Abbott Laboratories has more proof that it's really, really hard to come up with an effective new drug to combat heart disease. A pair of much-anticipated Abbott (ABT) studies were presented Nov. 14 at an American Heart Assn. meeting. The results were mixed, serving up some disappointment along with some hope.
One study looked at TriCor, a cholesterol-lowering drug. It found that TriCor improved a variety of symptoms in diabetics with high cholesterol, but didn't reduce fatal heart attacks, which was the goal of the research.
Another study looked at Simdax, used in Europe to stabilize heart-failure patients. Though it did a better job of improving symptoms in these patients than standard treatments, Simdax was no better at preventing deaths. Leading researchers concluded that more study is needed on both drugs, and Abbott's stock dropped some 7% to close at $40.52 a share on Oct. 14 on the news.
FAT BLOCKERS. That didn't stop cardiologists attending the AHA's annual Scientific Sessions meeting from thronging presentations about TriCor and Simdax, hoping they would come away with some insights on how to better treat their patients.
Granted, they already have a powerful tool in their arsenal -- the cholesterol-lowering statin drugs such as Lipitor and Zocor. Since statins were introduced 10 years ago, adverse cardiac events such as heart attacks have been reduced by one-third.
That means a solution is still desperately needed to stop the other two-thirds, since heart disease remains the No. 1 killer in developed nations.
QUALIFIED GAINS. Abbott had been hoping that TriCor, already on the market, would pick up where the statins left off. It belongs to a class of drugs known as fibrates, which lower LDL (or "bad" cholesterol), reduce fat molecules called triglycerides, and increase HDL (or "good" cholesterol) in the blood. Earlier studies had suggested that fibrates would work better for diabetics than statins.
A study of the drug in 9,795 men and women with Type 2 diabetes over five years, conducted in Australia, New Zealand, and Finland, found that those on the drug had 24% fewer nonfatal heart attacks than the control group, and a lower risk of kidney disease, bleeding in the eyes, and blood clots.
But there was no improved survival in the patients on TriCor, in part because the researchers discovered that significant numbers of patients in the placebo group had started taking statins over the five years of the study.
IMPROVING OUTLOOK. Dr. R. John Simes, director of the University of Sydney's clinical trials center and a lead investigator of the study, says TriCor does appear to have value in terms of improving quality of life for diabetics -- an important issue. But he added that for most patients, statins should remain the primary cholesterol-lowering drug until more data is gathered at TriCor from a much larger study that will end in 2009.
Dr. Scott Grundy of Southwestern Medical Center in Dallas notes that the study does offer indications that the outlook for heart disease is improving. There were fewer nonfatal heart attacks and coronary deaths overall than in past studies of the same type of patients, probably because of earlier, more intensive treatment with statins and other drugs.
That raises the question, Grundy says, of whether improvement in death rates should be the ultimate goal of clinical trials like the TriCor study. And Simes notes that there's much to be said for improving the quality of life for diabetics by avoiding blindness and the need for foot amputation, both of which were reduced by TriCor.
As a quality of life study, Simdax provided very promising results. The drug is targeted at patients entering the hospital with heart failure, a horribly debilitating disease that can leave victims bedridden and gasping for breath. There are few options for this disease. One of the newest, Johnson & Johnson's (JNJ) Natrecor, is under a cloud because of concerns that it may cause kidney damage.
GREATER STABILITY. Simdax stabilizes the amount of calcium in the heart cells, which regulates heart contractions. In a study of 600 hospitalized heart-failure patients, those on the drug had a 33% higher chance of improvement in their condition and a 30% lower chance of deterioration than those receiving standard therapy.
Although the death rate in both groups was the same, Dr. Milton Packer of Southwestern Medical Center says that by stabilizing the patient, the drug can reduce hospitalization costs. "We're really excited" about this drug, Packer says. "These people are all terribly, terribly sick. We desperately need better drugs for this patient group."
Simdax, developed by Orion Pharma of Finland, has been available in about 40 countries in Europe and Latin America since the late 1990s, but the U.S. Food & Drug Administration requested more data on the drug when Orion first sought approval several years ago. Officials of Abbott, which has the U.S. marketing rights, say they plan to meet with the FDA soon to discuss how to proceed with the drug.