WHITEHOUSE STATION, N.J. (AP) — 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 alone.
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.
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