Abstract |
A new formulation of zolmitriptan has been developed that dissolves on the tongue without the need for additional fluid intake. In this double-blind, parallel study, 471 patients were randomized to receive the zolmitriptan orally disintegrating tablet 2.5 mg (n=231) or matching placebo (n=240) to treat a single moderate or severe migraine. Headache relief following zolmitriptan 2.5 mg (63%) was significantly greater than with placebo (22%) at 2 h post-dose (primary endpoint; P < 0.0001). The zolmitriptan orally disintegrating tablet was also significantly more effective than placebo for 1-, 2- and 4-h pain-free response (8% vs. 3%, P=0.0207, 27% vs. 7%, P < 0.0001, and 37% vs. 11%, P < 0.0001, respectively). Of those patients stating a preference, 70% of patients preferred the orally disintegrating tablet to a conventional tablet. Zolmitriptan orally disintegrating tablets are an effective and convenient alternative to a conventional tablet, allowing migraine attacks to be treated anytime a migraine strikes, which can facilitate earlier treatment.
|
Authors | A J Dowson, E A MacGregor, R A Purdy, W J Becker, J Green, S L Levy |
Journal | Cephalalgia : an international journal of headache
(Cephalalgia)
Vol. 22
Issue 2
Pg. 101-6
(Mar 2002)
ISSN: 0333-1024 [Print] England |
PMID | 11972576
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Oxazolidinones
- Serotonin Receptor Agonists
- Tryptamines
- zolmitriptan
|
Topics |
- Administration, Oral
- Adult
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Migraine Disorders
(drug therapy, physiopathology)
- Oxazolidinones
(administration & dosage, adverse effects, chemistry, therapeutic use)
- Palliative Care
- Patient Satisfaction
- Recurrence
- Retreatment
- Serotonin Receptor Agonists
(administration & dosage, adverse effects, chemistry, therapeutic use)
- Solubility
- Tryptamines
|