Icosapent ethyl, which has an expected FDA decision date in September, is one of the most exciting topics at the American Diabetes Association (ADA) 2019 Scientific Sessions in San Francisco, CA. Robert Busch, MD, gives his thoughts on the clinical implications of the REDUCE-IT trials.
So reduce the trial as a cardiovascular mentioned patients with diabetes who don’t have cardiac disease but they have risk factors for cardiac disease and that was 30 percent of the study and 70 percent of the patients who already had and after us karateka vents either an mi or a stroke or some other athos karateka vent so to get into the study you had to have high
Triglycerides over 135 which isn’t that high but still elevated you had to have be on a statin so you were already on standard of care in terms of cardiac protection with a statin with an ldl that was below a hundred had to be 40 to 99 and and that’s basically got it you’e to the study what’s so interesting to me as an endocrinologist into my peers is you could
Have diabetes and a risk factor diabetes and hypertension diabetes and being a male over 55 or a female over 65 a diabetes and a low hdl or diabetes and smoking so you got it so basically these patients were in front of us every day when we’re practicing so of the patients with heart disease who got in many of those had diabetes so overall the study had about 58%
Of patients with diabetes and 30% diabetes and risk factors 70% cardiac disease but they could have had diabetes so that was a set up of the study but what you’ll buy into the study was is you had to have a triglyceride over 135 as a signal of additional cardiac risk the reason that’s a signal is previous studies have shown if your triglycerides are elevated you
Were at higher cardiac risk the importance of the study is no other drug ever showed that by adding it to patients with high triglycerides there was cardiac benefit so the other two bring drugs that have been tested in the past niacin and fibber cassidy had did not have positive outcomes so going into the study the hope would be it’d be positive but it was uncharted
Territory other omega-3 studies also did not show cardiac benefit so the bottom line of the study the study was continued about six years they were about almost about 8,000 something patients have on the vast seba and half on placebo and the bottom line is that the primary endpoint which was lowering non-fatal mi non-fatal stroke cardiac death we’ve asked realization
Or on stable management a hospitalization went down 25% that was the primary endpoint that was announced before last november at the heart meetings last november dr. bot from brigham and women’s hospital who’s the lead author they announced the other data 26% lowering of what’s called hard maison non fatal mi non fatal stroke and death and each separate outcome
Non fatal mi wa in town 31 percent stroke went down 28 percent and cardiovascular death del 20 percent so it’s so unique about the study not only was it a positive study but each specific endpoint in itself drove the outcome each one was statistically significant as was the overall outcome in terms of side effects the side effects there were three that were more
Than placebo some deemed peripheral edema without heart failure some mild constipation and there were a higher rate of hospitalization for atrial fib but there was a lower rate of stroke so the atrial fib was there unknown why but it did not lead to stroke there were less strokes by 28% and leave a super group so that’s pretty much what the study showed terms of
Impact to us as a prescribing physician we see patients with diabetes every day with risk factors and the triglycerides is often ignored and now looking at the triglycerides you’re gonna do something about it it’s an obligation to say look i want to lower my patients a my stroke death give a seba not a dietary supplement fish oil and not any of the other drugs
That lower triglycerides they’ve not been shown to have benefit but this shows very compelling evidence that it’s very beneficial i think with the data the way it is the american diabetes association has already authorized it as standard of care even before it goes to the fda in september to give its final blessing but the paper came out in november and the pigna
It was announced in november the new england journal lead article in january it was felt to be the most important cardiology article of the year for all of last year in march at the heart meetings they announced that total events not just first event went down 30% so for souls you had a stroke and you lived it still prevented the mi or other things like that so
Total events went down and my dupatta guess i can’t see why they wouldn’t approve it with such striking data with each individual endpoint mi and stroke and death and the and the five-point mace as well so my hope it would be approved and i hope that my colleagues would do it i’m doing after seeing the data i’m looking at triglycerides just had an obligation to get to utilize the drug
Transcribed from video
Robert Busch, MD: REDUCE-IT Trial Implications, Icosapent Ethyl for Diabetes Patients By HCPLive