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Guyatt G, Rennie D, Meade MO, Cook DJ
Part B Therapy
Chapter 11.4. Surrogate Outcomes
Heiner C. Bucher, Regina Kunz, Deborah J. Cook, Anne Holbrook, Gordon Guyatt
We have found a strong, more or less consistent, independent, and biologically plausible...


Topics Discussed: angiotensin receptor antagonists, angiotensin-converting enzyme inhibitors, cohort studies, diabetes mellitus, type 2, diabetic nephropathy, health outcomes, kidney failure, chronic, surrogate outcomes

Excerpt: "We have found a strong, more or less consistent, independent, and biologically plausible association between albuminuria and ESRD. Randomized trials in AT-II receptor blockers have shown a consistent relationship between decrease in albuminuria and ESRD in patients with type 2 diabetes. The evidence that ACE inhibitors reduce albuminuria and ESRD in patients with type 2 diabetes is less strong, but trials of ACE inhibitors in type 1 diabetes and nondiabetic renal disease provide additional evidence of the link between reduction of albuminuria and reduction of ESRD with ACE inhibitors. Although the case is not as strong as it could be, we might reasonably conclude that albuminuria is a surrogate marker that sufficiently fulfils our criteria, and we may therefore use evidence based on the surrogate marker to guide our decision whether to prescribe an ACE inhibitor in this patient with type 2 diabetes to lower the risk of ESRD. This evidence comes from the RCT that suggests that ACE inhibitors are not inferior to AT-II receptor blockers in reducing albuminuria but is limited by the wide CI...."
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