Headache最新文献

Objective: We conducted a randomized study to determine if, among emergency department (ED) patients with acute posttraumatic headache, the combination of intravenous (IV) metoclopramide plus dexamethasone would result in less headache intensity during the 48 h after ED discharge than IV metoclopramide plus placebo.

Background: Intravenous metoclopramide can improve acute posttraumatic headache among ED patients, though this benefit is not sustained beyond the ED visit.

Methods: This was a randomized, double-blind, placebo-controlled, parallel group study of IV dexamethasone for acute posttraumatic headache. We enrolled patients who presented to two EDs in the Bronx, NY, with moderate or severe headache that met criteria for acute posttraumatic headache, per the International Classification of Headache Disorders, 3rd edition. All study participants received metoclopramide 10 mg IV. They also were randomized to receive dexamethasone 10 mg IV or placebo (normal saline). The primary outcome was absence of moderate or severe headache within 48 h of ED discharge and no use of analgesic or headache medication within that time. We also report frequency of sustained headache relief. It defined as obtaining and maintaining a headache intensity of mild or none, without the use of rescue medication, for 48 h.

Results: Over a 42-month period commencing in June 2021, 2220 patients were approached for participation and 162 were enrolled. At baseline, slightly more patients in the placebo arm reported severe versus moderate pain. No other baseline differences were noted. After accounting for age, sex, and baseline pain intensity, dexamethasone was not associated with the primary outcome (Adjusted odds ratio 1.11, 95% confidence interval [CI] 0.57, 2.19, p = 0.751). Sustained pain relief was reported by 10/77 (13.0%) of dexamethasone participants and 12/79 (15.2%) of placebo participants (95% CI for difference - 2.2%: -13.1, 8.7%).

Conclusion: Among ED patients with acute moderate or severe posttraumatic headache, one dose of IV dexamethasone did not improve headache outcomes.

Objective: This study evaluated the pharmacokinetics of zavegepant in human breast milk and plasma following a single, 10 mg dose of zavegepant nasal spray.

Background: Zavegepant nasal spray is a member of the gepant class of medications; small molecule inhibitors of the calcitonin gene-related peptide receptor. It is approved in the United States for the acute treatment of migraine with or without aura in adults. However, the transfer of zavegepant to human breast milk in lactating women has not been assessed previously.

Methods: In this Phase 1, open-label, single-arm, single-dose, pharmacokinetic study (NCT06453356), 12 healthy lactating women received a single intranasal dose of 10 mg zavegepant. Blood and breast milk samples were collected over 24 h postdose to assess zavegepant pharmacokinetics. Safety was also assessed. The study was conducted from June 10 to September 26, 2024 at a single-site in the United States.

Results: Geometric mean (geometric percent coefficient of variation [CV%]) milk-to-plasma zavegepant concentration ratios were 0.21 (102%), 0.16 (76%), and 0.04 (130%) for area under the concentration-time curve from time 0 to 24 h postdose, area under the concentration-time curve from time 0 extrapolated to infinity, and maximum concentration, respectively. The geometric mean (geometric CV%) body weight normalized infant dose was 0.05 μg/kg/day (120%) and the geometric mean (geometric CV%) body weight normalized maternal dose was 132.8 μg/kg/day (10%). This resulted in a geometric mean (geometric CV%) relative infant dose of 0.04% (128%). One treatment-emergent adverse event (TEAE; mild dizziness) was reported in one (8%) participant. This TEAE was considered mild in severity. No clinically meaningful abnormalities were observed for vital signs, clinical laboratory testing, and local nasal assessments.

Conclusion: A single intranasal dose of 10 mg zavegepant was generally safe and well tolerated in healthy lactating women and the estimated infant exposure to zavegepant via breast milk is very low.

Objectives/background: This study was undertaken to evaluate patient reasons for nonadoption of migraine-preventive medications. Despite clear recommendations and eligibility criteria for migraine-preventive treatment by the American Headache Society and the availability of these treatments, many people with migraine are not taking appropriate preventive medications. Many are not seeking medical care in the first place, but even among those who are seeking medical care and have a diagnosis of migraine, the uptake of preventive medications remains low.

Methods: The OVERCOME (Observational Survey of the Epidemiology, Treatment, and Care of Migraine) study is an observational, longitudinal web-based survey conducted in more than 60,000 adults with migraine in the United States (US). The current analysis, a secondary post hoc analysis of the 2018-2020 baseline cross-sectional surveys, evaluated medication use in participants. In particular, the analysis investigates why some participants have never taken prescription medication for migraine prevention and examines how this group differs from those who are taking preventive medication, specifically in terms of disease severity and other patient-reported outcomes.

Results: Our findings revealed that among OVERCOME (US) participants who met criteria for migraine (n = 59,001), only approximately half (51.3%) had sought medical care for migraine in the previous 12 months, approximately one third (36.3%) had sought care and received a migraine diagnosis, and only 10% of participants had sought care, received a diagnosis of migraine, and were currently taking prescription medications for migraine prevention. Furthermore, among those who were eligible for migraine-preventive medication based on their headache frequency and associated disability (n = 22,249), 65.3% indicated they had never taken a preventive medication for migraine. The reasons for this were mostly medication-related (25.5% stated they were concerned about side effects, 23.3% said they did not like taking prescription medication, and 20.8% stated that their other medications worked well enough); however, there were also other reasons related to stigma, access, and communication with the health care provider that were noted by participants.

Conclusion: This study highlights an important need for patient education, especially as many of these individuals who had never taken medications to prevent migraine reported experiencing ≥15 monthly headache days (25.3%), severe interictal burden (43.3%), and severe migraine-related disability (53.1%). We believe that these results may be of interest to health care providers who see people with migraine and help them better understand and anticipate their patients' educational needs regarding migraine prevention.