Amarin Corp Plc (AMRN)

[Whalatane]

The key criticisms of the RESPECT-EPA trial were:

The trial was underpowered and failed to meet its primary endpoint of a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina requiring hospitalization, and coronary revascularization. The reduction in this endpoint was of borderline statistical significance (p=0.055).

The trial had a high number of patient withdrawals or protocol deviations, which added uncertainty to the conclusions.

The open-label design, without a placebo control, was a limitation that could have introduced bias.
While the trial showed a signal of benefit consistent with previous trials like JELIS and REDUCE-IT, the magnitude of the potential cardiovascular benefit was uncertain.

There were concerns about the increased risk of atrial fibrillation seen with icosapent ethyl, which could offset any potential cardiovascular benefits.

Some experts, like Dr. Steve Nissen, felt the many limitations of the RESPECT-EPA trial made the results uninterpretable and that it should not be used to support the data from the REDUCE-IT trial.

In summary, the RESPECT-EPA trial was criticized for being underpowered, having design limitations, and failing to provide definitive evidence on the cardiovascular benefits of icosapent ethyl, despite showing a signal of potential benefit.

Kiwi