Evidence map›Paper›PMID 34454420›Full record

ArticleThe journal of headache and pain2021

A close association of freedom from pain, migraine-related functional disability, and other outcomes: results of a post hoc analysis of randomized lasmiditan studies SAMURAI and SPARTAN.

Richard B Lipton, Simin K Baygani, Stewart J Tepper, John H Krege, Raghavendra Vasudeva, Eric M Pearlman, Paula M Hauck, Li Shen Loo

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The journal of headache and pain, 2021. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT02439320 phase3completednot on this map

A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2016Enrolled2,231ConditionsAcute MigraineArmsLasmiditan 100 mg, Lasmiditan 200 mg, Placebo (matches lasmiditan doses)
NCT02605174 phase3completednot on this map

A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2017Enrolled3,005ConditionsMigraine With or Without AuraArmsLasmiditan 50 mg, Lasmiditan 100 mg, Lasmiditan 200 mg, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
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

8 authors.

Richard B LiptonAlbert Einstein College of Medicine, Bronx, NY, USA.
Simin K BayganiEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA.
Stewart J TepperGeisel School of Medicine, Dartmouth College, Hanover, NH, USA.
John H KregeEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA.
Raghavendra VasudevaEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA.
Eric M PearlmanEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA.
Paula M HauckEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA.
Li Shen LooEli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA. loo_li_shen@lilly.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile pain freedom at 2 h is a key primary outcome for current trials for acute treatment of migraine, the relationship between the degree of head pain and other efficacy measures at 2 h has rarely been explored. Following lasmiditan treatment of a migraine attack with moderate or severe head pain, we contrast those who achieve pain freedom with those who achieve mild pain but not pain freedom 2 h post dosing.

methodsPatient-level data were pooled across studies and treatment arms from two Phase 3 trials comparing lasmiditan and placebo, SAMURAI and SPARTAN. This post hoc analysis assessed freedom from the most bothersome symptom (MBS), freedom from migraine-related functional disability (disability), and improved patient global impression of change (PGIC) in patients who achieved 2 h pain freedom compared to those who experienced 2 h mild pain. Mild pain differs from pain relief which is defined as either mild pain or pain freedom.

resultsPatients who achieved 2 h pain freedom (N = 913), in comparison with those with 2 h mild pain (N = 864), were significantly more likely to experience MBS freedom (91.9% vs. 44.9%), disability freedom (87.1% and 13.4%), and improved PGIC (86.5% and 31.5%) (p < 0.001 for all combinations). In addition, more patients who were pain free experienced both 2 h MBS freedom and 2 h functional disability freedom (83.6%) compared to those with mild pain (10.8%; p < 0.001). The proportion of patients with pain freedom who did not achieve either MBS or disability freedom (4.6%) was lower than in patients with mild pain (52.4%). Lastly, 55.2% of patients experienced mild pain before disability freedom compared to 72.1% who experienced pain freedom and disability freedom at the same time.

conclusionsThis study demonstrated that, at 2 h post treatment, patients who were pain free were more likely to achieve other outcomes including freedom from their MBS, freedom from migraine-related functional disability, and improved PGIC compared to those with mild pain, confirming that 2 h pain freedom is more robustly associated with other clinical outcomes than the 2 h mild pain endpoint.

trial registrationSAMURAI ( NCT02439320 ); SPARTAN ( NCT02605174 ).

Indexed as

Migraine DisordersBenzamidesDouble-Blind MethodFreedomHeadacheHumansPiperidinesPyridinesTreatment OutcomeBenzamideslasmiditanPiperidinesPyridinesEfficacy endpointsFunctional disabilityLasmiditanMigraineMost bothersome symptom (MBS)Pain freedomPain relief

Identifiers

PMID34454420
PMCPMC8400846

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.