From the FDA Drug Label
Hypertension: New-onset or worsening of pre-existing hypertension may occur. (5.3)
- CGRPIs and Blood Pressure: The FDA drug label states that new-onset or worsening of pre-existing hypertension may occur with the use of CGRPIs, such as erenumab-aooe 1.
- Extent of Increase: However, the label does not provide specific information on the extent to which CGRPIs increase blood pressure.
- Clinical Decision: Given the lack of specific information, it is difficult to determine the exact significance of the increase in blood pressure. As a conservative clinical decision, it is essential to monitor blood pressure in patients taking CGRPIs, especially those with pre-existing hypertension.
- Key Point: The FDA label does not provide a quantitative measure of the increase in blood pressure, making it challenging to assess the significance of the effect 1.
From the Research
Calcitonin Gene-Related Peptide Inhibitors (CGRPIs) can increase blood pressure, with the maximum estimated increase in mean systolic blood pressure being 5.2 mm Hg and mean diastolic blood pressure being 3.5 mm Hg, as observed in a prospective follow-up study 2.
Key Findings
- The study found that both systolic and diastolic blood pressure were increased at all time points compared to baseline in patients treated with erenumab and fremanezumab 2.
- The majority of patients remained within normal blood pressure limits, but some patients required antihypertensive treatment 2.
- Another study found that anti-CGRP treatment resulted in a small but persistent increase in the number of antihypertensives prescribed for patients with baseline hypertension, indicating an exacerbation of hypertension 3.
Clinical Implications
- Patients with pre-existing hypertension or cardiovascular disease should be monitored more closely when starting CGRPIs.
- The mechanism behind the slight blood pressure increase relates to CGRP's natural vasodilatory function in the body; when CGRP signaling is blocked, there may be reduced vasodilation, potentially leading to small increases in blood pressure.
- Despite these small increases, CGRPIs have demonstrated good cardiovascular safety profiles in clinical trials and post-marketing surveillance, and the blood pressure effects are generally not a reason to avoid these medications in most patients who might benefit from them for migraine prevention.
Recommendations
- Physicians should be aware of the potential risk of developing hypertension in patients treated with anti-CGRP (receptor) antibodies and monitor blood pressure accordingly 2.
- Patients with normal blood pressure can generally be treated with CGRPIs without significant concern for blood pressure effects.
- Further studies are needed to evaluate the long-term cardio-cerebrovascular safety of anti-CGRP treatment beyond the first four years 3.