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Articles

Investigators note that low itch and mild disease severity are maintained following a treatment-free interval of 80 days.

Tapinarof Results in Mild Atopic Dermatitis Activity During Treatment-Free Period

Researchers investigated the health benefits, utilization, harms, and costs associated with the use of alternative methods for colorectal cancer screening in Australia.

Younger Recommended Screening Age Can Lessen Colorectal Cancer Burden

A conversation with Chelsee Jensen, PharmD, BCPS, director of formulary management at the Mayo Clinic.

Q&A: Challenges Health Systems May Face When Integrating Biosimilars

COVID-19 vaccination before a SARS-CoV-2 infection was associated with a 75% reduced likelihood of long COVID symptoms that impact daily functioning among patients between the ages of 5 and 17 years.



COVID-19 mRNA Vaccines May Reduce Long COVID Risk in Children, Adolescents 

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Findings reported in JAMA Network Open don’t find racial disparities among those who meet the treatment criteria. But Black individuals were less likely than Asian or White individuals to be among those meet the criteria.

Why Is There Such A Large Disparity In Who Meets Critera For Hepatitis B Treatment?

In the 3 cases documented by researchers, hepatitis B surface antigen (HBsAG) levels were reduced by more than 50% after Japan began its COVID-19 vaccination program.

Does the COVID-19 Vaccine Help Hepatitis B Patients?

A trio of leading hepatitis researchers survey the treatments in development for chronic hepatitis B. They end on a high note: That for the first time in 20 years, a cure is in sight.

A Cure for Chronic Hepatitis B Could Be on the Horizon

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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 and get the latest drug information, industry trends, and patient care tips delivered straight to your inbox.

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.

Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our 

 and get the latest drug information, industry trends, and patient care tips, straight to your inbox.

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

Join Shawn Bjorndal, PharmD, RPh, and Jesse McCullough, PharmD, for the first episode of Dispensing Leadership, a new podcast from Drug Topics and RPhAlly.

Dispensing Leadership: Defining Your Philosophy

In today’s complex health care landscape, having leadership skills is an integral part of being a pharmacist. Strong leadership skills allow pharmacists to improve workflows, successfully guide their teams, and improve health outcomes. Without them, the result is disjointed dispensing of medication, uncoordinated patient care, and stagnated innovation.

In Dispensing Leadership, a new podcast offering from Drug Topics® and RPhAlly, Shawn Bjorndal, PharmD, RPh, a visionary health care executive with over 16 years of experience and founder of PGxAlly, and Jesse McCullough, PharmD, a pharmacist-turned-entrepreneur with a passion for leadership development, will discuss essential leadership skills for pharmacists, how to develop them, and, ultimately, how to advance the pharmacy profession.

In the first episode, Shawn and Jesse discuss why defining a philosophy is key for pharmacists who want to excel in their career. Jesse outlines the key components of creating a philosophy, including taking an inventory, asking how it can serve you, and the importance of not being afraid to upgrade or change if there are better ways to think about it.

“My call to action would be, to begin by taking an inventory,” Jesse said. “What are some of those common phrases or what are some of those common beliefs that you have? Those are absolutely your philosophy. Take an inventory of that. As you make that list, you need to ask yourself, ‘How do those philosophies serve me?’ Are they beneficial or are they detrimental to the work that you are trying to do?”

Be sure to tune in every month on Drug Topics for important conversations that will help you develop your skills to become an effective pharmacy leader. All episodes of Dispensing Leadership will be available in a video format via 

, with an audio version available through Spotify.

1. Aman M, Arakawa N, Anderson C. Leadership competencies and behaviors in pharmacy: A qualitative content analysis. 2025. 

https://doi.org/10.1016/j.sapharm.2025.02.001

Join Shawn Bjorndal, PharmD, RPh, and Jesse McCullough, PharmD, for the first episode of Dispensing Leadership, a new podcast from Drug Topics® and RPhAlly.

Practice Management

The FDA approved omalizumab-igec (Omlyclo) as the first interchangeable biosimilar referencing omalizumab (Xolair). This also marks the first respiratory biosimilar in the United States.

Omalizumab-igec is approved to treat moderate to severe persistent asthma in patients 6 years of age and older whose symptoms are not well controlled with inhaled corticosteroids, chronic rhinosinusitis with nasal polyps for patients older than 18 years old, and food allergy for individuals aged 1 year and older to reduce allergic reactions triggered by eating 1 or more foods that the patient is allergic to. It was approved in 2 dosage forms: a 75 mg/0.5 mL injection and a 150 mg/mL injection, which can be administered via single-dose prefilled syringes subcutaneously.

Adverse reactions can include injection site reactions, fever, headache, dizziness, and arthralgia. Furthermore, the FDA issued a boxed warning for anaphylaxis based on pre- and postmarketing reports of anaphylaxis after administration.

The biologics license application for the drug, previously known as CT-P39, was based on data from a global phase 3 clinical trial (

) that evaluated the efficacy, safety, and pharmacokinetics of CT-P39 compared to the reference product. Investigators analyzed data from the drug for patients with chronic spontaneous urticaria for up to 40 weeks, according to a company news release. The primary outcome included the equivalence of the efficacy and the potency between both drugs at 12 weeks. The secondary end point included dose response by Weekly Itch Severity Score at week 8 and week 24, Urticaria Activity Score at week 8, 12, and 24, Hives Severity Score at week 8, 12, and 24, pharmacokinetics, quality of life, and safety, including adverse events.

Investigators of the study found that there was equivalent efficacy between the drugs as well as comparable safety. There were 619 patients, with 204 receiving the biosimilar in the 300 mg dosage, 205 receiving the reference product in the 300 mg dosage, 107 receiving the biosimilar in the 150 mg dosage, and 103 receiving the reference product in the 150 mg dosage.

The mean change between the 300 mg products was evident for ISS7 at 12 weeks (treatment difference 0.77, 95% CI -0.37 to 1.90; US analysis: treatment difference 0.70, 90% CI -0.22 to 1.63). The trial also had comparable efficacy between the groups at both dose levels, with no impacts on switching. For safety, the adverse events were also comparable, according to the study authors.

This approval comes after the biosimilar’s approval in Canada, which came in December 2024. Like most biosimilars, this marks a cost-effective option for these patient populations.

1. Omalizumab-igec (Omlyclo). [package insert]. Celltrion; 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761399s000lbl.pdf. Accessed March 7, 2025.

2. Jeremias S. FDA Approves First Omalizumab Biosimilar. 

. March 7, 2025. Accessed March 7, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-omalizumab-biosimilar

3. Celltrion Usa completes submission of biologics license application (BLA) to US FDA for CT-P39, an interchangeable biosimilar candidate for Xolair (omalizumab). News release. Celltrion. March 10, 2024. Accessed March 7, 2025. https://www.prnewswire.com/news-releases/celltrion-usa-completes-submission-of-biologics-license-application-bla-to-us-fda-for-ct-p39-an-interchangeable-biosimilar-candidate-of-xolair-omalizumab-302084902.html

4. To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria (omalizumab). ClinicalTrials.gov identification: NCT04426890. Updated June 22, 2023. Accessed March 7, 2025. https://clinicaltrials.gov/study/NCT04426890

5. Saini SS, Maurer M, Dytyatkovska Y, et al. CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study. 

. Published online January 9, 2025. doi:10.1111/all.16446

Omalizumab-igec is approved to treat moderate to severe persistent asthma in patients 6 years and older whose symptoms are not well controlled with inhaled corticosteroids.

FDA Approves Omalizumab-Igec as First Interchangeable Biosimilar to Xolair

The discussion covers the benefits and risks of using continuous glucose monitoring (CGM) systems with smartphones.

Counseling Patinets on CGM and Smartphone Use

FDA issued an alert to patients of potential safety concerns for diabetes devices

, including continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems, specifically those that rely on a smartphone to deliver safety alerts. The agency received reports in which users said the safety alerts are not being delivered or heard, even in cases where the user thought they set the alerts to be delivered. The FDA reported that some cases of missing alerts contributed to events such as severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, and even death. Currently, the FDA is working with manufacturers to ensure that smartphone alerts are carefully evaluated prior to use by patients.

In the interview, Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, endocrine clinical pharmacy specialist, director of education & training in diabetes technology at the Cleveland Clinic Endocrinology & Metabolism Institute, discussed the benefits and risks of using continuous glucose monitoring (CGM) systems with smartphones. She discussed the recent alert by the FDA, alerting of potential missed notifications for Bluetooth devices. Further, Isaacs talked about preventing compatibility issues and how to counsel patients who are concerned.

What are your initial thoughts on the FDA's alert about potential missed safety notifications with smartphone-compatible diabetes devices?

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP: 

Well, I have a lot of thoughts about this. On one hand, I'm disappointed that we need to have this FDA alert and that we don't have technology that is just perfect, and we can trust the alerts all of the time. But I am happy that the FDA put out this alert because this is a reality with our current smartphones that there can be just issues that cause an alert to not be received, and I think it's really important that patients know about that so that they really can double check their glucose They can rely more on their symptoms versus only relying on an alert from a device. So I do think the FDA certainly did the right thing by putting this alert out.

: What are the potential consequences of missed safety notifications for patients with diabetes?

It can be quite serious. I mean worst-case scenario is if a person is having an urgent low glucose and doesn't receive an alert and therefore does not take action by eating, drinking, or treating their low; I mean, they can pass out. It could lead to death in the worst-case scenario. Now, fortunately, a lot of people will feel symptoms, and they can take action, and so usually that doesn't happen, but certainly there is that risk of that happening.

The FDA recommends that patients periodically check smartphone settings to ensure safety alerts are being delivered. How do you counsel patients on the best practices for checking these settings and confirming device functionality?

I think this is a really important point for anyone that works with patients in CGM. So generally, we discourage the automatic updates where you go to the latest operating system because it takes a little bit of time for these mobile apps to be tested and be compatible with the latest update, and so we actually train patients to toggle that off so it's not automatically updating, and that's one way to hopefully prevent that compatibility issue. The other thing I'd say is just periodically testing it. Now, most will know because they'll get a higher, they'll get a low, and they'll hear it go off. But I would say that if someone hasn't noticed an alert in a while, go ahead and check the system and make sure that it's still working, perhaps adjusting it to something they're more likely to reach with their number, and just confirming that it truly is going off; it's making a sound and everything.

What are some practical tips you can share with patients to ensure they receive critical alerts from their diabetes devices?

I would just say making sure that it's not automatically updating, going ahead and checking like they could change your high alert to like 140 if you want, and a person should hit that anytime they eat, so that doing those types of things can just double check that it truly is working. I'd also say it's important to remember that technology is not perfect all the time. So we want to back up. We really want people to still feel the symptoms of low glucose levels and not lose sight of what those are. Then also, I'd say, having a backup meter, just in case, because the instructions for all of them are, if a person has symptoms that don't line up with what the number is saying on the CGM device, they really should confirm with a finger stick. I think just remembering that technology, it's just not perfect 100% of the time.

Do you believe that the benefits of smartphone-compatible diabetes devices outweigh the risks associated with potential missed notifications?

No, I think 100%, the benefits are worth this risk. So I want to highlight that this is not a super common occurrence where the alerts aren't going off. I would say it's not something that happens to many people, so it is certainly not a common occurrence in terms of benefits of it being on the smartphone. There are so many, it makes it much easier to share data with the health care team. So through the Bluetooth and the data going into the cloud, we can see it. We don't have to download a device. We don't have to bring a patient into clinic. We can do a virtual visit, a phone visit. We can do remote monitoring with that data. So that makes it super useful, and then the other thing with smartphones is that all the CGMS have a follow app that you can use when it's on the smartphone versus if you're just using a separate reader or receiver, you can't use those follow apps. Then the other thing I'd say is that it's just a whole lot more convenient to carry 1 device instead of 2. So asking a person to have a separate reader or receiver and their phone, they're more likely leave it somewhere, or forget about it, or lose it, and then they're not going to get any alerts if that happens. So I think definitely the benefits outweigh the risks.

How do you address patient concerns about the reliability and safety of smartphone-compatible diabetes devices?

Using a smartphone that's been tested with the system is important. So there are a whole lot of different versions of smartphones, especially when it comes to Androids. I think there's a lot of different types, right? And on the respective CGM websites, you can get a list of the devices that are truly compatible along with the operating system. So it's important to use one that has been tested and true and everything, and then just going into the settings, making sure the critical alerts are on and everything. If there is any concern, all of them have a number, like a customer support number to call, to double check that it's working, it's compatible, and everything. So I think in doing those things generally, we can really trust the devices.

What is the role of that pharmacist in diabetes care for patients, especially with CGMs?

First of all, making sure patients know what the target ranges are and what all this data means, and I don't mean that the pharmacist needs to, like, go through and teach about glucose variability, and all of these like more complicated concepts. I just mean that we want a person to be able to see their number and understand, like, is this in range, or is this above, or are they having a low, and then what to do about it, and especially, I would say, treating low glucose levels, understanding that we generally consider, for most people under 70, to be a low, what to do about that, and then also setting alerts that are meaningful. Some people have the opposite problem, where they say their CGM is beeping and buzzing at them all the time, and even though they get all the alerts, they kind of ignore them because it's just alerting all the time, and so that's not good either. We want it to be meaningful alerts, and the pharmacist can have a great role in helping the person set a low that will be meaningful. For some people, that may be higher than 70, maybe that's going to be 80 or higher, and then setting a high alert that also is meaningful, or even turning it off for some people, and I think those are key things, and then also, I think it's great to go into the device turn off those automated updates for the operating system. That's a way to just prevent this kind of complication from coming up where they don't get any alerts.

Is there anything else you would like to add?

I think CGM systems are incredible, and when you think about how far we've come from blood glucose monitoring [(BGM)] devices to this growth of CGM where tons of people have access to it, and I know it's really annoying if someone should be getting alerts and they're not getting them. But think about the days of BGM, right? People aren't getting any alerts. If they don't say, in this moment, I'm going to check my glucose, I'm going to bring out my meter and poke my finger, right? They're not going to get an alert. So these devices are lifesaving, their life changing, and I'm really happy to see that more and more pharmacists are learning about these devices and bringing them to their patients and really supporting their use so that we can give the best outcomes for people with diabetes.

Recently, the FDA alerted users of missed notifications for continuous glucose monitoring devices and Bluetooth smartphone compatibility.

Robert Calandra

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