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| |  ASH MEETING: Imitrex Nasal Spray Effective For Adolescents With Acute Migraine BOSTON, MA -- June 14, 1999 -- Glaxo Wellcome Inc.’s Imitrex(R) (sumatriptan) Nasal Spray, a prescription drug for adults for the treatment of migraine, appears promising in the acute treatment of migraine in adolescents ages 12 to 17 according to data presented at the 41st annual American Association for the Study of Headache (AASH) scientific meeting. The study of more than 510 patients was designed to evaluate the safety and effectiveness of Imitrex Nasal Spray in adolescent migraineurs. "These data are important particularly because in adolescent patients, migraines are typically shorter in duration, making it difficult to evaluate the benefits of some adult medications," said Paul Winner, D.O., lead author of the study and director of the Palm Beach Headache Center where he specialises in treating children and adolescents with headaches. "These results suggest potential benefits of Imitrex Nasal Spray for the treatment of migraine in adolescents." In a double-blind, placebo-controlled trial in 46 sites across the United States, 653 migraine patients 12 to 17 years of age and diagnosed according to the International Headache Society criteria were randomised for treatment -- 510 were treated for a single migraine attack. The participants were divided into four groups: each group received placebo or one of the three doses of Imitrex Nasal Spray -- 5mg, 10mg or 20mg. The subjects self-administered the study medication on an outpatient basis under the supervision of a parent or guardian. The study measured headache relief rates, headache recurrence, associated migraine symptoms (sensitivity to light and sound) and adverse events for participants in each of the four treatment groups. Headache relief (severe or moderate pain reduced to mild or no pain) was reported as early as one hour postdose by 47 percent and 56 percent of patients using Imitrex Nasal Spray (10mg and 20mg respectively) compared with 41 percent of placebo patients. Headache relief two hours postdose was reported by more patients taking Imitrex Nasal Spray (66 percent, 64 percent and 63 percent at 5mg, 10mg and 20mg respectively) compared with 53 percent of patients taking placebo. Sensitivity to light and sound was reported less frequently two hours postdose among patients using Imitrex Nasal Spray 20mg versus placebo. -- sensitivity to light: 38 percent, 43 percent and 36 percent in patients taking Imitrex Nasal Spray 5mg, 10mg and 20mg respectively versus 48 percent for placebo There was no difference between groups in the use of rescue medication or incidence of headache recurrence. Taste disturbance, reported by two percent of patients taking placebo and 19 to 30 percent of patients taking Imitrex Nasal Spray, was the most common adverse event. When taste disturbance was not included in the calculation, the overall incidence of adverse events in the Imitrex groups was similar to placebo (reported by 39 percent of patients taking placebo and 29 percent, 28 percent and 42 percent in Imitrex 5mg, 10mg and 20mg respectively). Nausea was the most commonly reported adverse event after taste disturbance (reported by 17 percent of patients taking placebo and 13 percent, seven percent and 21 percent in Imitrex 5mg, 10mg and 20mg respectively). Imitrex Nasal Spray was generally well tolerated by patients in this study. From four to 10 percent of all school age children in the United States suffer from migraine, a debilitating biological disease that is characterised by severe head pain and often accompanied by one or more of the following symptoms: nausea, vomiting, and sensitivity to light, sound or smell. Migraines in adolescents are similar to those in adults but they are typically shorter in duration (two-48 hours in adolescents versus four-72 hours in adults). "Effective treatment for adolescent migraine sufferers is important since these debilitating headaches can lead to an increased absence from school and interfere with other important activities," Dr. Winner said. "Knowing that treatments are being studied for this population offers tremendous hope." Imitrex is not approved for use in adolescents. It is a selective serotonin (5-HT1) agonist indicated for the acute treatment of migraine with or without aura in adults (18 years and older). When introduced in 1993, Imitrex was the first medication in 50 years specifically formulated for the acute treatment of migraine. It has been used to treat more than 180 million migraine attacks in nine million patients world-wide. Imitrex should only be used when a clear diagnosis of migraine has been established. It is not intended for the prophylactic therapy of migraine or for use in the management of basilar or hemiplegic migraine. Imitrex is contraindicated in patients with history, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes, or other significant underlying cardiovascular diseases. Therefore, patients with risk factors for heart disease should be evaluated by a physician to determine if Imitrex is appropriate therapy. Patients who experience signs or symptoms of coronary vasospasm or other vasospastic reactions following Imitrex should be evaluated before receiving additional doses. Imitrex is contraindicated in patients with uncontrolled hypertension because it may increase blood pressure. Related Links: Imitrex, Glaxo Wellcome Inc.
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