Prospective randomized comparative study of the effect of pemafibrate add‐on or double statin dose on small dense low‐density lipoprotein‐cholesterol in patients with type 2 diabetes and hypertriglyceridemia on statin therapy

Abstract Aims/Introduction Small dense low‐density lipoprotein (sdLDL) is a more potent atherogenic lipoprotein than LDL. As sdLDL‐cholesterol (C) levels are determined by triglyceride and LDL‐C levels, pemafibrate and statins can reduce sdLDL‐C levels. However, it remains unclear whether adding pem...

Бүрэн тодорхойлолт

Номзүйн дэлгэрэнгүй
Үндсэн зохиолчид: Tsutomu Hirano, Toshiyuki Hayashi, Hiroe Sugita, Atsuko Tamasawa, Satoshi Goto, Masako Tomoyasu, Takeshi Yamamoto, Makoto Ohara, Michishige Terasaki, Hideki Kushima, Yasuki Ito, Sho‐ichi Yamagishi, Yusaku Mori
Формат: Өгүүллэг
Хэл сонгох:English
Хэвлэсэн: Wiley 2023-12-01
Цуврал:Journal of Diabetes Investigation
Нөхцлүүд:
Онлайн хандалт:https://doi.org/10.1111/jdi.14076
_version_ 1827629913949077504
author Tsutomu Hirano
Toshiyuki Hayashi
Hiroe Sugita
Atsuko Tamasawa
Satoshi Goto
Masako Tomoyasu
Takeshi Yamamoto
Makoto Ohara
Michishige Terasaki
Hideki Kushima
Yasuki Ito
Sho‐ichi Yamagishi
Yusaku Mori
author_facet Tsutomu Hirano
Toshiyuki Hayashi
Hiroe Sugita
Atsuko Tamasawa
Satoshi Goto
Masako Tomoyasu
Takeshi Yamamoto
Makoto Ohara
Michishige Terasaki
Hideki Kushima
Yasuki Ito
Sho‐ichi Yamagishi
Yusaku Mori
author_sort Tsutomu Hirano
collection DOAJ
description Abstract Aims/Introduction Small dense low‐density lipoprotein (sdLDL) is a more potent atherogenic lipoprotein than LDL. As sdLDL‐cholesterol (C) levels are determined by triglyceride and LDL‐C levels, pemafibrate and statins can reduce sdLDL‐C levels. However, it remains unclear whether adding pemafibrate or increasing statin doses would more effectively reduce sdLDL‐C levels in patients receiving statin therapy. Materials and Methods A total of 97 patients with type 2 diabetes and hypertriglyceridemia who were treated with statins were randomly assigned to the pemafibrate 0.2 mg/day addition or statin dose doubled, and followed for 12 weeks. sdLDL‐C was measured by our established homogenous assay. Results The percentage and absolute reductions of sdLDL‐C levels were significantly greater in the pemafibrate add‐on group than the statin doubling group (−32.8 vs −8.1%; −16 vs −3 mg/dL, respectively). Triglyceride levels were reduced only in the pemafibrate add‐on group (−44%), and LDL‐C levels were reduced only in the statin doubling group (−8%), whereas levels of non‐high‐density lipoprotein‐C and apolipoprotein B were similarly decreased (7–9%) in both groups. The absolute reductions of sdLDL‐C levels were closely associated with decreased triglyceride, LDL‐C, non‐high‐density lipoprotein‐C and apolipoprotein B. In the subgroup analysis, the effect of pemafibrate add‐on on sdLDL‐C reductions was observed irrespective of baseline lipid parameters or statin type. No serious adverse effects were observed in both groups. Conclusions In patients with type 2 diabetes and hypertriglyceridemia, the addition of pemafibrate to a statin is superior to doubling a statin in reducing sdLDL‐C without increasing adverse effects.
first_indexed 2024-03-09T13:59:03Z
format Article
id doaj.art-7b723e31cf984844b51b51d4814f39f0
institution Directory Open Access Journal
issn 2040-1116
2040-1124
language English
last_indexed 2024-03-09T13:59:03Z
publishDate 2023-12-01
publisher Wiley
record_format Article
series Journal of Diabetes Investigation
spelling doaj.art-7b723e31cf984844b51b51d4814f39f02023-11-30T11:41:37ZengWileyJournal of Diabetes Investigation2040-11162040-11242023-12-0114121401141110.1111/jdi.14076Prospective randomized comparative study of the effect of pemafibrate add‐on or double statin dose on small dense low‐density lipoprotein‐cholesterol in patients with type 2 diabetes and hypertriglyceridemia on statin therapyTsutomu Hirano0Toshiyuki Hayashi1Hiroe Sugita2Atsuko Tamasawa3Satoshi Goto4Masako Tomoyasu5Takeshi Yamamoto6Makoto Ohara7Michishige Terasaki8Hideki Kushima9Yasuki Ito10Sho‐ichi Yamagishi11Yusaku Mori12Diabetes Center Ebina General Hospital Ebina JapanDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine Showa University School of Medicine Tokyo JapanDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine Showa University School of Medicine Tokyo JapanAsoka Hospital Tokyo JapanDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine Showa University School of Medicine Tokyo JapanDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine Showa University School of Medicine Tokyo JapanDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine Showa University School of Medicine Tokyo JapanDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine Showa University School of Medicine Tokyo JapanDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine Showa University School of Medicine Tokyo JapanDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine Showa University School of Medicine Tokyo JapanClinical Diagnostics Department Denka Co., Ltd. Tokyo JapanDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine Showa University School of Medicine Tokyo JapanDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine Showa University School of Medicine Tokyo JapanAbstract Aims/Introduction Small dense low‐density lipoprotein (sdLDL) is a more potent atherogenic lipoprotein than LDL. As sdLDL‐cholesterol (C) levels are determined by triglyceride and LDL‐C levels, pemafibrate and statins can reduce sdLDL‐C levels. However, it remains unclear whether adding pemafibrate or increasing statin doses would more effectively reduce sdLDL‐C levels in patients receiving statin therapy. Materials and Methods A total of 97 patients with type 2 diabetes and hypertriglyceridemia who were treated with statins were randomly assigned to the pemafibrate 0.2 mg/day addition or statin dose doubled, and followed for 12 weeks. sdLDL‐C was measured by our established homogenous assay. Results The percentage and absolute reductions of sdLDL‐C levels were significantly greater in the pemafibrate add‐on group than the statin doubling group (−32.8 vs −8.1%; −16 vs −3 mg/dL, respectively). Triglyceride levels were reduced only in the pemafibrate add‐on group (−44%), and LDL‐C levels were reduced only in the statin doubling group (−8%), whereas levels of non‐high‐density lipoprotein‐C and apolipoprotein B were similarly decreased (7–9%) in both groups. The absolute reductions of sdLDL‐C levels were closely associated with decreased triglyceride, LDL‐C, non‐high‐density lipoprotein‐C and apolipoprotein B. In the subgroup analysis, the effect of pemafibrate add‐on on sdLDL‐C reductions was observed irrespective of baseline lipid parameters or statin type. No serious adverse effects were observed in both groups. Conclusions In patients with type 2 diabetes and hypertriglyceridemia, the addition of pemafibrate to a statin is superior to doubling a statin in reducing sdLDL‐C without increasing adverse effects.https://doi.org/10.1111/jdi.14076PemafibratesSmall dense low‐density lipoproteinType 2 diabetes
spellingShingle Tsutomu Hirano
Toshiyuki Hayashi
Hiroe Sugita
Atsuko Tamasawa
Satoshi Goto
Masako Tomoyasu
Takeshi Yamamoto
Makoto Ohara
Michishige Terasaki
Hideki Kushima
Yasuki Ito
Sho‐ichi Yamagishi
Yusaku Mori
Prospective randomized comparative study of the effect of pemafibrate add‐on or double statin dose on small dense low‐density lipoprotein‐cholesterol in patients with type 2 diabetes and hypertriglyceridemia on statin therapy
Journal of Diabetes Investigation
Pemafibrates
Small dense low‐density lipoprotein
Type 2 diabetes
title Prospective randomized comparative study of the effect of pemafibrate add‐on or double statin dose on small dense low‐density lipoprotein‐cholesterol in patients with type 2 diabetes and hypertriglyceridemia on statin therapy
title_full Prospective randomized comparative study of the effect of pemafibrate add‐on or double statin dose on small dense low‐density lipoprotein‐cholesterol in patients with type 2 diabetes and hypertriglyceridemia on statin therapy
title_fullStr Prospective randomized comparative study of the effect of pemafibrate add‐on or double statin dose on small dense low‐density lipoprotein‐cholesterol in patients with type 2 diabetes and hypertriglyceridemia on statin therapy
title_full_unstemmed Prospective randomized comparative study of the effect of pemafibrate add‐on or double statin dose on small dense low‐density lipoprotein‐cholesterol in patients with type 2 diabetes and hypertriglyceridemia on statin therapy
title_short Prospective randomized comparative study of the effect of pemafibrate add‐on or double statin dose on small dense low‐density lipoprotein‐cholesterol in patients with type 2 diabetes and hypertriglyceridemia on statin therapy
title_sort prospective randomized comparative study of the effect of pemafibrate add on or double statin dose on small dense low density lipoprotein cholesterol in patients with type 2 diabetes and hypertriglyceridemia on statin therapy
topic Pemafibrates
Small dense low‐density lipoprotein
Type 2 diabetes
url https://doi.org/10.1111/jdi.14076
work_keys_str_mv AT tsutomuhirano prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT toshiyukihayashi prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT hiroesugita prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT atsukotamasawa prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT satoshigoto prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT masakotomoyasu prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT takeshiyamamoto prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT makotoohara prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT michishigeterasaki prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT hidekikushima prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT yasukiito prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT shoichiyamagishi prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy
AT yusakumori prospectiverandomizedcomparativestudyoftheeffectofpemafibrateaddonordoublestatindoseonsmalldenselowdensitylipoproteincholesterolinpatientswithtype2diabetesandhypertriglyceridemiaonstatintherapy