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Int J Stroke. 2015 Jul;10(5):745-51. doi: 10.1111/ijs.12446. Epub 2015 Jan 12.

Modest blood pressure reduction with valsartan in acute ischemic stroke: a prospective, randomized, open-label, blinded-end-point trial.

Author information

1
Department of Neurology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.
2
Department of Neurology, Ilsan Paik Hospital, Inje University, Goyang, Korea.
3
Department of Neurology, Asan Medical Center, Seoul, Korea.
4
Department of Neurology, Eulji University Eulji General Hospital, Seoul, Korea.
5
Department of Neurology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.
6
Department of Neurology, Seoul St. Mary's Hospital, Catholic University of Korea, Seoul, Korea.
7
Department of Biostatistics, Korea University College of Medicine, Seoul, Korea.

Abstract

BACKGROUND AND AIMS:

To assess the efficacy and safety of modest blood pressure (BP) reduction with valsartan within 48 h after symptom onset in patients with acute ischemic stroke and high BP.

METHODS:

This was a multicenter, prospective, randomized, open-label, blinded-end-point trial. A total of 393 subjects were recruited at 28 centers and then randomly assigned in a 1:1 ratio to receive valsartan (n = 195) or no treatment (n = 198) for seven-days after presentation. The primary outcome was death or dependency, defined as a score of 3-6 on the modified Rankin Scale (mRS) at 90 days after symptom onset. Early neurological deterioration (END) within seven-days and 90-day major vascular events were also assessed.

RESULTS:

There were 372 patients who completed the 90-day follow-up. The valsartan group had 46 of 187 patients (24·6%) with a 90-day mRS 3-6, compared with 42 of 185 patients (22·6%) in the control group (odds ratio [OR], 1·11; 95% confidence interval [CI], 0·69-1·79; P = 0·667). The rate of major vascular events did not differ between groups (OR, 1·41; 95% CI, 0·44-4·49; P = 0·771). There was a significant increase of END in the valsartan group (OR, 2·43; 95% CI, 1·25-4·73; P = 0·008).

CONCLUSIONS:

Early reduction of BP with valsartan did not reduce death or dependency and major vascular events at 90 days, but increased the risk of END.

KEYWORDS:

blood pressure; ischemic stroke; outcome

PMID:
25580869
DOI:
10.1111/ijs.12446
[Indexed for MEDLINE]

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