Merck says cholesterol drug failed to show benefit

December 20, 2012

Drugmaker Merck & Co. said it will not seek U.S. approval for its cholesterol drug Tredaptive and is recommending doctors abroad stop prescribing it to new patients, based on failed study results.

The drug is sold in about 40 countries in Europe and elsewhere but is not a major product for Merck. In the first three quarters of 2012 the drug posted $13 million in sales.

The company said Thursday that results from a 25,700-patient study showed that adding Tredaptive to traditional statin therapy did not lower the risk of heart attack, stroke and related problems. Patients taking the cholesterol combination pill were also more likely to suffer serious, non-fatal adverse events. The study compared 4-year outcomes for patients taking Tredaptive plus statin drugs, to those taking statins alone.

Statins are a class of drugs that have long been used to lower levels of LDL, or "bad," cholesterol and slightly raise levels of HDL, or "good," cholesterol in the blood.

Tredaptive is a combination pill made up of niacin, which boosts good cholesterol, and laropiprant, which reduces the facial flushing caused by niacin.

Cowen & Co. analyst Steve Scala noted that the current statin treatment is a "high bar for a trial to overcome due to the substantial risk reduction associated with these drugs." Scala said in a research note that the uncertainty around the Tredaptive results "had been a long-standing reason to avoid Merck shares."

The Food and Drug Administration rejected Tredaptive in 2008 pending the more information about the drug's effects on the heart.

Company shares fell $1.03, or 2.4 percent, to $42.63 in morning trading.

Explore further: FDA panel to weigh revoking key use of Abbott drug

shares

Related Stories

FDA panel to weigh revoking key use of Abbott drug

May 17, 2011
(AP) -- A panel of advisers to the Food and Drug Administration will consider this week whether to revoke a key indication from Abbott's blockbuster cholesterol drug Trilipix.

Merck: FDA won't OK its combo cholesterol drug now

March 5, 2012
(AP) -- Federal regulators have rejected Merck & Co.'s new combination cholesterol drug, which includes a generic version of the mega-blockbuster Lipitor - at least for now.

FDA adds new safety information to statin drugs

February 28, 2012
(AP) -- Federal health officials are adding new safety warnings about risks of memory loss and elevated blood sugar to statins, a widely prescribed group of cholesterol-lowering medications.

No proof fibrate drugs reduce heart risk in diabetes patients on statins

August 10, 2011
Type 2 diabetes patients, who face higher risk of cardiovascular disease, often take a combination of medications designed to lower their LDL or "bad" cholesterol and triglyceride levels while raising their HDL or "good" ...

FDA approves first diabetes-cholesterol combo pill

October 7, 2011
(AP) -- The first combination pill for the millions of people with the dangerous combination of diabetes and high cholesterol won U.S. approval Friday, offering convenience - and savings - to patients taking multiple pills.

Recommended for you

Mind-body therapies immediately reduce unmanageable pain in hospital patients

July 25, 2017
Mindfulness training and hypnotic suggestion significantly reduced acute pain experienced by hospital patients, according to a new study published in the Journal of General Internal Medicine.

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.