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Paying for these new therapies, that may be curative for patients, remains a challenge.

The Pipeline Is Full of Expensive, Innovative Therapies

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.

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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

Analyzing psychiatric emergency department (ED) visits among an adolescent population, school openings were significantly associated with an increase in acute psychiatric emergencies, while COVID-19 lockdown restrictions were not. Their findings show an overall need to better understand children’s school-related stress, rather than pandemic-related mental health implications.

“The COVID-19 pandemic disrupted school for millions of students worldwide at different times and with variable intensity. This unique situation can offer an opportunity to study the association between school and psychiatric emergencies. The initial wave of the pandemic in the spring of 2020 was accompanied by a marked overall decrease in all pediatric ED visits but a less pronounced decrease for psychiatric visits,” wrote authors of a study published in 

Indeed, expanding the scope of COVID-19-related mental illness outside of just children, a KFF/CNN survey showed that 90% of US adults believe the country was facing a mental health crisis in 2023.

 With millions of Americans losing their jobs and forced to stay inside, US adults were faced with unprecedented stressors stemming from the COVID-19 pandemic. However, children faced similar types of restrictions but with different implications.

“In Italy, the strictest COVID-19 preventive restrictions (social lockdown with limitation of in-person schooling) started in the spring of 2020 and were in force for most of that year, with gradual attenuation, based on the fluctuating incidence of the infection, in 2021. School was online in many areas, at least during some weeks, until the summer of 2021. In-person school reopened in September 2021,” continued the authors.

Trust in US Physicians, Hospitals Decreased During COVID-19 Pandemic

From early pandemic-related lockdowns in 2020 to children returning to in-person schooling in September 2021, many adolescents’ obligations to attend school across the world were significantly disrupted. In this study, researchers aimed for a better understanding of COVID-19’s effect on adolescents’ ED psychiatric visits.

They analyzed all ED visits at 9 urban hospitals in Italy from January 1, 2018, to December 31, 2021. Researchers included a total of 13,014 ED visits (63.2% women; mean age, 13.8 years) in the study and separated individuals’ visits by category: pediatric ED visits, psychiatric ED visits, and psychiatric ED visits categorized by specific reasons; including psychomotor agitation, suicide ideation or attempt, and eating disorders.

Next, after recording ED visits and separating each into specific categories, researchers found “the disruption in the usual succession of school and holiday periods brought on by the COVID-19 pandemic at different times and with various degrees of intensity.”

From the beginning of 2018 through 2021, adolescent ED psychiatric visits increased over time, with significant increases associated with the opening of schools around the observed locales of Italy. Furthermore, an increase in ED visits were significantly more evident among the female population, finding that suicide attempts and ideations were the main causes of this population’s ED visits. For the male population, however, socioeconomic status was associated with an increase in ED psychiatric visits.

Throughout the study period, researchers found an overall increase in ED psychiatric visits for eating disorders, suicide ideations, and suicide attempts, with each condition increasing by over 249%.

While the first COVID-19-related state of emergency in Italy was announced on January 31, 2020, some variation of lockdowns persisted in the country throughout the study period, until the state of emergency was lifted in 2022, after the study period ended.

 “Another limitation is the time frame of only 4 years, which prevents assessing the trend in psychiatric ED visits antecedent to the pandemic,” wrote the authors.

 While researchers identified the short study window as a limitation to their results, the differences between school openings and closures and their effects on ED psychiatric visits were significant enough to suggest further studies on the social and stressful aspects of schooling and how they affect adolescent mental health.

More importantly, the researchers’ suggestion for future studies is not reliant on the disruptions of school attendance caused by the pandemic. Rather, they suggest future studies focus on the direct effect school openings and closures have on children’s mental health unrelated to COVID-19 restrictions.

“The results support the view that school may be a significant source of stress for youth and point to the need to investigate possible contributing factors, such as perceived academic pressure, individual vulnerabilities, parental expectations, and social stress from peer interaction, as potential mediators of school-associated mental health disturbances in youth. Future research should address differences in psychological well-being of students by school system as well as the association between school calendar and psychiatric ED visits,” they concluded.

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1. Davico C, Marcotulli D, Abbracciavento G, et al. COVID-19 pandemic school disruptions and acute mental health in children and adolescents. 

 2024;7(8):e2425829. doi:10.1001/jamanetworkopen.2024.25829

2. Panchal N, Saunders H, Rudowitz R, et al. The implications of COVID-19 for mental health and substance use. 

. March 20, 2023. Accessed August 27, 2024. 

https://www.kff.org/mental-health/issue-brief/the-implications-of-covid-19-for-mental-health-and-substance-use/

3. Italy ends COVID-19 state of emergency, curbs to be lifted gradually. 

. April 1, 2022. Accessed August 27, 2024. 

https://www.reuters.com/world/europe/italy-ends-covid-19-state-emergency-curbs-be-lifted-gradually-2022-04-01/

Researchers addressed the association of COVID-19 pandemic-related school disruptions with children’s incidence of acute psychiatric emergencies.

School Openings After COVID-19 Lockdowns Associated With Increased Psychiatric Emergencies

Positive results have been announced from a phase 3 trial evaluating the efficacy and safety of the digital therapeutic CT-132 for the preventative treatment of migraine in adult patients, Click Therapeutics announced in a release.

 The therapy, which is intended to be taken with existing medication, could provide additional clinical data that can benefit patients.

) study showed that CT-132 met its primary endpoint of change in monthly migraine days. The therapeutic also met key secondary endpoints, including change from baseline in Migraine-Specific Quality-of-Life Questionnaire (MSQ) and change from baseline in Migraine Disability Assessment (MIDAS).

CT-132 is a prescription digital therapeutic that is meant to be used alongside existing migraine medications in adult patients. The product delivers a proprietary 12-week clinical intervention that is designed to reduce brain hypersensitivity by modulating responses to environmental and internal stimuli. This helps patients by giving them the ability to engage in daily activities more fully.

“The clinical data demonstrate a successful reduction in monthly migraine days, which was the primary endpoint, as well as improving quality of life and reducing disability,” Stewart Tepper, MD, vice president of the New England Institute for Neurology and Headache said in a release.

 “This is the first migraine digital therapeutic to be studied with this degree of rigor, and the availability of CT-132 would be a very useful addition to our migraine armamentarium providing additional benefit to patients on migraine medication and expanding access to non-pharmacological treatment options.”

ReMMi-D was a randomized, double-blind, parallel-group, virtual phase 3 study evaluating the efficacy and safety of 2 prescription mobile applications for preventative treatment of episodic migraine in late adolescents and adults. The study cohort included 568 patients who randomly received either 1 of 2 digital therapies through a mobile application over a 12-week period as they went about normal daily activities.

The study found that patients who received CT-132 had a statistically significant reduction in monthly migraine days (MMDs), experiencing -3.04 MMDs by the end of treatment. The digital therapy improved MSQ from week 4 through week 12, and improved MIDAS by the end of the study period. Patients who received the therapy also reported improvements in their health as measured by the Patient Global Impression-Change (PGI-C). Additionally, patient engagement and adherence to the therapy were high and sustained throughout the 12 weeks. CT-132 was seen to be well tolerated, with no treatment-related adverse events observed during the study.

ReMMi-D was further supported by the ReMMiD-C (

) study. The phase 3 bridging study evaluated the efficacy and safety of CT-132 for the preventative treatment of migraine in 110 late adolescents and adults who were receiving calcitonin gene-related peptide (CGRP) inhibitor therapy.

"This is a significant milestone for more than one billion people worldwide living with migraine,” Shaheen Lakhan, MD, PhD, FAAN, chief medical officer of Click Therapeutics, said in a release.

 “Click has developed and evaluated a first-in-class digital migraine preventive therapeutic, CT-132, in 2 separate clinical studies to demonstrate a reduction in monthly migraine days, the gold standard measure. We look forward to advancing our FDA Breakthrough Designated asset through regulatory clearance and, if successful, offering a new therapeutic option that can be delivered to any eligible patient with a smartphone, meaningfully enhancing access to care.”

According to data from the CDC, 4.3% of adults in 2021 reported being bothered a lot by headache or migraine in the past 3 months.

 The neurological disorder is characterized by episodes of moderate-to-severe headaches that can last hours to days. Migraine, which can significantly impact daily activities, can be triggered by stress, hormonal changes, specific foods, and environmental influences.

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1. Click Therapeutics Announces CT-132 Met Primary Endpoint for the Reduction of Monthly Migraine Days in ReMMi-D Pivotal Trial. News Release. Click Therapeutics. September 4, 2024. Accessed September 4, 2024. 

https://www.clicktherapeutics.com/press/click-therapeutics-announces-ct-132-met-primary-endpoint-for-the-reduction/

2. Click Therapeutics Initiates Fully Remote Pivotal Trial Using Investigational Prescription Digital Therapeutics to Treat Episodic Migraine. News Release. Click Therapeutics. April 25, 2023. Accessed September 4, 2024. 

https://www.clicktherapeutics.com/press/click-therapeutics-initiates-fully-remote-pivotal-trial-using/

: Percentage of Adults Aged ≥18 Years Who Have Been Bothered a Lot by Headache or Migraine in the Past 3 Months, by Sex and Age Group — National Health Interview Survey, 2021. MMWR Morb Mortal Wkly Rep 2023;72:611. DOI: 

4. Pescador Ruschel MA, De Jesus O. Migraine Headache. [Updated 2024 Jul 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560787/

Click Therapeutics announced that CT-132 met its primary endpoint in the phase 3 ReMMi-D trial.

Digital Therapeutic Shows Significant Reduction in Episodic Migraine

A potential new prescription digital therapeutic for episodic migraine has been granted breakthrough status by the FDA. The move is notable both because it marks a vote of confidence for digital therapies and because the particular product is designed to prevent—not just treat—migraines.

Click Therapeutics said its investigational therapeutic, CT-132, won Breakthrough Device Designation late last year.

 The designation gives the product priority status and access to expedited review, assuming the company is able to demonstrate CT-132’s efficacy in clinical trials.

Austin Speier, Click’s chief strategy officer, said CT-132 would become a first-in-class therapy if it eventually makes it to market.

The number of digital therapeutics available for migraine is likely to expand. 

Ashley Gallagher

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