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.