Effects of adding spironolactone (25 mg once daily) to conventional antihypertensive medication, including an ACE inhibitor and/or an ARB in maximally recommended doses in 20 type 2 diabetic patients with nephropathy
| Conventional antihypertensive treatment
|
Mean difference (95% CI) | P value | |||
|---|---|---|---|---|---|
| + Placebo | + Spironolactone (25 mg once daily) | ||||
| Albuminuria (mg/24 h) | 1,566 (655–4,208) | 1,067 (429–2,358) | −33% (−41 to −25) | <0.001 | |
| 4-h albuminuria (μg/min) | 1,301 (844–2,005) | 741 (455–1,206) | −43% (−27 to −56) | <0.001 | |
| GFR (ml/min per 1.73 m2) | 74 ± 6 | 71 ± 6 | −3 (−6 to 0.3) | 0.08 | |
| Fractional albumin clearance (θalb) (×10−6) | 501 (318–791) | 298 (176–504) | −40% (−53 to −24) | <0.001 | |
| Systolic blood pressure (mmHg) | |||||
| Office | 142 ± 4 | 132 ± 4 | −10 (−16 to 5) | 0.001 | |
| 24-h | 138 ± 3 | 132 ± 3 | −6 (−10 to −2) | 0.003 | |
| Day (7:00 a.m. to 11:00 p.m.) | 141 ± 3 | 134 ± 3 | −7 (−11 to −3) | 0.001 | |
| Night (11:00 p.m. to 7:00 a.m.) | 129 ± 4 | 124 ± 5 | −5 (−13 to 3) | 0.17 | |
| Diastolic blood pressure (mmHg) | |||||
| Office | 76 ± 1 | 71 ± 2 | −5 (−9 to −1) | <0.01 | |
| 24-h | 71 ± 1 | 67 ± 1 | −4 (−6 to −2) | <0.001 | |
| Day (7:00 a.m. to 11:00 p.m.) | 74 ± 1 | 69 ± 1 | −4 (−7 to −2) | <0.001 | |
| Night (11:00 p.m. to 7:00 a.m.) | 65 ± 2 | 63 ± 2 | −2 (−6 to 1) | 0.16 | |
| Plasma creatinine (μmol/l) | 121 ± 7 | 132 ± 10 | 11 (3–19) | <0.01 | |
| Weight (kg) | 109.5 ± 5 | 108.2 ± 5 | −1.4 (−2.5 to −0.2) | 0.02 | |
| Urinary sodium excretion (mmol/l) | 217 (163–266) | 205 (139–293) | −7% (−2 to 15) | 0.08 | |
| Urinary K-to-Na ratio | 0.39 ± 0.04 | 0.42 ± 0.03 | 0.03 (−0.06 to 0.01) | 0.19 | |
| Plasma albumin (g/l) | 37.5 ± 0.6 | 37.9 ± 0.5 | 0.4 (−0.4 to 1.1) | 0.27 | |
| Plasma renin activity (ng angiotensin I ml−1 h−1 | 6 (3–12) | 16 (8–23) | 261% (190–360) | <0.001 | |
| Plasma aldosterone (pg/ml) | 39 (27–63) | 87 (50–143) | 225% (181–280) | <0.001 | |
| Plasma potassium (mmol/l) | 4.0 ± 0.1 | 4.3 ± 0.1 | 0.3 (0.1–0.4) | <0.01 | |
| Plasma sodium (mmol/l) | 140 ± 0.5 | 139 ± 0.6 | −1.4 (−2.4 to −0.4) | <0.01 | |
| Hemoglobin (mmol/l) | 8.0 ± 0.3 | 7.9 ± 0.2 | −0.04 (−0.2 to 0.1) | 0.66 | |
| A1C (%) | 7.8 ± 0.4 | 8.1 ± 0.3 | 0.3 (0.04–0.5) | 0.03 | |
| Plasma cholesterol (mmol/l) | 4.1 ± 0.3 | 4.2 ± 0.1 | 0.1 (−0.2 to 0.4) | 0.64 | |
| Plasma LDL (mmol/l) | 1.9 ± 0.1 | 2.0 ± 0.2 | 0.1 (−0.05 to 0.2) | 0.64 | |
| Plasma HDL (mmol/l) | 1.14 ± 0.06 | 1.15 ± 0.07 | 0 (−0.05 to 0.06) | 0.82 | |
Data during treatment with placebo and 25 mg spironolactone once daily are means ± SE or geometric mean (interquartile range). Changes from placebo to 25 mg spironolactone are expressed as mean difference (placebo - spironolactone) with 95% CI.