Evidence map›Paper›PMID 34591982›Full record

ArticleHeadache2021

Risk of hypertension in erenumab-treated patients with migraine: Analyses of clinical trial and postmarketing data.

David W Dodick, Stewart J Tepper, Jessica Ailani, Nicola Pannacciulli, Marco S Navetta, Brett Loop, Feng Zhang, Ani C Khodavirdi, Allison Mann, Ahmad Abdrabboh and 1 more

Open access · greenAbstract read
In one paragraph

Article in Headache, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
6.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Observational
  5. Review
  6. Observational
  7. Review
  8. Observational
  9. Article
  10. Evidence-based review and frontiers of migraine therapy.Neurogastroenterology and motility · 2025
    Review
  11. Article
  12. Article
  13. Blood pressure monitoring in elderly migraineurs starting an anti-CGRP monoclonal antibody: a real-world prospective study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Observational
  14. Article
  15. Migraine and Stroke: A Scoping Review.Journal of clinical medicine · 2024
    Article
  16. Evaluation of the risk of hypertension in patients treated with anti-CGRP monoclonal antibodies in a real-life study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
  17. Article
  18. Article
  19. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

David W DodickDepartment of Neurology, Mayo Clinic, Scottsdale, Arizona, USA.ORCID 0000-0002-9486-6790
Stewart J TepperDepartment of Neurology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA.
Jessica AilaniGeorgetown Headache Center, Medstar Georgetown University, Washington, DC, USA.
Nicola PannacciulliGlobal Medical Amgen Inc., Thousand Oaks, California, USA.
Marco S NavettaGlobal Medical Amgen Inc., Thousand Oaks, California, USA.
Brett LoopGlobal Patient Safety, Amgen Inc., Cambridge, Massachusetts, USA.
Feng ZhangGlobal Medical Amgen Inc., Thousand Oaks, California, USA.
Ani C KhodavirdiGlobal Medical Amgen Inc., Thousand Oaks, California, USA.
Allison MannMedical Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Ahmad AbdrabbohMedical Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Jawed KalimMedical Safety, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Amgen (United States) · USNovartis (United States) · USDartmouth College · USGeorgetown University · USMayo Clinic in Arizona · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the risk of hypertension in patients with migraine who received erenumab in clinical trials and in the postmarketing setting.

backgroundErenumab is a monoclonal antibody for migraine prevention that targets the calcitonin gene-related peptide (CGRP) receptor. Hypertension is a theoretical risk for inhibitors of the CGRP pathway. Although no evidence of an association between erenumab treatment and hypertension was observed during the clinical development program, adverse events (AEs) of hypertension have been identified in the postmarketing setting.

methodsSafety data from four phase 2 and phase 3 clinical trials were used to perform a pooled analysis of hypertension AEs in patients with migraine receiving erenumab. Postmarketing AEs of hypertension were identified from the Amgen Global Safety database from May 17, 2018, through January 31, 2020.

resultsIn the pooled analysis of clinical trials, hypertension AEs (placebo, 9/1043 [0.9%]; erenumab 70 mg, 7/893 [0.8%]; erenumab 140 mg, 1/507 [0.2%]) and percentage of patients initiating medication to treat hypertension (12/1043 [1.2%], 7/893 [0.8%], 1/507 [0.2%], respectively) were similar across treatment groups. A total of 362 AEs of hypertension were identified from the postmarketing setting, 26.2% (95/362) of which were serious, >245,000 patient-years of exposure. The exposure-adjusted incidence of hypertension was 0.144 per 100 patient-years.

conclusionsClinical trials did not demonstrate an increased risk of hypertension with erenumab compared with placebo, and AE rates of hypertension reported with erenumab in the postmarketing setting were generally low. Additional data are needed to fully characterize the extent to which hypertension is a risk associated with erenumab.

Indexed as

Drug-Related Side Effects and Adverse ReactionsAdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicFemaleHumansHypertensionMaleMiddle AgedMigraine DisordersProduct Surveillance, PostmarketingAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor Antagonistserenumabblood pressurecalcitonin gene-related peptidedrug safetyhypertensionindividual case safety reportpostmarketing surveillance

Identifiers

PMID34591982
PMCPMC9293040
OpenAlexW3204374415

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.