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Clinical Trial
. 2016 Jun;30(3):297-304.
doi: 10.1007/s10557-016-6655-4.

Clinical Profile of Statin Intolerance in the Phase 3 GAUSS-2 Study

Leslie Cho  1 , Michael Rocco  2 , David Colquhoun  3 , David Sullivan  4 , Robert S Rosenson  5 , Ricardo Dent  6 , Allen Xue  7 , Rob Scott  7 , Scott M Wasserman  7 , Erik Stroes  8
Affiliations
Clinical Trial

Clinical Profile of Statin Intolerance in the Phase 3 GAUSS-2 Study

Leslie Cho et al. Cardiovasc Drugs Ther. 2016 Jun.

Abstract

Purpose: Recent evidence suggests that statin intolerance may be more common than reported in randomized trials. However, the statin-intolerant population is not well characterized. The goal of this report is to characterize the population enrolled in the phase 3 Goal Achievement after Utilizing an anti-PCSK9 antibody in Statin Intolerant Subjects Study (GAUSS-2; NCT 01763905).

Methods: GAUSS-2 compared evolocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9) to ezetimibe in hypercholesterolemic patients who discontinued statin therapy due to statin-associated muscle symptoms (SAMS). GAUSS-2 was a 12-week, double-blind, placebo-controlled, randomized study that enrolled patients with elevated LDL-C who were either not on a statin or able to tolerate only a low-dose due to SAMS. Patients had received ≥2 statins and were unable to tolerate any statin dose or increase in dose above a specified weekly dose due to SAMS.

Results: Three hundred seven patients (mean [SD] age, 62 [10] years; 54 % males) were randomized 2:1 (evolocumab:ezetimibe). Mean (SD) LDL-C was 4.99 (1.51) mmol/L. Patients had used ≥2 (100 %), ≥3 (55 %), or ≥4 (21 %) statins. Coronary artery disease was present in 29 % of patients. Statin-intolerant symptoms were myalgia in 80 % of patients, weakness in 39 %, and more serious complications in 20 %. In 98 % of patients, SAMS interfered with normal daily activity; in 52 %, symptoms precluded moderate exertion.

Conclusion: Evaluation of the GAUSS-2 trial population of statin-intolerant patients demonstrates that most patients were high risk with severely elevated LDL-C and many had statin-associated muscle symptoms that interfered with their quality of life.

Keywords: Cholesterol; Evolocumab; Ezetimibe; LDL; Myalgia; Statin intolerance.

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