1 INDICATIONS AND USAGE
Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, tolower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarilystrokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (
1.1).
Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardialinfarction (
1.3).
1.1 Hypertension
Ramipril capsules are indicated for the treatment of hypertension, to lower blood pressure. Loweringblood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes andmyocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugsfrom 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 bloodpressure goals. For specific advice on goals and management, see published guidelines, such as thoseof 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 differentmechanisms of action, have been shown in randomized controlled trials to reduce cardiovascularmorbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some otherpharmacologic property of the drugs, that is largely responsible for those benefits. The largest andmost consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductionsin myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute riskincrease per mmHg is greater at higher blood pressures, so that even modest reductions of severehypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction issimilar across populations with varying absolute risk, so the absolute benefit is greater in patients whoare at higher risk independent of their hypertension (for example, patients with diabetes orhyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to alower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, andmany 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.
Ramipril capsules may be used alone or in combination with thiazide diuretics.
1.3 Heart Failure Post-Myocardial Infarction
Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestiveheart failure within the first few days after sustaining acute myocardial infarction. Administration oframipril capsules to such patients have been shown to decrease the risk of death (principallycardiovascular death) and to decrease the risks of failure-related hospitalization and progression tosevere/resistant heart failure
[see Clinical Studies (
14.3
)].