That trial randomized 413 patients with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk who did not have not adequately controlled lipids with maximally tolerated statins.
Patients were randomized in a 2:1 ratio to receive alirocumab or usual care (which included statin, ezetimibe, fenofibrate, or other lipid-lowering therapy).
The primary end point was percentage change in non-HDL cholesterol [total cholesterol minus HDL cholesterol] from baseline to week 24.
At 24 weeks, non-HDL cholesterol was lowered more among patients in the alirocumab group than those in the usual-care group (37.3% lower vs 4.7% lower, for a mean difference of 32.5%; P < .0001).
Similarly, LDL cholesterol was lowered more in the alirocumab group (43.3% vs 0.3%, P < .0001).
The most frequent treatment emergent adverse events were urinary-tract infection, diarrhea, and nasopharyngitis.
As in the other trial, fasting plasma glucose and HbA1c levels remained stable in both treatment groups.
"These studies demonstrate no new safety signal" and "superiority in reducing non-HDL cholesterol vs usual care, as well as an improvement in levels of other lipids vs usual care," Dr Henry said.
Third-Party Payer Makes Final Decision
Expanding upon his thoughts, Dr Eckel said whether this class of PCSK9 inhibitor drugs — alirocumab or its "kissing cousin" evolocumab — are going to be effective in reducing cardiovascular risk over time remains to be seen.
And "the idea of additional modification of lipoprotein in diabetes is an unanswered question," he added.
Moreover, "I'm always concerned when you're modifying multiple lipoproteins at the same time....Is it really the additional LDL lowering, or is it in fact these other particles that are remnants and/or VLDL-cholesterol-carrying particles that are contributing to the benefit?"
PCSK9 inhibitors are currently approved for patients who have familial hypercholesterolemia (LDL cholesterol consistently above 190 mg/dL) or for those who have atherosclerotic cardiovascular disease (such as a previous heart attack or stroke) and LDL cholesterol that is insufficiently lowered by current therapy, he noted. The patient could be on a maximum statin dose or no statin at all if they are intolerant.
"But the final decision is made by the third-party payer, because these drugs cost [around] $14,000 to $15,000 dollars a year in US or in Europe 6000 US dollar per year," he reiterated.
American Diabetes Association 2017 Scientific Sessions; June 11, 2016.
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