Treatment patterns of patients diagnosed with major headache disorders: A retrospective claims analysis

Objective: To describe patient characteristics, treatment patterns, and health care costs among patients diagnosed with major headache disorders overall and by type (tension-type headache [TTH], migraine, cluster headache [CH], or \u3e1 primary headache type), and secondarily to evaluate drug treatment patterns among triptan initiators with a major headache diagnosis. Methods: Using US claims data from January 2012 through December 2017, we identified adults with evidence of a major headache disorder: TTH, migraine, or CH; the first diagnosis date was deemed the index date. To evaluate triptan use specifically, patients who initiated triptans were identified; the first triptan claim date was deemed the index date. Patient characteristics, treatment patterns (concomitant treatments, adherence, number of fills), and annual health care costs data were obtained. Results: Of the 418,779 patients diagnosed with major headache disorders, the following 4 cohorts were created: TTH (8%), migraine (87%), CH (1%), and \u3e1 primary headache type (4%). The majority used analgesic (54–73%) and psychotropic (57–81%) drugs, primarily opioids (36–53%). Headache-related costs accounted for one-fifth of all-cause costs. Of the 229,946 patients who initiated triptans, the following 7 study cohorts were analyzed: sumatriptan (68%), rizatriptan (21%), eletriptan (5%), zolmitriptan (3%), naratriptan (2%), frovatriptan (1%), and almotriptan ( Conclusion: The primary headache disorder treatment paradigm is complex, with significant variability. Predominant concomitant use of opioids and switching to opioids is of concern, necessitating solutions to minimize opioid use. Switching to non-oral/fast-acting or targeted preventive therapies should be considered

Chronic paroxysmal hemicrania in paediatric age: report of two cases

Chronic paroxysmal hemicrania (CPH) is a rare primary headache syndrome, which is classified along with hemicrania continua and short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) as trigeminal autonomic cephalalgia (TACs). CPH is characterised by short-lasting (2–30 min), severe and multiple (more than 5/day) pain attacks. Headache is unilateral, and fronto-orbital-temporal pain is combined with cranial autonomic symptoms. According to the International Classification of Headache Disorders, 2nd edition, the attacks are absolutely responsive to indomethacin. CPH has been only rarely and incompletely described in the developmental age. Here, we describe two cases concerning a 7-year-old boy and a 11-year-old boy with short-lasting, recurrent headache combined with cranial autonomic features. Pain was described as excruciating, and was non-responsive to most traditional analgesic drugs. The clinical features of our children’s headache and the positive response to indomethacin led us to propose the diagnosis of CPH. Therefore, our children can be included amongst the very few cases of this trigeminal autonomic cephalgia described in the paediatric age

A review of diagnostic and functional imaging in headache

The neuroimaging of headache patients has revolutionised our understanding of the pathophysiology of primary headaches and provided unique insights into these syndromes. Modern imaging studies point, together with the clinical picture, towards a central triggering cause. The early functional imaging work using positron emission tomography shed light on the genesis of some syndromes, and has recently been refined, implying that the observed activation in migraine (brainstem) and in several trigeminal-autonomic headaches (hypothalamic grey) is involved in the pain process in either a permissive or triggering manner rather than simply as a response to first-division nociception per se. Using the advanced method of voxel-based morphometry, it has been suggested that there is a correlation between the brain area activated specifically in acute cluster headache — the posterior hypothalamic grey matter — and an increase in grey matter in the same region. No structural changes have been found for migraine and medication overuse headache, whereas patients with chronic tension-type headache demonstrated a significant grey matter decrease in regions known to be involved in pain processing. Modern neuroimaging thus clearly suggests that most primary headache syndromes are predominantly driven from the brain, activating the trigeminovascular reflex and needing therapeutics that act on both sides: centrally and peripherally

P.016 Reduction in migraine-associated burden over 24 weeks of treatment with eptinezumab in patients with chronic migraine

Background: To examine changes in the occurrence, severity, and symptoms of headache episodes in patients with chronic migraine (CM) following eptinezumab treatment. Methods: PROMISE-2 (NCT02974153) was a double-blind, placebo-controlled, parallel-group trial that randomized adults with CM to eptinezumab 100 mg, 300 mg, or placebo IV every 12 weeks for up to 24 weeks (2 infusions). Headache episodes (migraine and non-migraine) and their characteristics were reported in daily electronic diaries during the 28-day baseline period and throughout the 24-week treatment period. Results: A total of 1072 patients were included. Patients reported a mean of 20.4–20.6 monthly headache days during baseline across treatment groups. Mean monthly headache days decreased by 8.9 (100 mg) and 9.7 (300 mg) with eptinezumab versus 7.3 with placebo over weeks 1-24. Mean monthly headache episodes also decreased by 8.4 (100 mg) and 9.0 (300 mg) compared to 7.1 with placebo over weeks 1-24. Among headaches occurring post-treatment, decreases in severe pain, nausea, phonophobia, photophobia, and physical activity limitations were numerically greater than placebo. Conclusions: In patients with CM, eptinezumab numerically decreased the frequency and severity of monthly headache days and episodes more than placebo. Patients treated with eptinezumab reported a decrease in burdensome symptoms of headache episodes.</jats:p

Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

Background Galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, has demonstrated a significant reduction in monthly migraine headache days in phase 2 and 3 trials. In these analyses, we aimed to evaluate the safety and tolerability of galcanezumab compared with placebo for prevention of episodic or chronic migraine. Methods Data were integrated from three double-blind clinical studies for the up to 6-month galcanezumab exposure group (N = 1435), and from five clinical studies for the up to 1-year all-galcanezumab exposure group (N = 2276). Patients received a monthly 120 mg subcutaneous injection of galcanezumab (with a 240 mg loading dose in month 1), 240 mg galcanezumab, or placebo. Outcomes measured were treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and discontinuation due to AEs (DCAEs). Laboratory results, vital signs, electrocardiogram (ECG), suicidal ideation and behavior results were evaluated. Results TEAEs that occurred more frequently in galcanezumab-treated patients included injection site pain, injection site reactions excluding pain, constipation, vertigo, and pruritus. The proportion of DCAEs among galcanezumab-treated patients ranged between 1.8 and 3.0%, and differed from placebo group for galcanezumab 240 mg (P < 0.05). Fewer than 2.0% of patients in either galcanezumab dose-group compared with 1.0% of placebo-treated patients reported a SAE. There were no clinically meaningful differences between galcanezumab and placebo in laboratory measures, vital signs including blood pressure, ECGs, cardiovascular-related AEs, or suicidal ideation and behavior. Conclusions Galcanezumab demonstrated a favorable safety and tolerability profile for up to 1 year of treatment for the prevention of migraine.Paroxysmal Cerebral Disorder

Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies (vol 20, 25, 2020)

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