Vostally

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE VOSTALLY is an angiotensin converting enzyme (ACE) inhibitor indicated: for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ). In patients 55 years or older at high risk of developing a major cardiovascular event, VOSTALLY is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes ( 1.2 ). In adult patients with post-myocardial infarction heart failure to reduce the risk of cardiovascular death and hospitalization for heart failure ( 1.3 ). 1.1 Hypertension VOSTALLY 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 this drug. 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. VOSTALLY may be used alone or in combination with thiazide diuretics. 1.2 Reduction in the Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes VOSTALLY is indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. 1.3 Post-Myocardial Infarction Heart Failure VOSTALLY is indicated in adult patients with post-myocardial infarction heart failure to reduce the risk of cardiovascular death and hospitalization for heart failure [see Clinical Studies (14.3) ] . Dosage and administration 2 DOSAGE AND ADMINISTRATION Hypertension: Initial dose is 2.5 mg to 20 mg orally once daily. Adjust dosage according to blood pressure response after 2–4 weeks of treatment. The usual maintenance dose following titration is 2.5 mg to 20 mg orally daily as a single dose or equally divided doses ( 2.2 ). Reduction in the risk of myocardial infarction, stroke, or death from cardiovascular causes: 2.5 mg orally once daily for 1 week, 5 mg orally once daily for 3 weeks, and increased as tolerated to a maintenance dose of 10 mg orally once daily ( 2.3 ). Heart failure post-myocardial infarction: Starting dose of 2.5 mg orally twice daily. If patient becomes hypotensive at this dose, decrease dosage to 1.25 mg orally twice daily. Titrate at 3-week intervals as tolerated to a target dose of 5 mg orally twice daily ( 2.4 ). 2.1 Important Administration Information Instruct patients or caregivers to use an oral dosing syringe or oral dosing