Niacin Adverse Events in HPS2-THRIVENiacin Adverse Events in HPS2-THRIVE
Extended-release niacin and laropiprant added to simvastatin were associated with a significantly increased risk of definite myopathy. Interestingly, the risk of myopathy was significantly higher in randomized patients from China than in patients from Europe. Heartwire (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 27, 2013 Category: Consumer Health News Tags: Cardiology News Source Type: news
Niacin-Statin Combo May Cause Side Effects for Heart Patients
Title: Niacin-Statin Combo May Cause Side Effects for Heart PatientsCategory: Health NewsCreated: 2/26/2013 8:35:00 PMLast Editorial Review: 2/27/2013 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - February 27, 2013 Category: Cardiology Source Type: news
Coming Attraction: First Look At What Went Wrong With Niacin
In a few weeks, on March 9, the main results of the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study will be presented in San Francisco at the annual meeting of the American College of Cardiology. These results have been eagerly awaited since Merck's brief announcement in December that the trial had not met its primary endpoint and that it would no longer pursue approval of Tredaptive, the combination of extended-release niacin and laropiprant, in the US. The trial was designed to assess whether adding t...
Source: Forbes.com Healthcare News - February 27, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
HPS2-THRIVE: High myopathy risk with niacin/laropiprant
Extended-release niacin and laropiprant added to simvastatin were associated with a significantly increased risk of definite myopathy. Interestingly, the risk of myopathy was significantly higher in randomized patients from China than in patients from Europe. (Source: theHeart.org)
Source: theHeart.org - February 27, 2013 Category: Cardiology Source Type: news
MHRA Drug Safety Update: TredaptiveT (niacin-laropiprant) no longer recommended for prescribing
Source: MHRA
Area: News
The January issue of the MHRA's Drug Safety Update has featured new data from a long-term study (HPS2-THRIVE) involving over 25 000 patients which indicated that adding TredaptiveT (fixed dose niacin-laropiprant) to simvastatin did not provide significant additional benefit in reducing the risk of major vascular events compared with statin therapy alone. In addition, a higher frequency of bleeding (intracranial and gastro-intestinal), myopathy, infections and new-onset diabetes was seen in patients taking Tredaptive with simvastatin, compared with patients taking simvastatin alone.
In l...
Source: NeLM - Cardiovascular Medicine - January 30, 2013 Category: Cardiology Source Type: news
Trials Of Niacin And Atrial Fibrillation Device Will Headline American College Of Cardiology Program
Two big trials will highlight this year's American College of Cardiology meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific's long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation. Second is the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant. The final list of trials has been posted on the ACC website. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 22, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
Niacin/Laropiprant Products to Be Withdrawn in EU Next WeekNiacin/Laropiprant Products to Be Withdrawn in EU Next Week
The Committee for the Medicinal Products of Human Use of the European Medicines Agency has followed the advice of its pharmacovigilance risk assessment team and confirmed it will recommend suspension of niacin/laropiprant products. Doctors should no longer prescribe the agents, which will cease to be available in the EU as of next week. News Alerts (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 18, 2013 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news
Niacin/laropiprant products to be withdrawn in EU next week
The Committee for the Medicinal Products of Human Use of the European Medicines Agency has followed the advice of its pharmacovigilance risk assessment team and confirmed it will recommend suspension of niacin/laropiprant products. Doctors should no longer prescribe the agents, which will cease to be available in the EU as of next week. (Source: theHeart.org)
Source: theHeart.org - January 18, 2013 Category: Cardiology Source Type: news
Niacin/laropiprant products to be suspended worldwide
The European Medicines Agency (EMA) has recommended that the marketing, supply, and authorisations of three identical niacin/laropiprant products—Tredaptive, Pelzont, and Trevaclyn—for the treatment of adults with dyslipidemia be suspended across the European Union (Source: Pharmacy Europe)
Source: Pharmacy Europe - January 15, 2013 Category: Drugs & Pharmacology Source Type: news
PRAC recommends suspension of marketing authorisations of extended-release niacin/laropiprant (Tredaptive®) across the EU
Source: European Medicines Agency
Area: News
The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the marketing, supply and authorisations of extended-release niacin/laropiprant medicines (Tredaptive®) be suspended across the EU. This follows an assessment of the available data related to safety concerns, and the conclusion by the Committee that the risks are greater than the benefits in adults with dyslipidaemia. For further details, please see a related Q&A document at the link below.
The EMA recently advised that no new patients be started on tr...
Source: NeLM - Cardiovascular Medicine - January 14, 2013 Category: Cardiology Source Type: news
What Merck Told Doctors About Tredaptive Before It Stopped Selling It
This morning, Merck announced that it would suspend sales of Tredaptive, the heart drug that combines the B vitamin niacin with a new medicine, laropiprant, that prevents niacin's main side effect, hot, unpleasant, facial flushing. This comes just weeks after a big trial of Tredaptive not only found that the drug did not prevent heart attacks, strokes, and heart procedures as was expected bu that it also caused many serious side effects. The European Medicines Agency also issued a review saying that Tredaptive's benefits do not outweigh its risks. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 11, 2013 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news
Merck Pulls Niacin Drug
(MedPage Today) -- Merck is suspending worldwide availability of its niacin drug Tredaptive, after the European Medicines Agency recommended it no longer be marketed in Europe. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - January 11, 2013 Category: Cardiology Source Type: news
Niacin/Laropiprant Products to Be Suspended WorldwideNiacin/Laropiprant Products to Be Suspended Worldwide
The European's Medicines Agency is likely the first of many to propose the suspension of niacin/laropiprant products for dyslipidemia following the failure of the HPS-2 THRIVE trial; Merck confirms it will suspend availability of the medicine where it is available. News Alerts (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - January 11, 2013 Category: Cardiology Tags: Cardiology News Alert Source Type: news
Niacin/laropiprant products to be suspended worldwide
The European's Medicines Agency is likely the first of many to propose the suspension of niacin/laropiprant products for dyslipidemia following the failure of the HPS-2 THRIVE trial; Merck confirms it will suspend availability of the medicine where it is available. (Source: theHeart.org)
Source: theHeart.org - January 11, 2013 Category: Cardiology Source Type: news
Merck Provides Update on Next Steps for TREDAPTIVE™ (extended-release niacin/laropiprant)
Dateline City:
WHITEHOUSE STATION, N.J.
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada,
today announced the company is taking steps to suspend the availability
of TREDAPTIVE™ (extended-release niacin/laropiprant) tablets
worldwide. TREDAPTIVE is not approved for use in the United States.
Language:
English
Contact HTML:
MerckM...
Source: Merck.com - Research and Development News - January 11, 2013 Category: Pharmaceuticals Authors: hq_site_admin Tags: Research and Development News Source Type: news
