Abstract Details

Title Evaluation of Cardiovascular Risks in Adult Patients with Episodic or Chronic Migraine Treated With Galcanezumab: Data From Three Phase 3, Randomized, Double-Blind, Placebo-Controlled Studies

Topic Headache

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-010

Objective To evaluate data related to cardiovascular (CV) events in patients with episodic or chronic migraine from double-blind, placebo-controlled studies of galcanezumab, a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP).

Background CGRP is a potent microvascular vasodilator and has a hypothesized protective role in CV health. Increased CV risks have been reported in patients with migraine.

Design/Methods In 2 similarly designed episodic migraine 6-month studies and 1 chronic migraine 3-month study, data from patients randomized (1:1:2) to subcutaneous injection of galcanezumab 120 mg/month (following initial 240 mg loading dose) or 240 mg/month or placebo were pooled and grouped into CV disease risk “yes” or “no” subgroups based on reported medical history at baseline. Potential CV treatment-emergent adverse events (TEAE), identified using standard MedDRA queries and medical review, and categorical changes in blood pressure (BP), pulse, and electrocardiogram (ECG) were evaluated using the Cochran Mantel Haenszel test. Changes from baseline in BP, pulse, and ECG were evaluated using the analysis of covariance model.

Results At baseline, across all treatment groups, between 17% and 19% of patients were in the “yes” CV disease risk subgroup. Among treatment arms, the percentage of patients reporting ≥1 CV TEAE were low (<4%) and treatment-by-CV disease risk subgroup interactions were not significant. The same number of patients had CV-related serious adverse events in the galcanezumab 240 mg (n=3; acute myocardial infarction [MI], pulmonary embolism, and transient ischemic attack) and placebo (n=3; pulmonary embolism, deep vein thrombosis, and MI) groups and the events were not considered treatment-related; none occurred in the galcanezumab 120 mg group. LSmean and categorical changes from baseline in BP, pulse, and QTcF were similar across treatment groups.

Conclusions No clinically meaningful differences were observed for CV TEAEs, BP, pulse, or QTcF between patients treated with galcanezumab or placebo.

Authors/Disclosures
Tina Oakes PRESENTER	Tina Oakes has received personal compensation for serving as an employee of Eli Lilly. Tina Oakes has received stock or an ownership interest from Eli Lilly.
Richard Kovacs	Richard Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Richard Kovacs has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Cook Research Inc. Richard Kovacs has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Prilenia. Richard Kovacs has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for University Southern California. Richard Kovacs has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for American College of Cardiology. The institution of Richard Kovacs has received research support from NHLBI.
Noah Rosen, MD, FAAN	Dr. Rosen has received personal compensation for serving as an employee of Northwell Health. An immediate family member of Dr. Rosen has received personal compensation for serving as an employee of New York University. Dr. Rosen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/ Abbvie. Dr. Rosen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Rosen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer . Dr. Rosen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Rosen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/ Abbvie. Dr. Rosen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Pfizer. Dr. Rosen has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer.
Erin G. Doty, MD (Eli Lilly and Company)	Dr. Doty has received personal compensation for serving as an employee of Eli Lilly and Company, USA. Dr. Doty has stock in Eli Lilly and Company, USA.
Phebe Kemmer, PhD (Eli Lilly and Company)	Dr. Kemmer has received personal compensation for serving as an employee of Eli Lilly and Company. Dr. Kemmer has received stock or an ownership interest from Eli Lilly and Company.
Sheena K. Aurora, MD (Department of Neurology and Neurological Sciences)	Dr. Aurora has received personal compensation for serving as an employee of Alzheimer's Association.
	No disclosure on file

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