Real-life safety and effectiveness of amlodipine/valsartan combination in the treatment of hypertension

Чазова, И Е; Dongre, Neelesh; Vigdorchik, Alexey

doi:10.1007/s12325-010-0099-1

Cited by 22 publications

(23 citation statements)

References 15 publications

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“…A recent metaanalysis of CCB-based antihypertensive therapy found that the incidence of, and treatment withdrawal rate for, this toxicity increased with the duration of therapy, with 24% of patients reporting peripheral edema and 5% of patients as well as a 62% reduction in the risk of peripheral edema-related withdrawal (relative risk, 0.38; P<0.01) in a recent meta-analysis[33]. The 8.5% incidence of peripheral edema at study end reported here is similar to the 10.1% incidence in the free-dose series[6] and also consistent with prior clinical trial experiences with combination amlodipine/valsartan, in which incidences were typically <10%[12,18,32,34]. The reduction in incidence and severity of peripheral edema over time in the current single-pill and free-dose studies reflects the complementary mechanism of action of the CCB and ARB drug classes.…”

supporting

confidence: 75%

“…Effective dose-dependent BP lowering was observed, which corresponded to the initial degree of BP elevation [6].…”

Section: Reappraisal Of the 2007 European Hypertensionmentioning

confidence: 92%

“…The authors recently conducted a large observational study (n=2729) of a free-dose combination of the calcium channel blocker (CCB), amlodipine, and the angiotensin receptor blocker (ARB), valsartan [6]. Effective dose-dependent BP lowering was observed, which corresponded to the initial degree of BP elevation [6].…”

Section: Reappraisal Of the 2007 European Hypertensionmentioning

confidence: 99%

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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

IuA

Dongre

Vigdorchik³

et al. 2012

Adv Therapy

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supporting

confidence: 75%

“…Effective dose-dependent BP lowering was observed, which corresponded to the initial degree of BP elevation [6].…”

Section: Reappraisal Of the 2007 European Hypertensionmentioning

confidence: 92%

Section: Reappraisal Of the 2007 European Hypertensionmentioning

confidence: 99%

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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

IuA

Dongre

Vigdorchik³

et al. 2012

Adv Therapy

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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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“…Besides being very effective, such combination therapies of specific antihypertensive classes may also improve safety and tolerability. For example, addition of ARBs to CCBs has been shown to reduce the peripheral oedema associated with amlodipine monotherapy 45. Similarly, diuretic-induced hypokalaemia has been shown to be attenuated when RAAS blockade is combined with diuretic therapy 46.…”

Section: Discussionmentioning

confidence: 99%

Rationale and study design of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study

Williams

Cockcroft²,

Kario

et al. 2014

BMJ Open

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IntroductionHypertension in elderly people is characterised by elevated systolic blood pressure (SBP) and increased pulse pressure (PP), which indicate large artery ageing and stiffness. LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor (ARNI), is being developed to treat hypertension and heart failure. The Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study will assess the efficacy of LCZ696 versus olmesartan on aortic stiffness and central aortic haemodynamics.Methods and analysisIn this 52-week multicentre study, patients with hypertension aged ≥60 years with a mean sitting (ms) SBP ≥150 to <180 and a PP>60 mm Hg will be randomised to once daily LCZ696 200 mg or olmesartan 20 mg for 4 weeks, followed by a forced-titration to double the initial doses for the next 8 weeks. At 12–24 weeks, if the BP target has not been attained (msSBP <140 and ms diastolic BP <90 mm Hg), amlodipine (2.5–5 mg) and subsequently hydrochlorothiazide (6.25–25 mg) can be added. The primary and secondary endpoints are changes from baseline in central aortic systolic pressure (CASP) and central aortic PP (CAPP) at week 12, respectively. Other secondary endpoints are the changes in CASP and CAPP at week 52. A sample size of 432 randomised patients is estimated to ensure a power of 90% to assess the superiority of LCZ696 over olmesartan at week 12 in the change from baseline of mean CASP, assuming an SD of 19 mm Hg, the difference of 6.5 mm Hg and a 15% dropout rate. The primary variable will be analysed using a two-way analysis of covariance.Ethics and disseminationThe study was initiated in December 2012 and final results are expected in 2015. The results of this study will impact the design of future phase III studies assessing cardiovascular protection.Clinical trials identifierEUDract number 2012-002899-14 and ClinicalTrials.gov NCT01692301.

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Real-life safety and effectiveness of amlodipine/valsartan combination in the treatment of hypertension

Cited by 22 publications

References 15 publications

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

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

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

Rationale and study design of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study

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