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Researchers from NDPCHS have found that a widely used heart medication, spironolactone, does not help prevent heart problems in people with chronic kidney disease (CKD). The study, published in Nature Medicine, found no significant benefit from the drug and highlighted safety concerns that led many patients to stop the treatment.

Older woman checking prescription with cell phone

Chronic kidney disease is a major public health concern, affecting millions of people worldwide. As the kidneys gradually lose their ability to filter waste from the blood, patients are at higher risk of heart disease and stroke. While new treatments, like the medication finereone, have shown promise in CKD patients with diabetes, the effectiveness of similar drugs in those without diabetes is unclear  

The BARACK-D (Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease) trial was designed to evaluate whether one of these drugs – a medication called spironolactone - could lower the risk of heart disease, stroke, and other cardiovascular complications in people with moderate kidney disease.  

The researchers studied more than 1,300 people with stage 3b CKD, where the kidneys don't work as well as they should, but people aren't yet in need of dialysis or a kidney transplant. Half of the participants took a low dose of spironolactone along with their usual medicines, while the other half just continued with their regular care. The researchers followed both groups for three years to see if spironolactone could lower their risk of heart problems or death. 

Despite its common use for other conditions such as heart failure, the researchers found no significant reduction in cardiovascular events amongst participants treated with spironolactone.  

Dr Nicholas Jones, Lecturer in General Practice in NDPCHS and author of the study, explained: “Over the three years of the study, about 17% of people in both groups experienced serious heart problems or died, suggesting the medication didn't make a significant difference in improving outcomes for people with moderate CKD. In part, this may have been because many participants stopped taking spironolactone relatively early in the study because of treatment safety concerns. 

Two-thirds of participants on spironolactone discontinued treatment within six months. The most common reasons were worsening kidney function and side effects like high potassium levels and low blood pressure, which can be dangerous. Many participants who stopped spironolactone had only relatively mild side-effects, but the study set out very strict criteria for discontinuing treatment to ensure participants’ safety.  

Richard Hobbs, Mercian Professor of Primary Care at NDPCHS and lead author of the study, said: The result of our study is important because spironolactone is an established and relatively cheap alternative to newer drugs like finereone. If it had been effective, it could have been quickly adopted into clinical practice. Unfortunately, our trial did not show benefit from using spironolactone to prevent heart disease, so we cannot recommend that it should be used routinely for CKD patients unless there is another clear medical reason, like heart failure. 

Dr Clare TaylorAcademic General Practitioner at NDPCHS and an author of the study, said: The study did show how common heart problems are in people with kidney disease, highlighting the ongoing need for safe and effective treatments to manage cardiovascular risk in people with CKD, particularly as the population ages and the burden of CKD increases. 

The study underscores the need for more research into safe and effective treatments for heart problems in people with CKD. While spironolactone does not appear to be the solution, newer medications like finerenone may hold promise for a broader group of CKD patients. The authors emphasise that managing heart health in people with kidney disease remains crucial, and more studies are needed to find effective treatments for patients with kidney disease.