Probucol in albuminuric type 2 diabetes mellitus patients on renin-angiotensin system blockade

Sang Man Jin, Kyung Ah Han, Jae Myung Yu, Tae Seo Sohn, Sung Hee Choi, Choon Hee Chung, Ie Byung Park, Eun Jung Rhee, Sei Hyun Baik, Tae Sun Park, In Kyu Lee, Seung Hyun Ko, You Cheol Hwang, Bong Soo Cha, Hyoung Woo Lee, Moon Suk Nam, Moon Kyu Lee

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective - To determine the effect of probucol on urine albumin excretion in type 2 diabetes mellitus patients with albuminuria using angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Approach and Results - This was a 16-week, phase II, randomized, placebo-controlled, parallel-group study in type 2 diabetes mellitus patients with a urinary albumin/creatinine ratio of ≥300 mg/g using angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, conducted in 17 tertiary referral hospitals. Eligible patients were randomized to probucol 250 mg/d (n=44), probucol 500 mg/d (n=41), and placebo (n=41) groups in a ratio of 1:1:1 after block randomization procedures, keeping the treatment assignment blinded to the investigators, patients, and study assistants. The primary end point was change in the geometric mean of urinary albumin/creatinine ratio from baseline to week 16 (ClinicalTrials.gov identifier NCT01726816). The study was started on November 8, 2012, and completed on March 24, 2014. The least squares mean change±SE from baseline in urinary albumin/creatinine ratio at week 16 was -7.2±639.5 mg/g in the probucol 250 mg/d group (n=43; P=0.2077 versus placebo group), 9.3±587.4 mg/g in the probucol 500 mg/d group (n=40; P=0.1975 versus placebo group), and 259.0±969.1 mg/g in the placebo group (n=41). Although the majority of subjects were on statins, probucol treatment significantly lowered total cholesterol and low-density lipoprotein cholesterol levels. QT prolongation occurred in one and two subjects in control and probucol 250 mg/d groups, respectively. Conclusions - Four months of probucol up to 500 mg/d failed to reduce urinary albumin excretion.

Original languageEnglish
Pages (from-to)2108-2114
Number of pages7
JournalArteriosclerosis, thrombosis, and vascular biology
Volume36
Issue number10
DOIs
Publication statusPublished - 2016 Oct 1

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Probucol
Renin-Angiotensin System
Type 2 Diabetes Mellitus
Albumins
Placebos
Creatinine
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Albuminuria
Random Allocation
Least-Squares Analysis
Tertiary Care Centers
LDL Cholesterol
Cholesterol
Research Personnel
Urine

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Jin, Sang Man ; Han, Kyung Ah ; Yu, Jae Myung ; Sohn, Tae Seo ; Choi, Sung Hee ; Chung, Choon Hee ; Park, Ie Byung ; Rhee, Eun Jung ; Baik, Sei Hyun ; Park, Tae Sun ; Lee, In Kyu ; Ko, Seung Hyun ; Hwang, You Cheol ; Cha, Bong Soo ; Lee, Hyoung Woo ; Nam, Moon Suk ; Lee, Moon Kyu. / Probucol in albuminuric type 2 diabetes mellitus patients on renin-angiotensin system blockade. In: Arteriosclerosis, thrombosis, and vascular biology. 2016 ; Vol. 36, No. 10. pp. 2108-2114.
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abstract = "Objective - To determine the effect of probucol on urine albumin excretion in type 2 diabetes mellitus patients with albuminuria using angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Approach and Results - This was a 16-week, phase II, randomized, placebo-controlled, parallel-group study in type 2 diabetes mellitus patients with a urinary albumin/creatinine ratio of ≥300 mg/g using angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, conducted in 17 tertiary referral hospitals. Eligible patients were randomized to probucol 250 mg/d (n=44), probucol 500 mg/d (n=41), and placebo (n=41) groups in a ratio of 1:1:1 after block randomization procedures, keeping the treatment assignment blinded to the investigators, patients, and study assistants. The primary end point was change in the geometric mean of urinary albumin/creatinine ratio from baseline to week 16 (ClinicalTrials.gov identifier NCT01726816). The study was started on November 8, 2012, and completed on March 24, 2014. The least squares mean change±SE from baseline in urinary albumin/creatinine ratio at week 16 was -7.2±639.5 mg/g in the probucol 250 mg/d group (n=43; P=0.2077 versus placebo group), 9.3±587.4 mg/g in the probucol 500 mg/d group (n=40; P=0.1975 versus placebo group), and 259.0±969.1 mg/g in the placebo group (n=41). Although the majority of subjects were on statins, probucol treatment significantly lowered total cholesterol and low-density lipoprotein cholesterol levels. QT prolongation occurred in one and two subjects in control and probucol 250 mg/d groups, respectively. Conclusions - Four months of probucol up to 500 mg/d failed to reduce urinary albumin excretion.",
author = "Jin, {Sang Man} and Han, {Kyung Ah} and Yu, {Jae Myung} and Sohn, {Tae Seo} and Choi, {Sung Hee} and Chung, {Choon Hee} and Park, {Ie Byung} and Rhee, {Eun Jung} and Baik, {Sei Hyun} and Park, {Tae Sun} and Lee, {In Kyu} and Ko, {Seung Hyun} and Hwang, {You Cheol} and Cha, {Bong Soo} and Lee, {Hyoung Woo} and Nam, {Moon Suk} and Lee, {Moon Kyu}",
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Jin, SM, Han, KA, Yu, JM, Sohn, TS, Choi, SH, Chung, CH, Park, IB, Rhee, EJ, Baik, SH, Park, TS, Lee, IK, Ko, SH, Hwang, YC, Cha, BS, Lee, HW, Nam, MS & Lee, MK 2016, 'Probucol in albuminuric type 2 diabetes mellitus patients on renin-angiotensin system blockade', Arteriosclerosis, thrombosis, and vascular biology, vol. 36, no. 10, pp. 2108-2114. https://doi.org/10.1161/ATVBAHA.116.308034

Probucol in albuminuric type 2 diabetes mellitus patients on renin-angiotensin system blockade. / Jin, Sang Man; Han, Kyung Ah; Yu, Jae Myung; Sohn, Tae Seo; Choi, Sung Hee; Chung, Choon Hee; Park, Ie Byung; Rhee, Eun Jung; Baik, Sei Hyun; Park, Tae Sun; Lee, In Kyu; Ko, Seung Hyun; Hwang, You Cheol; Cha, Bong Soo; Lee, Hyoung Woo; Nam, Moon Suk; Lee, Moon Kyu.

In: Arteriosclerosis, thrombosis, and vascular biology, Vol. 36, No. 10, 01.10.2016, p. 2108-2114.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Probucol in albuminuric type 2 diabetes mellitus patients on renin-angiotensin system blockade

AU - Jin, Sang Man

AU - Han, Kyung Ah

AU - Yu, Jae Myung

AU - Sohn, Tae Seo

AU - Choi, Sung Hee

AU - Chung, Choon Hee

AU - Park, Ie Byung

AU - Rhee, Eun Jung

AU - Baik, Sei Hyun

AU - Park, Tae Sun

AU - Lee, In Kyu

AU - Ko, Seung Hyun

AU - Hwang, You Cheol

AU - Cha, Bong Soo

AU - Lee, Hyoung Woo

AU - Nam, Moon Suk

AU - Lee, Moon Kyu

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Objective - To determine the effect of probucol on urine albumin excretion in type 2 diabetes mellitus patients with albuminuria using angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Approach and Results - This was a 16-week, phase II, randomized, placebo-controlled, parallel-group study in type 2 diabetes mellitus patients with a urinary albumin/creatinine ratio of ≥300 mg/g using angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, conducted in 17 tertiary referral hospitals. Eligible patients were randomized to probucol 250 mg/d (n=44), probucol 500 mg/d (n=41), and placebo (n=41) groups in a ratio of 1:1:1 after block randomization procedures, keeping the treatment assignment blinded to the investigators, patients, and study assistants. The primary end point was change in the geometric mean of urinary albumin/creatinine ratio from baseline to week 16 (ClinicalTrials.gov identifier NCT01726816). The study was started on November 8, 2012, and completed on March 24, 2014. The least squares mean change±SE from baseline in urinary albumin/creatinine ratio at week 16 was -7.2±639.5 mg/g in the probucol 250 mg/d group (n=43; P=0.2077 versus placebo group), 9.3±587.4 mg/g in the probucol 500 mg/d group (n=40; P=0.1975 versus placebo group), and 259.0±969.1 mg/g in the placebo group (n=41). Although the majority of subjects were on statins, probucol treatment significantly lowered total cholesterol and low-density lipoprotein cholesterol levels. QT prolongation occurred in one and two subjects in control and probucol 250 mg/d groups, respectively. Conclusions - Four months of probucol up to 500 mg/d failed to reduce urinary albumin excretion.

AB - Objective - To determine the effect of probucol on urine albumin excretion in type 2 diabetes mellitus patients with albuminuria using angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Approach and Results - This was a 16-week, phase II, randomized, placebo-controlled, parallel-group study in type 2 diabetes mellitus patients with a urinary albumin/creatinine ratio of ≥300 mg/g using angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, conducted in 17 tertiary referral hospitals. Eligible patients were randomized to probucol 250 mg/d (n=44), probucol 500 mg/d (n=41), and placebo (n=41) groups in a ratio of 1:1:1 after block randomization procedures, keeping the treatment assignment blinded to the investigators, patients, and study assistants. The primary end point was change in the geometric mean of urinary albumin/creatinine ratio from baseline to week 16 (ClinicalTrials.gov identifier NCT01726816). The study was started on November 8, 2012, and completed on March 24, 2014. The least squares mean change±SE from baseline in urinary albumin/creatinine ratio at week 16 was -7.2±639.5 mg/g in the probucol 250 mg/d group (n=43; P=0.2077 versus placebo group), 9.3±587.4 mg/g in the probucol 500 mg/d group (n=40; P=0.1975 versus placebo group), and 259.0±969.1 mg/g in the placebo group (n=41). Although the majority of subjects were on statins, probucol treatment significantly lowered total cholesterol and low-density lipoprotein cholesterol levels. QT prolongation occurred in one and two subjects in control and probucol 250 mg/d groups, respectively. Conclusions - Four months of probucol up to 500 mg/d failed to reduce urinary albumin excretion.

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