PMID- 36498524
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230308
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 11
IP  - 23
DP  - 2022 Nov 25
TI  - A Multi-Center, Prospective Observational Study to Investigate the Safety, 
      Compliance, and Efficacy of Omethyl QTlet Soft Capsule.
LID - 10.3390/jcm11236949 [doi]
LID - 6949
AB  - 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.
FAU - Ki, You-Jeong
AU  - Ki YJ
AUID- ORCID: 0000-0003-0102-2810
AD  - Cardiovascular Division, Department of Internal Medicine, Kyung Hee University 
      Hospital, Kyung Hee University, Seoul 02447, Republic of Korea.
FAU - Han, Sang-Jin
AU  - Han SJ
AD  - Division of Cardiology, Department of Internal Medicine, Hallym University Sacred 
      Heart Hospital, Anyang 14068, Republic of Korea.
FAU - Cha, Tae-Joon
AU  - Cha TJ
AD  - Division of Cardiology, Kosin University Gospel Hospital, Busan 49267, Republic 
      of Korea.
FAU - Lee, Jae Hyuk
AU  - Lee JH
AD  - Division of Endocrinology, Department of Internal Medicine, Diabetes & 
      Endocrinology Center, Myongji Hospital, Hanyang University Medical Center, Goyang 
      10475, Republic of Korea.
FAU - Seo, Eui Kyo
AU  - Seo EK
AD  - Department of Neurosurgery, Ewha Womans University School of Medicine, Seoul 
      07804, Republic of Korea.
FAU - Yang, Jae Won
AU  - Yang JW
AUID- ORCID: 0000-0003-3689-5865
AD  - Division of Nephrology, Department of Internal Medicine, Yonsei University Wonju 
      College of Medicine, Wonju 26426, Republic of Korea.
FAU - Hwang, Won Min
AU  - Hwang WM
AUID- ORCID: 0000-0001-7548-6111
AD  - Divsion of Nephrology, Department of Internal Medicine, College of Medicine, 
      Konyang University, Daejeon 35365, Republic of Korea.
FAU - Jin, Dong Kyu
AU  - Jin DK
AD  - Division of Cardiology, Department of Internal Medicine, Soonchunhyang University 
      Cheonan Hospital, Cheonan 31151, Republic of Korea.
FAU - Park, Joo-Hyun
AU  - Park JH
AUID- ORCID: 0000-0002-4358-4208
AD  - Department of Family Medicine, Korea University Ansan Hospital, Korea University 
      College of Medicine, Ansan 15355, Republic of Korea.
FAU - Ryu, Han Young
AU  - Ryu HY
AD  - Department of Thoracic and Cardiovascular Surgery, Konyang University Hospital, 
      Daejeon 35365, Republic of Korea.
FAU - Park, Chang Gyu
AU  - Park CG
AUID- ORCID: 0000-0001-9654-9257
AD  - Cardiovascular Center, Korea University Guro Hospital, Seoul 08308, Republic of 
      Korea.
FAU - Lee, Jun Hong
AU  - Lee JH
AD  - Department of Neurology, National Health Insurance Service Ilsan Hospital, Goyang 
      10444, Republic of Korea.
FAU - Choi, Si Wan
AU  - Choi SW
AD  - Division of Cardiology, Department of Internal Medicine, Chungnam National 
      University Hospital, Chungnam National University School of Medicine, Daejeon 
      35015, Republic of Korea.
FAU - Cho, Eun Jeong
AU  - Cho EJ
AD  - Division of Cardiology, Department of Internal Medicine, Heart Brain Hospital, 
      Chung-Ang University Gwangmyeong Hospital, Chung-Ang University College of 
      Medicine, Gwangmyeong 14353, Republic of Korea.
FAU - Kim, Weon
AU  - Kim W
AUID- ORCID: 0000-0003-1264-9870
AD  - Cardiovascular Division, Department of Internal Medicine, Kyung Hee University 
      Hospital, Kyung Hee University, Seoul 02447, Republic of Korea.
LA  - eng
PT  - Journal Article
DEP - 20221125
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC9738535
OTO - NOTNLM
OT  - Omethyl QTlet soft capsule
OT  - hypertriglyceridemia
OT  - omega-3 fatty acids
COIS- The authors declare no conflict of interest.
EDAT- 2022/12/12 06:00
MHDA- 2022/12/12 06:01
PMCR- 2022/11/25
CRDT- 2022/12/11 01:13
PHST- 2022/10/12 00:00 [received]
PHST- 2022/11/15 00:00 [revised]
PHST- 2022/11/17 00:00 [accepted]
PHST- 2022/12/11 01:13 [entrez]
PHST- 2022/12/12 06:00 [pubmed]
PHST- 2022/12/12 06:01 [medline]
PHST- 2022/11/25 00:00 [pmc-release]
AID - jcm11236949 [pii]
AID - jcm-11-06949 [pii]
AID - 10.3390/jcm11236949 [doi]
PST - epublish
SO  - J Clin Med. 2022 Nov 25;11(23):6949. doi: 10.3390/jcm11236949.