PCSK9 Inhibitors, The Most Significant Advance in Lipid Lowering Therapy Since Statins? A Literature Review
OBJECTIVE: The purpose of this study was to evaluate efficacy, safety and cost of PCSK9 inhibitors.
METHODS: PubMed was used to search for literature regarding PCSK9 inhibitors up to May 1, 2018. Clinical trials, systematic reviews, meta-analyses and prescribing information were utilized for this review. Inclusion criteria was Phase II, III randomized control trials (RCT) and review articles comparing treatment of hypercholesterolemia in adults with and without PCSK9 inhibitors. All studies were completed from 2012-2017 and were conducted primarily in America.
RESULTS: Evolocumab and alirocumab are the only FDA approved PCSK9 inhibitors and have been shown to reduce baseline LDL-C by 50-60% in multiple clinical trials. Although there is no proven all-cause or cardiovascular mortality benefit associated with these drugs, there is a significant reduction in myocardial infarction (MI), stroke and coronary revascularization in treatment groups.
DISCUSSION: Low-density lipoprotein cholesterol (LDL-C) is a well characterized risk factor for cardiovascular disease (CVD). While hypercholesterolemia is often well controlled with statins, there remains a need for additional lipid lowering therapy in select patients. PCSK9 inhibitors represent a novel approach to lowering LDL-C in patients with familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease (ASCVD) alone or in combination with other cholesterol lowering medications. PCSK9 inhibitors are well tolerated, with the most common side effects being local injection site reactions and flu-like symptoms. High cost remains the most significant obstacle for widespread use. PCSK9 inhibitors have a valuable role in the lipid lowering treatment algorithm with their full therapeutic potential yet to be realized.