Trial reportAdvances in therapy2013
The fixed-dose combination of olmesartan/amlodipine was superior in central aortic blood pressure reduction compared with perindopril/amlodipine: a randomized, double-blind trial in patients with hypertension.
Trial report in Advances in therapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.
- Effect and safety of LCZ696 in the treatment of hypertension: A meta-analysis of 9 RCT studies.Medicine · 2019Pooled it
- Central blood pressure for the management of hypertension: Is it a practical clinical tool in current practice?Journal of clinical hypertension (Greenwich, Conn.) · 2020Trial
- Effect of Amlodipine/Valsartan Versus Nebivolol/Valsartan Fixed Dose Combinations on Peripheral and Central Blood Pressure.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2018Trial
- Fixed-Combination Olmesartan/Amlodipine Was Superior to Perindopril + Amlodipine in Reducing Central Systolic Blood Pressure in Hypertensive Patients With Diabetes.Journal of clinical hypertension (Greenwich, Conn.) · 2016Trial
- A Prospective Randomized, Double-Blind, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of Olmesartan/Amlodipine plus Rosuvastatin Combination Treatment in Patients with Concomitant Hypertension and Dyslipidemia: A LEISURE Study.Journal of clinical medicine · 2022Article
- Angiotensin Receptor Blockers in the Management of Hypertension: A Real-World Perspective and Current Recommendations.Vascular health and risk management · 2022Review
- Should Angiotensin-Converting Enzyme Inhibitors ever Be Used for the Management of Hypertension?Current cardiology reports · 2020Review
- Differential Effects of Combination of Renin-Angiotensin-Aldosterone System Inhibitors on Central Aortic Blood Pressure: A Cross-Sectional Observational Study in Hypertensive Outpatients.Cardiovascular therapeutics · 2020Observational
- Angiotensin Receptor Blockers Versus Angiotensin Converting Enzyme Inhibitors for the Treatment of Arterial Hypertension and the Role of Olmesartan.Advances in therapy · 2019Review
- The Role of Central Blood Pressure Monitoring in the Management of Hypertension.Current cardiology reports · 2018Review
- Management of Hypertension Using Olmesartan Alone or in Combination.Cardiology and therapy · 2017Review
- Must new drugs be superior to those already available? The role of noninferiority clinical trials.Journal of clinical hypertension (Greenwich, Conn.) · 2015Article
- Additional information regarding the SEVITENSION study.Advances in therapy · 2014Article
Corrections and comments
- Commented on by
- Erratum issued
- Erratum issued
- Erratum issued
Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.