Coronary artery disease – one of many self-inflicted wounds of Western society – fuels some of the largest pharmaceutical and device blockbusters of our time. Statins, stents, and the entire organization of our health system around STEMI care are all linked to coronary disease.
This JAMA article and its breathless lay coverage focus on a clinical trial for evolocumab (Repatha), one of the new proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. This trial, featuring evolocumab added to a statin versus a statin alone, evaluated this therapy using one of the most surrogate of surrogate markers: nominal change in percent coronary atheroma volume at 78 weeks.
As the press releases indicate, this trial was a massive success – the $14,000-per-dose PCSK9 inhibitor was positive for its primary endpoint. Patients taking just a statin continued to have excellent LDL levels and their coronary atheroma volume, as measured by intravascular ultrasound, was essentially unchanged. The evolocumab cohort, however, had even better LDL levels and … coronary atheroma volume was essentially unchanged. But, the difference between +0.05% and -0.95% is statistically significant, and therefore, the trial was a success.
There were, of course, in this trial with only 968 patients, no signals of clinically relevant benefit nor obvious reliable harm. Considering the fierce debate regarding whether statins are already overprescribed, despite being ubiquitously inexpensive, I do not see any reason to look forward to this $14,000 drug entering more widespread use.
“Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial”
http://jamanetwork.com/journals/jama/fullarticle/2584184