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Articles

The Affordable Care Act was passed in 2010 to make health care and prescription medicine more accessible. Did it succeed?

A Look Back at the Affordable Care Act

A recent study found that patients who consumed 5 or more servings a week of dark chocolate had a significantly lower rate of type 2 diabetes.

Dark Chocolate Consumption Associated with Reduced Risk of Type 2 Diabetes

TaQuina Warren, PharmD, owner of Focus Pharmacy in Smyrna, Delaware, explored the pharmacy profession from her perspective as an independent owner.

How This Pharmacist Achieved Dreams of Becoming an Independent Owner

The MOVe-NOW study will assess the investigational oral antiviral using a different formulation than what is currently approved under an emergency use authorization.

Phase 3 Trial to Evaluate Molnupiravir for Treatment of COVID-19 in High-Risk Adults

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Patients with chronic lymphocytic leukemia experienced functional T cell and antibody responses after receiving a vaccine for COVID-19.

COVID-19 Vaccines: T Cell, Antibody Responses Demonstrated in CLL

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

Don’t get left behind: Sign up today for our 

 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

Laird Leavoy is President of American Pharmacies, a member-owned purchasing cooperative for independent pharmacies with members across the nation. We spoke with Laird about his journey in mastering and sharing the principles of leadership and its vital role in the independent pharmacy community.

“Leadership is a foundation of my life,” said Leavoy. “Leadership’s all about the people around you. It’s the people around you being heard. It’s mutual respect.”

Laird has always held a leadership role throughout his professional career. He’s worked for over 35 years in the wholesale drug and pharmaceutical industry. His last position was with AmerisourceBergen (now Cencora) as the Vice President of Retail Pharmacy for the South Region before joining American Pharmacies in 2010. At that time, American Pharmacies was only in Texas with $400 million in sales. Today, they are in over 40 states with $2 billion in total revenue.

 to share his perspectives on leadership and how he demonstrates key leadership qualities in his daily work. From his strategies for recruiting top team members to his approach to communication with colleagues, Leavoy explained why leadership is a crucial quality not only for his organization but also for the pharmacy profession as a whole.

Drug Topics sat down with Laird Leavoy, President of American Pharmacies, to discuss the role leadership plays in the independent pharmacy industry.

Total Pharmacy Interviews

American Pharmacies: Powering the Profession Through Leadership

 focused on currently available immunizations, such as those for COVID-19, respiratory syncytial virus, and flu. In this slideshow, learn more about 3 new vaccines that are currently in development.

Messier MD, Wagner L, Hochreiter R, et al. 6-valent, OspA-based VLA15 Lyme disease vaccine candidate against Lyme Borreliosis in a healthy pediatric and adult study population: A phase 2 study update. Presented at: IDWeek 2024; October 16-19, 2024; Los Angeles, CA. Poster P-599.

Norovirus. National Foundation for Infectious Diseases. Reviewed July 2023. Accessed October 16, 2024. 

https://www.nfid.org/infectious-disease/norovirus/

About norovirus. CDC. Accessed October 16, 2024. 

https://www.cdc.gov/norovirus/about/index.html

Groom HC, Slaughter MT, Donald JL, et al. Attitudes toward a potential norovirus vaccine among patients with medically-attended acute gastroenteritis in the US. Presented at: IDWeek 2024; October 16-19, 2024; Los Angeles, CA. Poster P-598.

Moderna announces first participant dosed in pivotal phase 3 trial of investigational mRNA norovirus vaccine, mRNA-1403. News release. Moderna. September 30, 2024. Accessed October 16, 2024. 

https://investors.modernatx.com/news/news-details/2024/Moderna-Announces-First-Participant-Dosed-in-Pivotal-Phase-3-Trial-of-Investigational-mRNA-Norovirus-Vaccine-mRNA-1403/default.aspx

Shinde V, Neal S, Plested JS, et al. Immunogenicity and tolerability of the Novavax nanoparticle influenza vaccine (NIV) and COVID-influenza combination vaccine (CIC). Presented at: IDWeek 2024; October 16-19, 2024; Los Angeles, CA. Poster P-607.

Dozens of presentations at IDWeek 2024 focused on available immunizations, such as those for COVID-19, respiratory syncytial virus, and flu.

New Vaccines in the Pipeline: Norovirus, Lyme Disease, and Combination COVID-19–Flu | IDWeek 2024

Respiratory viruses don’t discriminate, but older adults are at an increased risk for respiratory tract infections. Per the CDC, most deaths due to respiratory viruses occur in individuals aged 65 years or older, with a sharp increase in risk as people age.

Vaccines for this population, therefore, are a crucial need. The first 2 RSV vaccines were approved in May 2023,

 with an additional vaccine—Moderna’s 

 Now, researchers are beginning to evaluate the efficacy of these vaccines over time, what vaccine uptake is like by age, demographic, and socioeconomic factors, and whether 

, targeting multiple lower respiratory tract threats, are worth pursuing in clinical development.

Check out more of our IDWeek coverage here.

Respiratory viruses and older adults. CDC. Accessed October 17, 2024. 

https://www.cdc.gov/respiratory-viruses/risk-factors/older-adults.html

Biscaldi L. Breaking: FDA approves first-ever RSV vaccine. 

. May 3, 2023. Accessed October 17, 2024. 

https://www.drugtopics.com/view/breaking-fda-approves-first-ever-rsv-vaccine

FDA: Pfizer RSV vaccine approved for use in older adults. 

June 1, 2023. Accessed October 17, 2024. 

https://www.drugtopics.com/view/fda-pfizer-rsv-vaccine-approved-for-use-in-older-adults

Biscaldi L. Breaking: FDA approves Moderna’s mRNA RSV vaccine, mRESVIA. 

. May 31, 2024. Accessed October 17, 2024. 

https://www.drugtopics.com/view/breaking-fda-approves-moderna-s-mrna-rsv-vaccine-mresvia

La EM, McGuiness CB, Singer D, Yasuda M, et al. RSV vaccination uptake among US adults aged ≥60 years who are at increased risk of severe RSV disease (August 2023-February 2024). Presented at: IDWeek 2024; October 16-19, 2024; Los Angeles, CA. Poster P-36.

Walsh EE, Woodside J, Marc GP, et al. Efficacy of a bivalent RSVpreF vaccine in older adults across a second RSV season. Presented at: IDWeek 2024; October 16-19, 2024; Los Angeles, CA. Poster P-600.

Tartof SY, Ackerson B, Kapadia B, et al. Respiratory syncytial virus (RSV) vaccine uptake among adults ≥60 years old in a large integrated healthcare system in the US. Presented at: IDWeek 2024; October 16-19, 2024; Los Angeles, CA. Poster P-56.

Davis M, Shapiro C, Adams MD, et al. Safety and immunogenicity of a respiratory syncytial virus and human metapneumovirus-like particle protein subunit combination vaccine in 60-85 year-old adults: interim results from a phase 2a clinical trial. Presented at: IDWeek 2024; October 16-19, 2024; Los Angeles, CA. Poster P-601.

Three RSV vaccines are currently FDA approved for use in adults aged 60 or older. 

At Higher Risk, Vaccine Efficacy, Uptake Are Crucial for Older Adult Populations | IDWeek 2024

In March 2024, the CDC released a Health Alert Network Health Advisory warning health care providers that cases of invasive meningococcal disease were on the rise. This increase has been attributed to 

 serogroup Y—more specifically, the meningococcal strain sequence type 1466.

Since 2021, cases of meningococcal disease have “increased sharply” in the US, and today, exceed prepandemic levels. There were 422 confirmed and probably cases reported in 2023, the largest number of reported cases in 2014.

Although meningococcal disease is rare, it can be life threatening, with 10% to 15% fatality rate

—even when patients receive appropriate antibiotic treatment. Vaccines, therefore, are a crucial tool for protection. To date, 

 is the only FDA-approved pentavalent vaccine protecting against serotypes ABCWY.

At IDWeek 2024, 2 posters presented data on additional meningitis vaccines in development. In the first,

 researchers from GSK presented a profile of the company’s pentavalent meningococcal ABCWY vaccine, which was 

 earlier this year. The MenABCWY vaccine combines antigenic components of the licensed 4-component meningococcal serogroup B vaccine (MenB-4C) and the serogroup ACWY vaccine (MenACWY-CRM).

Investigators presented data from the 12 clinical trials that were part of the vaccine’s clinical development program, inclusive of 7000 adults and adolescents in 13 countries.

Results of one phase 3 study demonstrated that for serogroup B, 2 doses of Men ABCWY 6 months apart was noninferior to 2 doses of MenB-4C 2 months apart. Immunological vaccine effectiveness was 78% when tested against a panel of 110 Men strains (95% CI, 77-79), with serum from 84% of participants killing more than 70% of strains.

Examining Pharmacists Role in the Current Vaccine Landscape

In a comparison of 2 doses of MenABCWY administered 6 months apart with 1 dose of MenACWY-CRM, a group of both MenACWY-primed and MenACWY-naïve patients, MenABCWY was noninferior and demonstrated a robust immune response against each serogroup. Additional data from a phase 2 study of all 5 serogroups showed persistence of antibodies at 2 and 4 years, as well as anamnestic booster responses 2 years after primary MenABCWY vaccination; similar immune responses were noted with the 0- to 6-month and 0- to 11-month MenABCWY vaccination schedules.

Ultimately, the safety and reactogenicity profile of the MenABCWY vaccine was “favorable overall” and consistent with the profile of MenB-4C.

 presented safety profile data from a phase 3 clinical study of the MenACWY conjugate vaccine (MenACYW-TT) a quadrivalent meningococcal conjugate vaccine (MenQuadfi), approved for use in children aged 2 years or older. In the study (NCT03673462), investigators compared MenACYW-TT with quadrivalent meningococcal vaccine MenACWY-CRM (Menveo) in healthy infants and toddlers.

Cases of meningococcal disease currently exceed prepandemic levels. 

Matthew Fowler

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