Merck & Co.’s Vytorin reduced the risks of second heart attacks and strokes in patients already on aggressive therapy, making it the first medicine to improve on the current standard of care for lowering cholesterol.
The results have immediate implications for the 1 million Americans who suffer mild heart attacks or chest pain each year. They may also make it easier for other experimental medicines from companies such as Indianapolis-based Eli Lilly and Co., Amgen Inc. and Sanofi to reach patients.
The findings from the controversial 18,000-patient study, under way for almost a decade, met the study’s primary endpoint, Merck said Monday in a written statement. The goal was to cut the rates of heart attack, stroke and death beyond the use of simvastatin, a powerful drug that has been a staple for 20 years since it was shown to reduce death rates 30 percent.
Merck released its statement ahead of the planned announcement of the full data Monday at the American Heart Association meeting in Chicago.
Leonard Schleifer, CEO of Regeneron Pharmaceuticals Inc., said the findings lift a potential cloud from a new type of medicines called PCSK9 inhibitors. Regeneron, working with Sanofi, is racing Amgen to win the first approval for the drugs that slash LDL levels by as much as 70 percent.
“It’s good news for us if people have further confidence in the LDL pathway,” he said in an interview before the results were announced. “That’s the pathway we are impacting. Suppose this didn’t work and people lost confidence. That would be a disaster.”
One in six deaths in the U.S. stems from heart disease, according to the American Heart Association.
The findings should boost demand for Vytorin and its ingredient Zetia, which already generate about $4 billion annually. They lose patent protection by 2017, meaning they may be even more heavily used once they go generic.
The current guidelines tell doctors to rely on statins such as simvastatin or Pfizer Inc.’s Lipitor, once the best-selling drug in the world. They no longer target a specific level of bad cholesterol, instead urging potent treatment for all patients.
Shares of Merck, based in Whitehouse Station, New Jersey, rose as much as 2.3 percent in early trading, to $60.42.
Lilly shares dipped 14 cents each, to $67.19.