Technology

The Pulse of Heart-Drug Research


Ongoing studies have the potential to change clinical practice and boost survival rates. Here's a guide to some of the most important

Huge advances against heart disease over the past decade have brought down the death rate in the U.S. from heart attacks, strokes, and other cardiovascular events by more than 22%. Nevertheless, heart disease still accounts for one out of three fatalities, making it by far the leading cause of death. And some 71.3 million Americans have one or more forms of cardiovascular disease.

Consequently, heart specialists are constantly searching for new ways to treat the disease -- and right now most of these searches focus on putting existing medicines and procedures to better use. Because heart disease afflicts so many people, any new drug must be tested on thousands before it is deemed effective. This process takes years and costs hundreds of millions of dollars.

So while new treatments wend their way through the testing process, massive clinical trials are also being conducted on existing treatments, in hopes that they can be better deployed.

On March 12-14, thousands of heart specialists will converge on Atlanta for the American College of Cardiology's (ACC) annual meeting. Much of the attention will focus on a handful of large trials, ones with mystifying acronyms that make the meeting schedule look a bit like a spam e-mail. Be aware, however, that these awkwardly named trials can have a huge impact on healthcare. Here is a preview of some of the key results:

Charisma.

This large prevention study compares the benefits of low-dose aspirin alone versus low-dose aspirin plus Plavix, a blood-thinning drug jointly marketed by Sanofi-Aventis (SNY) and Bristol-Myers Squibb (BMY). The trial participants are all at high risk of strokes, heart attacks, or other deadly cardiovascular events.

Asprin, which thins the blood, has been proven to prevent some of these events, but not enough of them. Earlier trials found that Plavix, approved in 1997 for patients already suffering from cardiovascular disease, improves the health of heart patients when combined with aspirin. Charisma aims to find out if the combination can keep a much broader swathe of the population out of the hospital.

The three-year trial, sponsored by Sanofi, enrolled 15,200 patients and was completed in July. Half the patients took daily doses of aspirin plus Plavix; the other half got aspirin plus a placebo. If the Plavix arm turns out to have significantly better outcomes, "then many if not most patients will soon be on both drugs," predicted Dr. Steven Nissen of Cleveland Clinic, the president-elect of ACC, at a press briefing in advance of the meetings.

Acuity.

The Medicines Company (MDCO) completed this 13,800 patient study in December, comparing its drug Angiomax against heparin, a generic, for patients with acute coronary syndromes (otherwise known as heart attacks and angina).

Angiomax was approved in 2000 as a treatment for unstable angina. Like heparin, it can both break down and prevent blood clots, but The Medicines Company is hoping Angiomax will prove both more effective and safer than heparin in a broad range of uses. Acute coronary syndrome is a major public health problem, so cardiologists will be watching the results of this trial closely.

Oasis 6.

This Glaxo-Smithkline (GSK) study, the sixth in a series, is testing the effectiveness of the clot-busting drug Arixtra against heparin or a placebo when given within 12 hours after a heart attack. The goal is to see which drug, if any, is better at preventing death or another heart attack within 30 days.

Arixtra is the first drug to block a blood-clotting mechanism called Factor Xa. Glaxo bought the drug from Sanofi in 2004, and dearly wants to prove its usefulness against acute coronary syndrome. (Currently it is only approved in the U.S. for use after orthopedic surgery.) The Oasis-6 study included 12,094 patients; Oasis 5, announced last September at the European Cardiology College annual meeting, demonstrated Arixtra's effectiveness in a different patient group.

Mist II.

An unusual trial for a heart meeting, Mist is a British study that aims to find a treatment for patients suffering from severe migraine headaches. It's being presented at ACC because headache specialists believe there may be a connection between the migraine and a common heart defect called patent foramen ovale, a gap between the right and left septum that can allow unfiltered blood to bypass the lungs and reach the brain directly.

This defect, normally harmless, is found in about 25% of the overall population -- and 50% of severe migraine sufferers. Boston-based NMT Medical (NMTI) has developed a coin-sized implantable device called STARflex used to close the defect. NMT figures that, of the 28 million migraine sufferers in the U.S., about 3 million could be candidates for the STARflex. Mist is the first large-scale trial of the device.

Arnst is a senior writer for BusinessWeek based in New York.

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