Safety and Antihypertensive Effect of Selara® (Eplerenone): Results from a Postmarketing Surveillance in Japan
Table 4
Serum potassium levels during eplerenone treatment relative to baseline levels.
Baseline level (mEq/L)
Maximal value (mEq/L)
Changes from baseline (mEq/L)
% changes from baseline (%)
Patients with ≥5.5 mEq/L ( (% [95% CI]))
Serum potassium ≤ 3.5
195
3.9 ± 0.4
0.69 ± 0.45
21.6 ± 15.5
0 (0.0 [0.0–1.9])
3.5 < serum potassium ≤ 4.5
1315
4.3 ± 0.4
0.25 ± 0.42
6.4 ± 10.6
19 (1.4 [0.9–2.2])
4.5 < serum potassium ≤ 5.0
263
4.7 ± 0.5
−0.02 ± 0.51
−0.27 ± 10.7
14 (5.3 [2.9–8.8])
Serum potassium > 5.0
51
5.0 ± 0.6
−0.41 ± 0.80
−7.1 ± 13.7
10 (19.6 [9.8–33.1])
Mean ± standard deviation. CI: confidence interval. The cases who had serum potassium data at baseline and additional timings during the PMS were included in this table. The number of the cases was 1,824 out of the safety analysis population ( = 3,166).
