Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients Evan Stein, MD, Harold Bays, MD, Michael Koren, MD, Rebecca Bakker-Arkema, RPh, MS, Charles Bisgaier, PhD Journal of Clinical Lipidology Volume 10, Issue 5, Pages 1212-1222 (September 2016) DOI: 10.1016/j.jacl.2016.08.002 Copyright © 2016 National Lipid Association Terms and Conditions
Figure 1 Study design. After patient consent, statin therapy was stabilized and all other lipid-modifying medications were discontinued during a run-in phase of up to 12 weeks. Patients were screened (over 6 weeks) and then randomized 1:1:1 to either gemcabene 300 mg QD, 900 mg QD, or matching placebo for 8 weeks. Low-density lipoprotein cholesterol (LDL-C); once daily (QD). Journal of Clinical Lipidology 2016 10, 1212-1222DOI: (10.1016/j.jacl.2016.08.002) Copyright © 2016 National Lipid Association Terms and Conditions
Figure 2 Patient disposition. A total of 211 patients were screened, 66 patients were randomized, and 61 patients completed the study. Withdrew (W/D); adverse event (AE). Journal of Clinical Lipidology 2016 10, 1212-1222DOI: (10.1016/j.jacl.2016.08.002) Copyright © 2016 National Lipid Association Terms and Conditions
Figure 3 Gemcabene effects on mean percent change in LDL-C, non-HDL-C, ApoB, and median percent change in CRP. LDL-C, low-density lipoprotein cholesterol; CRP, C-reactive protein; apoB, apolipoprotein B; non-HDL-C, non-high-density lipoprotein cholesterol. Journal of Clinical Lipidology 2016 10, 1212-1222DOI: (10.1016/j.jacl.2016.08.002) Copyright © 2016 National Lipid Association Terms and Conditions