GAUSS-2, RUTHERFORD-2, LAPLACE-2, DESCARTES, and TESLA Part B: PCSK9 inhibitors gain momentum.

Mohamed Hassan,Magdi Yacoub

doi:10.5339/gcsp.2014.49

Abstract

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Highlights

Lowering of low density lipoprotein (LDL) cholesterol (LDL-C) has been shown to be associated with significant reduction of adverse cardiovascular (CV) events.[1]
At 12 week, evolocumab Q2W achieved significant reduction in serum triglycerides, and lipoprotein (a), as well as significant increase (9.2% [95% confidence interval (CI): 4.7 to 13.7], p, 0.0001) in HDL-C level compared to placebo
DISCUSSION statins are the mainstay of treatment for lowering LDL-C concentration, additional LDLlowering therapies are needed to reduce residual CV risk especially in patients at very high risk, hereditary lipid disorders, or statin intolerance

Summary

INTRODUCTION

Lowering of low density lipoprotein (LDL) cholesterol (LDL-C) has been shown to be associated with significant reduction of adverse cardiovascular (CV) events.[1]. Data from several phase III studies have been recently released - as a part of the PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulation) comprehensive program (Table 2) These trials serve to clarify the efficacy of evolocumab in different groups of patients, and are critically reviewed here with particular reference to their clinical utility, and their place in future clinical practice. GAUSS-2 STUDY The Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects (GAUSS-2) study was a randomized, double-blind, phase III clinical trial that has been recently published in the Journal of the American College of Cardiology in June 2014.14 This study was designed to evaluate the efficacy and safety of subcutaneous (SC) evolocumab injection, compared to ezetemibe, in statin-intolerant (to at least 2 statins) hypercholesterolemic patients.

Monoclonal antibodies

Aim

Findings

DISCUSSION