Erik S G Stroes1, Andrey V Susekov2, Tjerk W A de Bruin3, Mats Kvarnström4, Hong Yang4, Michael H Davidson5. 1. Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands. 2. Faculty of Clinical Pharmacology and Therapeutics, Academy for Postgraduate Continuous Medical Education, Moscow, Russia. 3. AstraZeneca Gaithersburg, MD, USA. 4. AstraZeneca Gothenburg, Mölndal, Sweden. 5. Corvidia Therapeutics, Waltham, MA, USA; University of Chicago Medical Center, Chicago, IL, USA. Electronic address: mdavidso@bsd.uchicago.edu.
Abstract
BACKGROUND:Adult patients with severe hypertriglyceridemia (SHTG) are at increased risk of developing acute pancreatitis and cardiovascular disease. Omega-3carboxylic acids (OM3-CA) are approved for treatment as an adjunct to diet to reduce triglyceride (TG) concentrations in patients with SHTG. OBJECTIVE: The aim of the study was to assess efficacy and safety of the intermediate dose of OM3-CA (2 g daily), compared with olive oil 2 g daily, in reducing serum TG and lipid concentrations in patients with SHTG. METHODS: A randomized, double-blind, olive oil-controlled, parallel-group trial involving 162 adults with qualifying serum TG concentrations of at least 500 mg/dL (5.65 mmol/L) and <2500 mg/dL (28.25 mmol/L; <2000 mg/dL [22.60 mmol/L] in Canada). The treatment period after randomization was 12 weeks. Blood samples for measurement of fasting serum lipid concentrations were taken at baseline, 6, 10, and 12 weeks. RESULTS: Treatment with OM3-CA 2 g daily led to a significant reduction in TG concentrations (median of differences, -14.2% [95% confidence interval: -26.2%, -2.8%; P = .017]) and non-high-density lipoprotein cholesterol concentrations (median of differences, -9.0% [95% confidence interval: -14.8%, -2.8%; adjusted P = .018]) from baseline to the Week 12 endpoint, when compared with olive oil 2 g daily. These treatment effects were more pronounced in patients with qualifying TG concentrations >885 mg/dL (10 mmol/L). CONCLUSION: An intermediate dose of OM3-CA (2 g daily) significantly lowers TG and non-high-density lipoprotein cholesterol concentrations in patients with SHTG and may benefit individuals at risk of acute pancreatitis and cardiovascular disease.
RCT Entities:
BACKGROUND: Adult patients with severe hypertriglyceridemia (SHTG) are at increased risk of developing acute pancreatitis and cardiovascular disease. Omega-3 carboxylic acids (OM3-CA) are approved for treatment as an adjunct to diet to reduce triglyceride (TG) concentrations in patients with SHTG. OBJECTIVE: The aim of the study was to assess efficacy and safety of the intermediate dose of OM3-CA (2 g daily), compared with olive oil 2 g daily, in reducing serum TG and lipid concentrations in patients with SHTG. METHODS: A randomized, double-blind, olive oil-controlled, parallel-group trial involving 162 adults with qualifying serum TG concentrations of at least 500 mg/dL (5.65 mmol/L) and <2500 mg/dL (28.25 mmol/L; <2000 mg/dL [22.60 mmol/L] in Canada). The treatment period after randomization was 12 weeks. Blood samples for measurement of fasting serum lipid concentrations were taken at baseline, 6, 10, and 12 weeks. RESULTS: Treatment with OM3-CA 2 g daily led to a significant reduction in TG concentrations (median of differences, -14.2% [95% confidence interval: -26.2%, -2.8%; P = .017]) and non-high-density lipoprotein cholesterol concentrations (median of differences, -9.0% [95% confidence interval: -14.8%, -2.8%; adjusted P = .018]) from baseline to the Week 12 endpoint, when compared with olive oil 2 g daily. These treatment effects were more pronounced in patients with qualifying TG concentrations >885 mg/dL (10 mmol/L). CONCLUSION: An intermediate dose of OM3-CA (2 g daily) significantly lowers TG and non-high-density lipoprotein cholesterol concentrations in patients with SHTG and may benefit individuals at risk of acute pancreatitis and cardiovascular disease.