High blood pressure (BP) is a major risk factor associated with stroke in China. This is a subanalysis of patients from the China Status II study, aimed to evaluate the effectiveness and safety of valsartan/amlodipine (Val/Aml) single-pill combination (SPC) in hypertensive patients with different stroke subtypes (hemorrhagic, ischemic, or mixed).China Status II was a multicenter, postmarketing, prospective observational study in hypertensive patients uncontrolled on monotherapy. The study was an 8-week open-label treatment period with 2 4-week follow-ups. Change in BP from baseline to weeks 4 and 8, BP control rate, and response rate at weeks 4 and 8, and safety of 8-week treatment with Val/Aml (80/5 mg) were assessed.A total of 565 hypertensive patients with different types of stroke were analyzed in this China Status II substudy. Significant mean sitting systolic/diastolic BP (MSSBP/MSDBP) reductions from baseline to week 8 were observed across all stroke subtypes (P < .0001). At week 8, percentages of patients achieving MSSBP response (≥20 mm Hg reduction from baseline) were 76.3%, 74.4%, and 85.7%, MSDBP response (≥10 mm Hg reduction from baseline) were 67.8%, 65.9%, and 64.3%, and BP control (<140/90 mm Hg) were 74.6%, 80.5%, and 92.9%, in the hemorrhagic, ischemic, and mixed stroke subgroups, respectively. Adverse events (AEs) and serious AEs were reported in 5 patients (1%) and 1 patient (0.2%), respectively, in the ischemic stroke subgroup, while no AEs were reported in hemorrhagic and mixed stroke subgroups.Val/Aml SPC was effective in hypertensive patients with different stroke subtypes and was well tolerated.

The Journal of Clinical Hypertension

Efficacy of Olmesartan/Amlodipine Single‐Pill Combination on 24‐h Mean Systolic Blood Pressure Measured by Ambulatory Monitoring in Non‐Responders to Valsartan or Candesartan Monotherapy

Article

Author: Choi, Yun‐Seok ; Youn, Ho‐Joong ; Chung, Woo‐Baek ; Ihm, Sang‐Hyun

ABSTRACTThe aim of this study was to evaluate the efficacy of olmesartan/amlodipine (OLM/AML) single‐pill combination (SPC) therapy using ambulatory blood pressure monitoring (ABPM) in non‐responders to valsartan or candesartan monotherapy. Isolated systolic hypertension (ISH) is the most prevalent form of hypertension in middle‐aged and elderly individuals. Patients aged over 55 years who did not achieve the target systolic blood pressure (SBP < 140 mmHg) with valsartan 80 mg or candesartan 8 mg for at least 4 weeks were included. Doses were escalated from 20/5 mg to 40/5 mg and finally to 40/10 mg of OLM/AML SPC until patients reached the target SBP. Efficacy was assessed via ABPM by comparing baseline values with those in the 12th week. Office blood pressure (OBP) and brachial‐ankle pulse wave velocity (baPWV) were assessed at baseline, weeks 4, 8, and 12. Fifty‐four patients (average age 64 ± 6 years; 33 males) participated. The 24‐h mean BPs decreased significantly from an average of 146.2 ± 12.7/93.3 ± 9.2 mmHg to 129.7 ± 14.3/83.4 ± 10.7 mmHg (p < 0.001), and pulse pressures (PPs) from ABPM were reduced (p < 0.001). Additionally, significant reductions in night‐time SBP standard deviations (SDs) (14.7 ± 4.7 vs. 12.5 ± 3.9, p = 0.029) were observed at 12 weeks compared to baseline. OBPs significantly dropped from 151.1 ± 9.7/89.3 ± 8.3 mmHg to 125.5 ± 13.8/77.8 ± 8.8 mmHg after 12 weeks of SPC therapy (p < 0.001). Reductions in PPs of OBP and baPWVs were also observed. OLM/AML SPC therapy effectively reduced the 24‐h mean BP, as measured by ABPM, in hypertensive patients over 55 years old who failed to achieve a target SBP (< 140 mmHg) with angiotensin receptor blocker (ARB) monotherapy using valsartan 80 mg or candesartan 8 mg.Trial Registration: ClinicalTrials.gov identifier: NCT01713920

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