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Amlodipine/valsartan fixed-dose combination treatment in the management of hypertension: A double-blind, randomized trial.

ABSTRACT: BACKGROUND:To compare the fixed-dose combination (FDC) of amlodipine/valsartan 5/80?mg with valsartan 160?mg monotherapy for efficacy and safety in hypertensive patients. METHODS:We designed this double-blind, randomized, and noninferiority trial in which patients with elevated systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) were randomly assigned to receive amlodipine/valsartan 5/80?mg FDC or valsartan 160?mg monotherapy for 8 weeks. The primary endpoint was changes in office SBP and DBP from baseline to 8 weeks. Twenty-four-hour blood pressure (BP) and the incidence of adverse events were recorded. RESULTS:A total of 42 patients underwent randomization. At 8 weeks, office SBP changes were -16.5 ± 15.5 mmHg (p < 0.001) with amlodipine/valsartan 5/80?mg FDC and -6.9 ± 11.4 mmHg (p = 0.012) with valsartan 160?mg monotherapy while corresponding changes in office DBP were -9.8 ± 7.7 mmHg (p < 0.001) and -2.5 ± 6.6 mmHg (p = 0.095), respectively. The between-group differences were -9.6 mmHg (95% CI, -18.1 to -1.1; p = 0.028) for SBP and -7.3 mmHg (95% CI, -11.8 to -2.8; p = 0.002) for DBP. Furthermore, reductions in both 24-hour SBP (-9.2 mmHg; 95% CI, -16.4 to -2.1; p = 0.013) and DBP (-4.6 mmHg; 95% CI, -9.2 to -0.1; p = 0.048) were consistently greater with amlodipine/valsartan 5/80?mg FDC than with valsartan 160?mg. Overall, 27 and 23 adverse events occurred in the amlodipine/valsartan 5/80?mg FDC group and in the valsartan 160?mg monotherapy group, respectively. The majority were mild and were not related to study medications. There were no significant differences in safety between two treatments. CONCLUSION:Efficacy of amlodipine/valsartan 5/80?mg FDC was superior to that of valsartan 160?mg monotherapy while both treatments were well-tolerated.

SUBMITTER: Wang KL

PROVIDER: S-EPMC7526577 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Amlodipine/valsartan fixed-dose combination treatment in the management of hypertension: A double-blind, randomized trial.

Wang Kang-Ling KL Yu Wen-Chung WC Lu Tse-Min TM Chen Lung-Ching LC Leu Hsin-Bang HB Chiang Chern-En CE

Journal of the Chinese Medical Association : JCMA 20201001 10

<h4>Background</h4>To compare the fixed-dose combination (FDC) of amlodipine/valsartan 5/80 mg with valsartan 160 mg monotherapy for efficacy and safety in hypertensive patients.<h4>Methods</h4>We designed this double-blind, randomized, and noninferiority trial in which patients with elevated systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) were randomly assigned to receive amlodipine/valsartan 5/80 mg FDC or valsartan 160 mg monotherapy for 8 weeks. The primary endpoint was c ...[more]

PMID: 33009241

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Project description:IntroductionCentral blood pressure (BP), an important measure of cardiovascular risk, has been shown to be effectively reduced by calcium channel blockade with amlodipine (AML) plus renin-angiotensin system blockade by the angiotensin-converting enzyme inhibitor, perindopril (PER). The aim of the SEVITENSION study was to compare the central effects of PER/AML against renin-angiotensin system blockade with the angiotensin II receptor blocker olmesartan (OLM) plus AML.MethodsIn this multicenter, parallel group, non-inferiority study, patients received AML 10 mg during a 2- to 4-week run-in before randomization to 24 weeks of double-blind treatment with the fixed-dose combination of OLM/AML 40/10 mg or PER/AML 8/10 mg. Hydrochlorothiazide was added at Weeks 4, 8, or 12 in patients with inadequate BP control. The primary efficacy variable was the absolute change in central systolic BP (CSBP) from baseline to the final examination, measured by radial artery applanation tonometry and analyzed by parametric analysis of covariance. Secondary variables included 24-h ambulatory and seated BP measurements as well as BP normalization.ResultsOf 600 patients enrolled, 486 were randomized (244 to OLM/AML 40/10 mg, 242 to PER/AML 8/10 mg). The reduction in CSBP was larger with OLM/AML (14.5 ± 0.83 mmHg) than with PER/AML (10.4 ± 0.84 mmHg). The between-group difference was -4.2 ± 1.18 mmHg with 95% confidence intervals (-6.48 to -1.83 mmHg) within the predefined non-inferiority margin (2 mmHg). An integrated superiority test confirmed that OLM/AML was superior to PER/AML (p < 0.0001) in reducing CSBP. The superiority of OLM/AML over PER/AML was also established for the majority of secondary efficacy variables; at the final examination, 75.6% of OLM/AML recipients achieved BP normalization (mean seated systolic BP/diastolic BP <140/90 mmHg) compared with 57.5% of PER/AML recipients (p < 0.0001).ConclusionThe combination of OLM/AML was superior to PER/AML in reducing CSBP and other efficacy measures, including a significantly higher rate of BP normalization.

Project description:BACKGROUND:To determine whether the effectiveness and safety of fixed-dose combinations (FDCs) of amlodipine orotate/valsartan (AML/VAL) 5/160?mg are noninferior to those of valsartan/hydrochlorothiazide (VAL/HCTZ) 160/12.5?mg in hypertensive patients with inadequate response to valsartan 160?mg monotherapy. METHODS:This 8-week, active-controlled, parallel-group, fixed-dose, multicenter, double-blind randomized controlled, and noninferiority trial was conducted at 17 cardiovascular centers in the Republic of Korea. Eligible patients had mean sitting diastolic blood pressure (msDBP) ?90?mm?Hg despite monotherapy with valsartan 160?mg for 4 weeks. Patients were randomly assigned to treatment with AML/VAL 5/160?mg FDC (AML/VAL) group or VAL/HCTZ 160/12.5?mg FDC (VAL/HCTZ) group once daily for 8 weeks. A total of 238 patients were enrolled (AML/VAL group, n?=?121; VAL/HCTZ group, n?=?117), of whom 228 completed the study. RESULTS:At 8 weeks after randomization, msDBP was significantly decreased in both groups (-9.44?±?0.69?mm?Hg in the AML/VAL group and -7.47?±?0.71?mm?Hg in the VAL/HCTZ group, both P?<?.001 vs baseline). Between group difference was -1.96?±?1.00?mm?Hg, indicating that AML/VAL 5/160?mg FDC was not inferior to VAL/HCTZ 160/12.5?mg FDC at primary efficacy endpoint. Control rate of BP defined as the percentage of patients achieving mean sitting SBP (msSBP) <140?mm?Hg or msDBP <90?mm?Hg (target BP) from baseline to week 8 was significantly higher in the AML/VAL group than that in the VAL/HCTZ group (84.3% [n?=?102] in the AML/VAL group vs 71.3% [n?=?82] in the VAL/HCTZ group, P?=?.016). At 8 weeks after randomization, mean uric acid level was significantly increased in the VAL/HCTZ group compared to that at baseline (0.64?±?0.08?mg/dL; P?<?.001). However, it was slightly decreased from baseline in the AML/VAL group (-0.12?±?0.08?mg/dL; P?=?.085). The intergroup difference was significant (P?<?.001). CONCLUSION:The effectiveness and safety AML/VAL 5/160?mg FDC are noninferior to those of VAL/HCTZ 160/12.5?mg FDC in patients with hypertension inadequately controlled by valsartan 160?mg monotherapy.

Project description:To evaluate the blood pressure (BP) lowering efficacy and safety of CKD-828, a fixed-dose combination of S-amlodipine (the more active isomer of amlodipine besylate, which is calcium channel blocker) and telmisartan (long acting angiotensin receptor blocker), in patients with hypertension inadequately controlled with S-amlodipine monotherapy.Eligible patients (N=187) who failed to respond after 4-week S-amlodipine 2.5 mg monotherapy (sitting diastolic blood pressure [sitDBP] ?90 mmHg) to receive CKD-828 2.5/40 mg (n=63), CKD-828 2.5/80 mg (n=63), or S-amlodipine 2.5 mg (n=61) for 8 weeks. The primary efficacy endpoint, mean sitDBP change from baseline to Week 8, was compared between the combination (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) and S-amlodipine monotherapy groups. The safety was assessed based on adverse events, vital signs, and physical examination findings.After the 8-week treatment, changes in sitDBP/systolic BP (SBP) were -9.67±6.50/-12.89±11.78, -10.72±6.19/-13.79±9.41, and -4.93±7.26/-4.55±11.27 mmHg in the CKD-828 2.5/40 mg (P<0.0001/P<0.0001), CKD-828 2.5/80 mg (P<0.0001/P<0.0001), and S-amlodipine 2.5 mg (P<0.0001/P=0.0027) groups, respectively, which were all significant BP reductions. At Week 8, the CKD-828 2.5/40 mg (sitDBP/SBP: P=0.0002/P<0.0001) and CKD-828 2.5/80 mg (sitDBP/SBP: P=0.0001/P<0.0001) showed superior BP-lowering effects to S-amlodipine 2.5 mg (P<0.001). At Week 4, all groups showed significant antihypertensive effects but both CKD-828 combinations (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) exhibited superior BP-lowering effects to that of S-amlodipine 2.5 mg (sitDBP/SBP: P=0.0028/P=0.0001 and P<0.0001/P=0.0012, respectively). The adverse event incidence was significantly lower in the CKD-828 2.5/40 mg (9.52%, P=0.0086) than in the S-amlodipine 2.5 mg group (27.87%) and increasing the telmisartan dose induced no unexpected adverse events, suggesting the safety of CKD-828.CKD-828 is an effective and safe option for patients with inadequate responses to S-amlodipine monotherapy.

Dataset Information

Amlodipine/valsartan fixed-dose combination treatment in the management of hypertension: A double-blind, randomized trial.

Publications

Amlodipine/valsartan fixed-dose combination treatment in the management of hypertension: A double-blind, randomized trial.

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