Table S1.
Adequate and well-controlled studies included in pooled analysis
| Study grouping | Study number | Eplerenone dosea | Placebo control | Active control (doses) | Coadministration | Dosing protocol | Double-blind treatment duration | Key blood pressure inclusion criteria |
|---|---|---|---|---|---|---|---|---|
| Placebo-controlled, fixed-dose monotherapy | 0101 | 50, 100, 400 mg QD 25, 50, 200 mg BID | X | Spironolactone (50 mg BID) | Fixed dose (dose ranging) | 8 weeks | Sitting DBP of ≥95 mmHg and <114 m | |
| 0492 | 25, 50, 100, 200 mg | X | Fixed dose (dose ranging) | 12 weeks | Sitting DBP ≥95 mmHg and <110 mmHg and untreated mean sitting SBP <180 mmHg | |||
| 4033 | 50, 100, 200 mg QD | X | Fixed dose (dose ranging) | 8 weeks | Sitting DBP ≥95 mmHg and <115 mmHg | |||
| 015 (Pfizer Inc. Data on file [E3- 01-06-015 August 23, 2001]) | 25, 50, 200 mg | X | HCTZ (12.5, 25 mg) | HCTZ | Fixed dose (factorial design) | 8 weeks | Sitting DBP of ≥95 mmHg and <110 mmHg | |
| Placebo-controlled, titration-to-effect monotherapy | 0204 | 50, 100, 200 mg | X | Losartan (50, 100 mg) | Titration-to- effect | 16 weeks | Sitting DBP ≥95 mmHg and <110 mmHg and a mean sitting SBP <180 mmHg | |
| Placebo-controlled coadministration with other antihypertensives | 0235 | 50, 100 mg | X | ACE-I or A-II antagonist | Titration-to- effect | 8 weeks | Sitting DBP ≥95 mmHg and <110 mmHg and a mean sitting SBP <180 mmHg | |
| 024 (Pfizer Inc. Data on file [IE3- 99-02-024, October 10, 2001]) | 50, 100 mg | X | BB or CCB | Titration-to- effect | 8 weeks | Sitting DBP ≥95 mmHg and <110 mmHg and a mean sitting SBP <180 mmHg | ||
| Active-controlled, fixed-dose monotherapy | 0101 | 50, 100, 400 mg QD 25, 50, 200 mg BID | X | Spironolactone (50 mg BID) | Fixed dose (dose ranging) | 8 weeks | Sitting DBP of 95 mmHg and ≤114 mmHg | |
| 015 (Pfizer Inc. Data on file [E3- 01-06-015 August 23, 2001]) | 25, 50, 200 mg | X | HCTZ (12.5, 25 mg) | HCTZ | Fixed dose (factorial design) | 8 weeks | Sitting DBP of ≥95 mmHg and <110 mmHg | |
| Active-controlled, titration-to-effect monotherapy | 0204 | 50, 100, 200 mg | X | Losartan (50, 100 mg) | Titration-to- effect | 16 weeks | Sitting DBP ≥95 mmHg and <110 mmHg and a mean sitting SBP <180 mmHg | |
| Active-controlled, monotherapy, without placebo | 0196 | 100, 200 mg | Losartan (50, 100 mg) | Titration-to- effect | 16 weeks | Sitting DBP ≥90 mmHg and <115 mmHg and a mean SBP <200 mmHg | ||
| 0167 | 25, 50, 100, 200 mg | Enalapril (5, 10, 20, 40 mg) | Titration-to- effect | 12 months | Sitting DBP ≥95 mmHg and <110 mmHg and a mean sitting SBP <190 mmHg | |||
| 0228 | 50, 100, 200 mg | Amlodipine (2.5, 5, 10 mg) | Titration-to- effect | 24 weeks | Sitting SBP ≥150 mmHg and <165 mmHg, and PP ≥70 mmHg or Sitting SBP ≥165 mmHg and <200 mmHg, and DBP <95 mmHg | |||
| 026 (Pfizer Inc. Data on file [IE3–99–02–026, October 21, 2001]) | 50, 100, 200 mg | Amlodipine (2.5, 5, 10 mg) | Titration-to- effect | 16 weeks | Sitting DBP ≥95 mmHg and <110 mmHg and a mean sitting SBP <180 mmHg |
Note:
a
All regimens were QD unless otherwise noted.
Abbreviations: A-II antagonist, angiotensin II antagonist; ACE-I, angiotensin-converting enzyme inhibitor; BB, beta blocker; CCB, calcium-channel blocker; DBP, diastolic BP; HCTZ, hydrochlorothiazide; PP, pulse pressure; SBP, systolic BP.