Niacin Won't Help, May Harm Heart Patients
Taking the B vitamin offered no benefit in lowering cardiac deaths or heart attacks, researchers say Source: HealthDay Related MedlinePlus Pages: B Vitamins, Cholesterol, Statins (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - March 9, 2013 Category: Consumer Health News Source Type: news

Results from HPS2-THRIVE Study of TREDAPTIVE™ (extended-release niacin/laropiprant) Presented at American College of Cardiology Scientific Sessions
Dateline City:  SAN FRANCISCO SAN FRANCISCO--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that researchers from the Clinical Trial Service Unit at Oxford University presented results from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of TREDAPTIVE™(extended-release niacin/laropiprant) during a late-breaking clinical trials session at the American College of Cardiology 62nd Annual Scientific Sessions (abstract 300-14). Language: ...
Source: Merck.com - Research and Development News - March 9, 2013 Category: Pharmaceuticals Authors: hq_site_admin Tags: Research and Development News Corporate News Latest News Source Type: news

Nicotinic Acid Under Review by EMA, Following HPS2-THRIVENicotinic Acid Under Review by EMA, Following HPS2-THRIVE
Agencies worldwide suspended the marketing of niacin/laropiprant products in January; the new announcement from the European regulator is extending the review to products containing only nicotinic acid (or related substances). Heartwire (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 8, 2013 Category: Consumer Health News Tags: Cardiology News Source Type: news

EMA launches review of nicotinic acid on eve of HPS2-THRIVE late-breaker
Agencies worldwide suspended the marketing of niacin/laropiprant products in January; the new announcement from the European regulator is extending the review to products containing only nicotinic acid (or related substances). (Source: theHeart.org)
Source: theHeart.org - March 8, 2013 Category: Cardiology Source Type: news

ACC: Eyes Are on Watchman, Niacin
SAN FRANCISCO (MedPage Today) -- The Watchman left atrial appendage closure device and details from a failed niacin trial will be in the spotlight when the American College of Cardiology meeting kicks off Saturday. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - March 7, 2013 Category: Cardiology Source Type: news

Side-Effects Cause A Quarter Of Heart Patients To Stop Treatment In The HPS2-THRIVE Trial
The largest randomised study of the vitamin niacin in patients with occlusive arterial disease (narrowing of the arteries) has shown a significant increase in adverse side-effects when it is combined with statin treatment. Results from the HPS2-THRIVE study (Heart Protection Study 2 - Treatment of HDL to Reduce the Incidence of Vascular Events), including the reasons patients stopped the study treatment, were published online yesterday (Wednesday) in the European Heart Journal [1]... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - March 1, 2013 Category: Consumer Health News Tags: Cholesterol Source Type: news

Niacin-statin combo tied to skin, muscle side effects
NEW YORK (Reuters Health) - One-quarter of people taking niacin and statins as part of a four-year-long heart study dropped out early, often for medical reasons tied to niacin's side effects, a new study suggests. (Source: Reuters: Health)
Source: Reuters: Health - February 27, 2013 Category: Consumer Health News Tags: healthNews Source Type: news

Niacin-Statin Combo Tied to Skin, Muscle Side Effects
One-quarter of people taking niacin and statins as part of a four-year-long heart study dropped out early, often for medical reasons tied to niacin's side effects, a new study suggests.Source: Reuters Health Related MedlinePlus Pages: B Vitamins, Cholesterol, Statins (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - February 27, 2013 Category: Consumer Health News Source Type: news

Side Effects Dim Niacin Promise (CME/CE)
(MedPage Today) -- A highly significant increase in adverse events, in particular myopathy, appears to have been a driving force behind the decision to shut down a pivotal trial of Tredaptive, the agent that many hoped would improve niacin tolerance. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - February 27, 2013 Category: Cardiology Source Type: news

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

Muscle, skin and gastrointestinal problems cause a quarter of patients with heart disease and strokes to stop treatment in HPS2-THRIVE trial
The largest randomised study of the vitamin niacin in patients with occlusive arterial disease (narrowing of the arteries) has shown a significant increase in adverse side-effects when it is combined with statin treatment.  Results from the study, including the reasons patients stopped the study treatment, were just published in the EHJ.  Read more Topics: Cardiovascular Disease Prevention - Risk Assessment and Management (Source: ESC News and Press)
Source: ESC News and Press - February 27, 2013 Category: Cardiology 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

Niacin-Statin Combo May Cause Side Effects for Heart Patients
Study found that about one-quarter of participants dropped the vitamin due to adverse effects Source: HealthDay Related MedlinePlus Pages: Drug Reactions, Heart Diseases, Statins (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - February 27, 2013 Category: Consumer Health News 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 li...
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 ...
Source: NeLM - Cardiovascular Medicine - January 14, 2013 Category: Cardiology Source Type: news

Merck To Stop Producing Dyslipidemia Drug Tredaptive
Merck has just announced plans to stop producing the extended-release niacin/laropiprant drug TREDAPTIVE. The drug, used to manage dyslipidemia, is not approved in the U.S. and the company is about to suspend the worldwide availability of it completely. These measures come following the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, the results of which indicate that the drug is not nearly as effective as previously thought. The drug was found to be associated with a number of serious adverse events... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - January 12, 2013 Category: Consumer Health News Tags: Cholesterol Source Type: news

Tredaptive Cholesterol Drug Axed Over Serious Side Effect Fears
Doctors are being told that cholesterol drug Tredaptive does not work and can trigger serious and sometimes life-threatening side effects. They have been told to stop prescribing the medication. Merck has announced plans to stop producing the extended-release niacin/laropiprant drug Tredaptive . The drug, used to manage dyslipidemia (high levels of cholesterol and fat in the blood), is not approved in the U.S. and the company is about to suspend the worldwide availability of it completely... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - January 12, 2013 Category: Consumer Health News Tags: Cholesterol 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 Starts To Suspend Worldwide Availability Of Tredaptive
In the wake of the negative HPS2-THRIVE study announced last month, Merck said today that it was beginning to suspend the worldwide availability of Tredaptive, its combination of extended-release niacin and laropiprant. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 11, 2013 Category: Pharmaceuticals Authors: Larry Husten 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:  MerckMedia:Pamela Eisele, 908-423-5042orSkip Irvine, 267-305-5397orInvestors:Carol Ferguson, 908...
Source: Merck.com - Research and Development News - January 11, 2013 Category: Pharmaceuticals Authors: hq_site_admin Tags: Research and Development News Source Type: news

Merck Provides Update on Next Steps for Tredaptive (extended-release niacin/laropiprant)
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 11, 2013 - 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™... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 11, 2013 Category: Pharmaceuticals Source Type: news

Will Merck's Failure With Tredaptive Impact How Drugs Are Approved in Europe?
Just before the holiday season, Merck announced that it was halting a major clinical trial with its cardiovascular (CV) disease drug, Tredaptive. Tredaptive is a drug which combines extended-release niacin with laropiprant. Niacin (also known as Vitamin B3) is a drug that has been used for decades to help patients control dyslipidemia. Basically, niacin is one of the few compounds known to raise HDL, the so-called good cholesterol, albeit modestly. It has been prescribed to patients at risk for heart disease with abnormally low HDL. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 2, 2013 Category: Pharmaceuticals Authors: John LaMattina Source Type: news