Christian RuffGuest
Rushad PatellGuestJulia Sandrin-GowerHost
Yeah, I mean, if we're talking about venous thromboembolism in general, I think the main limitation is that there was never a dedicated trial to look at venous thromboembolism particularly.

And so really the data that we do have is either from a longitudinal real-world data, but there are some limitations to how those are... collected and it's always very hard to fully assess causality in real-world data.

Does that drug or therapy or intervention, is it truly causing a reduction or increase in event? Because without randomization, you can't fully account for confounding and differences that may be associated with the differences you're seeing.

And the problem when you look at any of these studies is venous thromboembolism is relatively uncommon if that's collected either for safety databases or randomly on clinical trials.

So you really need a dedicated trial that's specifically geared to collecting it in a high-risk environment.

population and that's why we see and rashad mentioned this we see some of this discordant data both from meta-analyses of clinical trials and some of the longitudinal data because the data that we have is just not of the highest quality for venous thromboembolism so that would really be the the biggest the data gap in the field is that you need high quality data where we have adjudicated outcomes for venous thromboembolism and i think until we do the clinical community, but also the regulators, I don't think we'll feel confident to say exactly what is the benefit and the impact of GLP-1 based therapies on VTE.

And just when we were looking for diabetes or weight loss or atherosclerotic cardiovascular disease or heart failure or kidney disease, they all had their dedicated trial where they pick patients at risk for that condition and demonstrated substantial improvement.

So I'm a big believer that it likely plays an important role that we have to wait for the hopefully the randomized trials.

For me, a VTE trial, the size of it is almost daunting because if you look at the actual absolute numbers for these, they're quite small.

In the absence of these randomized controlled trials, there's a couple of things we can do.

In general, I'm always advocating VTE should become a more uniformly collected, even if it's an adverse event in trials, so that when we do these systematic reviews, we can use them.

You see all these oncology trials and they don't report VTE and we know that VTE is a big side effect.

Yeah, I mean, if we're talking about venous thromboembolism in general, I think the main limitation is that there was never a dedicated trial to look at venous thromboembolism particularly.

And so really the data that we do have is either from a longitudinal real-world data, but there are some limitations to how those are... collected and it's always very hard to fully assess causality in real-world data.

Does that drug or therapy or intervention, is it truly causing a reduction or increase in event? Because without randomization, you can't fully account for confounding and differences that may be associated with the differences you're seeing.

And the problem when you look at any of these studies is venous thromboembolism is relatively uncommon if that's collected either for safety databases or randomly on clinical trials.

So you really need a dedicated trial that's specifically geared to collecting it in a high-risk environment.

population and that's why we see and rashad mentioned this we see some of this discordant data both from meta-analyses of clinical trials and some of the longitudinal data because the data that we have is just not of the highest quality for venous thromboembolism so that would really be the the biggest the data gap in the field is that you need high quality data where we have adjudicated outcomes for venous thromboembolism and i think until we do the clinical community, but also the regulators, I don't think we'll feel confident to say exactly what is the benefit and the impact of GLP-1 based therapies on VTE.

And just when we were looking for diabetes or weight loss or atherosclerotic cardiovascular disease or heart failure or kidney disease, they all had their dedicated trial where they pick patients at risk for that condition and demonstrated substantial improvement.

So I'm a big believer that it likely plays an important role that we have to wait for the hopefully the randomized trials.

For me, a VTE trial, the size of it is almost daunting because if you look at the actual absolute numbers for these, they're quite small.

In the absence of these randomized controlled trials, there's a couple of things we can do.

In general, I'm always advocating VTE should become a more uniformly collected, even if it's an adverse event in trials, so that when we do these systematic reviews, we can use them.

You see all these oncology trials and they don't report VTE and we know that VTE is a big side effect.
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