New lipid-modifying therapy phase 3 study shows reduced flushing

Br J Cardiol 2009;16:16-14 Leave a comment
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Phase III clinical study results with a nicotinic acid/laropiprant combination (Tredaptive®), show that in the treatment of patients with dyslipidaemia and primary hypercholesterolaemia, this new lipid-modifying therapy produced less flushing compared with those patients who were treated with extended-release nicotinic acid (Int J Clin Pract 2008;62:1959–70).

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Treatment with 2 g of the nicotinic acid/laropiprant combination produced a significant 18% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) and a 26% reduction in triglycerides compared to placebo across weeks 12-24. In addition, patients treated with the combination experienced significantly less flushing compared with those treated with extended-release nicotinic acid (0.2 days/week versus 0.7 days/week respectively).

Some 69% of patients treated with 1 g of the combination reported either no flushing symptoms, or mild flushing symptoms during the first week of treatment, compared to 44% of those who received extended-release nicotinic acid alone. More than twice as many patients on extended release nicotinic acid (22%) discontinued treatment due to flushing compared with those patients taking the combination (10%).

The nicotinic acic/laropiprant combination has recently received EU marketing authorisation.

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