Stephen Nicholls, PhD, MBBS, Monash University and Victorian Heart Hospital, expands on the patient characteristics and potential impacts of COVID-19 on SURPASS-CVOT, the phase 3 cardiovascular outcomes trial for tirzepatide.
Stephen Nicholls, PhD, MBBS, Monash University and Victorian Heart Hospital, Melbourne, Australia, elaborates on patient characteristics in the SURPASS-CVOT trial and how COVID-19 may impact patients in cardiovascular outcomes trial, given that this population, by definition, has comorbidities.
What were some characteristics of the patients enrolled in SURPASS-CVOT?
The SURPASS-CVOT allows for us to now extend the investigations beyond simply looking at "Does this agent improve glucose control, weight loss, those types of things," to actually addressing, "Does it improve cardiovascular outcomes?" Patients in this study have type 2 diabetes, they have a body mass index greater than 25, and because this is a cardiovascular outcome trial, they're high cardiovascular risk. These are patients who have clinically manifested ASCVD. So that can be either previous coronary disease, previous ischemic cerebral vascular disease, or established peripheral arterial disease.
Did COVID-19 affect trial enrollment?
I think COVID-19 has presented challenges for all of us in the clinical trial space. We were fortunate that we were able to recruit patients into this study without too much difficulty. And perhaps that does reflect a lot of excitement out there in the clinical space about the potential for a therapy like tirzepatide. We also know that this is not a placebo-controlled trial, it's actually comparing to an active drug, dulaglutide. So, in a lot of ways, every patient wins in this study, as opposed to most clinical trials where half the patients get a placebo. COVID-19 also then presents challenges for us in terms of making sure that we're able to see our patients through one of those visits and follow them.
Thankfully, we've been able to do that work closely with our sites, so that's been a great effort by our sites and our patients to continue throughout the trial. And then you can imagine that COVID-19 may potentially impact the clinical events in its own right, so our our adjudication committee has had to consider COVID-19 infection in terms of how they adjudicate events. And again, that's a challenge that has been faced by a number of clinical trials in the last few years, and we're pretty confident that we've got through at least COVID-19 so far with a trial that looks like it's on its way to be able to answer the question.
In general, how can investigators address potential effects of COVID-19 on patients in a cardiovascular outcomes trial?
I think COVID-19 presents a challenge for anybody in health care and clinical trials such as this. These are high-risk patients, so we want to make sure that these patients get the right health advice. Certainly, that includes promoting that they have a vaccine status [that] is up to date. One of the really good things in clinical trials and one of the reasons why I think patients like to participate in them is that they have a much closer relationship with the site; they're seen frequently by our study nurses and our principal investigators at the site level. It's been a great opportunity during an uncertain time for everybody for patients to have that extra degree of connection with clinicians who can be keeping an eye on them above and beyond, simply filling out the forms and checking how they're going from the trial perspective.