Mayumi Fukuda-Doi1,2,3, Haruko Yamamoto2, Masatoshi Koga1, Yuko Y Palesch4, Valerie L Durkalski-Mauldin4, Adnan I Qureshi5,6, Sohei Yoshimura1, Shuhei Okazaki7, Kaori Miwa1, Yasushi Okada8, Toshihiro Ueda9, Satoshi Okuda10, Jin Nakahara3, Norihiro Suzuki3, Kazunori Toyoda1,3. 1. Department of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan. 2. Center for Advancing Clinical and Translational Sciences (M.F.-D., H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan. 3. Department of Neurology, Keio University School of Medicine, Tokyo, Japan (M.F.-D., J.N., N.S., K.T.). 4. Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., V.L.D.-M.). 5. Zeenat Qureshi Stroke Institute, St. Cloud, MN (A.I.Q.). 6. Department of Neurology, University of Missouri, Columbia (A.I.Q.). 7. Department of Neurology (S. Okazaki), National Cerebral and Cardiovascular Center, Suita, Japan. 8. Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center Clinical Research Institute, Fukuoka, Japan (Y.O.). 9. Department of Strokology, Stroke Center, St. Marianna University Toyoko Hospital, Kawasaki, Japan (T.U.). 10. Department of Neurology, National Hospital Organization Nagoya Medical Center, Japan (S. Okuda).
Abstract
BACKGROUND AND PURPOSE: Evidence regarding sex differences in clinical outcomes and treatment effect following intracerebral hemorrhage is limited. Using the ATACH-2 trial (Antihypertensive Treatment in Intracerebral Hemorrhage-2) data, we explored whether sex disparities exist in outcomes and response to intensive blood pressure (BP)-lowering therapy. METHODS: Eligible intracerebral hemorrhage subjects were randomly assigned to intensive (target systolic BP, 110-139 mm Hg) or standard (140-179 mm Hg) BP-lowering therapy within 4.5 hours after onset. Relative risk of death or disability corresponding to the modified Rankin Scale score of 4 to 6 was calculated, and interaction between sex and treatment was explored. RESULTS: In total, 380 women and 620 men were included. Women were older, more prescribed antihypertensive drugs before onset, and had more lobar intracerebral hemorrhage than men. Hematoma expansion was observed less in women. After multivariable adjustment, the relative risk of death or disability in women was 1.19 (95% CI, 1.02-1.37, P=0.023). The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men (P for interaction=0.11), with inconclusive Gail-Simmon test (P=0.16). CONCLUSIONS: Women had a higher risk of death or disability following intracerebral hemorrhage. The benefit of intensive BP-lowering therapy in women is inconclusive, consistent with the overall results of ATACH-2. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01176565.
BACKGROUND AND PURPOSE: Evidence regarding sex differences in clinical outcomes and treatment effect following intracerebral hemorrhage is limited. Using the ATACH-2 trial (Antihypertensive Treatment in Intracerebral Hemorrhage-2) data, we explored whether sex disparities exist in outcomes and response to intensive blood pressure (BP)-lowering therapy. METHODS: Eligible intracerebral hemorrhage subjects were randomly assigned to intensive (target systolic BP, 110-139 mm Hg) or standard (140-179 mm Hg) BP-lowering therapy within 4.5 hours after onset. Relative risk of death or disability corresponding to the modified Rankin Scale score of 4 to 6 was calculated, and interaction between sex and treatment was explored. RESULTS: In total, 380 women and 620 men were included. Women were older, more prescribed antihypertensive drugs before onset, and had more lobar intracerebral hemorrhage than men. Hematoma expansion was observed less in women. After multivariable adjustment, the relative risk of death or disability in women was 1.19 (95% CI, 1.02-1.37, P=0.023). The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74-1.13) in women versus 1.13 (95% CI, 0.92-1.39) in men (P for interaction=0.11), with inconclusive Gail-Simmon test (P=0.16). CONCLUSIONS: Women had a higher risk of death or disability following intracerebral hemorrhage. The benefit of intensive BP-lowering therapy in women is inconclusive, consistent with the overall results of ATACH-2. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01176565.
Entities:
Keywords:
blood pressure; cerebral hemorrhage; clinical trial; hematoma; sex
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