Clinical profile of botulinum toxin A in patients with chronic headaches and cervical dystonia: a prospective, open-label, longitudinal study conducted in a naturalistic clinical practice setting.

BACKGROUND AND OBJECTIVES: Some evidence for the efficacy of botulinum toxin A as a preventive treatment for chronic primary headaches has been reported in randomized, controlled clinical studies. This study investigated the clinical profile of botulinum toxin A in a naturalistic clinical practice setting in a population of patients with cervical dystonia associated with chronic headache and a history of migraine. METHODS: This was a prospective, open-label, longitudinal study. Following a prospective run-in period, eligible patients were given three sets of botulinum toxin A injections at 8- to 12-week intervals over a 16- to 24-week period and were monitored for 3 months after the final injections. Efficacy was assessed in terms of headache-related disability (using the Migraine Disability Assessment [MIDAS] questionnaire), pain and emotional function (using the Short Pain Inventory [SPI]), quality of life (QOL, using the Short-Form-36 [SF-36] questionnaire) and patient-assessed headache frequency and severity, and medication use and its effectiveness. Safety was assessed as adverse events. The primary endpoint was the change in MIDAS score from baseline following treatment with botulinum toxin A. RESULTS: Twenty-four patients took part in the study and 17 (71%) completed the study. There were significant improvements in headache-related disability (MIDAS score), pain and emotional function (SPI), QOL (SF-36), headache frequency and medication use following treatment with botulinum toxin A (p < 0.05 for all endpoints). An efficacy response occurred within 8 weeks of treatment initiation and was maintained throughout the study duration. Botulinum toxin A was generally well tolerated. CONCLUSIONS: This study demonstrated that botulinum toxin A is an effective and well tolerated preventive treatment for chronic headache in patients with cervical dystonia and a history of migraine. These results warrant further investigation in a large, randomized, controlled study.

Patient preference for triptan formulations: a prospective study with zolmitriptan.

OBJECTIVES: To investigate patterns of patient preference for 3 formulations of zolmitriptan, in a primary care study utilizing a naturalistic longitudinal design. BACKGROUND: Although differences in efficacy between individual triptans tend to be small, migraine patients show clear preferences for individual triptans and formulations. The groups of patients suitable for the different triptan formulations, and the reasons underlying individual preferences, are not clearly understood. METHODS: Migraine patients entered a prospective, randomized, open, crossover, longitudinal design study, with patients receiving zolmitriptan formulations according to UK prescribing recommendations. Patients naïve to zolmitriptan received zolmitriptan 2.5-mg film-coated tablets or 2.5-mg Orally Disintegrating Tablets (ODT) for 1 month, before being crossed over to receive the alternative formulation for Month 2. All patients then received zolmitriptan nasal spray 5 mg for Month 3. Patients could then choose the formulation(s) of their choice for a further 7 months. Patients recorded their preferences for individual formulations, the reasons for their preferences, and also the headache-related disability (measured by the Migraine Disability Assessment [MIDAS] score) at clinic visits. Primary endpoints were the individual preferences and changes in MIDAS scores. Adverse events were also recorded. RESULTS: Forty-eight patients took part in the study. At baseline, most patients expressed a preference for conventional tablets. After 4 months, 46.9% of patients preferred zolmitriptan ODT, 43.8% zolmitriptan nasal spray, and 6.3% the conventional tablet. The most common reasons given for preferring conventional tablets were personal reasons: for zolmitriptan ODT, convenience and, to a lesser extent, speed of onset: for zolmitriptan nasal spray, speed of onset, and overall efficacy. MIDAS scores decreased significantly following treatment with zolmitriptan. Zolmitriptan was well tolerated. CONCLUSIONS: Patient experience of newer zolmitriptan formulations influenced a change in preference away from conventional tablets. Speed and efficacy were the key drivers of preference for zolmitriptan nasal spray, while convenience mostly drove preference for the ODT formulation. Open, longitudinal, naturalistic studies may, allowing for biases, sometimes be an appropriate way of conducting migraine studies in primary care.

Disability associated with headaches occurring inside and outside the menstrual period in those with migraine: a general practice study.

OBJECTIVES: This study investigated the disability of females who have migraine and other headache attacks occurring during and outside the menstrual period. METHODS: One thousand four hundred and thirty-four of 3470 female patients (41.3%) aged 14 to 50 years registered at a UK general practice completed two questionnaires. The first questionnaire assessed the prevalence of headache, depression, and bodily pain in the total population. The second questionnaire assessed the disability of all headaches over a 2-month period (to capture a complete menstrual cycle) for patients reporting migraine who were still menstruating. Disability was assessed as the time lost and time spent at less than 50% productivity in normal activities due to headache, and analyzed as rank sums using the Mann-Whitney U-test. RESULTS: The first part of the study showed that the prevalence of headache (66.1%), depression (55.4%), and bodily pain (40.6%) were high in this population of women. Thirty migraine patients who were still menstruating reported 89 migraine and 114 nonmigraine headache episodes in the second part of the study. For migraine, the rank order of time at less than 50% productivity was greater for attacks taking place inside the menstrual period than for those occurring outside the menstrual period. The comparison was significant for time at less than 50% productivity (P=.01). For nonmigraine headaches, the rank order of time lost was greater for attacks taking place outside the menstrual period than for those occurring inside the menstrual period. The comparison was not significant for time lost (P= .06). CONCLUSIONS: For those with migraine, migraine attacks that took place during the menstrual period tended to be slightly more disabling than those taking place outside the menstrual period, but the opposite was true for nonmigraine headache.