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Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions

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DOI

  1. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1)

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  2. Monitoring chronic headache and medication-overuse headache prevalence in Denmark

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  3. Diagnostic delay of cluster headache: A cohort study from the Danish Cluster Headache Survey

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  4. PACAP27 induces migraine-like attacks in migraine patients

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  1. Neck pain and headache after whiplash injury: a systematic review and meta-analysis

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  2. Intravenous Endothelin-1 Infusion Does Not Induce Aura or Headache in Migraine Patients With Aura

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  3. Plasma Glucose Levels Increase During Spontaneous Attacks of Migraine With and Without Aura

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  4. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1)

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. Investigation of sumatriptan and ketorolac trometamol in the human experimental model of headache

    Research output: Contribution to journalJournal articleResearchpeer-review

  • Messoud Ashina
  • David Kudrow
  • Uwe Reuter
  • David Dolezil
  • Stephen Silberstein
  • Stewart J Tepper
  • Fei Xue
  • Hernan Picard
  • Feng Zhang
  • Andrea Wang
  • Yanchen Zhou
  • Frank Hong
  • Jan Klatt
  • Daniel D Mikol
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BACKGROUND: Efficacy and safety of erenumab have been evaluated in a comprehensive clinical development program resulting in approval for migraine prevention in over 40 countries to date.

METHODS: This integrated safety analysis included four double-blind randomized trials and their extensions (up to three-plus years). Safety endpoints included exposure-adjusted patient incidences of adverse events, serious adverse events, and anti-erenumab antibodies.

RESULTS: In all, 2375 of the patients randomized across the four studies received at least one dose of erenumab (70 mg or 140 mg), with cumulative exposure of 2641.2 patient-years. Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years). During the long-term extensions, adverse events reported were similar to those observed during the double-blind treatment phase, and rates of injection site reactions, constipation, and muscle spasm were reported at lower rates than in the double-blind treatment phase. There were two deaths reported, both confounded by pre-existing conditions.

CONCLUSIONS: This pooled safety analysis revealed a favorable and stable adverse event profile over time for erenumab with more than three years of exposure.

TRIAL REGISTRATION: ClinicalTrials.gov NCT01952574, NCT02483585, NCT02456740, NCT02066415, and NCT02174861.

Original languageEnglish
JournalCephalalgia : an international journal of headache
Volume39
Issue number14
Pages (from-to)1798-1808
Number of pages11
ISSN0333-1024
DOIs
Publication statusPublished - 2019

ID: 58930498