Merck recommends that doctors stop prescribing the drug Tredaptive to new patients.(Photo: Daniel Hulshizer, AP)
WHITEHOUSE STATION, N.J. -- Drugmaker Merck & Co. says 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.
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 outcomes for
patients taking Tredaptive plus statin drugs, to those taking statins
Tredaptive combines the cholesterol drugs niacin and laropiprant. The drug is sold in about 40 countries, including Europe.
The Food and Drug Administration rejected Tredaptive in 2008 pending more information about the drug's effects on the heart.