Ince describes why patients who are considered fragile are often underdiagnosed and undertreated, and that the VOYAGER PAD analyses can encourage the treatment of the fragile population.
In an interview with Pharmacy Times, Avery Ince, MD, PhD, vice president of medical affairs, cardiovascular and metabolism at Janssen Scientific Affairs, LLC, discussed the challenges of diagnosing and treating patients with peripheral arterial disease (PAD), particularly those who are considered “fragile”. Further information will be presented during the American Heart Association conference in Philadelphia, Pennsylvania (November 11, 2023, to November 13, 2023).
Pharmacy Times: Why are patients who are considered “fragile” or “complex” considered harder to treat?
Avery Ince: …There tends not to be a lot of public awareness about peripheral arterial disease (PAD). [First], there's a lot of it, there are at least 12 million patients who have PAD. A number of recent studies suggest that there probably are twice as many adults in the [United States] who have it. The second thing I want to say is that it's a disease in which there's a narrowing of the arteries. So, think of the arteries of the thighs, the arteries in the calves, it's a narrowing of those arteries to the legs and, as a consequence of diminished blood flow to the toes, to the feet, to the ankles, [and so on], you can have tissue loss, damage, amputation…that's kind of the larger context.
…First of all, who are fragile patients…for the purposes of this discussion and of the study, are considered to be people who are over the age of 75—of which they're about 15 million—or under 110 pounds in weight, and then finally, people who have renal insufficiency where they have a GFR less than 50. And there are as many as 20% of the entire adult population who are fragile. Many doctors are reluctant to anticoagulants or otherwise treat patients who are fragile on the basis of the fact that they're older, they consider to be a bit sicker, more delicate, and there's a chance that you upset that benefit-risk ratio with treatment. And so, we think that this study is very important, because what it basically demonstrates is that even when you treat people who fit that particular definition, you actually get at least as much efficacy in that group, if not more.
Pharmacy Times: What impact can these new analyses have on how clinicians approach treatment regimens for patients living with peripheral arterial disease (PAD)?
Ince: They're important, because again, I think your rank and file physician is maybe not loath to treat, but is disinclined to treat people who are older, or who are smaller—110 pounds, certainly, or who are less—or people with chronic renal insufficiency, and so, because of the tendency to undertreat people there because of benefit-risk considerations, it's really important that these data indicate that you absolutely have to treat people who meet these descriptions. [First], because they benefit as much as people who are not fragile, and [second], because in a number of instances we actually saw the beneficial effect being a bit enhanced in the so-called fragile group versus the non-fragile group.
Pharmacy Times: What is significant about the VOYAGER PAD data being presented at this year’s American Heart Association meeting?
Ince: In some ways, it's similar to what we just talked about. I think that, generally speaking, PAD is a disease which is underdiagnosed and undertreated. And, frankly, there's an epidemic of undertreatment of PAD, and so, any data that are generated that indicate that it's not only safe from a benefit-risk perspective to treat these patients, but there's a lot of benefit that's conferred. I think those data are really important. So, to the extent to which [how] these kinds of data can help increase the number of people who are being treated for PAD, I think they're really quite important.