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Valturna (Aliskiren Hemifumarate / Valsartan) - Summary

 
 



WARNING: AVOID USE IN PREGNANCY  

When pregnancy is detected, discontinue Valturna   as soon as possible. When used in pregnancy during the second and third trimesters, d rugs that act directly on the renin-angiotensin - aldosterone system can cause injury and death to the developing fetus.   [ See Warnings and Precautions (5.1) ] .

 

VALTURNA SUMMARY

Valturna is a single tablet of aliskiren (an orally active, nonpeptide, potent direct renin inhibitor) and valsartan (an orally active, nonpeptide, specific angiotensin II antagonist acting on the AT1 receptor subtype).

Valturna is a combination of aliskiren, a direct renin inhibitor, and valsartan, an angiotensin II receptor blocker (ARB), indicated for the treatment of hypertension:

  • In patients not adequately controlled with monotherapy.
  • May be substituted for titrated components.
  • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

See all Valturna indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Valturna (Aliskiren / Valsartan)

Hypertension self-management program helps reduce blood pressure for high-risk patients
Source: Hypertension News From Medical News Today [2014.08.26]
Among patients with hypertension at high risk of cardiovascular disease, a program that consisted of patients measuring their blood pressure and adjusting their antihypertensive medication...

Increased stroke risk associated with low education, smoking and hypertension
Source: Hypertension News From Medical News Today [2014.08.19]
Adults smokers with limited education face a greater risk of stroke than those with a higher education, according to new research in the American Heart Association's journal Stroke.

The risk of resistant hypertension increases with the severity of sleep apnea
Source: Hypertension News From Medical News Today [2014.08.19]
A new study shows a strong association between severe, untreated obstructive sleep apnea and the risk of elevated blood pressure despite the use of high blood pressure medications.

Resistant hypertension: a review for physicians
Source: Hypertension News From Medical News Today [2014.08.18]
A new review article on resistant hypertension, which affects about 1 in 10 people with high blood pressure, is aimed at helping physicians assess and manage patients with the condition.

CDC study shows higher rates of hypertension among adults with disabilities
Source: Hypertension News From Medical News Today [2014.08.15]
CDC researchers report that adults with disabilities had higher rates of hypertension compared to adults without disabilities.

more news >>

Published Studies Related to Valturna (Aliskiren / Valsartan)

Comparison of the effects of aliskiren/valsartan in combination versus valsartan alone in patients with stage 2 hypertension. [2012]
The extent to which the combination of a renin inhibitor with an angiotensin receptor blocker (ARB) lowers clinic and ambulatory blood pressure (BP) versus an ARB alone in stage 2 hypertension is not well known. Hence, we performed an 8-week, randomized, double-blind study in 451 patients with stage 2 hypertension to compare the efficacy of the combination of aliskiren/valsartan 300/320 mg versus valsartan 320 mg...

Aliskiren and valsartan in stage 2 hypertension: subgroup analysis of a randomized, double-blind study. [2008.12]
INTRODUCTION: Patients with stage 2 hypertension require large absolute reductions in blood pressure (BP) to achieve recommended BP goals. Combination therapy with the direct renin inhibitor, aliskiren, and the angiotensin receptor blocker, valsartan, has been shown to produce greater BP reductions than either agent alone in a double-blind study in 1797 hypertensive patients... CONCLUSION: Combination therapy with aliskiren and valsartan provided significantly greater BP reductions over aliskiren or valsartan monotherapy and is an appropriate option for management of BP in patients with stage 2 hypertension.

Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial. [2007.07.21]
BACKGROUND: The aim of this study was to assess dual renin system intervention with the maximum recommended doses of aliskiren and valsartan, compared with each drug alone in patients with hypertension... INTERPRETATION: The combination of aliskiren and valsartan at maximum recommended doses provides significantly greater reductions in blood pressure than does monotherapy with either agent in patients with hypertension, with a tolerability profile similar to that with aliskiren and valsartan alone.

Comparative efficacy of aliskiren/valsartan vs valsartan in nocturnal dipper and nondipper hypertensive patients: a pooled analysis. [2012]
This pooled analysis of ambulatory blood pressure (BP) monitoring data from two 8-week randomized controlled trials compared the antihypertensive efficacy and safety of combination aliskiren/valsartan vs valsartan alone in hypertensive patients (nocturnal dippers or nondippers)...

Safety and tolerability of the direct renin inhibitor aliskiren in combination with angiotensin receptor blockers and thiazide diuretics: a pooled analysis of clinical experience of 12,942 patients. [2011.07]
Combinations of the direct renin inhibitor aliskiren with angiotensin receptor blockers (ARBs) or diuretics are effective therapeutic regimens for the treatment of hypertension. A large database of safety information has become available during the past several years with aliskiren in combination trials...

more studies >>

Clinical Trials Related to Valturna (Aliskiren / Valsartan)

Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes [Recruiting]
This is a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.

The Study of Novel Dual Renin Angiotensin Aldosterone System (RAAS) Blockade; Valsartan/Aliskiren in African American Patients With Hypertension and the Metabolic Syndrome [Recruiting]
Study purpose: African Americans with hypertension and markers of metabolic syndrome (small elevations in blood glucose, triglycerides and or weight) are at a high risk of cardiovascular (heart and blood vessel) problems. There is a circulating factor called angiotensin II that increases risk and may be more important in African Americans who have up to 20 times greater risk of losing kidney function and requiring dialysis. Research Investigators, including those at the University of Michigan, found one drug (Ramipril) that blocks angiotensin II effects significantly and improves kidney function in African Americans.

The purpose of The SAAVE Study is to determine whether the combination of two new blockers (Valsartan and Aliskiren) of angiotensin II, are better able to lower blood pressure, also improve some of the risk factors for cardiovascular problems and provide greater protection to the heart and kidneys.

Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus [Recruiting]
The purpose of the study is to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.

Aliskiren on Retinal Vasculature Treatment Study [Recruiting]
Hypertension affects approximately one fourth of the world population and therefore contributes substantially to the worldwide burden of cardiovascular (CV) disease and end-organ damage.

Changes in small artery structure characterized by an increased wall-to-lumen ratio (WLR) are characteristic feature of target organ damage in hypertension. Of clinical importance, structural arteries of small subcutaneous arteries have been shown to be of prognostic significance, with adverse prognosis in subjects with higher WLR. However, the assessment of arteriolar structure from biopsies of subcutaneous tissue is invasive and impractical in clinical practice. A new approach focuses on retinal arteriolar structural parameters by using scanning laser Doppler flowmetry (SLDF) with automatic full-field perfusion imaging analyses (9). This approach allows the non-invasive assessment of both the outer diameter (OD) and inner diameter (ID) of retinal arterioles in vivo and, thus, analyses vascular

remodeling of retinal arterioles by calculating WLR = (OD - ID) / ID).

A crucial role in the efforts of prevention of end-organ damage plays the renin angiotensin system (RAS). The increased mechanical strain on the vasculature at a higher BP can cause injury to the endothelial wall. Activation of the RAS increases BP and stimulates a local inflammatory response to repair the injury. Long-term or repeated response to injury leads to endothelial dysfunction and microvascular damage, and hence end-organ damage.

Combining RAS inhibitors may provide greater end-organ protection than use of either class alone. However, ONTARGET has failed to show superiority of the dual RAS blockade (ACE-I and ARB) in patients at high cardiovascular risk. The combination of ARBs and direct renin inhibitors (DRIs) emerged as the only available, valid and innovative option for blocking the RAS at two different sites (sequential blockade). Indeed, AVOID study and ALLAY study demonstrated that the DRI aliskiren has additional and to some extent blood pressure independent effects on albuminuria and left ventricular hypertrophy, both signs of subclinical organ damage in hypertension, respectively.

However, no data are available with respect to the effects of ARBs and DRIs on vascular properties in the short and long term To close this gab we focus in this study on vascular structural and functional changes since vascular adaptation to high blood pressure occurs in the early phase of hypertensive disease.

more trials >>

Reports of Suspected Valturna (Aliskiren / Valsartan) Side Effects

Cerebrovascular Accident (22)Blood Pressure Increased (16)Diabetes Mellitus (15)Renal Disorder (15)Hypertension (11)Drug Ineffective (10)Blood Pressure Fluctuation (10)Death (9)Malaise (9)Road Traffic Accident (8)more >>


Page last updated: 2014-08-26

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