Researchers have made significant advances with
Researchers have made significant advances with two medications aimed at managing cholesterol.
Cordaptive, produced by Merck, met its late-stage goals of increasing HDL, or good, cholesterol without inducing facial flush. Facial flushing is a common side effect of drugs used to raise HDL cholesterol levels. Researchers hope that by eliminating that side effect, more people will adhere to their cholesterol treatments and successfully reduce their risk of heart disease and heart attack.
There are still some questions about the safety of the treatment. The drug works by combining two treatments into one: it provides an extended-release of niacin, a vitamin that improves circulation and reduces blood cholesterol levels as well as laropiprant, to prevent the blood vessels from dilating in the face and neck.
During trials, patients receiving Cordaptive reported flushing 0.2 days per week, while patients receiving a placebo reported flushing 0.7 days per week. Of those taking the placebo, 22 percent discontinued treatment due to the flushing side effect. Only 10 percent of patients taking Cordaptive discontinued treatment. The drug will likely be reviewed for approval in 2008.
Two more pharmaceutical companies announced they will proceed into Phase III clinical trials of a fixed-dose combination of two blood lipid treatments. AstraZeneca''s Crestor and Abbot''s ABT-335 is a statin-fibrate combination treatment aimed at managing all three major blood lipids: HDL cholesterol, LDL cholesterol, and triglycerides. Statins reduce cholesterol levels in the blood by inhibiting a key enzyme used in the production of cholesterol. Fibrates are mainly used to reduce triglyceride levels, although they can also increase HDL cholesterol to a lesser extent.
Abbot will apply ABT-335 for approval as a monotherapy this year. Both companies will present the results of the Phase III trial of the combination therapy in 2008.
Therapeutics Daily Cardiovascular