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 (P1.10-010)

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 ( Conclusions: No clinically meaningful differences were observed for CV TEAEs, BP, pulse, or QTcF between patients treated with galcanezumab or placebo. Disclosure: Dr. Oakes has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Oakes holds stock and/or stock options in Eli Lilly. Dr. Kovacs has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Armaron, Prilenia, Jazz, and Lilly. Dr. Rosen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Axon Optics, Theranica, Allergan, Teva, Eli Lilly, Supernus, Promius, Curelator, Allergan. Dr. Doty has received personal compensation for consulting and serving on a scientific advisory board with Eli Lilly and Company, and has received personal compensation for speaking with the Allergan Botox Speakers Bureau, Amgen Speakers Bureau, and Teva Speakers Bureau. Dr. Doty holds stock and/or stock options in Eli Lilly and Company. Dr. Kemmer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Aurora has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Camporeale has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company.