The Gigantic Hall C at the 2018 American College of Cardiology Scientific Sessions in Orlando was jam-packed this morning with cardiologists, journalists and industry types eager to hear the results of the ODDYSEY trial of Sanofi/Regeneron’s PCSK9 inhibitors alirocumab (Praluent).
The results were presented in a new format with a panel of experts facing the presenter and asking questions after the presentation. Attendees could use the ACC18 smartphone app to answer questions themselves (although I never could find the right button to participate.)
Prior to the presentation Valentin Foster had attendees answer how often they prescribed PCSK9 inhibitors.
I was relieved to see that 52% of attendees said that they had not prescribed a PCSK9 inhibitor. I’ve gotten only a few patients on either Praluent or Repatha, the two available cholesterol lowering agents in this category primarily because of their expense. Most of my patients balk at paying $14,000 per year for cholesterol lowering.
The aim of ODDYSEY was to see if the high residual risk of cardiovascular events after an acute coronary syndrome even on high intensity statin therapy can be reduced by further reducing LDL-C with add-on therapy with Praluent, a fully human monoclonal antibody against the PCSK9 receptor.
Investigators enrolled 18, 924 patients with recent ACS in 57 countries between 2012 and 2017 and followed them for an average of 2.8 years. Patients had LDL-C>70 or ApoB>80 and 90% were on high-intensity statin therapy. They were randomized to SC Praluent q2 weeks versus SC placebo q2 weeks and the goal was to get LDL between 25 and 50 in the treatment group.
LDL dropped from 93 to 38 in the treatment group.
The primary end point of major adverse cardiac events (MACE) included CHD death, nonfatal MI, ischemic stroke and UAP requiring hospitalization.
MACE was reduced significantly by 15% with Praluent treatment with an absolute rate reduction of 1.6%.
Secondary end-points in nonfatal MI and stroke were also significantly reduced in the treatment arm.
All-cause death was reduced by 15% and was 4.1% in placebo arm, 3.5% in treatment arm.
Importantly the only differrence in adverse events between the treatment and placebo arm was a higher rate of local injection reactions in the treatment arm. There were no differences in neurocognitive , liver or renal AES.
Post-hoc analysis showed that most of the benefit was in those with LDL>100 with MACE of 11.5% versus 15%, a 24% reduction and an absolute rate reduction of 3.4%
After the study the audience was asked if this would change their practice and 62% said yes.
A few take home points for me
-This study lends further support to the LDL hypothesis and the concept that lower is better for CV risk reduction-even down to 25
-Really low LDL reduction appears safe
-I’ll consider PCSK9 therapy for my high risk patients , especially if I can’t get LDL<100 but I would really like to see the costs come down.
-I don’t think this is going to dramatically increase Praluent prescriptions
Are you much more likely to start writing PCSK9 prescriptions after the ODDYSEY trial? Login or join SERMO to contribute your opinions to this post.
Dr. Anthony Pearson is a clinical cardiologist and director of noninvasive cardiac imaging at St. Luke’s Hospital in St. Louis, Missouri. In his spare time he plays keyboards and guitar in the band, Dr. P and the Atherosclerotics. Blog: www.theskepticalcardiologist.com | Twitter: @skepcard