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Category: PCSK9

PCSK9 Inhibitors: 1 Year After Approval

One year after FDA approval, are PCSK9 inhibitors living up to expectations?

It’s been about 1 year since the two currently available PCSK9 inhibitors, evolocumab and alirocumab, received US FDA approval. (Bococizumab is still completing phase 3 studies.) Uptake, as most in the healthcare community know, has been slow, largely due to the cost associated with the two therapies.

The US FDA recently approved a monthly single-dose administration option for evolocumab. The system consists of a hands-free device which is designed to provide 420 mg of evolocumab in a single dose and allows patients the freedom of being able to continue with moderate physical activity such as walking, reaching, and bending. The cost is expected to remain similar to twice weekly dosing, and given how new it is, it remains to be seen what kind of impact on clinical practice it will have. Read more

ACC Releases Guidance on Role of Nonstatin Therapies for LDL-C Lowering

The American College of Cardiology (ACC) has released guidance on the role of nonstatin therapies in the lowering of LDL cholesterol, as additional data on their use have become available since the ACC and American Heart Association (AHA) last updated the cholesterol guidelines in 2013. According to Donald M. Lloyd-Jones, MD, Northwestern University Clinical and Translational Sciences Institute, and Chair of the document’s writing committee, the goal of this latest guidance is to assist clinicians in interpreting the newest data for use in clinical practice and help guide their patients in making treatment decisions.

Seven different algorithms were produced for patients with cardiovascular disease or comorbidities and recommends the consideration of nonstatin drugs for patients at high risk whose LDL has not been reduced by 50% with lifestyle and statin therapy. The algorithms endorse the four evidence-based statin benefit groups already identified in the 2013 ACC/AHA cholesterol guidelines and assume the patient is taking a statin or has attempted statin therapy. Two different algorithms were created for patients with familial hypercholesterolemia (FH) and recommend a lower threshold for the use of PCSK9 inhibitors. Read more