scholarly journals Comparison of the Effect of Fimasartan versus Valsartan on Blood Pressure Variability in Acute Ischemic Stroke: A Double-Blind Randomized Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-8
Author(s):  
Dong Hoon Shin ◽  
Soohwa Song ◽  
Yeong Bae Lee

Higher blood pressure variability (BPV) is associated with poor functional outcome and mortality in acute stroke. This randomized controlled trial was conducted to compare the effect on BPV between fimasartan and valsartan (Boryung Pharmaceutical Co., Ltd., Seoul, Republic of Korea) in patients with acute ischemic stroke. Eighty patients were randomly assigned to receive either valsartan or fimasartan after 7 days of acute ischemic stroke onset, for duration of 8 weeks. Of them, 62 patients completed the study [valsartan (n=31), fimasartan (n=31)]. We measured BP for 24 hours using ambulatory BP monitoring device before and after 8 weeks of starting BP medication. We calculated several indexes such as standard deviation (SD), weighted 24-hour BP with SD (wSD), coefficient of variation (CV), and average real variability (ARV) to assess BPV and to compare indexes of BPV between 2 drugs. SD values of systolic BP in daytime, nighttime, and 24 h period (15.55±4.02 versus 20.55±8.77, P=0.006; 11.98±5.52 versus 16.47±6.94, P=0.007; 17.22±5.30 versus 21.45±8.51, P=0.024), wSD of systolic BP (8.27±3.01 versus 10.77±4.18, P=0.010), and ARV of systolic BP (15.85±6.17 versus 19.68±7.83, P=0.040) of patients receiving fimasartan after 8 weeks were significantly lower than patients receiving valsartan. In paired t-test, SD values of daytime, nighttime, and 24 h period of systolic BP of patients receiving fimasartan were significantly decreased after 8 weeks (15.55±4.02 versus 18.70±7.04, P=0.038; 11.98±5.52 versus 17.19±7.35, P=0.006; 17.22±5.30 versus 20.59±5.91, P=0.015). Our study showed that fimasartan had greater effect on reducing BPV after acute ischemic stroke than valsartan. Trials registry number is KCT0003254.

2018 ◽  
Vol 39 (9) ◽  
pp. 1878-1887 ◽  
Author(s):  
Mahesh Kate ◽  
Negar Asdaghi ◽  
Laura C Gioia ◽  
Brian Buck ◽  
Sumit R Majumdar ◽  
...  

The effect of blood pressure (BP) reduction on cerebral blood flow (CBF) in acute ischemic stroke is unknown. We measured regional CBF with perfusion-weighted MRI before and after BP treatment in a three-armed non-randomized prospective controlled trial. Treatment arm assignment was based on acute mean arterial pressure (MAP). Patients with (MAP) >120 mmHg ( n = 14) were treated with intravenous labetalol and sublingual (SL) nitroglycerin (labetalol group). Those with MAP 100–120 mmHg ( n = 17) were treated with SL nitroglycerin (0.3 mg) (‘NTG Group’) and those with baseline MAP<100 mmHg ( n = 18) were not treated with antihypertensive drugs (untreated group). Forty-nine patients (18 female, mean age 65.3 ± 12.9 years) were serially imaged. Labetalol reduced MAP by 12.5 (5.7–17.7) mmHg, p = 0.0002. MAP remained stable in the NTG (6.0 (0.4–16, p = 0.3) mmHg and untreated groups (−0.3 (−2.3–7.0, p = 0.2) mmHg. The volume of total hypoperfused tissue (CBF<18 ml/100 g/min) did not increase after labetalol (−1.1 ((−6.5)–(−0.2)) ml, p = 0.1), NTG (0 ((−1.5)–4.5) ml, p = 0.72), or no treatment 0.25 ((−10.1)–4.5) ml, p = 0.87). Antihypertensive therapy, based on presenting BP, in acute stroke patients was not associated with an increased volume of total hypoperfused tissue.


2020 ◽  
pp. 1-3
Author(s):  
Maximilian Jorczyk

<b>Introduction:</b> Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. <b>Objective:</b> The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. <b>Methods:</b> This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for <i>Ureaplasma</i>. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). <b>Results:</b> Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O<sub>2</sub> dependency at 28 days/death in azithromycin-treated patients regardless of the detection of <i>Ureaplasma</i> in blood. <b>Conclusions:</b> Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O<sub>2</sub> dependency at 28 days/death in mechanically ventilated preterm neonates.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Adam de Havenon ◽  
Haimei Wang ◽  
Greg Stoddard ◽  
Lee Chung ◽  
Jennifer Majersik

Background: Increased blood pressure variability (BPV) is detrimental in the weeks to months after ischemic stroke, but it has not been adequately studied in the acute phase. We hypothesized that increased BPV in acute ischemic stroke (AIS) patients would be associated with worse outcome. Methods: We retrospectively reviewed inpatients at our hospital between 2010-2014 with an ICD-9 code of AIS; 213 were confirmed to have AIS by a vascular neurologist. A modified Rankin Score (mRS) after discharge was available in 148/213, at a mean of 86 ± 60 days. In 45/213 the discharge mRS was either 0 or 6, in which case they were included in the final analysis. BPV was measured as the standard deviation (SD) of each patient’s systolic blood pressure readings during the first 24 hours and 5 days of hospitalization (9,844 total readings), or until discharge if discharged in <5 days (Figure 1). The SBP SD was further divided in quartiles. A multivariate ordinal logistic regression with the outcome of mRS, the primary predictor of quartiles of SBP SD, and baseline NIH stroke scale (NIHSS) to control for initial stroke severity. Results: Mean±SD age was 64.2 ± 16.3 years, NIHSS was 12.6 ± 7.9, and mRS was 2.7 ± 2.1. The mean SBP SDs for the first 24 hours and 5 days were 12.1 ± 6.2 mm Hg and 14.1 ± 4.9 mm Hg. In the ordinal logistic regression model, the quartiles of SBP SD for the first 24 hours and 5 days were positively associated with higher mRS (OR = 1.37, 95% CI 1.01 - 1.74, p = 0.009; OR = 1.30, 95% CI 1.03 - 1.63, p = 0.028). This effect became even more pronounced in patients with the highest quartile of variability (OR = 2.76, 95% CI 1.29 - 5.88, p = 0.009; OR = 2.10, 95% CI 1.01 - 4.36, p = 0.046). Conclusion: In our cohort of 193 patients with AIS, there was a significant association between increased systolic BPV and worse functional outcome, after controlling for initial stroke severity. This data suggests that increased BPV may have a harmful effect for AIS patients, which warrants a prospective observational study.


2020 ◽  
Author(s):  
Jun Ni ◽  
Huisheng Chen ◽  
Guofang Chen ◽  
Yong Ji ◽  
Fei Yi ◽  
...  

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.


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