Micronized fenofibrate (Tricor - Abbott), a fibric acid derivative structurally similar to clofibrate (Atromid-S, and others) and gemfibrozil (Lopid, and others), has been approved by the FDA for treatment of hypertriglyceridemia. Increased serum triglyceride concentrations have been associated with an increased risk of coronary heart disease (J Jeppesen et al, Circulation, 97:1029, 1998).

Pravastatin - Bristol-Myers Squibb) and simvastatin (Zocor -Merck), two new inhibitors of cholesterol synthesis similar to lovastatin (Mevacor - Merck), have now been marketed in the USA for treatment of hypercholesterolemia. Lovastatin (Medical Letter, 29:99, 1987) is the most frequently prescribed of all cholesterol-lowering drugs in the USA. Pravastatin and simvastatin were previously reviewed in The Medical Letter when they became available in Canada (volume 33, page 18, 1991).

Fluvastatin (Lescol - Sandoz), an HMG-CoA reductase inhibitor, was recently marketed in the USA for treatment of hypercholesterolemia. A synthetic mevalonolactone derivative, it is chemically distinct from previously available drugs in this class.

The FDA has approved 2 products containing omega-3 polyunsaturated fatty acids (PUFAs) for treatment of patients with severe hypertriglyceridemia (>500 mg/dL). Lovaza (formerly Omacor) is available by prescription. The second FDA-approved omega-3 product, Vascepa, which contains only EPA, will not be available until 2013. Many other brands of fish oil capsules are sold over the counter (OTC) as dietary supplements; the US Pharmacopeia has verified that some of these contain their labeled content, are soluble in the body, and contain neither heavy metals...

Full-page newspaper advertisements are urging patients with high cholesterol levels who are stopping Baycol (cerivastatin) to ask their doctors about Pravachol (pravastatin), Lipitor (atorvastatin), Zocor (simvastatin) or Lescol (fluvastatin). Some advertisements come with a coupon for free medication. Lovastatin, which is available generically, has not appeared in similar advertisements. Cerivastatin was withdrawn from the market on August 8 because of post-marketing reports of 31 cases of fatal rhabdomyolysis.

Bexarotene, a retinoid analog, has been approved by the US Food and Drug Administration for oral treatment of dermatologic manifestations of refractory cutaneous T-cell lymphoma.

Cerivastatin (Baycol - Bayer), a new HMG-CoA reductase inhibitor (or "statin"), has been approved by the FDA for treatment of hypercholesterolemia. Cerivastatin is the sodium salt of a synthetic fluorophenyl pyridinyl-substituted heptanoic acid.

The FDA has approved the marketing of a second fixed-dose combination of extended-release niacin (Niaspan) with a generic statin. Niaspan/simvastatin (Simcor - Abbott) is approved for use in patients with hypercholesterolemia or mixed dyslipidemia (high LDL-cholesterol, low HDL-cholesterol and high serum triglycerides). Niaspan/lovastatin (Advicor) was marketed previously for the same indications.

The FDA has announced changes in the labeling of simvastatin to reduce the risk of myopathy. These changes include limiting the use of the 80-mg maximum dose to patients who have been taking it for 12 months or more without evidence of myopathy and new recommendations for use of simvastatin with other drugs. Simvastatin is available alone (Zocor, and others) and in combination with ezetimibe (Vytorin) and with niacin (Simcor).

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.