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Preference is a composite, patient-oriented endpoint incorporating efficacy, tolerability, formulation, and convenience of medications. The objective of this study was to compare patient preference for rizatriptan 10-mg wafer vs. eletriptan 40-mg tablet for acute treatment of migraine. In this multicentre, open-label, two-period, crossover study, out-patients were randomly assigned to treat the first of two moderate to severe migraines with rizatriptan or eletriptan and the second with the alternate therapy. Patients completed diary assessments at baseline and up to 24 h after taking study medication. At the last visit, patients completed a psychometrically validated preference questionnaire. A total of 372 patients (mean age 38 years, 85% female) treated two migraine attacks, and 342 patients (92%) expressed a preference for treatment. Significantly more ( P ≤ 0.001) patients preferred rizatriptan 10-mg wafer [61.1%; 95% confidence interval (CI) 55.7, 66.3] to eletriptan 40-mg tablet (38.9%; 95% CI 33.7, 44.3). The most common reason given for preference of either treatment was speed of headache relief. At 2 h, 80% and 69% of patients reported that rizatriptan and eletriptan, respectively, was convenient or very convenient to take (mean convenience score 1.99 vs. 2.31, respectively; P ≤ 0.001). Both triptans were well tolerated. In this head-to-head study designed to evaluate global patient preference, significantly more patients preferred the rizatriptan 10-mg wafer to the eletriptan 40-mg tablet for acute treatment of migraine. The single most important reason for preference was speed of relief, consistent with results from previous preference studies. [ABSTRACT FROM AUTHOR]

The introduction of the triptans brought advances in achieving complete and sustained pain resolution in migraine patients, compared with non-migraine-specific treatments. However, sustained pain-free rates for triptans recorded in many clinical trials are still relatively low. This may be due to study participants being treated late into the attack, when pain is already moderate or severe. Studies with almotriptan have shown that efficacy is enhanced when treatment is given early in a migraine attack while pain is still mild, compared with later administration when pain intensity is greater. Developments in our understanding of migraine pathophysiology provide a rationale for this phenomenon, with improved efficacy seen when abortive treatment is administered before central sensitization develops. A limited window of therapeutic opportunity exists early in an attack to improve the outcome of triptan treatment. Early intervention is recommended to avoid the significant pain and disability commonly associated with moderate or severe migraine. [ABSTRACT FROM AUTHOR]

Topiramate (TPM) has shown efficacy in migraine prophylaxis in two large placebo–controlled, dose–ranging trials. We conducted a randomised, doubleblind, multicentre trial to evaluate the efficacy and safety of two doses of topiramate vs placebo for migraine prophylaxis, with propranolol (PROP) as an active control. Subjects with episodic migraine with and without aura were randomised to TPM 100 mg/d, TPM 200 mg/d, PROP 160 mg/d (active control), or placebo. The primary efficacy measure was the change in mean monthly migraine frequency from the baseline phase relative to the double–blind treatment phase. Five hundred and seventy–five subjects were enrolled from 61 centres in 13 countries. TPM 100 mg/d was superior to placebo as measured by reduction in monthly migraine frequency, overall 50% responder rate, reduction in monthly migraine days, and reduction in the rate of daily rescue medication use. The TPM 100 mg/d and PROP groups were similar with respect to reductions in migraine frequency, responder rate, migraine days, and daily rescue medication usage. TPM 100 mg/d was better tolerated than TPM 200 mg/d, and was generally comparable to PROP. No unusual or unexpected safety risks emerged. These findings demonstrate that TPM 100 mg/d is effective in migraine prophylaxis. TPM 100 mg/d and PROP 160 mg/d exhibited similar efficacy profiles. [ABSTRACT FROM AUTHOR]

Context: Various guidelines recommend different strategies for selecting and sequencing acute treatments for migraine. In step care, treatment is escalated after first-line medications fail. In stratified care, initial treatment is based on measurement of the severity of illness or other factors. These strategies for migraine have not been rigorously evaluated.Objective: To compare the clinical benefits of 3 strategies: stratified care, step care within attacks, and step care across attacks, among patients with migraine.Design and Setting: Randomized, controlled, parallel-group clinical trial conducted by the Disability in Strategies Study group from December 1997 to March 1999 in 88 clinical centers in 13 countries.Patients: A total of 835 adult migraine patients with a Migraine Disability Assessment Scale (MIDAS) grade of II, III, or IV were analyzed as the efficacy population; the safety analysis included 930 patients.Interventions: Patients were randomly assigned to receive (1) stratified care (n = 279), in which patients with MIDAS grade II treated up to 6 attacks with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg, and patients with MIDAS grade III and IV treated up to 6 attacks with zolmitriptan, 2.5 mg; (2) step care across attacks (n = 271), in which initial treatment was with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg. Patients not responding in at least 2 of the first 3 attacks switched to zolmitriptan, 2.5 mg, to treat the remaining 3 attacks; and (3) step care within attacks (n = 285), in which initial treatment for all attacks was with aspirin, 800 to 1000 mg, plus metoclopramide, 20 mg. Patients not responding to treatment after 2 hours in each attack escalated treatment to zolmitriptan, 2.5 mg.Main Outcome Measures: Headache response, achieved if pain intensity was reduced from severe or moderate at baseline to mild or no pain at 2 hours; and disability time per treated attack at 4 hours for all 6 attacks, compared among the 3 groups.Results: Headache response at 2 hours was significantly greater across 6 attacks in the stratified care treatment group (52.7%) than in either the step care across attacks group (40.6%; P<.001) or the step care within attacks group (36.4%; P<.001). Disability time (6 attacks) was significantly lower in the stratified care group (mean area under the curve [AUC], 185.0 mm. h) than in the step care across attacks group (mean AUC, 209.4 mm. h; P<.001) or the step care within attacks group (mean AUC, 199.7 mm. h; P<.001). The incidence of adverse events was higher in the stratified care group (321 events) vs both step care groups (159 events in across-attack group; 217 in within-attack group), although most events were of mild-to-moderate intensity.Conclusion: Our results indicate that as a treatment strategy, stratified care provides significantly better clinical outcomes than step care strategies within or across attacks as measured by headache response and disability time. JAMA. 2000;284:2599-2605. [ABSTRACT FROM AUTHOR]

Our aim was to establish the validity and reliability of a patient-rated Migraine Treatment Optimization Questionnaire (M-TOQ) in primary care. Patients who met International Classification of Headache Disorders, 2nd edn criteria for migraine completed a 19-item questionnaire containing candidate items for the M-TOQ, and three questionnaires designed to test convergent/construct validity [Migraine Disability Assessment Scale (MIDAS), Headache Impact Test (HIT)-6 and Migraine-Specific Quality of Life Scale (MSQoL)]. A 15-item (M-TOQ-15) and a five-item (M-TOQ-5) questionnaire were derived. Two hundred and fifty-three adult patients were recruited. Five treatment optimization domains were identified: functioning, rapid relief, consistency of relief, risk of recurrence and tolerability; with Cronbach alphas of 0.70–0.84. The Cronbach α for M-TOQ-15 was 0.85, and it correlated well with MIDAS, HIT-6 and MSQoL ( r = 0.33–0.44). The Cronbach α for M-TOQ-5 was 0.66, and it also correlated well with the three questionnaires ( r = 0.33–0.41). The utility of the M-TOQ for assessing treatment benefit in research (M-TOQ-15) and primary care (M-TOQ-5) should be further validated. [ABSTRACT FROM AUTHOR]

Primary chronic headache can affect a patient's health-related quality of life (HQL). The Medical Outcomes Study Short Form (SF-36) questionnaire has been used to address this issue. We compare the impact of headache on the HQL of patients with migraine and chronic daily headache (CDH) using the SF-36 instrument. We analyzed a group of 115 consecutive patients; 62 migraine patients and 53 CDH patients completed the questionnaire. Patterns of disability were similar between the two groups, but CDH was marked by a lower level of health scales. Patients with CDH had a significantly worse pain score in physical functioning, role functioning (physical), bodily pain, general health perceptions, and mental health than patients with migraine headache. Our results in the migraine group were similar to findings in other publications, with the lowest scores in role functioning (physical) and bodily pain. There is no previous experience in CDH patients, but the present data suggest that the SF-36 questionnaire is valuable in determining the differences in functional status among headache types. These data suggest that the SF-36 is a reliable and valid measure of the HQL of patients with CDH, and may indeed prove to be valuable in studying the efficacy of therapeutic agents for this type of headache. [ABSTRACT FROM AUTHOR]