Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: Twenty-one type 2 diabetic patients with nephropathy were enrolled in a randomized, double-masked, cross-over study. Patients were treated in random order with spironolactone 25 mg once daily and matched placebo for 8 weeks, respectively, in addition to ongoing antihypertensive treatment including diuretics and maximally recommended doses of an ACE inhibitor and/or an ARB. At the end of each treatment period, albuminuria, 24-h ambulatory blood pressure (ABP), and glomerular filtration rate (GFR) were determined. RESULTS: During the addition of placebo, values were as follows: albuminuria (geometric mean [range]) 1,566 [655-7,762] mg/24 h, ABP (mean +/- SE) 138 +/- 3/71 +/- 1 mmHg, and GFR (mean +/- SE) 74 +/- 6 ml/min per 1.73 m2. During the addition of spironolactone, albuminuria was reduced by 33% (95% CI 25-41) (P < 0.001), fractional clearance of albumin by 40% (24-53) (P < 0.001), and 24-h ABP by 6 mmHg (2-10) for systolic and 4 mmHg (2-6) for diastolic (P < 0.001 for both). The change in albuminuria did not correlate with the change in systolic 24-h ABP (r = 0.19, P = 0.42) or diastolic 24-h ABP (r = 0.01, P = 0.96). Spironolactone treatment induced an insignificant reversible reduction in GFR of 3 ml/min per 1.73 m2 (-0.3 to 6) (P = 0.08). One patient was excluded from the study due to hyperkalemia. Otherwise treatment was well tolerated. CONCLUSIONS: Our study suggests that spironolactone safely adds to the reno- and cardiovascular protective benefits of treatment with maximally recommended doses of ACE inhibitor and ARB by reducing albuminuria and blood pressure in type 2 diabetic patients with nephropathy.
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Authors | Kasper Rossing, Katrine J Schjoedt, Ulla M Smidt, Frans Boomsma, Hans-Henrik Parving |
Journal | Diabetes care
(Diabetes Care)
Vol. 28
Issue 9
Pg. 2106-12
(Sep 2005)
ISSN: 0149-5992 [Print] United States |
PMID | 16123474
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antihypertensive Agents
- Diuretics
- Placebos
- Spironolactone
- Creatinine
- Potassium
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Topics |
- Antihypertensive Agents
(therapeutic use)
- Blood Pressure
- Body Mass Index
- Creatinine
(blood)
- Cross-Over Studies
- Diabetic Nephropathies
(blood, drug therapy, physiopathology)
- Diuretics
(therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Glomerular Filtration Rate
- Humans
- Male
- Middle Aged
- Placebos
- Potassium
(blood)
- Spironolactone
(therapeutic use)
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