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Assessment of patients' and physicians' compliance to an ACE inhibitor treatment based on urinary N-acetyl Ser-Asp-Lys-Pro determination in the Noninsulin-Dependent Diabetes, Hypertension, Microalbuminuria, Proteinuria, Cardiovascular Events, and Ramipril (DIABHYCAR) study.

AbstractOBJECTIVE:
The purpose of this study was to assess patients' and physicians' compliance with ACE inhibitor treatment, by measuring an endogenous biomarker of ACE inhibition, urinary N-acetyl-Ser-Asp-Lys-Pro (AcSDKP), in the Noninsulin-Dependent Diabetes, Hypertension, Microalbuminuria, Proteinuria, Cardiovascular Events, and Ramipril (DIABHYCAR) trial, which compared ramipril (1.25 mg o.d.) with placebo in 4,912 patients with type 2 diabetes and microalbuminuria/proteinuria.
RESEARCH DESIGN AND METHODS:
The urine AcSDKP-to-creatinine ratio was measured blind to treatment in all participants who completed follow-up and provided spot urine samples (n = 1,871).
RESULTS:
The median urinary AcSDKP-to-creatinine ratio was six times higher for ramipril than for placebo. Urinary AcSDKP-to-creatinine ratios displayed a bimodal distribution in both groups, with a very large intergroup overlap. Based on cluster analysis, we defined truly adherent ramipril patients as those with a ratio > or =4 nmol/mmol and truly adherent placebo patients as those with a ratio < 4 nmol/mmol. After excluding patients withdrawing prematurely from the study or known to have used a nonstudy ACE inhibitor, 27.3% of the 597 ramipril patients had ratios <4, indicating poor compliance, and 9.7% of the 621 placebo patients had ratios > or =4, indicating intake of a nonstudy ACE inhibitor. Correcting for compliance by using AcSDKP-guided analysis affected surrogate outcome results (decrease in systolic blood pressure and urinary albumin excretion) only slightly.
CONCLUSIONS:
The systematic use of spot urinary AcSDKP determination facilitated the detection of defects in compliance with ACE inhibitor treatment in both patients and physicians. Urinary AcSDKP measurement could be a useful biomarker for assessing compliance with ACE inhibition in the routine care of diabetic patients.
AuthorsMichel Azizi, Joël Ménard, Séverine Peyrard, Michel Lièvre, Michel Marre, Gilles Chatellier
JournalDiabetes care (Diabetes Care) Vol. 29 Issue 6 Pg. 1331-6 (Jun 2006) ISSN: 0149-5992 [Print] United States
PMID16732017 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Angiotensin-Converting Enzyme Inhibitors
  • Biomarkers
  • Oligopeptides
  • Placebos
  • goralatide
Topics
  • Aged
  • Albuminuria (psychology, urine)
  • Angiotensin-Converting Enzyme Inhibitors (therapeutic use)
  • Biomarkers (urine)
  • Diabetes Mellitus, Type 2 (psychology, urine)
  • Diabetic Angiopathies (drug therapy, psychology, urine)
  • Double-Blind Method
  • Female
  • Guideline Adherence
  • Humans
  • Hypertension (psychology, urine)
  • Male
  • Middle Aged
  • Oligopeptides (urine)
  • Patient Compliance
  • Physicians
  • Placebos
  • Proteinuria (psychology, urine)

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