AVII : just reflecting on Total events.
There was a landmark publication by Steven Haffner referred to as the “East West Study” published in the NEJM in 1998 and widely presented at Diabetes conferences for well over a decade after that date. There was a classic slide derived from this study which really has been imprinted in our minds and is vividly remembered even up to this very day !!!
The investigators posed a simple question; What was the risk of an MI in a non-diabetic ( NDM ) over a 7 year time period who had not had a prior MI compared with a non-diabetic who had experienced a prior MI and juxtaposed this same question for diabetics. ( North FYI, these were Type 2 Diabetics and not Type 1 Diabetics ).
The results were simply amazing!
Risk of MI in NDM without prior MI : 3.5%.
Risk of MI in NDM with prior MI : 18.8%.
Risk of MI in DM without prior MI : 20.2%.
Risk of MI in DM with prior MI ; 45%,
The conclusion; Type 2 Diabetics without a history of prior MI have the same risk of developing an MI as a non Diabetic who has suffered a prior MI!
This was a paradigm shift in the perception of Type 2DM and risk for long term complications! This landmark trial set the stage for Type 2 DM as being a CVD risk equivalent. All the guidelines including ADA and AACE changed where the philosophy of treating Type 2DM from a glucocentric approach where only the micro-vascular complications were considered to that of embracing the more enormous CV burden that Type 2 Diabetics face. Many KOLs at Diabetes conferences after the East West publication referred to Type 2 Diabetes as “Cardio-Diabetes” to encompass the important CV burden of Type 2 DM. Algorithms for Type 2 DM since then have included not only optimizing A1C but also decreasing CV burden with anti- platelet agents. Statins, Blood Pressure treatment. More recent guidelines have also included Type 2 DM glycemic agents which have shown CVE reduction such as SGLT 2 Inhibitors and GLP-1 agonists.
With this background if one considers the Demographics of the R-It population:
70% Secondary Prevention;
58% Type 2 Diabetics.
Total events to be considered include MI,
Stroke, hospitalization for unstable Angina plus coronary re-vascularization.
These events are way more than just the single MI endpoint in the landmark East West Study.
The importance of the presentation of Total events on 3/18 cannot be understated! ( AND Bhatt clearly knows that ! ) !!
That a dawn of a new paradigm, well beyond that of the landmark East West publication, is on the horizon is without question a reality which is unfolding in front of our eyes !
The total event data will not only allow clinicians to appreciate the magnitude of clinical benefit, but set the stage for Guidelines to follow ( after the seal of FDA approval) and Insurance Cos to willingly allocate V in a preferred status ( cost benefit analysis really being a no brainer even to the most mentally challenged! ).
AVII , like you, I am really really looking forward to the 3/18 presentation !!
