In this exclusive 鶹ý video, , director of the Frankel Cardiovascular Center at the University of Michigan, looks at the cumulative long-term effects of the ODYSSEY trial, which was presented at the recent American College of Cardiology meeting in New Orleans.
The following is a transcript of his remarks:
We're fortunate now to have two different PCSK9 inhibitors available for the treatment of patients with coronary disease who have not had low LDL cholesterol despite maximum statin therapy. The ODYSSEY trial involves patients who've had a recent acute coronary syndrome. What's really interesting, I think, is that when we do clinical trials, sometimes they get blank at first event and we don't actually ask the question, "What about reducing second, third, or fourth events?" which begins to get at this question, "Let's not just look for the first survival curve benefit. Let's ask the question, 'What happens downstream? Do those curves really diverge?'" They do.
ODYSSEY shows that each year there's a reduction of first, second, third, fourth events compared to the max dose statin arm. It gets at the question of cumulative benefit, and especially in younger patients, if you start imagining therapy for 10, 20, 30 years, you're talking about potentially a risk reduction that boggles our mind. To me, that's a very exciting part of the ODYSSEY trial. The investigators chose very carefully to look at that cumulative effect, not just on the first event.
Any time we start dealing with therapies that are monoclonal antibodies, we're dealing with a lot of cost to create it. In a society that is feeling the tension already, it's difficult to deal with. The cost benefit or the value of these agents if we show that over 5, 10 years there's further reduction in death, hospitalizations, expensive items, then that changes the way we look at them, at least to some degree.
Clearly, we need lower price. We need more competition. We need these drugs to be available to a large number of people who currently can't get them, but it certainly gets to that question.