Amlodipine/Valsartan Single-Pill Combination: A Prospective, Observational Evaluation of the Real-Life Safety and Effectiveness in the Routine Treatment of Hypertension

IuA, Karpov; Dongre, Neelesh; Vigdorchik, Alexey; Sastravaha, Krisada

doi:10.1007/s12325-011-0095-0

Cited by 18 publications

(12 citation statements)

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“…The mean reduction in msSBP was 19-32 mmHg (mean baseline BP 153.4/91.1 mmHg) with the 5/80, 5/160, and 10/160 mg doses of Aml/Val. However, other real-life studies report a mean SBP reduction of 29 to 44 mmHg (mean baseline BP 165.0/99.3 mmHg) with similar doses of Aml/Val [Chazova et al 2011;Karpov et al 2012]. The difference with the current study results with other realworld studies might be due to differences in the study population, which included pooled data from various countries, difference in baseline BP, and study duration.…”

Section: Discussioncontrasting

confidence: 81%

Real-life effectiveness, safety, and tolerability of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide single-pill combination in patients with hypertension from Pakistan

Khan¹,

Moin²,

Iktidar

et al. 2014

Therapeutic Advances in Cardiovascular Disease

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Section: Discussioncontrasting

confidence: 81%

Real-life effectiveness, safety, and tolerability of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide single-pill combination in patients with hypertension from Pakistan

Khan¹,

Moin²,

Iktidar

et al. 2014

Therapeutic Advances in Cardiovascular Disease

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“…It has been proposed that in high-risk hypertensive patients who require a rapid and pronounced BP control, single-pill combination (SPC) or fixed-dose combination can be beneficial as a first-line therapy [10]. SPCs offer several advantages such as improved efficacy, reduced adverse events (AEs), and improved patient compliance compared with monotherapy [8].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Valsartan/Amlodipine Single-Pill Combination in 11,422 Chinese Patients with Hypertension: an Observational Study

Liu

2014

Adv Ther

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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.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-014-0132-x) contains supplementary material, which is available to authorized users.

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“…Using a single combination pill compared with the use of 2 separate drugs reduced the risk of nonadherence by 24% [50]. In addition, 2 large-scale, noninterventional studies conducted in a real-world setting in Russia with combination therapies similar to those used in our model have demonstrated clinically significant reductions in BP [52], [53].…”

Section: Discussionmentioning

confidence: 77%

Simulating the Impact of Improved Cardiovascular Risk Interventions on Clinical and Economic Outcomes in Russia

Shum¹,

Alperin²,

Шальнова

et al. 2014

PLoS ONE

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ObjectivesRussia faces a high burden of cardiovascular disease. Prevalence of all cardiovascular risk factors, especially hypertension, is high. Elevated blood pressure is generally poorly controlled and medication usage is suboptimal. With a disease-model simulation, we forecast how various treatment programs aimed at increasing blood pressure control would affect cardiovascular outcomes. In addition, we investigated what additional benefit adding lipid control and smoking cessation to blood pressure control would generate in terms of reduced cardiovascular events. Finally, we estimated the direct health care costs saved by treating fewer cardiovascular events.MethodsThe Archimedes Model, a detailed computer model of human physiology, disease progression, and health care delivery was adapted to the Russian setting. Intervention scenarios of achieving systolic blood pressure control rates (defined as systolic blood pressure <140 mmHg) of 40% and 60% were simulated by modifying adherence rates of an antihypertensive medication combination and compared with current care (23.9% blood pressure control rate). Outcomes of major adverse cardiovascular events; cerebrovascular event (stroke), myocardial infarction, and cardiovascular death over a 10-year time horizon were reported. Direct health care costs of strokes and myocardial infarctions were derived from official Russian statistics and tariff lists.ResultsTo achieve systolic blood pressure control rates of 40% and 60%, adherence rates to the antihypertensive treatment program were 29.4% and 65.9%. Cardiovascular death relative risk reductions were 13.2%, and 29.6%, respectively. For the current estimated 43,855,000-person Russian hypertensive population, each control-rate scenario resulted in an absolute reduction of 1.0 million and 2.4 million cardiovascular deaths, and a reduction of 1.2 million and 2.7 million stroke/myocardial infarction diagnoses, respectively. Averted direct costs from current care levels ($7.6 billion [in United States dollars]) were $1.1 billion and $2.6 billion, respectively.

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Amlodipine/Valsartan Single-Pill Combination: A Prospective, Observational Evaluation of the Real-Life Safety and Effectiveness in the Routine Treatment of Hypertension

Abstract: Single-pill combination amlodipine/valsartan safely and effectively reduced BP across all hypertension grades and allowed the vast majority of patients to achieve BP goals.

Cited by 18 publications

References 32 publications

Real-life effectiveness, safety, and tolerability of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide single-pill combination in patients with hypertension from Pakistan

Real-life effectiveness, safety, and tolerability of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide single-pill combination in patients with hypertension from Pakistan

Efficacy and Safety of Valsartan/Amlodipine Single-Pill Combination in 11,422 Chinese Patients with Hypertension: an Observational Study

Simulating the Impact of Improved Cardiovascular Risk Interventions on Clinical and Economic Outcomes in Russia

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