Myocardial infarction associated with erenumab: A case report

Perino, Justine; Corand, Virginie; Laurent, Elise; Miremont-Salamé, Ghada; Pariente, Antoine; Colas, Jean-Laurent; Couffinhal, Thierry; Salvo, Francesco

doi:10.1002/phar.2706

Cited by 15 publications

(4 citation statements)

References 17 publications

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“…However, it should be acknowledged that these randomized-controlled trials had strict inclusion criteria and thus findings cannot be generalized to the general population. We must continue to rely on post-marketing surveillance and realworld observations to provide new insights into the safety of erenumab in a wider patient population [27,29,30].…”

Section: Discussionmentioning

confidence: 99%

Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials

et al. 2022

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Background Erenumab, a fully human monoclonal antibody that targets the calcitonin gene-related peptide receptor, has demonstrated efficacy and safety in the prevention of episodic and chronic migraine. There exists an unmet need to establish the safety of erenumab in older individuals, in view of existing multiple comorbidities, polypharmacy, and age-related physiological changes. This pooled analysis of five large migraine-prevention studies examined the safety of erenumab stratified across age groups, particularly in older populations. Methods Pooled and age-stratified analysis of safety data from the 12-week double-blind treatment phase (DBTP) of five randomized, placebo-controlled Phase 2 and 3 studies of erenumab in participants with episodic or chronic migraine across the age groups < 40 years, 40–49 years, 50–59 years, and ≥ 60 years was completed. The safety of erenumab across age groups was determined by assessing safety endpoints including treatment-emergent adverse events (AEs), serious AEs, and events leading to study drug discontinuation. Results Overall, 3345 participants across five studies were randomized to receive either placebo (n = 1359), erenumab 70 mg (n = 1132) or erenumab 140 mg (n = 854); 3176 (94.9%) completed the DBTP, and 169 (5.1%) discontinued, mainly due to participant decision (110; 3.3%). Overall, 1349 (40.6%), 1122 (33.8%), and 850 (25.6%) participants received at least one dose of placebo, erenumab 70 mg, and erenumab 140 mg, respectively. Incidence of treatment-emergent AEs was similar across all age groups for both doses of erenumab (70 mg or 140 mg) and placebo (< 40 years, 44.0% vs 44.4%; 40–49 years, 42.5% vs 49.2%; 50–59 years, 46.5% vs 41.6%; ≥ 60 years, 43.8% vs 59.4%). Incidence of treatment-emergent serious AEs overall, and stratified by age groups for both doses and placebo was low (< 40 years, 0.9% vs 1.2%; 40–49 years, 1.7% vs 1.9%; and 50–59 years, 1.6% vs 1.1%), with no serious AEs reported in participants aged ≥ 60 years. No deaths were reported. Conclusions Erenumab (70 mg or 140 mg) exhibited a similar safety profile compared with placebo across age groups in individuals with episodic or chronic migraine, with no increased emergence of events due to age. Erenumab was well tolerated in older participants with multiple comorbidities, polypharmacy, and age-related physiological changes. Trial registration number ClinicalTrials.gov Identifiers: NCT02066415, NCT02456740, NCT02483585, NCT03096834, NCT03333109.

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Section: Discussionmentioning

confidence: 99%

Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials

et al. 2022

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“…Erenumab treatment appears to be significantly associated with hypertension ( 72 ). Furthermore, case reports have described drug-related myocardial infarction ( 73 ) and ocular myasthenia gravis-like symptoms ( 74 ). Galcanezumab, on the other hand, is considered to potentially have higher efficacy and similar tolerability ( 75 ).…”

Section: Discussionmentioning

confidence: 99%

Drug-related side effects and adverse reactions in the treatment of migraine: a bibliometric and visual analysis

Wei,

Lv,

Yang

et al. 2024

Front. Neurol.

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BackgroundMigraine imposes a substantial global burden, impacting patients and society. Pharmacotherapy, as a primary treatment, entails specific adverse reactions. Emphasizing these reactions is pivotal for improving treatment strategies and enhancing patients’ well-being. Thus, we conducted a comprehensive bibliometric and visual analysis of relevant literature.MethodologyWe conducted a comprehensive search on the Science Citation Index Expanded within the Web of Science, restricting the literature for analysis based on criteria such as document type, publication date, and language. Subsequently, we utilized various analytical tools, including VOSviewer, Scimago Graphica, the R package ‘bibliometrix’, CiteSpace, and Excel programs, for a meticulous examination and systematic organization of data concerning journals, authors, countries/regions, institutions, keywords, and references.ResultsBy August 31, 2023, the literature was distributed across 379 journals worldwide, authored by 4,235 individuals from 1726 institutions. It featured 2,363 keywords and 38,412 references. ‘HEADACHE’ led in publication count, with ‘SILBERSTEIN S’ as the most prolific author. The United States ranked highest in publication volume, with ‘UNIV COPENHAGEN’ leading among institutions.ConclusionOur research findings indicate that researchers in the field continue to maintain a focus on the calcitonin gene-related peptide (CGRP) system and explore diverse mechanisms for drug development through the application of novel biotechnological approaches. Furthermore, it is imperative to enhance the assessment of clinical trial outcomes, consistently monitor the efficacy and safety of prominent drugs such as Erenumab and Fremanezumab. There is a need for further evaluation of acute and preventive treatments tailored to different populations and varying types of migraine.

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“…Earlier, a case report highlighted a CV-event that occurred 5 months after starting erenumab ( 17 ). Furthermore, during an open-label extension study a CV related death was reported ( 18 ).…”

Section: Introductionmentioning

confidence: 99%

Safety considerations in the treatment with anti-CGRP(R) monoclonal antibodies in patients with migraine

Van Der Arend,

Van Veelen,

De Ruijter

et al. 2024

Front. Neurol.

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BackgroundAnti-CGRP-(receptor-)monoclonal antibodies (anti-CGRP(R)-mAbs) represent a novel class of drugs for migraine treatment, but their long-term cerebrovascular and cardiovascular (CV) safety warrants further examination.MethodsIn this observational cohort study we assessed the CV safety for erenumab and fremanezumab in a real-world setting during a follow-up period of at least 1 year. Patients with hypertension or CV history were excluded. We conducted ECGs and collected clinical data at treatment initiation and thereafter every 3 months, including liver and kidney function, lipid-, electrolyte-and glucose levels.ResultsAmong patients receiving erenumab (n = 101) or fremanezumab (n = 92), 3.1% (6/193) developed abnormal ECGs or CV adverse events. Of these, three (1.6%) experienced moderate to severe CV adverse events (cerebellar stroke, spontaneous coronary artery dissection, and pericarditis) and discontinued treatment. The remaining three (1.6%) developed non-threatening ECG abnormalities without physical complaints. No significant changes were observed in liver and kidney function, lipid-, electrolyte-, or glucose levels.DiscussionWe observed CV events in 1.6% of patients with 1.5-year follow-up of anti-CGRP(R)-mAbs treatment. We advise awareness regarding CV events in patients with migraine undergoing CGRP-targeted treatment, not as a confirmation of increased risk but as a proactive measure to address potential multifactorial influences.

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Myocardial infarction associated with erenumab: A case report

Cited by 15 publications

References 17 publications

Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials

Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials

Drug-related side effects and adverse reactions in the treatment of migraine: a bibliometric and visual analysis

Safety considerations in the treatment with anti-CGRP(R) monoclonal antibodies in patients with migraine

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