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Articles

Drug Topics sat down with Adam J. James, PharmD, to discuss learnings from his extensive experience at Rite Aid.

Chain Pharmacist Leads the Way in Patient Care Innovation

In a systematic review, researchers explored the role of clinical pharmacists within a multidisciplinary team treating patients with inflammatory bowel disease.

Clinical Pharmacists Play Pivotal Role in Managing Inflammatory Bowel Disease

On June 26, 2024, the FDA approved ensifentrine (Ohtuvayre) for the treatment of COPD.

FDA Approves Ensifentrine, Novel Treatment for Chronic Obstructive Pulmonary Disease

David Pope, PharmD, Chief Pharmacy Officer at XiPhin, shared his thoughts on value-based care and how it is used within a pharmacy setting.

Q&A: How Pharmacists Stand in the Gap for Value-Based Care

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Findings from a systematic review found little difference in outcomes between biosimilar and reference product treatment options. 


Efficacy Outcomes of Some Cancer Biosimilars Indistinguishable Vs Reference Product

Cancer misinformation may be more prevalent among residents in rural vs urban areas, study finds. 

Cancer Fatalism Common Among Rural Residents

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

 Solutions Summit is set to take place on Saturday, October 19, 2024, from 9:00 AM to 3:00 PM. Looking toward the future of pharmacy, the event will focus on innovating with cutting-edge technology for community pharmacies. From discussing specific technologies such as artificial intelligence (AI) to highlighting overall concepts related to the future of community pharmacy, it will be a day for independent pharmacists to increase their knowledge and take new ideas into their practice going forward.

The day will begin with a keynote session presented by 

Scott Biggs, director of supplier services at IQVIA

. In the session, titled “Leveraging US Prescription Market Insights to Drive Pharmacy Innovation” sponsored by InterLink AI, Biggs will discuss prescribing trends and opportunities for innovation within the pharmacy industry. He will also explore what investments independent pharmacy owners can prioritize to drive efficiency and profitability.

“Attendees can look forward to learning about the latest trends impacting the pharmacy industry and how those data insights can inform innovation. For example, diabetes rates and increased prescribing of GLP-1s are driving demand for pharmacist-provided care, and strategic investments in technology can help give your team more bandwidth to provide it,” said IQVIA.

Ian Stone, senior vice president of Mesmerize

, will host a session titled “Patient Engagement and the Future of Community Pharmacy as a Health Care Destination.” Mesmerize is a point-of-care media company dedicated to connecting people with valuable information, resources, and tools that empower them to proactively manage their health and improve their lives. Stone’s presentation will focus on helping attendees learn valuable insights and strategies about how pharmacies can provide health care to customers beyond the traditional scope of services.

Attendees will also have the chance to hear from 

AJ Lipka, Business Development lead of Pharmacy Network Growth at Outcomes

. He will be discussing how brand-sponsored programs can help keep patients engaged and adherent throughout the medication journey, while driving revenue for your pharmacy. His session is titled “How Participating in Pharma Sponsored Programs Can Benefit Your Pharmacy.”

“We will provide a thorough overview of how our innovative, pharma-sponsored programs can help pharmacies boost their revenue while managing rising industry costs, all without compromising their primary focus: delivering exceptional service to their customers,” said Outcomes.

In a session titled “Navigating the Future: Key Technology Updates Every Community Pharmacist Should Know for 2024,” 

Timothy Aungst, PharmD, founder of The Digital Apothecary

, will aim to equip pharmacists with essential knowledge about the latest technological advancements shaping the community pharmacy environment.

, will also represent her innovative pharmacy solution company in a session titled “The Essential Tech Stack for Pharmacy Owners, With DiversifyRx’s Dr. Lisa Faast.” Attendees will learn how successful pharmacy owners need to be efficient and innovative, surrounding themselves with the proper technology to boost patient care, save time, and increase profitability.

There will be 2 free continuing education sessions worth 1.00 CE credit each for attendees of the October 19 summit. The sessions are titled “Integrating AI Innovations in Pharmacy Practice for Future Excellence” and “The Essential Role of Pharmacists in Improving Influenza Vaccination Coverage: Strategies to Increase Vaccine Uptake and Optimally Utilize Available Vaccines.”

“There are many pressures on pharmacy that are out of our control, but your own continuing education isn’t one of them. The 

 Solutions Summit is a great way to invest a few hours in yourself and, in this case, help you champion innovation wisely. The more we learn, the better we can work together to strengthen the pharmacy industry and the health outcomes of patients as a result,” said IQVIA.

Click here to register for this can’t-miss event before it’s too late

Ready to impress your pharmacy colleagues with the latest drug information, industry trends, and patient care tips? Sign up today for our 

The event will focus on innovating with cutting-edge technology, featuring the likes of pharmaceutical technology companies revolutionizing the industry.

Community Practice

Register Today: October 2024 Total Pharmacy Solutions Summit

The FDA has accepted Bayer’s New Drug Application (NDA) for elinzanetant, an investigational non-hormonal treatment for moderate-to-severe vasomotor symptoms (VMS) associated with menopause, the company announced in a release.

 The therapy is the first dual neurokinin-1 and 3 receptor antagonist in late-stage clinical development and is administered orally once daily.

“The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the US,” said Christine Roth, executive vice president, global product strategy and commercialization, and member of the pharmaceutical leadership team at Bayer, in the same release.

 “If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.”

The NDA application is supported by positive results from the OASIS 1, 2 and 3 phase three studies evaluating the efficacy and safety of elinzanetant versus placebo. Findings from OASIS 1 (

 and results of the phase three OASIS 3 (

) study supporting efficacy and additional long-term safety data were presented at The Menopause Society annual meeting in September 2024.

Opill Marks a New Era for Birth Control Access

OASIS 1 and 2 were randomized, double-blind, phase 3 clinical trials conducted among postmenopausal women aged 40 to 65 experiencing moderate to severe VMS. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks.

The primary endpoint included mean change in frequency and severity of moderate-to-severe VMS from baseline to weeks 4 and 12, measured by an electronic hot flash daily diary. Secondary endpoints included sleep quality and overall quality of life related to menopause.

A total of 309 and 324 participants across 184 sites in 15 countries completed OASIS 1 and 2, respectively. Although frequency and severity of VMS were comparable between the groups at baseline, elinzanetant reduced VMS frequency at weeks 4 and week 12. Elinzanetant also improved VMS severity at week 4 and week 12. Additionally, elinzanetant improved sleep disturbances and menopause-related quality of life at week 12 and its safety profile was favorable.

OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of VMS over 52 weeks. It enrolled and randomized 628 

 women between 40 and 65 years across 83 sites in 9 countries. Consistent with findings from OASIS 1 and OASIS 2, OASIS 3 showed that elinzanetant effectively reduced the frequency of moderate-to-severe VMS from baseline to week 12 compared to placebo.

“The detailed results of OASIS 3 are complementing the positive results of OASIS 1 and 2, addressing the question on its long-term profile and indicating the potential of elinzanetant to treat moderate to severe VMS associated with menopause,” said Christian Rommel, global head of research and development at Bayer AG’s Pharmaceuticals Division, in a separate news release.

 “We look forward to continuing our discussions with health authorities around the world regarding marketing authorizations for this compound.”

The OASIS 4 study is an expansion of the clinical phase 3 program and aims to investigate the efficacy and safety of elinzanetant in women with moderate-to-severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.

Beyond the OASIS program, Bayer is conducting NIRVANA (

), an exploratory phase 2 randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography.

Up to 80% of women experience VMS at some point during menopause, and by 2030, the global population of women in menopause is expected to reach 1.2 billion, with 47 million women entering this phase annually.

But despite the impact of menopausal symptoms on women’s health, “many go without treatment due to gaps in awareness, education, and limitation of treatment options available,” according to Roth.

 Bayer is working to close these gaps with the potential approval of elinzanetant by its Prescription Drug User Fee Act deadline of July 26, 2025.

Are you ready to elevate your pharmacy practice? Sign up today for our 

1. US Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant. Bayer. News release. October 9, 2024. Accessed October 10, 2024. 

https://www.bayer.com/media/en-us/us-food-and-drug-administration-fda-accepts-new-drug-application-for-elinzanetant/

2. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. 

. Published online August 22, 2024. doi:10.1001/jama.2024.14618

3. Data from phase III study OASIS 3 support efficacy and long-term safety of investigational compound elinzanetant in the treatment of moderate to severe vasomotor symptoms associated with menopause. Bayer. News release. September 10, 2024. Accessed October 10, 2024. https://www.bayer.com/en/us/news-stories/phase-iii-study-oasis-3

4. Bayer submits New Drug Application to US FDA for elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause. Bayer. August 1, 2024. Accesesd October 10, 2024. https://www.bayer.com/en/us/news-stories/new-drug-application-to-us-fda-for-elinzanetant

5. Lutton L. FDA accepts NDA for menopause drug, elinzanetant. 

 October 9, 2024. Accessed October 10, 2024. https://www.managedhealthcareexecutive.com/view/fda-accepts-nda-for-menopause-drug-elinzanetant

The therapy’s Prescription Drug User Fee Act date has been set for July 26, 2025.

FDA Accepts Bayer’s NDA for Elinzanetant to Treat Menopause Symptoms

1. NO PURCHASE NECESSARY. OPEN ONLY TO LEGAL RESIDENTS OF THE UNITED STATES OF AMERICA WHO ARE AT LEAST 18 YEARS OLD AT TIME OF ENTRY. Void where prohibited by law. This sweepstakes begins on October 10, 2024 at 12:01 a.m. ET and ends on November 30, 2024 at 11:59 p.m. ET (“Promotion Period”). Administrator’s computer is the official time keeping device for this Sweepstakes. Enter the Sweepstakes during the Promotion Period by: (1) complete the Salonpas survey sent to you by Drug Topics. Online entries must be received no later than 11:59 p.m. ET on November 29, 2024. Alternatively, anyone may enter the Sweepstakes by printing the words “Salonpas Sweepstakes,” along with his or her name, title, date of birth, street address, city, state, zip, and phone number on a 3.5" by 5" white index card. Mail the card to Salonpas Survey Attn: Marketing Department, 2 Commerce Drive, Cranbury, New Jersey 08512. To be considered eligible, entries must be received no later than November 29, 2024 at 11:59 p.m. ET. No methods of entry other than the methods specifically described herein will be accepted. Sponsor is not responsible for lost, late, misdirected or incomplete entries or unsuccessful attempts to enter. Incomplete entries and/or entries not received by the deadlines will not be eligible. Limit (1) one entry per person, per mailing address, per outer-mailing envelope, and per email address.
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Prize is not transferable. No cash or prize substitutions, except the sponsor reserves the right to substitute prizes of equal or greater value. Acceptance of Prize constitutes permission to use that winner's name, likeness, and photo, and hometown for promotional and publicity purposes in any media now known or later developed, worldwide, at no additional compensation unless prohibited by law. All costs and expenses associated with Prize acceptance and use not specified herein as being provided such as reservation fees, taxes, insurance and other expenses incurred by accepting the Prize are the sole responsibility of the Winner. By participating and accepting a prize, winner releases and agrees to hold harmless, Hisamitsu America, Inc. A subsidiary of Hisamitsu Pharmaceutical Co., Inc. and MultiMedia Medical, LLC, their respective parent company, subsidiaries, affiliates, service agencies, sponsors and any independent contractors of any kind arising in whole or in part, directly or indirectly, from acceptance, possession, use, or misuse of the prize or the participation in this sweepstakes or any sweepstakes-related activity.

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