Treatment with plozasiran (Redemplo) significantly reduced triglycerides among patients with severe hypertriglyceridemia, two phase III studies showed.
Compared with placebo, the small interfering RNA therapy reduced triglycerides by 79% in the SHASTA-3 trial and by 81% in SHASTA-4 (P<0.0001 for both) starting at 3 months after the first injection and sustained over 12 months, according to Gerald Watts, MD, PhD, from the University of Western Australia in Perth.
At 12 months, 91-93% of plozasiran-treated patients in the trials achieved triglyceride levels below 500 mg/dL -- the threshold for severe hypertriglyceridemia -- as compared with 50-51% of those on placebo (P<0.001 for both). And more than 50% of patients randomized to plozasiran had levels reduced below 150 mg/dL, compared with less than 10% of the placebo recipients, he reported at the European Society of Cardiology (ESC) Congress in Munich.
"Two years ago, we presented the PALISADE trial for FCS [familial chylomicronemia syndrome], which is a disorder which is 500 times less frequent than this one. Now we're presenting a disorder that is in day-to-day clinical practice," said Watts. "If the clinical guidelines support this, if the regulators give it a label, this agent has a good chance really, a very good chance of being game-changing in the clinic."
