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( Headache 2011;51:664-673) To evaluate the impact of a sumatriptan/naproxen sodium combination tablet on patient satisfaction, productivity, and functional disability in menstrual migraine treated during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea. Menstrual migraineurs with dysmenorrhea represent a unique patient population not previously studied. When health outcomes end points are analyzed alongside traditional efficacy end points in migraine studies, a more comprehensive and robust understanding of the many factors that may influence patients' choice of and adherence to pharmacological treatments for migraine is observed. In 2 replicate, multicenter, randomized, double-blind, placebo-controlled trials, participants with menstrual migraine and dysmenorrhea treated a single menstrual migraine attack with a single fixed-dose tablet of sumatriptan 85 mg formulated with RT Technology™ and naproxen sodium 500 mg (sumatriptan-naproxen sodium) or placebo. Participants randomized to sumatriptan-naproxen sodium were significantly more satisfied than those randomized to placebo at 24 hours post dose, as demonstrated by higher satisfaction subscale scores for efficacy ( P < .001 for both studies), functionality ( P = .003 for study 1; P < .001 for study 2), and ease of use ( P = .027 for study 1; P = .011 for study 2). There was little bothersomeness of side effects associated with either treatment. Use of sumatriptan-naproxen sodium was also associated with lower reported 'lost-time equivalents' in work and leisure time (pooled analysis, P = .003) and lower rates of functional disability ( P = .05, study 1; P < .001, study 2) compared with placebo. A fixed-dose combination tablet containing sumatriptan and naproxen sodium significantly improved patient satisfaction, productivity, and restoration of normal functioning in menstrual migraineurs with dysmenorrhea. [ABSTRACT FROM AUTHOR]

Objective.— To evaluate the efficacy and tolerability of coadministration of rizatriptan and acetaminophen in the acute treatment of migraine. Background.— Rizatriptan is a selective 5-HT1B/1D agonist approved for the acute treatment of migraine. Acetaminophen has been studied for acute migraine treatment. In consideration of the prominent central and peripheral mechanisms in migraine, the use of “multi-mechanism therapy” is gaining momentum in the treatment of acute migraine attacks. Study Design.— This was a randomized, double-blind, placebo-controlled trial conducted at 10 centers. Eligible patients with migraine according to International Headache Society criteria treated a single migraine attack of moderate or severe intensity within 4 h from pain onset. Patients were randomized into 1 of 4 groups (rizatriptan 10 mg + acetaminophen 1000 mg [RA], rizatriptan alone [R], acetaminophen alone [A], and placebo [P]). There were 3 co-primary hypotheses tested sequentially for 2-h pain relief: (1) RA would be superior to P; (2) if the first was fulfilled, RA would be superior to A; and (3) if the first 2 were fulfilled, RA would be superior to R. Results.— Of 173 patients who treated a migraine, 123 patients (71.5%) achieved pain relief within 2 h. RA (90%) was significantly better than P (46%) and A (70%), but only numerically better than R (77%) for 2-h pain relief. No significant differences were seen between the active treatment groups in adverse events. Conclusion.— Rizatriptan coadministered with acetaminophen achieved 2 of the 3 primary hypotheses, proving superior to both acetaminophen and placebo for 2-h pain relief, but failing to achieve superiority to rizatriptan alone. RA was as well tolerated as each of the individual agents. [ABSTRACT FROM AUTHOR]

Introduction.— Chronic migraine is a recent diagnostic term that has undergone evolution from its original description. Clinically it has been believed that medication overuse contributed to its development and would block attempts at prevention. Previous studies with Botulinum Toxin Type A have demonstrated that it is effective even in patients with medication overuse. This study undertakes to examine the effects of Botulinum Toxin Type A in the absence of medication overuse in patients with chronic migraine. Study Design.— Double-blind placebo-controlled randomized trial of Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm. Patients.— In total, 86 patients were enrolled. A total of 60 patients were randomized and 41 patients were treated with the study medication or placebo. Five patients failed to complete the study, which lasted 4 months after the study medication was injected. Results.— Botulinum Toxin Type A was statistically superior to placebo for the primary endpoint of reduction in migraine headache episodes. Six patients on Botulinum Toxin Type A compared with 3 patients on Placebo had at least a 50% reduction in their migraine episodes. Active treatment was superior to placebo for the secondary endpoints of total headache days, headache index, and quality of life measures. It showed numerical superiority to placebo for acute medication use and Migraine Disability Assessment Scores. Adverse events were rare and similar in both treatment groups. Conclusions.— The use of Botulinum Toxin Type A may be an effective treatment for chronic migraine when the patient does not have concomitant medication overuse. It was well tolerated in this trial. [ABSTRACT FROM AUTHOR]

Migraine is a chronic, intermittently disabling condition that affects physical, mental, and social aspects of health-related quality of life. Because patients seeking assistance with migraine most often present to primary care providers, these healthcare professionals play critical roles in the diagnosis and treatment process. A comprehensive migraine management plan involves a partnership between the patient and healthcare professional where treatment goals and strategies are established. Elements of such a plan should include preventive strategies to reduce the frequency and effects of future attacks as well as the use of acute treatments to address the immediate need for relief during an attack. Approaches to prevention include education, lifestyle modification, and, often, appropriate medication. Many medications have been used for acute treatment. Nonspecific agents include nonsteroidal anti-inflammatory drugs (NSAIDs), single or combination analgesics (sometimes including antiemetics or caffeine), and narcotics. Migraine-specific medications include ergot alkaloids and triptans (5-hydroxytryptamine1B/1D agonists). Various professional organizations have created guidelines to help providers in choosing appropriate management interventions. Clinical approaches to the patient with migraine include step care, whereby all patients begin on a simple or nonspecific treatment, stepping up to the next level of therapy if treatment is unsuccessful; or stratified care, whereby first-line therapy is tailored to the severity of the patient’s pattern of headache. Studies have demonstrated that for more disabled headache patients, the stratified-care approach results in more robust headache response with less disability and greater cost-effectiveness than step care. Patient satisfaction studies demonstrate that the use of migraine-specific abortive medications (triptans) is associated with a higher satisfaction rate than over-the-counter preparations, NSAIDs, and analgesic combinations. Patients who initially reported satisfaction with the latter medications also reported a preference for triptan therapy. Healthcare professionals can assist patients, not only by choosing the most appropriate medication but also by assessing whether the level of benefit the patient is currently receiving could be improved. [Copyright &y& Elsevier]

Objective.—To evaluate the effectiveness of eletriptan as a treatment for acute migraine in patients who were poor responders to Excedrin and had not yet been exposed to a triptan. Background.—Self-medication with over-the-counter drugs, such as Excedrin, is the most common treatment for migraine. Guidelines, however, recommend that triptans be used as first-line treatment of moderate to severe migraine—the severity affecting approximately 80% of migraineurs. Since over-the-counter medications, such as Excedrin, continue to be used in many patients, it is important that clinicians have information on the efficacy of triptans as first-line treatment and on treatment of migraineurs who have shown poor response to over-the-counter medications. Methods.—One hundred ten patients meeting criteria for migraine who were poor responders to Excedrin received open-label treatment with a 40-mg dose of eletriptan for one migraine attack. Efficacy assessments were made at 1, 2, 4, and 24 hours postdose and consisted of headache and pain-free response rates, absence of associated symptoms, and functional response. Results.—At 1 hour, the headache response rate was 44%; at 2 hours, 81%. The pain-free response rate at 1 hour was 14% and at 2 hours, 48%. At 2 hours, relief of baseline-associated symptoms ranged from 74% to 80%. Functional response was achieved by 82% of patients by 2 hours, and 68% of patients achieved relief of migraine that was sustained across 24 hours with no need for a second dose of eletriptan or for rescue medication. Eletriptan was well tolerated with adverse events being transient and mild to moderate in intensity. Conclusion.—Previous studies have established the efficacy of eletriptan as a first-line treatment for migraine. The results of this open-label trial demonstrate that the 40-mg dose of eletriptan had a high degree of efficacy and tolerability among patients who were poor responders to Excedrin. [ABSTRACT FROM AUTHOR]

Context: Small open-label and controlled trials suggest that the antiepileptic drug topiramate is effective for migraine prevention. Objective: To assess the efficacy and safety of topiramate for migraine prevention in a large controlled trial. Design, Setting, and Patients: A 26-week, randomized, double-blind, placebo-controlled study was conducted during outpatient treatment at 52 North American clinical centers. Patients were aged 12 to 65 years and had a 6-month history of migraine (International Headache Society criteria) and 3 to 12 migraines a month but no more than 15 headache days a month during a 28-day prospective baseline phase. Interventions: After a washout period, patients meeting entry criteria were randomized to topiramate (50, 100, or 200 mg/d) or placebo. Topiramate was titrated by 25 mg/wk for 8 weeks to the assigned or maximum tolerated dose, whichever was less. Patients continued receiving that dose for 18 weeks. Main Outcome Measures: The primary efficacy measure was change from baseline in mean monthly migraine frequency. Secondary efficacy measures included responder rate (proportion of patients with ≥50% reduction in monthly migraine frequency), reductions in mean number of monthly migraine days, severity, duration, and days a month requiring rescue medication, and adverse events. The month of onset of preventive treatment action was assessed. Results: Of 483 patients randomized, 468 provided at least 1 postbaseline efficacy assessment and comprised the intent-to-treat population. Mean monthly migraine frequency decreased significantly for patients receiving topiramate at 100 mg/d (-2.1, P = .008) and topiramate at 200 mg/d (-2.4, P<.001) vs placebo (-1.1). Statistically significant reductions (P<.05) occurred within the first month with topiramate at 100 and 200 mg/d. The responder rate was significantly greater with topiramate at 50 mg/d (39%, P = .01), 100 mg/d (49%, P<.001), and 200 mg/d (47%, P<.001) vs placebo (23%). Reduct... [ABSTRACT FROM AUTHOR]