Evidence map›Paper›PMID 35468729›Full record

ArticleThe journal of headache and pain2022

Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: a post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials.

Richard B Lipton, Rashmi B Halker Singh, Dennis A Revicki, Sihui Zhao, Anand R Shewale, Jordan E Lateiner, David W Dodick

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in The journal of headache and pain, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 10% 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.

NCT02828020 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

TypeinterventionalSponsorAllerganRan2016 to 2017Enrolled1,672ConditionsMigraine, With or Without AuraArmsUbrogepant, Placebo-matching Ubrogepant
NCT02867709 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

TypeinterventionalSponsorAllerganRan2016 to 2018Enrolled1,686ConditionsMigraine, With or Without AuraArmsUbrogepant, Placebo-matching Ubrogepant
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Observational
  6. Review
  7. Review
  8. Article
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

7 authors at 4 institutions in 1 country.

Richard B LiptonAlbert Einstein College of Medicine, Bronx, NY, USA.
Rashmi B Halker SinghMayo Clinic, Phoenix, AZ, USA.
Dennis A RevickiOutcomes Research Consulting, Sarasota, FL, USA.
Sihui Zhao *AbbVie, Madison, NJ, USA.
Anand R ShewaleAbbVie, 2525 Dupont Dr., Irvine, CA, 92612, USA. anand.shewale@abbvie.com.ORCID http://orcid.org/0000-0002-3138-5623
Jordan E Lateiner *AbbVie, 2525 Dupont Dr., Irvine, CA, 92612, USA.
David W DodickMayo Clinic, Phoenix, AZ, USA.
AbbVie (United States) · USMayo Clinic Hospital · USAlbert Einstein College of Medicine · USHealth Outcomes Solutions (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTriptans are the first-line option for the acute treatment of migraine attacks; however, triptans are contraindicated in people with certain underlying cardiovascular risk factors and are associated with inadequate efficacy or poor tolerability in some individuals. Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine.

methodsThis post hoc analysis of the phase 3 ACHIEVE trials examined the impact of ubrogepant on the Functional Disability Scale (FDS), satisfaction with medication, and Patient Global Impression of Change (PGIC) in participants who were self-reported triptan insufficient responders (TIRs), defined as those who are unable to take triptans due to contraindications, tolerability issues, or insufficient efficacy. Responder definitions for the FDS, satisfaction measures, and PGIC were based on qualitative interpretation of the respective response options for the pooled ubrogepant 50 mg and placebo groups.

resultsIn the pooled analysis population (n = 1799), 451 (25%) participants were TIRs, with most (80%) reporting insufficient efficacy with triptan use. A significantly higher proportion of TIRs treated with ubrogepant vs placebo reported being able to function normally from 2 to 8 h post dose (P < 0.05). Notably, significance was demonstrated at the time of the primary outcome assessments (2 h post dose), where rates of normal function were 38% for ubrogepant vs 29% for placebo (P = 0.048). A greater proportion of TIRs in the ubrogepant arm vs the placebo arm were satisfied with treatment at 2 (33% vs 21%, P = 0.006) and 24 h (58% vs 28%, P < 0.001) and indicated that their migraine improved at 2 h vs placebo (30% vs 18%, P = 0.006). Results were generally similar in the insufficient efficacy subpopulation of TIRs as in the overall TIRs group. Ubrogepant was safe and well tolerated in TIRs, with no new safety signals identified.

conclusionsIn people with migraine who are TIRs, individuals treated with ubrogepant had favorable 2-h outcomes, as measured by the FDS, satisfaction with medication, and PGIC, compared with placebo.

trial registrationClinicalTrials.gov: NCT02828020 (ACHIEVE I), registered July 11, 2016; NCT02867709 (ACHIEVE II), registered August 16, 2016.

Indexed as

Migraine DisordersTryptaminesCalcitonin Gene-Related Peptide Receptor AntagonistsHumansPersonal SatisfactionPyridinesPyrrolesRandomized Controlled Trials as TopicSerotonin 5-HT1 Receptor AgonistsCalcitonin Gene-Related Peptide Receptor AntagonistsPyridinesPyrrolesSerotonin 5-HT1 Receptor AgonistsTryptaminesubrogepantACHIEVECalcitonin gene–related peptide receptor antagonistFunctionalityMigrainePatient-reported outcomesSatisfactionTriptan

Identifiers

PMID35468729
PMCPMC9036751
OpenAlexW4224441867

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.