Coverage of the Endocrine Society's 2021 Annual Meeting

ENDO 2021

Research from an analysis of the AWARD-11 study is providing insight into the effects of increased doses of dulaglutide on HbA1c control and weight loss in patients with 

, data from the post-hoc analysis helps to inform clinicians on the effect of the expand doses, which received approval in September 2020, based on baseline HbA1c categories.

With the FDA basing their approval on the results of AWARD-11, a team led by Juan Frias, MD, of the National Research Institute, sought to further evaluate the safety and efficacy of alternate doses of dulaglutide according to baseline HbA1c levels. For the purpose of analysis, HbA1c subgroups were defined as less than 8%, 8-9%, 9 to less than 10%, and 10% or greater. A mixed-effects model was used to assess change in HbA1c from baseline at weeks 36 and 52.

Results of the investigators’ analyses indicated more patients randomized to the 3 mg or 4.5 mg dose of dulaglutide achieved an HbA1c of less than 7% at 36 weeks, regardless of baseline HbA1c level. In total, more than half of the patients randomized to 4.5 mg dulaglutide in each baseline HbA1c group were able to achieve an HbA1c of less than 7%.

Additionally, investigators pointed out this apparent improvement in HbA1c control seen with 4.5 mg dose was not associated with an increase in incidence of adverse gastrointestinal events. 

For more on the impact of this post-hoc analysis of AWARD-11 analysis, 

reached out to Juan Frias, MD, medical director of the National Research Institute.

This study, “Efficacy of Dulaglutide Expanded Doses by Baseline A1C Categories: Post Hoc Analysis of AWARD-11,” was presented virtually as part of ENDO 2021.

Videos

Juan Frias, MD, breaks down results of a post-hoc analysis of the AWARD-11 study examining expanded doses of dulaglutide according to baseline HbA1c levels.

Expanded Doses of Dulaglutide Safe, Efficacious Regardless of Baseline HbA1c

This article was originally published on 

Despite being the most common form of secondary hypertension, new research presented at ENDO 2021 suggests just 3% of high risk patients undergo screening for primary aldosteronism. 

An analysis of data from more than 11,000 patients seen in outpatient clinics from 2010-2019, results of the study indicate diagnosis occurs after onset of symptoms on most occasions, which led investigators to call for initiatives to encourage screening of primary aldosteronism in high risk patients.

"The results of our study indicate that initiatives to encourage PA screening are crucial for preventing cardiovascular and kidney disease in many patients with hypertension," said lead researcher Seda Grigoryan, MD, an internal medicine specialist at Michigan State University,

With improved screening rates offering an opportunity to improve care of patients and alleviate a significant burden on health systems, the current study was designed by Grigoryan and a team from Michigan State University and the University of Michigan.

The study was designed as a retrospective review of patients aged 18 and older with hypertension seen at university-affiliated outpatient clinics from 2010-2019 who met at least 1 of 4 screening criteria. Screening criteria included being on 3 or more anti-hypertensive medications, having hypertension before 40 years of age, having hypertension and a known adrenal mass, and having hypertension and obstructive sleep apnea. Investigators noted they excluded patients with known high-renin hypertension, renovascular hypertension, or congenital adrenal hyperplasia.

Overall, investigators identified 11,627 patients meeting at least 1 of their inclusion criteria. Upon analysis, results indicated just 3.27% were ever screened for primary aldosteronism. Compared to those who were never screened, patients screened were younger (47.5±17.8 vs 51.3±16.9; 

 <.0001), more often women (55.28% vs 45.71%; 

=.0003), had lower serum K levels (3.4±0.5 vs 3.7±0.4, 

 <.0001), and were more likely to have chronic kidney disease (29.27% vs 17.5%; 

 <.0001) and cerebrovascular accidents (9.21% vs 6.16%; 

When assessing impact of race/ethnicity on screening rates, investigators found 79.9% of those screened were White, 15.3% were Black, and 2.3% were Asian. However, investigators pointed out screening rates were higher among Asian (8.4%) and Black (6.1%) patients than White (2.8%) patients (

 <.0001). When assessing the impact of age, investigators found screening rates were similar among those regardless of whether they were young or older than 40 years of age.

Further analysis indicated screening rates were greatest among patients with adrenal nodules (35%) and were lowest among patients with hypertension and obstructive sleep apnea (2.1%).

In subgroup analyses of patients with resistant hypertension, those screened were younger (58.5±14.0 vs 68.7±12.8, 

<.0001) and more likely to be Black (20.7% vs 10.1%) than those not screened. In subgroup analyses of patients with adrenal masses, investigators found no sex, age, or race-based differences in those screened versus those not screened.

When assessing initiation of screening, investigators found screening was initiated most often by general internists (53.9%) and endocrinologists (15.8%) while rates were notably lower among nephrologists (9.5%) and cardiologists (4.2%).

This study, “Rates of Primary Aldosteronism Screening Among High-Risk Populations,” was presented virtually as part of ENDO 2021.

Articles

An analysis presented at ENDO 2021 suggests less than 5% of patients at high risk for primary aldosteronism undergo screening and most screenings occur after the onset of symptoms. 

Study Calls for Increased Screening of Primary Aldosteronism


New research suggests COVID-19 is associated with a unique form of inflammation of the thyroid gland.

Conducted by a team of investigators based in Italy, results of the ENDO 2021 study suggest 1-in-3 diagnosed with moderate to severe COVID-19 during the early outbreak in Europe was still experiencing signs of thyroid inflammation after 3 months, despite thyroid function having already normalized.

The dysfunction triggered by COVID-19 does not appear to be mediated by autoimmunity, investigators observed, and therefore warrants follow-up research in the event that patients may be at risk of permanent thyroid dysfunction.

Investigators, led by Ilaria Muller, MD, PhD, of the University of Milan, conducted a longitudinal follow-up study of patients to survive moderate to severe COVID-19 following hospitalization in acute medical units at a facility in Milan. Patients observed for this study had no history of thyroid disorders and/or treatment thereof.

Muller and colleagues assessed patients for serum thyroid function and autoantibodies, C reactive protein (CRP), full blood count (FBC), and thyroid ultrasound for every 3 months.

At the time of the ENDO 2021 presentation, 53 patients had been included in the follow-up trial. At 3 months following COVID-19 infection, all patients presented with increased median serum TSH concentrations from baseline. Serum concentrations of free-thyroxine, free0triiodothyronine, CRP, and FBC had normalized from baseline.

Negative autoantibodies to the TSH receptor were observed in all patients.

They observed atypical subacute thyroiditis in 15% of patients hospitalized for COVID-19—a significant increase from the 1% observed with such presentations in the same facility during spring 2019, prior to the pandemic.

“The atypical thyroiditis induced by COVID-19 is not associated with neck pain, affects more men than women and especially those severely ill, thus coexists with non-thyroidal illness syndrome,” investigators wrote. “Subacute thyroiditis is classically followed by subsequent occurrence of permanent thyroid dysfunction and autoimmunity, thus we have started a systematic follow-up program of these patients.”

In a statement accompanying the findings, Muller stressed the importance of continued monitoring for such uniquely affected COVID-19 patients.

“It is important to know whether SARS-CoV-2 virus has late-onset negative effects on the thyroid gland, in order to promptly diagnose, and eventually treat, the condition,” Muller said.

The study, “Early Follow-up of Atypical Thyroiditis Induced by SARS-CoV-2,” was presented at ENDO 2021.

A study from ENDO 2021 indicates moderate-to-severe COVID-19 infections are associated with atypical thyroid inflammation.

COVID-19 Could Cause Atypical Thyroid Inflammation

New research from McMaster University provides evidence that switching to a lower, maintenance dose of denosumab may be equally as effective at 

 as the standard 60 mg dose of denosumab.

An analysis of data from a real-world, prospective study presented at 

 indicates switching from denosumab 60 mg to denosumab 30 mg every 6 months did not result in decreases in BMD or increases in fractures, which led investigators to suggest it could be a treatment option in patients who have completed long-term denosumab therapy.

With the cessation of denosumab associated with an increased risk of bone remodeling, reductions in bone mineral density (BMD), and increase risk of fracture, a team led by Aliya Khan, MD, of McMaster University, sought to assess the efficacy of low dose denosumab in postmenopausal women with osteoporosis. To do so, Khan and colleagues designed their study to assess the efficacy switching from 60 mg to 30 mg denosumab every 6 months for up to 2 years in a cohort of women who had completed long-term treatment with denosumab.

For inclusion in the study, patients were required to be 50-90 years of age, have a BMD with a T-score of -2.5 or less at lumbar spine or total hip, have a BMI between 18.5-33.2, and have normal serum calcium, 24-hour calcium, creatinine, TSH, and phosphate levels. Investigators noted patients with an additional skeletal disorder, prior fragility fracture, eGFR below 15mL/min, or on oral steroids were excluded from the study.

Check out this ENDO 2021 study on prescribing practices of osteoporotic therapies among US clinicians.

In total, 127 patients were included in the study. Of these, 44 had received 60 mg denosumab for 3 years or longer and the other 83 began transitioning before completing 3 full years of therapy.

The primary endpoint was percent change in BMD at lumbar spine, total hip, femoral neck, and 1/3 radius at 12 months and 24 months. Secondary outcomes for the study were adverse effects and fracture events.

Upon analysis, results indicated patients in the study significant improvements in BMD at lumbar spine (n=55; 2.00%, 95% CI, 0.49-3.51%; 

=.01) at 12 months. However, there were no significant changes in BMD at the femoral neck, total hip, or 1/3 radial sites at 1 year.

In an analysis of patients with 3 or more years of denosumab therapy before transitioning, results pointed to significant changes in BMD at lumbar spine (4.65%; 95% CI, 2.29-7.01%; 

 <.001), femoral neck (4.87%; 95% CI, 1.46-8.28%; 

=.006), and 1/3 radial sites (4.95%; 95% CI, 0.73-9.17%, 

=.02), but noted no significant changes were seen at total hip. Investigators pointed out similar results were seen among the group of patients with less than 3 years of denosumab therapy.

Investigators also highlighted that no fracture events were observed among participants during the study.

“Switching from 60mg of denosumab to 30 mg every 6 months was not associated with reductions in BMD and may be a valuable treatment option in patients who have completed long term denosumab therapy,” wrote investigators.

Efficacy of Low Dose Denosumab in Maintaining Bone Mineral Density in Postmenopausal Women with Osteoporosis Switching From 60mg to 30mg 6 Monthly: A Real World, Prospective Observational Study

,” was presented virtually as part of ENDO 2021.

Switching from 60 mg to 30 mg denosumab every 6 months could be an option for patients who have completed long-term denosumab therapy, according to the results of a new study from McMaster University. 

Alternating Doses of Denosumab Therapy Equally as Effective, Real-World Study Finds

A once-weekly insulin injection shows promise at ENDO 2021 by demonstrating noninferiority to daily insulin degludec in its first in-human, outpatient trial.

A 32-week phase 2 trial in 399 patients with 

, results suggest patients receiving basal insulin Fc (BIF) saw a mean HbA1c improvement of 0.6% and these patients were able to achieve similar long-term blood glucose control to those receiving insulin degludec.

“These study results demonstrate that BIF has promise as a once-weekly basal insulin and could be an advancement in insulin therapy,” said Juan Frias, MD, the trial’s principal investigator and the medical director of the National Research Institute in San Diego, 

With an interest in assessing the safety and efficacy of BIF, which is a long-acting IgG Fc-fusion protein, the current study was designed to assess the novel agent against insulin degludec in a parallel arm trial in patients with diabetes previously treated with oral antidiabetic agents and basal insulin. The trial included 2 different dosing algorithms with 2 different fasting glucose targets (140 mg/dL or less and 120 mg/dL or less) compared against insulin degludec with a fasting glucose target of 100 mg/dL or less.

The 399-patient cohort had an average age of 60.2 years, a mean baseline HbA1c of 8.1%, and a mean duration of diabetes of 14.7 years. Upon analysis, investigators found both BIIF arms achieved noninferiority (margin=.4%) for the endpoint of HbA1c change from baseline to week 32. Investigators noted both BIF groups had a statistically significant smaller increase in body weight compared to insulin degludec from baseline to week 32.

Safety analyses indicated hypoglycemic events were not significantly different between the study arms. Investigators also noted treatment-related adverse events and serious adverse events were balanced across the study arms.

reached out to Frias to learn more about his perspective on data and key takeaways from the phase 2 trial for diabetes specialists.

This study, “Once Weekly Basal Insulin Fc (BIF) is Safe and Efficacious in Patients with Type 2 Diabetes Mellitus (T2DM) Previously Treated With Basal Insulin,” was presented virtually as part of ENDO 2021.

Learn more about once-weekly basal insulin Fc from Eli Lilly and Company in this interview with the lead investigator from their phase 2 trial, which was presented at ENDO 2021.

Once-Weekly Basal Insulin Fc Shows Promise in Phase 2 Trial

New research is shedding light on the reasons for increased costs associated with treating hip fractures.

Despite improvements in care resulting in shorter length of stays, the cost of surgical fixation of 

 has increased and the current analysis suggests the rise in cost is linked to increases in hospital charges and payments.

“The results confirm our hypothesis that hospital charges and payments contribute significantly more to the increasing cost of treating a hip fracture patient than surgeon charges and payments do," wrote investigators.

Led by Brian Werner, MD, a team from the University of Virginia Health sought to assess trends and variations in hospital charges and payment relative to surgeon charges and payments for surgical treatment of hip fractures using data from the PearlDiver database, which contains data related to fee-for-use administrative claims and provides a nationally representative sample of 51 million patients covered by Medicare parts A and B. Using ICD-9 and CPT codes, investigators identified 3028 patients who underwent closed reduction and percutaneous pinning (CRPP) and 25,341 patients who underwent open reduction internal fixation (ORIF) or intramedullary nail (IMN) from 2005-2014.

Of note, from PearlDiver investigators were also able to obtain information related to patient demographics, 90-day and one-year mortality, Charlson Comorbidity Index (CCI), and length of stay (LOS). Investigators calculated the ratio of hospital to surgeon charges (Charge multiplier: CM) and the ratio of hospital to surgeon payments (Payment multiplier: PM) for each year and region to assess trends over time. For the purpose of analysis, correlations between CM and PM and LOS were evaluated using a Pearson correlation coefficient.

Initial analysis indicated the number of CRPPs for femoral neck fracture performed annually remained relatively constant over the study period. Of note, when assessing patient characteristics, investigators found CCI increased from 6.0 in 2005 to 7.8 in 2014 (

=.033). Further analysis indicated these patients saw decreases in mean LOS (3.2 days in 2005 vs 2.8 days in 2014; 

=.001), 90-day in-hospital mortality (2.5% in 2005 vs 1.54% in 2014), and 1-year in-hospital mortality (5.63% vs 2.16%) over the study period.

When assessing changes in cost, investigators found the CM for CRPP increased from 10.1 in 2005 to 15.6 in 2014 (

 <.0001) while the PM for CRPP increased from 15. To 19.2 (

 <.0001). Among patients undergoing ORIF/IMN, investigators found CM increased from 11.9 in 2005 to 17.2 in 2014 (

 <.0001) while PM increased from 11.5 in 2005 to 17.4 in 2014 (

"Identifying and rectifying the sources of increased hospital charges – rather than continually minimizing surgeon reimbursement – will be tantamount to minimizing the financial burden of hip fractures on the health care system while continuing to deliver effective and efficient patient care in the coming years."

Increased Reimbursement for Surgical Fixation of Hip Fractures: The Difference between the Hospital and the Surgeon

Despite lower length of stays, costs of hip fracture surgeries have been on the rise in recent years and a new study suggests it could be linked to increased hospital charges rather than increased surgeon charges. 

Study Finds Increases in Hospital Charges Responsible for Rising Cost of Hip Fracture Surgery

Data from a phase 2 trial suggest daily use of subcutaneous semaglutide could be an effective treatment for nonalcoholic steatohepatitis (NASH).

A 72-week, double-blind, parallel-group trial of patients with biopsy-confirmed NASH, results of the study indicate treatment with semaglutide resulted in a significantly greater proportion of patients with NASH resolution than placebo.

With a limited number of options available for patients with NASH, identifying new therapies could revolutionize treatment and help mitigate the increased risk for morbidity and mortality seen among these patients. With recent trials proving 

 are more than just agents that provide modest weight loss and HbA1c control, investigators from the current study sought to determine the efficacy and safety of these agents, specifically semaglutide, in patients with NASH.

With this in mind, investigators designed the phase 2 trial as a double-blind, randomized trial in patients with confirmed NASH and liver fibrosis of stage F1, F2, or F3. As per the study design, patients were randomized in a 3:3:3:1:1:1 ratio to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg or corresponding placebo.

For the purpose of analysis, investigators chose the resolution of NASH with no worsening fibrosis as the primary endpoint of the study. Investigators also included a confirmatory secondary endpoint that was defined as an improvement of fibrosis stage with no worsening of NASH. Investigators noted analyses of these endpoints were only performed in patients with stage F2 or F3 fibrosis.

Patients included in the trial were 18-75 years of age, with or without type 2 diabetes, and had a BMI greater than 25 at baseline screening. Notable exclusion criteria included a glycated hemoglobin level greater than 9.5% at baseline screening, causes of chronic liver disease other than NASH, excessive alcohol consumption, and confounding concomitant drug use.

From January 2017 through September 2018, investigators enrolled 320 patients into their trial. This includes 80 receiving 0.1 mg semaglutide, 78 receiving 0.2 mg semaglutide, 82 receiving 0.4 mg semaglutide, and 80 receiving placebo. Overall, 302 patients completed the trial.

Upon analysis, results indicated 40%, 36%, and 59%, of patients randomized to 0.1, 0.2, and 0.4 mg semaglutide, respectively, achieved NASH resolution. In comparison, NASH resolution was only achieved by 17% in the placebo arm (

 <.001 for semaglutide 0.4 mg vs placebo).

When assessing fibrosis stage, investigators found improvement in fibrosis stage among 43% of patients in the 0.4 mg-group and among 33% of patients in the placebo group (

=.48). Further analysis indicated mean percent of weight loss was 13% in the 0.4 mg-group compared to 1% in the placebo group.

In their safety analyses, investigators found the incidence of nausea (42% vs 11%), constipation (22% vs 12%), and vomiting (15% vs 2%) were higher in the 0.4 mg -group than the placebo group. Additionally, malignant neoplasms were reported among 3 patients who received 0.4 mg semaglutide and no patients who received placebo. Investigators also pointed out neoplasm s were reported in 15% of patients receiving semaglutide and 8% of the placebo group, with no pattern of occurrence in specific organs.

“Among patients with stage F2 or F3 fibrosis, once-daily subcutaneous treatment with semaglutide at a dose of 0.4 mg was superior to placebo with respect to resolution of NASH without worsening of fibrosis after 72 weeks of treatment, with 59% of the patients in the 0.4-mg group having a response, as compared with 17% of those in the placebo group (odds ratio, 6.87; 95% CI, 2.60 to 17.63; P<0.001),” wrote investigators.

A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis

A phase 2 trial examining the effects of daily semaglutide over a 72-week period suggests the GLP1-RA could help patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) achieve NASH resolution.

Daily Semaglutide Effective for Nonalcoholic Steatohepatitis in Phase 2 Trial

This article was originally published on PracticalCardiology.com. 


New research provides further evidence in favor of including patient-reported outcomes in the management of heart failure patients. 

An analysis of patients from within the CHAMP-HF Registry, the 2872-patient study suggests patient-reported outcomes, as measured by the KCCQ-OS overall summary score, were more sensitive and better at tracking meaningful changes in health status over time when compared to use of NYHA class.

“Improvement in KCCQ-OS was independently associated with lower risk of subsequent mortality and the composite of mortality and HF hospitalization, whereas improvement in NYHA class was not associated with clinical outcomes,” wrote investigators.

With an interest in comparing the ability of the aforementioned scoring systems to characterize changes in disease state and their associations with clinical outcomes in HFrEF, the current study was designed by Stephen Greene, MD, of the Duke Clinical Research Institute, and a team of colleagues from multiple institutions, including Brigham and Women’s Hospital and University of Mississippi Medical Center. A prospective, noninterventional study inducted from December 2015-October 2017, the CHAMP-HF registry provided investigators with data related to more than 5000 patients with HF.

For inclusion in the current analysis, patients were required to have a diagnosis of chronic HF, a left ventricular ejection fraction of 40% or lower on most recent imaging within 12 months of enrollment, be receiving at least 1 oral medication at enrollment, and have completed data related to NYHA class and KCCQ-OS data at baseline and 12 months. Overall, 2872 patients met these criteria and were included in the study.

The median age of the study cohort was 68 years (IQR, 59-75 years), 30.4% were women, 75.1% identified as White, and the median ejection fraction was 30% (IQR, 23-35). Baseline assessments of NYHA class indicated 10.9% were NYHA class I, 59.5% were NYHA class II, 28.0% were NUHAclass III, and 1.6% were NYHA class IV. For KCCQ-OS, 39.4% scored between 75-100, 33.7% scored between 50-74, 21.3% scored between 25-49, and 5.6% of patients scored between 0-24.

At 12 months, 34.9% of patients had a change in NYHA, with 599 experiencing improvement and 403 experiencing a worsening score. For KCCQ-OS at 12 months, 2158 had a change of 5 or more, with 1388 experiencing an improvement and 26.8% experiencing a worsening score. Overall, the most common trajectory for KCCQ-OS was an improvement of 10 points or more (n=1047) and the most common trajectory of NYHA change was no change (n=1870).

In adjusted analyses, investigators found improvements in NYHA class were not associated with subsequent clinical outcomes, but an improvement of 5 or more points in KCCQ-OS was independently associated with decreased mortality (HR, 0.59; 95% CI, 0.44-0.80; 

 <.001) and mortality or hospitalization for worsening HF (HR, 0.73; 95% CI, 0.59-0.89; 

, Paul Heidenreich, MD, MS, of the VA Palo Alto Health Care System, commended Greene and colleagues for their work and outlining the prognostic value of capturing RPO, but also noted real-world barriers to implementation need to be addressed to effectively implement capturing this data.

“The implication of the study by Greene et al is that the NYHA class should be reconsidered if it does not match the patient-reported data. When used together, prognosis assessment and treatment decisions will be improved,” wrote Heidenreich.

Comparison of New York Heart Association Class and Patient-Reported Outcomes for Heart Failure With Reduced Ejection Fraction

An analysis of the CHAMP-HF registry indicates KCCQ-OS was more sensitive at tracking changes in disease state among heart failure patients, indicating the importance of including patient-reported outcome measures in heart failure management. 

NYHA Class Less Sensitive than KCCQ-OS for Capturing Heart Failure Progression

New research from Robert Wood Johnson Medical School suggests undergoing 

 could reduce risk of cancers, particularly obesity-related cancers in obese patients.

A retrospective analysis of claims data from more than 98,000 individuals with severe obesity and nonalcoholic fatty liver disease (NAFLD), results indicate undergoing bariatric surgery reduced risk of all types of cancer by almost 20% and reduced risk of obesity-related cancers by more than 30%.

"We knew that obesity leads to certain problems, including cancer, but no one had ever looked at it the other way around—whether weight loss actually reduced the risk of those cancers," said lead investigator Vinod K. Rustgi, MD, professor of medicine and clinical director of hepatology and Director of the Center for Liver Diseases and Liver Masses, Robert Wood Johnson Medical School, 

. "Our study showed that all cancers were decreased, but obesity-related cancers in particular were decreased even more.”

With the obesity pandemic continuing to grow and bariatric surgery representing one of the most efficacious avenues to mitigate obesity-related health risks, Rustgi and a team of colleagues sought to explore the effect of bariatric surgery on cancer risk using data from the Marketscan database. Investigators designed their analysis as a retrospective cohort study of patients 18-64 years of age with newly diagnosed NAFLD and severe obesity from 2007-2017.

In total, investigators identified 2,043,936 patients from within the database with a NAFLD diagnosis from 2008-2017. Of note, 2008 was used to ensure patients had at least 12 months of enrollment within the database prior to NAFLD diagnosis. After application of additional inclusion criteria, 98,090 patients were identified for final analyses.

Among this cohort, 33,435 patients had a BMI of 40 kg/m2 or more and underwent bariatric surgery. The most common type of bariatric surgery was laparoscopic adjustable gastric band (84.23%).

When compared to those who did not undergo surgery, surgery patients were younger (44.01 vs 45.93 years; 

 <.001), more likely to be women (73.77 vs 62.28%), and less likely to have a history of smoking (6.45 vs 10.13%; 

 <.001) compared to non-surgery patients.

Among those who did not undergo surgery, investigators identified 1,898 incident cancer cases over 115,890.11 person-years of follow-up. Among those who did undergo bariatric surgery, investigators identified 925 incident cancer cases over 67,389.82 person-years of follow-up. Based on these figures, investigators determined the crude rate of ratio among patients undergoing bariatric surgery was 0.84 (95% CI, 0.77-0.91). Additionally, the inverse probability of treatment weighting (IPTW)-adjusted analyses indicated risk of any cancer and obesity-related cancer was reduced by 18% (HR, 0.82; 95% CI, 0.76-0.89) and 35% (HR, 0.75; 95% CI, 0.56-0.75), respectively among those undergoing bariatric surgery.

Further analysis indicated adjusted risks of any cancer and obesity-related cancer were significantly lower among cirrhotic versus non-cirrhotic patients who underwent bariatric surgery (

 <.05). In fully-adjusted cause-specific models, investigates found the risks of hepatocellular carcinoma(HR, 0.48; 95% CI, 0.24-0.89), pancreatic cancer (HR, 0.46; 95% CI, 0.21-0.93), endometrial cancer (HR, 0.49; 95% CI, 0.31-0.73), thyroid cancer (HR, 0.61; 95% CI, 0.41-0.89), and multiple myeloma (HR, 0.33; 95% CI, 0.14-0.69) were all significantly lower among patients who underwent bariatric surgery.

"Understanding the connection between NAFLD and cancer may identify new targets and treatments, such as antidiabetic-, satiety-, or GLP-1-based medications, for chemoprevention in NAFLD/NASH. Though bariatric surgery is a more aggressive approach than lifestyle modifications, surgery may provide additional benefits, such as improved quality of life and decreased long-term healthcare costs," noted investigators in the aforementioned statement.

Bariatric Surgery Reduces Cancer Risk in Adults with Nonalcoholic Fatty Liver Disease and Severe Obesity,”

An analysis of data from the Marketscan database suggests undergoing bariatric surgery in severely obese patients with NAFLD could reduce risk of cancer among these patients. 

Bariatric Surgery Can Reduce Cancer Risk Among Severely Obese Patients

A little more than a year after becoming the first and only FDA-approved therapy for the treatment of thyroid eye disease, new research is sounding the alarm on a potential risk of hearing loss seen with teprotumumab (Tepezza).

While the study contained less than 30 patients, results indicate more than 50% of patients receiving 4 infusions reported experienced hearing loss symptoms, which is much higher than the 10% of patients who developed hearing symptoms in phase 2 and 3 trials.

With approval in January 2020, teprotumumab has the potential to be a life-altering therapy in patients with thyroid eye disease. However, 10% of patients in phase 2 and phase 3 studies reported developing hearing symptoms and, according to investigators, no studies had evaluated this association using audiograms or patulous eustachain tube (PET) testing. With this in mind, a team led by Andrea Kossler, MD, of Byers Eye Institute at Stanford University, designed the current study to further explore the incidence of otologic symptoms among patients receiving the fully human monoclonal antibody inhibitor of IGF-1R in a real-world setting.

Investigators followed all patients from a single institution and questioned them about otologic symptoms before, during, and after treatment with teprotumumab. All patients reporting otologic symptoms were referred for audiogram and PET testing. For the purpose of analysis, investigators only included patients with at least 4 infusions of teprotumumab.

Check out this podcast examining trends in incidence and treatment of thyroid eye disease in 2020.

In total, investigators identified 26 patients meeting inclusion criteria. The mean age of the study cohort was 56 (30-92) years and 23 of the patients were women. Upon analyses, 65% (n=17) of patients complained of otologic symptoms. Among patients reporting symptoms, 6 reported subjective hearing loss, 7 reported new tinnitus, 6 reported an ear plugging sensation or muffled hearing, and 3 reported autophony. Investigators pointed out the development of otologic symptoms occurred after a mean of 3.6 infusions.

Further analysis indicated 4 of the 17 patients reporting otologic symptoms had new or worsening sensorineural hearing loss. Additionally, 3 patients had PET documented one PET testing and confirmed by an otolaryngologist. Overall, 2 patients had both sensorineural hearing loss and PET. However, investigators noted PET patients experienced improvement but not the resolution of symptoms after discontinuing therapy for 3 months.

Based on the results of their study, investigators urge clinicians to be cognizant of the potential for otologic symptoms among patients receiving teprotumumab for treatment of thyroid eye disease.

“Providers should consider performing a baseline audiogram with PET testing and performing audiograms with PET testing for patients that develop hearing symptoms during or after therapy. Hearing loss is a concerning adverse event and its mechanism and reversibility should be further studied,” wrote investigators.

This study, “Teprotumumab and Hearing Dysfunction,” was presented virtually as part of ENDO 2021.

A single-center study presented at ENDO 2021 suggests more than half of the patients with thyroid eye disease patients treated with teprotumumab (Tepezza) developed otologic symptoms.

Study Finds Increases in Hospital Charges Responsible for Rising Cost of Hip Fracture Surgery

Daily Semaglutide Effective for Nonalcoholic Steatohepatitis in Phase 2 Trial

NYHA Class Less Sensitive than KCCQ-OS for Capturing Heart Failure Progression

Bariatric Surgery Can Reduce Cancer Risk Among Severely Obese Patients

Teprotumumab Linked to Hearing Loss, Tinnitus in New Study