI 2.23 to 6.35), 3.18 (95% CI 0.94 to 5.41), 2.66 (95% CI 1.47 to 3.85), 1.73 (95% CI 0.27 to 3.20) and 1.50 (95% CI 0.56 to 2.44) kg. For appetite improvement, Megace_H_Com, Megace_H and Androgen significantly improved standardised APP score, compared with placebo. There is no significant difference in serious adverse events from all interventions compared with placebo.ConclusionsOur findings suggest that several pharmacological interventions have potential to offer benefits in treatment of cachexia especially Megace_H and short-term use corticosteroids. Nonetheless, high-quality comparative studies to compare safety and efficacy are warranted for better management of cachexia.

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DDRE-04. EFFECTIVENESS AND SAFETY OF OSIMERTINIB FOR PATIENTS WITH LEPTOMENINGEAL METASTASES FORM NON-SMALL CELL LUNG CANCER: A SYSTEMATIC REVIEW AND META-ANALYSIS

Neuro-Oncology ◽

10.1093/neuonc/noab196.288 ◽

2021 ◽

Vol 23 (Supplement_6) ◽

pp. vi75-vi75

Author(s):

Lei Wen ◽

Changguo Shan ◽

hui Wang ◽

yanying Yang ◽

Minting Ye ◽

...

Keyword(s):

Lung Cancer ◽

Systematic Review ◽

Adverse Events ◽

Response Rate ◽

Meta Analysis ◽

Objective Response ◽

Small Cell ◽

Leptomeningeal Metastases ◽

Small Cell Lung ◽

Grade 3

Abstract BACKGROUND the FLAURA study established Osimertinib to be the priority choice for the treatment of metastatic non-small cell lung cancer (NSCLC) harboring mutated epidermal growth factor receptor (EGFR). However, like many previous studies, the FLAURA study excluded patients with symptomatic CNS metastases. Hence, we performed a systematic review and meta-analyses of studies to assess the efficiency and safety of Osimertinib for the treatment of NSCLC with leptomeningeal metastases (LM). METHODS We included studies published between 2010 and 2021 that evaluated the efficacy and toxicity of Osimertinib in NSCLC patients with LM. We searched PubMed, Embase, and oncology meeting abstracts (ASCO, ESMO and WCLC). Primary outcomes were objective response rate (ORR), disease control rate (DCR), any grade 3/4 toxicity rate. We used the random-effects model to generate pooled estimates for proportions. Newcastle-Ottawa Scale (NOS) was used to assess the certainty in the evidence. RESULTS Twelve studies reporting on 367 patients were included in the meta-analysis. Most patients (≥90%) received Osimertinib as at least second line of treatment. The objective response rate was 42% (95% CI, 24%-59%; n = 184), and CNS disease control rate was 90% (95% CI, 85%-94%; n = 154). Intracranial progression free survival and overall survival ranged from 3.7 to 15.6 months, and 11.0 to 18.8 months, respectively. Adverse events were similar with previous studies and Common Terminology Criteria for Adverse Events (version 3.0) grade 3 or higher adverse event rates was acceptable. CONCLUSION This meta-analysis confirmed that for advanced NSCLC with LM harboring EGFR-TKI-sensitizing mutations, Osimertinib showed impressive antitumor activity and acceptable toxicity.

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Fecal Microbiota Transplantation as Therapy for Treatment of Active Ulcerative Colitis: A Systematic Review and Meta-Analysis

Gastroenterology Research and Practice ◽

10.1155/2021/6612970 ◽

2021 ◽

Vol 2021 ◽

pp. 1-13

Author(s):

Xiaolei Liu ◽

Yan Li ◽

Kaichun Wu ◽

Yongquan Shi ◽

Min Chen

Keyword(s):

Systematic Review ◽

Ulcerative Colitis ◽

Adverse Events ◽

Clinical Remission ◽

Fecal Microbiota Transplantation ◽

Meta Analysis ◽

Fecal Microbiota ◽

Serious Adverse Events ◽

Significant Difference ◽

Endoscopic Remission

Aim. Increasing evidence supports the role of the gut microbiota in the etiology of ulcerative colitis (UC). Fecal microbiota transplantation (FMT) is a highly effective treatment against recurrent Clostridium difficile infection; however, its efficacy in UC is still controversial. A systematic review and meta-analysis was conducted to evaluate the efficacy and safety of FMT for treatment of active UC. Methods. We searched Cochrane, Medline, Web of Science, and Embase from inception to February 2020. Randomized controlled trials (RCTs) recruiting adults with active UC, which compared FMT with controls, were eligible. The primary outcome was combined clinical remission with endoscopic remission/response. Secondary outcomes included clinical remission, endoscopic remission, and serious adverse events. Relative risk (RR) with 95% confidence interval (CI) is reported. Results. Five RCTs with 292 participants were eligible for inclusion. When data were pooled for all patients, FMT was associated with a higher combined clinical remission with endoscopic remission/response; the RR of combined outcome not achieving after FMT vs. control was 0.79 (95% CI 0.70-0.88). FMT delivered via lower gastrointestinal route was superior to upper gastrointestinal route with regard to combined clinical remission with endoscopic remission/response ( RR = 0.79 , 95% CI 0.70-0.89). FMT with pooled donor stool ( RR = 0.69 , 95% CI 0.56-0.85) and higher frequency of administration ( RR = 0.76 , 95% CI 0.62-0.93) may be more effective with regard to clinical remission. There was no statistically significant difference in serious adverse events with FMT compared with controls ( RR = 0.98 , 95% CI 0.93-1.03). Conclusion. FMT shows a promising perspective with comparable safety and favorable clinical efficacy for the treatment of active UC in the short term. However, further larger, more rigorously conducted RCTs of FMT in UC are still needed in order to resolve the controversial questions.

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Efficacy and Safety of CGRP Monoclonal Antibodies for the Prevention of Migraine Compared with Placebo: A Systematic Review and Meta-Analysis

10.21203/rs.3.rs-39329/v1 ◽

2020 ◽

Author(s):

Xiaojing Yi ◽

Yun Chen ◽

Kun Chen ◽

Mo Liu ◽

Jiale Yi ◽

...

Keyword(s):

Systematic Review ◽

Monoclonal Antibodies ◽

Adverse Events ◽

Injection Site ◽

Response Rate ◽

Meta Analysis ◽

Upper Respiratory Tract ◽

Efficacy And Safety ◽

Upper Respiratory ◽

Secondary Outcomes

Abstract Background: Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are a novel class of drugs for migraine that includes erenumab, fremanezumab, galcanezumab and eptinezumab. In clinical trials, CGRP mAbs have been reported to show good efficacy in the prevention of episodic migraines or chronic migraines. Our aim was to evaluate the efficacy and safety of CGRP monoclonal antibodies in this study.Methods: We systematically searched for randomized controlled trials in the PubMed, Embase, ClinicalTrials.gov, and Cochrane Library databases. The primary outcome was overall mean change from baseline to end of treatment in the number of monthly migraine headache days (MMHDs). The secondary outcomes included 50% response rate, in the number of monthly headache days (MHDs), in the number of monthly headache hours (MHHs), and in the number of monthly acute migraine-specific medication days (MSMDs). The safety outcomes were evaluated in terms of reported adverse events. Results: Eighteen studies including 11,099 patients were included in the meta-analysis. The meta-analysis showed that CGRP mAbs exhibited a significant benefit in reducing the number of MMHDs compared to placebo (Episodic migraine: Std. MD -0.42, 95% CI -0.47 to -0.36; Chronic migraine: Std. MD -0.28, 95% CI -0.35 to -0.21). Similarly, CGRP mAbs were superior to placebo in the secondary outcomes of 50% response rate, MHDs, MHHs, and MSMDs. With respect to safety, serious adverse events and withdrawal due to adverse events were not significantly associated with CGRP mAbs. Fremanezumab was associated with a significantly higher incidence of any adverse event compared with placebo (RR 1.10, 95% CI 1.03 to 1.17). Galcanezumab was associated with significantly higher treatment-emergent adverse events compared with placebo (RR 1.11, 95% CI 1.04 to 1.17). Constipation and injection site pain were significantly higher with erenumab than placebo. Injection site erythema and injection site induration were significantly higher with fremanezumab than placebo. Upper respiratory tract infection, injection site erythema, injection site pruritus and injection site reaction were significantly higher with galcanezumab than placebo. Conclusions: This study confirms that CGRP mAbs are effective as preventive treatments for episodic migraines and chronic migraines. Adverse reactions at the injection site were associated with erenumab, fremanezumab and galcanezumab therapy. Constipation was more common with erenumab. The risk of upper respiratory tract infection was higher with galcanezumab.Systematic review registration: Our PROSPERO protocol registration number: CRD42019125928. Registered 26 November 2019.

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The safety, tolerability and mortality reduction efficacy of remdesivir; based on randomized clinical trials, observational and case studies reported safety outcomes: an updated systematic review and meta-analysis

Therapeutic Advances in Drug Safety ◽

10.1177/20420986211042517 ◽

2021 ◽

Vol 12 ◽

pp. 204209862110425

Author(s):

Chenchula Santenna ◽

Kota Vidyasagar ◽

Krishna Chaitanya Amarneni ◽

Sai Nikhila Ghanta ◽

Balakrishnan Sadasivam ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Adverse Events ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Antiviral Drug ◽

Mortality Reduction ◽

Serious Adverse Events ◽

Significant Difference ◽

Grade 3

Introduction: Remdesivir, an experimental antiviral drug has shown to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), both in vitro and in vivo. The present systematic review and meta-analysis were performed to quantify the safety and tolerability of remdesivir, based on safety outcome findings from randomized controlled trials, observational studies and case reports of remdesivir in coronavirus disease 2019 (COVID-19) patients. Methods: We have performed a systematic search in the PubMed, Google Scholar and Cochrane Library using specific keywords such as ‘COVID-19’ OR ‘SARS CoV-2’ AND ‘Remdesivir’. The study endpoints include total adverse events (AEs), serious adverse events (SAEs), grade 3 and grade 4 AEs, mortality and drug tolerability. Statistical analysis was carried out by using Revman 5.4 software. Results: Total 15 studies were included for systematic review, but only 5 randomized clinical trials (RCTs) ( n = 13,622) were included for meta-analysis. Visual inspection of the forest plots for remdesivir 10-day versus placebo and remdesivir 10-day versus 5-day groups revealed that there is a significant difference in SAEs [10-day remdesivir versus control (odds ratio [OR] = 0.55, 0.40–0.74) p = 0.0001; I2 = 0%; 10-day remdesivir versus 5-day remdesivir (OR = 0.56, 0.38–0.84) p = 0.005; I2 = 13%]. In grade 4 AEs, there is a significant difference in 10-day remdesivir versus control (OR = 0.32, 0.19–0.54) p = 0.0001; I2 = 0%, but not in comparison to 5-day remdesivir (OR = 0.95, 0.59–1.54) p = 0.85; I2 = 0%. But there is no significant difference in grade 3 AEs [remdesivir 10 day versus control (OR = 0.81, 0.59–1.11) p = 0.19; I2 = 0%; 10-day remdesivir versus 5-day remdesivir (OR = 1.24, 0.86–1.80) p = 0.25; I2 = 0%], in total AEs [remdesivir 10 day versus control (OR = 1.07, 0.66–1.75) p = 0.77; I2 = 79%; remdesivir 10 day versus 5 day (OR = 1.08, 0.70–1.68) p = 0.73; I2 = 54%)], in mortality [10-day remdesivir versus control (OR = 0.93, 0.80–1.08) p = 0.32; I2 = 0%; 10-day remdesivir versus 5-day remdesivir (OR = 1.39, 0.73–2.62) p = 0.32; I2 = 0%)] and tolerability [remdesivir 10 day versus control (OR = 1.05, 0.51–2.18) p = 0.89; I2 = 65%, 10-day remdesivir versus 5-day remdesivir (OR = 0.86, 0.18–4.01) p = 0.85; I2 = 78%]. Discussion & Conclusion: Ten-day remdesivir was a safe antiviral agent but not tolerable over control in the hospitalized COVID-19 patients with a need of administration cautiousness for grade 3 AEs. There was no added benefit of 10- or 5-day remdesivir in reducing mortality over placebo. To avoid SAEs, we suggest for prior monitoring of liver function tests (LFT), renal function tests (RFT), complete blood count (CBC) and serum electrolytes for those with preexisting hepatic and renal impairments and patients receiving concomitant hepatotoxic or nephrotoxic drugs. Furthermore, a number of RCTs of remdesivir in COVID-19 patients are suggested. Plain Language Summary Ten-day remdesivir is a safe antiviral drug with common adverse events in comparison to placebo. The rate of serious adverse events and grade 3 adverse events were significantly lower in 10-day remdesivir in comparison to placebo/5-day remdesivir. There was no significant difference in the rate of tolerability and mortality reduction in 10-day remdesivir over placebo/5-day remdesivir. There were no new safety signals reported in vulnerable populations, paediatric, pregnant and lactating women.

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