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RBI-4000 is a self-replicating RNA (srRNA) vaccine developed to stimulate virus-neutralizing immune responses to rabies for prophylactic use.

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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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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

The American Diabetes Association (ADA) recently released its updated Standards of Care, in which it is recommend that all patients taking insulin or those who are at high risk for hypoglycemia be prescribed glucagon.

The organization also recommends that family members, caregivers, school personnel, and others who provide support to patients with diabetes be educated on how to administer glucagon and where it is located in case of emergency.

, Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP, professor of pharmacy practice at Massachusetts College of Pharmacy and Health Sciences, and Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, director of education and training in diabetes technology at Cleveland Clinic, discussed the ADA's new Standards of Care and the benefits of allowing pharmacists to prescribe glucagon.

Wearing CGMs Can Help Student Pharmacists Improve Counseling Ability

, Goldman discussed the benefits of glucagon for patients with diabetes, challenges and barriers currently impacting glucagon prescribing, and how allowing pharmacists to prescribe glucagon could improve rates of prescribing and filling.

 What are the benefits of prescribing glucagon to patients with diabetes?

Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP:

 Most important is lifesaving potential. Ready-to-use glucagon provides a rapid intervention for severe hypoglycemia, especially when a person is unable to self-administer carbohydrates. I always tell patients that if you're in fear and you're alone, it is important for you to treat yourself. Same thing with their family members around them. Do not wait for unconsciousness.

We have improved accessibility now. We have new glucagon formulations. This is what's recommended by all accrediting bodies, all diabetes bodies across the world, including the American Diabetes Association. There's new, updated, 2025 guidelines that just came out, including the recommendation for ready-to-use glucagon. When I say that, what I mean is the intranasal or the auto-injectors. It's allowed for really ease of use for non-medical provider. You don't need to reconstitute it. There's no needles you have to attach. That's what we should be recommending. By having this available in easy to use [formulations] for patients and caregivers, it brings peace of mind and really increased confidence to that family or to that patient. It reduces that fear of severe episodes and empowers them to respond effectively and that enhances our outcomes. It really does reduce the risk of hospitalizations and those associated complications.

 Rates of glucagon prescriptions remain low. What are the current challenges or barriers preventing higher rates of glucagon prescribing?

 Among healthcare providers and patients about the importance of ready-to-use glucagon, there seems to be a lack of awareness. There's a lack of awareness on the updated guidelines and recommendations. There's also a lack of awareness on these new products that are available, that are easy to use, that are in that auto injector ready to use form, as well as the intranasal form. We need to make sure that we have healthcare provider awareness, but patient awareness also, Many patients are unaware that glucagon even exists or understand the importance of it.

Some other limitations might be the high cost and affordability, but insurance coverage is excellent for both of these available formulations. It’s outdated practice and not recommended to be using those older, more cumbersome formulations, like glucagon that has to be reconstituted. We really need to be recommending the ready to use glucagon. And the other thing is making sure the storage is known. Sometimes patients will find that they go to get it and it's expired. The newer formulations do have a longer shelf life.

 How would giving pharmacists prescriptive authority for glucagon improve rates of prescribing and filling?

 Allowing pharmacists to prescribe glucagon is something near and dear to my heart that I would absolutely recommend. Similar to when we think about what happened with Narcan to save people's lives, we really could have wider access. Pharmacists can identify at-risk patient and provide prescriptions on site, so bypassing the need for additional appointments. They often have more accessibility than physicians do, and that could reduce the delay in obtaining prescriptions at that point of care, because pharmacists are often that last touch point before they go home. They spend more time in the pharmacy than they necessarily do in their doctor's office. That pharmacist could provide and train patients on the use of glucagon at the time of dispensing. Pharmacists can provide hands on guidance about the glucagon and ensure patients understand its importance.

If they're filling a prescription somebody gets for insulin or they find out a patient that has a history of hypoglycemia right on the spot, being able to prescribe that can truly save people's lives. It also helps that pharmacists are in a position to be able to identify at risk patients and make those recommendations and have those timely prescriptions. It's also convenient. It's convenient for that patient, so that they have access to glucagon at a pharmacy visit when they're at the pharmacy. I think that that would drive a big public health impact. The pharmacy driven initiatives can normalize glucagon use and raise awareness about severe hypoglycemia and potentially save lives.

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1. American Diabetes Association Professional Practice Committee; 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes—2025. 

 1 January 2025; 48 (Supplement_1): S128–S145. 

2. Jennifer D. Goldman, Diana Isaacs; Out of Sight, Out of Mind: A Call to Action for the Treatment of Hypoglycemia. 

Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP, discusses the benefits of glucagon and why pharmacists should be able to prescribe it.

Q&A: Challenges, Barriers Impacting Glucagon Prescribing

The FDA is now requiring respiratory syncytial virus (RSV) vaccine manufacturers Pfizer and GSK to update their product prescribing information to include the vaccine’s increased risk of subsequent Guillain-Barré syndrome (GBS), according to an FDA news release.

“[GBS] is a rare neurological disorder in which a person’s immune system mistakenly attacks part of their peripheral nervous system—the network of nerves that carries signals from the brain and spinal cord to the rest of the body,” according to the National Institute of Neurological Disorders and Stroke (NINDS).

 “GBS begins suddenly and can increase in intensity over a period of hours, days, or weeks until certain muscles cannot be used at all.”

The 2 brand-name RSV vaccines currently approved and available to eligible patients are Pfizer’s Abrysvo and GSK’s Arexvy—which is an adjuvanted version of the RSV vaccine. Arexvy was the first product to receive FDA approval on May 3, 2023, and shortly after, Abrysvo was given approval on May 31, 2023. Both vaccines were manufactured to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older.

Important Updates in RSV Vaccination Guidelines | ASHP Midyear

While the FDA has not presented data that triggered a warning label for these vaccines, the main property GBS and RSV have in common is how each disease can impact respiratory health. According to the NINDS, GBS typically occurs after a respiratory or gastrointestinal bacterial or viral infection.

 With RSV serving an even greater risk to the respiratory system, individuals eligible to receive Abrysvo or Arexvy may already be at risk of GBS, even prior to receiving a vaccination.

Furthermore, despite occurring in “very rare cases,” vaccinations have been reported as possibly increasing GBS risk; these rare cases were reported before the FDA’s warning label.

Now, with minimal but further understanding of the RSV vaccine’s impact on GBS risk, the FDA is enforcing similar requirements for both vaccine manufacturers. The new warning label will read: “The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.”

While more data is needed for experts to fully understand the links between RSV vaccination and GBS, issuing a warning label was ultimately the FDA’s first step in order to ensure minimal patient impact. However, this may pose an unforeseen challenge for both Pfizer and GSK, who have been striving for further indications amongst their vaccines since initial approvals back in 2023.

“Pfizer’s RSV vaccine Abrysvo has been approved by the FDA for the prevention of RSV-associated LRTD in individuals aged 18 to 59 who are at increased risk of disease. This unadjuvanted, bivalent RSV prefusion F (RSVpreF) vaccine is the first and only RSV vaccine indicated for adults younger than 50 years,” wrote Lauren Biscaldi, MS, for 

While Pfizer continues to find new indications for its vaccine, GSK has also recently reported on its vaccine’s continued success. According to data presented at CHEST 2024, Arexvy has maintained significantly effective protection against LRTD through 3 RSV seasons.

“We are excited by these new data which show that a single dose of Arexvy could help protect millions of older adults at risk of RSV over 3 seasons and benefit public health,” said Tony Wood, GSK’s chief scientific officer.

 “This is the only RSV vaccine with efficacy and safety data available through 3 full seasons.”

As more research is conducted regarding immunization’s link to GBS, the FDA encourages any patients with adverse reactions to RSV vaccines to report them to the Vaccine Adverse Event Reporting System (

While the warning label for both manufacturers’ RSV vaccine does not undo the work each has done to save millions of lives, it’s a crucial piece of information that can ultimately improve public health—as long as pharmacists, physicians, and other certified vaccinators relay the proper education to their patients.

1. FDA requires Guillain-Barré Syndrome (GBS) warning in the prescribing information for RSV vaccines Abrysvo and Arexvy: FDA safety communication. News Release. FDA. January 7, 2025. Accessed January 8, 2025. 

https://www.fda.gov/safety/medical-product-safety-information/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and

2. Guillain-Barré syndrome. National Institute of Neurological Disorders and Stroke. December 20, 2024. Accessed January 8, 2025. 

https://www.ninds.nih.gov/health-information/disorders/guillain-barre-syndrome

3. Biscaldi L. FDA approves Abrysvo for adults 18-59 at increased risk for RSV. 

. October 23, 2024. Accessed January 8, 2025. 

https://www.drugtopics.com/view/fda-approves-abrysvo-for-adults-18-59-at-increased-risk-for-rsv

4. Biscaldi L. Arexvy maintains efficacy against RSV over 3 RSV seasons. 

https://www.drugtopics.com/view/arexvy-maintains-efficacy-against-rsv-over-3-rsv-seasons-chest-2024

Patients who receive either Pfizer or GSK’s respiratory syncytial virus vaccine may be at increased risk of Guillain-Barré syndrome.

FDA Requires Abrysvo, Arexvy RSV Vaccine Labels to Include Guillain-Barré Warning

In its yearly review examining evidence-based diets that promote positive health outcomes, 

 named the Mediterranean as the best overall diet heading into 2025.

 With the National Heart, Lung, and Blood Institute’s dietary approaches to stop hypertension (DASH) at the second spot,

 diets rich in high-fiber carbohydrates are essential to healthy outcomes.

“The best diets aren’t just about quick weight loss. These diets also provide the nutrients your body needs. Evidence has proven these diets to be effective at lowering your risk for diseases like heart disease and cancer,” wrote Johna Burdeos, RD, LD,for 

US News & World Report nutrition experts detailed the best types of diets for maintaining patient health in 2025.

Dan Langerman, Langermania

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