Efficacy of Antihypertensive Therapy in the Acute Stage of Cerebral Infarction - A Prospective, Randomized Control Trial.

Background: This study investigated whether patients in the acute stage of cerebral infarction (ACI) might benefit from single-drug antihypertensive therapy (AT) without the use of preset target levels.

Methods: A total of 320 ACI patients were randomly divided into an AT group and a control group (group C) (160 patients in each group). The AT group received single antihypertensive drug treatment after the first 48 hours of onset with 5 mg of amlodipine besylate or 150 mg of irbesartan once a day. The primary end-point event was mortality on the 14 day and in the 6 month after onset, significant dependent-survival status (SDS, Barthel Index ≤ 60), mortality/disability ratio (modified Rankin Scale ≥ 3), and recurrence rate of cardio-cerebral vascular events (RR-CVE).

Results: The National Institutes of Health Stroke Scale (NIHSS) score was 8.39 ± 3.21 vs. 8.16 ± 3.27 in the AT and C groups on entry to the study. On day 14, there were no significant differences in mortality (2.5% vs. 3.1%, p = 0.9994), SDS (50.0% vs. 49.0%, p = 0.864), and mortality/disability ratio (61.3% vs. 66.3%, p = 0.352) between the two groups, however the RR-CVE in the AT group was lower than in group C (4.4% vs. 11.9%, p = 0.014). In month 6, there were no significant difference in mortality rate between the two groups (3.1% vs. 3.8%, p = 0.767), however the SDS (23.4% vs. 34.4%, p = 0.033), mortality/disability ratio (32.1% vs. 45.0%, p = 0.018), and RR-CVE in group AT were lower than in group C (10.7% vs. 19.4%, p = 0.030).

Conclusions: Appropriate AT for patients with ACI does not worsen the disease condition and may improve the prognosis for the patients with moderate or mild stroke severity.