Evidence map›Paper›PMID 33749826›Full record

Trial reportHeadache2021

Efficacy of ubrogepant based on prior exposure and response to triptans: A post hoc analysis.

Andrew M Blumenfeld, Peter J Goadsby, David W Dodick, Susan Hutchinson, Chengcheng Liu, Michelle Finnegan, Joel M Trugman, Armin Szegedi

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Headache, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 8% 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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Molecular Mechanisms of Migraine: Nitric Oxide Synthase and Neuropeptides.International journal of molecular sciences · 2023
    Review
  12. Review
  13. Gepants - a long way to cure: a narrative review.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Review
  14. Review
  15. Article
  16. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 2 countries.

Andrew M BlumenfeldThe Neurology Center, Headache Center of Southern California, Carlsbad, CA, USA.
Peter J GoadsbyNIHR-Wellcome Trust King's Clinical Research Facility, King's College, London, UK.
David W DodickDepartment of Neurology, Mayo Clinic, Phoenix, AZ, USA.
Susan HutchinsonDepartment of Headache, Orange County Migraine and Headache Center, Irvine, CA, USA.ORCID https://orcid.org/0000-0001-6353-2846
Chengcheng LiuAbbVie, Madison, NJ, USA.
Michelle FinneganAbbVie, Madison, NJ, USA.
Joel M TrugmanAbbVie, Madison, NJ, USA.
Armin SzegediAbbVie, Madison, NJ, USA.
AbbVie (United States) · USNeurology Center of Southern California · USPain and Headache Center · USUniversity of California, Los Angeles · USWinnMed · US

Funding

Allergan
6 · The paper itself

Abstract

objectiveTo determine the potential efficacy of ubrogepant for acute treatment of migraine based on historical experience with triptans.

backgroundAlthough triptans have improved migraine treatment, their efficacy and tolerability may limit their utility in some individuals. Ubrogepant is a small-molecule, oral calcitonin gene-related peptide receptor antagonist approved by the Food and Drug Administration for acute treatment of migraine in adults.

methodsThis post hoc analysis of pooled data from the pivotal trials ACHIEVE I and II, identically designed, randomized, double-blind, phase 3, single-attack trials of ubrogepant in adults with a history of migraine with/without aura, examined the efficacy and tolerability of ubrogepant 50 mg versus placebo based on participants' historical experience with triptans: triptan responder, triptan-insufficient responder, and triptan naïve. Co-primary efficacy endpoints were pain freedom and absence of most bothersome migraine-associated symptom (MBS) 2 h post initial dose. Adverse events (AEs) within historical triptan experience subgroups were evaluated.

resultsIn the pooled analysis population (n = 1799), 682 (placebo, n = 350; ubrogepant 50 mg, n = 332), 451 (placebo, n = 223; ubrogepant, n = 228), and 666 (placebo, n = 339; ubrogepant, n = 327) participants were triptan responders, triptan-insufficient responders, and triptan-naïve, respectively. Response rates on co-primary efficacy endpoints were higher for ubrogepant versus placebo across all groups. Treatment-by-subgroup interaction p values based on odds ratios for pain freedom (p = 0.290) and absence of MBS (p = 0.705) indicated no significant impact of historical triptan experience on ubrogepant efficacy. AE incidence for ubrogepant did not differ appreciably across historical triptan experience subgroups.

conclusionsUbrogepant efficacy and tolerability did not differ for the acute treatment of migraine in participants classified as triptan responders, triptan-insufficient responders, and triptan-naïve based on their historical experience with triptans.

Indexed as

Outcome Assessment, Health CareAdultCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersPyridinesPyrrolesSerotonin 5-HT1 Receptor AgonistsCalcitonin Gene-Related Peptide Receptor AntagonistsPyridinesPyrrolesSerotonin 5-HT1 Receptor AgonistsubrogepantACHIEVEcalcitonin gene-related peptide receptor antagonistmigrainepain freedompain relieftriptan

Identifiers

PMID33749826
PMCPMC8252782
OpenAlexW3139305293

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.