In:
Cardiology, S. Karger AG, Vol. 135, No. 1 ( 2016), p. 3-12
Abstract:
〈 b 〉 〈 i 〉 Objectives: 〈 /i 〉 〈 /b 〉 To evaluate the efficacy and safety of icosabutate, an oral, once-daily, first-in-class medication, in reducing non-high-density lipoprotein cholesterol (non-HDL-C) in patients with persistent hypertriglyceridemia despite statin therapy. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 The study was designed to randomly assign 140 patients with fasting triglyceride levels ≥200 but 〈 500 mg/dl on a stable dose of statin therapy to receive either masked icosabutate 600 mg once daily or a control for 12 weeks. The primary end point was a percentage change in non-HDL-C from baseline to 12 weeks. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 With icosabutate, non-HDL-C levels were reduced (-9.2%) when compared with the control (-0.4%) for a between-group difference of -7.4% (p = 0.02). Compared with the control, icosabutate reduced triglycerides (-27.0%, p 〈 0.001), very- low-density lipoprotein (VLDL) cholesterol (-31.5%, p 〈 0.001) and apolipoprotein C-III (-22.5%, p 〈 0.001). LDL-C levels did not change (0.5%, p = 0.87). HDL-C (10.2%, p 〈 0.001) was increased. After 113 subjects had been randomized, the study was terminated due to a partial clinical hold imposed by US regulators after observing QT prolongation at supratherapeutic doses of icosabutate in a dog study. In this study, adverse events were balanced between treatment arms, and there were no discontinuations due to adverse events. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 Icosabutate was efficacious in lowering non-HDL-C and other biomarkers of cardiovascular risk and was generally well tolerated.
Type of Medium:
Online Resource
ISSN:
0008-6312
,
1421-9751
Language:
English
Publisher:
S. Karger AG
Publication Date:
2016
detail.hit.zdb_id:
1482041-9
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