Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials

Data from seven randomized, placebo-controlled, double-blind phase III clin ical trials were analysed to further evaluate the efficacy of rizatriptan 1 0 mg (n=2068) in comparison with placebo (n=1260) and rizatriptan 5 mg (n=1 486) for the acute treatment of a migraine attack. Migraine was diagnosed a ccording to International Headache Society criteria. Headache severity, ass ociated migraine symptoms and functional disability were measured immediate ly before dosing and at 0.5, 1, 1.5 and 2 h. Headache recurrence (return of moderate or severe headache after an initial response) was also recorded. In addition to conventional pain relief (reduction of moderate or severe he adache to mild or none) and pain free measures, the analysis looked at the elimination of associated migraine symptoms and disability in patients who had symptoms or disability at baseline. Maintenance of pain relief or pain- free status over 23 h was also analysed. At 2 h, rizatriptan 10 mg was sign ificantly more effective than placebo for pain relief (71% vs. 38%, P<0.001 ), and for elimination of pain, nausea, photophobia, phonophobia and functi onal disability. The benefit was maintained over 24 h; 37% of patients on r izatriptan 10 mg had sustained pain relief vs. 18% for placebo (P<0.001). R izatriptan 10 mg was also more effective than rizatriptan 5 mg, with a sign ificant superiority at 2h on all measures except for elimination of nausea. The benefit was maintained over 24 h; 38% of patients on rizatriptan 10 mg had sustained pain relief vs. 32% for rizatriptan 5 mg (P=0.001).