201 Safety considerations in the treatment with anti-CGRP antibodies 9 Laboratory values Among the laboratory values no outliers were detected with the principle component analyses. There was no mean change in ASAT, ALAT and GGT serum levels over time (Figure 3A). Only ALP showed a slight increase at 6 months (β= 2.77, 95% CI: 1.07 – 4.48, p=0.03). Cholesterol, LDL, HDL and triglyceride serum levels remained stable over time (Figure 3B). Similarly, no mean change was found in sodium, potassium, urea and glucose serum levels over time (Figure 3C). Furthermore, there were no mean changes in creatinine serum levels at each time point (Figure 3D). Notably, in the case of eGFR, there was an enhancement in kidney function, characterized by a significant mean increase in eGFR at the 9-month mark (β=3.05, 95% CI: 1.35 – 4.75, p=0.01). For comprehensive insight, detailed coefficients (95% CI) and p-values for each time point are available upon request for all variables. ECG conduction times and heart rate There was no mean change in PR interval time, QRS complex, QTc interval time or heart rate (HR) over time (eFigure 1). For these conduction times and the heart rate, estimated coefficients (95% CI) and p-values are available upon request. Complete case analyses Out of the initial 193 patients, n=67 were excluded from the analysis due to treatment discontinuation at any time point (Figure 1). We performed a complete case analysis with the remaining 126 patients to handle missing data and investigated the impact on all outcome variables over time. Notably, in the complete case analysis we no longer found an increase in ALP levels at 3 months (β=2.41, 95% CI: 0.36 – 4.46, p=0.42), nor did we find an elevation of eGFR (CKD-EPI) levels at 9 months (β=2.89, 95% CI: 1.03 – 4.75, p=0.05). Figure 2. Overview of all patients (n=193), categorized by patients that developed a moderate to severe CV event (n=3), patients that developed ECG abnormalities (n=3), patients that had baseline ECG abnormalities without physical complaints (n=13) and patients that had no CV event or ECG abnormalities (n=174).
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