Main results of the Ouabain and Adducin for Specific Intervention on Sodium in Hypertension Trial (OASIS-HT): a randomized placebo-controlled phase-2 dose-finding study of rostafuroxin

Table 4 Urinary excretion rate of electrolytes, plasma ouabain concentration and plasma renin activity on placebo and on rostafuroxin

		Mean level at the end of treatment period		Mean difference (95% CI)	P-values
	N	Placebo	Rostafuroxin	Active minus placebo	Treatment effect	Carryover effect	Period effect
Sodium (μmol/min)
Whole day	386	122.3 ± 53.1	117.3 ± 50.4	-5.1 (-10.5 to 0.4)	0.071	0.546	0.256
Daytime	386	128.2 ± 69.8	126.3 ± 86.7	-1.9 (-10.9 to 7.0)	0.672	0.802	0.880
Nighttime	386	115.6 ± 87.4	107.6 ± 67.8	-8.0 (-16.4 to 0.4)	0.061	0.710	0.112
Potassium (μmol/min)
Whole day	386	43.7 ± 22.1	43.5 ± 20.2	-0.2 (-2.6 to 2.2)	0.844	0.942	0.685
Daytime	386	49.5 ± 29.1	50.7 ± 38.4	1.2 (-2.8 to 5.2)	0.545	0.641	0.320
Nighttime	386	33.4 ± 27.3	32.3 ± 21.8	-1.1 (-4.2 to 2.0)	0.479	0.692	0.775
Sodium/potassium ratio
Whole day	386	2.84 (0.99 to 7.74)	2.72 (0.96 to 8.13)	0.96 (0.90 to 1.01)	0.122	0.434	0.154
Daytime	386	2.64 (0.81 to 8.29)	2.53 (0.77 to 8.66)	0.96 (0.90 to 1.02)	0.196	0.490	0.273
Nighttime	386	3.46 (1.03 to 10.6)	3.34 (1.06 to 11.6)	0.97 (0.90 to 1.04)	0.327	0.093	0.314
Plasma ouabain (pmol/L)	357	155.4 (56.8 to 453)	161.6 (57.7 to 425.0)	1.04 (0.98 to 1.10)	0.192	0.997	0.369
Plasma renin activity (ng/mL/h)	374	0.57 (0.11 to 2.62)	0.57 (0.12 to 2.95)	1.00 (0.94 to 1.07)	0.948	0.087	0.672
Aldosterone excretion (nmol/24 h)	334	25.7 (5.96 to 130)	25.5(4.99 to 111)	0.99(0.90 to 1.09)	0.862	0.366	0.377

Mean levels at the end of the treatment period are arithmetic means ± SD or geometric means (95% confidence interval). Mean differences were estimated using analysis of variance with sequence, subjects nested within sequence, and period and treatment group entered as covariables. Mean differences are expressed as the difference of rostafuroxin minus placebo or the ratio of rostafuroxin to placebo for non-transformed and logarithmically transformed variables, respectively. Abbreviations: CI, confidence interval; N = number of patients.

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