title: Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study.
abstract: OBJECTIVE
  The 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).
  
  
  METHODS
  We 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.
  
  
  RESULTS
  Five 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
  Olmesartan was well tolerated but did not improve renal outcome on top of ACEI.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00141453.
authors: Department of Nephrology, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550, Japan. ADS12069@nifty.com
authors: E
authors: E
authors: Imai
authors: J C N
authors: JC
authors: Chan
authors: S
authors: S
authors: Ito
authors: T
authors: T
authors: Yamasaki
authors: F
authors: F
authors: Kobayashi
authors: M
authors: M
authors: Haneda
authors: H
authors: H
authors: Makino
mesh_terms: D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use; D044466:Asian People / Q000706:statistics & numerical data; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000401:mortality; D003404:Creatinine / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000401:mortality; D003928:Diabetic Nephropathies / Q000188:drug therapy* / Q000401:mortality; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D006947:Hyperkalemia / Q000139:chemically induced; D006973:Hypertension / Q000188:drug therapy; D007093:Imidazoles / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000188:drug therapy / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011507:Proteinuria / Q000188:drug therapy; D020521:Stroke / Q000453:epidemiology; D013777:Tetrazoles / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D007093:Imidazoles; D013777:Tetrazoles; C437965:olmesartan; D003404:Creatinine