OnabotulinumtoxinA for treatment of chronic migraine: PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline

Stephen D. Silberstein, Andrew M. Blumenfeld, Roger K. Cady, Ira M. Turner, Richard B. Lipton, Hans Christoph Diener, Sheena K. Aurora, Mai Sirimanne, Ronald E. DeGryse, Catherine C. Turkel, David W. Dodick

Research output: Contribution to journalArticle

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Abstract

Acute headachemedication overuse (MO) is common in patientswith chronicmigraine (CM).Weevaluated safety and efficacy of onabotulinumtoxinA as preventive treatment of headache in CM patients with baseline MO (CM + MO) in a planned secondary analysis fromtwo similarly designed, randomized, placebo-controlled, parallel, Phase III trials. Patientswere randomized to treatment groups (155-195 U of onabotulinumtoxinA or placebo) using MO (patient-reported and diary-captured frequency of intake) as a stratifying variable. Of 1384 patients, 65.3% (n = 904) met MO criteria (onabotulinumtoxinA: n = 445, placebo: n = 459). For the CM + MO subgroup at Week 24, statistically significant between-treatment group mean changes from baseline favoring onabotulinumtoxinA versus placebo were observed for headache days (primary endpoint: -8.2 vs. -6.2; p < 0.001) and other secondary endpoints: frequencies of migraine days (p < 0.001), moderate/severe headache days (p < 0.001), cumulative headache hours on headache days (p < 0.001), headache episodes (p = 0.028), and migraine episodes (p = 0.018) and the percentage of patients with severe Headache Impact Test-6 category (p < 0.001). At Week 24, change from baseline in frequency of acute headache medication intakes (secondary endpoint) was not statistically significant (p = 0.210) between groups, except for triptan intakes (p < 0.001), where the onabotulinumtoxinA-treated groupwas favored. OnabotulinumtoxinA was effective andwell tolerated as headache prophylaxis in CM + MO patients.

Original languageEnglish (US)
Pages (from-to)48-56
Number of pages9
JournalJournal of the Neurological Sciences
Volume331
Issue number1-2
DOIs
StatePublished - Sep 15 2013

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Secondary Headache Disorders
Migraine Disorders
Headache
Placebos
Therapeutics
Tryptamines
onabotulinumtoxinA

Keywords

  • Botulinum toxin type A
  • Chronic migraine
  • Health-related quality of life
  • Medication overuse
  • OnabotulinumtoxinA
  • Prophylactic treatment

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

OnabotulinumtoxinA for treatment of chronic migraine : PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline. / Silberstein, Stephen D.; Blumenfeld, Andrew M.; Cady, Roger K.; Turner, Ira M.; Lipton, Richard B.; Diener, Hans Christoph; Aurora, Sheena K.; Sirimanne, Mai; DeGryse, Ronald E.; Turkel, Catherine C.; Dodick, David W.

In: Journal of the Neurological Sciences, Vol. 331, No. 1-2, 15.09.2013, p. 48-56.

Research output: Contribution to journalArticle

Silberstein, SD, Blumenfeld, AM, Cady, RK, Turner, IM, Lipton, RB, Diener, HC, Aurora, SK, Sirimanne, M, DeGryse, RE, Turkel, CC & Dodick, DW 2013, 'OnabotulinumtoxinA for treatment of chronic migraine: PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline', Journal of the Neurological Sciences, vol. 331, no. 1-2, pp. 48-56. https://doi.org/10.1016/j.jns.2013.05.003
Silberstein, Stephen D. ; Blumenfeld, Andrew M. ; Cady, Roger K. ; Turner, Ira M. ; Lipton, Richard B. ; Diener, Hans Christoph ; Aurora, Sheena K. ; Sirimanne, Mai ; DeGryse, Ronald E. ; Turkel, Catherine C. ; Dodick, David W. / OnabotulinumtoxinA for treatment of chronic migraine : PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline. In: Journal of the Neurological Sciences. 2013 ; Vol. 331, No. 1-2. pp. 48-56.
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abstract = "Acute headachemedication overuse (MO) is common in patientswith chronicmigraine (CM).Weevaluated safety and efficacy of onabotulinumtoxinA as preventive treatment of headache in CM patients with baseline MO (CM + MO) in a planned secondary analysis fromtwo similarly designed, randomized, placebo-controlled, parallel, Phase III trials. Patientswere randomized to treatment groups (155-195 U of onabotulinumtoxinA or placebo) using MO (patient-reported and diary-captured frequency of intake) as a stratifying variable. Of 1384 patients, 65.3{\%} (n = 904) met MO criteria (onabotulinumtoxinA: n = 445, placebo: n = 459). For the CM + MO subgroup at Week 24, statistically significant between-treatment group mean changes from baseline favoring onabotulinumtoxinA versus placebo were observed for headache days (primary endpoint: -8.2 vs. -6.2; p < 0.001) and other secondary endpoints: frequencies of migraine days (p < 0.001), moderate/severe headache days (p < 0.001), cumulative headache hours on headache days (p < 0.001), headache episodes (p = 0.028), and migraine episodes (p = 0.018) and the percentage of patients with severe Headache Impact Test-6 category (p < 0.001). At Week 24, change from baseline in frequency of acute headache medication intakes (secondary endpoint) was not statistically significant (p = 0.210) between groups, except for triptan intakes (p < 0.001), where the onabotulinumtoxinA-treated groupwas favored. OnabotulinumtoxinA was effective andwell tolerated as headache prophylaxis in CM + MO patients.",
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AU - Blumenfeld, Andrew M.

AU - Cady, Roger K.

AU - Turner, Ira M.

AU - Lipton, Richard B.

AU - Diener, Hans Christoph

AU - Aurora, Sheena K.

AU - Sirimanne, Mai

AU - DeGryse, Ronald E.

AU - Turkel, Catherine C.

AU - Dodick, David W.

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AB - Acute headachemedication overuse (MO) is common in patientswith chronicmigraine (CM).Weevaluated safety and efficacy of onabotulinumtoxinA as preventive treatment of headache in CM patients with baseline MO (CM + MO) in a planned secondary analysis fromtwo similarly designed, randomized, placebo-controlled, parallel, Phase III trials. Patientswere randomized to treatment groups (155-195 U of onabotulinumtoxinA or placebo) using MO (patient-reported and diary-captured frequency of intake) as a stratifying variable. Of 1384 patients, 65.3% (n = 904) met MO criteria (onabotulinumtoxinA: n = 445, placebo: n = 459). For the CM + MO subgroup at Week 24, statistically significant between-treatment group mean changes from baseline favoring onabotulinumtoxinA versus placebo were observed for headache days (primary endpoint: -8.2 vs. -6.2; p < 0.001) and other secondary endpoints: frequencies of migraine days (p < 0.001), moderate/severe headache days (p < 0.001), cumulative headache hours on headache days (p < 0.001), headache episodes (p = 0.028), and migraine episodes (p = 0.018) and the percentage of patients with severe Headache Impact Test-6 category (p < 0.001). At Week 24, change from baseline in frequency of acute headache medication intakes (secondary endpoint) was not statistically significant (p = 0.210) between groups, except for triptan intakes (p < 0.001), where the onabotulinumtoxinA-treated groupwas favored. OnabotulinumtoxinA was effective andwell tolerated as headache prophylaxis in CM + MO patients.

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