"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Valturna is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the ARE class to which the valsartan component of this drug principally belongs. There are no controlled trials demonstrating risk reduction with Valturna.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
A patient whose blood pressure is not adequately controlled with aliskiren alone or valsartan (or another angiotensin receptor blocker) alone may be switched to combination therapy with Valturna.
Valturna may be substituted for the titrated components.
Valturna may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
The choice of Valturna as initial therapy should be based on an assessment of potential benefits and risks.
Patients with Stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk.
Data from the high-dose multifactorial study [See Clinical Studies] provide estimates of the probability of reaching a target blood pressure with Valturna compared to aliskiren or valsartan monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Valturna 300/320 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable because of a small number of subjects with high baseline blood pressures.
Figure 1: Probability of Achieving Systolic Blood Pressure
(SBP) <140 mmHg in Patients at Endpoint
Figure 2: Probability of Achieving Diastolic Blood Pressure
(DBP) <90 mmHg in Patients at Endpoint
Figure 3: Probability of Achieving Systolic Blood Pressure
(SBP) <130 mmHg in Patients at Endpoint
Figure 4: Probability of Achieving Diastolic Blood Pressure
(DBP) <80 mmHg in Patients at Endpoint
At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy. For example, the mean baseline SBP/DBP for patients participating in this multifactorial study was 154/100 mmHg. A patient with a baseline blood pressure of 154/100 mmHg has about a 51% likelihood of achieving a goal of <140 mmHg (systolic) and 46% likelihood of achieving <90 mmHg (diastolic) on aliskiren alone, and the likelihood of achieving these goals on valsartan alone is about 47% (systolic) and 47% (diastolic). The likelihood of achieving these goals on Valturna rises to about 62% (systolic) and 60% (diastolic). The likelihood of achieving these goals on placebo is about 28% (systolic) and 25% (diastolic) [See DOSAGE AND ADMINISTRATION and Clinical Studies].
DOSAGE AND ADMINISTRATION
The recommended once-daily dose of Valturna is 150/160 mg or 300/320 mg. The recommended initial once-daily dose of Valturna is 150/160 mg. Titrate as needed to a maximum of 300/320 mg.
Patients switched from monotherapy to Valturna on average experience greater blood pressure reductions with use of the combination product.
The antihypertensive effect of Valturna is largely attained within 2 weeks. If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, the dose may be titrated up to a maximum of 300/320 mg.
A patient whose blood pressure is not adequately controlled with aliskiren alone or valsartan (or another angiotensin receptor blocker) alone may be switched to combination therapy with Valturna. The usual recommended starting dose is 150/160 mg once daily as needed to control blood pressure.
For convenience, patients receiving aliskiren and valsartan from separate tablets may instead wish to receive a single tablet of Valturna containing the same component doses.
The usual recommended starting dose of Valturna is 150/160 mg once daily as needed to control blood pressure. The dose may be titrated up to a maximum of 300/320 mg once daily.
Valturna is not recommended for use as initial therapy in patients with intravascular volume depletion [see WARNINGS AND PRECAUTIONS].
Relationship to Meals
Patients should establish a routine pattern for taking Valturna with regard to meals. High-fat meals decrease absorption substantially [see CLINICAL PHARMACOLOGY].
Dosage Forms and Strengths
- 150/160 mg aliskiren/valsartan tablets: light red, standard convex ovaloid, film-coated tablets with beveled edges debossed with NVR/HDU
- 300/320 mg aliskiren/valsartan tablets: light brown, shallow convex ovaloid, film-coated tablets with beveled edges debossed with NVR/SNB
Valturna is supplied as convex, beveled edged, ovaloid film-coated tablets.
All strengths are packaged in bottles and unit-dose blister packages (10 strips of 10 tablets) as described below.
Table 3: Valturna Tablets Supply
|Tablet||Color||Debossed||Debossed||NDC 0078- xxxx-xx|
|Aliskiren/ valsartan||Side l||Side 2||Bottle of 30||Bottle of 90||Blister Packages of 100|
|150 mg/160 mg||Light Red||NVR||HDU||0572-15||0572-34||0572-35|
|300 mg/320 mg||Light Brown||NVR||SNB||0574-15||0574-34||0574-35|
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) in original container. [See USP Controlled Room Temperature.]
Protect from moisture.
Dispense in original container.
Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. Revised: 04/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/7/2012
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