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Galcanezumab for the Management of Migraine: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

ABSTRACT: Introduction Migraine is a frequent neurological condition manifested by several episodes of headache. Calcitonin gene-related peptide (CGRP) has been shown to play a key role in the pathophysiology of migraine. Galcanezumab is a monoclonal antibody that binds CGRP and inhibits its action, without affecting the CGRP receptor. The aim of this study is to carry out a systematic review and meta-analysis of all randomized placebo-controlled trials that evaluated the efficacy of galcanezumab (120 mg or 240 mg) for the management of migraine. Methods We screened four databases (PubMed, SCOPUS, Embase, and Cochrane Central) from inception to October 10, 2020. Studies meeting the following criteria were included: (i) Patients: individuals with migraine, (ii) Intervention: galcanezumab at a dose of 120 mg or 240 mg, (iii) Comparator: placebo, (iv) Outcomes: prespecified efficacy and safety outcomes, and (v) Study design: randomized placebo-controlled trials. Efficacy outcomes included change in migraine headache days (MHDs), change in MHDs with acute medication use, patient global impression of severity (PGI-S) score, migraine-specific quality of life role function-restrictive domain (MSQ RF-R) score, and migraine disability assessment (MIDAS) score. Safety outcomes included frequency of injection-site pain, nasopharyngitis, and upper respiratory tract infection (URTI). Moreover, we used the Cochrane Collaboration's risk of bias tool to assess the risk of bias of the included studies. Review Manager Software, version 5.4.1, was used for statistical analysis. Mean difference and risk ratio with 95% confidence interval were used to analyze continuous and dichotomous outcomes, respectively. We used the fixed-effects and random-effects models to analyze homogeneous and heterogeneous data, respectively. Results A total of six studies comprising 4,023 patients were included in this systematic review and meta-analysis. When compared to placebo, both doses of galcanezumab were highly effective in decreasing MHDs (p<0.001), reducing MHDs with acute medication use (p<0.001), and improving the PGI-S score (p<0.001). On the other hand, MSQ RF-R and MIDAS scores were significantly enhanced only in the 240-mg dose group (p<0.001). With regard to side effects, the rates of injection-site pain and nasopharyngitis did not substantially differ between galcanezumab (inclusive of 120 mg and 240 mg) and placebo groups. Nonetheless, when compared to placebo, galcanezumab 120 mg, but not galcanezumab 240 mg, substantially correlated with a higher rate of URTI. Conclusions Galcanezumab is clinically safe and efficient for the management of migraine, and the use of a higher dose increases its efficacy. Future research directions should be geared toward determining the optimal dose of galcanezumab in the management of patients with migraine. Moreover, head-to-head comparative studies between galcanezumab and other related anti-CGRP receptor monoclonal antibodies are warranted.

SUBMITTER: Abu-Zaid A

PROVIDER: S-EPMC7755678 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Galcanezumab for the Management of Migraine: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

Abu-Zaid Ahmed A AlBatati Saud K SK AlHossan Abdullah M AM AlMatrody Rayan A RA AlGzi Ayman A Al-Sharief Rayan A RA Alsobyani Faris M FM Almubarak Amena F AF Alatiyah Nadeen S NS

Cureus 20201122 11

Introduction Migraine is a frequent neurological condition manifested by several episodes of headache. Calcitonin gene-related peptide (CGRP) has been shown to play a key role in the pathophysiology of migraine. Galcanezumab is a monoclonal antibody that binds CGRP and inhibits its action, without affecting the CGRP receptor. The aim of this study is to carry out a systematic review and meta-analysis of all randomized placebo-controlled trials that evaluated the efficacy of galcanezumab (120 mg ...[more]

PMID: 33376635

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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:ObjectiveTo evaluate the efficacy and safety of galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, in the preventive treatment of chronic migraine.MethodsA phase 3, randomized, double-blind, placebo-controlled study of LY2951742 in patients with chronic migraine (Evaluation of Galcanezumab in the Prevention of Chronic Migraine [REGAIN]) was a phase 3 study with a 3-month double-blind, placebo-controlled treatment phase and a 9-month open-label extension. Eligible patients 18 to 65 years of age with chronic migraine were randomized 2:1:1 to monthly subcutaneous injections of placebo (n = 558), galcanezumab 120 mg (with a 240-mg loading dose, n = 278), or galcanezumab 240 mg (n = 277). The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days (MHDs) during the 3-month double-blind treatment phase.ResultsMean number of monthly MHDs at baseline was 19.4 for the total sample. Both galcanezumab dose groups demonstrated greater overall mean reduction in the number of monthly MHDs compared to placebo (placebo -2.7, galcanezumab 120 mg -4.8, galcanezumab 240 mg -4.6) (p < 0.001 for each dose compared to placebo). There were no clinically meaningful differences between galcanezumab doses and placebo on any safety or tolerability outcome except for a higher incidence of treatment-emergent injection-site reaction (p < 0.01), injection-site erythema (p < 0.001), injection-site pruritus (p < 0.01), and sinusitis (p < 0.05) in the galcanezumab 240-mg group relative to placebo.ConclusionsBoth doses of galcanezumab were superior to placebo in reducing the number of monthly MHDs. Galcanezumab appears efficacious, safe, and well tolerated for the preventive treatment of chronic migraine.Clinicaltrialsgov identifierNCT02614261.Classification of evidenceThis interventional study provides Class I evidence that galcanezumab is superior to placebo in the reduction of the number of monthly MHDs.

Project description:Background: Parkinson's disease (PD) is a debitlitating, chronic, progressive neurodegenerative disorder without modifying therapy. Here, we aimed to evaluate the available evidence of herbal medicine (HM) formulas for patients with PD according to randomized double-blind placebo-controlled clinical trials. Methods: HM formulas for PD were searched in eight main databases from their inception to February 2018. The methodological quality was assessed using Cochrane Collaboration risk of bias tool. Meta-analysis was performed using RevMan 5.3 software. Results: Fourteen trials with Seventeen comparisons comprising 1,311 patients were identified. Compared with placebo groups, HM paratherapy (n = 16 comparisons) showed significant better effects in the assessments of total Unified Parkinson's Disease Rating Scale (UPDRS) (WMD: -5.43, 95% CI:-8.01 to -2.86; P < 0.0001), UPDRS I (WMD: -0.30, 95% CI: -0.54 to -0.06; P = 0.02), UPDRS II (WMD: -2.21, 95% CI: -3.19 to -1.22; P < 0.0001), UPDRS III (WMD: -3.26, 95% CI:-4.36 to -2.16; P < 0.00001), Parkinson's Disease Quality of Life Questionnaire (p < 0.01) and Parkinson's Disease Questionnaire-39 (WMD: -7.65, 95% CI: -11.46 to -3.83; p < 0.0001), Non-motor Symptoms Questionnaire (p < 0.01) and Non-Motor Symptoms Scale (WMD: -9.19, 95% CI: -13.11 to -5.28; P < 0.00001), Parkinson's Disease Sleep Scale (WMD: 10.69, 95% CI: 8.86 to 12.53; P < 0.00001), and Hamilton depression rating scale (WMD: -5.87, 95% CI: -7.06 to -4.68; P < 0.00001). The efficiency of HM monotherapy (n = 1 comparison) was not superior to the placebo according to UPDRS II, UPDRS III and total UPDRS score in PD patients who never received levodopa treatment, all P > 0.05. HM formulas paratherapy were generally safe and well tolerated for PD patients (RR: 0.41, 95% CI: 0.21 to 0.80; P = 0.009). Conclusion: The findings of present study supported the complementary use of HM paratherapy for PD patients, whereas the question on the efficacy of HM monotherapy in alleviating PD symptoms is still open.

Project description:Gastrointestinal (GI) dysmotility is a common complication in acute, critically ill, postoperative, and chronic patients that may lead to impaired nutrient delivery, poor clinical, and patient-reported outcomes. Several pharmacological and nonpharmacological interventions to treat GI dysmotility were investigated in dozens of clinical studies. However, they often yielded conflicting results, at least in part, because various (nonstandardized) definitions of GI dysmotility were used and methodological quality of studies was poor. While a universally accepted definition of GI dysmotility is yet to be developed, a systematic analysis of data derived from double-blind placebo-controlled randomized trials may provide robust data on absolute and relative effectiveness of various interventions as the study outcome (GI motility) was assessed in the least biased manner.To systematically review data from double-blind placebo-controlled randomized trials to determine and compare the effectiveness of interventions that affect GI motility.Three electronic databases (MEDLINE, SCOPUS, and EMBASE) were searched. A random effects model was used for meta-analysis. The summary estimates were reported as mean difference (MD) with the corresponding 95% confidence interval (CI).A total of 38 double-blind placebo-controlled randomized trials involving 2371 patients were eligible for inclusion in the systematic review. These studies investigated a total of 20 different interventions, of which 6 interventions were meta-analyzed. Of them, the use of dopamine receptor antagonists (MD, -8.99; 95% CI, -17.72 to -0.27; P = 0.04) and macrolides (MD, -26.04; 95% CI, -51.25 to -0.82; P = 0.04) significantly improved GI motility compared with the placebo group. The use of botulism toxin significantly impaired GI motility compared with the placebo group (MD, 5.31; 95% CI, -0.04 to 10.67; P = 0.05). Other interventions (dietary factors, probiotics, hormones) did not affect GI motility.Based on the best available data and taking into account the safety profile of each class of intervention, dopamine receptor antagonists and macrolides significantly improve GI motility and are medications of choice in treating GI dysmotility.

Dataset Information

Galcanezumab for the Management of Migraine: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

Publications

Galcanezumab for the Management of Migraine: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

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