Achieving LDL cholesterol target levels <1.81 mmol/L may provide extra cardiovascular protection in patients at high risk

Exploratory analysis of the Standard Versus Intensive Statin Therapy for Patients with Hypercholesterolaemia and Diabetic Retinopathy study

for the EMPATHY Investigators

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Abstract

Aims: To assess the benefits of intensive statin therapy on reducing cardiovascular (CV) events in patients with type 2 diabetes complicated with hyperlipidaemia and retinopathy in a primary prevention setting in Japan. In the intension-to-treat population, intensive therapy [targeting LDL cholesterol <1.81 mmol/L (<70 mg/dL)] was no more effective than standard therapy [LDL cholesterol ≥2.59 to <3.10 mmol/L (≥100 to <120 mg/dL)]; however, after 3 years, the intergroup difference in LDL cholesterol was only 0.72 mmol/L (27.7 mg/dL), and targeted levels were achieved in <50% of patients. We hypothesized that the intergroup difference in CV events would have been statistically significant if more patients had been successfully treated to target. Materials and Methods: This exploratory post hoc analysis focused on intergroup data from patients who achieved their target LDL cholesterol levels. The primary endpoint was the composite incidence of CV events. A Cox proportional hazards model was used to estimate hazard ratios (HRs) for incidence of the primary endpoint in patients who achieved target LDL cholesterol levels in each group. Results: Data were analysed from 1909 patients (intensive: 703; standard: 1206) who achieved target LDL cholesterol levels. LDL cholesterol at 36 months was 1.54 ± 0.30 mmol/L (59.7 ± 11.6 mg/dL) in the intensive group and 2.77 ± 0.46 mmol/L (107.1 ± 17.8 mg/dL) in the standard group (P < 0.05). After adjusting for baseline prognostic factors, the composite incidence of CV events or deaths associated with CV events was significantly lower in the intensive than the standard group (HR 0.48; 95% confidence interval 0.28-0.82; P = 0.007). Conclusions: This post hoc analysis suggests that achieving LDL cholesterol target levels <1.81 mmol/L may more effectively reduce CV events than achieving target levels ≥2.59 to <3.10 mmol/L in patients with hypercholesterolaemia and diabetic retinopathy.

Original languageEnglish
Pages (from-to)791-800
Number of pages10
JournalDiabetes, Obesity and Metabolism
Volume21
Issue number4
DOIs
Publication statusPublished - Apr 1 2019

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Diabetic Retinopathy
Hypercholesterolemia
LDL Cholesterol
Therapeutics
Incidence
Primary Prevention
Hyperlipidemias
Proportional Hazards Models
Type 2 Diabetes Mellitus
Japan
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

@article{c587becb644c40d48d83881f98bbbc13,
title = "Achieving LDL cholesterol target levels <1.81 mmol/L may provide extra cardiovascular protection in patients at high risk: Exploratory analysis of the Standard Versus Intensive Statin Therapy for Patients with Hypercholesterolaemia and Diabetic Retinopathy study",
abstract = "Aims: To assess the benefits of intensive statin therapy on reducing cardiovascular (CV) events in patients with type 2 diabetes complicated with hyperlipidaemia and retinopathy in a primary prevention setting in Japan. In the intension-to-treat population, intensive therapy [targeting LDL cholesterol <1.81 mmol/L (<70 mg/dL)] was no more effective than standard therapy [LDL cholesterol ≥2.59 to <3.10 mmol/L (≥100 to <120 mg/dL)]; however, after 3 years, the intergroup difference in LDL cholesterol was only 0.72 mmol/L (27.7 mg/dL), and targeted levels were achieved in <50{\%} of patients. We hypothesized that the intergroup difference in CV events would have been statistically significant if more patients had been successfully treated to target. Materials and Methods: This exploratory post hoc analysis focused on intergroup data from patients who achieved their target LDL cholesterol levels. The primary endpoint was the composite incidence of CV events. A Cox proportional hazards model was used to estimate hazard ratios (HRs) for incidence of the primary endpoint in patients who achieved target LDL cholesterol levels in each group. Results: Data were analysed from 1909 patients (intensive: 703; standard: 1206) who achieved target LDL cholesterol levels. LDL cholesterol at 36 months was 1.54 ± 0.30 mmol/L (59.7 ± 11.6 mg/dL) in the intensive group and 2.77 ± 0.46 mmol/L (107.1 ± 17.8 mg/dL) in the standard group (P < 0.05). After adjusting for baseline prognostic factors, the composite incidence of CV events or deaths associated with CV events was significantly lower in the intensive than the standard group (HR 0.48; 95{\%} confidence interval 0.28-0.82; P = 0.007). Conclusions: This post hoc analysis suggests that achieving LDL cholesterol target levels <1.81 mmol/L may more effectively reduce CV events than achieving target levels ≥2.59 to <3.10 mmol/L in patients with hypercholesterolaemia and diabetic retinopathy.",
author = "{for the EMPATHY Investigators} and Hiroshi Itoh and Issei Komuro and Masahiro Takeuchi and Takashi Akasaka and Hiroyuki Daida and Yoshiki Egashira and Hideo Fujita and Jitsuo Higaki and Hirata, {Ken ichi} and Shun Ishibashi and Takaaki Isshiki and Sadayoshi Ito and Atsunori Kashiwagi and Satoshi Kato and Kazuo Kitagawa and Masafumi Kitakaze and Takanari Kitazono and Takanari Kitazono and Katsumi Miyauchi and Tomoaki Murakami and Toyoaki Murohara and Koichi Node and Susumu Ogawa and Yoshihiko Saito and Yoshihiko Seino and Takashi Shigeeda and Shunya Shindo and Masahiro Sugawara and Seigo Sugiyama and Yasuo Terauchi and Hiroyuki Tsutsui and Hiroyuki Tsutsui and Kazunori Utsunomiya and Masakazu Yamagishi and Tsutomu Yamazaki and Shoei Yo and Koutaro Yokote and Kiyoshi Yoshida and Michihiro Yoshimura and Nagahisa Yoshimura and Kazuwa Nakao and Ryozo Nagai",
year = "2019",
month = "4",
day = "1",
doi = "10.1111/dom.13575",
language = "English",
volume = "21",
pages = "791--800",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "4",

}

TY - JOUR

T1 - Achieving LDL cholesterol target levels <1.81 mmol/L may provide extra cardiovascular protection in patients at high risk

T2 - Exploratory analysis of the Standard Versus Intensive Statin Therapy for Patients with Hypercholesterolaemia and Diabetic Retinopathy study

AU - for the EMPATHY Investigators

AU - Itoh, Hiroshi

AU - Komuro, Issei

AU - Takeuchi, Masahiro

AU - Akasaka, Takashi

AU - Daida, Hiroyuki

AU - Egashira, Yoshiki

AU - Fujita, Hideo

AU - Higaki, Jitsuo

AU - Hirata, Ken ichi

AU - Ishibashi, Shun

AU - Isshiki, Takaaki

AU - Ito, Sadayoshi

AU - Kashiwagi, Atsunori

AU - Kato, Satoshi

AU - Kitagawa, Kazuo

AU - Kitakaze, Masafumi

AU - Kitazono, Takanari

AU - Kitazono, Takanari

AU - Miyauchi, Katsumi

AU - Murakami, Tomoaki

AU - Murohara, Toyoaki

AU - Node, Koichi

AU - Ogawa, Susumu

AU - Saito, Yoshihiko

AU - Seino, Yoshihiko

AU - Shigeeda, Takashi

AU - Shindo, Shunya

AU - Sugawara, Masahiro

AU - Sugiyama, Seigo

AU - Terauchi, Yasuo

AU - Tsutsui, Hiroyuki

AU - Tsutsui, Hiroyuki

AU - Utsunomiya, Kazunori

AU - Yamagishi, Masakazu

AU - Yamazaki, Tsutomu

AU - Yo, Shoei

AU - Yokote, Koutaro

AU - Yoshida, Kiyoshi

AU - Yoshimura, Michihiro

AU - Yoshimura, Nagahisa

AU - Nakao, Kazuwa

AU - Nagai, Ryozo

PY - 2019/4/1

Y1 - 2019/4/1

N2 - Aims: To assess the benefits of intensive statin therapy on reducing cardiovascular (CV) events in patients with type 2 diabetes complicated with hyperlipidaemia and retinopathy in a primary prevention setting in Japan. In the intension-to-treat population, intensive therapy [targeting LDL cholesterol <1.81 mmol/L (<70 mg/dL)] was no more effective than standard therapy [LDL cholesterol ≥2.59 to <3.10 mmol/L (≥100 to <120 mg/dL)]; however, after 3 years, the intergroup difference in LDL cholesterol was only 0.72 mmol/L (27.7 mg/dL), and targeted levels were achieved in <50% of patients. We hypothesized that the intergroup difference in CV events would have been statistically significant if more patients had been successfully treated to target. Materials and Methods: This exploratory post hoc analysis focused on intergroup data from patients who achieved their target LDL cholesterol levels. The primary endpoint was the composite incidence of CV events. A Cox proportional hazards model was used to estimate hazard ratios (HRs) for incidence of the primary endpoint in patients who achieved target LDL cholesterol levels in each group. Results: Data were analysed from 1909 patients (intensive: 703; standard: 1206) who achieved target LDL cholesterol levels. LDL cholesterol at 36 months was 1.54 ± 0.30 mmol/L (59.7 ± 11.6 mg/dL) in the intensive group and 2.77 ± 0.46 mmol/L (107.1 ± 17.8 mg/dL) in the standard group (P < 0.05). After adjusting for baseline prognostic factors, the composite incidence of CV events or deaths associated with CV events was significantly lower in the intensive than the standard group (HR 0.48; 95% confidence interval 0.28-0.82; P = 0.007). Conclusions: This post hoc analysis suggests that achieving LDL cholesterol target levels <1.81 mmol/L may more effectively reduce CV events than achieving target levels ≥2.59 to <3.10 mmol/L in patients with hypercholesterolaemia and diabetic retinopathy.

AB - Aims: To assess the benefits of intensive statin therapy on reducing cardiovascular (CV) events in patients with type 2 diabetes complicated with hyperlipidaemia and retinopathy in a primary prevention setting in Japan. In the intension-to-treat population, intensive therapy [targeting LDL cholesterol <1.81 mmol/L (<70 mg/dL)] was no more effective than standard therapy [LDL cholesterol ≥2.59 to <3.10 mmol/L (≥100 to <120 mg/dL)]; however, after 3 years, the intergroup difference in LDL cholesterol was only 0.72 mmol/L (27.7 mg/dL), and targeted levels were achieved in <50% of patients. We hypothesized that the intergroup difference in CV events would have been statistically significant if more patients had been successfully treated to target. Materials and Methods: This exploratory post hoc analysis focused on intergroup data from patients who achieved their target LDL cholesterol levels. The primary endpoint was the composite incidence of CV events. A Cox proportional hazards model was used to estimate hazard ratios (HRs) for incidence of the primary endpoint in patients who achieved target LDL cholesterol levels in each group. Results: Data were analysed from 1909 patients (intensive: 703; standard: 1206) who achieved target LDL cholesterol levels. LDL cholesterol at 36 months was 1.54 ± 0.30 mmol/L (59.7 ± 11.6 mg/dL) in the intensive group and 2.77 ± 0.46 mmol/L (107.1 ± 17.8 mg/dL) in the standard group (P < 0.05). After adjusting for baseline prognostic factors, the composite incidence of CV events or deaths associated with CV events was significantly lower in the intensive than the standard group (HR 0.48; 95% confidence interval 0.28-0.82; P = 0.007). Conclusions: This post hoc analysis suggests that achieving LDL cholesterol target levels <1.81 mmol/L may more effectively reduce CV events than achieving target levels ≥2.59 to <3.10 mmol/L in patients with hypercholesterolaemia and diabetic retinopathy.

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U2 - 10.1111/dom.13575

DO - 10.1111/dom.13575

M3 - Article

VL - 21

SP - 791

EP - 800

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 4

ER -