Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled studyReport as inadecuate

Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study - Download this document for free, or read online. Document in PDF available to download.


, Volume 54, Issue 12, pp 2978–2986

First Online: 13 October 2011Received: 03 May 2011Accepted: 01 September 2011


Aims-hypothesisThe renal and cardiovascular protective effects of angiotensin receptor blocker ARB remain controversial in type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor ACEI.

MethodsWe examined the effects of olmesartan, an ARB, on primary composite outcome of doubling of serum creatinine, endstage renal disease and death in type 2 diabetic patients with overt nephropathy. Secondary outcome included composite cardiovascular outcomes, changes in renal function and proteinuria. Randomisation and allocation to trial group were carried out by a central computer system. Participants, caregivers, the people carrying out examinations and people assessing the outcomes were blinded to group assignment.

ResultsFive hundred and seventy-seven 377 Japanese, 200 Chinese patients treated with antihypertensive therapy 73.5% n = 424 received concomitant ACEI, were given either once-daily olmesartan 10–40 mg n = 288 or placebo n = 289 over 3.2 ± 0.6 years mean±SD. In the olmesartan group, 116 developed the primary outcome 41.1% compared with 129 45.4% in the placebo group HR 0.97, 95% CI 0.75, 1.24; p = 0.791. Olmesartan significantly decreased blood pressure, proteinuria and rate of change of reciprocal serum creatinine. Cardiovascular death was higher in the olmesartan group than the placebo group ten vs three cases, whereas major adverse cardiovascular events cardiovascular death plus non-fatal stroke and myocardial infarction and all-cause death were similar between the two groups major adverse cardiovascular events 18 vs 21 cases, all-cause deaths; 19 vs 20 cases. Hyperkalaemia was more frequent in the olmesartan group than the placebo group 9.2% vs 5.3%.

Conclusions-interpretationOlmesartan was well tolerated but did not improve renal outcome on top of ACEI.

Trial registration: ClinicalTrials.gov NCT00141453

Funding: The ORIENT study was supported by a research grant from Daiichi Sankyo.

KeywordsAngiotensin receptor blocker Diabetic nephropathy Macroproteinuria Type 2 diabetes AbbreviationsACEIAngiotensin-converting enzyme inhibitors

ARBAngiotensin II receptor blocker

CVDCardiovascular disease

ESRDEndstage renal disease

HFHeart failure

IDMCIndependent data monitoring committee

IDNTIrbesartan Type II Diabetic Nephropathy Trial

MIMyocardial infarction

ORIENTOlmesartan Reducing Incidence of End stage renal disease in diabetic Nephropathy Trial

RENAALReduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan

SCrSerum creatinine

TIATransient ischaemic attack

UACRUrinary albumin-creatinine ratio

E. Imai and J. C. N. Chan contributed equally to this study.

Electronic supplementary materialThe online version of this article doi:10.1007-s00125-011-2325-z contains peer-reviewed but unedited supplementary material, including a list of the ORIENT study investigators, which is available to authorised users.

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Author: E. Imai - J. C. N. Chan - S. Ito - T. Yamasaki - F. Kobayashi - M. Haneda - H. Makino - for the ORIENT study investigator

Source: https://link.springer.com/

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