Navigation Links
The effect of eplerenone vs. placebo on cardiovascular mortality
Date:8/29/2011

Today results from a new sub-analysis of the EMPHASIS-HF study showed significant reductions in death and hospitalization for five pre-defined high-risk patient sub-groups with chronic heart failure (CHF) and mild symptoms treated with eplerenone in addition to standard therapy versus those treated with placebo and standard therapy.

Commenting on the findings presented for the first time during the European Society of Cardiology Congress (ESC) Hot Line Session on 29th August 2011, EMPHASIS-HF investigator Professor Bertram Pitt, Division of Cardiology, University of Michigan School of Medicine, U.S., said: "The consistency of the efficacy and safety of eplerenone in addition to standard therapy on pre-specified "high-risk subgroups" and the persistence of a significant beneficial effect on the primary endpoint (CV mortality/hospitalization for HF) over an additional 7 months of follow up on douBle blind TherApy in #Onjunction with the prior benefi#iaL requLts fr/m EPHESUS presents compelling evidence for the use of eplerenone in patients with systolic chronic HF NYHA class II and mild symptoms."

Eplerenone has been shown to reduce the primary endpoint of cardiovascular mortality or hospitalization for heart failure (CV mortality/Hosp.HF ), as well as total mortality, total hospitalizations, and new onset atrial fibrillation/flutter in patients with NYHA class II chronic systolic heart failure (NEJM 2011;364:11-21-and ESC-HF 2011). To further determine the applicability of these results to clinical practice the efficacy and safety of eplerenone 25-50 mg/day was evaluated in 5 pre-specified high-risk subgroups including: Age > 75 years, Diabetes Mellitus (DM), estimated glomerular filtration rate (eGFR) < 60 ml/min /1.73 m2, Left ventricular ejection fraction (LVEF) < 30 %, and Systolic blood pressure ( SBP) < median of 123 mm Hg.

Results primary endpoint-for high-risk patient subgroups

In patients > 75 years of age 78 (23.6%) of 330 patients on eplerenone and 107 (32.7%) of 327 on placebo had a primary endpoint - Hazard ratio (HR) 0.66, p<0.004, 95% Confidence Intervals (CI ) 0.49-0.88.

In patients with history of diabetes 99 (21.6%) of 459 on eplerenone and 141 (35.2%) of 400 on placebo had primary endpoint - HR 0.54, p= <0.0001, (CI) 0.42-0.70.

In patients with eGFR< 60 ml/min /1.73 m2 107 (24.4%) of 439 on eplerenone and 163 (34.5%) of 473 on placebo had a primary endpoint - HR 0.62, p=0.0001, CI 0.49-0.79.

In patients with a LVEF <30% 180 (19.3%) of 934 patients on eplerenone and 267 (27.3%) of 978 on placebo had a primary endpoint - HR 0.65, p<0.0001, CI 0.53-0.78.

In patients with a SBP< median 123 mm Hg 138 (20.6%) of 669 patients on eplerenone and 201 (29.4 %) of 683 on placebo had a primary endpoint HR 0.63, p=<0.0001, CI 0.51-0.79.

No new safety information emerged as a result of this analysis. In each of these high risk subgroups patients receiving eplerenone had a significant increase (p<0.05) in the incidence of hyperkalaemia (K+> 5.5 mmol/l). However, there was no significant increase in serious hyperkalemia (K+>6.0 mmol/l), hyperkalaemia leading to drug discontinuation, hospitalization for hyperkalemia, or hospitalization for worsening renal function.

Importantly, after the trial was prematurely stopped for efficacy on March 25, 2010 (primary endpoint [CV mortality and HF hospitalization] HR 0.63, p< 0.0001, CI 0.54-0.74) additional primary endpoints were observed while patients remained on double blind therapy over an additional mean 7 months of follow up (primary endpoint - HR 0.66 , p< 0.0001 CI 0.57-0.77). This new sub-analysis further demonstrated that the beneficial effect of eplerenone remained significant across the wider study population over the additional follow-up period.

Results secondary endpoints

In the five pre-specified high risk groups, the key secondary endpoints of all-cause hospitalization and HF hospitalization, achieved statistically significant (p<0.01) relative risk reductions for the eplerenone group compared to the placebo group.


'/>"/>

Contact: Jacqueline Partarrieu
press@escardio.org
33-633-473-335
European Society of Cardiology
Source:Eurekalert

Related medicine news :

1. Exercise can substitute effectively as second medication for people with depression
2. Metformin and exercise combination less effective for glucose control
3. PET scans confirm effectiveness of estrogen-blocking drugs in breast cancer patients
4. AIDS researchers isolate new potent and broadly effective antibodies against HIV
5. Stanford discovery may eliminate potentially lethal side effect of stem cell therapy
6. Many Men Underestimate Prostate Surgery Side Effects
7. Radiofrequency ablation safely and effectively treats Barretts esophagus
8. Psychiatrists failing to adequately monitor patients for metabolic side-effects of prescribed drugs
9. CPAP Therapy Most Effective for Sleep Apnea, Experts Say
10. Penn study finds more effective approach against Achilles heel of ovarian cancer
11. Sentinel node biopsy safe, effective in head and neck melanomas, U-M study finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/21/2017)... ... 21, 2017 , ... Salveo for life, a company that distributes an effervescent ... United States as part of its presence to expand its market reach. , Using ... the productions of nasty toxins as a result of drinking alcohol, eliminating those toxins ...
(Date:1/21/2017)... ... 21, 2017 , ... Northern California Medical Associates (NCMA) is ... multi-specialty medical group. The dermatology practice provides general dermatologic treatment, outpatient surgery, clinical ... this excellent dermatology practice to our group’s medical services,” explains NCMA CEO, Ruth ...
(Date:1/20/2017)... ... ... A new partnership between Goodwill® and Roadie, Inc. aims to make it easier ... couches to dressers and bicycles. Roadie — the national on-the-way delivery network — will ... through February 28th. , “January is an exciting time when resolutions are made ...
(Date:1/20/2017)... ... , ... Lice Troopers, the lice removal company based in South Florida, has ... holiday season. , “It happens every year around this time,” says owner, Arie ... which is the head-to-head gateway that lice need to spread.” , As children return ...
(Date:1/20/2017)... ... January 20, 2017 , ... Vitamin Well ... VW+ 002. The drinks have been produced in collaboration with Zlatan Ibrahimovic and ... your workout. , After a successful launch in Sweden last year, the next ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... , Jan. 19, 2017 Conference Call and Webcast ... VNDA ) today announced it will release results for the fourth ... closes. ... will host a conference call at 4:30 PM ET on Wednesday, ... and full year 2016 financial results and other corporate activities. To ...
(Date:1/19/2017)... LONDON , January 19, 2017 Incretin ... Sympathomimetics and Others The global anti-obesity drugs ... the first half of the forecast period and CAGR of 38.7% ... expected to grow at a CAGR of 32.8% from 2016 to ... million in 2021, and $24,063 million in 2027. ...
(Date:1/19/2017)... BOCA RATON, Fla. , Jan. 19, 2017 ... ), a medical device company specializing in the ... conditions, such as keloids, with superficial radiation therapy, ... quarter and full year 2016 financial results on Thursday, ... The Company will hold a conference call ...
Breaking Medicine Technology: