TY - JOUR
T1 - Risk of cardiovascular disease in patients with multiple sclerosis treated with fingolimod compared to natalizumab
T2 - A nationwide cohort study of 2095 patients in Denmark
AU - Framke, Elisabeth
AU - Thygesen, Lau Caspar
AU - Malmborg, Morten
AU - Schou, Morten
AU - Sellebjerg, Finn
AU - Magyari, Melinda
PY - 2024/2
Y1 - 2024/2
N2 - BACKGROUND: Fingolimod may be associated with risk of developing cardiovascular disease (CVD). Studies including reference groups and long follow-up are scarce.OBJECTIVES: We hypothesized that patients treated with fingolimod would be at higher risk of developing CVD compared to patients treated with natalizumab.METHODS: A nationwide 12-year cohort study linking individual-level data from the Danish Multiple Sclerosis Registry with health registries on 2095 adult patients with multiple sclerosis (MS) without any health records of CVD at follow-up start. Exposure to fingolimod and natalizumab was defined by the first treatment of at least 3 months. Cohort entry was from 2011 to 2018. We defined CVD as a composite measure, including hypertension, ischemic heart disease, atrial fibrillation, heart failure, and stroke. We used multivariable adjusted Cox regression.RESULTS: There were 28.8 and 17.4 CVD events per 1000 person-years in fingolimod and natalizumab groups, respectively. Compared to natalizumab-treated patients, fingolimod-treated patients had a higher risk of CVD (hazard ratio (HR) = 1.57; 95% confidence interval (CI) = 1.18-2.08). Hypertension comprised 200 of 244 CVD events.CONCLUSION: We found an increased risk of CVD in patients with MS treated with fingolimod. This increased risk was mainly due to hypertension.
AB - BACKGROUND: Fingolimod may be associated with risk of developing cardiovascular disease (CVD). Studies including reference groups and long follow-up are scarce.OBJECTIVES: We hypothesized that patients treated with fingolimod would be at higher risk of developing CVD compared to patients treated with natalizumab.METHODS: A nationwide 12-year cohort study linking individual-level data from the Danish Multiple Sclerosis Registry with health registries on 2095 adult patients with multiple sclerosis (MS) without any health records of CVD at follow-up start. Exposure to fingolimod and natalizumab was defined by the first treatment of at least 3 months. Cohort entry was from 2011 to 2018. We defined CVD as a composite measure, including hypertension, ischemic heart disease, atrial fibrillation, heart failure, and stroke. We used multivariable adjusted Cox regression.RESULTS: There were 28.8 and 17.4 CVD events per 1000 person-years in fingolimod and natalizumab groups, respectively. Compared to natalizumab-treated patients, fingolimod-treated patients had a higher risk of CVD (hazard ratio (HR) = 1.57; 95% confidence interval (CI) = 1.18-2.08). Hypertension comprised 200 of 244 CVD events.CONCLUSION: We found an increased risk of CVD in patients with MS treated with fingolimod. This increased risk was mainly due to hypertension.
KW - Adult
KW - Cardiovascular Diseases/chemically induced
KW - Cohort Studies
KW - Denmark/epidemiology
KW - Fingolimod Hydrochloride/adverse effects
KW - Humans
KW - Hypertension
KW - Immunosuppressive Agents/adverse effects
KW - Multiple Sclerosis, Relapsing-Remitting
KW - Multiple Sclerosis/drug therapy
KW - Natalizumab/adverse effects
UR - http://www.scopus.com/inward/record.url?scp=85182470438&partnerID=8YFLogxK
U2 - 10.1177/13524585231221415
DO - 10.1177/13524585231221415
M3 - Journal article
C2 - 38205784
SN - 1352-4585
VL - 30
SP - 184
EP - 191
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
IS - 2
ER -