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EU approves new dyslipidemia drug


A new drug to combat dyslipidemia and primary hypercholesterolemia has been approved for marketing in the European Union.

Tredaptive in 1g/20mg tablets has been approved to provide lipid-modifying therapy for patients in the EU, Iceland and Norway. The Merck Sharp & Dohme product combines nicotinic acid (niacin) and laropiprant to create a new flushing pathway inhibitor.

Clinical studies involving more than 4,700 patients found that Tredaptive reduced LDL-cholesterol levels, raised HDL-cholesterol levels and decreased triglycerides. High LDL-C, low HDL-C and elevated triglycerides are risk factors associated with heart attacks and strokes.

The regulatory authorities have approved it to treat dyslipidemia, particularly in patients with combined mixed dyslipidemia and in patients with primary hypercholesterolemia.

It should be used together with statins when the cholesterol lowering effects of statin monotherapy is inadequate, while it is to be used as monotherapy only in patients in whom statins are considered inappropriate or not tolerated.

Copyright PA Business 2008

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