Niacin Drug Tredaptive Fails Clinical Trial; No US Sales in Future

Pharmaceutical giant Merck & Co. suffered another blow when it found that one of its products, cholesterol drug Tredaptive, failed at preventing heart attacks, strokes, or deaths and increased unwanted side effects causing serious harm. The drug, not sold in the U.S. but available in Europe, will no longer be prescribed for new patients, although Merck said patients currently taking it can continue.

The results came about after a costly study with 25,000 patients designed to gain regulators’ approval for selling Tredaptive in the U.S. Following the outcome of the study, Merck said it will no longer seek to enter the American market with the drug. The European Medicines Agency, a watchdog group, is reviewing Tredaptive and will issue an opinion on its safety and efficacy in January.

Tredaptive uses niacin, a vitamin, and an experimental drug called laropiprant in hopes of raising HDL, the “good” cholesterol. The laropiprant was added to reduce facial flushing, the rush of blood to the skin that niacin causes. When prescribed at a high dosage, niacin is considered a drug rather than a vitamin. The study found that not only did it fail at preventing heart attacks and strokes, it also increased the number of serious, non-fatal side effects. Specifics on the side effects were not indicated, but the full report, out in March 2013, will clarify those.

The drug does not represent a large portion of Merck’s revenue, generating around $50 million a year, compared to Merck’s $47 billion overall revenue. Rather, it is a blow to Merck’s reputation and their research and development, although their large scale clinical trial has been lauded for committing to discover the real results of Tredaptive before bringing it to the U.S. market.

Not only that, but the study has far-reaching implications about the efficacy of niacin. Millions of cardiologists prescribe niacin to their patients, but Tredaptive’s failure now brings into question whether it makes any difference in patient outcomes or not. (Niacin has been prescribed for decades to treat high cholesterol.) Other drug companies such as Abbott, the maker of Niaspan, will surely see sales fall for their versions of the B-vitamin.

This case also once again brings into light the ever-changing tide of the opinion of the medical community. For years, niacin was known to be a safe and effective drug for managing high cholesterol, and the ideas of “good” and “bad” cholesterol are ingrained in most Americans’ consciousnesses. Now the idea of HDL, “good” cholesterol, is brought into question as a theory, being called again a hypothesis, and this study only adds fuel to the fire. A story from Forbes drew comparisons between niacin drugs and fish oil, wondering if fish oil medicines will soon suffer the same damage to their reputations as Tredaptive did as larger studies more closely examine the benefits and drawbacks of such drugs.

image via mims.co.uk

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