Study findings indicate that the use of mineralocorticoid receptor antagonists is associated with a lower risk of all-cause hospitalization among older patients with heart failure (HF) and concomitant diabetes mellitus or chronic kidney disease (CKD).
The risk of hyperkalemia and acute renal insufficiency was only increased among patients with HF and preserved ejection fraction.
Lauren Beth Cooper, MD, of Duke, presented the results of this retrospective study at the Scientific Sessions of the American Heart Association (AHA) held November 12 to 16, 2016, in New Orleans, LA. Other coinvestigators from Duke included Steven Lippmann, PhD, Melissa Greiner, MS, Jacob Kelly, MD, Abhinav Sharma, MD, and Adrian Hernandez, MD.
The increased risk of hyperkalemia or acute renal insufficiency has traditionally limited the use of mineralocorticoids in this population, but the findings from this study indicate that these agents may be safe and beneficial in a select group of patients.
Using the AHA’s Get With The Guidelines-Heart Failure registry, Cooper and coinvestigators used data from 2005 to 2013 that were linked to Medicare claims. The study included 16,848 patients who were hospitalized for HF (with preserved or reduced ejection fraction), had a history of diabetes mellitus or CKD, and were not taking a mineralocorticoid receptor antagonist at the time of the hospital admission.
The primary end point of the study was all-cause mortality at 30 days, 1 year, or 3 years.
Approximately 12% of patients were prescribed a mineralocorticoid receptor antagonist at discharge. These patients were younger, had a higher rate of diabetes mellitus, had a lower rate of CKD, and, among those with HF, had a higher rate of reduced ejection fraction.
Mineralocorticoid use was not associated with the primary end point of the study (Table).
Table. Mineralocorticoid Use and Rates of Mortality and Hospitalization
|Time Point||HR (95% CI)||P Value|
|Mortality||30 d||0.94 (0.68-1.30)||.69|
|1 y||0.99 (0.91-1.09)||.89|
|3 y||1.02 (0.94-1.09)||.68|
|All-cause hospitalization||30 d||0.97 (0.87-1.09)||.63|
|1 y||0.92 (0.87-0.98)||.01|
|3 y||0.93 (0.89-0.98)||.006|
|Rehospitalization for HF||30 d||0.83 (0.69-0.99)||.04|
|1 y||0.93 (0.84-1.03)||.15|
|3 y||0.94 (0.87-1.02)||.14|
CI = confidence interval, HF = heart failure, HR = hazard ratio.
With regard to the secondary end points of the study, mineralocorticoid use was not associated with all-cause rehospitalization at 30 days; however, it was significantly associated with a decreased risk of rehospitalization at 1 and 3 years. This relationship remained after adjusting for discharge medications. Use of a mineralocorticoid receptor antagonist was significantly associated with rehospitalization for HF at 30 days, but not at 1 and 3 years.
Mineralocorticoid use was associated with an increased risk of hospitalization with a diagnosis of hyperkalemia and acute renal insufficiency at 30 days, 1 year, and 3 years. Mineralocorticoids were also associated with a significantly increased risk of hospitalization due to a primary diagnosis of hyperkalemia at 1 and 3 years and of acute renal insufficiency at all 3 time points.
“It is worth noting that, despite the increased risk of hospitalization for hyperkalemia and acute kidney injury, there was an overall decrease in the risk of hospitalization for patients treated with mineralocorticoid receptor antagonists, suggesting that the benefits of therapy outweigh the risks in this high-risk patient population,” said Cooper.
She added that similar conclusions were reached in previous analyses from landmark clinical trials of mineralocorticoid use in HF, with sustained benefit of mineralocorticoid receptor antagonists despite an increased risk of adverse events.
Source: Cooper LB, Lippmann SJ, Greiner MA, et al. Mineralocorticoid receptor antagonist use in patients with heart failure and co-morbid diabetes or CKD. Presented at: American Heart Association Scientific Sessions 2016; November 12-16, 2016; New Orleans, LA. Abstract 533.