The increase in hospitalization risk seen with Vascepa was small vs the survival gains seen from decreased rates of heart attack, stroke, and revascularization, noted Deepak L. Bhatt, MD, MPH, Brigham and Women’s Hospital Heart & Vascular Center.
The increase in hospitalization risk seen with Vascepa (icosapent ethyl) was small vs the survival gains seen from decreased rates of heart attack, stroke, and revascularization, noted Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart & Vascular Center, professor of medicine at Harvard Medical School.
Can you discuss the greater risk of atrial fibrillation seen with Vascepa (icosapent ethyl) in the REDUCE-IT trial?
That’s a really great question. I think a lot of people don’t realize icosapent ethyl has been available in the United States for years and been in use in a large number of patients prior to REDUCE-IT, for the FDA indication that it had: triglycerides greater than or equal to 500 mg/dL. There’s actually a lot of real-world use and safety data about the drug.
But in absolute terms, it was pretty modest. In absolute terms, it was an increase in hospitalizations for atrial fibrillation [AFib] of about 2.1% in the placebo arm to about 3.1% in the drug arm, over the course of an average of 5 years. So the absolute increase was actually quite small, especially when compared with the large reductions in things like heart attack and stroke and revascularization, and those sorts of end points.
Furthermore, these data, we need to really get them published, and we’re in the process of writing them up, but the data I’m about to cite are in the public domain. I presented them at the FDA panel on icosapent ethyl for its approval for the REDUCE-IT indication.
So we looked at the prerandomization subgroup of patients with a history of atrial fibrillation and the postrandomization subgroup of patients who developed atrial fibrillation in the trial. And in both those subgroups, as in the overall trial, there was no increase in stroke—which is, of course, the most feared complication from atrial fibrillation.
It’s a consistent benefit even in that patient that has atrial fibrillation. Maybe this isn’t obvious to everyone, but in the trial we didn’t provide any specific guidance around atrial fibrillation. We didn't say, “Oh, if the patient develops atrial fibrillation, stop the study drug.” It’s not as though the physicians in the study—which obviously was a blinded study—were reacting to atrial fibrillation by stopping the drug. So that’s why I think, and consistent with the label, there’s no black-box warning or anything for AFib.
I think if a patient has atrial fibrillation, and otherwise meets the criteria to be on icosapent ethyl per the label and per the REDUCE-IT trial, I think it’s fine to use the drug, and safe to use the drug, if the patient has well-controlled atrial fibrillation.
On the other hand, if they’ve got out-of-control atrial fibrillation, the rate’s not well controlled, then I'd say, “Control the rate. Why is it that patient has uncontrolled atrial fibrillation?” You know, deal with that more acute problem. But then in the stable, outpatient setting, if their atrial fibrillation is totally controlled, well treated with whatever strategy is appropriate for that patient—usually, that’ll be rate control, sometimes it will be rhythm control, usually it will be anticoagulation—I think it’s fine and safe to use icosapent ethyl. We've got a fair number of those sorts of patients in the trial.
And again, we do need to get this out in print, but the data are in the public domain from my presentation at the FDA.