Efficacy and tolerability of frovatriptan in acute migraine treatment: systematic review of randomized controlled trials.

OBJECTIVE To evaluate the efficacy and tolerability of frovatriptan in acute migraine treatment. METHODS Systematic review and meta-analysis of randomized controlled trials. Clinical trials of frovatriptan were systematically identified through electronic searches and historical searches up until February 2005. Studies were included if they were (i) double-blind, randomized, placebo controlled trials that evaluated frovatriptan 2.5 mg in acute migraine treatment and (ii) reporting the efficacy data in terms of pain-free, headache response, headache recurrence, or relief of migraine-associated symptoms. Two authors extracted data independently. Disagreements were resolved through discussion. The efficacy was estimated using risk ratio (RR), risk difference, and number needed to treat together with 95% confidence intervals. RESULTS Five trials involving a total of 2,866 patients were included. Frovatriptan 2.5 mg was more effective than placebo in rendering patient pain-free (RR 3.70, 95% CI 2.59-5.29, P < 0.0001 at 2 h and 2.67, 95% CI 2.21-3.22, P < 0.0001 at 4 h post-dose). It was also superior to placebo in reducing headache severity. The pooled RR was 1.66 (95% CI 1.48-1.88, P < 0.0001) and 1.83 (95% CI 1.66-2.00, P < 0.0001), respectively, at 2 and 4 h after treatment. In those whose headache was relieved at 4 h, the risk of headache recurrence within 24 h was reduced by 26% with frovatriptan (RR 0.74, 95% CI 0.59-0.93, P = 0.009). Frovatriptan was also superior to placebo in improving symptoms associated with migraine. At 2 h after dosing, frovatriptan reduced the risk of nausea by 14% (95% CI 6-20%, P = 0.0005), photophobia 17% (95% CI 12-22%, P < 0.0001), and phonophobia 14% (95% CI 17-20%, P < 0.0001). The corresponding numbers at 4 h after dosing were 37% (95% CI 30-43%, P < 0.0001), 34% (95% CI 29-39%, P < 0.0001) and 30% (95% CI 23-36%, P < 0.0001), respectively. Frovatriptan caused more adverse events than did placebo (RR 1.31, 95% CI 1.07-1.62, P = 0.01). CONCLUSION The available evidence suggests that frovatriptan is more effective but may cause more adverse events than placebo in the treatment of acute moderate to severe migraine. It is effective in providing pain relief and reducing the risk of recurrence. However, its effectiveness relative to other more established agents needs to be better defined by appropriate head to head trials.