Summary of Design

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Summary of Design

• Aim Effect of Ramipril (up to 10mg/d) or Vit E
  (400 IU/d) vs its placebo on CV death, M I or
  stroke (primary)
• Design Randomized double blind, 2x2 factorial,
• People with high CV risk, exclusion
  macroalbuminuria, s-creatinine gt 2.3 mg/dl
• Size 9541 patients followed for 4 to 6 years
• Organization 267 hospitals from 19 countries in
  North South America and Europe, Coordinated by
  the CCC at McMaster University, Hamilton, Canada
• Principal investigator S . Yusuf, Coordinator
  Europe J Mann, J Ostergren, B. Wolfenbuttel

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G E R
Gerstein, Mann, Yusuf, JAMA 2001 286 421 - 8
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ACR and future development of clinical
proteinuria / overt nephropathy
Baseline microalbuminuria was associated with the
development of clinical proteinuria
in Diabetes 20.1 / 4 years No diabetes
4.9 / 4 years In those with microalbuminuria,
the risk was 17 - 20-fold higher than in those
without (plt0.0001 after adjusting for all risk
factors monitored in HOPE)
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Progression of Albuminuria MA ? ON or None ?
MA/ON
Ramipril Placebo N () N
() All patients 909 (19) 1032 (22) RR (95
CI) 0.88 (0.81-0.96) p 0.0056
MA microalbuminuria ON overt nephropathy
5
Serum creatinine in all diabetic patients, and in
diabetics with renal insufficiency (RI)
N 333
Serum creatinine (mg/dl)
Mann, Gerstein, et al, Ann Int Med 2002
N 3,571
years