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Table 3 Coexistence of positive outcome(s) with head pain outcome at 2 h

From: 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

Proportion with additional outcomes at 2 h

Pain freedom (N = 913)

Improved to mild pain (N = 864)

Continued moderate/

severe pain (N = 1052)

Number of outcomes

Outcome(s)

1

MBS freedom, n (%)

839 (91.9)

388 (44.9)*

108 (10.3)*

 

Functional disability freedoma, n (%)

795 (87.1)

116 (13.4)*

12 (1.1)*

 

PGIC (much better/very much better)b, n (%)

790 (86.5)

272 (31.5)*

18 (1.7)*

2

Both MBS freedom and disability freedoma, n (%)

763 (83.6)

93 (10.8)*

3 (0.3)

3

MBS freedom, disability freedoma, and PGIC (much better/very much better)b, n (%)

683 (74.8)

64 (7.4)*

2 (0.2)

Neither MBS nor disability freedoma achieved, n (%)

42 (4.6)

453 (52.4)*

935 (88.9)*

Neither MBS freedom, disability freedoma, nor PGIC (much better/very much better) b achieved, n (%)

16 (1.8)

356 (41.2)*

925 (87.9)*

  1. *p < 0.001 versus group with pain freedom at 2 h. P-values were only calculated from odds ratios if the number of patients in each specific category was ≥10
  2. aFunctional disability was assessed with the question “How much is your migraine interfering with your normal activities?” Response options were “not at all”, “mild interference”, “marked interference”, or “need complete bed rest”. Functional disability freedom was defined as having “Not at all” recorded at 2 h. Patients who recorded “Not at all” at the time of dosing were excluded from the analysis
  3. bPGIC was assessed with the question “How do you feel after taking study medication?” with responses recorded using a 7-point Likert scale, ranging from “very much better” to “very much worse”. Patients who reported “much better” or “very much better” were considered to have improved with treatment
  4. Notes: Data from the total population (all treatment arms combined). p-values were generated from a two-sided test from a logistic regression model with study, head pain outcome group, and background use of medication to reduce the frequency of migraine as covariates. Firth’s penalized likelihood approach was used to address issues of quasi-complete separation
  5. MBS: most bothersome symptom; PGIC: patient global impression of change
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The Journal of Headache and Pain

ISSN: 1129-2377

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