WHITEHOUSE STATION, N.J. -- Drugmaker Merck & Co. says itwill not seek U.S. approval for its cholesterol drug Tredaptive and isrecommending doctors abroad stop prescribing it to new patients, basedon failed study results.
Results from a 25,700-patient studyshowed that adding Tredaptive to traditional statin therapy did notlower the risk of heart attack, stroke and related problems. Patientstaking the cholesterol combination pill were also more likely to sufferserious, non-fatal adverse events. The study compared outcomes forpatients taking Tredaptive plus statin drugs, to those taking statinsalone.
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.