OBJECTIVE: To determine the speed of onset of headache response and duration of response with zolmitriptan 5 mg orally disintegrating tablet (ODT) in the acute treatment of migraine. BACKGROUND: Rapid pain relief is important for migraine sufferers. The early efficacy (30 minutes) of the 5 mg dose of the zolmitriptan ODT formulation was evaluated. METHODS: In this double-blind, parallel-group trial, 670 patients were randomised to receive either zolmitriptan 5 mg ODT (n=329) or matching placebo (n=341) to treat two migraine headaches of moderate or severe intensity. RESULTS:Zolmitriptan 5 mg ODT was significantly more effective than placebo in achieving a headache response (reduction in migraine headache intensity from moderate or severe to mild or no pain) at 30 minutes (16.5% vs 12.5%; p=0.048; primary endpoint), 1 hour (p <0.0001), and 2 hours (p <0.0001). Significantly more patients achieved a sustained headache response for 24 hours with zolmitriptan 5 mg ODT than with placebo (42.5% vs 16.4%; p <0.0001). Zolmitriptan 5 mg ODT also produced a higher pain-free rate than placebo at all timepoints (0.5, 1 and 2 hours post-dose), with the differences becoming significant at 1 hour. Adverse events were reported by 37.7% of the patients treated with zolmitriptan 5 mg ODT and 18.1% of the patients treated with placebo. Those that occurred most often for the patients treated with zolmitriptan 5 mg ODT were tightness (7.0%), dizziness (6.7%), somnolence (6.7%) and paraesthesias (6.1%). CONCLUSIONS: A significant headache response as early as 30 minutes post-dose and good maintenance of this headache response at 24 hours makes zolmitriptan 5 mg ODT an excellent acute treatment for migraine. Together with the relatively low adverse event rate, these data demonstrate that zolmitriptan 5 mg ODT is a valuable therapy for migraine sufferers.
RCT Entities:
OBJECTIVE: To determine the speed of onset of headache response and duration of response with zolmitriptan 5 mg orally disintegrating tablet (ODT) in the acute treatment of migraine. BACKGROUND: Rapid pain relief is important for migraine sufferers. The early efficacy (30 minutes) of the 5 mg dose of the zolmitriptan ODT formulation was evaluated. METHODS: In this double-blind, parallel-group trial, 670 patients were randomised to receive either zolmitriptan 5 mg ODT (n=329) or matching placebo (n=341) to treat two migraine headaches of moderate or severe intensity. RESULTS:Zolmitriptan 5 mg ODT was significantly more effective than placebo in achieving a headache response (reduction in migraineheadache intensity from moderate or severe to mild or no pain) at 30 minutes (16.5% vs 12.5%; p=0.048; primary endpoint), 1 hour (p <0.0001), and 2 hours (p <0.0001). Significantly more patients achieved a sustained headache response for 24 hours with zolmitriptan 5 mg ODT than with placebo (42.5% vs 16.4%; p <0.0001). Zolmitriptan 5 mg ODT also produced a higher pain-free rate than placebo at all timepoints (0.5, 1 and 2 hours post-dose), with the differences becoming significant at 1 hour. Adverse events were reported by 37.7% of the patients treated with zolmitriptan 5 mg ODT and 18.1% of the patients treated with placebo. Those that occurred most often for the patients treated with zolmitriptan 5 mg ODT were tightness (7.0%), dizziness (6.7%), somnolence (6.7%) and paraesthesias (6.1%). CONCLUSIONS: A significant headache response as early as 30 minutes post-dose and good maintenance of this headache response at 24 hours makes zolmitriptan 5 mg ODT an excellent acute treatment for migraine. Together with the relatively low adverse event rate, these data demonstrate that zolmitriptan 5 mg ODT is a valuable therapy for migraine sufferers.
Authors: P Tfelt-Hansen; G Block; C Dahlöf; H C Diener; M D Ferrari; P J Goadsby; V Guidetti; B Jones; R B Lipton; H Massiou; C Meinert; G Sandrini; T Steiner; P B Winter Journal: Cephalalgia Date: 2000-11 Impact factor: 6.292
Authors: Joseph T Morott; Manjeet Pimparade; Jun-Bom Park; Chelsea P Worley; Soumyajit Majumdar; Zhuoyang Lian; Elanor Pinto; Yunxia Bi; Thomas Durig; Michael A Repka Journal: J Pharm Sci Date: 2014-11-19 Impact factor: 3.534
Authors: Paola Sarchielli; Franco Granella; Maria Pia Prudenzano; Luigi Alberto Pini; Vincenzo Guidetti; Giorgio Bono; Lorenzo Pinessi; Massimo Alessandri; Fabio Antonaci; Marcello Fanciullacci; Anna Ferrari; Mario Guazzelli; Giuseppe Nappi; Grazia Sances; Giorgio Sandrini; Lidia Savi; Cristina Tassorelli; Giorgio Zanchin Journal: J Headache Pain Date: 2012-05 Impact factor: 7.277