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- Title
Blood pressure elevation in erenumab‐treated patients with migraine: A retrospective real‐world experience.
- Authors
Chhabra, Nikita; Mead‐Harvey, Carolyn; Dodoo, Christopher A.; Iser, Courtney; Taylor, Hallie; Chaudhary, Hira; Vanood, Aimen; Dodick, David W.
- Abstract
Background: Erenumab is a monoclonal antibody that targets the calcitonin gene‐related peptide (CGRP) receptor and is approved for the preventative treatment of migraine in adults. CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension. While there has not been evidence of hypertension in preclinical models or clinical trials, post‐marketing data suggest erenumab may be associated with hypertension. This led to a warning in the United States Food and Drug Administration prescribing information for erenumab. Objective: To determine the frequency of worsening blood pressure (BP) after initiation of erenumab in patients with migraine and how this is associated with hypertension. Methods: This is an observational retrospective cohort study evaluating patients at a tertiary headache or neurology department. Systolic and diastolic BPs were compared between the initial visit prior to initiation of erenumab, and follow‐up visit while on erenumab. Worsening BP was defined as moving from a lower stage to a higher stage of BP, as defined by the American Heart Association. Serious adverse vascular events were also recorded. Results: A total of 335 patients were included in the final analysis (mean [SD] age of 45.7 [14.40] years, 83.9% [281/335] female). At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The median (interquartile range) time to follow‐up appointment from initial appointment was 20.5 (13.3–35.3) weeks. The mean (SD) BP at baseline was systolic 124.7 (15) mmHg and diastolic 77 (11) mmHg, and at follow‐up was systolic 124.0 (15) mmHg and diastolic 77.8 (9) mmHg. Overall, 23.3% (78/335) of all patients had worsening BP, whereas 13/225 (3.9%) patients had improvement in their BP. Patients with atrial fibrillation were more likely to develop worsening BP (odds ratio, 4.9, 95% confidence interval 1.12–21.4; p = 0.035). There was no association between worsening BP and pre‐existing hypertension, sex, body mass index, or age. One patient had non‐ST elevation myocardial infarction attributed to a hypertensive emergency while on erenumab. Conclusion: We found that 23.3% of patients initiated on erenumab may have developed worsening BP, suggesting the need for BP monitoring in patients initiated on erenumab. Plain Language Summary: This study aimed to determine how often blood pressure (BP) increases in patients with migraine after initiation of erenumab, a migraine preventative treatment. We compared patients' BP before starting erenumab versus while on erenumab. We found that nearly a quarter of patients developed higher BP, suggesting the need for BP monitoring in patients taking erenumab.
- Subjects
MIGRAINE prevention; THERAPEUTIC use of monoclonal antibodies; AMERICAN Heart Association; CLINICAL drug trials; DRUG side effects; BODY mass index; NON-ST elevated myocardial infarction; HYPERTENSION; CLINICAL trials; SCIENTIFIC observation; RETROSPECTIVE studies; CALCITONIN; UNITED States. Food &; Drug Administration; DESCRIPTIVE statistics; MONOCLONAL antibodies; ODDS ratio; PHARMACY information services; ATRIAL fibrillation; BLOOD pressure; DRUG development; CONFIDENCE intervals; MIGRAINE; ADULTS
- Publication
Headache: The Journal of Head & Face Pain, 2024, Vol 64, Issue 3, p233
- ISSN
0017-8748
- Publication type
Article
- DOI
10.1111/head.14679