Amlodipine, hydrochlorothiazide, and valsartan and Atorvastatin Calcium

• Generic Name: amlodipine / hydrochlorothiazide / valsartan
• Dosage Forms: n.a.
• Other Brand Names: Exforge HCT

Amlodipine is a calcium channel blocker. Hydrochlorothiazide is a thiazide diuretic (water pill). Valsartan is an angiotensin II receptor antagonist.

Amlodipine, hydrochlorothiazide, and valsartan is a combination medicine used to treat high blood pressure (hypertension).

Amlodipine, hydrochlorothiazide, and valsartan is usually given after other treatments have failed.

Amlodipine, hydrochlorothiazide, and valsartan may also be used for purposes not listed in this medication guide.

• Generic Name: atorvastatin
• Dosage Forms: n.a.
• Other Brand Names: Lipitor

ACC/AHA cholesterol management guideline recommends statins as first-line therapy for prevention of atherosclerotic cardiovascular disease (ASCVD) in adults; extensive evidence demonstrates that statins can substantially reduce ASCVD risk when used for secondary prevention or primary prevention (in high-risk patients). Relative reduction in ASCVD risk is correlated with degree of LDL-cholesterol lowering; therefore, use maximum tolerated statin intensity to achieve optimum ASCVD benefits. According to ACC/AHA, atorvastatin may be used for primary or secondary prevention in adults when moderate- or high-intensity statin therapy is indicated.

Adjunct to nondrug therapies (lifestyle modifications) in patients without clinical evidence of CHD who have multiple risk factors (e.g., age, smoking, hypertension, low HDL-cholesterol concentrations, family history of early CHD) to reduce the risk of MI, stroke, or angina and the risk of undergoing revascularization procedures. Consider benefits, adverse effects, drug interactions, and patient preferences before initiating statin therapy for primary prevention.

Adjunct to nondrug therapies (i.e., lifestyle modifications ) in patients without clinical evidence of CHD who have type 2 diabetes mellitus and multiple risk factors (e.g., retinopathy, albuminuria, smoking, hypertension) to reduce the risk of MI or stroke. Consider benefits, adverse effects, drug interactions, and patient preferences before initiating statin therapy for primary prevention in such patients. Addition of a nonstatin drug (i.e., fenofibrate) to statin therapy in patients with type 2 diabetes mellitus not shown to provide incremental ASCVD risk reduction benefit beyond that provided by statin monotherapy.

Adjunct to nondrug therapies (i.e., lifestyle modifications ) in patients with clinical evidence of CHD to reduce the risk of nonfatal MI, fatal and nonfatal stroke, angina, or hospitalization for CHF, and the risk of undergoing revascularization procedures. Unless contraindicated, statins are considered first-line therapy in patients 21–75 years of age with clinical ASCVD (i.e., acute coronary syndromes; history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin). Addition of a nonstatin drug (i.e., niacin) to statin-based therapy (i.e., simvastatin with or without ezetimibe) in patients with established cardiovascular disease not shown to provide incremental ASCVD risk reduction benefit beyond that provided by statin monotherapy.

Has been used in patients with CHD to slow the progression of coronary atherosclerosis.

Intensive antilipemic therapy (atorvastatin 80 mg daily) shown to be more effective than moderate antilipemic therapy (pravastatin 40 mg daily) in reducing the risk of cardiovascular events in patients hospitalized for acute coronary syndrome (16% reduction in composite risk of death or major cardiovascular events for atorvastatin compared with pravastatin regimen). Intensive antilipemic therapy also more effective in slowing progression of coronary atherosclerosis in patients with CHD.

May use in fixed combination with amlodipine when treatment with both atorvastatin (for prevention of cardiovascular events) and amlodipine (for hypertension and/or CAD) is appropriate.

Dyslipidemias

Adjunct to nondrug therapies (e.g., dietary management) in adults to decrease elevated serum total cholesterol, LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations, and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIa or IIb). May use in combination with ezetimibe for additive antilipemic effects. Also used in combination with fenofibrate to decrease triglyceride concentrations and increase HDL-cholesterol concentrations in patients with mixed dyslipidemia and CHD (or CHD risk equivalents) who are on optimal statin therapy; however, no incremental benefit on cardiovascular morbidity and mortality beyond that provided by statin monotherapy.

Adjunct to nondrug therapies (e.g., dietary management) to decrease elevated serum total cholesterol, LDL-cholesterol, and apo B concentrations in the management of heterozygous familial hypercholesterolemia in boys and postmenarchal girls 10–17 years of age who, despite an adequate trial of dietary management, have a serum LDL-cholesterol concentration of ≥190 mg/dL or a serum LDL-cholesterol concentration of ≥160 mg/dL and either a family history of premature cardiovascular disease or ≥2 other cardiovascular risk factors.

Adjunct to nondrug therapies (e.g., dietary management) for the management of primary dysbetalipoproteinemia (Fredrickson type III).

Adjunct to nondrug therapies (e.g., dietary management) for the management of elevated serum triglyceride concentrations (Fredrickson type IV). However, fibric acid derivatives provide greater benefit in patients with elevated triglyceride concentrations compared with statins.

Reduction of elevated serum total and LDL-cholesterol concentrations in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering therapies (e.g., plasma LDL-apheresis) or when such therapies are not available. May use in combination with ezetimibe for additive antilipemic effects.

Has reduced total and LDL-cholesterol concentrations in patients with hypercholesterolemia associated with or exacerbated by renal transplantation undergoing use of protease inhibitors.

Has reduced total and LDL-cholesterol concentrations in hypercholesterolemic patients undergoing peritoneal dialysis.

May use in fixed combination with amlodipine when treatment with both atorvastatin (for dyslipidemias) and amlodipine (for hypertension and/or CAD) is appropriate.