194 Chapter 9 SAEs, has limitations due to a short 6-month follow-up period and reliance on only self-reported adverse events, which likely leads to underreporting.15 Earlier, a case report highlighted a CV-event that occurred 5 months after starting erenumab.17 Furthermore, during an open-label extension study a CV related death was reported.18 These CV-related AEs are particularly noteworthy since clinical trials typically focus on enrolling patients with migraine who need to be generally in good health. Therefore, other reviews have emphasized the importance of incorporating real-world data and post-marketing surveillance studies to validate and expand upon these trial results.19 Of particular concern are post-marketing case reports of elevated BP associated with erenumab, raising questions about CV safety.20 An independent study found an average increase of 5.2 mm Hg in systolic BP and 3.5 mm Hg in diastolic BP after starting anti-CGRP(R)-mAbs erenumab or fremanezumab in patients with migraine.21, 22 Studies with clinical data collected from independent researchers and with longer follow-up time seem important to obtain a more comprehensive insight and understanding of individual responses and side-effects. In this observational cohort study we assessed the safety of erenumab and fremanezumab regarding CV safety by assessing CV events and ECGs during a period of at least one year of treatment with anti-CGRP(R)-mAbs in a real world setting. METHODS All patients with migraine who received treatment with either erenumab or fremanezumab at the Leiden Headache Center were considered eligible for inclusion. Exclusion criteria were established based on elevated risks of cardiovascular disease (CVD), and included hypertension at baseline, a medical history of hypertension and a prior CV event. At the time of this study we defined hypertension as a systolic BP ≥140 mmHg and/or a diastolic BP ≥90 mmHg in accordance with the 2018 ESC/ ESH guidelines.23 In addition, we excluded patients that were previously treated with an anti-CGRP(R)-mAb and thus had no distinct baseline period. After one baseline month patients started treatment with either erenumab or fremanezumab. Due to the restricted availability of anti-CGRP(R)-mAbs in the Netherlands at the time of inclusion, all patients had to have at least 6 monthly migraine days (MMD) and failed on ≥ 4 migraine prophylactic treatments, including at least candesartan, beta-blockers, valproate and topiramate. Treatment failure was defined as ineffective treatment, discontinuation because of side effects or ineligibility because of contra-indications. Migraine diagnosis was made by a neurology resident in consultation with a neurologist with headache
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