Research Article
Safety and Antihypertensive Effect of Selara® (Eplerenone): Results from a Postmarketing Surveillance in Japan
Table 1
Patient characteristics.
| | Factors | Categories | Analysis populations | | Safety analysis population, = 3,166 (%) |
| | Sex | Male | 1,640 (51.8) |
| | Age (years) | Mean ± SD | 67.6 ± 12.8 | | <35 | 21 (0.7) | | 35 to <45 | 149 (4.7) | | 45 to <55 | 343 (10.8) | | 55 to <65 | 689 (21.8) | | 65 to <75 | 897 (28.3) | | 75 to <85 | 845 (26.7) | | ≥85 | 222 (7.0) |
| | BMI (kg/m2) | Mean ± SD | 24.4 ± 4.1 | | <25 | 1,411 (44.6) | | ≥25 | 875 (27.6) | | Unknown | 880 (27.8) |
| | Targeted disease | Hypertension | 2,919 (92.2) | | Other reasons | 247 (7.8) |
| | Severity of hypertension | Mild | 922 (29.1) | | Moderate | 1,548 (48.9) | | Severe | 395 (12.5) | | Unknown | 54 (1.7) |
| | Inpatients/outpatients | Inpatients | 191 (6.0) | | Outpatients | 2,975 (94.6) |
| | Fasting glucose (mg/dL) | Mean ± SD | 110.0 ± 36.8 | | <110 | 1,271 (40.1) | | 110 to <126 | 255 (8.1) | | ≥126 | 294 (9.3) | | Not examined | 1,346 (42.5) |
| | HbA1c (%) | Mean ± SD | 5.7 ± 1.0 | | <5.8 | 1,106 (34.9) | | 5.8 to <6.5 | 289 (9.1) | | ≥6.5 | 247 (7.8) | | Not examined | 1,524 (48.1) |
| | Hepatic function disorder | No | 2,647 (83.6) | | Yes | 472 (14.9) | | Mild | 405 (12.8) | | Moderate | 47 (1.5) | | Severe | 6 (0.2) | | Unknown | 14 (0.4) | | Unknown | 47 (1.5) |
| | Renal impairment | No | 2,697 (85.2) | | Yes | 426 (13.5) | | Mild | 323 (10.2) | | Moderate | 88 (2.8) | | Severe | 11 (0.3) | | Unknown | 4 (0.1) | | Unknown | 43 (1.4) |
| | Heart failure | No | 2,631 (83.1) | | Yes | 513 (16.2) | | Unknown | 22 (0.7) |
| | NYHA functional class | I | 197 (6.2) | | II | 199 (6.3) | | III | 56 (1.8) | | IV | 13 (0.4) | | Unknown | 70 (2.2) |
| | Diabetes | No | 2,490 (78.6) | | Yes | 634 (20.0) | | Unknown | 42 (1.3) |
| | Primary aldosteronism | No | 3,121 (98.6) | | Yes | 45 (1.4) |
| | Initial dose of eplerenone (mg/day) | Mean ± SD | 45.5 ± 13.7 | | 25 | 718 (22.7) | | 50 | 2,358 (74.5) | | 75 | 6 (0.2) | | 100 | 78 (2.5) | | Other reasons | 6 (0.2) |
| | Serum potassium concentrations (mEq/L) | Mean ± SD | 4.1 ± 0.5 | | ≤3.5 | 239 (7.5) | | >3.5 to ≤5.0 | 1,991 (62.9) | | >5.0 | 59 (1.9) | | Unknown | 877 (27.7) |
| | Creatinine clearance (mL/min) | Mean ± SD | 77.6 ± 33.9 | | >80 | 851 (26.9) | | ≥50 to ≤80 | 753 (23.8) | | ≥30 to <50 | 345 (10.9) | | <30 | 87 (2.7) | | Unknown | 1,130 (35.7) |
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SD: standard deviation; BMI: body mass index; HbA1c: glycated hemoglobin A1c; NYHA: New York Heart Association; CrCl: creatinine clearance.
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