The FDA has recently approved 2 new drugs for treatment of chronic hepatitis C virus (HCV) infection. Simeprevir (Olysio – Janssen) is the third oral protease inhibitor to be approved for use in combination with peginterferon and ribavirin for treatment of chronic HCV genotype 1 infection in adults with compensated liver disease. Telaprevir (Incivek) and boceprevir (Victrelis) were approved in 2011 for the same indication. Sofosbuvir (Sovaldi – Gilead), a nucleotide analog polymerase inhibitor that has been approved for use with and without interferon for treatment of multiple HCV...

Atorvastatin (Lipitor - Parke-Davis), an HMG-CoA reductase inhibitor (or 'statin'), was recently approved by the US Food and Drug Administration for treatment of primary hypercholesterolemia and mixed dyslipidemia. A single stereoisomer of a pyrrole derivative, the new drug is chemically different from other statins.

Rosuvastatin (Crestor - AstraZeneca), an HMG-CoA reductase inhibitor (or "statin"), was recently approved by the FDA for lowering serum cholesterol and triglyceride concentrations and raising HDL cholesterol levels. Rosuvastatin, like other statins, inhibits the enzyme that catalyzes the rate-limiting step in cholesterol synthesis, but it is claimed to be more potent than the others. All of these drugs must be taken indefinitely; if they are discontinued, lipid levels return to baseline.

The FDA has approved the subcutaneously injected PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor alirocumab (Praluent – Sanofi/Regeneron) as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol (LDL-C). It was not approved for general use in statin-intolerant patients. Alirocumab is the first PCSK9 inhibitor to be approved in the US. Evolocumab (Repatha – Amgen), another PCSK9 inhibitor, was...

The FDA recently approved three new drugs for treatment of hyperlipidemia. Ezetimibe (ez et' i mibe; Zetia) is the first in a new class of drugs that inhibit intestinal absorption of cholesterol. Extended-release lovastatin (Altocor) is a new formulation of lovastatin (Mevacor, and others). Extended-release niacin plus (immediate-release) lovastatin (Advicor) is the first fixed-dose combination of lipid-lowering drugs.

Changes caused by one drug in the absorption, distribution, metabolism or excretion of another may lead to a pharmacokinetic adverse drug interaction (DN Juurlink et al, JAMA 2003; 289:1652). Additive drug interactions, such as vasodilation caused by both sildenafil (Viagra) and nitrates, can also have adverse effects.

The FDA has approved the oral adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid for use alone (Nexletol – Esperion) and in a fixed-dose combination with the cholesterol absorption inhibitor ezetimibe (Nexlizet) as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-cholesterol (LDL-C). Bempedoic acid is the first ACL inhibitor to be approved in the US.

The FDA has approved the marketing of pitavastatin (Livalo – Kowa), an HMG-CoA reductase inhibitor (“statin”), for treatment of primary hyperlipidemia or mixed dyslipidemia. It has been available in Japan since 2003. All of the statins now available in the US are listed in the table on page 58.

New guidelines from The National Cholesterol Education Program recommend, as a therapeutic option, lowering treatment goals for LDL cholesterol (LDL-C) from <100 mg/dL to <70 mg/dL for patients at very high risk for coronary heart disease and from 130 mg/dL to <100 mg/dL for those at moderately high risk. A likely consequence of these recommendations is increased use of statins and use of higher doses with a concomitant increase in adverse effects.

The lipid-lowering drug rosuvastatin is now available in a sprinkle capsule formulation (Ezallor Sprinkle – Sun Pharma). Rosuvastatin tablets (Crestor, and generics) have been available since 2003.1,2The new formulation is being marketed specifically for residents of long-term care facilities who have difficulty swallowing. Ezallor Sprinkle capsules can be swallowed whole or opened and their contents sprinkled over applesauce or mixed with water for administration via nasogastric tube.For those long-term care residents who still have a reasonable indication for a statin but have difficulty...