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Articles

Women experiencing later menopause may face a heightened risk of asthma, underscoring the possible role of estrogen in the development of the condition.

Women with Delayed Menopause May Face Increased Risk of Asthma

Cassandra Esperant, PharmD, AAHIVP, leverages her skills as a clinical pharmacist to champion the health of patients with HIV, both in her clinical practice and through education initiatives.

Meet the Specialty Pharmacist Championing HIV Care

Researchers addressed the gut-first hypothesis of Parkinson disease by identifying how mucosal damage impacts risk of development. 

Risk of Parkinson Disease Increases With Gastrointestinal Mucosal Damage

Timothy Aungst, PharmD, Founder of The Digital Apothecary, discussed advancements in digital health and what to be aware of regarding the future of technology.

Navigating the Future: Key Technology Updates Every Community Pharmacist Should Know for 2024

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Anita N. Jackson, PharmD, is a clinical associate professor, University of Rhode Island, College of Pharmacy, Kingston, RI.

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.

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

Even outside of respiratory virus season, vaccination is an important tool to decrease rates of vaccine-preventable diseases. In part 2 of his immunization presentation, David Ha, PharmD, BCIDP, infectious diseases manager at Stanford Health Care, presented at the National Community Pharmacists Association 2024 Annual Meeting and Expo, reviewed the latest CDC Advisory Committee on Immunization Practices (ACIP) updates on vaccines for meningococcal disease, human papillomavirus, and tetanus, diphtheria, and pertussis, among others.

According to data from the CDC, 2023 had the highest rate of cases of 

 in adults since 2014, man of which were driven by bacterial strains that compose serogroup Y. In adolescents, meningococcal disease cases associated with serogroups ACWY have decreased due to routine vaccination, but cases due to serogroup B remain similar—and college students are at the highest risk for serogroup B meningococcal disease.

In October 2023, a pentavalent meningococcal vaccine targeting serogroups ABCW and Y (Penbraya) was approved by the FDA for use in individuals aged 10 to 25 years. Other meningococcal vaccines are available as well: a quadrivalent vaccine targeting serogroups ACWY (Menveo and MedQuadfi), and a vaccine targeting serogroup B (Bexsero and Trumenba).

“One of the unfortunate challenges with meningococcal B vaccination is, this vaccine—as opposed to the quadrivalent [vaccine]—is not quite as immunogenic,” Ha said. “You get protection for maybe 2 years or so after vaccination, so it really is ideal to time that second dose as close as possible to when [patients] are matriculating into college.”

“I would highly recommend checking your local college websites; in my home state, for example, all state schools require Men B vaccination,” Ha said. State public health websites should also provide this information. “These are great resources if you’re trying to push the marketing of Men B vaccination, because it’s really important that we get future students vaccinated—ideally on time—for their matriculation.”

While human papillomavirus (HPV) vaccine recommendations have stayed largely the same, there have been “really great data” around the outcomes of this vaccine.

“[The HPV vaccine] is one of the most effective vaccines that we have to date,” Ha explained. “It is highly immunogenic, especially if you give it at a young age; the earlier you give it, the better.” Clinical outcomes, he added, have been “fantastic.” Looking at data from sequential cohorts of vaccinated patients, “we’re seeing lower and lower and lower rates of vaccine-type HPV, which has led to reduced pre-cancer incidence rates and reduced cervical cancer incidence rates in the United States,” Ha said.

With only one vaccine available—a 9-valent HPV vaccine (Gardasil-9), ACIP recommendations have remained unchanged. Gardasil-9 should be administered in a 2-dose series in adolescents aged 9 to 14 years, with the first dose ideally at age 11 or 12. The second dose should be administered 6 to 12 months later, but if more than 5 months have passed, a third dose should be administered. For those catching up—including adolescents and young adults aged 15 to 26 years, a 3-dose series administered at months 0, 1to 2, and 6 is recommended.

Patient-Level Interventions Can Increase HPV Vaccination Rates in Communities | IDWeek 2024

Although the vaccine is more effective if given earlier, there is an option for adults aged 27 to 45 to catch up. Using shared clinical decision making, a 3-dose series can be considered for adults at high risk—for example, those with new sex partners or those with limited prior sexual exposure. If patients in this population previously received a bivalent or quadrivalent vaccine (Cervarix or Gardasil, respectively, discontinued in 2016 and 2017), the vaccination series may be completed with the 9-valent vaccine. Perhaps most importantly for this age group, prior HPV infection does not preclude these individuals from vaccination.

There are 2 clades of Mpox currently circulation: Clade I, which is responsible for ongoing outbreaks in countries such as the Democratic Republic of Congo, and Clade II, which has continued to circulate at low levels in the US.

“[Mpox] is one of the more under-recognized, and more limited, [vaccines] in terms of access,” Ha said. “it’s a very important vaccine, and maybe only about 25% of patients in the US who are indicated for the vaccine have actually received it.” For pharmacists who care for patient populations where Mpox vaccination would make sense, Ha recommended incorporating routine Mpox vaccination as part of practice.

“I’ve personally seen a couple of cases of Mpox, and it can be quite severe,” Ha added. “I can’t underscore enough for really all of these [diseases]—but for Mpox in particular—the importance of vaccination those who it is indicated for.” This list includes individuals with known exposure to someone diagnosed with mpox; gay, bisexual, or other men who have sex with a partner who has more than 1 sex partner or a new diagnosis of a sexually transmitted infection; individuals who have sex at commercial sex venues or locations where mpox transmission is occurring; or those who have a sex partner with any of the previous risks.

The Smallpox and Monkeypox vaccine, live, non-replicating (Jynneos) is the only vaccine available to vaccinate against Mpox. For Clade II—currently endemic in the US—a 2-dose series of Jynneos protected against both severe disease and hospitalization, with approximately 86% effectiveness with 2 doses and approximately 75% effectiveness with 1 dose. For Clade I, Jynneos is “likely to be effective.”

There has been a massive spike in Dengue virus cases this year, especially in Puerto Rico, American Samoa, the Marshall Islands, the US Virgin Islands, Micronesia, and Palau. “Paired with the fact that our dengue vaccine, [dengue tetravalent vaccine, live; Dengvaxia] has been discontinued—and so the supply that we have access to now is being…distributed on a limited basis to these areas [with transmission],” Ha explained that there is no end in sight for the current 

Dengvaxia was initially approved in May 2019 for children and adolescents aged 9 to 16 years, and recently discontinued by Sanofi Pasteur due to lack of demand. Additionally, Takeda withdrew their company’s FDA application for a dengue vaccine.

ACIP recommendations for diphtheria, tetanus, and pertussis vaccination remain unchanged, Ha said: Adults aged 19 and older should receive 1 dose of the Tdap vaccine regardless of the timing of their last dose, followed by a Tdap booster ever 10 years.

“There is an active Td [tetanus and diphtheria vaccine] shortage, so [the preference is for] Tdap for these boosters,” Ha said. Pregnant women should receive 1 dose of Tdap with every pregnancy, “regardless of how many Tdap [vaccinations] they have in the past.”

“There’s been a massive uptick in pertussis cases in the US, and a lot of this has to do with the lifting of COVID-19 restrictions, so we’re starting to see more transmission,” Ha said. Adult Tdap vaccine coverage is hovering at approximately 40%, and there has been a 4-fold increase in cases of pertussis from September 2023 to September 2024. “If you’ve seen a case of pertussis, it is a very tough disease, with high morbidity and a significant mortality rate as well. I can’t stress [enough] the importance of Tdap vaccination.”

 remain unchanged as well. Adults aged 50 years and older should receive 2 doses of zoster vaccine, recombinant, adjuvanted (Shingrix), regardless of history of herpes zoster or varicella infection or previous vaccination with the herpes zoster vaccine (Zostavax). Adults 19 and older who are immunocompromised should receive 2 doses of Shingrix as well.

Coverage of the National Community Pharmacists Association 2024 Annual Convention and Expo was supported by Red Sail, with independent editorial content creation on-site by the 

1. Ha D. Dose of protection: Travel and nonrespiratory vaccine updates. Presented at: National Community Pharmacists Association 2024 Annual Convention and Expo; October 26-29, 2024; Columbus, OH.

A second immunization session focused on updates in meningococcal disease, HPV, and Mpox.

ACIP Recommendations for Non-Respiratory Immunizations Remain Largely Unchanged | NCPA 2024

The CDC Advisory Committee on Immunization Practices (ACIP) has voted to lower recommended age for pneumococcal vaccination from 65 years to 50 years of age.

Following the announcement, both Merck and Pfizer released statements applauding the ACIP decision.

 Both companies manufacture FDA-approved pneumococcal vaccines. ACIP also recommended that adults aged 19 to 49 years with certain underlying conditions or risk factors who have not received a 

, or whose vaccination history is unknown, receive a vaccination. CDC Director Mandy K. Cohen, MD, MPH, endorsed these recommendations.

“The CDC’s decision to lower the age-based vaccination recommendations to begin at age 50 has the potential to be a practice-changing milestone,” said Eliav Barr, senior vice president, head of global clinical development, and chief medical officer at Merck.

 “This recommendation is a significant step forward in the efforts to enhance equitable access and may improve vaccination rates.”

 Luis Jodar, PhD, pointed out that expanding the use of Pfizer's pneumococcal vaccine “also provides the opportunity to limit the reemergence of disease-causing strains like serotype 4, which has recently affected certain US adult populations.” Jodar is the senior vice president of vaccines and anti-infectives chief medical affairs officer at Pfizer.

 bacteria are responsible for pneumococcal pneumonia; infections are the leading bacterial cause of pneumonia hospitalizations in the US. Additionally, there are approximately 30,000 cases of, and 3000 deaths related to, invasive pneumococcal disease each year.

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

Currently, there are 4 recommended pneumococcal vaccines

: PCV21, a pneumococcal 21-valent conjugate vaccine (

); PCV15, a pneumococcal 15-valent conjugate vaccine (

); and PPSV23, a pneumococcal vaccine, polyvalent (

), all manufactured by Merck; and PCV20, a pneumococcal 20-valent conjugate vaccine (

Another potential immunization option is currently in development: 

 is a 31-valent pneumococcal conjugate vaccine candidate manufactured by Vaxcyte. In early September, the company reported positive topline data from its phase 1/2 of VAX-31 (

), which increases coverage to more than 95% of invasive pneumococcal disease circulating in adults aged 50 years and older in the US.

 and is indicated for active immunization to prevent invasive disease and pneumonia caused by 

serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in adults, as well as active immunization for the prevention of pneumonia caused by 

serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in adults.

 Per national-level CDC data from 2018 to 2022, the serotypes covered by Capvaxive “are responsible for more cases of invasive pneumococcal disease in adults compared to PCV20,” the news release from Merck noted. “In adults 50 years of age and older, Capvaxive covers the serotypes responsible for approximately 84% of [invasive pneumococcal disease] cases, compared to approximately 52% covered by PCV20.” The company also noted that there are no current studies comparing the efficacy of Capvaxive and Prevnar 20.

Prevnar 20 is indicated for the prevention of invasive disease caused by 

strains 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals aged 6 weeks and older; the prevention of otitis media caused by 7 of the 20 strains in individuals aged 6 weeks to 5 years of age, and active immunization for the prevention of pneumonia caused by 

 strains 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults. An indication for the prevention of pneumonia caused by 

serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in adults “is approved based on immune response.”

CDC recommends lowering the age for pneumococcal vaccination from 65 to 50 years old. News release. CDC. October 23, 2024. Accessed October 24, 2024. 

https://www.cdc.gov/media/releases/2024/s1023-pneumococcal-vaccination.html

CDC’S ACIP recommends Merck’s Capvaxive (pneumococcal 21-valent conjugate vaccine) for pneumococcal vaccination in adults 50 years of age and older. News release. Merck. October 23, 2024. Accessed October 24, 2024. 

https://www.merck.com/news/cdcs-acip-recommends-mercks-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-pneumococcal-vaccination-in-adults-50-years-of-age-and-older/

Advisory Committee on Immunization Practices recommends Prevnar 20 (20-valent pneumococcal conjugate vaccine) for adults aged 50 and older. News release. Pfizer. October 23, 2024. Accessed October 24, 2024. 

https://www.pfizer.com/news/press-release/press-release-detail/advisory-committee-immunization-practices-recommends

Pneumococcal disease. National Foundation for Infectious Diseases. Accessed October 24, 2024. 

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

The new recommendations suggest vaccination at age 50, rather than age 65. 

Anita N. Jackson, PharmD

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