Trajectory of blood pressure after initiating anti-calcitonin gene-related peptide treatment of migraine: a target trial emulation from the veterans health administration
Abstract Background Calcitonin gene-related peptide (CGRP) is involved in migraine pathophysiology and blood pressure regulation. Although clinical trials have established the cardio-cerebrovascular safety profile of anti-CGRP treatment, limited high-quality real-world evidence exists on its long-te...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-08-01
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| Series: | The Journal of Headache and Pain |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s10194-023-01640-y |
| _version_ | 1797452039734689792 |
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| author | Kaicheng Wang Brenda T. Fenton Vinh X. Dao Alexander B. Guirguis Sarah E. Anthony Melissa Skanderson Jason J. Sico |
| author_facet | Kaicheng Wang Brenda T. Fenton Vinh X. Dao Alexander B. Guirguis Sarah E. Anthony Melissa Skanderson Jason J. Sico |
| author_sort | Kaicheng Wang |
| collection | DOAJ |
| description | Abstract Background Calcitonin gene-related peptide (CGRP) is involved in migraine pathophysiology and blood pressure regulation. Although clinical trials have established the cardio-cerebrovascular safety profile of anti-CGRP treatment, limited high-quality real-world evidence exists on its long-term effects on blood pressure (BP). To address this gap, we examined the safety of anti-CGRP treatment on BP in patients with migraine headache in the Veterans Health Administration (VHA). Methods We emulated a target trial of patients who initiated anti-CGRP treatment or topiramate for migraine prevention between May 17th, 2018 and February 28th, 2023. We calculated stabilized inverse probability weights to balance between groups and then used weighted linear mixed-effect models to estimate the systolic and diastolic BP changes over the study period. For patients without hypertension at baseline, we estimated the cumulative incidence of hypertension using Kaplan–Meier curve. We also used weight mixed-effect Poisson model to estimate the number of antihypertension medications for patients with hypertension at baseline. Results This analysis included 69,589 patients and 554,437 blood pressure readings. of these, 18,880 patients received anti-CGRP treatment, and they were more likely to be women, have a chronic migraine diagnosis and higher healthcare utilization than those received topiramate. Among patients without hypertension at baseline, we found no significant differences in systolic BP changes over the four-year follow-up between anti-CGRP (slope [standard error, SE] = 0.48[0.06]) and topiramate treated patients (slope[SE] = 0.39[0.04]). The incidence of hypertension was similar for anti-CGRP and topiramate group (4.4 vs 4.3 per 100 person-years). Among patients with hypertension at baseline who initiated anti-CGRP treatment, we found a small but persistent effect on exacerbating hypertension during the first four years of treatment, as evidenced by a significant annual 3.7% increase in the number of antihypertensive medications prescribed (RR = 1.037, 95%CI 1.025–1.048). Conclusions Our findings suggest that anti-CGRP treatment is safe regarding blood pressure in patients without hypertension. However, for those with baseline hypertension, anti-CGRP treatment resulted in a small but persistent increase in the number of antihypertensives, indicating an exacerbation of hypertension. Future studies are needed to evaluate the cardio-cerebrovascular safety of anti-CGRP treatment beyond the first four years. |
| first_indexed | 2024-03-09T15:02:02Z |
| format | Article |
| id | doaj.art-6b43af7c97ec45ca98d1c668500fdd1f |
| institution | Directory Open Access Journal |
| issn | 1129-2377 |
| language | English |
| last_indexed | 2024-03-09T15:02:02Z |
| publishDate | 2023-08-01 |
| publisher | BMC |
| record_format | Article |
| series | The Journal of Headache and Pain |
| spelling | doaj.art-6b43af7c97ec45ca98d1c668500fdd1f2023-11-26T13:50:51ZengBMCThe Journal of Headache and Pain1129-23772023-08-0124111010.1186/s10194-023-01640-yTrajectory of blood pressure after initiating anti-calcitonin gene-related peptide treatment of migraine: a target trial emulation from the veterans health administrationKaicheng Wang0Brenda T. Fenton1Vinh X. Dao2Alexander B. Guirguis3Sarah E. Anthony4Melissa Skanderson5Jason J. Sico6Department of Veterans Affairs, Research, Education, Evaluation and Engagement Activities Center for Headache, Headache Centers of ExcellenceDepartment of Veterans Affairs, Research, Education, Evaluation and Engagement Activities Center for Headache, Headache Centers of ExcellencePharmacy Benefits Management Services, VA Minneapolis Health Care SystemPharmacy Benefits Management Services, VA Connecticut Healthcare SystemDepartment of Veterans Affairs, Research, Education, Evaluation and Engagement Activities Center for Headache, Headache Centers of ExcellenceDepartment of Veterans Affairs, Research, Education, Evaluation and Engagement Activities Center for Headache, Headache Centers of ExcellenceDepartment of Veterans Affairs, Research, Education, Evaluation and Engagement Activities Center for Headache, Headache Centers of ExcellenceAbstract Background Calcitonin gene-related peptide (CGRP) is involved in migraine pathophysiology and blood pressure regulation. Although clinical trials have established the cardio-cerebrovascular safety profile of anti-CGRP treatment, limited high-quality real-world evidence exists on its long-term effects on blood pressure (BP). To address this gap, we examined the safety of anti-CGRP treatment on BP in patients with migraine headache in the Veterans Health Administration (VHA). Methods We emulated a target trial of patients who initiated anti-CGRP treatment or topiramate for migraine prevention between May 17th, 2018 and February 28th, 2023. We calculated stabilized inverse probability weights to balance between groups and then used weighted linear mixed-effect models to estimate the systolic and diastolic BP changes over the study period. For patients without hypertension at baseline, we estimated the cumulative incidence of hypertension using Kaplan–Meier curve. We also used weight mixed-effect Poisson model to estimate the number of antihypertension medications for patients with hypertension at baseline. Results This analysis included 69,589 patients and 554,437 blood pressure readings. of these, 18,880 patients received anti-CGRP treatment, and they were more likely to be women, have a chronic migraine diagnosis and higher healthcare utilization than those received topiramate. Among patients without hypertension at baseline, we found no significant differences in systolic BP changes over the four-year follow-up between anti-CGRP (slope [standard error, SE] = 0.48[0.06]) and topiramate treated patients (slope[SE] = 0.39[0.04]). The incidence of hypertension was similar for anti-CGRP and topiramate group (4.4 vs 4.3 per 100 person-years). Among patients with hypertension at baseline who initiated anti-CGRP treatment, we found a small but persistent effect on exacerbating hypertension during the first four years of treatment, as evidenced by a significant annual 3.7% increase in the number of antihypertensive medications prescribed (RR = 1.037, 95%CI 1.025–1.048). Conclusions Our findings suggest that anti-CGRP treatment is safe regarding blood pressure in patients without hypertension. However, for those with baseline hypertension, anti-CGRP treatment resulted in a small but persistent increase in the number of antihypertensives, indicating an exacerbation of hypertension. Future studies are needed to evaluate the cardio-cerebrovascular safety of anti-CGRP treatment beyond the first four years.https://doi.org/10.1186/s10194-023-01640-yAnti-CGRPBlood pressureHypertensionMigraine |
| spellingShingle | Kaicheng Wang Brenda T. Fenton Vinh X. Dao Alexander B. Guirguis Sarah E. Anthony Melissa Skanderson Jason J. Sico Trajectory of blood pressure after initiating anti-calcitonin gene-related peptide treatment of migraine: a target trial emulation from the veterans health administration The Journal of Headache and Pain Anti-CGRP Blood pressure Hypertension Migraine |
| title | Trajectory of blood pressure after initiating anti-calcitonin gene-related peptide treatment of migraine: a target trial emulation from the veterans health administration |
| title_full | Trajectory of blood pressure after initiating anti-calcitonin gene-related peptide treatment of migraine: a target trial emulation from the veterans health administration |
| title_fullStr | Trajectory of blood pressure after initiating anti-calcitonin gene-related peptide treatment of migraine: a target trial emulation from the veterans health administration |
| title_full_unstemmed | Trajectory of blood pressure after initiating anti-calcitonin gene-related peptide treatment of migraine: a target trial emulation from the veterans health administration |
| title_short | Trajectory of blood pressure after initiating anti-calcitonin gene-related peptide treatment of migraine: a target trial emulation from the veterans health administration |
| title_sort | trajectory of blood pressure after initiating anti calcitonin gene related peptide treatment of migraine a target trial emulation from the veterans health administration |
| topic | Anti-CGRP Blood pressure Hypertension Migraine |
| url | https://doi.org/10.1186/s10194-023-01640-y |
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