Safety and efficacy of interleukin-6-receptor inhibitors in the treatment of neuromyelitis optica spectrum disorders: a meta-analysis

Abstract Background Interleukin-6-receptor inhibitors like Tocilizumab and Satralizumab are showing promising results in the treatment of Neuromyelitis Optica spectrum disorder (NMOSD). We aimed to investigate the efficacy and safety of various Interleukin-6-receptor inhibitors in the management of NMO/NMOSD. Methods PubMed, Embase, and The Cochrane Library were systematically searched for suitable studies. Change in Annualized Relapse Ratio (ARR), Change in Extended Disability Status Scale (EDSS) s, the proportion of relapse-free patients and proportion of patients with adverse events, including serious adverse events and mortality were the parameters considered for the meta-analysis for Tocilizumab. Mean difference (MD) with 95% CI was used to quantify the change in ARR and change in EDSS before and after treatment. A forest plot was prepared to indicate the efficacy and adverse effects outcomes. The results were compared with those of Satralizumab included in two trials. Results A total of nine studies with 202 patients were included in our study. Tocilizumab found a good proportion (76.95% CI: 0.61–0.91; p < 0.001) of relapse free patients at follow up. It also significantly reduced mean ARR (mean difference: -2.6, 95% CI: − 2.71 to − 1.68; p < 0.001) and but did not show significant difference in change in EDSS score (mean difference = − 0.79, 95% CI: − 1.89 to − 0.31; p = 0.16). Also, the toxicity profile of Tocilizumab was acceptable considering the proportions of patients with adverse events 56% (95% C.I.;0.27–0.85, I2 = 88.95%, p < 0.001), proportions of patients with serious adverse events 11% (95% C.I.; 0.05 to 0.17, I2 = 0%, p < 0.001) and zero treatment related deaths. SAkura studies for Satralizumab showed similar relapse free patients (70% to 80%) and reduction of ARR and EDSS from baseline. Some studies of Tocilizumab have shown to reduce pain and fatigue while trials of Satralizumab had non-significant findings. Conclusion Interleukin-6-receptor inhibitors therapy showed a promising result with good efficacy and acceptable adverse events profile for treatment of NMOSD.

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Safety and Efficacy of IL-6 Inhibitors in the Treatment of Neuromyelitis Optica Spectrum Disorders. A Meta-analysis

10.21203/rs.3.rs-577115/v1 ◽

2021 ◽

Author(s):

Sanjeev Kharel ◽

Suraj Shrestha ◽

Rajeev Ojha ◽

Neha Guragain ◽

Rakesh Ghimire

Keyword(s):

Adverse Events ◽

Neuromyelitis Optica ◽

Meta Analysis ◽

Subcutaneous Administration ◽

Mean Difference ◽

Cochrane Library ◽

Forest Plot ◽

Serious Adverse Events ◽

Relapse Risk ◽

Significant Difference

Abstract BackgroundInterleukin-6 (IL-6) inhibitors like Tocilizumab and Satralizumab are showing promising results in the treatment of Neuromyelitis Optica spectrum disorder (NMOSD). We aimed to investigate the efficacy and safety of various IL-6 inhibitors in the management of NMO/NMOSD.MethodsPubMed, Embase, and The Cochrane Library were systematically searched for suitable studies. Change in Annualized Relapse Ratio (ARR), Change in Extended Disability Status Scale (EDSS) s, the proportion of relapse-free patients, on trial relapse risk, and proportion of patients with adverse events, including serious adverse events and mortality were the parameters considered for the meta-analysis. Mean difference (MD) with 95% CI was used to quantify the change in ARR and change in EDSS-before and after treatment. While pooled risk ratio between the intervention group and placebo group was used in Randomized Controlled Trial (RCTs). A forest plot was prepared to indicate the efficacy outcomes.Results A total of nine studies with 202 patients were included in our meta-analysis. IL-6 inhibitors found a good proportion (75%,95% CI: 0.62–0.89; p<0.001) of relapse free patients at follow up. It also significantly reduced mean ARR (mean difference: -2.6 95% CI: -2.71 to -1.68; p<0.001) and on trial relapse risk (RR: 0.46; 95% CI: 0.32‐0.66; P< 0.001) but did not show significant difference in change in EDSS score (mean difference=-0.79, 95% CI: -1.89 to -0.31; p=0.16). Also, the toxicity profile of IL-6 inhibitors was acceptable considering the proportions of patients with adverse events (72%, 95% C.I.;0.59-0.84, I2=85.29%, p<0.001), proportions of patients with serious adverse events (18%;95% C.I.; -3.68 to 4.04, I2=0%, p=0.93) and zero treatment related deaths. In subgroup analysis, we found subcutaneous administration to be superior (81%;95% CI:0.74-0.82) than intravenous route (67%; 95% CI:0.67-0.89) in relapse free maintenance.ConclusionIL-6 inhibitor therapy showed significant benefits in reducing mean ARR, relapse risk and increasing the number of relapse-free patients with acceptable adverse events profile.

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Efficacy and Safety of PEGPH20 in Pancreatic Cancer: A Systematic Review and Meta-Analysis

Current Cancer Therapy Reviews ◽

10.2174/1573394717666210616152341 ◽

2021 ◽

Vol 17 ◽

Author(s):

Vinod Solipuram ◽

Harish Gopalakrishna ◽

Gayatri Naira ◽

Akhila Mohan

Keyword(s):

Pancreatic Cancer ◽

Placebo Group ◽

Febrile Neutropenia ◽

Adverse Events ◽

Meta Analysis ◽

Progression Free Survival ◽

Cochrane Library ◽

Thromboembolic Events ◽

Serious Adverse Events ◽

Significant Difference

Introduction: Pancreatic cancer is an aggressive tumor that had an estimated 57,600 new cases and 47,050 deaths in 2020 in the US alone. Recent studies have targeted tumor microenvironment (TME) for better delivery of systemic chemotherapy like PEGPH20, which degrades hyaluronic acid in the extracellular matrix (ECM). A meta-analysis of these Randomized controlled trials (RCTs) to test the efficacy of PEGPH20 was performed. Methods: A systematic search was performed using PubMed, Embase, and Cochrane library without language limitations from inception to July 30, 2020. A total of 59 articles was identified, and 3 RCTs were included in the final analysis. The primary outcome was progression-free survival (PFS), and secondary outcomes were overall survival (OS), deaths from adverse events, thromboembolic events, serious adverse events (SAE), and febrile neutropenia. Results: There was no statistically significant improvement in PFS (HR= 0.94; 95%CI (0.79, 1.11)) in the PEGPH20 group when compared to the standard treatment/placebo group. There was no significant difference among OS (HR= 0.99, 95%CI (0.83, 1.17), deaths from adverse events (RR=0.97; 95%CI (0.54, 1.73)), thromboembolic events (RR= 1.49; 95%CI (0.92, 2.44)), and febrile neutropenia (RR= 0.88; 95%CI (0.45, 1.72), however, there was statistically significant increase in SAE (RR = 1.59; 95%CI (1.01, 2.52) in the PEGPH20 group compared to the placebo group. Conclusion: This meta-analysis showed that PEGPH20 did not improve the PFS or OS. Moreover, there is an increased incidence of serious adverse events with the use of PEGPH20 compared to standard therapies.

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529. Systematic Review and Meta-Analysis of Ivermectin Safety Profile in COVID-19 Trials

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.728 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S365-S365

Author(s):

Hannah Wentzel ◽

Junzheng Wang ◽

Abbienaya Dayanamby ◽

Victoria Pilkington ◽

Jacob Levi ◽

...

Keyword(s):

Adverse Events ◽

Day Treatment ◽

Meta Analysis ◽

Safety Data ◽

Adverse Event Reporting ◽

Forest Plot ◽

Serious Adverse Events ◽

Treatment Trials ◽

Significant Difference

Abstract Background There is a continued and pressing need for safe and effective treatment of COVID-19. Significant survival benefits have been shown by dexamethasone, tocilizumab and sarilumab, however they are only recommended in hospitalised COVID-19 patients. Ivermectin is a well-established and readily available antiparasitic drug which may be suitable for treatment in mild and moderate disease stages. It recently demonstrated anti-viral properties in vitro and now over 80 clinical trials have been registered worldwide to test its effectiveness in COVID-19 patients. This meta-analysis aims to collect data on adverse events reported in new COVID-19 treatment trials for the use of ivermectin as a repurposed medication. Methods Data was extracted from randomised trials of COVID-19 treatment trials identified through systematic searches of PUBMED, EMBASE, MedRxiv and trial registries. The primary outcome of this meta-analysis is the frequency of adverse events. Key safety events included serious, gastrointestinal, neurological, cardiovascular and dermatological adverse events. Results Overall, 18 trials investigating ivermectin for COVID-19 in a total of 2496 participants reported safety data and were included. There was no significant difference in the proportion of all adverse events between ivermectin and the comparator. There were 371/1261 (29%) adverse events recorded in the ivermectin containing arms and 376/1284 (29%) in the control arms (RR 1.02 [95% CI 0.77 - 1.34]; p = 0.91). There was no significant difference in the rate of serious adverse events across treatment arms (RR 1.95 [95% CI 0.75 - 5.11]; p = 0.18). No significant differences between ivermectin and the control were seen across different subcategories of adverse events. Figure 1 shows a summary of the results for all adverse events. Forest plot comparing ivermectin and the control for all adverse events in COVID-19 trials, subdivided into single-day dosing trials and multi-day dosing trials. Conclusion The results of recent COVID-19 trials show that overall, ivermectin is safe and well-tolerated. No significant difference in adverse event reporting was found across all subgroups in single and multi-day treatment regimens for the studies analysed. Safety reporting methodologies often varied across trials. Future and ongoing trials should be encouraged to collect and monitor safety data systematically. Disclosures All Authors: No reported disclosures

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Assessment of the effect of vacuum-formed retainers and Hawley retainers on periodontal health: A systematic review and meta-analysis

PLoS ONE ◽

10.1371/journal.pone.0253968 ◽

2021 ◽

Vol 16 (7) ◽

pp. e0253968

Author(s):

Bowen Li ◽

Yifeng Xu ◽

Cailian Lu ◽

Zhenheng Wei ◽

Yongyue Li ◽

...

Keyword(s):

Meta Analysis ◽

Grey Literature ◽

Mean Difference ◽

Cochrane Library ◽

Periodontal Health ◽

Probing Depth ◽

Significant Difference ◽

Orthodontic Patients ◽

The Cochrane Library ◽

Sulcus Probing Depth

Background Recently, increasing attention has been paid to the periodontal health of orthodontic patients in the maintenance stage in clinical practice. The focus of this meta-analysis was to compare the effects of vacuum-formed retainers (VFR) and Hawley retainers (HR) on periodontal health, in order to provide a reference for clinical selection. Methods From the establishment of the database until November 2020, a large number of databases were searched to find relevant randomized control trials, including the Cochrane Library databases, Embase, PubMed, Medline via Ovi, Web of Science, Scopus, Grey Literature in Europe, Google Scholar and CNKI. Related literature was manually searched and included in the analysis. Two researchers screened the literature according to relevant criteria. The size of the effect was determined using RevMan5.3 software, and the mean difference and 95% confidence intervals (CI) were used to estimate the results using a random effects model. Results This meta-analysis included six randomized controlled trials involving 304 patients. The results of the meta-analysis showed that there was no statistical difference in sulcus probing depth status between the VFR group and the HR group, including at 1, 3, and 6 months. Compared with the VFR group, the HR group showed a lower gingival index at 1 month (mean difference = 0.12, 95%CI: 0.06 to 0.19) and 3 months (mean difference = 0.11, 95%CI: 0.06 to 0.17), while there was no statistically significant difference at 6 months (mean difference = 0.10, 95%CI: -0.07 to 0.27). The plaque index of the HR group also showed a good state at 1 month (mean difference = 0.06, 95%CI: 0.01 to 0.12), 3 months (mean difference = 0.12, 95%CI: 0.08 to 0.16), and 6 months (mean difference = 0.19, 95%CI: 0.09 to 0.29). Subgroup analysis of PLI showed that when all teeth were measured, PLI status was lower in the HR group at 6 months (mean difference = 0.32, 95%CI: 0.18 to 0.46). PLI status was also low for the other teeth group (mean difference = 0.15, 95%CI: 0.08 to 0.22). Conclusion Our meta-analysis showed that patients using the Hawley retainer had better periodontal health compared with those using vacuum-formed retainers. However, more research is needed to look at the periodontal health of patients using these two retainers.

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The Relationship between Use of Low Molecular Weight Heparin during Pregnancy and Risk of Peripartum Adverse Events: A Meta-Analysis

Annals of Hematology & Oncology ◽

10.26420/annhematoloncol.2021.1372 ◽

2021 ◽

Vol 8 (11) ◽

Author(s):

Xiaorong Y ◽

◽

Shan L ◽

Shengji S ◽

Tao S ◽

...

Keyword(s):

Molecular Weight ◽

Adverse Events ◽

Pregnant Women ◽

Low Molecular Weight Heparin ◽

Meta Analysis ◽

Cochrane Library ◽

Premature Delivery ◽

Low Molecular Weight ◽

Significant Difference ◽

Fetal Complications

Introduction: To summarize the trials investigated on relationship between low molecular weight heparin use during pregnancy and peripartum adverse events. Meta-analysis was performed to evaluate the effect of Low Molecular Weight Heparin (LMWH) on maternal and fetal complications. Methods: Electronic research was performed in Cochrane Library, MEDLINE and EMBASE through October 2020. The primary outcome was the incidence of maternal and fetal complications during peripartum period. RevMan 5.3 was used for data analysis. Results: 11 articles were finally included. Meta-analysis showed there was no significant difference in abortion, premature delivery, stillbirth, preeclampsia and postpartum hemorrhage events between pregnant women who used LMWH and those who not. Conclusion: Using LMWH in pregnant women does not increase pregnancy related maternal and fetal complications.

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Comparison between Ologen implant and Mitomycin C in trabeculectomy: A Systematic Review and Meta-Analysis

10.21203/rs.2.10619/v1 ◽

2019 ◽

Author(s):

Xiaoyan Liu ◽

Yali Du ◽

Min Lei ◽

Leyi Zhuang ◽

Peng Lv

Keyword(s):

Adverse Events ◽

Success Rate ◽

Data Extraction ◽

Meta Analysis ◽

Collagen Matrix ◽

Current Evidence ◽

Cochrane Library ◽

Significant Difference ◽

Mean Differences ◽

Alternative Choice

Abstract Objective To evaluate the effectiveness and safety of the biodegradable collagen matrix (Ologen) implant in trabeculectomy. Research design and methods We searched Pubmed, Cochrane library, Embase and Web of Science databases to find studies that met our pre-stated inclusion criteria. Reference lists of retrieved articles were also reviewed. The search was finished by February 2019. Study selection, data extraction, quality assessment, and data analyses were performed according to the Cochrane standards. Either a fixed or a random-effects model was used to calculate the overall combined risk estimates. The efficacy measures were the weighted mean differences (WMDs) for the intraocular pressure reduction (IOPR) and the glaucoma medications reduction, the odds ratio (OR) for the success rate and adverse events. Results Fifteen randomized controlled trials involved 682 eyes were included in the meta-analysis. There were no statistically differences between two groups in the IOPR at any time postoperatively. The MD of the IOPR was [MD= -0.45,95% Confidence Interval (CI), (-2.36,1.46), P=0.65] at one day, [MD= -0.82,95% CI, (-1.97, 0.33), P=0.16] at one week, [MD= -1.33, 95% CI,(-3.12, 0.47), P=0.15] at one month, [MD= 0.11,95% CI, (-1.87, 2.08), P=0.92] at three months, [MD= -0.60,95% CI, (-2.27, 1.06), P=0.48] at six months, [MD= -0.33,95% CI, (-1.99, 1.32), P=0.69] at one year, [MD= -0.13,95% CI, (-1.90, 1.65), P=0.89] at two years, [MD= 2.54,95% CI, (-2.83, 7.90), P=0.35] at three years, [MD= 3.04,95% CI, (-3.95, 10.03), P=0.39] at five years. There was no statistically significant difference between the Ologen groups and MMC groups concerned the complete success rate [OR=1.19, 95%CI, (0.83, 1.71), P=0.35]. With regard to the adverse events, no obvirously significance was observed. Seven studies reported the change of antiglaucoma medications. We found that the change of antiglaucoma medications is higher in MMC groups than that in Ologen groups [MD=-0.18, 95%CI, (-0.33, -0.03), P=0.02]. There is no significant difference in complications between the two groups. Conclusions From the current evidence, Ologen may be an alternative choice for trabeculectomy when considering the efficacy and safety. However, MMC might be the preferred choice concerned cost-effectiveness.

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Safety and Efficacy of Fremanezumab for the Prevention of Migraine: a Meta-analysis from Random Clinical Trails

10.21203/rs.2.22379/v1 ◽

2020 ◽

Cited By ~ 1

Author(s):

Bixi Gao ◽

Nan Sun ◽

Yanbo Yang ◽

Yue Sun ◽

Mingjia Chen ◽

...

Keyword(s):

Adverse Events ◽

Neurological Diseases ◽

Meta Analysis ◽

Cochrane Library ◽

Serious Adverse Events ◽

Safety And Efficacy ◽

Therapeutic Drugs ◽

Primary Endpoints ◽

Calcitonin Gene ◽

Clinical Trails

Abstract Background Fremanezumab (TEV-48125) is a fully humanized immunoglobulin G isotype 2a selective monoclonal antibody that potently binds to calcitonin gene-related peptide (CGRP). It is one of novel therapeutic drugs for the prevention of migraine, which is one of the most common neurological diseases worldwide. Several clinical trails have been conducted to investigate the safety and efficacy of fremanezumab, but there is no systematic review of existing literature has been performed. Hence, we performed a meta-analysis to investigate the efficacy and safety of fremanezumab for prevention of migraine. Method Pubmed (MEDLINE), Embase, and Cochrane Library were searched from January 2001 to August 2019 for randomized controlled trials (RCTs). Five RCTs with 3379 patients were finally included in our study. Result We pooled 3379 patients from 5 RCTs, the primary endpoints were mean monthly migraine and headache days, baseline to week 12. We found that fremanezumab led to a significant reduction in migraine days (P < 0.0001) and headache days (P < 0.0001) during 12 weeks compared with placebo. In addition, after using fremanezumab, the risk of at least one adverse event (P=0.001) or related to the trail regimen (P=0.0005) significantly increase compared with placebo. Conclusions Fremanezumab has good efficacy for the prevention of migraine. The administration of fremanezumab can cause some mild adverse events but not serious adverse events.

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The Effectiveness and Safety of Thunder Fire Moxibustion for Treating Allergic Rhinitis: A PRISMA Compliant Systematic Review and Meta-Analysis

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/6760436 ◽

2020 ◽

Vol 2020 ◽

pp. 1-13

Author(s):

Ting Yuan ◽

Jun Xiong ◽

Jun Yang ◽

Xue Wang ◽

Yunfeng Jiang ◽

...

Keyword(s):

Allergic Rhinitis ◽

Adverse Events ◽

Assessment Tool ◽

Total Effective Rate ◽

Meta Analysis ◽

Effective Rate ◽

Cochrane Library ◽

Level Of Evidence ◽

Randomized Controlled ◽

Significant Difference

Background. Allergic rhinitis (AR) is a noninfectious inflammatory disease caused by allergic individuals exposed to allergens. Western medicine therapy for treating AR causes obvious adverse events, while thunder fire moxibustion (TFM) is known as a safe and effective treatment for AR. Therefore, we conducted this meta-analysis to evaluate the effectiveness and safety of TFM for treating AR. Methods. PubMed, Web of Science, Embase, the Cochrane Library, CNKI, WanFang, VIP, and CBM from inception to April 5, 2020, were searched without any language restriction. Reviewers identified studies, extracted data, and assessed the quality, independently. The primary outcomes were the total effective rate and the TNSS. The secondary outcomes included TNNSS, RQLQ, VAS, serum IgE, IgA, or IgG level, and adverse events. Randomized controlled trials (RCTs) were collected; methodological quality was evaluated using the Cochrane risk of bias assessment tool (RoB), and the level of evidence was rated using the GRADE approach. Meta-analysis was performed using the RevMan5.3.0 software. Results. A total of 18 RCTs were included, including 1600 patients. The results of this meta-analysis showed a statistically significant effect in a total effective rate of T = TFM (RR = 1.07; 95% CI [1.03, 1.12]; P=0.45; I2 = 0%) and T = TFM + other treatments (RR = 1.18; 95% CI [1.11, 1.25]; P=0.03; I2 = 53%). In addition, TFM intervention also showed significant difference in total symptom score (T = TFM + other treatments) (MD = −1.42; 95% CI [−1.55, −1.29]; P=0.03; I2 = 60%) in patients with AR. Conclusion. Existing evidence shows that TFM is safe and effective for AR. Due to the universal low quality of the eligible trials and low evidence level, we should draw our conclusions with caution. Therefore, clinical researchers should carry out more large-sample, multicentre, high-quality randomized controlled clinical trials in the future to verify the clinical efficacy of TFM in treating AR.

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Serotonin–norepinephrine reuptake inhibitors for the prevention of migraine and vestibular migraine: a systematic review and meta-analysis

Regional Anesthesia and Pain Medicine ◽

10.1136/rapm-2019-101207 ◽

2020 ◽

Vol 45 (5) ◽

pp. 323-330 ◽

Cited By ~ 4

Author(s):

Fengzhi Wang ◽

Jiaoqi Wang ◽

Yumeng Cao ◽

Zhongxin Xu

Keyword(s):

Weighted Mean Difference ◽

Meta Analysis ◽

Mean Difference ◽

Vestibular Migraine ◽

Cochrane Library ◽

Severity Scores ◽

Significant Difference ◽

Norepinephrine Reuptake ◽

Better Than

Background and objectivesThe role of serotonin–norepinephrine reuptake inhibitors (SNRIs) in migraine prophylaxis has not been completely established. Current treatments for vestibular migraine (VM) are based on scarce evidence. We aimed to perform an updated review focusing on the efficacy and tolerability of SNRIs for migraine and VM prevention.MethodsWe searched the PubMed, Web of Science, and Cochrane Library databases for relevant studies. The primary outcome was migraine frequency. In the case of VM, the Dizziness Handicap Inventory (DHI) scores and Vertigo Severity Scores (VSSs) were extracted.ResultsSix randomized controlled trials involving 418 patients were analyzed. Patients receiving SNRIs had fewer migraine days than those receiving a placebo (standardized mean difference −0.38, 95% CI −0.76 to −0.01, p=0.04). The effects of SNRIs and other active drugs were comparable. In patients with VM, venlafaxine had a significant advantage over other active drugs in decreasing the VSS (weighted mean difference (MD) −1.45, 95% CI −2.11 to −0.78, p<0.0001) and the emotional domain score of the DHI (MD −2.64, 95% CI −4.97 to −0.31, p=0.03). We found no significant difference in the rate of withdrawals due to any reason or withdrawals due to side effects between SNRIs and active drugs and between SNRIs and a placebo.ConclusionsSNRIs were clinically safe and effective for migraine and VM prophylaxis, were better than a placebo, and not inferior to other active drugs. SNRIs may be a preferable choice for patients with VM with psychiatric disorders.

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A Systematic Review and Meta-Analysis of Therapeutic Efficacy and Safety of Alirocumab and Evolocumab on Familial Hypercholesterolemia

BioMed Research International ◽

10.1155/2021/8032978 ◽

2021 ◽

Vol 2021 ◽

pp. 1-16

Author(s):

Xiaoyue Ge ◽

Tiantian Zhu ◽

Hao Zeng ◽

Xin Yu ◽

Juan Li ◽

...

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Familial Hypercholesterolemia ◽

Meta Analysis ◽

Density Lipoprotein ◽

Apolipoprotein A1 ◽

Cochrane Library ◽

Efficacy And Safety ◽

Apo B ◽

Significant Difference

Objectives. The aim of this study was to provide the first study to systematically analyze the efficacy and safety of PCSK9-mAbs in the treatment of familial hypercholesterolemia (FH). Methods. A computer was used to search the electronic Cochrane Library, PubMed/MEDLINE, and Embase databases for clinical trials using the following search terms: “AMG 145”, “evolocumab”, “SAR236553/REGN727”, “alirocumab”, “RG7652”, “LY3015014”, “RN316/bococizumab”, “PCSK9”, and “familial hypercholesterolemia” up to November 2020. Study quality was assessed with the Cochrane Collaboration’s tool, and publication bias was evaluated by a contour-enhanced funnel plot and the Harbord modification of the Egger test. After obtaining the data, a meta-analysis was performed using R software, version 4.0.3. Results. A meta-analysis was performed on 7 clinical trials (926 total patients). The results showed that PCSK9-mAbs reduced the LDL-C level by the greatest margin, WMD −49.14%, 95% CI: −55.81 to −42.47%, on FH versus control groups. PCSK9-mAbs also significantly reduced lipoprotein (a) (Lp (a)), total cholesterol (TC), triglycerides (TG), apolipoprotein-B (Apo-B), and non-high-density lipoprotein cholesterol (non-HDL-C) levels and increased HDL-C and apolipoprotein-A1 (Apo-A1) levels of beneficial lipoproteins. Moreover, no significant difference was found between PCSK9-mAbs treatment and placebo in common adverse events, serious events, and laboratory adverse events. Conclusion. PCSK9-mAbs significantly decreased LDL-C and other lipid levels with satisfactory safety and tolerability in FH treatment.

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