Adam’s Journal
In the past few months, a pair of promising heart drugs failed in clinical trials. What happened? And what does it mean for the treatment of heart disease?
Dr. Scofield Prescribes
In late July, Novo Nordisk announced that in a much-anticipated clinical trial of a drug that targeted inflammation, the drug did no better than a placebo at preventing cardiovascular disease complications and deaths.
Then, in early September, Novartis unveiled the results of its trials of a drug directed at lowering a protein – known as lipoprotein A – thought to cause heart attacks and strokes. Again, in thousands of patients with heart disease, the investigational medication fared no better than a placebo.
Each of these results was quite disappointing. And each was also confounding, because in both trials, the drugs did what they were supposed to do.
Confused? Let me explain.
Elevated levels of inflammation and lipoprotein A have both been shown to bring higher risk for cardiac events and deaths. And the experimental drugs succeeded in lowering those levels: one brought down inflammation, while the other decreased lipoprotein A by 80%.
However, despite those decreased levels, people continued to experience cardiac events – and deaths – at the same rates as similar trial participants who weren’t taking the drugs. The most obvious conclusion is that while inflammation and lipoprotein A have been found to be associated with cardiac disease, it turns out they might not cause it.
Think of it like gray hair and aging. Yes, a loss of hair color comes with getting older. But a drug that stopped our coifs from graying would not prevent the march of Father Time.
So, these things we believed were causes of heart disease may just be markers that point to something deeper. If that’s the case, then the question for researchers becomes what is that something deeper?
In the meantime, the companies will dig into the results of these trials to see if there’s something that can be salvaged. Perhaps the drugs might work in a different group of subjects than the ones included in the studies, such as people who are at high risk but have not yet experienced cardiac events. Or maybe they may need to cut levels of inflammation or lipoprotein A even lower to see results.
Regardless, the failure of these large and expensive trials will almost certainly throw cold water on development of future medications in this area. As a result, I wouldn’t expect too many near-term changes to the toolbox we’re currently using to manage cardiovascular disease: diet, exercise, not smoking, and controlling blood pressure and cholesterol using existing drugs.
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Dr. Hal Scofield is a physician-scientist at the Oklahoma Medical Research Foundation, and he also serves as Associate Chief of Staff for Research at the Oklahoma City VA Medical Center. Adam Cohen is OMRF’s senior vice president and general counsel. Send your health questions to contact@omrf.org.
