Galcanezumab for the preventive treatment of episodic and chronic migraine in real life: A prospective multicenter study in Colombia and Mexico including effects on anxiety and depression - On behalf of ASOLACE

Author:

Munoz-Cerón Joe1,Vélez-Jiménez Karina2,Bohorquez-Valderrama Stephanía3,Ildefonso Rodríguez-Leyva4,Hernández-Beltrán Natalia5,Gallo-Eugenio Loren1,Moreno-Rodríguez Claudia6,Jiménez-Jaramillo Juan7,Guerra-Posada Carolina8,Ramos-Romero Marta9,Bernal-Cobo Rafael7,Rojas-Villegas Yessica10,Cavanzo-Henao Paula11,Reydmar López-González12

Affiliation:

1. Hospital Universitario Mayor MEDERI, Universidad del Rosario

2. Hospital Ángeles Lomas, Ciudad de México

3. Hospital Kennedy

4. Hospital Central Dr. Ignacio Morones Prieto

5. Neuromédica-EPS SURA

6. Clínica Universitaria Colombia – Keralty

7. Clínica Confamiliar

8. Clínica SOMA

9. Hospital La Misericordia

10. Clinica Ospedale

11. Compensar EPS

12. Hospital San Vicente Fundación Rio Negro

Abstract

Abstract Introduction Galcanezumab is an innovative therapeutic option for individuals with migraine. To date, there is no information regarding treatment results for Colombia and Mexico. The aim of this study was to determine the efficacy and tolerability of galcanezumab in real life in patients from Colombia and Mexico. Materials and methods This was a prospective, independent, multicenter, real-life study. Ninety-eight patients ≥18 years of age with a diagnosis of episodic and chronic migraine (ICHD3 criteria) were included. At baseline, 3 months and 6 months, comparative analyses of migraine days/month, the HIT-6, GAD-7, PHQ-9 scales, analgesic days/month, global self-perception and incidence of collateral effects were performed. Results Ninety-eight patients were included [mean age, 43.6 (SD 12.91); age range, 18-82 years; women, 85.7%]. At baseline, 72.4% and 27.6% of patients had chronic migraine and episodic migraine, respectively. In the episodic migraine group, there was a decrease in migraine days from baseline [6.7 (IQR 9-3.5)] to 3 months [2 (IQR 4-1)] and 6 months [2 (IQR 3.5-1)] of follow-up(p 0.01 baseline vs 6 months). Patients with chronic migraine changed from [24.2 (IQR 30-20)] at baseline to [9 (IQR 4-19.25)] at month 3 and to [6 (IQR 15-4)] at the end of follow-up (p< 0.01). HIT-6, GAD-7 and PHQ-9 scores were significantly lower at months 3 and 6 than at baseline. De novo constipation occurred in 8% of participants. Conclusion This study offers evidence of the efficacy of galcanezumab in real life, including an impact on psychiatric variables.

Publisher

Research Square Platform LLC

Reference16 articles.

1. Aurora SK, Brin MF. Chronic Migraine: An Update on Physiology, Imaging, and Therapies. 2016.

2. Edvinsson L. CGRP as the target of new migraine therapies — successful translation from bench to clinic. Nat Rev Neurol [Internet]. 2018;14(June). http://dx.doi.org/10.1038/s41582-018-0003-1.

3. Blocking CGRP in migraine patients;Deen M;– a review of pros and cons,2017

4. Edvinsson L. Calcitonin gene-related peptide (CGRP) and the pathophysiology of headache: therapeutic implications. CNS Drugs [Internet]. 2001;15(10):745–53. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11602001.

5. Evaluation of galcanezumab for the prevention of episodic migraine: The EVOLVE-1 randomized clinical trial;Stauffer VL;JAMA Neurol,2018

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