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Effect of TAK-085 on Low-density Lipoprotein Particle Size in Patients with Hypertriglyceridemia: A Double-blind Randomized Clinical Study.
Cardiovasc Ther. 2015 Dec; 33(6):317-23.CT

Abstract

BACKGROUND

Low-density lipoproteins (LDLs) comprise a heterogeneous group of particles with various size and density. A shift to larger LDL particle size is mainly the result of a decrease in small dense LDL (sd-LDL) levels and an increase in large buoyant LDL (lb-LDL) levels.

METHODS

In a randomized, double-blind study of TAK-085 (containing docosahexaenoic and eicosapentaenoic acid-ethyl esters [EPA-E]) and an EPA-E product in Japanese patients with hypertriglyceridemia, exploratory evaluations of the effects of the LDL particle size were performed on the basis of LDL-cholesterol/apolipoprotein B ratios and LDL subfractions, which were analyzed with a polyacrylamide gel electrophoresis system.

RESULTS

Patients were randomized to 12-week treatment with TAK-085 4 g/day (N = 210), TAK-085 2 g/day (N = 205), or EPA-E 1.8 g/day (N = 195). Treatment with TAK-085 4 g/day, TAK-085 2 g/day, and EPA-E 1.8 g/day caused an increase in the LDL cholesterol/apolipoprotein B ratios (3.99%, 3.35%, and 0.66%, respectively), the mean diameter of LDL particles (1.12%, 0.84%, and 0.67%, respectively), and the level of lb-LDL at the end of the study (16.37%, 9.51%, and 7.31%, respectively). The increases in the LDL cholesterol/apolipoprotein B ratios and the mean diameter of LDL particles from baseline to the end of the study were greater with TAK-085 4 g/day than EPA-E 1.8 g/day. TAK-085 4 g/day and TAK-085 2 g/day caused a decrease in the sd-LDL levels (-16.21% and -6.96%, respectively).

CONCLUSION

TAK-085 produced a favorable shift in the LDL particle size in Japanese patients with hypertriglyceridemia. JAPIC Clinical Trials Information: Japic CTI-090937.

Authors+Show Affiliations

Center of Diabetes, Endocrine and Metabolism, School of Medicine, Sakura Hospital, Toho University, Chiba, Japan.Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26222126

Citation

Tatsuno, Ichiro, et al. "Effect of TAK-085 On Low-density Lipoprotein Particle Size in Patients With Hypertriglyceridemia: a Double-blind Randomized Clinical Study." Cardiovascular Therapeutics, vol. 33, no. 6, 2015, pp. 317-23.
Tatsuno I, Kudou K, Kagawa T. Effect of TAK-085 on Low-density Lipoprotein Particle Size in Patients with Hypertriglyceridemia: A Double-blind Randomized Clinical Study. Cardiovasc Ther. 2015;33(6):317-23.
Tatsuno, I., Kudou, K., & Kagawa, T. (2015). Effect of TAK-085 on Low-density Lipoprotein Particle Size in Patients with Hypertriglyceridemia: A Double-blind Randomized Clinical Study. Cardiovascular Therapeutics, 33(6), 317-23. https://doi.org/10.1111/1755-5922.12146
Tatsuno I, Kudou K, Kagawa T. Effect of TAK-085 On Low-density Lipoprotein Particle Size in Patients With Hypertriglyceridemia: a Double-blind Randomized Clinical Study. Cardiovasc Ther. 2015;33(6):317-23. PubMed PMID: 26222126.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of TAK-085 on Low-density Lipoprotein Particle Size in Patients with Hypertriglyceridemia: A Double-blind Randomized Clinical Study. AU - Tatsuno,Ichiro, AU - Kudou,Kentarou, AU - Kagawa,Tomoya, PY - 2015/7/30/entrez PY - 2015/7/30/pubmed PY - 2016/11/3/medline KW - Docosahexaenoic acid KW - Eicosapentaenoic acid KW - Large buoyant low-density lipoprotein KW - Low-density lipoprotein particle size KW - Small dense low-density lipoprotein SP - 317 EP - 23 JF - Cardiovascular therapeutics JO - Cardiovasc Ther VL - 33 IS - 6 N2 - BACKGROUND: Low-density lipoproteins (LDLs) comprise a heterogeneous group of particles with various size and density. A shift to larger LDL particle size is mainly the result of a decrease in small dense LDL (sd-LDL) levels and an increase in large buoyant LDL (lb-LDL) levels. METHODS: In a randomized, double-blind study of TAK-085 (containing docosahexaenoic and eicosapentaenoic acid-ethyl esters [EPA-E]) and an EPA-E product in Japanese patients with hypertriglyceridemia, exploratory evaluations of the effects of the LDL particle size were performed on the basis of LDL-cholesterol/apolipoprotein B ratios and LDL subfractions, which were analyzed with a polyacrylamide gel electrophoresis system. RESULTS: Patients were randomized to 12-week treatment with TAK-085 4 g/day (N = 210), TAK-085 2 g/day (N = 205), or EPA-E 1.8 g/day (N = 195). Treatment with TAK-085 4 g/day, TAK-085 2 g/day, and EPA-E 1.8 g/day caused an increase in the LDL cholesterol/apolipoprotein B ratios (3.99%, 3.35%, and 0.66%, respectively), the mean diameter of LDL particles (1.12%, 0.84%, and 0.67%, respectively), and the level of lb-LDL at the end of the study (16.37%, 9.51%, and 7.31%, respectively). The increases in the LDL cholesterol/apolipoprotein B ratios and the mean diameter of LDL particles from baseline to the end of the study were greater with TAK-085 4 g/day than EPA-E 1.8 g/day. TAK-085 4 g/day and TAK-085 2 g/day caused a decrease in the sd-LDL levels (-16.21% and -6.96%, respectively). CONCLUSION: TAK-085 produced a favorable shift in the LDL particle size in Japanese patients with hypertriglyceridemia. JAPIC Clinical Trials Information: Japic CTI-090937. SN - 1755-5922 UR - https://www.unboundmedicine.com/medline/citation/26222126/Effect_of_TAK_085_on_Low_density_Lipoprotein_Particle_Size_in_Patients_with_Hypertriglyceridemia:_A_Double_blind_Randomized_Clinical_Study_ L2 - https://doi.org/10.1111/1755-5922.12146 DB - PRIME DP - Unbound Medicine ER -