Stability, responsiveness, and reproducibility of a visual analog scale for treatment satisfaction in migraine

Objectives.— To evaluate the stability, responsiveness, and reproducibility of a simple visual analog scale (VAS). Background.— In order to help physicians in the management of migraine in everyday general practice and assess whether the treatments that they are currently prescribing are actually effective, a VAS of treatment satisfaction with acute migraine treatments has been developed. Methods.— The study used an open‐label, multicenter, prospective design. Adult patients fulfilling diagnostic criteria for migraine and who consulted a participating hospital or community neurology clinic were eligible. At inclusion, patients rated their satisfaction with their current treatment on the VAS. Those scoring 7‐10 (satisfied) on the VAS were allocated to the VASCO cohort, and those scoring 0‐4 (dissatisfied) were switched to almotriptan and allocated to the ALMO cohort. Patients scoring between 4 and 7 were assigned to 1 or other cohort at the physician's discretion. The VAS was re‐administered at home the next day and also after the treatment of 3 further headaches, both at home and at a follow‐up visit. Results.— Ninety‐eight patients in the VASCO cohort and 102 in the ALMO cohort were analyzed. Stability was evaluated in the VASCO cohort: 55/98 patients initially satisfied with treatment remained so at study end, whereas 7/98 became dissatisfied. Responsiveness of the VAS to a change in treatment was evaluated in the ALMO cohort: 64/102 patients moved to a higher treatment satisfaction category, whereas 6/102 moved to a lower one. Reproducibility of the VAS was determined in 4 settings (both at the inclusion visit and at study closure in both cohorts). In each setting, VAS scores were compared between consultation and at‐home ratings. In 3 of the 4 settings (both measures in the ALMO cohort and at study closure in the VASCO cohort), good agreement was observed between the 2 ratings (κ = 0.62‐0.69). At inclusion in the VASCO cohort, agreement was only fair (κ = 0.33). Conclusions.— The VAS scale described here is a responsive and easy‐to‐use tool for evaluating treatment satisfaction and for monitoring changes to treatment if these are required.     

Use of antimigraine treatments by general practitioners

(Headache 2011;51:1122‐1131) Objectives.— To assess headache treatment patterns in 2 groups: general practitioners (GPs) who suffered from migraine themselves (GP‐M) and GPs having a close family member with migraine (GP‐CFM). The secondary objective was to assess the impact of migraine on activities of daily living in these 2 groups. Background.— Personal experience of migraine may influence prescribing practices of physicians treating patients with migraine. Little data are available on perceptions of migraine by GPs. Methods.— This was an observational, cross‐sectional, pharmacoepidemiological survey conducted in primary care in France. Most GPs completed 1 of 2 questionnaires, and GPs belonging to both groups could complete both. Data were collected on headache treatments used (GP‐M) or prescribed (GP‐CFM), and on self‐reported (GP‐M) or described (GP‐CFM) migraine features and impact on daily activities. Results.— The most frequently reported acute headache treatments in both groups were triptans and non‐steroidal anti‐inflammatory drugs (>75% of GPs); >81% of GPs in both groups were satisfied with acute headache treatments. Only 6.9% of the GP‐M group used and 17.2% of the GP‐CFM group prescribed a prophylactic treatment, which was considered satisfactory by 46.2% and 56.1%, respectively. In the preceding 3 months, 79.4% of the GP‐M group reported handicap in daily activities due to migraine, 23.6% interruption of extraprofessional activities and 7.6% interruption of work. In the GP‐CFM group, 32.6% described interruption of extraprofessional activities and 57.3% interference with daily activities or work. Conclusions.— Acute headache treatment prescribed by French GPs for their own migraines or those of their relatives respect practice guidelines and is considered as effective and satisfactory. Use of prophylactic medication is low and its effectiveness perceived as limited. Better use of prophylactic treatments may attenuate the impact of migraine on daily activities.     

Responsiveness of migraine-ACT and MIDAS questionnaires for assessing migraine therapy

Background.— Migraine is frequently undertreated. The 4‐item Migraine Assessment of Current Therapy (Migraine‐ACT) questionnaire is a simple and reliable tool to identify patients requiring a change in current acute migraine treatment. Objective.— To investigate the responsiveness of the Migraine‐ACT tool, and compare it with that of the Migraine Disability Assessment (MIDAS) questionnaire, for patients with migraine at 1100 primary care sites in Spain. Methods.— Patients eligible for this open‐label, 2‐visit prospective study reported migraine for >1 year and ≥1 migraine attack per month and were new to the clinic or on follow‐up care for <6 months. Validated Spanish versions of the Migraine‐ACT and MIDAS questionnaires were administered, and patient satisfaction with treatment was recorded, at baseline and at 3 months. Results.— A total of 3272 patients, 78% female, were enrolled, and 2877 (88%) returned for the 3‐month visit. Investigators changed baseline migraine treatment for 72% of returning patients; 85% and 80% of these patients had improved Migraine‐ACT and MIDAS scores at 3 months, respectively. Patients who reported being completely or very satisfied with migraine treatment numbered 492 (15%) at baseline and 1406 (49%) at 3 months. Migraine‐ACT and MIDAS score agreement for improvement at 3 months was poor (κ = 0.339). Both the mean MIDAS score and the distribution of Migraine‐ACT scores improved over the course of 3 months; however, Migraine‐ACT scores were significantly (P < .001) more sensitive (83% vs 75%) and specific (72% vs 58%) than MIDAS scores. The area under the curve in the receiver‐operating characteristic analysis was significantly (P < .0001) greater for Migraine‐ACT (0.82) as compared with the MIDAS (0.70) questionnaire. Conclusions.— These results suggest that the Migraine‐ACT questionnaire can be used more reliably than the MIDAS questionnaire for detecting improvements in treatment of new and follow‐up patients with migraine.     

"Mixing triptans": patient satisfaction

(Headache 2011;51:135‐140) Background.— Although some patients may prefer using an oral triptan other than sumatriptan and injectable sumatriptan to treat an attack of persistent migraine, administration of 2 different triptans within a 24‐hour period currently is contradicted. Objective.— We sought to determine patient satisfaction with an acute migraine treatment regimen wherein patients were permitted to administer an oral triptan other than sumatriptan and injectable sumatriptan within 24 hours of one another Methods.— We evaluated a consecutive series of migraine patients who either had tried and failed oral sumatriptan or were using another oral triptan and were satisfied with it. We advised subjects that they could administer their oral triptan and injectable sumatriptan within a single 24‐hour period (but not within 2 hours of one another); we termed such treatment “mixing triptans.” We asked all subjects to keep detailed written headache diaries for the 6‐month treatment period, and at the 6‐month end‐of‐study visit we asked subjects who had treated at least 3 migraine attacks by mixing triptans to rate their satisfaction with that treatment according to a 5‐point Likert scale. Results.— Of the 200 subjects enrolled, 132 (66%) used an oral triptan other than sumatriptan and injectable sumatriptan within a 24‐hour period on at least 3 occasions. At their final follow‐up visits, 117 (89%) of the 132 reported themselves “very satisfied” or “satisfied” with this specific treatment regimen. No serious adverse events were recorded. Conclusion.— The option of sequentially using an oral triptan other than sumatriptan and injectable sumatriptan to treat a given attack of migraine appears to correlate with a high rate of patient satisfaction. While in our subject population this treatment regimen was well tolerated, our study results do not suffice to establish the safety of “mixing triptans.”     

Rescue therapy for acute migraine, part 1: triptans, dihydroergotamine, and magnesium

Objective.— To review and analyze published reports on the acute treatment of migraine headache with triptans, dihydroergotamine (DHE), and magnesium in emergency department, urgent care, and headache clinic settings. Methods.— MEDLINE was searched using the terms “migraine” and “emergency,” and “therapy” or “treatment.” Reports from emergency department and urgent care settings that involved all routes of medication delivery were included. Reports from headache clinic settings were included only if medications were delivered by a parenteral route. Results.— Acute rescue treatment studies involving the triptans were available for injectable and nasal sumatriptan, as well as rizatriptan. Effectiveness varied widely, even when the pain‐free and pain‐relief statistics were evaluated separately. As these medications are known to work best early in the migraine, part of this variability may be attributed to the timing of triptan administration. Multiple studies compared triptans with anti‐emetics, dopamine antagonists, and non‐steroidal anti‐inflammatory drugs. The overall percentage of patients with pain relief after taking sumatriptan was roughly equivalent to that recorded with droperidol and prochlorperazine. Sumatriptan was equivalent to DHE when only paired comparisons were performed. While the data extracted suggest that magnesium may be effective in treating all symptoms in patients experiencing migraine with aura across all migraine patients, its effectiveness seems to be limited to treating only photophobia and phonophobia. Conclusions.— Although there are relatively few studies involving health‐care provider‐administered triptans or DHE for acute rescue, they appear to be equivalent to the dopamine antagonists for migraine pain relief. The relatively rare inclusion of a placebo arm and the frequent use of combination medications in active treatment arms complicate the comparison of single agents with each other.     

Sumatriptan-naproxen migraine efficacy in allodynic patients: early intervention

Objective.— This study evaluated the effectiveness of a single fixed‐dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg (sumatriptan–naproxen) using a very early treatment paradigm in migraine patients whose attacks were historically accompanied by cutaneous allodynia. Background.— Evidence suggests that allodynic migraineurs may demonstrate a better response when treated prior to developing central sensitization, and that these patients are treated more effectively with a compound of sumatriptan and naproxen sodium than either drug alone. This study targeted patients who have accompanying allodynia using a very early treatment paradigm where treatment was initiated while symptoms were still mild. Methods.— This was an open‐label prospective, outpatient study of adult migraineurs who had screened positive for cutaneous allodynia and typically experienced moderate to severe pain preceded by an identifiable mild pain phase. Patients were treated with sumatriptan–naproxen using a very early intervention paradigm in 4 test migraines over 12 weeks where dosage occurred within 30 minutes of symptom onset. Data from diaries and questionnaires were used to evaluate the primary endpoints of sustained pain‐free response at 24 hours post dose (using no second dose of study drug and no other rescue drugs), and overall satisfaction with sumatriptan–naproxen. Results.— Forty allodynic migraineurs enrolled in this study and reported a total of 160 migraines. Of these migraines, 78 (49%) achieved sustained pain‐free at 24 hours and 94 (59%) were reported as pain‐free at 2 hours. The number of patients who rated their Overall Satisfaction following treatment with sumatriptan–naproxen as “Satisfied” (satisfied or very satisfied) was 32 (80%) after the first migraine and 25 (63%) after 3 or more migraines. Conclusions.— In this open‐label study, allodynic patients reported that their migraine attacks responded well and they achieved a high degree of satisfaction following treatment with a fixed‐dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg administered in a very early treatment paradigm.     

Examining the utility of in-clinic "rescue" therapy for acute migraine

Background.— Management options currently are limited for patients with acute migraine whose symptoms prove refractory to self‐administered therapy. Objective.— To evaluate the clinical utility and cost‐effectiveness of a management program offering in‐clinic “rescue” treatment for patients with acute migraine. Methods.— Two hundred consecutive migraine patients presenting to a university‐based headache clinic were randomized to receive either optimal self‐administered medical therapy for acute migraine (“standard therapy”) or similar therapy plus the option of in‐clinic parenteral drug administration should self‐administered therapy prove ineffective (“rescue therapy”). Patients randomized to the latter group were restricted to a maximum of 2 “rescue visits” per month, and all patients were followed for one year. Patients “rescued” in clinic were contacted by telephone 24 hours following treatment to evaluate their treatment response. The primary analysis involved a comparison of the number of emergency department (ED) visits for headache recorded within each group over the one‐year period of study. For all ED visits in the rescue group and for a randomly selected and equal number of ED visits within the standard group, the direct costs associated with those visits were assessed, and the direct costs of all in‐clinic rescue visits also were recorded and analyzed. Results.— The 2 groups studied were similar in terms of age, gender ratio, migraine subtype, migraine‐related disability status at baseline and type/extent of medical insurance coverage. Over the one‐year study period, the rescue group recorded 423 in‐clinic rescue visits and reported 27 ED visits for headache treatment. The standard therapy group reported 73 ED visits (27 vs 73 visits; P < .01). The total direct costs associated with ED visits were $45,330 for the rescue group (mean $1690 per ED visit) and (by extrapolation from the sample selected) $147,971 for the standard therapy group (mean $2027 per ED visit). The total direct cost of the 423 “rescue visits” was $33,647 (mean $80 per visit). In 79% of the 423 rescue encounters, the patients involved reported no residual functional disability 24 hours following treatment. Of those in the rescue group who sought in‐clinic rescue, 89% reported themselves “very satisfied” with such management. Conclusion.— Providing the alternative of in‐clinic “rescue” for acute migraine refractory to self‐administered therapy offers an attractive alternative for patients and appears to substantially lower use of an ED for headache treatment and the cost associated with that use.     

Rizatriptan for treatment of acute migraine in patients taking topiramate for migraine prophylaxis

Objective.— To assess efficacy and tolerability of rizatriptan orally disintegrating tablet (ODT) for treatment of acute migraine in patients using topiramate for migraine prophylaxis. Background.— There are limited data from prospective controlled trials demonstrating the benefit of triptans in patients who experience migraine attacks while taking prophylactic medication. Methods.— This was a worldwide, randomized, placebo‐controlled, double‐blind, multiple‐attack study in adults with a >1‐year history of migraine taking a stable dose of topiramate for migraine prophylaxis and experiencing ≥2 moderate/severe attacks per month. Participants treated 3 moderate/severe attacks in crossover fashion (2 with rizatriptan 10‐mg ODT, 1 with placebo) following random assignment to 1 of 3 treatment sequences. The primary end point was 2‐hour pain relief. Results.— Two‐hour pain relief was significantly greater with rizatriptan compared with placebo (55.0% vs 17.4%, P < .001). Response rates also favored rizatriptan for sustained pain relief from 2‐24 hours (32.6% vs 11.1%, P < .001), 2‐hour pain freedom (36.0% vs 6.5%, P < .001), normal functional ability at 2 hours (42.2% vs 12.7%, P < .001), and overall treatment satisfaction at 24 hours (60.8% vs 33.6%, P < .001). Few participants reported adverse experiences (16 [15.8%] with rizatriptan, 3 [3.2%] with placebo); none were serious. Conclusion.— Rizatriptan 10‐mg ODT was superior to placebo at all pain end points for treatment of acute migraine in patients using topiramate for migraine prophylaxis. Rizatriptan was generally well tolerated in this population. These results are comparable with those from clinical trials in patients not using prophylaxis, suggesting that the use of topiramate does not affect the efficacy or tolerability of rizatriptan for acute migraine treatment.     

Efficacy, tolerability, and patient satisfaction with 50- and 100-mg sumatriptan tablets in those initially dissatisfied with the efficacy of 50-mg sumatriptan tablets

BACKGROUND: Both 50- and 100-mg sumatriptan tablets are effective and well tolerated in the acute treatment of migraine. However, given a choice between the 2 doses, many patients in clinical practice and clinical studies prefer the 100-mg dose. OBJECTIVE: This study was designed to assess whether patients initially dissatisfied with the efficacy of 50-mg sumatriptan tablets would be satisfied with 100-mg sumatriptan tablets. METHODS: In phase 1 of the study, triptan-naive patients with migraine (International Headache Society diagnosis) received open-label treatment of 3 migraine attacks with 50-mg sumatriptan tablets. At the end of phase 1, those who were dissatisfied with the efficacy but satisfied with the tolerability of 50-mg sumatriptan tablets entered phase 2 and were randomized in a double-blind, parallel-group fashion to receive either 50- or 100-mg sumatriptan tablets for the treatment of 3 attacks. Patients who were satisfied with the efficacy or dissatisfied with the tolerability of the 50-mg tablets in phase 1 were given the option of continuing open-label treatment with 50-mg sumatriptan tablets in phase 2. The primary end point was the percentage of patients satisfied with medication at the end of phase 2 double-blind treatment. Patient satisfaction with specific medication attributes was assessed using the Patient Perception of Migraine Questionnaire. RESULTS: Seven hundred twenty-two patients were enrolled in phase 1 of the study (the intent-to-treat population), 609 of whom had evaluable satisfaction data at the end of open-label treatment. Three hundred twenty-six (54%) of these patients were satisfied with 50-mg sumatriptan tablets, whereas 283 (46%) were not satisfied. Among those who were dissatisfied, lack of efficacy was cited as the sole reason for dissatisfaction by 242 (86%). Two hundred thirty-one of those who were dissatisfied with efficacy only and wished to continue the study were randomized to double-blind treatment with either 50-mg sumatriptan tablets (n = 123; 82% female, 18% male; mean age, 37.6 years) or 100-mg sumatriptan tablets (n = 108; 86% female, 14% male; mean age, 36.0 years). The remaining 310 patients elected to continue open-label treatment with 50-mg sumatriptan tablets. At the end of double-blind treatment, 64 of 101 patients (63%) in the 100-mg group indicated that they were satisfied with treatment, compared with 55 of 113 (49%) in the 50-mg group (P = 0.031). Across the 3 attacks treated in the double-blind phase. headache relief 2 hours postdose was reported by 47% to 53% of patients in the 50-mg group and 45% to 60% of patients in the 100-mg group. The overall incidence of patients reporting > or =1 adverse event was 19% (23/123) in the 50-mg group and 22% (24/108) in the 100-mg group. CONCLUSIONS: For most patients, 50 mg is the appropriate starting dose of sumatriptan tablets. In patients who experience inadequate relief with 50 mg, increasing the dose to 100 mg is an appropriate therapeutic option.     

Migraine and Migraines of Specialists: Perceptions and Management

(Headache 2010;50:1115‐1125) Objectives.— To describe the perception of migraine by neurologists in France, to compare perceptions between neurologists who did and did not suffer from migraines and to describe treatments used for their own migraines. Background.— Patients with migraine are usually undertreated, as treatment guidelines are frequently not followed and, therefore, resulting treatment satisfaction is low. One reason for this may be inappropriate perceptions of physicians concerning the seriousness of the pathology and the need to treat. However, available information on physician perceptions of migraine is limited. Methods.— This was an observational, epidemiological survey conducted both in hospital‐ and community‐based neurologists in France. Participating neurologists completed an anonymous questionnaire which collected data on demographics, migraine status, and perceptions of migraine. Neurologists who considered themselves migraineurs also provided data on migraine impact, treatment and on treatment satisfaction. Distributions of responses to questions on migraine perceptions were compared between migraineur and nonmigraineur neurologists. Results.— The study included 368 neurologists, of whom 179 (48.6%) were migraineurs themselves. Some 92.3% of participants claimed to be very or quite interested in migraine. Migraine was considered a real illness by 96.5% of neurologists and to be very or quite disabling by 96.6%. Around half perceived migraine as a challenging condition to manage with respect to unrealistic patient expectations (46.2%), time‐consuming treatment (48.9%), and complications because of anxious or depressive comorbidity (59.9%) or medical nomadism (consulting multiple physicians for the same condition; 47.0%). No significant differences in any perception items were observed between migraineur and nonmigraineur neurologists. In total, 83.1% of neurologists were satisfied with acute headache treatments and 60.4% with prophylactic headache treatments. The most frequently reported treatments for neurologist's own migraines were nonsteroidal anti‐inflammatory drugs (used by 57.0%) and triptans (50.3%). Conclusions.— French neurologists are interested and concerned about migraine but find it challenging to treat. Migraine perceptions do not differ between neurologists who do and do not suffer from migraines themselves. Neurology training needs to prepare medical students adequately for the challenges of migraine treatment in terms of patient communication and psychiatric issues.     

The GRIM2005 study of migraine consultation in France II. Psychological factors associated with treatment response to acute headache therapy and satisfaction in migraine

The objective of this analysis was to identify variables associated with treatment response in subjects with migraine. Data were collected from a sample of 10 000 subjects. A battery of questionnaires assessing clinical and psychological variables was completed. Migraine diagnosis was attributed using an algorithm based on the IHS criteria and treatment response using the ANAES criteria. We identified 1534 subjects, of whom 1443 were treated. For 54.2%, at least one ANAES criterion for treatment response was unfulfilled. Non-response was associated with female gender, high HIT-6 impact scores and high HAD psychological distress scores. The strongest associations with non-response were identified for four psychological variables: elevated scores on the CSQ catastrophization subscale and the 'Consequences' and 'Acceptance' dimensions of the Brief COPE, and low scores on the 'Positive Reinterpretation' Brief COPE dimension. In conclusion, many individuals with migraine respond inadequately to treatment. Behavioural interventions aimed at modifying coping strategies may improve outcome.     

Treatment satisfaction and efficacy of the rapid release formulation of sumatriptan 100 mg tablets utilising an early intervention paradigm in patients previously unsatisfied with sumatriptan

Aims: To evaluate treatment satisfaction, efficacy and functional ability of the rapid release formulation of sumatriptan 100 mg tablets (sumatriptan RT 100 mg) in an early intervention paradigm in patients who were dissatisfied with low‐dose sumatriptan and not completely satisfied with their current migraine regimen. Methods: Experienced migraineurs who reported a mild migraine pain phase, dissatisfaction with the previous sumatriptan treatment and some dissatisfaction with their current treatment regimen had no experience with sumatriptan at the 100 mg dose were enrolled in an open‐label, single group study. Subjects were instructed to treat four migraine attacks within 30 min of the onset of mild pain. Treatment satisfaction was measured with the Patient Perception of Migraine Questionnaire Revised version (PPMQ‐R) questionnaire. Results: More than half of the subjects were either very satisfied or satisfied with the efficacy of early intervention sumatriptan RT 100 mg after each attack and at the follow‐up study visit. The mean total PPMQ‐R score was 75.2 out of 100. Between 63% and 73% of subjects were pain‐free within 4 h of dosing. Between 79% and 90% of subjects reported an ability to function normally within 4 h of taking the study medication. Conclusion: Subjects who were previously unsatisfied with lower doses of sumatriptan and less than very satisfied with their current treatment regimen were more likely to be satisfied or very satisfied with sumatriptan RT 100 mg in an early intervention paradigm. Results were consistent across four migraine attacks and at a follow‐up visit. The treatment satisfaction results corresponded with positive results on efficacy measures and a functional status measure.     

Satisfaction with current migraine therapy: experience from 3 centers in US and Sweden

OBJECTIVE: To assess the level of satisfaction and determinants of satisfaction or dissatisfaction of patients presenting in tertiary care, in regard to their usual care (UC) for the acute treatment of migraine. DESIGN/METHODS: Patients seen in 3 headache centers were assessed by means of 21 attributes related to their UC. Questions covered satisfaction with efficacy (including onset of relief, degree of relief, consistency of action, ease of use), tolerability (lack of side effects overall, CNS side effects, other side effects), and willingness to continue using the same medication and to change to another medication. All questions were answered on a 5-point scale (where 1 was strongly agree, 2 was agree, 3 was neutral, 4 was disagree, and 5 was strongly disagree). RESULTS: We assessed 183 subjects (74.8% women, mean age = 39.3 years). UC consisted, as a single drug or combination, of: triptan conventional tablets--62%; triptan disintegrating tablets--8%; sumatriptan nasal spray 9%; sumatriptan injection, 9%; nontriptans--19.6%. Most (54%) had no benefit within the first hour of treatment. The maximum benefit took more than 1 hour to be reached in 69%, and more than 2 hours in 36%. After the maximum benefit had been reached, pain worsened in 61%. Although 58% were satisfied with the degree of relief, 37% were dissatisfied with the speed of effect, 50% with the recurrence of pain, and 42% with the need for a second dose. Most were satisfied with the tolerability (56%). Finally, most (79.7%) said they were willing to try another acute medication. CONCLUSIONS: An important subset of patients, including a large subgroup of patients using triptans, is dissatisfied with their UC. Clinical trials assessing patients' preference should be conducted to complement the information from clinical trials.     

Oral transmucosal fentanyl citrate for the treatment of migraine headache pain in outpatients: a case series

BACKGROUND: Migraine headache pain that does not respond to traditional antimigraine medications frequently requires treatment in the emergency department (ED) with parenteral opioids. Rapid onset of pain relief in an outpatient setting for migraine headache is the primary objective of patients and clinicians. Oral transmucosal fentanyl citrate (OTFC; ACTIQ) is a novel opioid product designed to deliver rapid analgesia to patients who experience breakthrough pain (BTP). OBJECTIVE: To evaluate the effectiveness, tolerability, and patient satisfaction with OTFC for the outpatient treatment of acute, refractory migraine headache pain. PATIENTS AND METHODS: Twenty patients with recurrent acute, refractory migraine headaches who had been referred to this headache clinic are reported in this case series. All patients had a history of tolerating parenteral opioids in the ED when experiencing refractory migraine pain and had been treated with outpatient opioid therapies in attempts to manage their migraine pain. Patients were prescribed OTFC (400 microg) as rescue treatment for moderate or severe migraine headache pain as outpatients. Patients were instructed to self-administer OTFC at home and complete a diary recording: pain intensity (11-point scale; 10 = worst pain imaginable to 0 = no pain) before and 15, 30, 60, and 120 minutes after OTFC; satisfaction with the effectiveness of OTFC (selecting 1 of 7 categories ranging from "very dissatisfied" through "very satisfied") rated at 120 minutes; and adverse events. RESULTS: Eighteen patients (13 female) experienced a migraine and self-administered OTFC. OTFC successfully treated migraine episodes in all 18 outpatients; no patient went to an ED. OTFC rapidly reduced pain intensity, with significant improvement at 15 minutes that was sustained and provided progressively more pain relief at 30, 60, and 120 minutes (all P <.01). Mean (SEM) pain intensity significantly declined from 8.83 (0.35) pretreatment to 2.28 (0.67) at 120 minutes, an average reduction of 75% (P <.01). Patients' satisfaction ratings with OTFC were overwhelmingly positive, with 94% being satisfied and more than half (56%) being "very satisfied." Three (17%) patients experienced nausea, two (11%) somnolence, and one (6%) each itching, vomiting, and dry mouth. All adverse events were mild or moderate in severity. CONCLUSIONS: OTFC rapidly and significantly relieved acute, refractory migraine pain in outpatients, prevented the need for an ED visit, and was associated with high patient satisfaction ratings. The rapid onset of migraine headache pain relief in this case series is consistent with the analgesic effect reported with the use of OTFC in patients with BTP. OTFC was well tolerated in these patients who had a history of tolerating parenteral opioids in the ED when experiencing refractory migraine pain and had been treated with outpatient opioid therapies in attempts to manage their migraine pain. OTFC may be effective for outpatient treatment of acute, refractory migraine headache pain. Further controlled studies are warranted.     

Long-term evaluation of sumatriptan and naproxen sodium for the acute treatment of migraine in adolescents

Objectives.— To evaluate the long‐term safety, tolerability, effectiveness, impact on quality of life, and medication satisfaction of sumatriptan/naproxen sodium in the acute treatment of migraine headache in adolescents. Methods.— This 12‐month, multicenter, open‐label, safety study was conducted in adolescents (aged 12‐17 years) with an average of 2‐8 migraines/month typically lasting >2 hours untreated for >6 months prior to initiation. Subjects were instructed to treat migraines as early as possible and were allowed to rescue 2 hours post dose with a single dose of a naproxen‐containing product, over‐the‐counter pain reliever, or anti‐emetics. Subjects were advised not to take a second tablet of sumatriptan/naproxen sodium without at least a 24‐hour headache‐free period. Safety evaluations included adverse events, laboratory tests, and vital signs and electrocardiogram evaluation. Other evaluations included freedom from pain, quality of life, and medication satisfaction. Results.— Of the 656 subjects enrolled, 622 (95%) treated at least 1 migraine with sumatriptan/naproxen sodium, of which 435 (70%) and 363 (58%) completed 6 and 12 months of the study, respectively. Overall, there were 12,927 exposures to sumatriptan/naproxen sodium: on average 2.5 tablets were taken per month per subject. The most common treatment‐related adverse events were nausea (7%), dizziness (3%), muscle tightness (3%), and chest discomfort (3%). There were no deaths; 4 subjects had 5 serious adverse events (suicide attempt, hemolytic anemia and syncope, suicidal ideation, spontaneous abortion) unrelated to sumatriptan/naproxen sodium and resolved without sequelae. Seven percent of subjects discontinued participation in the study because of an adverse event; 5% of subjects discontinued due to lack of efficacy. Overall, 42% of the migraine attacks were pain‐free within 2 hours of treatment with sumatriptan/naproxen sodium, subjects reported improvements from baseline in 2 of 3 quality of life domains over time, and were generally satisfied with the efficacy and overall treatment at the end of the study. Conclusion.— In adolescent migraineurs, after up to 12 months and over 12,000 exposures to sumatriptan/naproxen sodium, there were no new or clinically significant findings in the safety parameters, including the frequency and nature of adverse events, as compared to the individual components or to the adverse event profile in adults. In addition, sumatriptan/naproxen sodium provided freedom from pain over time, improvements in quality of life and medication satisfaction.     

Meta‐Analysis of the Efficacy and Safety of Naproxen Sodium in the Acute Treatment of Migraine

(Headache 2010;50:808‐818) Objective.— To assess the efficacy and safety of naproxen sodium in the treatment of acute migraine attacks. Background.— Non‐steroidal anti‐inflammatory drugs including naproxen sodium have been used in treating migraine attack. A number of clinical trials of naproxen sodium in migraine have been reported. However, it remains to be established whether naproxen sodium unequivocally offers clinical benefits taken into account the desired outcomes in acute migraine therapy as recommended by the International Headache Society. Methods.— Clinical trials were identified through electronic searches (MEDLINE, EMBASE, EBM review, and the Cochrane Library) up to June 2009 and historical searches of relevant articles. Studies were included in the meta‐analysis if they were (1) double‐blind, randomized, placebo‐controlled trials that evaluated naproxen sodium tablet in moderate or severe migraine attacks in adult patients, and (2) reporting the efficacy in terms of headache relief, pain‐free, relief of migraine‐associated symptoms, sustained headache relief, sustained pain‐free, or headache recurrence. Data extraction and study quality assessment were performed independently by 2 investigators. Disagreements were resolved by a third investigator. Treatment effects and adverse effects were expressed as risk ratio. A random effects model was used when significant heterogeneity existed, otherwise the fixed effects model was performed. Results.— We identified 16 published randomized controlled trials of naproxen in the treatment of migraine. Four trials met the inclusion criteria and were included in the meta‐analysis. Naproxen sodium was more effective than placebo in reducing pain intensity and providing pain‐free within 2 hours in adults with moderate or severe migraine attacks. The pooled risk ratios were 1.58 (95% confidence interval [CI] 1.41‐1.77, P < .00001), and 2.22 (95% CI 1.46‐3.37, P = .0002), respectively, for headache relief at 2 hours and pain‐free at 2 hours. It was also effective in achieving headache relief at 4 hours, relief of migraine‐associated symptoms, sustained headache relief, and sustained pain‐free responses. There was no significant difference in headache recurrence rate between naproxen sodium and placebo. The risk of any adverse event was greater with naproxen sodium than with placebo (pooled risk ratio 1.29, 95% CI 1.04‐1.60, P = .02). The adverse events commonly associated with naproxen sodium were nausea, dizziness, dyspepsia, and abdominal pain. Conclusions.— The available evidence suggests that naproxen sodium is more effective but may cause more adverse events than placebo in the acute treatment of moderate to severe migraine. It is effective in reducing headache intensity, rendering pain‐free at 2 hours and improving migraine‐associated symptoms. However, its effectiveness relative to other active comparators needs to be better defined by appropriate head‐to‐head clinical trials.     

Defining Refractory Migraine: Results of the RHSIS Survey of American Headache Society Members

Objectives.— To gauge consensus regarding a proposed definition for refractory migraine proposed by Refractory Headache Special Interest Section, and where its use would be most appropriate. Background.— Headache experts have long recognized that a subgroup of headache sufferers remains refractory to treatment. Although different groups have proposed criteria to define refractory migraine, the definition remains controversial. The Refractory Headache Special Interest Section of the American Headache Society developed a definition through a consensus process, assisted by a literature review and initial membership survey. Design.— A 12‐item questionnaire was distributed at the American Headache Society meeting in 2007 during a platform session and at the Refractory Headache Special Interest Section symposium. The same questionnaire was subsequently sent to all American Headache Society members via e‐mail. A total of 151 responses from AHS members form the basis of this report. The survey instrument was designed using Survey Monkey. Frequencies and percentages of the survey were used to describe survey responses. Results.— American Headache Society members agreed that a definition for refractory migraine is needed (91%) that it should be added to the International Classification of Headache Disorders‐2 (86%), and that refractory forms of non‐migraine headache disorders should be defined (87%). Responders believed a refractory migraine definition would be of greatest value in selecting patients for clinical drug trials. The current refractory migraine definition requires a diagnosis of migraine, interference with function or quality of life despite modification of lifestyle factors, and adequate trials of acute and preventive medicines with established efficacy. The proposed criteria for the refractory migraine definition require failing 2 preventive medications to meet the threshold for failure. Although 42% of respondents agreed with the working definition of refractory migraine, 43% favored increasing the number to 3 (50%) or 4 (26%) preventive treatment failures. When respondents were asked if they felt that the proposed definition was appropriate to select patients for invasive procedures (patent foramen ovale repair or stimulators) only 44% agreed. Conclusions.— There is a consensus for a need for a definition for refractory migraine and that it should be added to the International Classification of Headache Disorder‐2. There was also general agreement by the responders that refractory forms of non‐migraine headache disorders should be defined.