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Novel mineralocorticoid receptor antagonist well tolerated in HF patients with CKD
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A next-generation mineralocorticoid receptor antagonist was associated with improved potassium and kidney tolerance in HF patients with chronic kidney disease, according to late-breaking data presented at Heart Failure Congress 2013.
The phase 2, randomized, double blind ARTS trial evaluated the effects of BAY 94-8862 (Bayer), a nonsteroidal mineralocorticoid receptor antagonist considered to be associated with less renal risk than earlier-generation mineralocorticoid receptor antagonists, according to background information from investigators.
Faiez Zannad, MD, PhD, FESC, of the Université de Lorraine, Nancy, France, presented data from the active comparator-controlled part B arm of the ARTS trial. Part B included 393 patients with HF (NYHA Class II/III) and mild or moderate chronic kidney disease (CKD; estimated glomerular filtration rate, 30 to 60 mL/minute) randomly assigned BAY 94-8862 2.5 mg, 5 mg or 10 mg once daily or 5 mg twice daily; placebo; or open-label spironolactone. The study was conducted at 55 centers in 10 countries.
According to results presented, patients assigned BAY 94-8862 in any dose had smaller mean increases in serum potassium concentration compared with patients assigned spironolactone (P<.0001 for once-daily doses; P=.0107 for twice-daily dose). The incidence of hyperkalemia was 12.7% in the spironolactone group vs. 5.3% in the BAY 94-8862 group (P=.048).
All doses of BAY 94-8862 were safe and well tolerated. Both the investigational drug and spironolactone produced an almost equal effect on B-type natriuretic peptide, amino terminal proBNP and albuminuria, according to information in the release.
“The fourth-generation drug is better tolerated when it comes to potassium and the kidney, even in patients at higher risk because of pre-existing moderate CKD,” Zannad said in the press release. “There is a real unmet need in this population because, while mineralocorticoid receptor antagonists are not contraindicated, many doctors are wary of using them because of the side effects in the kidney. This study is an important step toward investigating newer and wider indications for mineralocorticoid receptor antagonists.”
The researchers said further studies will investigate BAY 94-8862 in other patient populations, including those with HF and diabetes.
For more information:
Zannad F. Late breaking trials 2. Presented at: Heart Failure Congress 2013; May 25-28, 2013; Lisbon, Portugal.