A randomized, double-blind, four-arm parallel-group study of the efficacy and safety of azelnidipine and olmesartan medoxomil combination therapy compared with each monotherapy in Japanese patients with essential hypertension: the REZALT study

Ogihara, Toshio; Saruta, Takao; Shimada, Kazuyuki; Kuramoto, Kizuku

doi:10.1038/hr.2009.163

Cited by 143 publications

(180 citation statements)

References 27 publications

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“…The mechanism responsible for the association between salt intake and strokes is still unknown, but may be related to artery thickness, stiffness and platelet reactivity. It has been suggested that approximately 40% of Japanese people have high sodium sensitivity [28], so dietary modification is of particular value for prevention of stroke recurrence.…”

Section: Discussionmentioning

confidence: 99%

Recurrence Risk after Noncardioembolic Mild Ischemic Stroke in a Japanese Population

Kono

Yamada²,

Kamisaka³

et al. 2011

Cerebrovasc Dis

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Background and Purpose: This study aimed to identify the recurrence rate and risk factors or clinical variables predictive of vascular events after mild ischemic stroke (IS). Methods: From December 2006 to September 2007, patients with acute IS with a modified Rankin Scale of 0∼1 were consecutively enrolled in this study. Variables including sex, family history of vascular disease, age, height, weight, stroke subtype, blood pressure, lipid profile, fasting glucose, HbA1c, smoking, alcohol consumption, exercise habits, waist circumference, ankle-brachial pressure index, salt intake and physical activity were assessed. The primary outcome was stroke recurrence or other vascular events such as myocardial infarction, angina pectoris, and peripheral artery disease. Survival curves were calculated by Kaplan-Meier survival analysis, and hazard ratios for recurrence were determined by univariate and multivariate Cox proportional hazards regression models. Results: A total of 102 mild IS patients (78 men and 24 women, mean age 64 years) were successfully followed for 3 years. Of those 102 patients, 25 (24.5%) had stroke recurrence, and 4 (3.9%) had a coronary event. Among the variables studied, abnormal ankle-brachial pressure index, metabolic syndrome, stroke subtypes, salt intake and poor lifestyle management were significant independent predictors of stroke recurrence or cardiovascular events. Conclusions: In mild IS patients within 3 years after onset, not only pathophysiological factors but also lifestyle factors can aid in the identification of patients at high risk for recurrence.

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Section: Discussionmentioning

confidence: 99%

Recurrence Risk after Noncardioembolic Mild Ischemic Stroke in a Japanese Population

Kono

Yamada²,

Kamisaka³

et al. 2011

Cerebrovasc Dis

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“…Blood pressure at the clinic was measured 3 times using a standard mercury sphygmomanometer with the patient in the sitting position after resting for at least 5 min, according to the guidelines of the Japanese Society of Hypertension 2009 [13]. Home blood pressure measurements were planned over a consecutive 3-day period.…”

Section: Methodsmentioning

confidence: 99%

Secondary Prevention of New Vascular Events with Lifestyle Intervention in Patients with Noncardioembolic Mild Ischemic Stroke: A Single-Center Randomized Controlled Trial

Kono¹,

Yamada²,

Yamaguchi

et al. 2013

Cerebrovasc Dis

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Background: Lifestyle modification is associated with a substantially decreased risk of cardiovascular events. However, the role of lifestyle intervention for secondary prevention in patients with noncardioembolic ischemic stroke is inadequately defined. We assessed the hypothesis that lifestyle intervention can reduce the onset of new vascular events in patients with noncardioembolic mild ischemic stroke. Methods: We conducted an observer-blind randomized controlled trial that enrolled 70 patients (48 men, mean age 63.5 years) with acute noncardioembolic mild ischemic stroke. The patients were allocated in equal numbers to a lifestyle intervention group or a control group. We performed lifestyle interventions, which comprised exercise training, salt restriction and nutrition advice for 24 weeks. Then all patients were prospectively followed up for occurrence of the primary endpoints, including hospitalization due to stroke recurrence and the onset of other vascular events. We also evaluated systolic blood pressure (SBP) at the clinic and at home, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), hemoglobin A1c (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) to compare the efficacy of the lifestyle interventions. Results: This trial was terminated earlier than expected because of the prespecified early stopping rule for efficacy. After the 24-week intervention period, the intervention group showed a significant increase in daily physical activity and a significant decrease in salt intake (physical activity, p = 0.012; salt intake, p < 0.001), with a significant difference between the randomized groups (physical activity, p < 0.001; salt intake, p = 0.018). Similarly, blood pressure was decreased and the HDL-C levels were increased in the intervention group (SBP, p < 0.001; HDL-C, p = 0.018), with significant differences between the randomized groups (SBP, p < 0.001; HDL-C, p = 0.022). In contrast, LDL-C, HbA1c and hs-CRP tended to decrease in the intervention group, but this decrease did not achieve significance. After a median follow-up period of 2.9 years, 12 patients allocated to the control group and 1 patient in the lifestyle intervention group experienced at least 1 vascular event. A sequential plans analysis indicated the superiority of the lifestyle intervention in interim analysis. Kaplan-Meier survival curves after the log-rank test showed a significant prognostic difference between the randomized groups (p = 0.005). Conclusions: Lifestyle intervention with appropriate medication is beneficial for reducing the incidence of new vascular events and improving vascular risk factors in patients with noncardioembolic mild ischemic stroke.

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“…In the REZALT study, the use of an automatic blood pressure meter (ABPM) showed that the effects of olmesartan in combination with azelnidipine persisted for 24 hours. 14 In other studies using an APBM, differences in blood pressure control were reported between ARBs and between CCBs. For example, in double-blind comparative studies, the 24-hour persistence of olmesartan was significantly longer than that of candesartan 12 while the persistence of azelnidipine was longer than that of amlodipine.…”

Section: Discussionmentioning

confidence: 99%

The combination of OLmesartan and a CAlcium channel blocker (azelnidipine) or candesartan and a calcium channel blocker (amlodipine) in type 2 diabetic hypertensive patients: The OLCA study

Daikuhara

Kikuchi

Ishida

2012

Diabetes and Vascular Disease Research

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Angiotensin II receptor blockers (ARB) are often co-administered with a calcium channel blocker (CCB) for treating hypertension. In this open-label randomised study, untreated diabetic hypertensive patients were randomised to receive either olmesartan 20 mg/day or candesartan 8 mg/day for 12 weeks. Patients with blood pressure exceeding 130/80 mm Hg received add-on 16 mg/day azelnidipine to ongoing olmesartan (OL group) or 5 mg/day amlodipine to ongoing candesartan (CA group) for 24 weeks. Home-measured and clinic-measured blood pressure decreased in both groups. Fasting blood glucose, haemoglobin A1c (HbA1c) and urinary albumin levels decreased significantly in the OL group but not in the CA group. In conclusion, this study revealed clinically relevant differences between two combinations of an ARB+CCB in diabetic hypertensive patients. Olmesartan and azelnidipine had a more persistent early morning antihypertensive effect and produced greater decreases in heart rate, fasting blood glucose and HbA1c (National Glycohemoglobin Standardization Program values) levels, and microalbuminuria than did candesartan and amlodipine.

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A randomized, double-blind, four-arm parallel-group study of the efficacy and safety of azelnidipine and olmesartan medoxomil combination therapy compared with each monotherapy in Japanese patients with essential hypertension: the REZALT study

Cited by 143 publications

References 27 publications

Recurrence Risk after Noncardioembolic Mild Ischemic Stroke in a Japanese Population

Recurrence Risk after Noncardioembolic Mild Ischemic Stroke in a Japanese Population

Secondary Prevention of New Vascular Events with Lifestyle Intervention in Patients with Noncardioembolic Mild Ischemic Stroke: A Single-Center Randomized Controlled Trial

The combination of OLmesartan and a CAlcium channel blocker (azelnidipine) or candesartan and a calcium channel blocker (amlodipine) in type 2 diabetic hypertensive patients: The OLCA study

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