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Investigators of a recent study said targeted interventions are needed to reduce the global burden, particularly in developing countries.

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ASHP Midyear 

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Kathryn Litten is a clinical assistant professor at the University of Texas at Austin’s College of Pharmacy. She's worked as a clinical pharmacist since 2019 and is a board-certified ambulatory care pharmacist.

Kathryn Litten, PharmD, discussed the pharmacist’s role in helping patients manage metabolic dysfunction-associated steatotic liver disease.

Q&A: Importance of Managing Comorbidities for Patients with MASLD | ASHP Midyear

Kathryn Litten, PharmD, joined Drug Topics to discuss how pharmacists can counsel patients with metabolic dysfunction-associated steatotic liver disease.

How Pharmacists Can Help Patients Manage MASLD | ASHP Midyear

journal explores issues within pharmacy, from the impact advocacy can have in community pharmacies to staffing shortages across multiple sectors within pharmacy. This month’s issue also explored the importance of disease awareness months and how they are opportunities to maximize valued care. Check out a preview of this month’s issue here.

download the PDF of the Total Pharmacy August 2024 issue here

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See what’s trending in pharmacy with a preview of the Total Pharmacy August issue.

Total Pharmacy

In This Issue: Total Pharmacy August 2024

Combining sodium glucose co-transporter 2 inhibitors (SGLT2is) with glucagon-like peptide-1 receptor agonists (GLP-1RAs) may offer additional protection against cardiovascular and kidney disease in patients with type 2 diabetes (T2D), according to the results of a new meta-analysis published in 

 and presented at the 61st European Renal Association Congress in Stockholm, Sweden.

Separately, SGLT2is and GLP-1RAs have demonstrated cardiovascular benefits. However, little clinical literature has focused on outcomes associated with using the medicines together. Due to the growing prevalence of GLP-1RAs in the 

 and obesity landscape, accelerated by an increasing number of indications for the agent class, this is a crucial area for further study.

The SGLT2 Inhibitor Meta-analysis Cardio-Renal Trialists’ Consortium (SMART-C) is the largest assessment of outcomes for the combined therapeutic use of SGLT2is and GLP-1RAs. The study gathered data from 12 large-scale, placebo-controlled trials of SGLT2is involving 73,238 patients with diabetes. Of these, 3065 were already receiving GLP-1RAs.

Overall, SGLT2is lowered the risk of major adverse cardiovascular events by 11% and hospitalization for heart failure or cardiovascular death by 23% compared to placebo. Notably, this benefit was seen regardless of whether patients were also taking GLP-1RAs.

When used together with GLP-1RAs, SGLT2is reduced the risk of chronic kidney disease progression by 33% and slowed the annual loss of kidney function by nearly 60%.

The study found no additional safety concerns when SGLT2is were used in combination with GLP-1RAs.

Study Reveals Robust Benefits of Semaglutide in Protecting Against Kidney, CV Events in Patients With T2D

Current meta-analysis results build off positive results of the landmark FLOW trial (

). Published earlier in May, results of the international, double-blind, randomized, placebo-controlled phase 3 trial spotlighted semaglutide’s effectiveness in lowering the risk of kidney failure, decelerating worsening kidney function, and protecting against the risk of cardiovascular events and death, in patients with T2D.

“SGLT2 inhibitors have clear protective effects against heart failure and chronic kidney disease, while GLP-1 receptor agonists can reduce the risk of heart attack, stroke, and also kidney disease—as recently demonstrated in the landmark FLOW trial,” said Brendon Neuen, lead author, clinical associate professor, senior research fellow at The George Institute for Global Health, and director of kidney trials at Sydney’s Royal North Shore Hospital, in a news release.

 “Our findings support using this combination to further improve outcomes in patients with type 2 diabetes who meet guideline recommendations for both therapies.”

Elevated glucose from diabetes can damage blood vessels in the heart and kidneys, increasing the risk of 

 and kidney disease. In fact, diabetes is the most common cause of chronic kidney disease.

Moreover, estimates predicting that T2D prevalence will more than double in the next 30 years, surpassing 1 billion global cases by 2050, further strengthen the need for research into diabetes care.

 According to Neuen in an interview with 

 conducted over email, the current study offers valuable insights for developing global treatment strategies for the condition.

"These findings, which represent the largest and most comprehensive evaluation of the combined use of SGLT2i and GLP-1RA, provides the clearest evidence yet that combined use of both medicines can further reduce cardiovascular and kidney disease," said Neuen. "We anticipate that these findings will inform how people with diabetes are treated worldwide, including influencing major clinical practice guidelines.

Although current results suggest that using SGLT2is and GLP-1RAs in tandem may offer robust protection against cardiovascular and kidney disease, further research is needed to fully understand the long-term effects of the combination therapy.

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1. Apperloo E, Neuen BL et al. Efficacy and safety of sodium glucose co-transporter 2 inhibitors with and without glucagon-like peptide-1 receptor agonists: A SMART-C collaborative meta-analysis of randomised controlled trials. 

. 2024. doi: 10.1016/S2213-8587(24)00183-9

2. Massaro L. Study reveals robust benefits of semaglutide in protecting against kidney, CV events in patients with T2D. 

https://www.drugtopics.com/view/study-reveals-robust-benefits-of-semaglutide-in-protecting-against-kidney-cv-events-in-patients-with-t2d

3. Combining popular diabetes drugs offers complementary heart and kidney benefits. News release. The George Institute for Global Health. July 9, 2024. Accessed July 10, 2024. 

https://www.georgeinstitute.org/media-releases/combining-popular-diabetes-drugs-offers-complementary-heart-and-kidney-benefits

4. Mayo Clinic Staff. Chronic kidney disease. Fact sheet. Accessed July 8, 2024. 

https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/symptoms-causes/syc-20354521

5. Klein HE. Diabetes prevalence expected to double globally by 2050. 

https://www.ajmc.com/view/diabetes-prevalence-expected-to-double-globally-by-2050

When used together, sodium glucose co-transporter 2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) were able to lower the risk of major adverse cardiovascular events and kidney disease by 11% and 33%, respectively.

Clinical

SGLT2i, GLP-1RA Combination Therapy Offers Robust Protection Against Cardiovascular, Kidney Disease

According to SURMOUNT-1 and SURMOUNT-2 trial research, the glucagon-like peptide-1 (GLP-1) tirzepatide showed significantly greater weight loss among patients with obesity who did and did not have type 2 diabetes (T2D) when compared with patients using semaglutide. Research data was presented at the American Society of Health-System Pharmacists (ASHP) 2024 Midyear Clinical Meeting.

“Recently, it has been approved for the management of moderate-to-severe obstructive sleep apnea. However, semaglutide has an indication for cardiovascular risk reduction whether used for people living with [T2D] or obesity. Tirzepatide’s cardiovascular evidence among people with [T2D] should be forthcoming in 2025, but it will be a few more years until evidence is reported on these outcomes in individuals living with obesity,” said Jennifer Clements, PharmD, BCACP, BC-ADM, BCPS, CDCES, FADCES, FCCP.

Clements gave a presentation at ASHP Midyear 2024 titled “Let the Debate Begin: GLP-1 Receptor Agonists vs Newer Incretin Mimetics for Obesity and Type 2 Diabetes.” After the session, she caught up with 

 to discuss the current indications of tirzepatide and semaglutide, who they compare to each other, and what to expect from each medication in the future.

 Can you discuss the data from the SURMOUNT clinical trials that demonstrate an edge for tirzepatide over semaglutide?

The SURMOUNT-1 trial included adults with at least 1 unsuccessful dietary effort to lose weight. In addition, their weight was classified as overweight or obesity in the presence of a comorbidity (eg, hypertension, hyperlipidemia). SURMOUNT-1 trial investigated the efficacy and safety of tirzepatide among adults with [T2D] who were overweight or had obesity. Both trials had coprimary outcomes, which included percent change in body weight and achievement of 5% (or more) weight loss from baseline to week 72.

When looking at the results in SURMOUNT-1 trial, tirzepatide had statistically and clinically significant reduction versus placebo. The weight reduction was 15.9%, 19.5%, and 20.9% with tirzepatide 5 mg, 10 mg, and 15 mg, respectively. In addition, more than 85% of individuals achieved the 5% (or more) weight loss goal of 5%. It was more common for individuals to discontinue tirzepatide due to gastrointestinal reactions, which is consistent with other evidence with GLP-1 receptor agonists. From the SURMOUNT-2 trial, change in body weight was -12.8% and -14.7% with tirzepatide 10 mg and 15 mg, respectively, when compared [with] placebo. The percentage was not the same as SURMOUNT-1 trial given that there is insulin resistance among people with [T2D]. More than three-fourths of individuals achieved that minimum weight loss goal of 5% or more in the SURMOUNT-2 trial. Safety outcomes were consistent and similar with discontinuation due to gastrointestinal adverse events in the first couple of months in the SURMOUNT-2 trial.

When comparing semaglutide versus tirzepatide, tirzepatide has greater weight loss in those living with obesity with or without [T2D]. In addition, it has different cardiovascular outcomes among those with obesity and heart failure with preserved ejective fraction. Recently, it has been approved for the management of moderate-to-severe obstructive sleep apnea. However, semaglutide has an indication for cardiovascular risk reduction whether used for people living with [T2D] or obesity. Tirzepatide’s cardiovascular evidence among people with [T2D] should be forthcoming in 2025, but it will be a few more years until evidence is reported on these outcomes in individuals living with obesity. The person with [T2D] and other comorbid conditions will make the decision about what treatment is going to be best for them. Decisions will vary from person to person based on individual needs and preferences. In addition, there should be shared decision-making on the best agent for an individual when considering lifestyle habits, budget/financial restraints, and insurance coverage.

2024 ASHP Midyear Clinical Meeting and Exhibition here

Jennifer Clements, PharmD, BCACP, BC-ADM, BCPS, CDCES, FADCES, FCCP, discussed the benefits of tirzepatide compared with semaglutide.

Health System

Q&A: Factors Showing Tirzepatide is More Beneficial Than Semaglutide | ASHP Midyear

How Nonstatin Therapies Can Optimize Patients’ Cardiovascular Health 

Lipid-lowering medications, also known as antihyperlipidemic drugs, are designed to lower patients’ cholesterol levels, in turn creating better cardiovascular outcomes.

 However, when it comes to the use of antihyperlipidemic drugs, patients are presented with multiple options.

John Bucheit, PharmD, Ambulatory Care Pharmacist and Assistant Professor at the Virginia Commonwealth University’s School of Pharmacy, discussed the 2 main types of cholesterol-maintaining medications: statins and nonstatins. Statins are considered the first line of defense when it comes to the regulation of a patients’ cholesterol. Nonstatins, on the other hand, are typically used in conjunction with statins.

“When I think about lipid-lowering medications, I think about [it] as all-hands-on-deck. Cardiovascular disease is the number 1 cause of death in the United States. I really try to avoid looking at an ‘either or’ approach to statins versus nonstatins, and really think about how can we best manage this patient's cholesterol levels,” said Bucheit.

At the American Society of Health-System Pharmacists 2024 Midyear Clinical Meeting and Exhibition, held December 8 to 12 in New Orleans, Louisiana, Bucheit hosted a session titled “Get Low: Use of Non-Statin Therapies in Reducing Residual Cardiovascular Risk.” 

caught up with him after to get further insights on nonstatins for improving patients’ cardiovascular health.

1. Antihyperlipidemic. Cleveland Clinic. September 22, 2023. Accessed December 9, 2024. 

https://my.clevelandclinic.org/health/treatments/antihyperlipidemic

2. Beyond statins: What you need to know about other LDL cholesterol-lowering treatments. CardioSmart by the American College of Cardiology. August 25, 2023. Accessed December 9, 2024. 

https://www.cardiosmart.org/topics/high-cholesterol/treatment/beyond-statins-other-ldl-lowering-treatments

John Bucheit, PharmD, discussed lipid-lowering medications and how nonstatins can be beneficial for cardiovascular health.

How Nonstatin Therapies Can Optimize Patients’ Cardiovascular Health | ASHP Midyear

The diagnostic pathways of metabolic dysfunction-associated steatohepatitis (MASH) can be more successfully understood with the introduction of discrete event simulation (DES) using non-invasive tests (NITs), according to a poster presented at the American Society of Health-System Pharmacists 2024 Midyear Clinical Meeting and Exhibition.

“MASH, previously referred to as nonalcoholic steatohepatitis, is a leading cause of liver-related morbidity, mortality, and high costs. Early and accurate identification of patients with non-cirrhotic MASH may decrease long-term resource utilization and cost,” wrote authors of the poster.

According to American Liver Foundation statistics, MASH is growing increasingly prevalent in the US. There are currently around 9 to 15 million US adults with MASH, accounting for up to 6.5% of the population. Furthermore, these rates are expected to rise by 63% come the year 2030.

With the disease burden of MASH impacting a large group of US adults, health care experts are looking to alleviate the high health care costs that have accompanied the increase in MASH cases across the country. Using the DES model, researchers aimed to establish a standard of care and service that models the capabilities of currently accepted screening strategies.

Tai Chi Intervention, Liver Disease Prevalence for People with OA

“A DES model was built comparing the use of various [NITs] and combinations of sequential NITs to identify patients with MASH and advanced fibrosis. The entire care pathway was considered including screening, disease progression, outpatient and inpatient care, and cost data over a 3-year time horizon,” they continued.

The DES was designed for study participants to move through the model, capturing the utilization and costs of health care, as well as yearly disease progression, for participants with MASH. Researchers then simulated the diagnosis of MASH in 5 separate screening scenarios (SS): enhanced liver fibrosis (ELF) alone; magnetic resonance elastography (MRE) alone; transient elastography (TE) alone; ELF followed by TE; and ELF followed by MRE.

The DES model included a total of 100,000 participants with at-risk MASH. For the ELF SS, 86% of patients were successfully diagnosed, while 26% of cirrhotic patients were identified correctly. For the MRE-only SS, 82% were successfully diagnosed and 66% of cirrhotic patients were identified correctly. For the TE-only SS, 68% were successfully diagnosed and 42% of cirrhotic patients were identified correctly.

Finally, for the 2 scenarios using screening methods in conjunction with ELF, 92% of patients were correctly diagnosed when TE followed ELF, and 93% of patients were correctly diagnosed when MRE followed ELF.

After testing multiple screening strategies for the diagnosis of MASH, researchers agree that a DES model using NITs can advance the industry’s current knowledge regarding how to quickly and effectively diagnose this specific type of liver disease. While the success and effectiveness of screening for MASH diagnosis were researchers’ top priority in the study, they believe further advancements in DES models will lead to an even faster and more accurate diagnosis going forward.

“This DES model effectively simulated MASH diagnostic pathways using NITs,” concluded authors of the poster.

 “Improvements in screening will result in early and accurate diagnosis. Future simulation will include modeling inpatient and outpatient outcomes and associated resources and costs based on accuracy of screening.”

1. Kim Y, Loughry E, Dinani A, et al. Service and care pathways for health systems to aid identification and management of patients with metabolic dysfunction-associated steatohepatitis (MASH): A discrete event simulation (DES) model. Presented at: American Society of Health-System Pharmacists 2024 Midyear Clinical Meeting and Exhibition; December 8-12, 2024; New Orleans, LA. Poster 4-074.

2. Real World Health Care Editorial Staff. MASH 101: What you need to know about an emerging liver disease. Health Well Foundation. August 7, 2024. Accessed December 10, 2024. 

https://www.healthwellfoundation.org/realworldhealthcare/mash-101-what-you-need-to-know-about-an-emerging-liver-disease/

Researchers observed the use of a discrete event simulation using non-invasive tests for patients with nonalcoholic steatohepatitis.

DES Model Successfully Simulated MASH Diagnosis | ASHP Midyear

With growing prominence of cardiovascular disease in the US, several medications and therapeutic agents have been approved by the FDA to help patients relieve their symptoms. And with a slew of medications available, it’s important for pharmacists to educate their patient population on the therapies most useful for each specific individual.

According to John Bucheit, PharmD, Ambulatory Care Pharmacist and Assistant Professor at the Virginia Commonwealth University’s School of Pharmacy, a combination of statins and nonstatins can achieve better patient outcomes.

“I really try to avoid looking at an ‘either or’ approach to statins versus nonstatins, and really think about how can we best manage this patient's cholesterol levels,” he said.

at the American Society of Health-System Pharmacists 2024 Midyear Clinical Meeting and Exhibition, held December 8 to 12 in New Orleans, Louisiana. Learn from a medication and ambulatory care expert on how patients can better manage their cholesterol levels.

: Why might a nonstatin therapy be a better choice for a patient to manage cardiovascular risk?

When I think about lipid-lowering medications, I think about [it] as all-hands-on-deck. Cardiovascular disease is the number 1 cause of death in the United States. I really try to avoid looking at an ‘either or’ approach to statins versus nonstatins, and really think about how can we best manage this patient's cholesterol levels. So, statins have robust safety and efficacy data, and they come in many different strengths. They're also relatively inexpensive now that they've been out for a really long time. [For] our nonstatins, we do have some low-cost nonstatin agents, as well as some more expensive agents. So, using that combination is really important to optimize that patient's cardiovascular health.

: Why is recent research promising for nonstatin therapies?

I think the big take-home point from our presentation is that it's an exciting time to be in lipid management. It's really good for patients because there are more and more options, as well as more and more data coming out showing that nonstatin agents are beneficial for patients with cardiovascular disease or at higher risk for cardiovascular disease. Being able to use combinations of products to optimize our patient's health is something that the data is continuing to support and more advances with that as we look forward to the next set of clinical practice guidelines.

John Bucheit, PharmD, joined Drug Topics to discuss statins and nonstatins’ efficacy in treating cardiovascular disease.

Kathryn Litten, PharmD, BCACP

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