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Table 2— 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 ({theta}alb) (x10–6) 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.





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