Editor's Note: This article has been edited to clarify the title of Dr. Galimella as MBBS, MPH.
In an interview with Pharmacy TimesĀ®, Pranav Garimella, MBBS, MPH, chief medical officer of the American Kidney Fund and board-certified nephrologist at UC San Diego Health, discusses what the recent FDA approval of semaglutide (Ozempic, Wegovy; Novo Nordisk), a glucagon-like peptide-1 receptor agonist (GLP-1 RA) to reduce kidney disease and cardiovascular death risky in adults with type 2 diabetes (T2D) and chronic renal disease (CKD) averaged in patients in this population. Galimella explains the efficacy data behind Semaglutide's approval and details the mechanisms of action behind the progression of kidney disease and the demonstrated reduction of cardiovascular events.
Pharmacy Times: What does the approval of semaglutide to reduce the risk of death from kidney disease in CKD mean for patients in this population?
Key takeout
1. Semaglutide slows the progression of kidney disease, reduces cardiovascular events, and addresses the major causes of death in patients with CKD with T2D.
2. Beyond glucose and blood pressure control, its anti-inflammatory and vascular protective effects contribute to its cardiovascular and renal benefits.
3. Semaglutide is expected to be a core treatment along with RAS inhibitors, SGLT2 inhibitors and mineralocorticoid RAS in the management of CKD-related complications.
Pranav Garimella, MBBS, MPH, Chief Medical Officer, American Kidney Fund: Semaglutide is an exciting new drug just approved by the FDA to manage and prevent the progression of kidney disease in patients with type 2 diabetes (T2D). This is an exciting new development and the kidney community is really seeing results from a float trial that this approval is a significant milestone and is based on a new therapeutic adjunct that can be used in this highly risky T2D population that we often see. It was not just the progression of renal failure that has stopped. It is a cardiovascular disease event and the cause of death in these patients. And I think that in reality, being able to slow both kidney and cardiovascular disease is an important advance in caring for this patient population.
Pharmacy Times: Can you explain how semaglutide behavioral mechanisms work to reduce the risk of death in CKD patients?
Galimella: Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists (RAS), and has demonstrated a reduction in cardiovascular morbidity and mortality in addition to weight loss and glycemic control. In addition to these, GLP-1 RA has a variety of effects throughout the metabolism and vasculature. They have anti-inflammatory effects. They have antithrombotic effects. It is also thought to be able to stabilize the plaques in these blood vessels, leading to a less atherosclerotic systemic environment. What this does is to decrease [overall] It is the burden of cardiovascular disease, which could be one of the reasons why diabetics, and even CKD, have fewer cardiovascular events when taking GLP-1 RA. Recently, there has been a large meta-analysis of several trials that have shown a reduction of up to 15% in these major cardiovascular events. So this is a truly exciting new development in this field.
Pharmacy Times: How does semaglutide differ from standard CKD treatments? Could semaglutide one day become the standard care option for CKD?
Galimella: Historically, CKD treatment has really focused on managing the underlying causes. It is usually a treatment for diabetes, treatment for hypertension, and even high cholesterol levels. GLP-1 RA like Semaglutide affects glucose control and blood pressure control, but the advantages do not seem to be contrary to those found in glucose and blood pressure alone. I think it relates to some of the other non-blood pressure and glucose effects I just mentioned. Therefore, the results of semaglutide in CKD actually provide the promise that treatment strategies can have a significant impact on the entire cardiovascular system, and some of these medications can be reconstructed and used to prevent cardiovascular and heart failure complications, not only for treatment of diabetes. Renin-Angiotensin System (RAS) Inhibitors and Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors and mineralocorticoids RAS, semaglutide or GLP-1 RAS are very likely to be the fourth pillar of managing cardiovascular complications essentially from T2D and IT. With more data available on patients with diabetes and CKD, we hope that the use of GLP-1 RAS will be incorporated into guidelines-oriented therapies to manage these patients.
