Pemafibrate (K-877) add-on to statin: More trials report
Two new trials add to evidence of robust reduction in triglycerides when this new selective peroxisome proliferator-activated receptor alpha (SPPARMalpha) agonist is added to statin therapy. In one trial, 188 patients treated with pitavastatin were randomized to add-on treatment with pemafibrate 0.1, 0.2, and 0.4 mg/day for 12 weeks; the other trial evaluated pemafibrate either as a fixed dose of 0.2 mg/day, or with the possibility of up-titration (0.2 mg/kg increasing to 0.4 mg/day) in combination with any statin for 24 weeks in 423 patients. Compared with statin monotherapy, pemafibrate add-on therapy was associated with reduction in triglycerides, remnant cholesterol and apolipoprotein B48 by about 50%, as well as improvement in the atherogenic lipoprotein profile. Pemafibrate also appeared to be well tolerated with no signal for any increase in unexpected adverse events compared with statin monotherapy.
Efficacy and safety of K-877, a novel selective peroxisome proliferator-activated receptor ? modulator (SPPARM?), in combination with statin treatment: Two randomised, double-blind, placebo-controlled clinical trials in patients with dyslipidaemia.
Arai H, Yamashita S, Yokote K et al.