Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on valsartan monotherapy

Sinkiewicz, Włądysław; Glazer, Robert; Kavoliūnienė, Aušra; Miglinas, M.; Prak, H.; Wernsing, Margaret; Yen, Joseph

doi:10.1185/03007990802630588

Cited by 18 publications

(8 citation statements)

References 32 publications

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“…In this study, relatively large changes in SeBP were seen in the group that continued with dual‐combination treatment and received a placebo instead of HCTZ. Similar results have been observed in other antihypertensive trials with a “nonresponder” design . For fixed‐combination medicinal products, the European Medicines Agency (EMA) prefers that confirmatory clinical trials use a parallel‐group design .…”

Section: Discussionsupporting

confidence: 65%

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Adding Hydrochlorothiazide to Olmesartan/Amlodipine Increases Efficacy in Patients With Inadequate Blood Pressure Control on Dual‐Combination Therapy

Rump

Ammentorp

Laeis

et al. 2015

J of Clinical Hypertension

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This randomized, parallel‐group study in patients inadequately controlled on olmesartan medoxomil/amlodipine (OLM/AML) 40/10 mg assessed the effects of adding hydrochlorothiazide (HCTZ) 12.5 mg and 25 mg, using seated blood pressure (SeBP) measurements and ambulatory blood pressure (BP) monitoring. Enrolled patients were screened and tapered off of therapy if required. All patients received OLM/AML 40/10 mg and those with mean seated BP (SeBP) ≥140/90 mm Hg after 8 weeks (n=808) were randomized (1:1:1) to continue with OLM/AML 40/10 mg or receive OLM/AML/HCTZ 40/10/12.5 or 40/10/25 mg for a further 8 weeks. The primary endpoint was the change in seated diastolic BP (SeDBP) from the start to the end of the randomized treatment period. The addition of HCTZ 25 mg significantly reduced SeDBP (−2.8 mm Hg; P<.0001), lowered seated systolic BP (SeSBP) and ambulatory DBP and SBP, and improved BP goal rates. In patients uncontrolled on OLM/AML 40/10 mg, adding HCTZ led to further BP reductions, particularly in ambulatory BP.

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Section: Discussionsupporting

confidence: 65%

“…Similar results have been observed in other antihypertensive trials with a "nonresponder" design. [16][17][18][19][20][21][22][23][24][25] For fixed-combination medicinal products, the European Values are expressed as number (percentage). a Drug-related is defined as definitely, probably, or possibly related to randomized study medication.…”

Section: Discussionmentioning

confidence: 99%

Adding Hydrochlorothiazide to Olmesartan/Amlodipine Increases Efficacy in Patients With Inadequate Blood Pressure Control on Dual‐Combination Therapy

Rump

Ammentorp

Laeis

et al. 2015

J of Clinical Hypertension

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“…To estimate the number of subjects needed for this study, relevant published articles were used for reference by searching with the terms ARB plus CCB formulation, 8 weeks, and essential hypertension. [10,11] The standard deviation (SD) associated with each group was estimated by using the total number of subjects and confidence intervals (CIs). It was estimated that approximately 240 subjects would need to be enrolled so that there would be 114 evaluable subjects, 57 in each group in order to detect a difference of 4 mmHg in DBP at the p < 0.05 significance level with 80% power.…”

Section: Discussionmentioning

confidence: 99%

Comparison of the Efficacy and Safety of Fixed-Dose Amlodipine/Losartan and Losartan in Hypertensive Patients Inadequately Controlled with Losartan

Hong

Park

Kim

et al. 2012

American Journal Cardiovascular Drugs

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“…Studies have further shown that amlodipine/ valsartan provides additional BP control in hypertensive patients not controlled by an ACE inhibitor/CCB combination, [75] and compared with valsartan monotherapy, [76] amlodipine monotherapy [77] or felodipine monotherapy. [77] In a multicentre study of 133 patients with moderate hypertension who had not responded to 5 weeks' treatment with the ACE inhibitor/CCB combination of ramipril 5 mg and felodipine 5 mg, an additional 5 weeks of treatment with amlodipine/ valsartan 10 mg/160 mg resulted in clinically and statistically significant additional mean BP reductions of 15.4/7.0 mmHg (p < 0.0001).…”

Section: Amlodipine/valsartan Fixed-dose Combination Therapymentioning

confidence: 99%

“…Amlodipine/valsartan combination therapy was significantly more effective at lowering BP than valsartan monotherapy in a double-blind study of patients with mild-to-moderate essential hypertension. [76] A total of 947 patients were randomized to once-daily amlodipine/valsartan 5 mg/160 mg, amlodipine/valsartan 10 mg/160 mg or valsartan 160 mg monotherapy for 8 weeks. Mean SBP/DBP reductions from baseline were 12.2/9.6 mmHg and 14.3/11.5 mmHg for the Pooled tolerability data (%) from 3155 patients with mild-tomoderate hypertension treated in two randomized, double-blind, 8-week factorial trials of different doses of amlodipine and valsartan, alone or in combination.…”

Section: Amlodipine/valsartan Fixed-dose Combination Therapymentioning

confidence: 99%

Efficacy of Fixed-Dose Combination Therapy in the Treatment of Patients with Hypertension

Silva

2010

Clinical Drug Investigation

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Early initiation of rational and effective combination therapy consisting of antihypertensive drugs with two different and complementary mechanisms of actions is increasingly becoming accepted in clinical practice and by guidelines as a first-line approach to control blood pressure (BP) and prevent cardiovascular outcomes in patients with hypertension. Once-daily combination therapy provides more rapid control of BP, which is important for preventing cardiovascular events, with similar or improved tolerability compared with the component monotherapies, and improved adherence because of regimen simplification. Combination therapy with a calcium channel antagonist (calcium channel blocker [CCB]) and an inhibitor of the renin-angiotensin-aldosterone system (RAAS) is a rational approach to achieve BP goals and provide protection against renal and cardiovascular morbidity and mortality. A number of CCB/RAAS inhibitor combinations, including CCB/angiotensin-converting enzyme (ACE) inhibitor and CCB/ angiotensin II type 1 receptor antagonist (angiotensin receptor blocker [ARB]) combinations are available as fixed-dose formulations. There is substantial evidence for the BP-lowering efficacy of CCB/RAAS inhibitor combinations in diverse patient populations, and their use in combination is associated with favourable tolerability and fewer adverse metabolic effects than some other combination therapies. Recent evidence from large outcome trials supports the use of CCB/RAAS inhibitor combinations for reducing the risk of cardiovascular and renal events, particularly in high-risk patients, together with evidence that the benefits of CCB/RAAS inhibitor combinations may extend beyond their efficacy in lowering BP in terms of protecting against fatal and nonfatal stroke, myocardial infarction and cardiovascular-related deaths. The efficacy of the CCB amlodipine and the ARB valsartan in lowering BP and protecting against cardiovascular events and stroke across a range of hypertensive patient populations has been established over many years. Fixed-dose amlodipine/valsartan combinations are available in many countries and have shown greater BP reductions and better BP control than the respective monotherapies in diverse patient populations, together with a favourable tolerability profile. Once-daily amlodipine/valsartan is a rational and convenient treatment option for the effective management of patients with hypertension, improving adherence to antihypertensive medication and protecting against cardiovascular and renal morbidity and mortality.

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Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on valsartan monotherapy

Cited by 18 publications

References 32 publications

Adding Hydrochlorothiazide to Olmesartan/Amlodipine Increases Efficacy in Patients With Inadequate Blood Pressure Control on Dual‐Combination Therapy

Adding Hydrochlorothiazide to Olmesartan/Amlodipine Increases Efficacy in Patients With Inadequate Blood Pressure Control on Dual‐Combination Therapy

Comparison of the Efficacy and Safety of Fixed-Dose Amlodipine/Losartan and Losartan in Hypertensive Patients Inadequately Controlled with Losartan

Efficacy of Fixed-Dose Combination Therapy in the Treatment of Patients with Hypertension

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