Dataset Information

Different dosage regimens of Eptinezumab for the treatment of migraine: a meta-analysis from randomized controlled trials.

ABSTRACT:

Background

Migraine is one of the most common neurological diseases around the world and calcitonin gene-related peptide (CGRP) plays an important role in its pathophysiology. Therefore, in the present study, we evaluated the efficacy of monoclonal antibodies blocking the CGRP ligand or receptor in episodic and chronic migraine.

Objective

The objective of our study is implementing a meta-analysis to systematically evaluate the efficacy and safety of eptinezumab for the treatment of migraine compared with placebo.

Method

We searched the Medline, Embase, Cochrane Library and Clinicaltrials.gov for randomized controlled trials (RCTs) which were performed to evaluate eptinezumab versus placebo for migraine up to September 2020. The data was assessed by Review Manager 5.3 software. The risk ratio (RR) and standard mean difference (SMD) were analyzed using dichotomous outcomes and continuous outcomes respectively with a random effect model.

Result

We collected 2739 patients from 4 RCTs: the primary endpoint of efficacy was the change from baseline to week 12 in mean monthly migraine days (MMDs). We found that eptinezumab (30?mg, 100?mg, 300?mg) led to a significant reduction in MMDs (P?=?0.0001,P?ConclusionsIn the present study, we found that eptinezumab is safe and has significant efficacy in the treatment of migraine, especially the dose of 300?mg.

SUBMITTER: Yan Z

PROVIDER: S-EPMC7937260 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Different dosage regimens of Eptinezumab for the treatment of migraine: a meta-analysis from randomized controlled trials.

Yan Zeya Z Xue Tao T Chen Shujun S Wu Xin X Yang Xingyu X Liu Guangjie G Gao Shan S Chen Zhouqing Z Wang Zhong Z

The journal of headache and pain 20210306 1

<h4>Background</h4>Migraine is one of the most common neurological diseases around the world and calcitonin gene-related peptide (CGRP) plays an important role in its pathophysiology. Therefore, in the present study, we evaluated the efficacy of monoclonal antibodies blocking the CGRP ligand or receptor in episodic and chronic migraine.<h4>Objective</h4>The objective of our study is implementing a meta-analysis to systematically evaluate the efficacy and safety of eptinezumab for the treatment o ...[more]

PMID: 33676408

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Project description:BACKGROUND:Intranasal lidocaine has been shown to be effective in treating patients with acute migraines; however, its efficacy is still controversial. In this study, we intend to assess the efficacy and safety of intranasal lidocaine compared with a placebo or an active comparator for the treatment of migraines. METHOD:PubMed, EMBASE, Cochrane library, and Scopus databases were searched from their inceptions to November 2018. Randomized controlled studies investigating the efficacy of intranasal lidocaine compared with a placebo or an active comparator were selected. Two reviewers independently extracted and synthesized data using a random-effects model. The primary outcome was pain intensity. The secondary outcomes were success rate, the need for rescue medicine, and relapse occurrences. We registered the study at PROSPERO with an ID of CRD42018116226. RESULTS:Six studies (n = 613) were eligible for the meta-analysis. Overall, the results revealed that the study population who was administered intranasal lidocaine had a lower pain intensity at 5 min (standardized mean difference (SMD) = -0.61; 95% CI = -1.04 to -0.19) and 15 min (SMD = -0.72; 95% CI = -1.14 to -0.19), had a higher success rate (RR = 3.55; 95% CI: 1.89 to 6.64) and a less frequent need for rescue medicine (RR = 0.51; 95% CI = 0.36 to 0.72) than the control group. These beneficial effects were not observed when an antiemetic was administered. Furthermore, intranasal lidocaine use had no significant influence on the relapse rate (RR = 0.89; 95% CI = 0.51-1.56), regardless of the use of antiemetics. Using lidocaine caused local irritation in up to 49.4% of the patients in one report but did not cause major adverse events. CONCLUSION:Intranasal lidocaine can be considered a useful option for patients with an acute migraine. It yields a high success rate, a low pain intensity, an infrequent need for rescue medicine, and tolerable adverse events. The administration of antiemetics is an important confounding factor.

Project description:BACKGROUND:Galcanezumab is a novel monoclonal antibody that target to calcitonin gene-related peptide (CGRP). It has been tested for the preventive treatment of migraine and episodic cluster headache by multiple randomized clinical trials (RCTs) and have been found to reduce headache frequency. METHODS:We systematically searched PubMed and Embase on Cochrane Central Register of Controlled Trials (CENTRAL) from the earliest date to August 1, 2019. Relative risk (RR) and weighted mean difference (WMD) were used to evaluate clinical outcomes. RESULTS:Seven studies were pooled with 3889 patients. Subcutaneous injection of Galcanezumab at 120?mg, 240?mg leads to a statistically significant response rate for the treatment of migraine compared with placebo (120?mg: RR?=?1.51; 95% CI, 1.33 to 1.70; P?<?0.001; 240?mg: RR?=?1.58; 95% CI, 1.43 to 1.76; P?<?0.001). Among them, 120?mg group has the same treatment efficacy with 240?mg group (50% response: RR?=?1.06; 95% CI, 0.92 to 1.22; P?=?0.425; 75% response: RR?=?1.07; 95% CI, 0.94 to 1.23; P?=?0.301; 100% response; RR?=?1.06; 95% CI, 0.81 to 1.37; P?=?0.682; MHD: RR?=?-?0.08; 95% CI, -?0.55 to -?0.40; P?=?0.748) while related to a lower risk for adverse events for the treatment of migraine (120?mg RR?=?1.06; 95% CI, 0.99 to 1.14; P?=?0.084; 240?mg: RR?=?1.17; 95% CI, 1.09 to 1.25; P?<?0.001). 300?mg per month galcanezumab is effective for the prevention of episodic cluster headache measured by at least 50% reduction of cluster headache frequency at week 3 (RR?=?1.36; 95% CI, 1.00-1.84; P?=?0.048). CONCLUSIONS:Use of galcanezumab is related to a significantly reduced monthly headache frequency compared with placebo for the treatment of migraine and episodic cluster headache, 120?mg has the same treatment efficacy with 240?mg group while related to a lower risk for adverse effects for the treatment of migraine. 300?mg per month galcanezumab is effective for the prevention of episodic cluster headache with no significantly increased adverse events.

Project description:BackgroundThe humanized anti-CGRP monoclonal antibody eptinezumab has been evaluated in five large-scale clinical trials conducted in patients with migraine. This integrated analysis was conducted to evaluate the comprehensive safety and tolerability of eptinezumab in patients with migraine across these studies.MethodsData were pooled from four randomized, double-blind, placebo-controlled studies and the first year of one open-label study.ResultsThe pooled population comprised 2867 adults with migraine: eptinezumab, n = 2076 (4797 infusions); placebo, n = 791 (1675 infusions). A total of 1137/2076 (54.8%) patients who received eptinezumab and 414/791 (52.3%) patients who received placebo experienced ≥1 treatment-emergent adverse event (TEAE); rates were similar across eptinezumab dose groups (10-1000 mg). For most patients with TEAEs, the events were mild or moderate in severity and considered unrelated to study drug by the investigators. Thirty infusion-site AEs occurred in 27/2076 (1.3%) patients who received eptinezumab and 7 in 7/791 (0.9%) patients who received placebo. Infusion-site AEs led to infusion interruption in 19/2076 (0.9%) and 5/791 (0.6%) patients in the eptinezumab and placebo groups, respectively. Nasopharyngitis occurred in ≥2% of patients in the eptinezumab 300-mg group and with an incidence of at least 2 percentage points greater than in the placebo group; however, in most patients (eptinezumab, 139/140; placebo 40/41), its occurrence was considered not related to study treatment. Adverse events coded to hypersensitivity occurred for 23/2076 (1.1%) patients treated with eptinezumab and no patients in the placebo group. If additional TEAE terms that could indicate hypersensitivity are considered (e.g., urticaria, flushing/hot flush, rash, and pruritus), hypersensitivity reactions in the two pivotal placebo-controlled phase 3 studies occurred in ≥2% of patients in the eptinezumab 100-mg and 300-mg groups, and the incidence was at least 2 percentage points greater in either of these groups than in the placebo group. Most hypersensitivity reactions were not serious and resolved with standard medical treatment or observation without treatment, usually within 1 day.ConclusionsIn adults with migraine, the intravenous administration of eptinezumab every 12 weeks demonstrated a favorable safety and tolerability profile.Trial registrationClinicalTrials.gov (Identifiers: NCT01772524 , NCT02275117 , NCT02559895 , NCT02974153 , NCT02985398 ).

Dataset Information

Different dosage regimens of Eptinezumab for the treatment of migraine: a meta-analysis from randomized controlled trials.

Background

Objective

Method

Result

Publications

Different dosage regimens of Eptinezumab for the treatment of migraine: a meta-analysis from randomized controlled trials.

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