Abstract | OBJECTIVE: 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.
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Authors | Michel Azizi, Joël Ménard, Séverine Peyrard, Michel Lièvre, Michel Marre, Gilles Chatellier |
Journal | Diabetes care
(Diabetes Care)
Vol. 29
Issue 6
Pg. 1331-6
(Jun 2006)
ISSN: 0149-5992 [Print] United States |
PMID | 16732017
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiotensin-Converting Enzyme Inhibitors
- Biomarkers
- Oligopeptides
- Placebos
- goralatide
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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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