Universität zu Köln

Nissen, Steven E., Dent-Acosta, Ricardo E., Rosenson, Robert S., Stroes, Erik, Sattar, Naveed, Preiss, David ORCID: 0000-0003-3139-1836, Mancini, John, Ballantyne, Christie M., Catapano, Alberico, Gouni-Berthold, Ioanna, Stein, Evan A., Xue, Allen, Wasserman, Scott M., Scott, Rob and Thompson, Paul D. (2016). Comparison of PCSK9 Inhibitor Evolocumab vs Ezetimibe in Statin-Intolerant Patients: Design of the Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin-Intolerant Subjects 3 (GAUSS-3) Trial. Clin. Cardiol., 39 (3). S. 137 - 145. HOBOKEN: WILEY-BLACKWELL. ISSN 1932-8737

Full text not available from this repository.

Abstract

Statins are the accepted standard for lowering low-density lipoprotein cholesterol (LDL-C). However, 5% to 10% of statin-treated patients report intolerance, mostly due to muscle-related adverse effects. Challenges exist to objective identification of statin-intolerant patients. Evolocumab is a monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9), resulting in marked LDL-C reduction. We report the design of Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin-Intolerant Subjects 3 (GAUSS-3), a phase 3, multicenter, randomized, double-blind, ezetimibe-controlled study to compare effectiveness of 24 weeks of evolocumab 420 mg monthly vs ezetimibe 10 mg daily in hypercholesterolemic patients unable to tolerate an effective statin dose. The study incorporates a novel atorvastatin-controlled, double-blind, crossover phase to objectively identify statin intolerance. Eligible patients had LDL-C above the National Cholesterol Education Project Adult Treatment Panel III target level for the appropriate coronary heart disease risk category and were unable to tolerate >= 3 statins or 2 statins (one of which was atorvastatin <= 10 mg/d) or had a history of marked creatine kinase elevation accompanied by muscle symptoms while on 1 statin. This trial has 2 co-primary endpoints: mean percent change from baseline in LDL-C at weeks 22 and 24 and percent change from baseline in LDL-C at week 24. Key secondary efficacy endpoints include change from baseline in LDL-C, percent of patients attaining LDL-C <70 mg/dL (1.81 mmol/L), and percent change from baseline in total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B. Recruitment of 511 patients was completed on November 28, 2014.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Nissen, Steven E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dent-Acosta, Ricardo E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosenson, Robert S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stroes, Erik UNSPECIFIED UNSPECIFIED UNSPECIFIED Sattar, Naveed UNSPECIFIED UNSPECIFIED UNSPECIFIED Preiss, David UNSPECIFIED orcid.org/0000-0003-3139-1836 UNSPECIFIED Mancini, John UNSPECIFIED UNSPECIFIED UNSPECIFIED Ballantyne, Christie M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Catapano, Alberico UNSPECIFIED UNSPECIFIED UNSPECIFIED Gouni-Berthold, Ioanna UNSPECIFIED UNSPECIFIED UNSPECIFIED Stein, Evan A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Xue, Allen UNSPECIFIED UNSPECIFIED UNSPECIFIED Wasserman, Scott M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Scott, Rob UNSPECIFIED UNSPECIFIED UNSPECIFIED Thompson, Paul D. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-282452
DOI:	10.1002/clc.22518
Journal or Publication Title:	Clin. Cardiol.
Volume:	39
Number:	3
Page Range:	S. 137 - 145
Date:	2016
Publisher:	WILEY-BLACKWELL
Place of Publication:	HOBOKEN
ISSN:	1932-8737
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language RANDOMIZED-TRIAL; THERAPY; SAFETY; DISCONTINUATION; CHOLESTEROL; ALIROCUMAB; SYMPTOMS; MYOPATHY; EFFICACY Multiple languages Cardiac & Cardiovascular Systems Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28245