In this video, DocWire News Medical Lead, Dr. Payal Kohli, provided background and takeaways the PROMINENT trial, which failed to demonstrate that pemafibrate improved cardiovascular outcomes in patients with diabetes and hyertriglyceridemia. The study was presented at the 2022 American Heart Association (AHA) Scientific Sessions.
Dr. Payal Kohli: Yes, another trial that I would say is game changing, but game changing because it came out to be negative. The PROMINENT study was a study of a fibrate, pemafibrate, in patients who had essentially been cherry picked to benefit from this medication. Based on previous trials, we’ve always hemmed and hawed because we’ve seen mixed data as to whether fibrates reduce cardiovascular risk. We know that they reduce triglycerides, but does that translate into reduction in cardiovascular risk? The subset that appeared to benefit the most is the subset that was picked in PROMINENT, the one with low HDL and high triglycerides, enriched subset for the most likely to benefit.
The results were actually kind of surprising. The trial was stopped early for futility because it didn’t seem to appear to have any benefit, and there appeared to be a bigger risk of renal adverse events as well as venous thromboembolism. Now, there was a small signal for benefit for fatty liver disease, so maybe the drug will get pursued and developed further along that path. But to me, this was very definitive evidence in a long line of trials, including ACCORD and FIELD and others, that tell us that fibrates treat the number, they don’t treat the cardiovascular risk. We really have to think differently about triglycerides, where it’s not just the lower is better paradigm that we do with LDL, but really more thinking about cardiovascular risk reduction.
At this point, I hope that everyone takes the message away from this trial that they need to deescalate fibrate therapy if they’re using it for cardiovascular risk reduction. The only patients that should really get fibrates are those with severe hypertriglyceridemia, triglycerides greater than 500 that aren’t controlled on outcomes drugs like IPE or icosapent ethyl. But otherwise, if you have somebody on a fibrate, you really got to stop, pause, ask yourself the question of whether they need that fibrate and whether they ought to be switched to something else that’s not just going to treat the number, but also treat the risk.