Result placebo , 1 A perfect adherence was notified


Seven trial, six
of them was randomized clinical trial  ,
one cohort study.  That enrolled 960
participants were included in the present systematic review, the mean duration
of follow-up of 9.1+_3.0 months.

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 The Characteristics of the included studies
are summarized in Table , Spironolactone was used in five  of the included trials, whereas eplerenone was
used in 2 studies ,3 studies were conducted in a double-blind fashion comparing
spironolactone  against placebo , one
study was conducted in a double-blind  comparing
eplerenone against placebo . All 7 studies included baseline and follow-up
echocardiographic examination of study participants.


Spironolactone in patients with HFpEF


Spironolactone was used in five  of the included trials, whereas eplerenone was
used in 2 studies ,3 studies were conducted in a double-blind fashion comparing
spironolactone  against placebo , 1

A perfect adherence was notified in both groups, high K level and
decrease resting BP were Couse the full dose not to be taken in 10% of the
participants. Equal numbers of participants were receiving spironolactone and
placebo and followed for 4 months. Adverse events were seen in 23 pt. equally
distributed between the tow groups. Chest pain, SOB, syncope, hypotension was
the most common. No significant different in quality of life, LV structure and
function and arterial function.

2 Of 251 patients screened from November 2011 to February 2015, 150 were
suitable for randomization to spironolactone or placebo. A total of 19 subjects
(13%) discontinued study participation before the 6-month follow-up visit and
were not considered in the analysis. There were no differences between both
arms in the proportion of patients graded according to the severity of LV
diastolic dysfunction . In comparison with placebo, treatment with
spironolactone significantly improved peak VO2, the spironolactone arm also
showed favorable changes in metabolic equivalents, exercise time, OUES,
anaerobic threshold, and RER at followup Peak heart rate at exercise and heart
rate reserve significantly increased at follow-up in the spironolactone group.
No changes were found in maximal exertional BP. Although resting systolic (p ¼
0.02) and diastolic BP (p ¼ 0.05) decreased from baseline to follow-up with
spironolactone, these changes were not significant compared with placebo. No
significant alterations were noted at follow-up in circulating BNP and
galectin-3 in both study arms. Significant improvement with spironolactone (as
compared with placebo) was found in subgroups
above and below an RER of 1 (the achievement of which was used to define
maximum effort), with the effect size being medium at RER >1 and large at
RER3>. Adverse events during follow-up were rare , Spironolactone was
associated with a small increase in serum potassium. There were no significant
differences in all patient characteristics presented in between the groups of
enrollees with complete and incomplete follow-up.

 3 There were 19 patients with
high and 15 with low aldosterone levels. There were no significant differences
in age, sex, race, body mass index, clinic and 24-h ambulatory BP levels,
duration of HTN and number of antihypertensive medications in high- versus
normal-aldosterone patient groups. There was no significant change in any
studied parameter of diastolic function with spironolactone treatment at 3 or 6
months of follow-up , except that peak early-diastolic longitudinal strain rate
in the normal aldosterone group was significantly decreased at 6 months
compared to baseline. Notably, the LV ejection fraction was preserved in both
highand normal-aldosterone groups. There were no significant changes in LV
ejection fraction with time due to spironolactone therapy.

As previously reported by our group,12 there were significant reductions
in LVMI (g m?2 ) at 3 and 6 months of follow-up during spironolactone treatment
in both the high-aldosterone group (80 ± 4 (baseline), 67 ± 3 (3 months), 63 ±
3 (6 months)) and the normal-aldosterone group (81 ± 4 (baseline), 73 ± 3 (3
months), 71 ± 3 (6 months)); all comparisons Po0.001 versus baseline .

4  From January 1, 2005
to December 31, 2009, 6022 patients with hypertension visited our hospital
(department of inpatient or outpatient). We included a total of 1610 patients
with hypertension, LVH and suspected LV diastolic dysfunction, in which 68
patients have medical records of spironolactone prescription, while 1542
patients without spironolactone treatment. The final study population comprised
65 patients with spironolactone therapy and 1542 patients without
spironolactone therapy. After propensity score matching, a total of 65 patients
receiving spironolactone and 130 patients without spironolactone treatment were

E/E? significantly declined in the spironolactone group (change from
baseline: 0.6 ± 0.7, P b 0.001) and non-spironolactone group (change from
baseline: 0.3 ± 0.7, P b 0.001). And the change of E/E? was much more prominent
in the spironolactone group (P = 0.005). After a median follow-up of 7.4 years,
the new onset symptomatic HFpEF occurred in 3 patients (4.6%) of the
spironolactone group and 21 patients (16.2%) of the non-spironolactone group (P
= 0.021). After 5-year follow-up, For multivariate regression analysis,
variables with P b 0.10 (age, LVMI, E/E?, beta-blocker prescription, ACEI/ARB
exposure and spironolactone treatment) from univariate regression analysis were
entered into the multivariate logistic regression model. The result showed that
spironolactone exposure (OR 0.177, 95% CI: 0.045–0.687, P = 0.012) was
associated with a reduced risk of new onset of symptomatic HFpEF, and the
elevation of LVMI (OR 1.053, 95% CI: 1.011– 1.097, P = 0.012) or E/E? (OR
1.280, 95% CI: 1.015–1.615, P = 0.037) was associated with a high risk of new
onset of symptomatic HFpEF.

Eplerenone In patients with HFpEF

Of the 198 patients screened, 150 were excluded, of which 28 patients
refused to participate or appeared unable to adhere to the study procedures and
122 met at least 1 exclusion criterion including significant comorbidities (n 5
27), Forty-eight patients were enrolled in the open label period and assigned
to receive eplerenone 25 mg daily for 2 weeks. Two patients developed serum
potassium levels O 5 mEq/L. Although the 6MWD improved significantly from
baseline in both groups, there was no significant difference in the change in
6MWD between the eplerenone and placebo arms. There was also no significant
difference in change in NYHA class between groups at week 26. there were no
significant differences by treatment group in change from baseline to week 26 in
left ventricular size, wall thickness and mass, or in left atrial volume or
Doppler mitral inflow measurements. p. In addition, there was no significant
difference in the change in early diastolic annular velocity, E0 in the
eplerenone group (0.8 6 1.99 cm/s) compared to the placebo group (0.11 6 1.86
c/sec; P 5 .12).

A total of 42 patients (21 per group; mean age,
63.5 ± 9.1 years; 37 male,  mean body
mass index 27.1 ± 3.5 kg/m2) were included in the study. No adverse effects
were noted during the duration of the study. Consistency of the measurement was
verified using endothelium-independent vasodilatation after glyceryl
trinitrate, which showed no significant differences. There was no significant
difference in the number of circulating EPCs after treatment with eplerenone
compared with placebo also , no significant differences in platelet adhesion
were seen between eplerenone and placebo