03200nas a2200373 4500000000100000008004100001100001900042700001300061700001300074700001600087700001800103700001900121700001700140700001700157700002000174700002000194700002200214700001800236700001700254700001500271700001700286700002200303700001300325700001700338700002800355700001500383700001600398700001500414245008200429300001200511490000800523520228100531022001402812 2013 d1 aArima Hisatomi1 aDavis S.1 aHata Jun1 aHeeley Emma1 aWoodward Mark1 aAnderson Craig1 aHuang Yining1 aWang Jiguang1 aStapf Christian1 aLindley Richard1 aRobinson Thompson1 aLavados Pablo1 aParsons Mark1 aLi Yuechun1 aWang Jinchao1 aHeritier Stephane1 aLi Qiang1 aR Simes John1 aINTERACT2 Investigators1 aDelcourt C1 aChalmers J.1 aNeal Bruce00aRapid blood-pressure lowering in patients with acute intracerebral hemorrhage a2355-650 v3683 a
BACKGROUND: Whether rapid lowering of elevated blood pressure would improve the outcome in patients with intracerebral hemorrhage is not known.
METHODS: We randomly assigned 2839 patients who had had a spontaneous intracerebral hemorrhage within the previous 6 hours and who had elevated systolic blood pressure to receive intensive treatment to lower their blood pressure (with a target systolic level of <140 mm Hg within 1 hour) or guideline-recommended treatment (with a target systolic level of <180 mm Hg) with the use of agents of the physician's choosing. The primary outcome was death or major disability, which was defined as a score of 3 to 6 on the modified Rankin scale (in which a score of 0 indicates no symptoms, a score of 5 indicates severe disability, and a score of 6 indicates death) at 90 days. A prespecified ordinal analysis of the modified Rankin score was also performed. The rate of serious adverse events was compared between the two groups.
RESULTS: Among the 2794 participants for whom the primary outcome could be determined, 719 of 1382 participants (52.0%) receiving intensive treatment, as compared with 785 of 1412 (55.6%) receiving guideline-recommended treatment, had a primary outcome event (odds ratio with intensive treatment, 0.87; 95% confidence interval [CI], 0.75 to 1.01; P=0.06). The ordinal analysis showed significantly lower modified Rankin scores with intensive treatment (odds ratio for greater disability, 0.87; 95% CI, 0.77 to 1.00; P=0.04). Mortality was 11.9% in the group receiving intensive treatment and 12.0% in the group receiving guideline-recommended treatment. Nonfatal serious adverse events occurred in 23.3% and 23.6% of the patients in the two groups, respectively.
CONCLUSIONS: In patients with intracerebral hemorrhage, intensive lowering of blood pressure did not result in a significant reduction in the rate of the primary outcome of death or severe disability. An ordinal analysis of modified Rankin scores indicated improved functional outcomes with intensive lowering of blood pressure. (Funded by the National Health and Medical Research Council of Australia; INTERACT2 ClinicalTrials.gov number, NCT00716079.).
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