Infusing a novel mimetic preparation (MDCO-216) with a statin did not stop the progression of coronary atherosclerosis compared to placebo in statin-treated patients with acute coronary syndromes, according to a new study published online in JAMA Cardiology. The double-blind, randomized trial included 122 statin-treated patients with acute coronary syndrome (113 of whom had evaluable imagine results at follow-up), who were either given 5 infusions of 20 mg/kg MDCO-216 (n=59) or placebo (n=67). The primary efficacy measure was nominal change in percent atheroma volume out to 36 days.
same MoA, same (abscence of) effect… with MDCO-216 (presented at AHA 2016 if I remember well)
Effect of Infusion of High-Density Lipoprotein Mimetic Containing Recombinant Apolipoprotein A-I Milano on Coronary Diseasehttps://t.co/hc9UoUvEnR
— Bertrand Delsuc (@BertrandBio) July 26, 2018
According to the study results, decrease in atheroma volume was 0.94% in the MDCO group and 0.21% in the placebo group (95% CI, −0.07 to 1.52; P=0.07). They researchers also reported a decrease in HDL-C levels in the MDCO group versus placebo (P<0.001), no difference in the normalized decrease of total atheroma volume (P=0.67), and no differences in atheroma volume in the sickest segment of the patient population (P=0.83).
— Benoit Arsenault (@ArsenaultBenoit) July 25, 2018
HDL focused interventions keep coming up short. https://t.co/blV9NDIc5g
— Jerad Dumolt, PhD, RD (@JeradDumolt) July 25, 2018
“This provides further disappointing news for the clinical development of therapies that target HDL in the setting of contemporary medical treatment for patients with coronary disease,” the researchers concluded. “Until such an agent does not prove to have beneficial effect on coronary atherosclerosis or clinical events, increasing interest will focus on alternative approaches to reducing residual cardiovascular risk.”
Source: JAMA Cardiology