Headache
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We sought to analyze publicly available information about patient harm associated with an iontophoretic sumatriptan patch, to identify what went wrong and to suggest ways in which similar problems might be prevented in the future. ⋯ Our review identified several problems with the development, testing, approval, and marketing of the Zecuity patch. To improve the process of developing headache treatments, it is important to consider the lessons that can be drawn from an examination of this high-profile failure of the drug development and regulatory system.
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Comparative Study
Anxiety, Incentives, and Adherence to Self-Monitoring on a Mobile Health Platform: A Naturalistic Longitudinal Cohort Study in People With Headache.
To evaluate factors associated naturalistically with adherence to a mobile headache diary. ⋯ This naturalistic observational study confirmed evidence from clinical observation and research: adherence to mobile headache diaries is a challenge for a significant proportion of people with headache. Endorsing higher levels of daily anxiety, younger age, and downloading the app for free (vs either paying for the self-monitoring app or receiving a physician referral coupon) were associated with poorer adherence to keeping a mobile headache diary.
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To examine the disability, health care resource utilization, and direct annual costs among patients with migraine, categorized according to the number of headache days experienced in the past month. ⋯ In patients with migraine, as the number of headache days increased, so did the burden of disease (disability, health care utilization, and direct costs). Elucidating the burden associated with EM and CM has implications for guiding treatment decisions and management of patients with migraine.
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Randomized Controlled Trial
100% Response Rate to Galcanezumab in Patients With Episodic Migraine: A Post Hoc Analysis of the Results From Phase 3, Randomized, Double-Blind, Placebo-Controlled EVOLVE-1 and EVOLVE-2 Studies.
To characterize adult patients with episodic migraine who achieved 100% response to galcanezumab treatment. ⋯ More than a third of the patients with episodic migraine treated with galcanezumab 120 mg or 240 mg achieved 100% response for at least 1 month. More patients had 100% monthly response in the last 3 months of the 6-month double-blind period. For those with 100% response for at least 1 month, the average time between nonconsecutive MHD for the entire treatment period was nearly 1 month and approached 2 months for patients with 3 or more months of 100% response.
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Most persistent posttraumatic headaches (PPTH) have a phenotype that meets diagnostic criteria for migraine or probable migraine. Although symptoms of autonomic dysfunction have been well described among those with migraine, the presence and relative severity of such symptoms among those with PPTH have yet to be reported. ⋯ Symptoms of autonomic dysfunction were greatest among those with PPTH compared to migraine and healthy controls. Among individuals with PPTH, number of lifetime TBIs was associated with greater symptoms of autonomic dysfunction, while greater headache burden was associated with higher vasomotor domain autonomic dysfunction subscores, potentially indicating that PPTH patients with higher disease burden have an increased risk for having autonomic dysfunction. Symptoms of autonomic dysfunction should be ascertained during the clinical management of patients with PPTH and might be a characteristic that helps differentiate PPTH from migraine.