Abbott’s Cholesterol Combo Fails to Protect Heart in Study
Abbott Cholesterol Combination Fails to Protect Heart
Tim Boyle/Bloomberg
The Abbott logo stands outside one of its facilities in Des Plaines, Illinois, U.S. Abbott paid $3.4 billion for Kos Pharmaceuticals Co. in 2006 to gain Niaspan, a version of the vitamin niacin that was seen at the time to be part of the next wave of heart drugs.
The Abbott logo stands outside one of its facilities in Des Plaines, Illinois, U.S. Abbott paid $3.4 billion for Kos Pharmaceuticals Co. in 2006 to gain Niaspan, a version of the vitamin niacin that was seen at the time to be part of the next wave of heart drugs. Photographer: Tim Boyle/Bloomberg
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
Niaspan accounted for 2.6 percent of the company’s revenue last year with $927 million in sales. Abbott dropped 1.6 percent, or 83 cents, to $52.14 in New York Stock Exchange composite trading at 4 p.m., the biggest percentage decline since March 16.
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.
David Lewis, an analyst at Morgan Stanley in San Francisco, said in a note that there was “overreaction” to the data and that it “should not noticeably impact use of Niaspan.”
The study, dubbed Aim-High, followed patients with a history of heart disease and low levels of good cholesterol for 32 months, 18 months fewer than planned. Investigators had hypothesized that giving Niaspan to patients whose levels of bad cholesterol were under control would have additional clinical benefit. The trial was funded by the NIH with additional support from Abbott.
Types of Cholesterol
Good cholesterol, or HDL, flushes fat deposits from arteries to the liver to be purged from the body. Statins such as simvastatin and Pfizer Inc. (PFE)’s top-selling Lipitor work by decreasing levels of LDL, or bad cholesterol, which clogs arteries and leads to heart attacks.
Cardiovascular disease is the leading cause of death in the U.S., killing about 830,000 people a year, according to the American Heart Association.
The Aim-High 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.
Pfizer Failure
Questions about the benefits of raising good cholesterol have swirled since New York-based Pfizer’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.
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.
The Aim-High findings show regulators need to demand long- term studies to prove medicines improve health, rather than clearing the treatments based on laboratory tests of markers like cholesterol, said Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio.
Niacin does all the things that doctors would expect to benefit patients, such as lowering bad cholesterol and triglycerides while raising good cholesterol, said Nissen, who prescribes it for his patients.
“This was the group everybody thought had the best chance at a benefit,” he said today in a telephone interview. “At this point, we have to take a deep breath and realize we’re not as smart as we thought we were.”
To contact the reporters on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net; Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net.
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.
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