A provider toolkit with clinically relevant resources related to diagnosis and management of central precocious puberty.

CPP Provider Toolkit

A pair of experts in the management of diabetes review the role of insulin therapy and review the approval process for biosimilars, including the FDA's approval of the first interchangeable insulin biosimilar.

Interchangeable Insulin Biosimilars: A Game Changer in Diabetes Management

Podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP aimed at providing real-world perspective on the latest advances in diabetes management.

New research provides an overview of the long-term quality of life benefits achieved after parathyroidectomy for people with 

A systematic review of English-language published studies published from June 1998 through February 15, 2021, results of the study detail the improvements in quality of life observed up to 10 years after parathyroidectomy among people with primary hyperparathyroidism.

“This systematic review brings together 20 years of research investigating QOL after treatment with parathyroidectomy for patients with primary hyperparathyroidism,” wrote investigators. “Based on these 31 studies, there is strong evidence in the literature that parathyroidectomy is associated with improvements in preoperative, nonspecific, neurocognitive symptoms and quality of life, and these improvements are sustained in the long term.”

Led by a trio of investigators from the Department of Surgery at the Medical College of Wisconsin, the research effort was undertaken with the intent of describing the impact of undergoing parathyroidectomy for primary hyperparathyroidism on long-term quality of life and specific quality of life properties among this patient population. With this in mind, investigators designed their systematic review to evaluate these associations among studies on the subject published in the English language with a minimum of 1 year of follow-up data within the PubMed and Scopus databases from June 1998 through February 15, 2021.

Using Medical Subject Heading terms for hyperparathyroidism, parathyroid hormone, parathyroidectomy, hypercalcemia, and quality of life, investigators identified 31 studies conducted in 14 countries for inclusion in their systematic review. Of note, the original search had returned 3008 studies, with the majority of these studies being eliminated from inclusion due to being duplicates or not meeting inclusion criteria. 

Of the 31 studies included, 22 were prospective cohort studies, 5 were randomized clinical trials, 1 was a cases series, 1 was a cross-sectional study, 1 was a case-control study, and 1 was a retrospective cohort study. Regarding quality of life assessments, 21 studies used the 12-item Short-Form Health Survey, a general tool to measure equality of life, and 8 used a disease-specific quality of life measurements, with the remaining using a combination of 10 additional quality of life tools.

Upon analysis, 87% (n=27) of the 31 studies demonstrated significant score improvement in long-term quality of life following parathyroidectomy, including a single study that provided evidence of continued improvement in quality of life 10 years after parathyroidectomy. Investigators highlighted 13% (n=4) of studies included in the review reported mixed results.

“This systematic review suggests that surgical intervention with parathyroidectomy is associated with improved and sustained long-term QOL in patients with primary hyperparathyroidism. This review identifies 2 key gaps in the current guidelines: a lack of standardized methodology for assessing quality of life and a lack of specificity regarding which components of quality of life should be considered when counseling patients about parathyroidectomy,” investigators added.

Long-term Quality of Life After Parathyroidectomy for Primary Hyperparathyroidism

Articles

A systematic review of studies published from 1998-2021 provides insight into the potential long-term quality of life improvements achieved after undergoing parathyroidectomy in patients who primary hyperparathyroidism, with results shedding light on the quality of life changes up to 10 years after parathyroidectomy. 

Study Details Long-Term Quality of Life Improvements After Parathyroidectomy in Primary Hyperparathyroidism

A new analysis of data from the SURPASS program suggests use of tirzepatide (Mounjaro) could help people with 

 reach glycemic targets in a fraction of the time as other medications.

Results of the analysis, which were presented at the European Association for the Study of Diabetes (EASD) Annual Meeting, indicate a weekly injection of tirzepatide helped adults with type 2 diabetes reach glycemic targets 4-12 weeks sooner than those receiving semaglutide 1 mg and long-acting insulin degludec.

“Tirzepatide is unique because it mimics two natural insulin-releasing and appetite-suppressing hormones in one injection”, said lead investigator Adie Viljoen, MD, a consultant metabolic physician and chemical pathologist from the East and North Hertfordshire NHS Trust in the United Kingdom, in a statement. “The speed we are seeing in glucose-lowering and weight loss is beyond anything else we have available right now and it may put adults with type 2 diabetes in a better position for preventing long-term complications. But it is important to remember that these medications should be used in addition to diet and exercise.”

approval of Eli Lilly’s novel dual GIP/GLP-1

, which occurred in May 2022, based on the results of the SURPASS program, multiple analyses have been conducted since the initial data release providing further insight into the effects of tirzepatide at different dosages and against different comparators. 

 beginning in June 2022, the agent has been embraced as a potential paradigm-shifting therapy with significant benefits on both diabetes and obesity. In the current study, which was an exploratory preplanned analysis, investigators leveraged data from the SURPASS-2 and -3 trials to assess time to achieve glycemic targets. This was assessed using the Kaplan Meier method and hazard ratios were calculated using Cox proportional hazards model.

In the overall SURPASS-2 trial, use of tirzepatide was compared against use of semaglutide 1.0 mg. Results of the study suggested use of tirzepatide was associated with greater improvements in HbA1cfrom baseline and proportion of people reaching HbA1c goals at 40 weeks. In the SURPASS-3 trial, use of tirzepatide was compared against titrated insulin degludec. Results of the study indicated use of tirzepatide was associated with greater improvements in HbA1c change from baseline and the proportion of patients reaching HbA1c at 52 weeks.

In the present analyses, initial results indicated use of tirzepatide was associated with a significantly faster time to reach HbA1c levels of 7% or lower and 6.5% or lower. The median time to achieve an HbA1c of 7% or below was 8.1 weeks across all tirzepatide doses compared with 12 weeks for semaglutide and 12.1 weeks for titrated insulin degludec. The median time to achieve an HbA1c of 6.5% or below was 12.1 weeks across all tirzepatide doses, 15.7 weeks with semaglutide 1.0 mg, and 24.1 weeks with titrated insulin degludec. In analyses pertaining to weight loss, results indicated tirzepatide was associated with a faster time to achieve 5% change in body weight than semaglutide 1.0, with those receiving tirzepatide achieving this at a median of 12 weeks when using tirzepatide at 10 or 15 mg compared to 24 weeks with semaglutide.

“Even a modest weight loss of 5% of initial body weight is associated with clinically significant improvements in weight-related health issues for many individuals”, Viljoen added in the aforementioned statement. “For people with type 2 diabetes to be able to achieve these improvements in health in around half the time is pretty incredible.”

This study, “Patients with type 2 diabetes reach glycaemic targets faster with tirzepatide compared to semaglutide and titrated insulin degludec,” was presented at EASD.

An analysis of data from SURPASS-2 and -3 provides evidence demonstrating the reduction in time to achieve glycemic targets and weight loss with use of tirzepatide compared with semaglutide 1.0 mg and long-acting insulin degludec. 

Tirzepatide Cuts Time to Glycemic Targets by 4-12 Weeks vs Other Diabetes Therapies

Results of a new study should serve as a warning related to the impact of rising temperatures on risk of adverse outcomes in patients with 

As climate change continues to touch each corner of the earth, results of the study, which leveraged data from nationwide administrative databases in Japan from 2012-2019, suggest extreme heart was linked to a more than 60% increase in risk of a hyperglycemic emergency in the next 3 days, which investigates indicate was consistent across different types of hyperglycemic emergencies and type of diabetes.

“Relative risks for standard and extreme heat effect on emergency hospitalization for hypoglycemia were found to be 1.33 and 1.65, respectively, and similar risks were found for hyperglycemia. In most regions, the higher the temperature, the higher the relative risk,” said lead investigator Takeo Fujiwara, MD, PhD, MPH, 

. 

With extreme heat linked to an uptick in adverse health outcomes, and in the wake of recent data illustrating this effect in patients with diabetes, the current study was launched by investigators in the Department of Global Health Promotion at Tokyo Medical and Dental University. With the intent of estimating the associations between heat exposure and hospitalization in patients with diabetes, investigators designed the present study as an analysis of data from daily hospitalizations extracted from a nationwide administrative database in Japan linked with temperature in each region from 2012-2019. Investigators noted a distributed lag non-linear model was used to assess nonlinear and lagged effects of heat exposure on hospitalization, with events of interest defined as diabetic ketoacidosis, hyperosmolar hyperglycemic state, and hypoglycemia.

From the dates, investigators identified 45,482 hospitalizations for hyperglycemic emergencies and 62,042 hospitalizations for hypoglycemia during the study period. The most common form of hyperglycemic emergency was diabetic ketoacidosis, which accounted for 84.9% of all hyperglycemic emergencies included in the trial. Investigators pointed out 52.8% of hyperglycemic emergencies occurred in patients with type 2 diabetes and the majority occurred among patients aged 15 years or older (94.6%). Investigators also pointed out the majority of patients who experienced hospitalization (65.8%) were older than 65 years old.

Upon analysis, results indicated the pooled relative risk of heat effect (90th percentile of temperature vs 75th percentile of temperature) and extreme heat effect (99th percentile of temperature vs 75th percentile of temperature) for hyperglycemic emergencies over 0-3 lag days were 1.27 (95% CI, 1.16-1.39) and 1.64 (95% CI, 1.38-1.93), respectively. Further analysis suggested the pooled relative risk for heat effect and extreme heat effect on hospitalization for hypoglycemia were 1.33 (95% CI, 1.17-1.52) and 1.65 (95% CI, 1.29-2.10), respectively. Investigators also pointed out these associations appeared to be consistent by type of hyperglycemic emergencies and type of diabetes.

“To the best of our knowledge, this is the first study to show the association between ambient temperature and hyperglycemic emergencies and hypoglycemia using distributed lag non-linear model, which allows us to assess the nonlinear and lag effects of ambient temperature. The findings of previous studies evaluating the effects of ambient temperature on diabetic patients were limited to all-cause mortality and all-cause hospitalization,” investigators added.

Association between heat exposure and hospitalization for diabetic ketoacidosis, hyperosmolar hyperglycemic state, and hypoglycemia in Japan,

An analysis of data from more than 100,000 hospitalizations for hypoglycemia and hyperglycemic emergencies provides insight into the purported increase in risk for these events observed with extreme heat. 

High Temperatures Linked to Increased Hospitalizations for People with Diabetes

The US Preventive Services Task Force has released their first recommendation statement outlining the organization’s stance on screening for 

 in children and adolescents without known diabetes or prediabetes or without symptoms of either.

Released on September 13, the USPSTF concluded in their recommendation statement, which is the first on the subject for this particular patient population, that there was insufficient evidence to assess the balance of benefits and harms of screening for type 2 diabetes or prediabetes in children and adolescents, awarding an I grade to the statement.

“The rate of prediabetes and type 2 diabetes in youth is increasing. The challenge is that we don’t have the evidence to tell us whether or not screening in primary care helps improves the health of children and teens,” says Task Force member Michael Cabana, MD, MA, MPH, director of the Division of General Pediatrics at the University of California, San Francisco, in 

. “It is important that healthcare professionals be aware of the signs and symptoms of prediabetes and type 2 diabetes and use their judgment when determining whether or not to screen youth."

 the recommendation statement was composed by Mangione and represents the first time the USPSTF has issued a recommendation statement on the topic. Although they opted to issue an I grade, which indicates a lack of sufficient evidence to make a recommendation, for the statement, the authors noted the importance of diabetes prevention in this population and provided suggestions for practice. Among these suggestions were an emphasis on obesity and excess adipose tissue, awareness of the increased risk among minority populations,

In the past, the USPSTF has awarded B graded recommendations, which indicate high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial, on screening for obesity in children and adolescents, screening for prediabetes and type 2 diabetes in adults, and screening for gestational diabetes in pregnant persons.

USPSTF conducted an evidence report and systematic review

 of available data related to the topic. From the PubMed/MEDLINE, Cochrane Library, and trial registries, investigators identified 8 publications for inclusion in their review. Of these 8, 6 were from the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study. Upon review, investigators found none of the eligible studies directly assessed benefits or harms of screening in these populations.

Near the conclusion of their recommendation statement, authors highlighted multiple research needs and knowledge gaps in need of addressing. These included the effects of screening on health outcomes in children and adolescents considered to be at higher risk, effects of lifestyle interventions, pharmacotherapy, or both for treatment of screen-detected prediabetes and diabetes on health outcomes in children and adolescents, and the effects of screening on health outcomes in child and adolescent populations reflective of the prevalence of diabetes in the US, particularly in racial and ethnic groups with a higher prevalence of diabetes than non-Hispanic White youth.

, Elvira Isganaitis, MD, MPH, and Lori Laffel, MD, MPH, both of Harvard Medical School, underlined the attention this statement should bring to existing knowledge and research gaps related to a subject that could have a substantial, population-level impact. Further in the editorial, the pair touched on optimal strategies while awaiting a firmer conclusion on the benefits and harms of screening in this patient population.

“For now, while awaiting more data and definitive guidelines, pediatricians and primary care clinicians can continue to emphasize the importance of healthy lifestyles for children and their families, maintain a watchful approach to detect clinical symptoms of hyperglycemia, and continue to follow risk-based screening recommendations for type 2 diabetes in overweight or obese youth with at least 1 additional risk factor,” Isganaitis and Laffel wrote.

This USPSTF recommendation statement, titled “

Screening for Prediabetes and Type 2 Diabetes in Children and Adolescents

Released on September 13, the US Preventive Services Task Force concluded there was a lack of sufficient evidence related to the benefits and harms of screening in their first-ever recommendation statement on screening for type 2 diabetes and prediabetes in children with no known history or symptoms of either disease. 

USPSTF Issues First Recommendation Statement on Type 2 Diabetes Screening in Children and Adolescents

Data from a new study is sounding the alarm on trends in the trajectory of 

Presented at the American Society of Bone and Mineral Research (ASBMR) 2022 Annual Meeting, results of the study, which was conducted by investigators at the University of Hong Kong, suggest the number of annual hip fractures are expected to nearly double worldwide by 2050 compared to the 2018 rate, with the largest proportional increase seen among men. 

"Our study also showed that the use of anti-osteoporosis medications following a hip fracture is lower in men than in women by 30% to 67%,” said lead investigator Ching-lung Cheung, Associate Professor, in the University of Hong Kong’s Department of Pharmacology and Pharmacy, 

. "Thus, more attention should be paid to preventing and treating hip fractures in men."

Despite the increased risk of mortality and morbidity associated with hip fractures, fracture prevention and osteoporosis remain among the most overlooked adverse events among an aging population. With this in mind, Cheung and a team of colleagues designed the present study as a multinational real-world study using data from 19 countries and a common data model to assess temporal trends in age- and sex-standardized annual incidence of hip fracture to project hip fracture rates through 2050 using predicted population sizes from the World Bank.

For the purpose of analysis, investigators pooled data from patients aged 50 years and older with an admission diagnosis of hip fracture from 2005-2018. Investigators aimed their analyses at determining the age- and sex-standardized annual incidence of hip fracture, mortality, and pharmacological treatment rates within 12 months. The primary outcomes of interest were hip fracture counts by 2030 and 2050. Of note, the 19 countries included in the study included representation from Oceania, Asia, North and Western Europe, North America, and South America.

Upon analysis, investigators found the global age- and sex-standardized incidence of hip fracture was estimated to be 202 per 100,000 individuals, with greater rates observed among women (267 per 100,000 individuals) than their male counterparts (176 per 100,000 individuals. However, investigators pointed out there was significant variability observed between the countries included in the study. Further analysis suggested the average change in standardized hip fracture incidence varied from -2.8% to +4.4% per year. The greatest declines in fracture incidence were observed in Denmark, Singapore, and Hong Kong which saw annual declines of -2.8%, -2.8%, and -2.4%, respectively. The greatest increases in fracture incidence were observed in Thailand, Netherlands, and South Korea which saw annual increases of 4.4%, 2.1%, and 1.2%, respectively.

Additional analysis indicated use of pharmacological treatment within 12 months of hip fracture ranged from 11.5% to 50.3% among the countries reporting use examined in the study, with annual trends pointing to declines in use among more than half of the countries included. Based on the results of their analyses, investigators purported worldwide hip fracture counts would likely double by 2050 compared to the 2018 figures.

Global Epidemiology of Hip Fracture – Secular Trends of Incidence, Treatment Rate, and Mortality from 2005 to 2018; A Multinational Real-world Study with Common Data Model

A study presented at ASBMR 2022 leveraging data from more than a dozen countries details trends in hip fracture incidence and projects potential incidence increases by 2050. 

Study Finds Global Hip Fractures Expected to Double by 2050

The US Food and Drug Administration has issued an alert to users related to a potential cybersecurity risk for Medtronic MiniMed 600 Series Insulin Pump Systems.

Announced on September 20, the FDA’s alert, which pertains to multiple systems including the MiniMed 630 G and MiniMed 670G, points out the agency had not been made aware of any reports related to this cybersecurity vulnerability. The FDA’s alert also noted 

Medtronic has issued an Urgent Medical Device Correction

 on their own website notifying users as well as providing recommended actions.

“There is a potential issue associated with the communication protocol for the pump system that could allow unauthorized access to the pump system. If unauthorized access occurs, the pump’s communication protocol could be compromised, which may cause the pump to deliver too much or too little insulin,” noted the 

FDA’s September 20 Cybersecurity alert.

On their website, Medtronic provides the Urgent Medical Device Correction, a list of model numbers impacted by the issue, and a multitude of frequently asked questions for device users. Within these resources, Medtronic notes the issue was identified through an internal review and, while the event meets the definition of a recall, users are not required to return their devices.

, which was signed by Chirag Tilara, vice president of Quality at Medtronic Diabetes, and Robert Vigersky, MD, chief medical officer at Medtronic Diabetes, the pair recommended all patients turn off the “Remote Bolus” feature on their pump if it is turned on, which is on by default. The letter also urged users to conduct any connection linking of devices in a nonpublic setting. Additional recommended precautions from Medtronic included keeping pump and connected system components within user control at all times, be attentive to pump notifications, alarms, and alerts, and immediately cancel any boluses you or your care partner did not initiate.

“Medtronic has recently identified a potential issue through internal testing whereby, under specific circumstances, the communication between the components of the pump system could be compromised through unauthorized access,” reads the letter. “For unauthorized access to occur, a nearby person other than you or your care partner would need to gain access to your pump at the same time that the pump is being paired with other system components. This cannot be done over the internet.”

In the aforementioned release, the FDA noted they are working with Medtronic to identify, communicate, and prevent adverse events related to this incident. The FDA urged those with questions to reach out to Medtronic at 1-800-646-4633, option 1.

Announced on September 20, the alerts from the FDA and Medtronic notify users of a potential cybersecurity risk identified through internal testing at Medtronic that would allow unauthorized users to the pump's communication protocol, which could allow unauthorized boluses.

Cybersecurity Risk with MiniMed 600 Systems Prompts Alert from FDA, Medtronic

Data from a study led by investigators from the University of Texas and the University of Miami is providing insight into the effects of bariatric surgery on long-term body weight and risk of comorbidities in adolescent populations with 

An analysis of data from nearly 100 patients who underwent metabolic and bariatric surgery at 21 years of age or younger, results of the study suggest undergoing such a procedure was associated with a mean reduction in body weight of 31.3% more than a decade after undergoing surgery, with results indicating undergoing surgery was also associated with long-term 

“There are long-term benefits to completing bariatric surgery before the age of 22,” said Sarah Messiah, PhD, MPH, senior author of the study and professor and director of the Center for Pediatric Population Health at UTHealth School of Public Health-Dallas, 

. “The durability of the positive health outcomes isn’t well known this far out at this young age. It’s been a gap in understanding that this research has helped fill.”

As the obesity epidemic has ballooned, so has the popularity and knowledge base surrounding bariatric surgery as a potential treatment for obesity. In more recent years, bariatric surgery among adolescent populations has begun to increase as the safety of procedures has become more well-established. However, as investigators of the current study note, fewer research efforts have been undertaken to examine the long-term impact of metabolic and bariatric surgeries beyond 10 years of follow-up in adolescent populations.

With this in mind, Messiah and colleagues designed the current study as an analysis of long-term outcomes after bariatric surgery in patients aged 15-21 years before surgery and with a minimum of 10-18 years of follow-up from a single academic medical center. In total, 96 individuals who underwent surgery between 2002-2010 were identified for inclusion in the investigators’ analyses. Before surgery, this cohort had a mean age of 18.7±1.6 years, a median BMI of 45.0 kg/m2, and 83% were female. Investigators also pointed out 5.2% had type 2 diabetes, 13.5% had hypertension, and 14.6% had hyperlipidemia.

The majority of patients (90.6%) underwent gastric bypass while 9.4% underwent laparoscopic adjustable gastric banding )LAGB, and 1.0% underwent sleeve gastrectomy. The mean follow-up time of participants was 14.2±2.2 years. Upon analysis, results indicated the mean total decrease in body weight among adolescents who had undergone bariatric surgery was 31.3% (IQR, 20.0-38.9%), with body weight reductions of 32.0% (IQR, 21.3-40.1%) observed among RYGB participants and 22.5% (IQR, 0.64-28.3%) among LAGB participants.

Further analysis suggested individuals with hyperlipidemia, and diabetes or hyperglycemia before surgery reported 100% remission at follow-up (

 <.05). Investigators also pointed out decreases in the prevalence of multiple comorbidities was decreased at baseline compared to before surgery, including hypertension (13.5% vs 1%; 

 <.001), gastroesophageal reflux disease (13.5% vs 3.1%; 

“Adolescents are the fastest-growing segment of the severe obesity epidemic in the US, and the COVID-19 pandemic has exacerbated the problem,” Messiah added. “The evidence from this study supports recent recommendations from the American Academy of Pediatrics to increase access to surgery for adolescents. We hope this data could change barriers to access for these children.”

Long-Term Outcomes after Adolescent Bariatric Surgery

Journal of the American College of Surgeons.

An analysis of nearly 15 years of follow-up data from 97 patients who underwent bariatric surgery during adolescence provides insight into the benefits of surgery on weight loss and comorbidities among those with severe obesity. 

Benefits of Bariatric Surgery in Adolescents Endure Beyond a Decade, Study Shows

After demonstrating efficacy and safety as a weight loss agent in randomized clinical trials, a retrospective cohort study from a Mayo Clinic-led team is providing insight into the real-world effects of 2.4 mg semaglutide (Wegovy) for weight management.

With data from more than 150 patients treated at a referral center for 

 prescribed semaglutide for 3 months or more between January 1, 2021-March 15, 2022, results of the study suggest the mean weight loss achieved at 3 months was 5.9% of body weight, with this improving to 10.9% at 6 months and further analysis indicating more than 50% of semaglutide users achieving weight loss of 10% or more at 6 months.

“This study may be a stepping stone to demonstrating the effectiveness of semaglutide for patients aiming to lose weight. These results may support the applicability of semaglutide in a less controlled environment, as previously proven in RCTs,” wrote investigators.

US FDA’s approval of 2.4 mg semaglutide

 in June 2021 for chronic weight management in patients with overweight or obesity, the weekly GLP-1 receptor agonist became the first drug to receive such an approval in more than half a decade. Based on the results of the pivotal STEP program, the agent boasted a mean weight loss of 6% of body weight at 3 months and 12% of body weight at 28 weeks. Now, more than a year removed from FDA approval, investigators launched the current study citing a lack of retrospective studies assessing effectiveness of the increased doses of semaglutide outside of a clinical trial setting.

Designed as a retrospective review of electronic medical record data from individuals in the Mayo Clinic Health system using 1.7 mg or 2.4 mg semaglutide from January 1, 2021-March 15, 2022, the study’s primary endpoint of interest was the percentage of weight loss, with secondary endpoints examining the proportion of patients achieving weight loss of 5% or more, 10% or more, 15% or more, and 20% or more after 3 and 6 months as well as the percentage of weight loss for patients with or without type 2 diabetes after 3 and 6 months. For inclusion in the investigators’ analyses, individuals were required to have a BMI of 27 kg/m2 or greater and be prescribed weekly semaglutide for 3 months or more. Major exclusion criteria included hoister of bariatric procedures, receipt of other antiobesity medications, and have an active malignant neoplasm.

A total of 408 patients were identified for potential inclusion. After application of exclusion criteria and those who were denied based on insurance or a national shortage of semaglutide, 175 individuals were identified for inclusion in the investigators’ final analyses. This cohort had a mean age of 49.3 (SD, 12.5) years, 75.4% were female, and 88.0% were White. The cohort had a mean BMI of 41.3 (SD, 9.1) kg/m2, 16.0% had type 2 diabetes, and 58.3% had 6-month follow-up data available.

Upon analysis, results indicated the mean weight loss at 3 months was 6.7 (SD, 4.4) kg, which was equivalent to a mean weight loss of 5.9% (SD, 3.7%) (

 <.001). At 6 months, the mean weight loss was 12.3 (SD, 6.6) kg, which was equivalent to a mean weight loss of 10.9% (SD, 5.8%) (

 <.001). Among the 102 patients with at least 6 months of follow-up, 87.3% achieved a weight loss of 5% or more, 54.9% achieved a weight loss of 10% or more, 23.5% achieved a weight loss of 15% or more, and 7.8% achieved a weight loss of 20% or more. Further analysis suggested people with type 2 diabetes had. A lower mean percentage of weight loss at 3 months (3.9% [SD, 3.1%] vs 6.3% [SD, 3.7%]) and at 6 months (7.2% [SD, 6.3%] vs 11.8% [SD, 5.3%]) compared to their counterparts without type 2 diabetes (

“The findings of this cohort study suggest that semaglutide is clinically effective for weight loss at 3 and 6 months for people with overweight or obesity,” investigators added. “Although our study lacked the stringent and closely controlled nature of RCTs, we report similar weight loss results within the same time period as in RCTs. Studies with greater sample sizes and longer periods of follow-up are further needed to support the effectiveness of semaglutide.”

Weight Loss Outcomes Associated With Semaglutide Treatment for Patients With Overweight or Obesity

A retrospective analysis of EMR data from Mayo Clinic referral centers provides an overview of the effects of 2.4 mg semaglutide on weight loss in populations outside of clinical trial settings. 

Real-World Data Backs 2.4 mg Semaglutide (Wegovy) for Weight Management in Obesity

The COVID-19 pandemic, now in its third year, has led to a host of setbacks in public health in addition to its specific toll on human lives. As a result of widespread lockdowns, many people have been stuck inside with little to do. With greater than 40% of American adults already struggling with obesity, the pandemic was thought to increase social isolation while decreasing access to health care and high-quality nutritious food sources.

A recent investigation by Jaime Amandoz, MD, and colleagues in Texas found nearly one-third of people with 

 gained more than 5% of their body weight in the first year of the COVID-19 pandemic, with 1 in 7 gaining 10%. Amandoz believes the increased anxiety produced in obese patients due to their increased risk for serious COVID-19 illness and death is the driving force behind the dramatic weight gain.

“The COVID-19 pandemic is a fascinating model for individual and social stress and showed that changes in mental health can really preclude people from maintaining a healthy body weight,” Amandoz said.

Leveraging surveys, the investigators of this study found very high levels of self-reported stress, anxiety, depression, and maladaptive eating behaviors among adults with obesity during the COVID-19 pandemic.

 Prior research by this team of investigators looked at the impact of stay-at-home orders on the mental health and behaviors of obese patients. They found that 70% of patients found weight loss to be more difficult during the lockdowns with large portions reporting less exercise and more stress-related eating.

In the current report, Amandoz and fellow researchers found that the majority of obese patients surveyed gained around 4.3% of their body weight during the pandemic.

 Another study cited in their work showed that 48% of all American adults gained weight during the pandemic further supporting these new data.

 Those surveyed tended to be of higher education and economic status. The investigators speculate that those of lower socioeconomic status likely faced even greater stress and more weight gain.

Factors associated with greater weight gain included eating less healthy food, not sleeping as much, and exercising less.

Finally, those people reporting the highest levels of anxiety, depression, and stress gained the most weight.

“It’s not just about telling people to eat less and move more, there’s a mental health aspect that has to be integrated into treating the whole person as well,” Amandoz notes.

These results make sense. The stress of a pandemic coupled with isolation and fear put a significant strain on the mental health of obese patients already struggling to lose weight. As we move into and beyond the third year of COVID-19 we as clinicians need to evaluate our patients for stress, anxiety, and depression making available to them enhanced support and targeted interventions. When access to care is limited, we need to find alternatives such as virtual visits and responsible office encounters. Education and encouragement become even more important when our patients are dealing with mental health challenges. Addressing those mental health challenges should be a part of every visit.

Every effort needs to be made to identify those patients at highest risk for weight gain. The challenges experienced by isolated obese patients should not be underestimated. The stigma and mental health problems already experienced by obese patients should be assumed to be significantly worse during the pandemic but with support, understanding, and encouragement, we can mitigate the added strain. Amandoz points out that people in weight management programs typically lose weight.

As such, we should do everything we can to get obese patients in and keep them in these programs, programs that should evaluate and address the patients mental as well as physical health.

Almandoz JP, Xie L, Schellinger JN, et al. Changes in body weight, health behaviors, and mental health in adults with obesity during the COVID-19 pandemic. Obesity (Silver Spring). 2022;1‐12. doi:10.1002/oby.23501

Khubchandani J, Price JH, Sharma S, Wiblishauser MJ, Webb FJ. COVID-19 pandemic and weight gain in American adults: a nationwide population-based study. Diabetes Metab Syndr. 2022;16: 102392. doi:10.1016/j.dsx.2022.102392

New research from a team at University of Texas Southwestern describes the impact of the COVID-19 pandemic on mental health and subsequent increases in body weight among people with obesity. 

Declining Mental Health During COVID-19 Pandemic Linked to Worsening Obesity

An analysis of online survey data from people with type 2 diabetes is providing new insight into patient preferences related to newer oral therapies in 

A custom survey assessing responses to blinded drug profile comparisons comparing empagliflozin 25 mg, oral semaglutide 14 mg, and sitagliptin 100 mg, results of the study provide insight into the most important attributes and most concerning risks pertaining to these newer agents, with results indicating the highest blinded preference score was for the profile matching empagliflozin followed by sitagliptin then oral semaglutide.

“These findings have significant implications as they suggest that patients may be hesitant to initiate guideline-directed medical therapy oral antihyperglycemic therapies with cardiovascular benefit due to side effect concerns,” investigators wrote. “It is possible that these findings reflect a lack of awareness amongst patients of the CV risks associated with T2DM and more focus on side effects and short-term quality of life.”

In recent years, the field of cardiometabolic health has experienced an explosion in knowledge and advancement led primarily by the revelation of the cardiorenal protective benefit provided by some antihyperglycemic agents, such as SGLT2 inhibitors, oral GLP-1 receptor agonists, and DPP-4 inhibitors. However, despite the growing knowledge of these benefits, uptake of these agents has lagged behind, even with inclusion in recent guideline updates.

Led by Gianluigi Savarese, MD, of the Division of Cardiology at Karolinska Institute, and Abhinav Sharma, MD, of the Division of Cardiology at McGill University, the present study was launched with the intent of developing a more thorough understanding of patient preferences related to oral therapies antihyperglycemic agents. With this in mind, investigators designed the current study as an analysis of data from a custom survey distributed to the dQ&A Diabetes Patient Panel, which is a patient panel of more than 15,000 people with type 1 or type 2 diabetes.

Distributed between August 16-23, 2019, investigators received completed surveys from 553 (67.9%) of the 815 patients contacted and issued surveys. Within the survey, participants were presented with hypothetical, blinded, pairwise, drug profile comparison choices, with benefits and harms derived from phase 3 trials for each agent.

Regarding participant characteristics, 25% had an HBa1c of 6.5-7%, 24% had an HbA1c greater than 8%, 26% had a known history of cardiovascular disease, 55% had cardiovascular disease risk only, and 62% were insulin users. Investigators pointed out all demographic and health outcomes data were self-reported, respondents received $10 for participation in surveys, and the median time to completion was 14.5 minutes.

Upon analysis, investigators found genital infection risk was the most important attribute of an agent’s clinical profile (relative score: 19% [z-test, 

=.077]). The next most important attributes from the patient perspective were fasting requirements (15%), weight reduction (15%), risk of vomiting (14%), cardiovascular benefit (12%), and risk of nausea (11%). Investigators highlighted HbA1c and ability to take other medications were considered the most important factor by 8% and 6% of respondents, respectively. When blinded to drug names and dose, 41% of survey respondents chose a profile similar to empagliflozin, 31% chose a profile similar to sitagliptin, 11% chose a profile similar to oral semaglutide, and 17% elected to choose none of the options.

“These results can facilitate broader conversation between patients and clinicians in determining patient-centric therapies, as advised by the American Diabetes Association and European Society of Cardiology guidelines for type 2 diabetes mellitus treatment and may lead to improved compliance and outcomes,” investigators added in their conclusion.

Patient preferences for newer Oral therapies in type 2 diabetes,