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

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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

Keywords

  • albuminuria
  • antioxidants
  • diabetic nephropathies
  • probucol
  • type 2 diabetes mellitus

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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  • Cite this

    Jin, S. M., Han, K. A., Yu, J. M., Sohn, T. S., Choi, S. H., Chung, C. H., Park, I. B., Rhee, E. J., Baik, S-H., Park, T. S., Lee, I. K., Ko, S. H., Hwang, Y. C., Cha, B. S., Lee, H. W., Nam, M. S., & Lee, M. K. (2016). Probucol in albuminuric type 2 diabetes mellitus patients on renin-angiotensin system blockade. Arteriosclerosis, Thrombosis, and Vascular Biology, 36(10), 2108-2114. https://doi.org/10.1161/ATVBAHA.116.308034