News | December 15, 2008

New Drug Therapy Approved for Cholesterol Management

December 15, 2008 - The FDA has approved Abbott's TRILIPIX (fenofibric acid) delayed-release capsules, the first and only fibrate indicated for use in combination with a statin for cholesterol management.

The drug is indicated for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels. TRILIPIX has not been shown to prevent heart disease or heart attack.

"Only 35 percent of patients with lipid problems are currently being treated with lipid therapies and many are not reaching treatment targets for all three key lipids," said Michael Davidson, M.D., clinical professor and director of Preventive Cardiology, University of Chicago Pritzker School of Medicine. "The approval of TRILIPIX is good news for patients because now there is a new treatment option that can be used alone or in combination with a statin to help address lipid problems."

The TRILIPIX clinical trial program was designed to evaluate the efficacy and safety of a fibrate in combination with various statins. The efficacy and safety of TRILIPIX in combination with the three most commonly prescribed statins - rosuvastatin, atorvastatin and simvastatin - was evaluated in three randomized, multicenter, double-blind, controlled, 12-week Phase III studies, totaling 2,698 patients with mixed dyslipidemia. Patients included in the studies had multiple lipid problems, with an LDL > 130 mg/dL, triglycerides > 150 mg/dL and HDL less than 40 mg/dL for men and less than 50 mg/dL for women. A total of 1,911 patients who completed one of the 12-week studies subsequently enrolled in a 52-week long-term, open-label extension study.

The Phase III combination studies all met their primary endpoints. Combination therapy significantly improved HDL and triglycerides compared to statin therapy alone, and significantly improved LDL compared to TRILIPIX alone. All of the combinations and the statins had clinically meaningful reductions in LDL.

Abbott and AstraZeneca are working together to develop a fixed-dose combination of Abbott's TRILIPIX and AstraZeneca's CRESTOR(R) (rosuvastatin calcium) with plans to submit a new drug application to the FDA in 2009.

For more information: www.trilipix.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Abbott Initiates XIENCE Short DAPT Clinical Trial
News | Antiplatelet and Anticoagulation Therapies| August 03, 2017
Abbott recently announced the first patient has been enrolled in a clinical study evaluating the short-term use of...
Study Discovers Anticoagulant Drugs Are Being Prescribed Against Safety Advice
News | Antiplatelet and Anticoagulation Therapies| July 25, 2017
July 25, 2017 — A study by researchers at the University of Birmingham has shown that general practitioners (GPs) are
long-duration dual anti-platelet therapy (L-DAPT) compared to short-duration dual antiplatelet (S-DAPT) after DES stent implantation
News | Antiplatelet and Anticoagulation Therapies| July 12, 2017
June 12, 2017 — Researchers have evaluated the long-term efficacy and safety of long-duration dual anti-platelet ther
Sex-Specific Cardiovascular Drug Dosages Needed to Reduce Adverse Reactions in Women
News | Womens Healthcare| July 07, 2017
Sex-specific cardiovascular drug dosages are needed to reduce adverse reactions in women, according to a position paper...
Bayer Now Enrolling Patients for Global Pulmonary Arterial Hypertension Study
News | Hypertension| July 05, 2017
Bayer has enrolled the first patient in a global Phase IV study assessing the clinical effects of riociguat in patients...
FDA Grants Priority Review of Xarelto sNDA for 10 mg Dose
News | Antiplatelet and Anticoagulation Therapies| June 29, 2017
Janssen Research & Development LLC announced the U.S. Food and Drug Administration (FDA) accepted for Priority...
radial access, transradial access trial using anticoagulants
News | Radial Access| June 15, 2017
June 15, 2017 — In patients undergoing t...
Cost comparison between NOACs, novel oral anticoagulants
News | Antiplatelet and Anticoagulation Therapies| May 31, 2017
May 31, 2017 – The results from the first real-world, matched head-to-head study comparing all-cause healthcare costs
Data was positive from the Watchman Left Atrial Appendage Closure (LAAC) Device from the EWOLUTION registry
News | Atrial Fibrillation| May 30, 2017
May 30, 2017 — Data was positive for safety and efficacy rates of the Watchman Left Atrial Appendage Closure (LAAC) D
Overlay Init