Zolmitriptan: A Comparison of the Efficacy and Safety of Oral 2.5 mg and 5 mg
Authors: Nick Syrett; Tim Brandreth
Source: Headache Care, Volume 1, Number 4, December 2004 , pp. 303-305(3)
Publisher: Informa Healthcare
Abstract:Background: Oral zolmitriptan is available in two dose strengths (2.5 mg and 5 mg) and two bioequivalent formulations (conventional and orally dispersible tablets). All four presentations have demonstrated onset of action within 30 minutes and significant pain free rate as early as one hour after dosing. Objectives: To assess the relative efficacy and tolerability of 2.5 mg and 5 mg doses of zolmitriptan. Methods: A post-hoc analysis of efficacy and tolerability data from all six studies where patients were randomised to receive 2.5 mg and 5 mg oral doses. In addition, a further study was reviewed where patients were given free choice to treat multiple attacks with either 2.5 mg or 5 mg. Results: The 5 mg dose of oral zolmitriptan demonstrated the following advantages over the 2.5 mg oral dose: Higher effects at early time points: pain free odds ratio 1.25 at 1 hour (p < 0.05); total symptom relief at earlier time points: odds ratio 1.25 at 1 hour (p < 0.05). Increased duration of effect: complete response odds ratio 1.19 (p < 0.05); sustained pain free at 24 hours odds ratio 1.19 (p < 0.05). During the long term study, more attacks were treated with 5 mg (57%) than with 2.5 mg (43%), with a higher proportion of attacks treated with 5 mg being of severe pain. No increase in serious adverse events nor study withdrawals. Conclusions: The 2.5 mg dose of oral zolmitriptan is fast and highly effective in the acute treatment of migraine. The 5 mg dose can offer even more efficacy benefits to some patients, with no clear tolerability penalty, plus is chosen by more patients when headache pain is severe.
Document Type: Short communication
Publication date: 2004-12-01