PMID- 24382338 OWN - NLM STAT- MEDLINE DCOM- 20140825 LR - 20211021 IS - 1476-511X (Electronic) IS - 1476-511X (Linking) VI - 13 DP - 2014 Jan 2 TI - Efficacy and tolerability of adding coenzyme A 400 U/d capsule to stable statin therapy for the treatment of patients with mixed dyslipidemia: an 8-week, multicenter, double-blind, randomized, placebo-controlled study. PG - 1 LID - 10.1186/1476-511X-13-1 [doi] AB - BACKGROUND: Patients with mixed hyperlipidemia usually are in need of combination therapy to achieve low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG) target values for reduction of cardiovascular risk. This study investigated the efficacy and safety of adding a new hypolipidemic agent, coenzyme A (CoA) to stable statin therapy in patients with mixed hyperlipidemia. METHODS: In this multi-center, 8-week, double-blind study, adults who had received >/=8 weeks of stable statin therapy and had hypertriglyceridemia (TG level at 2.3-6.5 mmol/L) were randomized to receive CoA 400 U/d or placebo plus stable dosage of statin. Efficacy was assessed by the changes in the levels and patterns of lipoproteins. Tolerability was assessed by the incidence and severity of adverse events (AEs). RESULTS: A total of 304 patients with mixed hyperlipidemia were randomized to receive CoA 400 U/d plus statin or placebo plus statin (n = 152, each group). After treatment for 8 weeks, the mean percent change in TG was significantly greater with CoA plus statin compared with placebo plus statin (-25.9% vs -4.9%, respectively; p = 0.0003). CoA plus statin was associated with significant reductions in TC (-9.1% vs -3.1%; p = 0.0033), LDL-C (-9.9% vs 0.1%; p = 0.003), and non- high-density lipoprotein cholesterol (-13.5% vs -5.7%; p = 0.0039). There was no significant difference in the frequency of AEs between groups. No serious AEs were considered treatment related. CONCLUSIONS: In these adult patients with persistent hypertriglyceridemia, CoA plus statin therapy improved TG and other lipoprotein parameters to a greater extent than statin alone and has no obviously adverse effect. TRIAL REGISTRATION: Current Controlled Trials ClinicalTrials.gov ID NCT01928342. FAU - Lai, Jiangtao AU - Lai J FAU - Wu, Bifeng AU - Wu B FAU - Xuan, Tianming AU - Xuan T AD - Department of Cardiology, First Affiliated Hospital, College of Medicine, Zhejiang University, 79# Qingchun Road, 310003 Hangzhou, China. xuantianming2012@gmail.com. FAU - Liu, Zhong AU - Liu Z FAU - Chen, Junzhu AU - Chen J LA - eng SI - ClinicalTrials.gov/NCT01928342 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140102 PL - England TA - Lipids Health Dis JT - Lipids in health and disease JID - 101147696 RN - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors) RN - 0 (Triglycerides) RN - SAA04E81UX (Coenzyme A) SB - IM MH - Adult MH - Aged MH - Coenzyme A/*administration & dosage/adverse effects MH - Double-Blind Method MH - Drug Therapy, Combination MH - Dyslipidemias/*drug therapy MH - Female MH - Humans MH - Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Treatment Outcome MH - Triglycerides/blood PMC - PMC3881496 EDAT- 2014/01/03 06:00 MHDA- 2014/08/26 06:00 PMCR- 2014/01/02 CRDT- 2014/01/03 06:00 PHST- 2013/11/12 00:00 [received] PHST- 2013/12/28 00:00 [accepted] PHST- 2014/01/03 06:00 [entrez] PHST- 2014/01/03 06:00 [pubmed] PHST- 2014/08/26 06:00 [medline] PHST- 2014/01/02 00:00 [pmc-release] AID - 1476-511X-13-1 [pii] AID - 10.1186/1476-511X-13-1 [doi] PST - epublish SO - Lipids Health Dis. 2014 Jan 2;13:1. doi: 10.1186/1476-511X-13-1.