TY - JOUR
T1 - OnabotulinumtoxinA for treatment of chronic migraine
T2 - PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline
AU - Silberstein, Stephen D.
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.
N1 - Funding Information:
This study was funded by Allergan, Inc.
Funding Information:
Richard B. Lipton receives research support from the NIH [ PO1 AG03949 (Program Director), PO1AG027734 (Project Leader), RO1AG025119 (Investigator), RO1AG022374-06A2 (Investigator), RO1AG034119 (Investigator), RO1AG12101 (Investigator), K23AG030857 (Mentor), K23NS05140901A1 (Mentor), and K23NS47256 (Mentor)], the National Headache Foundation , and the Migraine Research Fund ; serves on the editorial boards of Neurology and Cephalalgia and as senior advisor to Headache; has reviewed for the NIH and NINDS; holds stock options in eNeura Therapeutics (a company without commercial products); and serves as a consultant or advisory board member for or has received honoraria from: Allergan, American Headache Society, Autonomic Technologies, Boston Scientific, Bristol-Myers Squibb, Cognimed, Colucid, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, MAP, Merck, Nautilus Neuroscience, Novartis, NuPathe, Pfizer, and Vedanta.
PY - 2013/9/15
Y1 - 2013/9/15
N2 - 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.
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.
KW - Botulinum toxin type A
KW - Chronic migraine
KW - Health-related quality of life
KW - Medication overuse
KW - OnabotulinumtoxinA
KW - Prophylactic treatment
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U2 - 10.1016/j.jns.2013.05.003
DO - 10.1016/j.jns.2013.05.003
M3 - Article
C2 - 23790235
AN - SCOPUS:84882455542
SN - 0022-510X
VL - 331
SP - 48
EP - 56
JO - Journal of the neurological sciences
JF - Journal of the neurological sciences
IS - 1-2
ER -