Phase III Data Published On The Effect Of 'Tredaptive' (nicotinic Acid /laropiprant) Combined With Simvastatin On LDL-C, HDL-C And Triglyceride Levels

Main Category: Cardiovascular / Cardiology
Also Included In: Cholesterol;  Statins;  Blood / Hematology
Article Date: 01 Apr 2009 - 1:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Results from a phase III clinical study published in the latest issue of British Journal of Cardiology showed that patients with primary hypercholesterolaemia or mixed dyslipidaemia) when treated with 2 g 'Tredaptive' (nicotinic acid/ laropiprant) co-administered with simvastatin (pooled across 20 mg or 40 mg doses) (n= 609), experienced reduced LDL-C by nearly 48%, increased HDL-C by nearly 28%, and reduced triglyceride levels by approximately 33% following 12 weeks of treatment.1

The primary study endpoint was change in LDL-C levels in patients treated with 2 g 'Tredaptive' co-administered with simvastatin compared to those treated with 2 g of the drug alone. Secondary endpoints included change in LDL-C, HDL-C, and triglyceride levels in patients treated with 2 g of the drug and simvastatin (pooled) compared to those treated with simvastatin alone.1

In the other treatment arms, 2 g 'Tredaptive' alone (n = 192) reduced LDL-C by 17%, increased HDL-C by approximately 23%, and reduced triglycerides by nearly 22%; and simvastatin alone (pooled) (n = 585) reduced LDL-C by 37%, increased HDL-C by 6%, and reduced triglycerides by nearly 15%.1 Comparative lipid efficacy results were measured as mean percent change from baseline for LDL-C and HDL-C, and median percent change for triglycerides.1

"The results in this study suggest that nicotinic acid / laropiprant, used with a statin, could offer another approach to treat patients with dyslipidaemia," said Christie M. Ballantyne, M.D., associate chief and professor of medicine, Baylor College of Medicine, and co-author of the study.

High LDL-C, low HDL-C and elevated triglycerides are all risk factors associated with heart attacks and strokes.2,3,4

- Prescribing information

For full prescribing information of 'Tredaptive', please refer to the Summary of Product Characteristics (SPC) included in this email. If the SPC is missing, please contact any of the individuals listed at the start of this release for a copy.

About the study

The double-blind, parallel, 12-week study with seven treatment arms in almost 1,400 patients evaluated treatment with an initial 1g of 'Tredaptive' (1g modified-release nicotinic acid/20mg laropiprant) co-administered with simvastatin 10mg to 40mg in weeks one through four which was increased to a 2 g dose (two tablets each containing 1 g modified-release nicotinic acid/20 mg of laropiprant) co-administered with simvastatin 20mg to 40 mg and maintained for weeks 5 through 12 (n = 590). Tolerability and the safety profile of the combination were also evaluated.

Cardiovascular disease

Cardiovascular disease (CVD) is a general term referring to diseases that affect the heart or blood vessels. Coronary heart disease (CHD), also known as coronary artery disease (CAD), is one of the most common forms of CVD and is the leading cause of death globally.5 Major risk factors for CVD include abnormal blood lipids, meaning not only high LDL-C but also high levels of triglycerides and low levels of HDL-C.6,7 CVD is one of the main causes of death in Europe, accounting for over 4.3 million deaths (48% of all mortality).8 It is also the UK's number one killer with more than one in three people dying from cardiovascular disease.9 Coronary Heart Disease by itself is the most common cause of death in the U.K. accounting for 101,000 deaths per year.9

About Merck Sharp & Dohme

Merck Sharp & Dohme Limited (MSD) is the UK subsidiary of Merck & Co., Inc., of Whitehouse Station, New Jersey, USA, a leading research-based pharmaceutical company that discovers, develops, manufactures and markets a wide range of innovative pharmaceutical products to improve human health.

Forward-Looking Statement

This press release contains "forward-looking statements" about product development, product potential or about financial performance based on current expectations of the management of Merck & Co., Inc. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck & Co., Inc. undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

References

1. Gleim G, Ballantyne C, Liu N et al. Efficacy and safety profile of co-administered ER niacin/laropiprant and simvastatin in dyslipidaemia. Br J Cardiol 2009;16:90-7

2. 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) - 5 - Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001;285:2486-2497

3. 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

4. Kannel WB. Status of risk factors and their consideration in antihypertensive therapy. Am J Cardiol. 1987;59:80ª-90A

5. World Health Organization. The Top 10 causes of death factsheet. November 2008 http://www.who.int/mediacentre/factsheets/fs310_2008.pdf [Access on 24.03.09]

6. Heart UK, 'Risk factors for CHD' factsheet, http://www.heartuk.org.uk/images/uploads/healthylivingpdfs/HUKcfs_I_Risk_Factors.pdf [Access on 24.03.09]

7. Department of Health, Health Survey for England 2003, Volume 2, 'Risk factors for cardiovascular disease

8. European Heart Network. European Cardiovascular disease statistics 2008 edition

9. Allender S, Peto V, Scarborough P, et al. Coronary heart disease statistics 2007, Chapter 1. British Heart Foundation, London

Source
Merck Sharp & Dohme