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Author J. Brandes |
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[article] Montelukast for migraine prophylaxis = a randomized, double-blind, placebo-controlled study [printed text] / J. Brandes, Author ; W.H. Visser, Author ; M.V. Farmer, Author ; A.L. Schuhl, Author ; W. Malbecq, Author ; France Vrijens , Author ; C.R. Lines, Author ; S.A. Reines, Author . - 2004 . - 581-6.
Languages : English (eng)
in Headache > 44(2004)6 [06/01/2004] . - 581-6
Descriptors: Classification
W 1 Serials. Periodicals
Indexation
2008-52 ; Acetates ; Adult ; Double-Blind Method ; Female ; Humans ; Journal Article ; Leukotriene Antagonists ; Male ; Migraine Disorders ; Peer Review ; prevention and control ; R149 ; Treatment outcomeAbstract: OBJECTIVE:
To evaluate the efficacy and tolerability of montelukast 20 mg in the prophylactic treatment of migraine.
BACKGROUND:
A previous small open-label study in migraine patients suggested prophylactic efficacy for montelukast, an antagonist of the cysteinyl leukotriene receptor that is used in the treatment of asthma. We sought to confirm these findings in a randomized controlled trial.
METHODS:
This multicenter, randomized, double-blind, placebo-controlled, parallel-groups study enrolled adult migraine outpatients who experienced > or =3 and < or =8 migraine attacks per month for the last 6 months. Patients were entered into a 2-month, single-blind, placebo run-in phase. Only patients who experienced > or =3 migraine attacks in the second month were eligible to enter the subsequent 3-month, double-blind treatment phase of the study. The primary efficacy endpoint was the percentage of patients reporting at least a 50% decrease in migraine attack frequency per month during the double-blind treatment period (months 3-5) compared to baseline (run-in month 2).
RESULTS:
A total of 93 patients were randomized to montelukast 20 mg and 84 patients to placebo at the end of the placebo run-in month 2; 76 patients on montelukast and 72 patients on placebo completed the double-blind treatment period. Over 3 months of treatment, there was no significant difference between the two groups in the percentage of patients who reported at least a 50% decrease in migraine attack frequency per month: 15.4% for montelukast versus 10.3% for placebo (P= .304). In addition, montelukast 20 mg was not significantly superior to placebo on any of the secondary endpoints. There were no differences between treatment groups for adverse events.
CONCLUSION:
Montelukast 20 mg was well tolerated in migraine patients but was not an effective prophylactic for prevention of migraine.Link for e-copy: http://vdic.idm.oclc.org/login?url=http://onlinelibrary.wiley.com/doi/10.1111/j. [...] Format of e-copy: VDIC IP recognition Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=2547 [article]Randomized, placebo-controlled trial of rofecoxib in the acute treatment of migraine. / S. Silberstein in Neurology, 62(2004)9 ([05/01/2004])
[article] Randomized, placebo-controlled trial of rofecoxib in the acute treatment of migraine. [printed text] / S. Silberstein, Author ; S. Tepper, Author ; J. Brandes, Author ; M. Diamond, Author ; J. Goldstein, Author ; P. Winner, Author ; S. Venkatraman, Author ; France Vrijens , Author ; W. Malbecq, Author ; W.H. Visser, Author ; C. Lines, Author ; E. Yuen, Author . - 2004 . - 1552-7.
Languages : English (eng)
in Neurology > 62(2004)9 [05/01/2004] . - 1552-7
Descriptors: Classification
W 1 Serials. Periodicals
Indexation
Acute Disease ; administration and dosage ; Adult ; adverse effects ; Cyclooxygenase Inhibitors ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; England ; Health Status ; Humans ; Journal Article ; Lactones ; Male ; Migraine Disorders ; Pain Measurement ; Peer Review ; Placebos ; Quality of Life ; Sulfones ; Treatment outcomeAbstract: OBJECTIVE: To investigate the clinical profile of rofecoxib, a long-acting (approximately 17-hour half-life) selective cyclo-oxygenase-2 inhibitor, for the acute treatment of migraine.
METHODS: A randomized, double-blind, placebo-controlled, parallel-group study was conducted. Patients age > or =18 treated a moderate or severe migraine headache with placebo (n = 182), rofecoxib 25 mg (n = 183), or rofecoxib 50 mg (n = 192). The primary efficacy measure was headache relief (mild or no pain) 2 hours after dose.
RESULTS: The proportions of patients with migraine headache relief at 2 hours after dose were 34.3% for placebo, 54.0% for rofecoxib 25 mg (p < 0.001 vs placebo), and 56.7% for rofecoxib 50 mg (p < 0.001 vs placebo). Rofecoxib 25 and 50 mg were superior to placebo in providing pain freedom at 2 hours, 24-hour sustained headache relief, and 24-hour sustained pain freedom; in reducing photophobia, phonophobia, nausea (50 mg only), and functional disability at 2 hours after dose; and in improving some quality-of-life scores over 24 hours. More patients on rofecoxib 50 mg reported adverse events (39.6%) than patients on rofecoxib 25 mg (26.8%) or placebo (23.6%) regardless of drug relatedness; however, the incidences of drug-related adverse events were similar between treatment groups. These adverse events were generally mild or moderate in severity. The most commonly reported adverse events were dry mouth, dizziness, somnolence, nausea, dyspepsia, paresthesia, and asthenia, with similar incidences between treatment groups.
CONCLUSION: Rofecoxib 25 and 50 mg were effective and generally well tolerated for the acute treatment of migraine attacks.Link for e-copy: http://tiny.cc/udlbs Format of e-copy: IP recognition ((via CEBAM - personal login recquired) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=2509 [article]