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| |  Almotriptan Effective, Well Tolerated for Treatment of Menstrually Related Migraine: Presented at IHS/AHS By Liz Meszaros PHILADELPHIA -- September 13, 2009 -- Almotriptan is safe and effective in the treatment of menstrually related migraine (MRM), according to data presented here on September 12 at the 14th Congress of the International Headache Society & the 51st Annual Scientific Meeting of the American Headache Society (IHS/AHS). In a randomised, prospective, crossover, double-blind, placebo-controlled, multicentre study, 122 patients with MRM received treatment of 2 consecutive MRM attacks in 2 distinct menstrual cycles, followed by an open follow-up phase consisting of treatment with almotriptan 12.5 mg of 2 further MRM attacks. All patients suffered MRM with regular menstrual cycles, and had at least a 1-year history of migraine and a minimum 6-month history of regularly occurring MRM. For the primary endpoint of the study -- pain-free at 2 hours after treatment -- almotriptan was superior to placebo (48.4% vs 26.2%, respectively; risk ratio [RR] = 1.81; 95% confidence interval [CI], 1.28-2.57; P = .0008). Almotriptan was also superior to placebo in achieving secondary endpoints, including a sustained pain-free state (36.1% vs 17.2%; P = .0022), sustained pain-free state with no adverse events (33.6% vs 16.4%; P = .0061), and rescue medication use (39.3% vs 59.8%; P = .0004). “Over time, sustained pain-free status and sustained pain-free status with no adverse effects were achieved by twice as many patients treated with almotriptan compared with placebo,” noted Gianni Allais, MD, Women’s Headache Centre, Department of Gynaecology and Obstetrics, University of Torino, Turin, Italy. Significant differences were also seen in migraine-associated symptoms at 2 hours in patients treated with almotriptan versus placebo, respectively, including nausea (19% vs 36.7%; P = .0007), photophobia (33.1% vs 49.2%; P = .0083), and phonophobia (30.6% vs 41.7%; P = .0566). During the open phase of the trial, similar or improved results were seen in all evaluated parameters. For both the almotriptan and placebo groups, the rate of adverse events was approximately 6%. “In a population affected by difficult-to-treat migraines such as MRM, these clinical data confirm the statistically significant superiority of almotriptan over placebo,” concluded Dr. Allais. “In consideration of its efficacy and tolerability, almotriptan may be considered a first-choice treatment of mild and moderate to severe pain in women affected by MRM.” [Presentation title: A Randomized, Prospective, Cross-Over, Double Blind, Placebo-Controlled Multicentre Study to Assess the Efficacy and Tolerability of Almotriptan 12.5 mg in Menstrually-Related Migraine. Abstract PO05]a
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