Sumatriptan/Naproxen sodium for migraine: efficacy, health related quality of life, and satisfaction outcomes

OBJECTIVE: To describe the pain relief, satisfaction, and health-related quality of life results of moderate or severe migraines treated with a sumatriptan/naproxen sodium combination tablet. METHODS: Sumatriptan and naproxen sodium as a single-dose formulation tablet was used to treat moderate to severe migraines over a 12-month period in a phase 3, open-label, multicenter study (n = 565) in patients with at least 6 months' history of migraine headaches. RESULTS: Seventy percent of all attacks were treated with 1 dose of sumatriptan/naproxen sodium. Overall subjects treated 24,485 attacks; of these, 81% attacks achieved pain relief and 60% pain-free by 2 hours. At 3 months, the percentage of patients satisfied or very satisfied increased from baseline on all 8 Patient Perception of Migraine Questionnaire (PPMQ) items and remained high throughout the study. Mean Migraine-Specific Quality of Life Questionnaire (MSQ) domain scores also increased by 13-15 points from baseline during this time and remained high. CONCLUSIONS: Sumatriptan/naproxen sodium provides consistent relief of migraine attacks over 12 months, resulting in improved patient satisfaction and migraine specific quality of life.     

Quality-of-Life Differences Between Patients With Episodic and Transformed Migraine

OBJECTIVE: To determine whether there are any differences in health-related quality of life between patients with migraine and those with transformed migraine. BACKGROUND: There are no published reports comparing the health-related quality of life between patients with migraine and patients with transformed migraine. METHODS: We conducted a retrospective analysis examining the health-related quality of life of patients with transformed migraine and migraine seen at a specialty headache clinic. Data collected included the Short Form-36 (SF-36) and the Migraine Disability Assessment questionnaires as well as demographic information. Both of these forms are part of the initial evaluation at the headache clinic. A t test with Bonferroni correction was used to test for significant differences in the SF-36 domains between the groups. RESULTS: Data were collected for 90 patients, 46 with transformed migraine and 44 with migraine. There were no significant differences between groups with respect to sex, race, or age. Over the last 90 days prior to their first visit, patients with transformed migraine reported having a headache an average of 69 days compared with patients with migraine who averaged 18 days with headache (P<.05). Compared with patients with migraine, patients with transformed migraine had statistically (P<.05) and clinically significant (difference >5 points) lower mean scores on seven of the eight SF-36 domains and both the mental and physical summary scores of the SF-36. CONCLUSIONS: The results of this study suggest that patients with transformed migraine have a lower health-related quality of life than patients with migraine. These findings indicate that the headache chronicity associated with transformed migraine has a significant influence on quality of life. The results highlight the importance of effective management of headaches to avoid the progression of migraine to the more disabling transformed migraine.     

Effectiveness of eletriptan in acute migraine: primary care for Excedrin nonresponders

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.     

Sumatriptan treatment for migraine in a health maintenance organization: economic, humanistic, and clinical outcomes

This study was undertaken to assess the impact of 12 months of sumatriptan therapy (6 mg subcutaneously) for migraine on health care use, health-related quality of life, productivity, patient satisfaction with the medication, and clinical efficacy in a health maintenance organization (HMO). One hundred forty-eight patients received open-label sumatriptan for 12 months for the treatment of migraine. Medical records were reviewed to obtain information on the frequency of migraine-related health care use during the 12 months before and during sumatriptan treatment. Patients completed questionnaires on their productivity at work, health-related quality of life, and satisfaction with medication at baseline and after 3, 6, and 12 months of sumatriptan treatment. For each migraine, patients recorded pain severity scores before and after taking sumatriptan and the time between dosing and onset of meaningful relief. Sumatriptan was associated with significant reductions in migraine-related use of general outpatient services, telephone calls, urgent care services, and emergency department visits (P < 0.05); a significant increase in the use of pharmacy services (P < 0.05); and significant and sustained improvements in health-related quality-of-life scores compared with baseline (P < 0.001). Patients lost significantly less time from work and were significantly more satisfied with sumatriptan compared with their usual therapy (P < 0.05). Two hours after dosing, 81% of patients experienced reduction of moderate or severe pain to mild or no pain, and 90% of all patients experienced meaningful relief of pain. The use of sumatriptan for 12 months in an HMO was associated with reductions in health care use and improved health-related quality of life, productivity, and patient satisfaction with medication.     

Impact of headache on quality of life in a general population survey in France (GRIM2000 Study)

OBJECTIVES: The objectives of this study were to determine the impact of headache on health-related quality of life in a nationwide sample of the French general population using a disease-specific measure, the Qualité de Vie et Migraine (QVM), to compare quality of life in subjects reporting different headache to types, and to evaluate the relationship between quality of life and severity, frequency, associated disability, and treatment responsiveness of headaches. METHODS: The QVM questionnaire was included within a large epidemiological survey of 1486 headache sufferers. Diagnosis was assigned retrospectively using an algorithm based on the International Headache Society classification. Headache severity was assessed with the MIGSEV scale and disability with the MIDAS scale. RESULTS: The mean global QVM score in the sample was 80.2. Quality of life was poorer in subjects with chronic daily headache (QVM score: 66.2) than in those with migraine (QVM score: 76.7), while those with other forms of episodic headache had the best quality of life (QVM score: 91.7). Quality-of-life scores were correlated with frequency, severity, disability, and treatment resistance of headaches (P <.001). CONCLUSION: The QVM scale is a sensitive tool to measure health-related quality of life in headache sufferers in the general population.     

Migraine treatment with rizatriptan and non-triptan usual care medications: a pharmacy-based study

OBJECTIVE: To compare the effectiveness of rizatriptan to other non-triptan medications in the relief of migraine headache in usual care settings. BACKGROUND: Although rizatriptan has been shown to provide effective relief of migraine symptoms in clinical trials, limited data exist directly comparing its effectiveness with non-triptan medications. METHODS: Migraineurs aged 18 to 55 who had been prescribed a new antimigraine drug (rizatriptan 10 mg or a selected class of non-triptan oral medications) were recruited to participate in the study through a national retail pharmacy chain. Participants completed a baseline questionnaire at the enrollment and reported their treatment experiences by filling out the treatment diary after using the newly prescribed medication. The treatment outcomes of patients receiving rizatriptan were compared with those receiving non-triptan medications. Logistic regression analysis was applied to test statistical significance with adjustment for potential confounding factors. RESULTS: Of the 728 patients who entered the study, 693 (95.2%) completed the treatment diary. Patients treated with rizatriptan (192) and non-triptans (501) reported the following outcomes, respectively--onset of headache relief within 30 minutes post-dose: 25% versus 18%; self-defined significant headache relief within 2 hours post-dose: 71% versus 54%; pain free or mild pain at 2 hours post-dose: 58% versus 47%; completely symptom-free within 2 hours of post-dose: 32% versus 20%; return to usual activities within 2 hours post-dose: 39% versus 35%; and satisfied with treatment: 67% versus 55% (P <.05 in all comparisons with exception of returning to usual activities). CONCLUSION: Rizatriptan was significantly more effective than non-triptans in the relief of migraine headaches for patients obtaining prescribed migraine medications from a retail pharmacy. Additional studies at other usual care settings may be needed to confirm the findings.     

Probable migraine in the United States: results of the American Migraine Prevalence and Prevention (AMPP) study

Probable migraine (PM) is a prevalent migraine subtype fulfilling all but one criterion for migraine with or without aura. The aims of this study were: (i) to describe the epidemiology, medical recognition and patterns of treatment for PM in the USA; (ii) to compare the patterns of preventive PM treatment in the population with expert panel guidelines for preventive treatment. A validated self-administered headache questionnaire was mailed to a random sample of 120,000 US households. Subjects were classified as PM according to the second edition of the International Classification of Headache Disorders (ICHD-2). The questionnaire also assessed patterns of migraine treatment. Guidelines for preventive medication use were developed by a panel of headache experts, who used headache frequency and impairment to assess the need for preventive therapy and the gap between current and ideal use. Our sample consisted of 162 576 individuals aged > or = 12 years. The 1-year period prevalence of PM was 4.5% (3.9% in men and 5.1% in women). In women and men, prevalence was higher in middle life, between the ages of 30 and 59 years. The prevalence of PM was significantly higher in African-Americans than in Whites (female 7.4% vs. 4.8%; male 4.8% vs. 3.7%) and inversely related to household income. During their headaches, most (48.2%) had at least some impairment, while 22.1% were severely disabled. The vast majority (97%) of PM sufferers used acute treatments, although 71% usually treated with over-the-counter medication. Most PM sufferers (52.8%) never used a migraine-preventive treatment and only 7.9% were currently using preventive medication. According to the expert panel guidelines, prevention should be offered (16.9%) or considered (11.5%) for 28.4% of the PM sufferers in the survey. We conclude that PM is a frequent, undertreated, sometimes disabling disorder. It has an epidemiological profile similar to migraine. In contrast to migraine, which is less prevalent in African-Americans than in Whites, PM is more prevalent in African-Americans than in Whites. In the USA, many with PM do not receive adequate treatment.     

Efficacy of topiramate in migraine prophylaxis: a retrospective chart analysis

OBJECTIVE: Topiramate, a broad-spectrum anticonvulsant with multiple mechanisms of action, may be effective in preventing migraine headaches. We report the results of a retrospective chart review of patients treated with topiramate for prophylaxis of migraine. METHODS: Patients with a diagnosis of migraine who had at least one follow-up visit after > or =4 weeks on topiramate were eligible; 69 patients (56 women and 13 men) aged 18 to 68 years met these criteria. Charts were reviewed for frequency of mild or moderate/severe headaches at the start of topiramate (baseline) and at all subsequent visits up to 24 weeks. RESULTS: The 28-day frequency of moderate/severe migraines declined significantly from baseline to end of treatment (10.6 +/- 8.4 to 7.4 +/- 7.7, respectively; P = 0.0004), whereas that of mild headaches did not demonstrate a significant change (from 11.8 +/- 8.9 to 11.0 +/- 10.0). Among the 38 patients who had not responded previously to >or =9 preventive medications, the monthly frequency of moderate/severe (but not mild) headaches decreased significantly from baseline to end of treatment. Patients who previously had not responded to <9 prior medications experienced significant declines in both mild and moderate/severe headaches. The most common adverse events were paresthesias, drowsiness, diarrhea, decreased appetite, and weight loss. Twenty-seven patients discontinued topiramate therapy, 20 as a result of adverse events and 7 due to lack of response. CONCLUSION: Topiramate may be effective in reducing the frequency of both mild and moderate/severe migraine headaches. In particular, topiramate may offer relief to patients with moderate/severe migraines who do not respond to other treatments.     

Prevalence and Burden of Headache and Migraine in Germany

Objective.— To determine prevalence and burden of headache and migraine in the general population in Germany including patterns of healthcare and medication use.
Methods.— Telephone interviews were conducted on a representative sample of the general population in Germany aged ≥18 years (n = 7341). Migraine was diagnosed according to the International Headache Society criteria.
Results.— One-year prevalence was: headache 60.2%, migraine 10.6%, nonmigrainous severe headache 24.7% (women 66.6%, 15.6%, and 27.1%; men 53.0%, 5.3%, and 22.2%). Approximately 60% of headache sufferers reported severe headaches, 30% of which were migrainous. Migraineurs reported more often frequent headaches, disability, use of analgesics, and medical consultation than individuals with nonmigrainous severe headaches. Only 42% of migraineurs had consulted a physician and the majority relied exclusively on over-the-counter medication.
Conclusion.— Migraine accounts for a great part of the healthcare impact of headaches in Germany. However, the majority of migraineurs do not seek medical care and may not be optimally treated.     

Determinants of migraine-specific quality of life

This paper reports an analysis of two randomized controlled trials of rizatriptan, in which the 24-h Migraine Quality of Life QuestionnaireCopyright was used to assess migraine-specific quality of life in patients receiving acute treatment. The objective of the analysis was to determine which clinical effects of a migraine medication, as measured by traditional clinical trial endpoints, contribute to a better short-term health-related quality of life. The results demonstrate that patients who experience complete pain relief and are able to function at their normal ability within 2 h and experience no headache recurrence have the highest migraine-specific quality of life scores. Patients who were satisfied with medication at 2 h had higher migraine-specific quality of life scores than those who were not satisfied. In conclusion, migraine therapy that provides rapid, complete, and sustained pain relief, with restoration of functional ability, has the most beneficial impact on short-term health-related quality of life for migraineurs.     

The efficacy of divalproex sodium in the prophylactic treatment of children with migraine

OBJECTIVE: To determine the beneficial use of divalproex sodium as a prophylactic treatment for migraine in children. BACKGROUND: Previous studies for treatment of migraine in adults have shown a greater than 50% reduction in migraine attack frequencies. Few data exist, however, regarding the efficacy and safety of divalproex sodium use in children with migraine. METHODS: We studied the incidence of headache relief in our patients with migraine aged 16 years and younger treated with divalproex sodium prophylactically at our institution from July 1996 to December 1998 to determine medication dosage used, concomitant headache medications, and possible adverse effects. RESULTS: A total of 42 patients, ranging in age from 7 to 16 years (mean age, 11.3 years), were treated with divalproex sodium for headache. All had a history of migraine with or without aura. Baseline headache frequency during a minimum 6-month period was one to four headaches per month. Divalproex sodium dosage ranged from 15 mg/kg/day to 45 mg/kg/day. Of the 42 patients, 34 (80.9%) successfully discontinued their abortive medications. After 4 months' treatment, 50% headache reduction was seen in 78.5% of patients, 75% reduction in 14.2% of patients, and 9. 5% of patients became headache-free. CONCLUSION: These results indicate divalproex sodium to be an effective and well-tolerated treatment for the prophylaxis of migraine in children.     

Anticephalgic Photoprotective Premeditated Mask. A Report of a Successful Double-Blind Placebo-Controlled Study of a New Treatment for Headaches With Associated Frontalis Pain and Photophobia

This study was performed to determine the efficacy of an anticephalgic photoprotective premedicated mask in the treatment of migraine and/or tension-type headaches. There were 54 patients. They were given masks and numbered bottles of topical medication containing either salicin or placebo. The patients were instructed to apply the medication to their frontalis region in the event they should suffer a headache, apply a photoprotective mask, and lie down. Furthermore, they were instructed to take their usual oral or parenteral medications, if required, for relief of the headache. They subsequently filled out forms rating the degree of relief which they attributed to the topical medications and the masks using a 0 to 10 scale. They were also simply asked if this form of treatment helped or not.
Seven of the 20 patients receiving placebo stated the medication and mask helped. The placebo group rated the treatment an average of 4.31 on a 0 to 10 scale. Twenty-eight of 34 patients receiving salicin stated it was effective. The salicin group rated it 7.42 on a 0 to 10 scale ( P <0.001). The majority of the salicin patients stated the duration of their headaches was significantly reduced, as was their need for analgesic and/or narcotic medications.
This study demonstrates a significant difference between placebo and salicin in association with the photoprotective mask in treating migraines and/or tension-type headaches with associated frontalis pain and photophobia.