Observational studyAdvances in therapy2014
Efficacy and safety of valsartan/amlodipine single-pill combination in 11,422 Chinese patients with hypertension: an observational study.
Observational study in Advances in therapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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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.
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Who cites it
16 citing papers in PubMed.
- Effectiveness of Valsartan/Amlodipine Single-pill Combination in Hypertensive Patients With Excess Body Weight: Subanalysis of China Status II.Journal of cardiovascular pharmacology · 2015Trial
- Clinical efficacy and psychological benefits of combination therapy in elderly patients with hypertension.American journal of translational research · 2025Article
- Management of Hypertension in the Asia-Pacific Region: A Structured Review.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024Review
- Effectiveness of Valsartan's Single-Pill Combination Therapies on Blood Pressure Control in Hypertensive Patients: Malaysian Single-Centre Real-World Experience.The Malaysian journal of medical sciences : MJMS · 2023Article
- Article
- A Retrospective, Observational, EMR-Based Real-World Evidence Study to Assess the Incidence of Pedal Edema in Essential Hypertensive Patients on Amlodipine or Cilnidipine.International journal of hypertension · 2022Article
- Effectiveness of Amlodipine on Blood Pressure Control in Hypertensive Patients in India: A Real-World, Retrospective Study from Electronic Medical Records.Drugs - real world outcomes · 2020Article
- Efficacy of amlodipine besylate and Valsartan for the treatment of mild to moderate hypertension.Medicine · 2019Article
- Blood pressure response to metoprolol and chlorthalidone in European and African Americans with hypertension.Journal of clinical hypertension (Greenwich, Conn.) · 2017Article
- Effectiveness and safety of valsartan/amlodipine in hypertensive patients with stroke: China Status II subanalysis.Medicine · 2017Observational
- Formulations of Amlodipine: A Review.Journal of pharmaceutics · 2016Review
- In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorothiazide, among Palestinian hypertensive patients.Therapeutics and clinical risk management · 2016Article
- Amlodipine/valsartan single pill combination therapy in Chinese patients not controlled on previous monotherapy.Journal of thoracic disease · 2015Article
- Real-world effectiveness of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide in high-risk patients and other subgroups.Vascular health and risk management · 2015Observational
- Gender difference in the response to valsartan/amlodipine single-pill combination in essential hypertension (China Status II): An observational study.Journal of the renin-angiotensin-aldosterone system : JRAASObservational
- To compare anti-albumin urea effects of valsartan alone with combination of valsartan and amlodipine in patients of chronic kidney disease.Pakistan journal of medical sciencesArticle
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSingle-pill combination (SPC) therapy of two drugs is recommended by international guidelines, including the Chinese guidelines (2010), for the treatment of hypertension in high-risk patients who require marked blood pressure (BP) reductions. Real-world data on the efficacy and safety of valsartan/amlodipine (Val/Aml) SPC are scarce. The present study is the first observational study in China to evaluate the efficacy (primary endpoint) and safety of Val/Aml (80/5 mg) SPC in Chinese patients with hypertension whose BP was not adequately controlled by monotherapy in a real-world setting.
methodsThis prospective, multicenter, open-label, post-marketing observational study included 11,422 Chinese adults (≥18 years) with essential hypertension from 238 sites of 29 provinces who were prescribed once-daily Val/Aml (80/5 mg) SPC. Patients were treated for 8 weeks. The primary efficacy variable of the study included changes in mean sitting systolic BP (MSSBP) and mean diastolic BP (MSDBP) from baseline to week 8 (end point). The secondary efficacy variable of the study included BP control rate and response rate at week 4 and 8. Safety assessments included recording and measurement of all adverse events (AEs) and vital signs in the safety population.
resultsA significant reduction of 27.1 mmHg in MSSBP (159.6 vs. 132.5 mmHg; P < 0.0001) and 15.2 mmHg in MSDBP (95.6 vs. 80.4 mmHg; P < 0.0001) from baseline was observed at week 8. The BP-lowering efficacy of Val/Aml SPC was independent of age and comorbidities. BP control of <140/90 mmHg was achieved in 76.8% (n = 8,692) of the patients. The most frequently reported AEs were dizziness (0.2%), headache (0.2%), upper respiratory tract infection (0.2%), and edema (0.2%). Only three serious AEs were reported and they were not drug-related.
conclusionThis is the first evidence-based real-world data in Chinese hypertensive patients which demonstrate the efficacy and safety of Val/Aml (80/5 mg) SPC.
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