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.

Combining a statin with another drug that lowers low-density lipoprotein cholesterol (LDL-C), such as colesevelam (Welchol), niacin (Niaspan, and others), or ezetimibe (Zetia), can reduce LDL-C levels more than a statin alone, but studies convincingly demonstrating that such combinations improve clinical outcomes have been lacking. The results of a long-term randomized, double-blind clinical trial (IMPROVE-IT) recently presented at the American Heart Association's Scientific Sessions 2014 indicate that addition of ezetimibe to simvastatin in high-risk patients reduces cardiovascular...

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).

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...

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.

Vytorin, a fixed-dose combination of the cholesterol absorption inhibitor ezetimibe (Zetia - Merck/Schering Plough) and the HMG-CoA reductase inhibitor ("statin") simvastatin (Zocor - Merck), has been approved by the FDA for treatment of hypercholesterolemia. It is available as tablets containing 10 mg of ezetimibe combined with 10, 20, 40 or 80 mg of simvastatin.

A highly concentrated omega-3 polyunsaturated fatty acid (PUFA) preparation (Omacor - Reliant) has been approved by the FDA as an adjunct to diet for treatment of very high plasma triglyceride concentrations (>=500 mg/dL). Omacor is a combination of the ethyl esters of icosapentaenoic (EPA) and docosahexaenoic (DHA) acids. It is the first drug derived from omega-3 PUFAs to be sold by prescription.

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 results of the AIM-HIGH trial conducted by the US National Heart, Lung and Blood Institute (NHLBI) were recently published. The goal of the trial was to test whether addition of niacin to intensive statin therapy would further reduce the risk of cardiovascular disease. The trial was stopped prematurely after an average follow-up of 3 years because niacin therapy had not shown any clinical benefit.

Risedronate (Actonel - Procter & Gamble), a pyridinyl bisphosphonate, has been approved by the FDA for oral treatment of Paget's disease of bone. Characterized by excessive bone resorption, bony deformity, disorganized bone remodeling and structural weakness, Paget's disease occurs in up to 3% of people older than 55 in Europe and North America (PD Delmas and PJ Meunier, N Engl J Med, 336:558, 1997).