Optimal dose of erenumab for preventive treatment of episodic migraine: a systematic review and meta-analysis

2021 ◽  
Vol 19 ◽  
Author(s):  
Yanbo Yang ◽  
Mingjia Chen ◽  
Da Wu ◽  
Yue Sun ◽  
Fan Jiang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Response Rate ◽  
Meta Analysis ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Cochrane Library ◽  
Migraine Treatment ◽  
Increased Risk ◽  
Significant Difference ◽  
Safety Outcomes

Background : Erenumab is a novel monoclonal calcitonin gene–related peptide receptor antibody that is used for the preventive treatment of migraine. Objectives : To evaluate overall safety and efficacy and dose-response relationship of erenumab in patients with episodic migraine and patients with prior migraine treatment failures. Methods : We searched randomized clinical trials on PUBMED, EMBASE database, and Cochrane Library database. A pair-wise meta-analysis and Bayesian network analysis were performed. Results : For efficacy outcomes, the network meta-analysis suggests that compared with erenumab 70 mg, participants received erenumab 140 mg reported significantly decreased monthly acute migraine-specific medication days(MSMD) and increased 50% response rate, and erenumab was most likely to be ranked first for monthly migraine days(MMD), MSMD and 50% response rate. For safety outcomes, the network meta-analysis has found no significant difference between the 70 mg group and the 140 mg group measured by adverse events and serious adverse events. For patients with ≥2 treatment failures, 140mg erenumab group, patients with ≥2 treatment failures reported significantly reduced MMD and MSMD, increased 50%, and 75% response rate, compared with placebo. For safety outcomes, no significant difference was found between 140 mg erenumab group and the placebo group. Conclusion : Erenumab was effective in patients with episodic migraine. 140 mg erenumab was associated with better efficacy outcomes without increased risk for developing adverse events compared with 70 mg erenumab, and 140 mg erenumab was effective in patients with prior migraine treatment failures.

Different Doses of Erenumab for Preventive Treatment of Episodic Migraine: A Systematic Review and Network Meta-Analysis

2020 ◽  
Author(s):  
Yanbo Yang ◽  
Mingjia Chen ◽  
Zilan Wang ◽  
Yue Sun ◽  
Fan Jiang ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Response Rate ◽  
Meta Analysis ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Cochrane Library ◽  
Migraine Treatment ◽  
Increased Risk ◽  
Significant Difference ◽  
Safety Outcomes

Abstract Background Erenumab is a novel monoclonal calcitonin gene–related peptide receptor antibody that is used for the preventive treatment of migraine.Objectives To evaluate overall safety and efficacy and dose-response relationship of erenumab in patients with episodic migraine and patients with prior migraine treatment failures.Methods We searched randomized clinical trials on PUBMED, EMBASE database, and Cochrane Library database. A pair-wise meta-analysis and Bayesian network analysis were performed.Results For efficacy outcomes, the network meta-analysis suggests that compared with erenumab 70 mg, participants received erenumab 140 mg reported significantly decreased MSMD and increased 50% response rate, and erenumab was most likely to be ranked first for MMD, MSMD and 50% response rate. For safety outcomes, the network meta-analysis has found no significant difference between the 70 mg group and the 140 mg group measured by AE and SAE. For patients with ≥2 treatment failures, 140mg erenumab group, patients with ≥2 treatment failures reported significantly reduced MMD and MSMD, increased 50%, and 75% response rate, compared with placebo. For safety outcomes, no significant difference was found between 140 mg erenumab group and the placebo group.Conclusion Erenumab was effective in patients with episodic migraine. 140 mg erenumab was associated with better efficacy outcomes without increased risk for developing adverse events compared with 70 mg erenumab, and 140 mg erenumab was effective in patients with prior migraine treatment failures.Registration number: CRD42020198985

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.

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

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.

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

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.

Assessment of the Ovarian Reserve by Serum Anti-Müllerian Hormone in Rheumatoid Arthritis Patients: A Systematic Review and Meta-Analysis

2021 ◽  
pp. 1-8
Author(s):  
Xian-hui Zhang ◽  
Ying-an Zhang ◽  
Xin Chen ◽  
Peng-yan Qiao ◽  
Li-yun Zhang
Keyword(s):  
Rheumatoid Arthritis ◽  
Ovarian Reserve ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Dmard Treatment ◽  
Standard Mean Difference ◽  
Increased Risk ◽  
Significant Difference ◽  
Newcastle Ottawa Scale ◽  
The Cochrane Library

<b><i>Background:</i></b> The ovarian reserve has been reported to be diminished in patients with rheumatoid arthritis. However, these results are still controversial. Anti-Müllerian hormone (AMH) is considered a reliable biomarker for the ovarian reserve. We thus performed a meta-analysis to evaluate the AMH levels and the effect of DMARDs on the ovarian reserve in rheumatoid arthritis patients. <b><i>Methods:</i></b> PubMed, EMBASE, the Cochrane Library, and 2 Chinese databases (CNKI and Wanfang database), up to September 2021, were searched for relevant studies. The Newcastle-Ottawa scale (NOS) was used to assess the quality of the included studies. Pooled standard mean difference (SMD) with 95% confidence intervals (CIs) were determined with the random-effects model. The heterogeneity was described by <i>I</i><sup><i>2</i></sup> statistic and <i>p</i> value from the Cochrane Q test. <b><i>Results:</i></b> Eight eligible studies (679 patients and 1,460 controls) were included in the meta-analysis. Compared with healthy control, the AMH levels in RA patients were significantly lower with the pooled SMD of −0.40 (95% CI: −0.66 to −0.14). However, in comparison of AMH with and without DMARD treatment, there was no significant difference with the pooled SMD of −0.1 (95% CI: −0.39 to 0.19). <b><i>Conclusion:</i></b> The results indicated that there was an increased risk of ovarian failure in RA patients and which is not related to DMARD treatment.

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

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.

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

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.

scholarly journals Effect of Early Intravenous Immunoglobulin Therapy in Kawasaki Disease: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 8 ◽  
Author(s):  
Fan Yan ◽  
Huayong Zhang ◽  
Ruihua Xiong ◽  
Xingfeng Cheng ◽  
Yang Chen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Kawasaki Disease ◽  
Intravenous Immunoglobulin ◽  
Meta Analysis ◽  
The United States ◽  
Cochrane Library ◽  
Ivig Treatment ◽  
Intravenous Immunoglobulin Therapy ◽  
Increased Risk ◽  
Significant Difference

Background: In the latest 2017 American Heart Association guidelines for Kawasaki disease (KD), there are no recommendations regarding the early administration of intravenous immunoglobulin (IVIG). Therefore, the purpose of this systematic review and meta-analysis was to investigate the effects of early IVIG therapy on KD.Methods: We searched databases including the PubMed, Medline, the Cochrane Library, and the Clinicaltrials.gov website until July 2019.Results: Fourteen studies involving a total of 70,396 patients were included. Early treatment with IVIG can lead to an increased risk of IVIG unresponsiveness [OR 2.24; 95% CI (1.76, 2.84); P = 0.000]. In contrast to the studies performed in Japan [OR 1.27; 95% CI (0.98, 1.64); P = 0.074] that found no significant difference in coronary artery lesions (CAL) development, studies conducted in China [OR 0.73; 95% CI (0.66, 0.80); P = 0.000] and the United States [OR 0.50; 95% CI (0.38, 0.66); P = 0.000] showed a reduced risk in the occurrence of CAL with early IVIG treatment.Conclusions: At present, the evidence does not support the treatment with IVIG in the early stage of the onset of KD. But, early IVIG treatment could be a protective factor against the development of CAL, which needs to be further clarified.

A Systematic Review and Meta-Analysis of Thalidomide in Patients with Previously Untreated Multiple Myeloma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3570-3570 ◽  
Author(s):  
Lisa Hicks ◽  
Adam Haynes ◽  
Donna E. Reece ◽  
Irwin Walker ◽  
Jordan A. Herst ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Relative Risk ◽  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Response Rate ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Number Needed To Treat ◽  
Vte Prophylaxis ◽  
American Society

Abstract Background: Multiple myeloma disproportionately affects the elderly and is currently an incurable malignancy. New therapies for myeloma, particularly oral therapies, are urgently needed. Objectives: To determine if thalidomide with or without other agents, improves response rate (≥ 50% reduction in monoclonal protein), survival, and/or progression in patients with previously untreated myeloma. To determine the frequency and significance of major adverse events associated with thalidomide in this setting. Methods: A literature search of Medline (1966–June 2006), Embase (1980–June 2006), the Cochrane Library, abstracts from the annual meetings of the American Society of Hematology (1999–2005) and the American Society of Oncology (1999–2006) was completed with a pre-specified search strategy. No language restrictions were applied. Randomized controlled trials of induction thalidomide (any dose, any duration) for adults with previously untreated multiple myeloma were included. Trials of exclusively maintenance therapy were excluded. Two reviewers independently extracted data. The methodological quality of selected trials was assessed and summarized. Weighted data was expressed as relative risk, risk difference, number needed to treat (NNT), and number needed to harm (NNH). A random-effects model was used. Results: Six eligible studies involving almost two thousand patients (N=1875) were identified and meta-analyzed. Two studies were published and four were reported in abstract form only. Five studies reported overall response rate (ORR); the four largest trials reported statistically significant improvements in ORR with the addition of thalidomide to standard therapy. The weighted relative risk of responding to a thalidomide-containing regimen versus control was 1.50 (95% CI 1.21 to 1.86). The NNT to achieve one additional response with thalidomide was 4 (95% CI 2.9 to 8.3). Two trials reported improvements in EFS/PFS. One trial reported an improvement in OS. The risk of VTE, peripheral neuropathy, and constipation was consistently elevated with thalidomide such that for every 50 patients treated with a thalidomide-containing-regimen, one could expect 12 to 13 additional patients to respond, 4 additional patients to develop VTE (NNH 12.5; 95% CI 8.3 to 20), 2 additional patients to develop peripheral neuropathy (NNH 25; 95% CI 16.7 to 50), and 4 additional patients to develop constipation (NNH14; 95% CI 10 to 25). In our analyses, prophylactic anticoagulation appeared to decrease, but not abolish, the risk of VTE with thalidomide. Conclusions: Thalidomide improves response rate and possibly progression free and overall survival in patients with previously untreated myeloma. It also increases the incidence of VTE, neuropathy, constipation and other adverse events. Further studies are required to confirm the survival advantage seen in one study, and to determine the optimum strategy for VTE prophylaxis.

scholarly journals Differential Dermatologic Adverse Events Associated With Checkpoint Inhibitor Monotherapy and Combination Therapy: A Meta-Analysis of Randomized Control Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Yang Ge ◽  
Huiyun Zhang ◽  
Nathaniel Weygant ◽  
Jiannan Yao
Keyword(s):  
Relative Risk ◽  
Combination Therapy ◽  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
High Grade ◽  
Treatment Regimens ◽  
Increased Risk ◽  
Significant Difference ◽  
Dermatologic Adverse Events

Background: As immune checkpoint inhibitors (ICIs) transition to the forefront of cancer treatment, a better understanding of immune related adverse events (IRAEs) is essential to promote safe clinical practice. Dermatologic adverse events are the most common IRAEs and can lead to drug withdrawal and decreased quality of life. This meta-analysis aimed to investigate the risk of the most prevalent dermatologic adverse events (pruritus and rash) among various ICI treatment regimens.Methods: A systematic search of electronic databases was performed to identify qualified randomized controlled trials (RCTs). Data for any grade and high grade pruritus and rash were extracted for meta-analysis. Two reviewers independently assessed methodological quality. The relative risk summary and 95% confidence interval were calculated.Results: 50 RCTs involving 29941 patients were analyzed. The risk of pruritus (2.15 and 4.21 relative risk respectively) and rash (1.61 and 3.89 relative risk respectively) developing from CTLA-4 or PD-1/-L1 inhibitor were increased compared to placebo, but this effect was not dose-dependent. PD-1/-L1 plus CTLA-4 inhibitor was associated with increased risk of pruritus (1.76 and 0.98 relative risk respectively) and rash (1.72 and 1.37 relative risk respectively) compared to either monotherapy. Compared with CTLA-4 inhibitor, PD-1/-L1 inhibitor had a significantly decreased risk of pruritus and rash in both monotherapy and combination therapy (0.65 and 0.29 relative risk respectively). No significant difference was found between PD-1/-L1 inhibitor combined with chemotherapy and PD-1/-L1 monotherapy in any grade and high grade rash (0.84 and 1.43 relative risk respectively). In subgroup analyses, PD-1 inhibitor was associated with reduced risk of pruritus and rash compared to PD-L1 inhibitor.Conclusion: Our meta-analysis demonstrates a better safety profile for PD-1/-L1 inhibitor compared to CTLA-4 inhibitor in terms of pruritus and rash among both monotherapy and multiple combination therapies. PD-L1 inhibitor may contribute to an increased risk of pruritus and rash compared to PD-1 inhibitor.

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