Ki You-Jeong, Han Sang-Jin, Cha Tae-Joon, Lee Jae Hyuk, Seo Eui Kyo, Yang Jae Won, Hwang Won Min, Jin Dong Kyu, Park Joo-Hyun, Ryu Han Young, Park Chang Gyu, Lee Jun Hong, Choi Si Wan, Cho Eun Jeong, Kim Weon
Cardiovascular Division, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul 02447, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang 14068, Republic of Korea.
J Clin Med. 2022 Nov 25;11(23):6949. doi: 10.3390/jcm11236949.
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.
ω-3脂肪酸已被证明在降低甘油三酯（TG）水平方面有效；然而，由于药丸尺寸较大，出现了耐受性问题。本研究的目的是检验Omethyl QTlet软胶囊（OQCs）的安全性、依从性和疗效。这项多中心、前瞻性、观察性研究评估了OQCs的安全性、依从性和疗效。有ω-3脂肪酸摄入史的高甘油三酯血症患者被纳入本研究，并被开了八周的OQCs（2克 - 4克/天）。记录所有不良事件（AE）、药物不良反应（ADR）和严重不良事件（SAE）以进行安全性评估。使用问卷评估治疗依从性，并通过从基线起八周后血脂和脂蛋白水平的变化评估疗效。对580名患者分析了用药便利性，对563名患者进行了疗效测试。AE和ADR发生率分别为8.2%和5.7%。只有两例SAE。在患者中，55.8%的人表示OQC改善了用药便利性，从基线到八周TG、总胆固醇、低密度脂蛋白胆固醇（LDL-C）和非高密度脂蛋白胆固醇（non-HDL-C）的平均变化分别为−37.88毫克/分升、−11.56毫克/分升、−5.55毫克/分升和−10.87毫克/分升（p值<0.001）。在之前服用过ω-3脂肪酸的患者中，OQCs在降低TG方面显示出安全性和疗效，并且证实与ω-3脂肪酸相比，药物依从性也有所提高。
