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Published on: June 2, 2014
Blood pressure elevation in erenumab-treated patients with migraine: A retrospective real-world experience
Nikita Chhabra1, Carolyn Mead-Harvey2, Christopher A Dodoo2
1Department of Neurology, Mayo Clinic, Scottsdale, Arizona, USA.
Insights
Erenumab, a migraine preventative, was associated with worsening blood pressure in 23.3% of patients. This highlights the need for regular blood pressure monitoring in individuals receiving erenumab treatment for migraine.
Area of Science:
- Neurology
- Cardiology
- Pharmacology
Background:
- Erenumab is a CGRP receptor antagonist used for migraine prevention.
- While preclinical and clinical trials showed no hypertension risk, post-marketing data and FDA labeling indicate a potential association.
- Calcitonin gene-related peptide (CGRP) plays a role in regulating vascular tone.
Purpose of the Study:
- To assess the incidence of elevated blood pressure (BP) in migraine patients after starting erenumab.
- To investigate the relationship between erenumab use and worsening BP, including hypertension.
Main Methods:
- An observational retrospective cohort study was conducted.
- Blood pressure (BP) was compared pre- and post-erenumab initiation using American Heart Association staging.
- Serious adverse vascular events were also documented.
Main Results:
- Of 335 patients, 23.3% experienced worsening BP; 3.9% showed improvement.
- Worsening BP was linked to atrial fibrillation (OR 4.9, p=0.035) but not baseline hypertension, sex, BMI, or age.
- One patient experienced a hypertensive emergency with non-ST elevation myocardial infarction.
Conclusions:
- A significant proportion of patients (23.3%) on erenumab may experience worsening blood pressure.
- Monitoring blood pressure is recommended for patients initiating erenumab therapy.
- Further research may clarify the mechanisms and clinical significance of erenumab-associated BP changes.
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.
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