Amarin presented results from the latest study on its fish oil-based Vascepa/Vazkepa CVD medication (icosapent ethyl, aka IPE), suggesting that IPE improves users’ coronary physiology — thus giving Amarin a new hemodynamic angle to support its previous findings that IPE reduces plaque and MACE.
With two FDA clearances and 20 million prescriptions so far, Vascepa has achieved quite a bit, but it hasn’t yet reached what some viewed as its early potential.
- Vascepa’s arguably slow start hasn’t been helped by follow-up analysis suggesting that IPE’s MACE reductions might not be as strong as initially presented in its 2018 REDUCE-IT trial.
- Amarin followed-up in 2020 with the EVAPORATE trial, which showed that IPE significantly reduced plaque burden among patients on statin therapy with known CAD, although REDUCE-IT still gets the most public attention.
The new EVAPORATE-FFRCT study looks to provide physiologic evidence to further support IPE’s REDUCE-IT trial results.
Researchers applied HeartFlow’s FFR-CT analysis to CTA imaging data from 47 IPE and placebo participants in the EVAPORATE trial (507 coronary lesions). The IPE group had similar average baseline FFR-CT values versus the placebo group (0.83 vs. 0.84), but showed…
- Significantly improved average FFR-CT values in the distal coronary segment in the most diseased vessel per patient at 9 months (0.01 vs. −0.05; P = 0.002) and 18 months (−0.01 vs. −0.09; P = 0.003) — the primary endpoint
- Statistically insignificant changes in translesional FFR-CT values (−0.06 vs. −0.09; P = 0.054) across the 140 most severe coronary lesion per vessel — the secondary endpoint
In other words, the EVAPORATE-FFRCT study demonstrated that IPE delivers significant, early, and sustained coronary physiology improvements, while providing mechanistic insights into the often-discussed results from the REDUCE-IT trial.
These results also highlight FFR-CT software’s potential for drug research and for assessing patients’ treatment response, noting that EVAPORATE-FFRCT is the first trial to use FFR-CT to determine the personalized effectiveness of CVD drugs.
Although this new EVAPORATE-FFRCT data might not be enough to quiet Vascepa’s REDUCE-IT critics, it does provide solid evidence that IPE improves coronary physiology and could add more credibility to the results from its previous trials.
Perhaps more notable for readers who aren’t focused on Vascepa, this study could pave the way for a wider range of FFR-CT use cases, including drug research and assessing treatment responses.