John Buse Part 2, Observe 4D Study

In part 2 of this Exclusive Interview, John Buse explains the Observe 4D real-world study, which looked at the relationship between the use of SGLT-2 and heart failure and amputation outcomes, in a conversation with Diabetes in Control Publisher Steve Freed.

John Buse, PhD, MD, is professor, chief of the Division of Endocrinology, and director of the Diabetes Center at the University of North Carolina at Chapel Hill School of Medicine.

Transcript of this video segment:

Freed:  So, let’s get into it. I think you had eight presentations.

Buse:  I think so.

Freed:   Let’s start with what is the OBSERVE 4D trial and why was it conducted?

Buse:  Yeah. So, it’s actually not a trial. It’s a so-called observational study. It’s part of what we — which now is commonly referred to as real world evidence. The way the data is collected and analyzed is, it’s so-called, claims data. So, when a patient goes to a pharmacy and gets a particular drug, a code is recorded and that can be tracked through data sets; when patients go to the hospital for a heart attack, or for an amputation there’s a claim registered and coded, and that can be tracked in the database. And the pharmacoepidemiologist who led this study used four large administrative claims data sets involving millions of people and hundreds of thousands of patients with diabetes, and looked at the relationship of SGLT-2 drug use in individual patients and downstream outcomes with regards to heart failure and amputations. And the reason that’s of interest is the clinical trials have suggested that these SGLT-2 Inhibitors are really good for reducing heart failure hospitalizations. And the CANVAS Program with Canagliflozin suggested that there was a numerically small but statistically significant increase in the risk of amputations. So, in the study we have a positive control, the heart failure. And basically the bottom-line is the SGLT-2 Inhibitor use is not associated with amputation and the SGLT-2 Inhibitor use is associated with reductions and hospitalizations for heart failure.

Freed:   How was the study designed?

Buse: It’s designed as a pharmacoepidemiology study. So, you get all the data and then you look for so-called new users, so these are people who haven’t been on an SGLT-2 Inhibitor before in the data set and then prescription for SGLT-2 Inhibitor drops in the data set for an individual patient, that person then becomes an SGLT-2 Inhibitor patient. And then the comparison was done basically against all other drugs in diabetes but using a similar design. And then they followed the people on SGLT-2 Inhibitors versus the people on non-SGLT-2 Inhibitors in the database. It’s not randomized like a clinical trial. It’s Dr. A prescribes to Patient B an SGLT-2 Inhibitor. Dr. X prescribes to Patient Y a Pioglitazone. And it’s just a mixture of all these people in the database, but because there’s so many numbers it’s really quite a powerful technique.

Return to the main page.