التفاصيل البيبلوغرافية
| العنوان: |
Acute treatment of migraine with zolmitriptan 5 mg orally disintegrating tablet. |
| المؤلفون: |
Spierings, Egilius L.H., Rapoport, Alan M., Dodick, David W., Charlesworth, Bruce |
| المصدر: |
CNS Drugs; 2004, Vol. 18 Issue 15, p1133-1141, 9p, 1 Diagram, 7 Charts, 1 Graph |
| مصطلحات موضوعية: |
THERAPEUTICS, MIGRAINE, HEADACHE, HEAD diseases, PAIN, CENTRAL nervous system diseases, NEUROLOGICAL disorders, CLINICAL trials, COMPARATIVE studies, DRUG delivery systems, HETEROCYCLIC compounds, RESEARCH methodology, MEDICAL cooperation, ORAL drug administration, RESEARCH, DRUG tablets, TIME, TRYPTAMINE, EVALUATION research, SEROTONIN agonists, RANDOMIZED controlled trials, TREATMENT effectiveness, BLIND experiment, ACUTE diseases |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
