The results were presented today at the 46th American Headache Society annual meeting.
"Patients too often will delay taking prescription medication, believing the pain will go away, which is not the optimal way to treat migraines," said Dr. Jan Brandes, clinical instructor in the department of neurology at Vanderbilt University School of Medicine and a neurologist at the Nashville Neuroscience Group. "This study provides new evidence that migraine sufferers should treat at the first signs of an attack, and clearly demonstrates the effectiveness of Relpax in treating migraine, especially when taken early during the mild pain phase."
Overall, migraine patients taking Relpax 40 mg, the recommended daily dose, experienced significantly higher two-hour pain-free rates than those taking placebo (47 percent vs. 22 percent). Among patients who waited to take Relpax 40 mg until the attack became moderate to severe, two-hour pain-free rates were 39 percent (compared with 21 percent taking placebo). However, among the 25 percent of patients who treated their attack with Relpax 40 mg when the pain was still mild, two-hour pain-free rates jumped to 68 percent (compared with 25 percent taking placebo). The highest two-hour pain-free rates were seen among patients with mild pain taking Relpax 40 mg within 30 minutes of pain onset (71 percent vs. 23 percent on placebo). In addition, sustained pain-free rates were higher for patients who treated with Relpax 40 mg when the pain was mild (56 percent) compared with those treating when the pain was moderate to severe (30 percent).
"I was always reluctant to treat my migraine right away, thinking there was a chance that the pain wouldn't get any worse or that maybe it wasn't a migraine this time. Of course, it usually got worse," said Vanessa Simmons, a 26-year old migraine sufferer. "Taking my doctor's advice, I've gotten in the habit of treating as soon as I feel an attack coming on and I am still amazed at how quickly the pain goes away when I treat early with Relpax, and I am able to get back to my day."
The study findings are from a randomized, double-blind, placebo-controlled clinical trial of 613 patients aged 18-65 who met the International Headache Society criteria for migraine. Patients were randomly assigned Relpax 20 mg, Relpax 40 mg or placebo to treat a single migraine attack. Regardless of pain severity, patients took the study medication as soon as they were sure the headache was a migraine. The primary outcome was the pain-free rate two hours after dose.
About Migraine
It is estimated that 28 million Americans suffer from migraine, including almost one in five women and one in 15 men. Migraine is a severe, throbbing pain usually on one side of the head, often accompanied by nausea and sensitivity to light and sound. Migraine usually lasts from a few hours to several days, impairing the most routine activities.
One study published in 1999 estimated that migraines cost American employers about $13 billion a year due to missed workdays and impaired work function. Migraine is most prevalent among people 25 to 55 years of age – the peak productive years.
Despite the impact and prevalence of migraine, the condition remains significantly underdiagnosed and undertreated. Less than half of sufferers are diagnosed and about 40 percent treat their pain with prescription medication. In addition, surveys of migraine sufferers have found that about two-thirds are dissatisfied with current treatment.
About Relpax
Relpax® (eletriptan HBr) is a product in the class of drugs known as "triptans." It has been studied in clinical trials involving more than 9,000 patients and more than 70,000 migraine attacks and shown to provide relief of migraine pain and its associated symptoms of nausea and sensitivity to light and sound. For some people, Relpax starts to work in as little as 30 minutes and most people get relief within two hours. Clinical studies have also shown that more people experienced relief with one dose of Relpax than those taking Imitrex® (sumatriptan).
The most common side effects reported in clinical trials with Relpax compared with placebo included dizziness (6 percent vs. 3 percent), nausea (5 percent vs. 5 percent), weakness (5 percent vs. 3 percent), and tiredness (6 percent vs. 3 percent). The adverse events seen with Relpax are similar to adverse events reported with triptans as a class.
As with other triptans, it is strongly recommended that Relpax not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors, unless a clinical evaluation provides evidence that the patient is free of underlying cardiovascular disease. Relpax should not be used within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir.
Full prescribing information for Relpax® (eletriptan HBr) is available upon request. For more information on RELPAX visit www.relpax.com or call 1-866-4-RELPAX.
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