标题: [转贴] Abbott’s Cholesterol Combo Fails to Protect Heart in Study [打印本页] 作者: 何鸿燊 时间: 2011-5-26 16:33 标题: Abbott’s Cholesterol Combo Fails to Protect Heart in Study
By Catherine Larkin and Michelle Fay Cortez - May 26, 2011
Abbott Laboratories (ABT)’ Niaspan failed to prevent heart attacks and may have boosted stroke risk in a U.S.-funded study that calls into question the benefit of raising good cholesterol to combat the leading cause of death.
The National Institutes of Health said today it stopped a 3,414-person study early after the addition of Niaspan to simvastatin, a standard therapy for high cholesterol, was linked to strokes in 1.6 percent of patients, compared with 0.7 percent in the control group. The combination failed to reduce heart attacks, heart-related hospitalizations and the need for procedures to reduce chest pain and restore strong blood flow.
Abbott, based in Abbott Park, Illinois, paid $3.4 billion for Kos Pharmaceuticals Co. in 2006 to gain Niaspan, a version of the vitamin niacin that has led a new wave of heart drugs to raise good cholesterol. The findings may also jeopardize medicines in that group being developed by Merck & Co., Eli Lilly & Co. (LLY) and Roche Holding AG. (ROG)
“This sends us a bit back to the drawing board in terms of trying to figure out how to approach this hypothesis,” Susan Shurin, acting director of the NIH’s National Heart, Lung, and Blood Institute, said today on a conference call with reporters.
Shares Fall
Abbott shares fell the most in seven months in intraday trading as investors feared a decline in use of Niaspan, which accounted for 2.6 percent of the company’s revenue last year with sales of $927 million. The drugmaker dropped 99 cents, or 1.9 percent, to $51.98 at 2:05 p.m. in New York Stock Exchange composite trading. Earlier shares fell as much as 2.7 percent, the biggest intraday decline since Oct. 27.
Abbott sells a combination of Niaspan and simvastatin called Simcor. The company’s Trilipix and Tricor pills are also designed to raise good cholesterol. Outside advisers to the FDA recommended last week that Abbott conduct a new trial of Trilipix after a government study failed to show heart benefits.
“Today’s news is a major surprise to us and another setback for Abbott’s cholesterol franchise,” Larry Biegelsen, an analyst at Wells Fargo in New York, said today in a note to clients. He estimated that sales of Niaspan may fall by 20 percent to 30 percent as a result of the trial data.
The study, dubbed Aim-High, followed patients with a history of heart disease and low levels of good, or HDL, cholesterol for 32 months, 18 months fewer than planned. Investigators had hypothesized that giving Niaspan to patients whose levels of bad, or LDL, cholesterol were under control would have additional clinical benefit. The trial was funded by the NIH with additional support from Abbott.
‘Unanswered Questions’
The study population didn’t include everyone who might benefit from Niaspan and “there are a number of unanswered questions that remain,” Abbott said today in a statement.
The U.S. Food and Drug Administration is reviewing the results and isn’t changing its recommendations for Niaspan use at this time. Almost a third of the strokes occurred in patients who had stopped taking Niaspan so “it is unclear what role, if any,” the drug played in the risk imbalance, the FDA said.
Questions about the benefits of raising good cholesterol have swirled since New York-based Pfizer Inc. (PFE)’s torcetrapib raised heart risks in a December 2006 trial. The approach was revived in November at the American Heart Association meeting in Chicago, when a study showed Merck’s anacetrapib raised levels of good cholesterol and slashed bad cholesterol. Patients on the drug had fewer heart complications, though the numbers were small, the Whitehouse Station, New Jersey-based company found.
Market Estimate
Roche, based in Basel, Switzerland, and Lilly of Indianapolis have similar drugs in development, which analysts estimate may generate as much as $15 billion in peak annual sales if the benefits are confirmed in large trials.
“Right now, using niacin in high-risk patients, we ought not to really be doing it,” Bob Eckel, a professor of medicine at the University of Colorado and past president of the heart association, said in a telephone interview. “To say that the HDL door is shut is premature” for other drugs under development to raise good cholesterol, he said.
Cardiovascular disease is the leading cause of death in the U.S., killing about 830,000 people a year, according to the AHA.作者: aimei 时间: 2011-5-26 17:26
Bad news
Thanks for sharing作者: 看彩云伴海鸥 时间: 2011-5-26 17:46
Co--Thank you for sharing。作者: 何鸿燊 时间: 2011-5-26 19:00
