Friday, 21 December 2012

Chinese trial results sink hopes for niacin as lipid therapy

Niacin (Tredaptive) caused higher rates of myopathy in Chinese patients
Results from a Chinese trial have forced Merck to drop plans to seek U.S. regulatory approval for the lipid modifying drug niacin after it failed to reduce the risk of heart attacks and strokes, while increasing the risk of adverse health events.
The company also recommended doctors not start new patients on the combination of niacin and an anti-flushing drug (Tredaptive) in the approximately 40 countries where it is sold outside the U.S.
The negative outcome deals a blow to Merck, which has been trying to bring new drugs to market to help offset patent expirations for top drugs that have triggered sales-eroding generic competition.
The drug's failure also reinforces questions about the effectiveness of niacin - the key component of Tredaptive, as well as the broader strategy of seeking to raise levels of good cholesterol as a way to combat cardiovascular disease.
Tredaptive is a single-pill combination of niacin, a B vitamin that has been available for more than half a century, with a Merck-developed compound called laropiprant. Niacin is known primarily for increasing levels of good cholesterol, which theoretically should help ward off heart attacks and other cardiovascular events. Niacin also has been shown to lower bad cholesterol and triglycerides, a fatty substance in the bloodstream.
Laropiprant is designed to inhibit a common side effect of niacin, a reddening of the skin known as flushing.
Merck believed the flushing side effect has hampered the use of niacin and that combining it with laropiprant would make the drug more palatable to patients.
Merck initially applied in 2007 for U.S. Food and Drug Administration approval of Tredaptive, based on studies showing it improved cholesterol levels and inhibited flushing. But the FDA declined to approve it, asking Merck to wait for the outcome of a study called "HSP2-Thrive."
HPS2-Thrive tested whether adding Tredaptive to a regimen including simvastatin—which belongs to an older class of cholesterol-lowering drugs known as statins—reduces cardiovascular risk compared with the statin therapy alone.
The University of Oxford's clinical trial service unit conducted the HPS2-Thrive study, which enrolled about 25,670 patients at high risk of heart attack and related cardiovascular events. Of those enrolled, 14,741 were from Europe—the U.K. and Scandinavia—and 10,932 were from China, Merck said. Patients in the study were followed for a median of 3.9 years.
Merck said Thursday that Tredaptive plus statin therapy didn't significantly reduce the risk of the combination of coronary deaths, nonfatal heart attacks, strokes or procedures known as revascularizations, compared with statin therapy.
There was a statistically significant increase in the incidence of some types of nonfatal serious adverse events in the group that received Tredaptive.
The Oxford Clinical Trial Service Unit said in a separate statement posted online that it would present full results in the first quarter of 2013. One of the study investigators, Richard Haynes, said: "It has long been known that niacin causes a number of side effects, and the HPS2-Thrive study allows these to be explored in more detail."
The Oxford researchers earlier said that the Chinese patients seemed to be more prone to myopathy with niacin
Source: WSJ

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