ER niacin/laropiprant (MK-0524A): Merck receives Not Approvable Letter from FDA
Monday 28, 2008 - The action letter was received by the Company for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia. The Company plans to meet with and submit additional information to enable the agency to further evaluate the risk/benefit profile of this product, according to Peter S. Kim, Executive Vice President and President, Merck Laboratories.
On April 24, 2008 the Committee for Medicinal Products for Human Use recommended marketing approval for MK-0524A in Europe.
HDL Forum will provide further information on this when available.
AHA 2008 Reports
Results from PERISCOPE: pioglitazone slows atherosclerosis
Data from the PERISCOPE (Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation) trial reported at Scientific Sessions of the American College of Cardiology 2008 Meeting suggest that pioglitazone can prevent atherosclerosis progression and produce clinically meaningful changes in cardiovascular risk factors including high-density lipoprotein (HDL) cholesterol in patients with type 2 diabetes. The results were reported by Dr Steve Nissen, Cleveland Clinic, Ohio and lead author of the paper.
Read more...
STRADIVARIUS: Rimonabant fails to slow atherosclerosis progression
Rimonabant has failed to show any benefit on progression of atherosclerosis in STRADVIVARIUS (Strategy to Reduce Atherosclerosis Development Involving Administration of Rimonabant-The Intravascular Ultrasound Study) in patients with abdominal obesity and coronary artery disease (CAD). The study was presented by Dr Steve Nissen, Cleveland Clinic, Ohio during the American College of Cardiology 2008 Scientific Sessions, and published simultaneously in the Journal of the American Medical Association.
Read more...
AHA 2007 Reports
Niacin/laropiprant plus simvastatin shows additive lipid-modifying effects
Extended-release niacin/laropiprant co-administered with simvastatin improved overall lipid control in patients with primary hypercholesterolaemia or mixed dyslipidaemia.
Read more...
Efficacy of new niacin/simvastatin combination product
A study in more than 600 patients with dyslipidaemia showed that a new combination extended release niacin/simvastatin product was effective and well-tolerated.
Read more...
HDL protective against cardiac rhythm disturbances
Low HDL cholesterol levels are associated with increased risk of developing cardiac arrhythmia in patients with non-ST elevation acute coronary syndromes.
Read more...
Data from FIELD: Dyslipidaemia an important discriminator of cardiovascular risk
Marked dyslipidaemia, including low HDL cholesterol and elevated triglycerides, is a key factor influencing cardiovascular risk in patients with type 2 diabetes and features of the metabolic syndrome.
Read more...
Novel therapy increases HDL cholesterol
Administration of KC706, an oral p38 MAP kinase inhibitor, increases HDL cholesterol levels in patients with mixed dyslipidaemia.
Read more...
***
New Joint European SocietyÕs guidelines on CVD prevention
HDL cholesterol is now incorporated in the interactive version of SCORE, HeartScore, for cardiovascular risk assessment.
Read more...
HDL cholesterol and acute coronary syndromes
Prognosis after an acute coronary syndrome is worse in patients with low HDL cholesterol levels, highlighting the need to investigate the benefit of HDL cholesterol-raising therapy.
Read more...
Anti-inflammatory role of HDL cholesterol: data from the ATTICA study
Results from the ATTICA study show an inverse relationship between HDL cholesterol and inflammatory markers, including C-reactive protein.
Read more...
Low HDL cholesterol increases the risk of cardiovascular events or stroke despite statin therapy
Low HDL cholesterol significantly increases the risk of an event by 24%, in patients who failed to achieve LDL cholesterol targets despite statin use.
Read more...
Combination nicotinic acid/laropiprant: effective with reduced flushing
Extended release (ER) nicotinic acid plus laropiprant, a PGD2 antagonist, provided effective overall lipid control with significantly less flushing than reported with ER nicotinic acid alone.
Read more...
Promising data on new CETP inhibitor
MK-0859, a new cholesteryl ester transfer protein (CETP) inhibitor, produces effective dose-dependent lipid-lowering and is well tolerated.
Read more...
HDL may protect against development of hypertension
Higher HDL cholesterol levels may protect against the development of hypertension in middle-aged men.
Read more...
Corporate sponsor
