Publications by authors named "Brett Dabruzzo"

Background And Objectives: Three phase 3 trials demonstrated the efficacy and safety of atogepant in episodic migraine (EM) and chronic migraine (CM) across 12-week treatment periods. This analysis evaluates improvements in efficacy and functional outcomes in the first 4 weeks of treatment with the oral calcitonin gene-related peptide receptor antagonist, atogepant, for the preventive treatment of migraine.

Methods: ADVANCE, ELEVATE, and PROGRESS were phase 3, multicenter, randomized, double-blind, placebo-controlled 12-week trials.

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Background: Migraine is associated with obesity. These analyses evaluated weight change with atogepant used as a preventive migraine treatment.

Methods: Five atogepant clinical trials in adults with migraine (one phase 2b/3; four phase 3) were included: Three 12-week, randomized, placebo-controlled trials (episodic migraine: two; chronic migraine: one); one 40-week, open-label extension trial and one 52-week, standard care, randomized, long-term safety trial in episodic migraine.

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Introduction: Combination use of atogepant and onabotulinumtoxinA has the potential to be more effective than either alone for the preventive treatment of chronic migraine (CM) due to their complementary mechanisms of action. This analysis collected real-world data to evaluate the safety, tolerability, and effectiveness of adding atogepant to onabotulinumtoxinA as a combination preventive treatment for CM.

Methods: This retrospective, longitudinal, multicenter chart review included adults with CM who received ≥ 2 consecutive cycles of onabotulinumtoxinA before ≥ 1 month of onabotulinumtoxinA and atogepant combination treatment.

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Article Synopsis
  • OnabotulinumtoxinA (onabotA) is believed to help reduce migraine symptoms by blocking certain nerve pathways during their activation process in the brain and spinal cord.
  • A study was conducted on anesthetized rats to observe how onabotA injections affected the activation of specific nerve cells in response to a triggering event called cortical spreading depression (CSD).
  • Results showed that onabotA significantly reduced activation in wide-dynamic range neurons, preventing enhanced responses to mechanical stimuli, indicating its effectiveness in moderating migraine-related nerve sensitivity.
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Objective: To estimate the number needed to treat and cost per additional responder for atogepant and rimegepant versus placebo for the preventive treatment of episodic migraine (EM) in the United States.

Background: Migraine has an enormous impact on a person's daily activities and quality of life, and results in significant clinical and economic burden to both individuals and society. It is important to understand the comparative efficacy and economic value of oral calcitonin gene-related peptide receptor antagonists (gepants) for preventive treatment of EM.

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Article Synopsis
  • Atogepant is an oral medication designed to prevent chronic migraines and was tested in a study involving participants with and without medication overuse.
  • The study involved 755 adults and assessed the impact of two dosages of atogepant compared to a placebo over 12 weeks, measuring changes in headache and migraine days.
  • Results showed significant reductions in migraine and headache days, along with reduced medication use, particularly in participants treated with atogepant, highlighting its effectiveness in managing chronic migraines.
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Background: Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine in adults. These analyses evaluated the proportions of clinical trial participants who experienced sustained responses to atogepant over 12 or 52 weeks of treatment.

Methods: These were post hoc analyses of ADVANCE, a 12-week, double-blind, randomized trial of atogepant 10, 30, and 60 mg once daily vs.

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Objective: To analyze data from the Chronic Migraine Epidemiology and Outcomes-International (CaMEO-I) Study in order to characterize preventive medication use and identify preventive usage gaps among people with migraine across multiple countries.

Background: Guidelines for the preventive treatment of migraine are available from scientific organizations in various countries. Although these guidelines differ among countries, eligibility for preventive treatment is generally based on monthly headache day (MHD) frequency and associated disability.

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Article Synopsis
  • - Atogepant is a specific oral medication for preventing migraines in adults, addressing the need for treatments that are both effective and well-tolerated, as traditional options often fail to maintain patient adherence due to side effects.
  • - The analysis combined data from two short-term trials and two long-term safety studies, involving over 2,900 participants to evaluate atogepant's safety and tolerability compared to a placebo and standard care.
  • - Results showed that while a significant portion of participants on atogepant experienced treatment-emergent adverse events, most events were not serious and only a few caused participants to drop out, with common side effects including upper respiratory infections, constipation, and nausea.
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Recently, we showed that while atogepant-a small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist-does not fully prevent activation of meningeal nociceptors, it significantly reduces a cortical spreading depression (CSD)-induced early response probability in C fibres and late response probability in Aδ fibres. The current study investigates atogepant effect on CSD-induced activation and sensitization of high threshold (HT) and wide dynamic range (WDR) central dura-sensitive trigeminovascular neurons. In anaesthetized male rats, single-unit recordings were used to assess effects of atogepant (5 mg/kg) versus vehicle on CSD-induced activation and sensitization of HT and WDR trigeminovascular neurons.

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Objective: To characterize the direct impact of monthly headache days (MHDs) on health-related quality of life (HRQoL) in people with migraine and the potential mediating effects of anxiety, depression, and allodynia.

Background: Although the general relationship between increased migraine frequency (i.e.

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Objective: To evaluate the efficacy and safety of ubrogepant for the acute treatment of perimenstrual migraine (pmM) attacks.

Background: Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine in adults.

Methods: After completing one of two phase 3 trials, participants could enroll in a phase 3, 52-week, open-label, long-term safety extension trial and were re-randomized 1:1:1 to usual care, ubrogepant 50 mg, or ubrogepant 100 mg.

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Article Synopsis
  • Atogepant is an oral medication designed to prevent episodic migraines by blocking certain receptors related to migraine pathways.
  • A 52-week trial showed that adults taking atogepant 60 mg once daily experienced significant improvements in quality of life and reductions in headache impact compared to standard care.
  • By week 52, nearly 81% of participants had a meaningful improvement in headache impact, indicating atogepant's effectiveness over the treatment period.
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Objective: To evaluate potential drug-drug interactions of ubrogepant and atogepant.

Background: Ubrogepant and atogepant, calcitonin gene-related peptide (CGRP) receptor antagonists, are recently approved drugs for acute and preventive treatment of migraine, respectively. For patients with migraine who are prescribed atogepant for the preventive treatment of migraine, health care providers could prescribe ubrogepant for the acute treatment of breakthrough migraine attacks.

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Importance: Some patients with migraine, particularly those in primary care, require effective, well-tolerated, migraine-specific oral preventive treatments.

Objective: To examine the efficacy of atogepant, an oral, small-molecule, calcitonin gene-related peptide receptor antagonist, using 4 levels of mean monthly migraine-day (MMD) responder rates.

Design, Setting, And Participants: This secondary analysis of a phase 3, double-blind, placebo-controlled randomized clinical trial evaluated the efficacy and safety of atogepant for the preventive treatment of migraine from December 14, 2018, to June 19, 2020, in adults with 4 to 14 migraine-days per month at 128 sites in the US.

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Background: Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist for the preventive treatment of migraine.

Methods: In the double-blind, phase 3 ADVANCE trial, participants with 4-14 migraine days/month were randomized to atogepant 10 mg, 30 mg, 60 mg, or placebo once daily for 12 weeks. We evaluated the time course of efficacy of atogepant for the preventive treatment of migraine.

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