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:12/2/2016)... PA (PRWEB) , ... December 02, 2016 , ... ... and pharmaceutical organizations to build intelligent, connected applications, was named the best Sales ... , The winner announcement was made today by the Software & Information ...
(Date:12/2/2016)... ... December 02, 2016 , ... ‘Tis the season for giving! Today, 20 ... the National Family Partnership and the Drug Enforcement Administration as part of the National ... the 10 winning schools who decorated their campuses with this year’s Red Ribbon Week ...
(Date:11/30/2016)... Northridge, CA (PRWEB) , ... November 30, 2016 ... ... Elyson, announce that they now offer a comprehensive in-house dental plan for all ... dentists have developed a plan that gives patients a number of perks, including ...
(Date:11/30/2016)... PALMYRA, Wisconsin (PRWEB) , ... November 30, 2016 ... ... inclusion in the 2016 Deloitte Wisconsin 75, an annual ranking and recognition of ... consecutive year on the list, having ranked from 2008-2016. In addition, Standard Process ...
(Date:11/30/2016)... Chino Hills, CA (PRWEB) , ... November 30, ... ... in eating disorder and mental health treatment has announced the opening of a ... specialized residential treatment for girls with mental health issues such as severe anxiety, ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... FRANCISCO , Dec. 2, 2016  PipelineRx, a ... telepharmacy, will be offering demonstrations of its SaaS-based ... Society of Health-System Pharmacists 2016 Midyear Clinical Meeting ... Vegas . With nearly 300 hospital clients ... services and technology designed to dramatically improve pharmacy ...
(Date:12/2/2016)... December 2, 2016 On Thursday, ... honored excellence in research, development and innovation in the ... dinner was held in the presence of Sergey Tsyb, ... Russian Federation , Natalia Sanina, First Vice ... Murashko , Head of Roszdravnadzor, National Service of Control ...
(Date:12/2/2016)...  Eli Lilly and Company (NYSE: LLY ... provide updated financial guidance for 2016 on Thursday, December ... on that day with the investment community and media ... The conference call will begin at 10 a.m. ET. ... live webcast of the conference call through a link ...
Breaking Medicine Technology: