Pharmacovigilance / Neurological/Mental Health

4A-04 - DARWIN EU® - Incidence of Erectile Dysfunction, Insomnia, and Hypertension in Incident Migraine and by Prophylactic Treatment initiation, Including CGRP Antagonists

Monday, August 25, 2025

5:00 PM - 5:15 PM ET

Presenting Author(s)

Julieta Politi, MD PhD MPH

Department of Medical Informatics, Erasmus Medical Center, Netherlands

Co-Author(s)

GI

Ger Inberg

Department of Medical Informatics, Erasmus Medical Center, Netherlands
TN

Tuomo Niemen

Finnish Care Register for Health Care, Finland
TW

Tiina Wahlfors

Finnish Care Registry for Health Care, Finland
JB

James Brash, PhD

Senior Data Scientist
IQVIA, Real World Solutions, Brighton, United Kingdom, United Kingdom
IK

Isabella Kaczmarczyk

IQVIA Real World Solutions, United Kingdom
DV

Dina Vojinovic

IQVIA, Real World Solutions, Amsterdam, The Netherlands, Netherlands
JV

Jakov Vuković, MD

Public health physician
Croatia National Public Health Information System, Croatia, Croatia
GS

Gabriel Sanfélix-Gimeno, PharmD, PhD

Health Services Research and Pharmacoepidemiology Unit. The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO).
Valencia, Comunidad Valenciana, Spain
FS

Francisco Sanchez-Saez

Foundation for the Promotion of Health and Biomedical Research in the Valencian Community, Spain
TD

Talita Duarte Salles

Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain, Spain
Katia Verhamme, MD, PhD

Associate Professor of Use and Analysis of Observational Data
Erasmus University Rotterdam (EUR) - Erasmus Medical Center (MC)
Rotterdam, Zuid-Holland, Netherlands

Background: Monoclonal antibodies targeting the calcitonin gene-related peptide antagonists (CGRPa) are indicated for migraine prophylaxis. Potential associations between CGRPa treatment and insomnia, erectile dysfunction (ED), and hypertension have been suggested.

Objectives: We aimed to characterise individuals newly initiating CGRPa and estimate incidence rates of ED, insomnia, and hypertension among individuals with incident migraine, stratified by different prophylactic treatments, including CGRPa.

Methods: Multinational cohort study using electronic health records from primary and outpatient specialist care (IQVIA DA Germany, and VID [Spain], FinOMOP-HILMO [Finland], and NAJS [Croatia], which also include hospital care), mapped to OMOP Common Data Model. Individuals registered in a contributing database between 2018-2023 and with at least ≥365 days of prior database history were included. Characterisation was conducted on new CGRPa users. Incidence rates (IR [cases/1000 person-years]) for ED (men only), insomnia, and hypertension were estimated in the general population and the incident migraine cohort for the entire study period. The incident migraine cohort was stratified by newly initiated prophylactic treatment classes (index date) (CGRPa, anti-epileptics, TCA, beta-blockers, and calcium-channel blockers) and IRs calculated within one year of index.

Results: New CGRPa initiators (n=17,420) were mostly female, with a median age of 42-48 years. Treatment duration (first drug era) ranged between 31 and 233 days across databases. Erenumab was the most frequently prescribed CGRPa (46.8-69.7% across databases). IRs in the general population ranged from 0–3 for ED, 11–25 for hypertension, and 5–17 for insomnia per 1,000 PY (across databases). In the incident migraine population, IRs were higher, ranging from 1–6 for ED, 23–34 for hypertension, and 15–45 for insomnia. IR within one year of starting prophylactic treatments were consistently low across treatment classes for ED (0-9). Hypertension rates varied widely by treatment class, ranging between 0-253 per 1,000 PY across treatment groups (highest for Beta-blockers). For insomnia, IR varied across treatment groups between 0-64 (highest for TCAs).

Conclusions: CGRPa users in four European countries were predominantly females aged 42-48. All rates were higher in the incident migraine population than the general population. Across all prophilactic treatment classes, ED rates were low, while hypertension varied widely, especially in Beta-blocker users. Insomnia was highest in TCA. Results do not support increased rates of ED, insomnia, and hypertension among CGRPa users compared to other prophylactic treatments or to the entire incident migraine cohort.