Symptoms of cutaneous sensitivity pre-treatment and post-treatment: results from the rizatriptan TAME studies.

The presence of cutaneous allodynia may predict response to triptans. Identical randomized double-blind studies were conducted comparing the efficacy of rizatriptan 10 mg or placebo administered within 1 h of headache onset, while pain was mild. The primary endpoint was freedom from pain at 2 h. Presence of symptoms suggesting cutaneous sensitivity (SCS) at baseline and at 2 h post-treatment was recorded. Before treatment, 29% of rizatriptan patients and 22% of placebo patients reported SCS. At 2 h, the percentage of patients with SCS was significantly decreased with rizatriptan. The presence of SCS pre-treatment was not predictive of response to rizatriptan. Most patients with SCS at 2 h were non-responders. Early treatment with rizatriptan significantly reduced the percentage of patients with SCS at 2 h. The presence of SCS at baseline did not predict pain-free response, but presence of SCS at 2 h correlated with lack of a 2-h pain-free response.

Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies.

These are the first prospective studies to use criteria for menstrual migraine proposed in the 2004 revision of the International Classification of Headache Disorders (ICHD-II) to examine the efficacy of rizatriptan for treatment of a menstrual attack. Two identical protocols (MM1 and MM2) were randomized, parallel, placebo-controlled, double-blind studies. Adult women with ICHD-II menstrual migraine were assigned to either rizatriptan 10-mg tablet or placebo in a 2 : 1 ratio. Patients treated a single menstrual migraine attack of moderate or severe pain intensity. The primary end-point was 2-h pain relief and the secondary end-point was 24-h sustained pain relief. A total of 707 patients (MM1 357, MM2 350) treated a menstrual migraine attack. The percentage of patients reporting 2-h pain relief was significantly greater for rizatriptan than for placebo (MM1 70% vs. 53%, MM2 73% vs. 50%), as was the percentage of patients reporting 24-h sustained pain relief (MM1 46% vs. 33%; MM2 46% vs. 33%). Rizatriptan 10 mg was effective for the treatment of ICHD-II menstrual migraine, as measured by 2-h pain relief and 24-h sustained pain relief.

Comparison of rizatriptan 5 mg and 10 mg tablets and sumatriptan 25 mg and 50 mg tablets.

This randomized, double-blind, two-attack, placebo-controlled, crossover study explored the efficacy and tolerability of rizatriptan 10 mg compared with sumatriptan 50 mg as well as rizatriptan 5 mg compared with sumatriptan 25 mg in the acute treatment of migraine. Following randomization to one of six possible treatment sequences, patients (n = 1447) treated two sequential attacks, of moderate or severe intensity, separated by at least 5 days. Patients assessed pain severity, migraine-associated symptoms, and functional disability at 0.5, 1, 1.5, and 2 h post treatment. Compared with placebo, all treatments were effective. On the primary endpoint of time to pain relief, rizatriptan 10 mg was not statistically different from sumatriptan 50 mg [odds ratio (OR) 1.10, P = 0.161], and rizatriptan 5 mg was statistically superior to sumatriptan 25 mg (OR 1.22, P = 0.007). In general, rizatriptan 10 mg and 5 mg treatment resulted in improvement compared with the corresponding doses of sumatriptan on measures of pain severity, migraine symptoms, and functional disability and the 5-mg dose reached statistical significance on almost all measures. All treatments were generally well tolerated.

Preference comparison of rizatriptan ODT 10-mg and sumatriptan 50-mg tablet in migraine.

OBJECTIVE: To compare the proportion of patients who prefer rizatriptan orally disintegrating tablet (ODT) 10-mg to sumatriptan 50-mg tablet. BACKGROUND: Migraineurs express treatment preference based on a variety of attributes including the speed of pain relief and medication formulation. Rizatriptan ODT is an orally disintegrating formulation of rizatriptan, a selective 5-HT1B/1D receptor agonist. This study was conducted to determine patient preference between rizatriptan ODT 10-mg and sumatriptan 50-mg tablet for the acute treatment of migraine. METHODS: This was a multicenter, randomized, open-label, two-period crossover study conducted in the United States with 524 enrolled patients. Patients treated a single moderate or severe headache in each treatment period. Patients treated one migraine with either rizatriptan ODT 10-mg or sumatriptan 50-mg tablet, then treated a second migraine with the alternate therapy. Patients completed diary assessments at baseline, and 30, 45, 60, 90, and 120 minutes postdose and rated headache severity on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). At the final study visit following treatment of their second migraine, patients expressed preference for one of the two study medications by completing an interviewer-administered Global Preference Question and then responded to a self-administered series of questions to capture their most important reason for preferring one study medication over the other. Safety measurements were recorded through standard adverse experience reporting. RESULTS: Three hundred eighty-six patients treated two migraine attacks. For those patients who expressed a preference for either rizatriptan ODT or sumatriptan (n = 374), the percentage of patients who preferred rizatriptan ODT 10-mg (57%, n = 213) was significantly greater than those who preferred sumatriptan 50-mg tablet (43%, n = 161) (P<.01). For those patients who treated two migraine attacks and had drug severity measures for both attacks (n = 384), a significantly greater percentage of patients reported pain relief after taking rizatriptan ODT than sumatriptan at the 45- and 60-minute time points (38% versus 29% and 58% versus 49%, respectively) (P<.01). In addition, a significantly greater percentage of patients taking rizatriptan ODT reported a pain-free status at the 60- and 120-minute time points (23% versus 17% [P<.05] and 60% versus 52% [P<.01], respectively). Both rizatriptan ODT and sumatriptan were well tolerated. CONCLUSIONS: A significantly greater proportion of patients preferred rizatriptan ODT 10-mg to sumatriptan 50-mg tablet for the acute treatment of migraine. Efficacy and safety data are consistent with the preference findings.

Do patients with obstructive sleep apnea wake up with headaches?

BACKGROUND: There is a controversy regarding the association of obstructive sleep apnea (OSA) and morning headaches. This study investigates whether this relationship exists. METHODS: This is a retrospective study of 80 consecutive patients with OSA who underwent sleep polysomnography from December 1996 to March 1997. Patients were interviewed about their headache history. Headaches were classified according to International Headache Society criteria and the severity graded by the Chronic Pain Index. Headache characteristics were compared with those of 22 control patients with periodic limb movement disorder. Headache response to continuous positive airway pressure or uvulopalatopharyngoplasty in the patients with OSA was also assessed. RESULTS: Forty-eight (60%) patients had headaches in the year prior to study. Twenty-five of the 48 patients had headaches that did not fit any category. Of these 25 patients, 23 (48% of total group) reported awakening headaches. These awakening headaches were significantly more common in the OSA group compared with the periodic limb movement disorder group, 9 (41%) of whom had headaches, none of which occurred on awakening. The proportion of common types of headaches in both groups was similar. The awakening headaches were brief (shorter than 30 minutes), and their occurrence and severity correlated with OSA severity. Of the 29 patients with OSA who were treated with continuous positive airway pressure or uvulopalatopharyngoplasty, awakening headaches improved by a mean of 80% compared with minimal improvement of migraine, tension, and cervicogenic headaches. CONCLUSIONS: Awakening headaches are associated with OSA. These headaches are of brief duration, and their occurrence and severity increase with increasing OSA severity. Treatment of OSA with continuous positive airway pressure or uvulopalatopharyngoplasty can reduce these headaches.

Quality of life assessment among migraine patients treated with sumatriptan.

PURPOSE: Quality of life evaluations can enhance traditional measures of therapeutic efficacy. The purpose of our study was to evaluate the impact of sumatriptan on the quality of life of patients with migraine headaches. PATIENTS AND METHODS: Migraine patients who were given a prescription for sumatriptan completed an SF-36 questionnaire and a nine-item pain questionnaire. Six to 9 months later, patients were mailed another copy of the SF-36 and the nine-item pain questionnaire. We compared the pretreatment and posttreatment scores for the SF-36 and for each question of the nine-item pain questionnaire. RESULTS: The pretreatment SF-36 was completed by 255 patients. The pretreatment pain questionnaire was completed by 86 of these patients. Follow-up questionnaires were returned by 147 patients (58%). Three of the eight SF-36 scales: role functioning--physical, bodily pain, and social functioning showed significant (P < 0.05) improvement with treatment. On the nine-item pain-specific questionnaire, three items--pain interference with normal work, ability to walk or move about, and enjoyment of life showed statistically significant (P < 0.05) improvement after sumatriptan treatment. CONCLUSIONS: Sumatriptan caused a significant improvement in the quality of life of patients with very severe migraine. This improvement was measurable by both the general quality of life instrument and the pain-specific questionnaire.

Persistent positive visual phenomena in migraine.

Ten patients with migraine developed persistent positive visual phenomena lasting months to years. The complaints were similar in their simplicity and involvement of the entire visual field and usually consisted of diffuse small particles such as TV static, snow, lines of ants, dots, and rain. Neurologic and ophthalmologic examinations were normal, and EEGs were normal in eight of eight patients tested. MRI was normal in all patients except one who had nonspecific biparietal white matter lesions and another with a small venous angioma. Treatment of this unusual complication of migraine was unsuccessful.

Does quality of life differ among headache diagnoses? Analysis using the medical outcomes study instrument.

BACKGROUND: To analyze the differences in quality of life associated with headache diagnoses using the Medical Outcomes Study Short Form Health Survey (SF-20). METHODS: A patient interview survey using the SF-20 Short Form Health Survey was conducted in a headache clinic within a multi-specialty group practice. All six health components of the SF-20 were included in the study. Headache diagnoses were made using IHS criteria. RESULTS: 208 consecutive headache patients were studied. Patients with cluster headache had a significantly higher (worse) pain score (P < 0.018) and higher percentage of patients with poor health due to pain (P < 0.005) than patients with migraine headache. There were fewer cluster patients with poor health associated with physical functioning than tension-type (P < 0.020) or mixed headache (P < 0.022) patients. Poor health associated with social functioning was greater for cluster (P < 0.011) and tension-type headache (P < 0.015) than for migraine. There was a significantly higher percentage of tension-type headache patients with poor health associated with mental health (P < 0.002) than patients with migraine. CONCLUSIONS: The SF-20 is a reliable and valid measure of quality of life for patients with different headache diagnoses. Distinct headache diagnoses are marked by unique patterns of impairment and quality of life.

Quality of life and well-being of headache patients: measurement by the medical outcomes study instrument.

OBJECTIVE: To assess the reliability and validity of the Medical Outcomes Study (MOS) Short Form Health Survey as an indicator for quality of life in patients with chronic headaches. DESIGN: Patient interview survey. SETTING: A headache clinic within a multi-specialty group practice. PATIENTS: 208 consecutive patients seeking evaluation of headache at the above site. MEASUREMENTS: All six health components of the MOS Short Form Health Survey were included in the study. MAIN RESULTS: The MOS Short Form Health Survey was both reliable and valid in the group of patients with headache. Patients with headache had significantly worse physical, social, and role functioning, and worse mental health than did patients with chronic diseases (P < 0.0001). The functioning associated with chronic headaches was worse than that associated with major chronic medical conditions such as arthritis and diabetes, and was comparable to the level of functioning associated with recent myocardial infarction or congestive heart failure. CONCLUSIONS: The MOS survey is a reliable measure of quality of life for patients with chronic headaches. Chronic headache disorders cause significantly more morbidity and impairment of function than has previously been appreciated.