MSD's Tredaptive cuts cholesterol and triglycerides

Merck Sharp & Dohme, the UK subsidiary of US drug major Merck & Co, has published Phase III results that demonstrate Tredaptive 2g (nicotinic acid/laropiprant), a new lipid-modifying therapy for patients with dyslipidemia and primary hypercholesterolemia, produced a significant 18% reduction from baseline in low-density lipoprotein cholesterol, a 20% increase in high-density lipoprotein cholesterol and a 26% decline in triglycerides compared to placebo across 12 to 24 weeks, alone or added to ongoing statin therapy. These appeared in the International Journal of Clinical Practice.

The drug also significantly reduced both non-HDL-C, another measure of lipids which includes a broader spectrum of atherogenic lipoproteins, and Apolipoprotein B, as well as raising Apolipoprotein A-I.

Tredaptive, which was recently authorized for marketing in the European Union, combines nicotinic acid with a novel flushing pathway inhibitor called laropiprant. Patients treated with Tredaptive experienced significantly-less flushing compared with those given extended-release nicotinic acid (0.2 days/week versus 0.7 days/week respectively). In addition, 69% of patients treated with 1g of Tredaptive reported either no flushing symptoms, or mild ones during the first week of treatment, compared to 44% of those who received extended-release nicotinic acid alone. The impact of flushing was illustrated with more than twice as many patients on extended-release nicotinic acid discontinuing their treatment due to flushing compared with subjects taking Tredaptive (22% vs 10%).