Press Releases

'Tredaptive' combines nicotinic acid (niacin) and laropiprant, a novel flushing pathway inhibitor.  Clinical studies have shown nicotinic acid/laropiprant to reduce LDL-cholesterol (LDL-C, or "bad" cholesterol) levels, raise HDL-cholesterol (HDL-C, or "good" cholesterol) and decrease triglycerides (a type of fat in the blood).¹  High LDL-C, low HDL-C and elevated triglycerides are risk factors associated with heart attacks and strokes.^2,3,4
 
"The value of treating lipid disorders by targeting HDL-C and triglycerides as well as LDL, has been shown in a number of studies and is reflected by the fact all major risk calculators include HDL-C." said George Kassianos, GP in Bracknell, Berkshire and Fellow of the European Society of Cardiology. "Nicotinic acid/laropiprant helps manage all three of these important cardiovascular risk factors and can provide physicians with a new option on top of statins,
particularly in the case of high risk patients."
 
Nicotinic acid/laropiprant is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-C and triglycerides and low HDL-C) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).¹

Nicotinic acid/laropiprant should be used in patients in combination with statins, when the cholesterol lowering effects of statin monotherapy is inadequate. It can be used as monotherapy only in patients in whom statins are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments (e.g. exercise, weight
reduction) should be continued during therapy.¹   
 
“The approval of nicotinic acid/laropiprant in the European Union further reinforces our long-standing commitment to the cardiovascular area by bringing novel and innovative therapies to patients.  The product provides comprehensive management of all three lipid parameters –  LDL-C, HDL-C and triglycerides – for many patients,” said Stefan Oschmann, President, MSD, Europe, Middle East, Africa and Canada.  
 
Nicotinic acid/laropiprant provided significant improvements in LDL-C, HDL-C and triglycerides. When added to ongoing statin therapy or alone, nicotinic acid/laropiprant 2000 mg/40 mg provided significant improvements in LDL-C, HDL-C and triglycerides when administered for a 24 week period.  Nicotinic acid/laropiprant 1000 mg/20 mg daily tablet was initiated at the study start; at week 4 the daily dose was advanced to the maintenance dose of 2000 mg/40 mg (2 x 1000 mg/20 mg tablets) through the remaining 20 weeks of the study.  Across weeks 12 to 24 of the study, placebo adjusted results showed that nicotinic acid/laropiprant significantly reduced LDL-C levels (-18 percent), increased HDL-C levels (20 percent) and reduced triglyceride levels (-25 percent).¹
 
When nicotinic acid/laropiprant was co-administered with simvastatin (data pooled across 1000 mg/20 mg or 2000 mg/40mg doses) LDL-C was reduced by 48 percent, HDL-C increased by 28 percent and triglycerides were reduced by 33 percent following 12 weeks of treatment.¹
 
Flushing with nicotinic acid/laropiprant (modified-release tablet) was significantly less than with nicotinic acid (prolonged release formulation). In clinical studies, patients taking nicotinic acid/laropiprant (modified-release tablet) experienced significantly less moderate-to-extreme flushing than with nicotinic acid (prolonged release formulation).  Patients were initiated on either 1000 mg/20 mg of nicotinic acid/laropiprant or 1000 mg of nicotinic acid or placebo.  After 4 weeks, patients were advanced to 2000 mg/40mg or 2000 mg respectively.¹

References
1. Summary of Product Characteristics for 'Tredaptive'
2. Kannel WB. Status of risk factors and their consideration in antihypertensive therapy. Am J Cardiol. 1987;59:80A–90A
3. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP)
4. Nordestgaard BG, Benn M, Schnohr P et al. Nonfasting triglycerides and risk of myocardial
infarction, ischemic heart disease, and death in men and women. JAMA. 2007;298:299–308