Newly published results indicate that the injectable PCSK9 inhibitoralirocumab(Praluent, Sanofi/Regeneron) was more cost-effective in patients with a recentacute coronary syndrome(ACS) and uncontrolled 'bad'low-density lipoprotein cholesterol(LDL-C) (despite statins) if they also had diabetes.
The findings, from a prespecified analysis of theODYSSEY OUTCOMEStrial, werepublished onlineJuly 1 in theLancet Diabetes & Endocrinologyby lead author Kausik K. Ray, MD, MBChB, Imperial College, London, UK.
When results of the analysis werefirst reportedby Ray at theAmerican Diabetes Association (ADA) 2018 Scientific Sessions, the cost of the injectable drug was a major concern, as a year's supply was $14,000 at that time in the United States.
However, alirocumab and a competitor PCSK9 inhibitorevolocumab(Repatha, Amgen) both cost about $5800 a year now, which by back of the envelope estimates still means an annual cost of around $125,000 to prevent one event over 2 years.
And although expensive, the cost is covered by insurance for certain appropriate candidates, explained Amit Khera, MD, director, Preventive Cardiology Program, UT Southwestern Medical Center, Dallas, Texas, who was not involved in the study.
So finding the groups of patients who will benefit most from these pricy drugs is key, he toldMedscape Medical News.
The current results "remind us that patients with diabetes who have ACS" are a high-risk group who have a "double whammy," which makes some of them appropriate candidates for more aggressive LDL-C lowering with PCSK9 inhibitors, added Khera, who is also president of the American Society of Preventive Cardiology.
Statins First, Then Ezetimibe? Or PSCK9 Inhibitors in a Select Few
Frederick J. Raal, PhD, and Farzahna Mohamed, MB, Division of Endocrinology and Metabolism, Department of Medicine, University of the Witwatersrand, Johannesburg, South Africa, also agree that this study supports aggressive LDL-C lowering with a PCSK9 inhibitor in patients with both ACS and diabetes.
In anaccompanying editorialthey write: "The analysis suggests that while we await the results of outcomes studies with...newer agents [such as fibrates,icosapentethyl, bempedoic acid, and angiopoietin-like 3 inhibitors], we should aim to reduce LDL-C aggressively in people with diabetes, since their absolute cardiovascular (CV) risk is high and there does not seem to be a threshold below which LDL-C lowering is not associated with further CV benefit."
First-line therapy remains a high-intensity statin, with the addition ofezetimibeif necessary, they continue.
After that, "a PCSK9 inhibitor should be considered in patients who are intolerant to statins, those who do not achieve optimal LDL-C concentrations with existing therapy, or in those with progressiveatherosclerosisdespite this therapy."
