195 Safety considerations in the treatment with anti-CGRP antibodies 9 expertise, or by neurologists themselves, based on the International Classification of Headache Disorders (ICHD)-3 criteria.24 Patients with a second headache diagnosis other than tension-type headache were excluded. Approval for this study was obtained from the LUMC Medical Ethical Committee who declared no ethical concerns. Treatment All patients started treatment with either erenumab 70 mg or fremanezumab 225 mg, administered subcutaneously once every 4 weeks. Patients administered the initial injection themselves under supervision of a physician or a headache nurse, and subsequent injections were administered at home. After 3 months, patients had a consultation with their treating physician, after which the erenumab dose was optionally increased to 140 mg for the subsequent 3 months based on a joint decision between patient and physician mainly taking the (side-)effects into account. As there is a strict policy in the Netherlands regarding medication overuse headache (MOH), and polypharmacy is not part of Dutch clinical practice, none of the patients used additional prophylactic treatment simultaneously with erenumab or fremanezumab or suffered from additional MOH. Thus, other preventive medication was tapered off, including a wash-out period of 1 month before anti-CGRP(R)-mAbs were administered. Data collection Patients had a consultation at the Leiden Headache Center at the start of treatment (baseline) and thereafter every three months (3, 6, 9, 12, 15 and 18 months) until treatment was discontinued. All CV adverse events were documented in the electronic patient file over the entire follow-up period (18 months) and subsequently discussed with both a neurologist (GMT) and a cardiologist for further evaluation and management. For all patients that developed CV adverse events, the SCORE2 prediction model was used to estimate 10-year fatal and non-fatal cardiovascular risk at baseline, using the table of moderate CV risk due to their diagnosis of migraine.25 Factors included in this prediction model are sex, age, systolic BP, smoking status and non-HDL cholesterol. Laboratory values were collected from the electronic patient records at each timepoint, with a minimum follow-up of 12 months. The collected laboratory values included electrolytes (sodium, potassium, urea), glucose, liver function (alkaline phosphatase (ALP), alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) and gammaglutamyl transferase (GGT)), kidney function (creatinine and the estimated glomerular filtration rate (eGFR)) and lipids (cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides). The eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
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