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. 2017 Feb 28;2017(2):CD008996. doi: 10.1002/14651858.CD008996.pub2

Saruta 2004.

Methods Study design: randomized controlled trial
Study grouping: parallel group
Participants Baseline characteristics
Eplerenone 50 mg daily

  • Female (%): 36.7 (18/49)

  • Mean age (years ±SD): 54.2 ± 11.3

  • Mean active renin (mU/L): 5.7 (N = 48)

  • Asian (%): 100 (49/49)

  • BMI female (mean kg/m2 ±SD): 24.1 ± 2.6

  • BMI male (mean kg/m2 ±SD): 25.6 ± 2.9

  • Mean SBP (mmHg ±SD): 153.5 ± 13.34

  • Mean DBP (mmHg ±SD): 100.2 ± 4.59

  • 24‐h ABPM: SBP (mmHg ±SD): 150.0 ± 13.76 (N = 15)

  • 24‐h ABPM: DBP (mmHg ±SD): 92.6 ± 5.16 (N = 15)


Placebo

  • Female (%): 32.0 (16/50)

  • Mean age (years ±SD): 54.3 ± 10.55

  • Mean active renin (mU/L): 10.1 (N = 48)

  • Asian (%): 100 (50/50)

  • BMI female (mean kg/m2 ±SD): 23.3 ± 3.5

  • BMI male (mean kg/m2 ±SD): 25.8 ± 3.3

  • Mean SBP (mean mmHg ±SD): 150.5 ± 11.67

  • Mean DBP (mean mmHg ±SD): 100.6 ± 5.64

  • 24‐hour ABPM: SBP (mmHg ±SD): 152.4 ± 15.92 (N = 13)

  • 24‐hour ABPM: DBP (mmHg ±SD): 96.1 ± 6.51 (N = 13)


Eplerenone 100 mg daily

  • Female (%): 30.4 (14/46)

  • Mean age (years ±SD): 52.8 ± 10.02

  • Mean active renin (mU/L): 6.3 (N = )

  • Asian (%): 100 (46/46)

  • BMI female (mean kg/m2 ±SD): 23.0±3.4

  • BMI male (mean kg/m2 ±SD): 25.0±3.3

  • Mean SBP (mean mmHg ±SD): 156.1±14.25

  • Mean DBP (mean mmHg ±SD): 101.7±5.72

  • 24‐hour ABPM: SBP (mean mmHg ±SD): 153.1±14.21 (N=14)

  • 24‐hour ABPM: DBP (mean mmHg ±SD): 96.4±7.77 (N=14)


Eplerenone 200 mg daily

  • Female (%): 27.1 (13/48)

  • Mean age (years ±SD): 52.6 ± 10.76

  • Mean active renin (mU/L): 8.0 (N = 47)

  • Asian (%): 100 (48/48)

  • BMI female (mean kg/m2 ±SD): 25.0 ± 3.3

  • BMI male (mean kg/m2 ±SD): 25.1 ± 2.4

  • Mean SBP (mean mmHg ±SD): 152.8 ± 16.10

  • Mean DBP (mean mmHg ±SD): 100.9 ± 5.05

  • 24‐hour ABPM: SBP (mean mmHg ±SD): 155.1 ± 13.49 (N = 16)

  • 24‐hour ABPM: DBP (mean mmHg ±SD): 97.3 ± 6.34 (N = 16)


Inclusion criteria:

  • Men and women aged 20‐80 years old

  • History of hypertension (treated or untreated)

  • Untreated hypertension as defined by a cuff seated diastolic BP (seDBP) ≥ 95 mmHg and < 115 mmHg

  • Postmenopausal or surgically sterile women

  • ECG without evidence of an arrhythmia requiring treatment

  • A serum potassium level of 3.55. mmol/L


Exclusion criteria:

  • Secondary, severe, labile, or malignant hypertension

  • New York Heart Association class II–IV heart failure

  • Coronary artery disease

  • Severe valvular heart disease

  • Cerebrovascular disease

  • Diabetes mellitus

  • Liver disease

  • Kidney disease

  • Taking systemic vasodilators/vasoconstrictors, alfa‐ or beta‐blockers for treatment of prostatic hypertrophy, other drugs known to affect BP, antiarrhythmics, systemic glucocorticoids, hormonal replacement, immunosuppressive or cytotoxic drugs, nicotine, fluconazole, itraconazole, erythromycin, or regular use of NSAIDs

  • Taking medications that could alter the GI absorption of study medication. History of alcohol or substance abuse. Allergy or sensitivity to study drug
Interventions Intervention characteristics
Eplerenone 50 mg daily
Placebo
Eplerenone 100 mg daily
Eplerenone 200 mg daily
Outcomes Blood pressure (seated)

  • Outcome type: continuous outcome


Pulse pressure (change from baseline)

  • Outcome type: continuous outcome

  • Reporting: fully reported

  • Unit of measure: mmHg

  • Direction: lower is better

  • Data value: change from baseline

  • Notes: pulse pressure = SBP ‐ DBP


Mean change in SBP

  • Outcome type: continuous outcome

  • Reporting: partially reported

  • Unit of measure: mmHg

  • Direction: lower is better

  • Data value: change from baseline


Mean change in DBP

  • Outcome type: continuous outcome

  • Reporting: partially reported

  • Unit of measure: mmHg

  • Direction: lower is better

  • Data value: change from baseline


Mean change in 24 h ambulatory SBP

  • Outcome type: continuous outcome

  • Reporting: partially reported

  • Unit of measure: mmHg

  • Direction: lower is better

  • Data value: change from baseline


Mean change in 24 h ambulatory DBP

  • Outcome type: continuous outcome

  • Reporting: partially reported

  • Unit of measure: mmHg

  • Direction: lower is better

  • Data value: change from baseline
Identification Sponsorship source: Grant from Pfizer Inc
Country: Japan
Setting: 22 centers in Japan
Comments:
Author's name: Takao Saruta
Institution: Department of Internal Medicine, Keio University School of Medicine
Email: takao_saruta@ybb.ne.jp or saruta@sc.itc.keio.ac.jp
Address: 35 Shinanomachi, Shinjuku‐ku Tokyo 160‐8582, Japan
Notes —
Risk of bias
Bias Authors' judgement Support for judgement
Sequence Generation Unclear risk Judgement comment: No information provided. An email was sent to both takao_saruta@ybb.ne.jp and saruta@sc.itc.keio.ac.jp on 14 November 2015 for clarification.
Allocation concealment Unclear risk Judgement comment: not reported
Blinding of participants and personnel 
 All outcomes Unclear risk Judgement comment: the study did not specify how blinding of participants or personnel was done.
Blinding of outcome assessors 
 All outcomes Unclear risk Judgement comment: study did not address this. An email has been sent to both takao_saruta@ybb.ne.jp and saruta@sc.itc.keio.ac.jp on 14 November2015 for clarification.
Incomplete outcome data 
 All outcomes Low risk Quote: "one patient in the eplerenone 50‐mg group had no post dose BP measurement due to withdrawal of informed consent and was therefore excluded from the efficacy analysis."
Judgement comment: only 1 patient dropped out. No other missing data for adjusted mean change in systolic and diastolic blood pressure at week 8. Unlikely to affect results in the group of 49.
Selective outcome reporting Low risk Judgement comment: the study protocol is not available but published report included all of the prespecified outcomes
Other sources of bias High risk Quote: "Disclosure: This research was supported by a grant from Pfizer Inc."