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• W3119828188 abstract "Type 2 diabetes is the primary contributing risk factor for chronic kidney disease (CKD), which develops in approximately 40% of patients with diabetes. Historically, treatment options for diabetic-induced CKD have included a narrow list of agents, mainly ACE inhibitors and ARBs, which slow progression of tissue fibrosis. However, very recently, the medical community has seen a potential surge in new applications for diabetes drugs for preventing CKD progression, despite the slow development of novel agents that target diabetic CKD pathology specifically. Results from a Phase III clinical trial for the novel agent finerenone, published in the October 2020 issue of the New England Journal of Medicine, have set a promising stage for favorable CKD treatment outcomes for patients with type 2 diabetes. Molecularly, finerenone is a dihydropyridine (DHP) and does not have steroid homology, like spironolactone. Pharmacists may recall that this makes the drug very similar in structure to peripheral calcium channel blockers, such as amlodipine. However, finerenone's novel therapeutic effect in type 2 diabetes CKD is not a result of vasodilation, but of selective inhibition of the mineralocorticoid receptor, ultimately resulting in aldosterone antagonism. Although preliminary evidence for use of traditional mineralocorticoid receptor antagonists (MRAs) has not yet yielded a hard clinical benefit, insights from surrogate outcomes over the years have given hope. A meta-analysis published in the American Journal of Kidney Diseases, for example, observed a 30% reduction in proteinuria in patients with CKD when traditional MRAs, such as spironolactone, were added to a regimen of ACE inhibitors or ARBs. In addition, a recent review of kidney disease pathophysiology published in Kidney International suggested that MRAs may mitigate proinflammatory processes that result from CKD-associated hyperaldosteronism—such as reducing local increases in reactive oxygen species and inflammatory cytokines—that ultimately contribute to kidney tissue fibrosis and failure. Indeed, preliminary evidence published in the Journal of Nephrology in 2020 indicated that this benefit may extend to the novel nonsteroidal MRAs, such as finerenone. Traditional MRAs have set the stage nicely for the Phase III trial of finerenone to investigate the most selective MRA to date. While traditional MRAs may offer a benefit, their structural similarity to steroid hormones can cause collateral damage with long-term use, such as gynecomastia, erectile dysfunction, and hyperglycemia. Conversely, the unique nonsteroidal DHP structure of finerenone conveys a more selective binding to the mineralocorticoid receptor, with minimal metabolic and hormonal adverse effects. In addition, preliminary evidence published in JAMA in 2015 suggest a lesser degree of hyperkalemia compared with spironolactone. Remarkably, the data published in the New England Journal of Medicine from FIDELIO-DKD, the Phase III trial, demonstrated that patients with type 2 diabetes and CKD receiving finerenone had a statistically significant 18% relative reduction in a composite outcome for renal failure, glomerular function decrease (40% reduction from baseline), and kidney disease–related mortality after a median follow-up of 2.6 years, compared with patients on standard-of-care ACE/ARB therapy. In addition, a time-to-event analysis revealed a significant relative reduction in cardiovascular events just 1 month after treatment began. The results of the FIDELIO-DKD trials are encouraging but have raised further questions about finerenone's efficacy compared with existing agents—SGLT2 inhibitors and steroidal MRAs, primarily. “Finerenone is distinctly different, not only from the SGLT2 inhibitors, but from its cousins, spironolactone and eplerenone,” said George Bakris, MD, lead investigator of the FIDELIO-DKD trial, in a video statement in the American Journal of Managed Care. “Finerenone reduces albuminuria to the same extent as SGLT2s.” He went on to note that finerenone's benefit in slowing progression of kidney disease, however, was similar, but not quite as good as the SGLT2s. Bakris hypothesized that the lesser degree of benefit seen with finerenone could be a result of a lack of exclusion of patients taking SGLTs within the FIDELIO-DKD trial. “Unfortunately, the numbers are too small when you look at the events to make a statement about whether there was additivity or synergy between the two compounds,” said Bakris. Results from other Phase III trials investigating nonsteroidal MRAs are eagerly anticipated. While the data for finerenone are still in their infancy and more long-term data are needed, one thing is certain: New treatment strategies for tackling diabetic CKD have been long overdue." @default.
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• W3119828188 date "2021-01-01" @default.
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• W3119828188 title "Novel drug may introduce new avenue for diabetes treatment" @default.
• W3119828188 doi "https://doi.org/10.1016/j.ptdy.2020.12.020" @default.
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