• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Heart Drug Combo Reduces "Flushing"

Heart Drug Combo Reduces "Flushing"

September 7, 2007
CenterWatch Staff

Merck reported positive results from a phase III trial of Cordaptive for the treatment of dyslipidemia. Cordaptive was shown to lower LDL --or bad -- cholesterol and raise HDL -- or good -- cholesterol, while lowering some of the side effects of such drugs.

The drug is a combination of extended-release niacin and an investigative compound called laropiprant (MK-0524). laropiprant is an inhibitor of niacin-induced flushing, a common side effect of some cholesterol drugs. The combo is being investigated for the prevention of coronary heart disease (CHD, coronary artery disease) and atherosclerosis.

The double-blind, randomized trial enrolled 1,613 subjects who received Cordaptive (1 gram/day), extended-release niacin alone (1 gram/day) or placebo. After four weeks, the active treatment groups doubled their respective doses to 2 grams per day for an additional 20 weeks.

The co-primary endpoints were the effects of 2 grams of Cordaptive versus placebo on percent changes in LDL-cholesterol (LDL-C) across weeks 12 to 24, and the effects of 1 gram of Cordaptive versus extended-release niacin on flushing symptom severity during the first week of treatment. In the subjects who advanced to 2 grams of Cordaptive, LDL-C levels were reduced from baseline by an average of 19% (versus a reduction of 0.5% with placebo). In addition, in the subjects receiving 1 mg of Cordaptive, 69% reported either no flushing symptoms or mild flushing symptoms during the first week of treatment compared to 44% of those who received extended-release niacin alone.

Secondary endpoints included the effects of 2 grams of Cordaptive versus placebo on HDL-cholesterol (HDL- C) levels, triglyceride levels and other lipid parameters, and the flushing frequency and intensity of 2 grams of Cordaptive compared to extended-release niacin alone.  In the subjects receiving Cordaptive 2 mg their HDL-C levels increased by an average of 19% (versus a reduction of 1.2% with placebo), and their triglyceride levels were reduced by an average of 22% (versus an increase of 3.6% with placebo). By week 24, the frequency of moderate or greater flushing was 2 days/week for subjects receiving 2 grams of Cordaptive or a placebo versus 7 days/week among those treated with 2 grams of extended-release niacin.

A New Drug Application (NDA) for Cordaptive for the treatment of dyslipidemia is currently under review by the FDA. A decision is expected by mid 2008.

Upcoming Events

  • 06Jun

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

  • 07Jun

    Developing World-Class SOPs: Optimizing Quality and Compliance

  • 08Jun

    Implementing ICH E8 R1 Recommendations Increases Site and Participant Relationship Scoring Measures

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • MAGI East 2023

    MAGI East 2023 Preview: Janssen Reports on Environmental Impact of Trials

  • Complexity-360x240.png

    Phase 3 Trials Significantly Rising in Complexity, Says CSDD

  • Quality Level Scale

    Build Quality into Trials Like You’d Build a House, Says FDA’s BIMO Director

  • DE&I

    Trust-Building, Community Connection Still Essential to DE&I Efforts, Experts Say

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing