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FDA's stand on compounding is bad for R.Ph.s and patients

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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See what’s trending in pharmacy with a preview of the Total Pharmacy August issue.

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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

Once-weekly dosing of insulin efsitora alfa (efsitora) has been shown to deliver comparable results to daily insulin in reducing hemoglobin A

) levels in adults with type 1 diabetes (T1D) and type 2 diabetes (T2D), announced Eli Lilly and Company in dual news releases.

 This weekly dosing option has the potential to simplify diabetes management for either condition.

The announcements come on behalf of positive results from the QWINT-5 (

) trials, which are part of Lilly's larger QWINT phase 3 global clinical development program. Whereas the QWINT-5 trial evaluated once-weekly insulin efsitora compared to once-daily insulin degludec in adults with T1D who require daily basal and multiple daily mealtime insulin injections,

 QWINT-2 evaluated once-weekly insulin efsitora compared to once-daily insulin degludec in adults with T2D who are insulin naïve.

Data were presented at the European Association for the Study of Diabetes Annual Meeting 2024.

Speaking to the QWINT-5 trial, Jeff Emmick, MD, PhD, senior vice president of product development at Lilly, said: “When we commercialized insulin more than 100 years ago, it marked the beginning of our commitment to people living with type 1 diabetes—today’s announcement continues that legacy. These results underscore the potential of efsitora to help some people living with type 1 diabetes lower their A1c with only 1 basal insulin injection per week, while also highlighting the complexity of treating this chronic disease.”

The multicenter, treat-to-target, randomized, parallel-design, open-label QWINT-5 study recruited 692 participants across the US, Argentina, Japan, Poland, Puerto Rico, Slovakia and Taiwan.

 During the 52-week treatment period, participants were randomized to receive insulin efsitora once weekly or insulin degludec once daily administered subcutaneously.

The primary endpoint was the change in HbA

Insulin efsitora successfully met its primary endpoint of reducing HbA

 levels as effectively as daily insulin after 26 weeks of treatment. Analyses demonstrated that insulin efsitora was able to lower HbA

 by 0.53%, compared to 0.59% for insulin degludec, resulting in final HbA

 levels of 7.37% and 7.32%, respectively.

In a key secondary endpoint, insulin efsitora and insulin degludec showed comparable results in time in range, as measured by continuous glucose monitoring (CGM), during the 4 weeks leading up to week 26.

Additionally, the estimated combined rates of patient-reported severe or clinically significant (blood glucose <54 mg/dL) nocturnal hypoglycemic events per patient-year of exposure were similar between insulin efsitora and insulin degludec over the 52-week study period, measuring at 14.03 with insulin efsitora and 11.59 with insulin degludec. There was no evidence of increased duration of hypoglycemia with efsitora compared to insulin degludec based on 

Estimated rates of severe hypoglycemic events per patient-year of exposure through week 52 were 0.14 with insulin efsitora and 0.04 with insulin degludec. More than half (64%) of the reported severe hypoglycemic events with insulin efsitora took place during the initial 12 weeks of the trial’s treatment period. Incidence of severe hypoglycemia in both treatment groups declined after week 12.

FDA Clears New Disposable Insulin Patch Pump for Patients With T1D and T2D

On QWINT-2, Emmick said, “For the past century, we’ve been searching for the next scientific breakthrough that would alleviate the complexity that comes with starting insulin treatment. With these results, we believe we’re headed towards a future where people with type 2 diabetes who use basal insulin can achieve their desired results with a simple treatment option like efsitora."

The parallel-design, open-label, treat-to-target, randomized controlled clinical trial QWINT-2 study recruited 928 participants across the US, Brazil, Canada, China, Czech Republic, Germany, Greece, Japan, Korea, Mexico, and Puerto Rico.

 Participants were randomized to receive insulin efsitora once weekly or insulin degludec once daily administered subcutaneously during the 52-week treatment period.

The primary endpoint was to demonstrate non-inferiority in reducing HbA

 at week 52 with insulin efsitora compared to insulin degludec. The study also assessed efficacy and safety for patients using and not using glucagon-like peptide-1 receptor agonists (GLP-1s).

In QWINT-2, insulin efsitora met its primary endpoint of non-inferior HbA

 reduction. Compared to insulin degludec, insulin efsitora reduced HbA

 by 1.34% versus 1.26%, resulting in an HbA

 of 6.87% for insulin efsitora and 6.95% for insulin degludec at 52 weeks.

Additionally, participants using insulin efsitora experienced 45 minutes more time in range per day compared to insulin degludec, without additional time in hypoglycemia compared to insulin degludec.

Further, insulin efsitora demonstrated a safety profile similar to daily insulin. No severe hypoglycemic events were reported with insulin efsitora, while 6 occurred with insulin degludec. Overall, hypoglycemia rates were low, with estimated combined rates of severe or clinically significant events per patient-year of exposure being 0.58 for insulin efsitora and 0.45 for insulin degludec.

Both insulin efsitora and insulin degludec had similar rates of severe or clinically significant nocturnal 

, estimated at 0.08 events per patient-year of exposure. Hypoglycemia rates were also comparable among people using GLP-1s and those not using them.

Reducing the frequency of insulin injections with the development of a once-weekly insulin has the potential to simplify treatment for diabetes, ease the burden of care for people with diabetes and their caregivers, and improve adherence and glycemic outcomes. For those who administer insulin daily, a once-weekly insulin could lower the number of insulin injections from about 365 to 52 per year.

The QWINT phase 3 global clinical development program for insulin efsitora in diabetes launched in 2022 and has enrolled over 4000 people living with T1D or T2D across 5 global registration studies.

“With the data we have seen from our phase 3 program so far, we are confident in efsitora’s potential to transform diabetes care and will continue to pursue new treatment options until we can eliminate the disease entirely,” said Emmick.

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1. With once-a-week dosing, insulin efsitora alfa delivers A1C reduction compared to daily insulin in adults with type 1 diabetes. News release. Eli Lilly and Company. September 10, 2024. Accessed September 12, 2024. 

https://investor.lilly.com/news-releases/news-release-details/once-week-dosing-insulin-efsitora-alfa-delivers-similar-a1c

2. Once-weekly dose of insulin efsitora alfa delivers A1c reduction consistent with the most advanced daily insulin in people with type 2 diabetes. News release. September 10, 2024. Accessed September 12, 2024. 

https://investor.lilly.com/news-releases/news-release-details/once-weekly-dose-insulin-efsitora-alfa-delivers-a1c-reduction

3. Bergenstal RM, Weinstock RS, Mathieu C, et al. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomized non-inferiority trial. 

. Published online September 10, 2024. doi:10.1016/S0140-6736(24)01804-X

4. Wysham C, Bajaj HS, Del Prato S, et al. Insulin efsitora versus degludec in type 2 diabetes without previous insulin treatment. 

. Published online September 10, 2024. doi:10.1056/NEJMoa2403953

Two phase 3 trials demonstrated that once-weekly insulin efsitora is as effective as daily insulin in lowering HbA1c in both type 1 (T1D) and type 2 diabetes (T2D). 

Lilly’s Once-Weekly Insulin Efsitora Offers Comparable Results to Daily Insulin in T1D, T2D

Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP, discusses key risk factors for hypoglycemia and what education programs should emphasize so people with diabetes and their caregivers can improve its management.

Education is Crucial to Prevent Hypoglycemia in Patients with Diabetes

Diabetes is a serious public health concern in the United States. Over 38 million Americans have the condition, with an additional 97.6 million estimated to have pre-diabetes.

 Diabetes prevalence is expected to increase significantly in the coming years, highlighting the critical need to increase prevention and management efforts.

L.D. King

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