5PSQ-143 Assessing cardiovascular safety of anti-CGRP treatments: insights from real-world data in elderly and cardiovascular patients

<h3>Background and Importance</h3> Phase 2 and 3 clinical trials evaluating anti-CGRP monoclonal antibody therapies have not demonstrated an increased incidence of vascular events or vascular complications in patients undergoing treatment. However, it is important to note that patients over 65 years of age and those with pre-existing cardiovascular conditions were excluded from these trials. <h3>Aim and Objectives</h3> To analyse the cardiovascular safety profile of anti-CGRP monoclonal antibodies in elderly patients and in those with a history of cardiovascular disease. <h3>Material and Methods</h3> Observational, retrospective study conducted in a medium-complexity hospital. All patients treated with anti-CGRP therapy through the outpatient clinic module were included. Clinical data of the patients were obtained from the electronic medical records. We included arterial hypertension as a cardiovascular-related condition. Adverse effects experienced by the patients were recorded using forms completed during pharmaceutical care consultations. The Chi-squared test was used to compare the total proportions of cardiovascular events. <h3>Results</h3> A total of 119 patients undergoing anti-CGRP therapy were evaluated. Median follow-up was 587 days. Of these, 84.03% had no pre-existing cardiovascular conditions, and 13 patients (10.92%) were over the age of 65. Among the patients with pre-existing cardiovascular conditions (15.97%), 15 had arterial hypertension (78.94%), two presented with angina pectoris (19.52%), three had documented arrhythmias (20%), and three were diagnosed with dyslipidaemia (20%). Notably, no cardiovascular events were reported following the initiation of anti-CGRP therapy in this cohort. Post-treatment cardiovascular events occurred in four patients (3.36%), with two cases of arterial hypertension (50%) one case of arrhythmia (25%), and one case of cerebrovascular disease (25%). Only one of these patients was over 65 years of age, and none had pre-existing cardiovascular conditions. There were no statistically significant differences in post-treatment cardiovascular events between elderly patients and those without pre-existing cardiovascular conditions (p = 0.918); and between patients with and without pre-existing cardiovascular conditions (p = 0.847). <h3>Conclusion and Relevance</h3> These findings suggests that anti-CGRP treatments may be similarly safe across these groups. Real-World Data studies provide valuable insights that may not be captured in controlled trial environments. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest