Sex Differences in Blood Pressure-Lowering Therapy and Outcomes Following Intracerebral Hemorrhage: Results From ATACH-2

Mayumi Fukuda-Doi, Haruko Yamamoto, Masatoshi Koga, Yuko Y Palesch, Valerie L Durkalski-Mauldin, Adnan I Qureshi, Sohei Yoshimura, Shuhei Okazaki, Kaori Miwa, Yasushi Okada, Toshihiro Ueda, Satoshi Okuda, Jin Nakahara, Norihiro Suzuki, Kazunori Toyoda, Mayumi Fukuda-Doi, Haruko Yamamoto, Masatoshi Koga, Yuko Y Palesch, Valerie L Durkalski-Mauldin, Adnan I Qureshi, Sohei Yoshimura, Shuhei Okazaki, Kaori Miwa, Yasushi Okada, Toshihiro Ueda, Satoshi Okuda, Jin Nakahara, Norihiro Suzuki, Kazunori Toyoda

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.

Keywords: blood pressure; cerebral hemorrhage; clinical trial; hematoma; sex.

Figures

Figure 1.
Figure 1.
Sex difference in the modified Rankin scale at 90 days.
Figure 2.
Figure 2.
Sex difference in outcomes following intracerebral hemorrhage at 90 days [Model 1]: Adjusted for Glasgow Coma Scale score, age, intraventricular hemorrhage, initial hematoma volume, and hematoma expansion. [Model 2]:additionally adjusted for initial edema volume and perihematomal edema expansion rate.
Figure 3.
Figure 3.
Sex difference in efficacy and safety of intensive SBP-lowering in intracerebral hemorrhage (ICH) AE:adverse event, SAE: serious AE

Source: PubMed

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