1 INDICATIONS & USAGE
Valsartan Tablet, USP is an angiotensin II receptor blocker (ARB) indicated for:
Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1)
Treatment of heart failure (NYHA class II-IV); Valsartan Tablets, USP significantly reduced hospitalization for heart failure (1.2)
Reduction of cardiovascular mortality in clinically stable
patients with left ventricular failure or left ventricular dysfunction following
myocardial infarction (1.3)
1.1 Hypertension
Valsartan Tablets, USPareindicated for the treatment of hypertension, to lower blood pressure.Lowering blood pressure reduces the risk of fatal and nonfatalcardiovascular 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 class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Valsartan Tablets, USP.
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 Programs 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 cardiovascularoutcome benefit has been a reduction in the risk of stroke, but reductions in myocardialinfarction 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 (e.g., 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.
Valsartan Tablets, USP may be used alone or in combination with other antihypertensive agents.
1.2 Heart Failure
Valsartan tablets is indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, Valsartan tablets significantly reduced hospitalizations for heart failure. There is no evidence that Valsartan tablets provides added benefits when it is used with an adequate dose of an ACE inhibitor. [See Clinical Studies (14.2)]
1.3 Post-Myocardial Infarction
In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Valsartan Tablet is indicated to reduce cardiovascular mortality. [See Clinical Studies 14.3)]