A Multi-Center, Prospective Observational Study to Investigate the Safety, Compliance, and Efficacy of Omethyl QTlet Soft Capsule

You Jeong Ki, Sang Jin Han, Tae Joon Cha, Jae Hyuk Lee, Eui Kyo Seo, Jae Won Yang, Won Min Hwang, Dong Kyu Jin, Joo Hyun Park, Han Young Ryu, Chang Gyu Park, Jun Hong Lee, Si Wan Choi, Eun Jeong Cho, Weon Kim

Research output: Contribution to journalArticlepeer-review

Abstract

Omega-3 fatty acids have been shown to be effective in lowering triglyceride (TG) levels; however, tolerability issues arise due to the large size of the pills. The purpose of this study was to examine the safety, compliance, and efficacy of Omethyl QTlet soft capsules (OQCs). This multi-center, prospective, observational study evaluated the safety, compliance, and efficacy of OQCs. Patients with hypertriglyceridemia with a history of omega-3 fatty acid intake were enrolled in this study and were prescribed OQCs (2 g–4 g/day) for eight weeks. All adverse events (AEs), adverse drug reactions (ADRs), and serious adverse events (SAEs) were recorded for safety evaluation. Adherence to treatment was assessed using questionnaires, and efficacy was assessed by changes in lipid and lipoprotein levels after eight weeks from baseline. The convenience of taking medication was analyzed for 580 patients, and the efficacy test was performed for 563 patients. The AE and ADR rates were 8.2% and 5.7%, respectively. There were only two SAEs. Of the patients, 55.8% responded that the OQC improved medication convenience, and mean changes in TG, total cholesterol, LDL-C, and non-HDL-C from baseline to eight weeks were −37.88 mg/dL, −11.56 mg/dL, −5.55 mg/dL, and −10.87 mg/dL, respectively (p-values < 0.001). In patients who had previously taken omega-3 fatty acids, OQCs showed safety and efficacy in lowering TG, and it was confirmed that compliance with medicine also improved compared to omega-3 fatty acids.

Original languageEnglish
Article number6949
JournalJournal of Clinical Medicine
Volume11
Issue number23
DOIs
StatePublished - Dec 2022

Keywords

  • hypertriglyceridemia
  • omega-3 fatty acids
  • Omethyl QTlet soft capsule

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