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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)

ESC: Coffee, Naps, and Depression in Hypertension (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.29]
(MedPage Today) -- Observations support naps but suggest risk with espresso and depression

Medical News Today: Could hypertension during pregnancy signal elevated risk for siblings?
Source: Featured Health News from Medical News Today [2015.08.28]
The male siblings of women who have high blood pressure during pregnancy are at an increased risk of developing cardiovascular disease in later life, a new study finds.

Could hypertension during pregnancy signal elevated risk for siblings?
Source: Biology / Biochemistry News From Medical News Today [2015.08.28]
The male siblings of women who have high blood pressure during pregnancy are at an increased risk of developing cardiovascular disease in later life, a new study finds.

Common 'heart attack' blood test may predict future hypertension
Source: Hypertension News From Medical News Today [2015.08.27]
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressureAnalysis of blood samples from more than 5,000 people suggests that a more sensitive...

ICD-10: Coding for Hypertension and Heart Disease
Source: Medscape Business of Medicine Headlines [2015.08.25]
There are some important elements to be aware of when coding for hypertension, heart disease, and kidney disease in ICD-10.
Medscape Business of Medicine

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 [Terminated]
This was 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 [Withdrawn]
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.

Effects of Valsartan and Aliskiren on Hemostatic Indices in Hypertensive Diabetics [Active, not recruiting]
People with both hypertension and diabetes have a higher chance of developing heart and arterial problems that could be reduced with anti-coagulant therapy. Valsartan (Diovan), an FDA approved angiotensin-II receptor antagonist (blocker) clinically indicated for the treatment of essential hypertension is known to inhibit platelet activity in both an in vitro and ex vivo setting. Aliskiren (Tekturna) is a recently FDA-approved potent direct renin inhibitor which is also an effective anti-hypertensive agent in patients with mild-to-moderate hypertension and which, in vitro, modulates antithrombin III in plasma. Therefore, in addition to being clinically approved anti-hypertensive medications, combining these two agents will potentially target both primary hemostasis (platelets) and anticoagulant (antithrombin-III is a cornerstone substrate for heparin) properties to exert their anti-thrombotic efficacy simultaneously. This combination strategy may not only improve hypertension management, but also improve vascular outcomes in high-risk diabetic population via favorable effects on anti-thrombotic activity. Importantly, there have been no significant additional safety concerns of using the combination of aliskiren and valsartan. The investigators hypothesis is that valsartan 160 mg/daily in combination with aliskiren 150-300 mg/daily for 4 weeks will favorably affect blood levels of platelet/coagulation/fibrinolytic biomarkers (ie, diminish platelet activity, and enhance antithrombin III potency) when compared with monotherapy with aliskiren 150mg/daily in hypertensive patients with type 2 diabetes mellitus.

Bioavailability of Aliskiren and Valsartan Combined as a Single Tablet vs. the Same Medications Given Separately to Healthy Subjects. [Completed]
This study will assess the bioavailability of aliskiren and valsartan as a single tablet compared to the same doses of the two drugs given as two separate tablets in healthy subjects.

Bioavailability of Aliskiren and Valsartan as a Single Tablet vs. the Same Doses of the Two Drugs Given Separately to Healthy Subjects. [Completed]
This study will assess the bioavailability of aliskiren and valsartan as a single tablet compared to the same doses of the two drugs given as two separate tablets in healthy subjects.

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: 2015-08-29

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