Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia

Phase 4 Completed 68 enrolled Kuhnil Pharmaceutical Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia

Timeline

Start: 2009-02
Primary completion: 2011-02
Completion: 2011-02

Outcome

Met primary endpoint

paper the change in the TG level in the combination therapy group differed significantly from the change in the statin monotherapy group (-34.8% vs. -15.2%, p=0.0176). PMID 32821712 ↗

Publications

Son JW, Kim CH, Nam MS, Park IB, Yoo SJ. Efficacy and Safety of Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy in Korean Patients with Type 2 Diabetes and Hypertriglyceridemia: a Randomized Controlled Trial. J Lipid Atheroscler. 2019 Sep;8(2):221-231. doi: 10.12997/jla.2019.8.2.221. Epub 2019 Jul 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omega-3-acids ethylesters 90	Unknown	4 g	—
Background	Atorvastatin	Small molecule	—	—
Background	Pravastatin	Small molecule	—	—
Background	Rosuvastatin	Small molecule	—	—
Background	Simvastatin	Small molecule	—	—