Merck Reports Encouraging Results in Pivotal Heart Drug Study
Posted on: Monday, 3 September 2007, 15:15 CDT
Merck & Co. said that Phase III study results with its heart drug Cordaptive reduced "bad" cholesterol while raising levels of "good" cholesterol. The drug also significantly reduced flushing, the company added.
The combination drug contains Merck-developed extended-release niacin and laropiprant - a novel flushing pathway inhibitor. Cordaptive lowered LDL-cholesterol (LDL-C) levels, increased HDL-cholesterol (HDL-C) levels and reduced triglyceride levels compared to placebo. Patients treated with Cordaptive also reported significantly less flushing compared to those patients treated with extended-release niacin alone.
Across weeks 12 to 24 of the study, two grams (two one-gram tablets) of Cordaptive produced significant percent changes from baseline in LDL-C levels (-18%), HDL-C levels (20%) and triglyceride levels (-26%) relative to placebo. In addition, patients treated with Cordaptive reported significantly less flushing both at the initiation of therapy and during maintenance therapy, compared to patients on extended-release niacin alone.
Merck has already submitted a new drug application to the FDA and anticipates a decision in the second quarter of 2008. The company added that it is also moving forward as planned with filings in countries outside the US.
Source: Datamonitor
Related Articles
- Mazal Plant Pharmaceuticals Announces Filing of Provisional Patent for Cholesterol/HDL Investigational New Drug Formulation
- CRESTOR(R) Now Indicated to Slow the Progression of Atherosclerosis in Patients With Elevated Cholesterol
- Merck Niacin Drug Controls Cholesterol
- Experimental Drug Cuts Rare, Lethal Cholesterol Levels in Patients
- Merck's Investigational MK-0524 Significantly Reduced Flushing Caused By Extended-Release Niacin in Phase II Study
- WelChol and Ezetimibe Combination Therapy Provides Significant LDL-C Reductions
- First-Ever Large-Scale Prospective Study in Hispanic Patients With Elevated Cholesterol Demonstrates Significant Cholesterol Reductions With CRESTOR(R)
- Data Analysis Showed VYTORIN(R) (Ezetimibe/Simvastatin) Significantly Reduced LDL ''Bad'' Cholesterol and C-Reactive Protein (CRP) in Patients With High Cholesterol Compared to Zocor(R) (Simvastatin)
- Lifestream Technologies Signs Agreement With Polymer for New Cholesterol/HDL Test; Lifestream to Bring a New Cholesterol/HDL Test to Market
- Study: Drug Underprescribed Cholesterol-Lowering Statins Not Getting to at-Risk Heart Disease Patients
 |
 |
User Comments (0)
RSS Feeds