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 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.

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

Researchers identify source of opioids' side effects

January 17, 2017

A commercially available drug may help drastically reduce two side effects of opioid painkillers—a growing tolerance and a paradoxical increased sensitivity to pain—without affecting the drugs' ability to reduce pain, ...

CVS generic competitor to EpiPen, sold at a 6th the price

January 12, 2017

CVS is now selling a rival, generic version of Mylan's EpiPen at about a sixth of its price, just months after the maker of the life-saving allergy treatment was eviscerated before Congress because of its soaring cost to ...

Many misuse OTC sleep aids: survey

December 29, 2016

(HealthDay)—People struggling with insomnia often turn to non-prescription sleep remedies that may be habit-forming and are only intended for short-term use, according to a new Consumer Reports survey.

The pill won't kill your sexual desire, researchers say

December 15, 2016

Taking the pill doesn't lower your sexual desire, contrary to popular belief, according to research published in the Journal of Sexual Medicine. The authors of the research, from the University of Kentucky and Indiana University ...

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.