Researchers find drug used widely to treat eye condition has 'no benefit'

In continuation of my update on Eplerenone, 

Researchers from the University of Bristol and University Hospital Southampton have found that a drug used widely to treat a common eye condition has "no benefit" and should no longer be used. Eplerenone, which is primarily used to treat heart failure, is currently offered widely by ophthalmologists as a treatment for central serous chorioretinopathy (CSCR) based on limited clinical data.

The condition causes fluid to accumulate under the retina and can lead to vision loss in up to a third of patients.

It is the fourth most common retinal disease and affects 10 in 100,000 men and two in 100,000 women mainly in their 30s and 40s.

Eplerenone, which is one of a group of drugs that decrease the activity of hormones that regulate salt and water in the body, was found to improve vision in a small number of patients in early-stage research.

However, it is also associated with side effects including raised potassium levels which can affect heart rhythm, and a decrease in blood pressure.

As a result, Professor Andrew Lotery, a consultant ophthalmologist at University Hospital Southampton, launched the first study into the long-term efficacy and safety of the drug for CSCR.

The £1 million trial, funded by the Medical Research Council and National Institute for Health Research Efficacy and Mechanism Evaluation (EME) Programme, saw 111 patients at 22 sites across the UK receive either the medication or an identical placebo tablet for up to 12 months.

The results, published today by The Lancet, showed there was no benefit of treating patients with eplerenone compared to those who took a placebo.

"Despite a lack of robust clinical trial evidence, eplerenone and other similar drugs are widely used by ophthalmologists as first line therapy for the treatment of CSCR," explained Prof Lotery, a professor of ophthalmology at the University of Southampton.

"However, as these drugs can have side effects such as hyperkalaemia, which causes a rise in potassium and can affect heart rhythm, it was important to the NHS that we determine efficacy and safety."After a year of follow-up, this study found no benefit of treating patients with eplerenone compared to those patients that took a placebo tablet."

He added: "This is an important practice-changing finding and should prompt ophthalmologists to stop treating CSCR with eplerenone, instead opting to participate in future trials of other potential interventions."

The study was co-led by Professor Sobha Sivaprasad, a consultant ophthalmologist at Moorfields Eye Hospital, and managed by researchers from the Bristol Trials Centre at Bristol Medical School at the University of Bristol which co-designed the study and analysed the data. Twenty-two hospitals participated and recruited participants to the study.

Professor Barnaby Reeves, of the Bristol Trials Centre, said: "It has been rewarding to collaborate on a study that has generated such a clear answer—all aspects of participants' vision that we measured showed no benefit of eplerenone. Researchers can now focus their attention on alternative interventions."

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)33132-0/fulltext

https://en.wikipedia.org/wiki/Eplerenone

Drug may improve outcomes after heart attack

 We know that, Eplerenone (INN)  is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is similar to the diuretic spironolactone, though it is much more selective for the mineralocorticoid receptor in comparison (i.e., does not possess any antiandrogen, progestogen, or estrogenic effects), and is specifically marketed for reducing cardiovascular risk in patients following myocardial infarction. It is marketed by Pfizer under the trade name Inspra. Eplerenone is a potassium-sparing diuretic, meaning that it helps the body get rid of water but still keep potassium....

Now,

The REMINDER (Reduction of heart failure morbidity in patients with acute ST-elevation myocardial infarction) trial was a randomized, double-blind trial of 1,012 patients who had a heart attack caused by a complete blockage of one of the heart's arteries. Patients had no signs or history of heart failure. They were given either eplerenone or placebo in addition to standard therapy. Overall, patients taking eplerenone were 38 percent less likely to have poor outcomes than those given a placebo.

Eplerenone counteracts a hormone called aldosterone, which can increase blood pressure. The drug is currently approved to treat hypertension and as a treatment for patients who have heart failure several days after a heart attack.

"This is the first randomized trial to test a mineralocorticoid receptor agonist during the acute phase of heart attack, and the results suggest a clinical benefit," said Gilles Montalescot, MD, PhD, lead investigator of the study and professor of cardiology and head of the Cardiac Care Unit at Pitié-Salpétrière Hospital, Paris.

About 5.8 million Americans have heart failure, a condition in which the heart cannot pump enough blood to meet the body's oxygen and energy needs. Improvements in heart attack treatment have increased chances of survival, but damage after heart attack is one risk factor for heart failure. Clinical trials and registries show that in the 30 days after a first heart attack, between 8.6 percent and 40 percent of patients will be diagnosed with heart failure.

Drug may improve outcomes after heart attack