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Frovatriptan Comparable to Sumatriptan in the Treatment of Migraine: Presented at IHS/AHS

By Liz Meszaros

PHILADELPHIA -- September 12, 2009 -- Therapy with frovatriptan may provide a viable option to treatment with sumatriptan in patients with migraine, according to an analysis presented here on September 11 at the 14th Congress of the International Headache Society & the 51st Annual Scientific Meeting of the American Headache Society (IHS/AHS).

In the head-to-head trial, frovatriptan had similar rates of sustained pain-free response with no adverse events at 4 to 24 hours and sustained pain response with no adverse events at 2 to 24 and 4 to 24 hours compared with sumatriptan. Frovatriptan was also better tolerated than sumatriptan, with significantly fewer adverse events.

John Campbell, BSc, Endo Pharmaceuticals Inc., Chadds Ford, Pennsylvania, and colleagues conducted a post hoc analysis of a multicentre, double-blind, randomised, placebo-controlled, parallel-group phase 3 trial, conducted from May 1, 1997, through January 29, 1998.

Data from 1,206 patients were included. All were aged 18 years or older, with a >=1 year history of International Headache Society-defined migraine, and 1 to 8 moderate or severe attacks per month for the previous 2 months, who treated 1 attack with frovatriptan 2.5 mg, sumatriptan 100 mg, or placebo.

Patients rated migraine severity immediately before, and at 2, 4, 6, 12, and 24 hours postdosing, and recorded adverse events.

This post hoc analysis evaluated sustained pain-free response (SPF) defined as being pain free at 4 hours with no rescue medication needed or recurrence within 24 hours, SPF with no adverse events (SNAE), sustained pain response (SPR), and SPR with no adverse events (SPRNAE). Endpoints were analysed using a 2-sample test for equality of proportions without continuity correction.

Efficacy of the patients was assessed using the intent-to-treat patient population (n = 1,196). In patients treated with frovatriptan, the rate of SNAE from 4 to 24 hours was 10.4% (49/472), compared with 9.1% (43/474) in patients treated with sumatriptan (P = .50 vs frovatriptan), and 2.9% (7/241) in those treated with placebo (P = .001 vs frovatriptan).

The SPRNAE rate was similar in the frovatriptan and sumatriptan groups from 2 to 24 hours, at 12.3% (58/472) for frovatriptan compared with 12.9% (61/474) for sumatriptan (P = .79 vs frovatriptan). It was significantly lower in the placebo group at 6.6% (16/241; P = .02 vs frovatriptan).

The SPRNAE rate from 4 to 24 hours was numerically higher for frovatriptan than sumatriptan (17.8% vs 16.9%, respectively; P = 0.71), and significantly lower in the placebo group (8.3%; P = .001).

In addition, significantly fewer patients treated with frovatriptan experienced adverse events (36.0% vs 43.6%; P = .02). Nausea, paresthesia, skeletal pain, vomiting, and asthenia were significantly more common with sumatriptan vs frovatriptan (P < .05 for each).

"Frovatriptan may be a good option for patients with slower-onset, longer-duration, or recurrent migraines or for patients who have difficulty tolerating sumatriptan," said Campbell. "In this head-to-head trial, SNAE and SPRNAE rates for frovatriptan and sumatriptan were equivalent. Thus, patients might benefit from a trial of frovatriptan if they have longer duration or recurrent migraine, or difficulty tolerating sumatriptan."

Funding for this study was provided by Endo Pharmaceuticals Inc.

[Presentation title: Acute Migraine Therapy With Frovatriptan vs Sumatriptan: Comparison Based on Sustained Pain-free Response With No Adverse Events. Abstract PO20]

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