1.1. Adults
HMG-CoA reductase inhibitors, or statins, are lipid-lowering agents that competitively inhibit HMG-CoA reductase, the enzyme that catalyzes cholesterol biosynthesis. Inhibiting this enzyme results in decreases in total cholesterol, low density lipoprotein cholesterol (LDL-C), triglycerides (TG) and apoprotein B (Apo B), increases in high-density lipoprotein cholesterol (HDL-C), as well as increases in the number of LDL receptors on hepatic and extrahepatic tissues. Clinical and epidemiologic studies have documented that low HDL-C, high LDL-C and elevated TG augment atherosclerosis development and are risk factors for cardiovascular disease, while higher HDL-C levels and lower LDL-C concentrations are associated with reduced cardiovascular risk1-13.
Statins are FDA-approved to manage hyperlipidemia (including hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia, and primary dysbetalipoproteinemia) in adults, treat homozygous familial hypercholesterolemia in adults, reduce the risk of coronary heart disease mortality and cardiovascular events in patients at high risk for coronary events, slow the progression of coronary atherosclerosis in patients with coronary artery disease by reducing total cholesterol and LDL-C levels, provide primary prevention of coronary artery disease in patients with risk factors for coronary artery disease but without symptomatic cardiovascular disease, promote secondary prevention of coronary events in patients with cardiovascular disease, and treat adolescents with heterozygous familial hypercholesterolemia unresponsive to diet therapy1-13.
Statin combination therapies are FDA-approved to manage primary hyperlipidemia/mixed dyslipidemia and homozygous familial hypercholesterolemia (Vytorin) when monotherapy is deemed inadequate1-14. Caduet is FDA-approved in those patients requiring both amlodipine and atorvastatin1,15. Roszet (ezetimibe/ rosuvastatin) is FDA approved for the management of homozygous familial hypercholesterolemia alone or in combination with other LDL-C lowering therapies and primary non-familial hyperlipidemia1,16.
Higher statin doses may be necessary in patients who respond poorly to initial prescribed amounts. Doses may be escalated incrementally every four weeks at minimum, based on patient need and tolerance, to the maximum recommended dose. However, the FDA now recommends limiting use of the highest simvastatin dose (80 mg) to only those patients who have been taking the dose for 12 months or more without evidence of myopathy, due to greater risks for muscle injury compared to lower simvastatin doses or other statins1,10.
Recommended adult statin maintenance doses as mono- and combination therapy should not exceed the maximum doses listed in Tables 1 and 2.
Drug | Dosage Form/Strength | Maximum Recommended Dosage |
---|---|---|
atorvastatin (Lipitor, generic) | 10 mg, 20 mg, 40 mg, 80 mg tablets |
|
fluvastatin (generics, Lescol XL, generics) | 20 mg, 40 mg capsules; 80 mg extended-release tablets |
|
lovastatin (generics) | 10 mg, 20 mg, 40 mg tablets |
|
lovastatin (Altoprev) | 20 mg, 40 mg, 60 mg extended-release tablets |
|
pitavastatin calcium (Livalo, generics ) | 1 mg, 2 mg, 4 mg tablets |
|
pitavastatin magnesium (Zypitamag) | 1 mg, 2 mg, 4 mg tablets |
|
pravastatin (Pravachol, generics) | 10 mg, 20 mg 40 mg, 80 mg tablets |
|
rosuvastatin (Crestor, generics) | 5 mg, 10 mg, 20 mg, 40 mg tablets |
|
rosuvastatin (Ezallor Sprinkle) | 5 mg, 10 mg, 20 mg, 40 mg sprinkle capsules |
|
simvastatin (Zocor, FloLipid, tablet generics) | 5 mg, 10 mg, 20 mg, 40 mg, 80 mg tablets; 20 mg/5 mL, 40 mg/5 mL suspension |
|
Drug | Dosage Form/Strength | Maximum Recommended Dosage |
---|---|---|
amlodipine/atorvastatin (Caduet, generics) | 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg tablets |
|
ezetimibe/ rosuvastatin (Roszet) | 10 mg/5 mg, 10 mg/ 10mg, 10 mg/20 mg, 10 mg/40 mg oral tablets |
|
ezetimibe/ simvastatin (Vytorin, generics) | 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg tablets |
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