Sep 30, 2016

Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients

Journal of Clinical Lipidology
Evan SteinCharles Bisgaier

Abstract

Ezetimibe added to statin therapy further reduces LDL-C and clinical atherosclerotic cardiovascular disease compared to statin alone. However, the number of effective and safe oral agents for patients not at LDL-C goal is limited. In prior clinical trials, gemcabene reduced LDL-C and was generally well-tolerated in nearly 900 patients treated for up to 12 weeks. To evaluate the LDL-C lowering and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients. This was an 8-week, double-blind, placebo-controlled, randomized, phase 2 study in men and postmenopausal women ≥18 and ≤65 years of age with LDL-C ≥130 mg/dL (3.4 mmol/L) while on low-intensity to high-intensity stable statin (the majority on moderate intensity) therapy. Sixty-six patients were randomized 1:1:1 to gemcabene 300 mg, 900 mg, or placebo QD. Gemcabene 300 mg and 900 mg produced a mean percent change in LDL-C of -23.4 ± 4.7% (P = .005) and -27.7 ± 4.3% (P < .001), respectively, vs -6.2 ± 4.3% for placebo. The median percent change in CRP was -26.1% (P = .196) and -53.9% (P < .001) for gemcabene 300 mg and 900 mg, respectively, vs -11.1% for placebo. Gemcabene 300 mg and 900 mg were well-tolerated with no significant difference in AEs c...Continue Reading

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Mentioned in this Paper

Clinical Study by Phase
Low Density Lipoprotein Cholesterol Measurement
Anticoagulants, Oral
Abdominal Pain
Polychemotherapy
Hypercholesterolemia
Evaluation
Cardiovascular Diseases
Adverse Event
Hyperlipidemia, Group A

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