Coverage of the Endocrine Society's 2021 Annual Meeting

ENDO 2021

A systematic review and meta-analysis of more than 50 studies are offering clinicians further insight into the cardiometabolic risk profile of patients with pediatric type 2 diabetes.

The study, which was conducted by investigators at McMaster University, suggests both hypertension and albuminuria were common among patients with pediatric diabetes and investigators also noted there was a disproportionate burden among Pacific Islander and Indigenous youth.

“These data are relevant for health care professionals and policymakers, as clinical services treating pediatric patients with type 2 diabetes need to be resourced to track kidney screening and treatments to improve outcomes,” wrote investigators.

With cardiorenal comorbidities posing a major threat to the overall health and quality of life for patients with diabetes later in life, M. Constantine Samaan, MD, MSc, of the Department of Pediatrics at McMaster University, and a team of colleagues sought to assess the prevalence of hypertension and albuminuria in patients with pediatric type 2 diabetes. To do so, investigators designed the current study as a systematic review and meta-analysis of data from the MEDLINE, Embase, CINAHL, Cochrane Library, Web of Science, gray literature, and references from the inception of each database through February 20, 2020.

For the purpose of analysis, investigators limited their search to observational studies with at least 10 participants reporting the prevalence of hypertension and/or albuminuria in pediatric patients with type 2 diabetes. Three different teams made up of 2 independent reviewers each screen a total of 7614 articles and determined 60 met the study’s inclusion criteria.

The primary outcome of interest for investigators was the pooled prevalence rates for hypertension and albuminuria. Investigators also assessed pooled prevalence rates by sex and racial/ethnic group as secondary outcomes. Investigators noted their meta-analysis was conducted using a random-effects model and followed the MOOSE guidelines.

Within the 60 studies identified by investigators, mean diabetes duration ranged from inclusion at diagnosis to 15.0 years after diagnosis and mean age at diagnosis ranged from 6.5 to 21.0 years. Among the 60 studies included, 46 reported prevalence of hypertension and 39 studies reported the prevalence of albuminuria.

Upon analysis, results suggested hypertension was present among 25.33% (95% CI, 19.57-31.53) of patients. When assessing factors associated with hypertension, investigators found male participants were at a greater risk than their female counterparts (OR, 1.42; 95% CI, 1.10-1.83) and patients classified as Pacific Islander and Indigenous youth when compared to their other racial/ethnic groups (Pacific Islander youth: 26.71% [95% CI, 14.54%-40.72]; Indigenous youth: 26.48% [95% CI, 17.34-36.74]; White youth: 20.95% [95% CI, 12.65-30.57]; African American youth: 19.04% [95% CI, 12.01-27.23]; Hispanic/Latino youth: 15.11% [95% CI, 6.56-26.30]; Asian youth: 18.37% [95% CI, 9.49-29.23]).

Assessment of the studies reporting albuminuria suggested a prevalence of 22.17% (95% CI, 17.34-27.38). While there were no differences observed based on patient sex, investigators pointed out prevalence was greater among Pacific Islander, Indigenous, and Asian youth than White youth (Pacific Islander youth: 31.84% [95% CI, 11.90-55.47]; Indigenous youth: 24.27% [95% CI, 14.39-35.73]; Asian youth: 23.00% [95% CI, 18.85-27.41]; White youth: 12.59% [95% CI, 7.75-18.33]). Investigators highlighted heterogeneity was high among studies, with a low to moderate risk of bias observed.

“Hypertension and albuminuria were frequent comorbidities of pediatric type 2 diabetes, and Pacific Islander and Indigenous youth had a disproportionately higher burden of these conditions than youth from other racial groups,” wrote investigators. “There is a critical need for personalized screening and treatment strategies to provide renoprotection from prolonged hyperglycemia and obesity to prevent end-stage kidney disease, future cardiovascular disease, and improve life expectancy.”

Prevalence of Hypertension and Albuminuria in Pediatric Type 2 Diabetes

Articles

A study from McMaster University is providing updated information related to the prevalence of hypertension and albuminuria in younger patients with type 2 diabetes. 

Hypertension, Albuminuria Present in Nearly 1-in-4 Cases of Pediatric Type 2 Diabetes

Data from a new study conducted by investigators at the Leibniz Center for Diabetes Research in Germany is providing clinicians with further insight into specific characteristics associated with worse COVID-19 outcomes in patients with diabetes.

A systematic review and meta-analysis of observational studies examining phenotypes of individuals with diabetes and COVID-19, the study’s results indicate associations with COVID-19 related death in people with 

 were similar to those found among those without diabetes.

“Our living systemic review and meta-analysis provides the best current evidence on associations between phenotypes of individuals with diabetes and confirmed SARS-CoV-2 and COVID-19 related death and severity of COVID-19,” wrote investigators

The first edition of a living systematic review and meta-analysis, investigators from Europe designed the current study in an effort to determine what factors were associated with COVID-19 related death and increased severity of the disease in patients with type 1 or type 2 diabetes. With this in mind, investigators performed a search of the PubMed, Web of science, Epistemonikos, and COVID-19 Research Database and identified studies obtained from this search for inclusion in their analyses.

From these 4 databases, investigators identified a total of 4150 records for possible inclusion. After application of inclusion criteria and eliminating duplicate articles, investigators selected 22 publications for inclusion in their final analyses. These studies ranged in size from 29 patients to 9460, with the total population from all publications at 17,687.

In regard to study characteristics, 14 studies were conducted in Asia, 5 were conducted in North America, and 3 were conducted in Europe. Among the studies, 13 did not specify the type of diabetes, 5 only included individuals with type 2 diabetes, and 4 studies included both type 1 and type 2 diabetes. Investigators also noted risk of bias was classified as low in 6 studies, moderate in 8 studies, and high in 8 studies.

For the purpose of analysis, investigators planned to use a random effect meta-analysis to determine the summary relative risks (SRR) and to use the GRADE tool to evaluate the certainty of results.

Upon analysis, results suggested there was a high to moderate certainty of evidence for association between male sex ([SRR, 1.28; 95% CI, 1.02-.61], n=10 studies), being older than 65 years of age ([SRR, 3.49; 95% CI, 1.82-6.69], n=6 studies), pre-existing comorbidities ([cardiovascular disease: SRR, 1.56; 95% CI, 1.09-2.24], n=8 studies; [chronic kidney disease: SRR, 1.93; 95% CI, 1.28-2.90], n=6 studies; [chronic obstructive pulmonary disease: SRR, 1.40; 95% CI, 1.21-1.62], n=5 studies), diabetes treatment ([insulin use: 1.75; 95% CI, 1.01- 3.03], n=5 studies; [metformin use: 0.50; 95% CI, 0.28-0.90], n=4 studies) and increased blood glucose at admission (11 mmol/L or more: SRR, 8.60; 95% CI, 2.25-32.83], n=2 studies).

“Male sex, older age and some pre-existing conditions, as well as the use of insulin, most of which are potential indicators for a more progressive course of diabetes, were associated with increased risk of COVID-19 related death and severity in individuals with diabetes and SARS-CoV-2 infection, whereas metformin use was associated with a lower risk of death,” wrote investigators.

Investigators highlighted similar, but overall weaker and less precise associations were observed between his phenotypes of diabetes and severity of COVID-19.

Risk phenotypes of diabetes and association with COVID-19 severity and death: a living systematic review and meta-analysis

A systematic review and meta-analysis of data from nearly 2 dozen studies is providing new insight into the phenotypes of patients with diabetes associated with worse outcomes from COVID-19.

Phenotypes Associated with Severe COVID-19 Similar Among Patients with and without Diabetes

Using multi-trajectory modeling, researchers are providing new insight into the impact of lifestyle patterns and early life influences have on BMI and the overall health of children.

Conducted by a team from Deakin University and other Australian institutions, results of the study indicate lifestyle patterns in early life, such as maternal dietary patterns and television viewing time, had a major influence on 

"The findings will inform early childhood obesity prevention intervention and policy, and will be of great interest to pediatricians, researchers, policymakers and the general public," said Miaobing Zheng, PhD, study investigator and research fellow at the Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences at Deakin University, 

With the obesity epidemic’s growth expected to continue booming in the US and abroad, opportunities for early intervention represent could help attenuate the societal burden of the ongoing crisis. To develop a greater understanding of how early lifestyle patterns impact BMI z score trajectory, investigators designed their study as an assessment of data from children within the Melbourne Feeding Activity and Nutrition Trial (InFANT) program, which included a longitudinal cohort of children followed for 15 months as part of parent-focused cluster RCT.

The InFANT program was created with the goal of reducing obesity risk behaviors in children until 18 months of age. The program also included multiple additional follow-ups without interventions for children aged 42-60 months. Using data from these patients, investigators hope to use multi-trajectory modeling

Investigators identified 3 unique trajectory groups based on lifestyle patterns and BMI z scores defined as: Unhealthy lifestyle patterns and low BMI z, healthy lifestyle pattern and mid BMI z, and unhealthy lifestyle and high BMI z. Overall, 439 patients from the program reached the 60-month follow-up. Among these children 30% had unhealthy lifestyle patterns and a low BMII z, 53% had healthy lifestyle patterns and mid BMI z, and 17% had unhealthy lifestyle patterns and high BMI z.

Upon analysis, investigators found child birth weight (OR, 1.89; 95% CI, 1.28- 2.79) and maternal “fruit and vegetables” dietary pattern score (OR 1.22; 95% CI, 1.01- 1.47) were associated with higher odds of placement into the healthy lifestyle pattern and mid BMI z group compared to the unhealthy lifestyle patterns and low BMI z group. Additionally, child birth weight maternal prepregnancy BMI, and higher maternal television-viewing time were associated with greater odds of placement into the unhealthy lifestyle pattern and high BMI z group.

Investigators pointed out sex, breastfeeding duration, maternal country of birth, maternal “cereal and sweet foods” and “high-energy snack and processed foods” dietary pattern scores, and maternal physical activity were not associated with placement into any specific trajectory group. Further analysis into duration of breastfeeding investigators pointed out no associations were observed related to breastfeeding duration and the trajectory groups.

“There is no doubt that children copy the behaviors observed in the presence of parents: healthy and unhealthy," said Liliana Aguayo, PhD, MPH, The Obesity Society member and research assistant professor from the Hubert Department of Global Health at Emory University, in the aforementioned statement. Of note, Aguayo was not associated with this study. "Evidence from this study highlights the importance of early childhood as a critical period for development of obesity. More research is needed to identify effective approaches to simultaneously address parent and child health behaviors."

Association Between Longitudinal Trajectories of Lifestyle Pattern and BMI in Early Childhood,

An analysis of data from the Australian  InFANT program suggests early lifestyle patterns or parental influences can help to predict obesity or BMI trajectory in early life. 

Lifestyle Patterns, Early Influences Play Role in Risk of Obesity, BMI Trajectory in Childhood

This article was originally published on 

Research from an international team of investigators is providing new insight into the relationship between diabetes and neurological health.


An analysis of databases from Europe, results of the study suggest earlier onset of 

 in adulthood and midlife was linked to increased risk of developing dementia.


“In this longitudinal study, younger age at onset of diabetes was significantly associated with a higher HR of dementia. Data spanning 35 to 75 years for age of diabetes onset showed every 5-year earlier onset of diabetes was significantly associated with higher hazard of dementia,” wrote investigators. “Late-onset diabetes was not significantly associated with subsequent dementia.”

The study included 7 clinical assessments between 1985 and 2016 where venous blood samples were taken either in the morning after a minimum 8-hour fast or a 5-hour fast after a light, fat-free breakfast. Fasting glucose was measured with the glucose-oxidase method.

Each examination collected data on self-reported physician-diagnosed type 2 diabetes, as well as prescriptions of diabetes medications. The national Hospital Episode Statistics (HES) database was linked for follow-up on participants.

Investigators defined type 2 diabetes as having a fasting glucose greater than 126 mg/dL at the clinical examination, use of medication, physician-diagnosed diabetes, or record of diabetes in the HES database from 1985-2019.

The team’s secondary exposures included the Finnish Diabetes Risk Score (FINDRISC), fasting glucose, and prediabetes.

Incidence of dementia was assessed using data from a trio of registers, including the HES, the Mental Health Services Data Set, and the Office for National Statistics Mortality Register, through March 2019.

Within the study period, 639 patients (6.3%) were diagnosed with dementia. Investigators pointed out these patients were more likely to have chronic conditions during the follow-up period and have a worse cardiovascular risk profile at 60 years old.

When assessing incidence of diabetes, investigators found 1710 participants (16.9%) developed diabetes and 153 (8.9%) of these participants were subsequently diagnosed with dementia. Overall, dementia rates were 1.76 per 1000 person-years in participants without diabetes and 6.25 in participants with diabetes, with an HR of 1.40 (95% CI, 1.15-1.70).

At age 55, the dementia rate per 1000 person-years was 3.14 in participants without diabetes and 5.06 in participants with diabetes, at a hazard ratio (HR) of 2.14 (95% CI, 1.44-3.17). At age 70, the dementia rate was 8.85 per 1000 person-years in participants without diabetes and 13.88 per 1000 person-years in participants with diabetes, with a HR of 1.58 (95% CI, 1.22-2.03).

The data for diabetes onset from 0-5 years earlier pointed to a significant association with subsequent dementia, with an HR of 1.53 (95% CI, 1.03-2.29) and a dementia rate of 8.63 per 1000 person-years. Diabetes onset from 6-10 years earlier had a dementia rate of 10.51 per 1000 person-years.

Investigators considered diabetes status at age 70, where the HR of patients with diabetes onset more than 10 years earlier was 2.12 (95% CI, 1.50-3.00), with a dementia rate of 18.30 per 1000 person-years.

Diabetes onset 6-10 years earlier was associated with an HR of 1.49 (95% CI, 0.95-2.32), with a dementia rate of 12.99 per 1000 person-years. The rate of diabetes onset 0-5 years earlier was associated with an HR of 1.11 (95% CI, 0.70- 1.76), with a dementia rate of 10.00 per 1000 person-years.

In an analysis adjusted for sociodemographic and health factors, investigators found that at every 5-year younger age at the onset of type 2 diabetes had an association with an HR of dementia of 1.24 (95% CI, 1.06-1.46) at age 70.

Investigators concluded younger age at onset of diabetes had a significant association with a higher HR of dementia.

Investigators were unable to determine the specific mechanisms behind the association. They hypothesized it may be due to connections between brain metabolic dysfunction and insulin resistance, as well as higher rates of hypoglycemia in diabetes treatment increasing the risk of dementia.


Association Between Age at Diabetes Onset and Subsequent Risk of Dementia

An analysis of data from 10k patients in the UK suggests onset of type 2 diabetes at an earlier age could signal increased risk of dementia later in life. 

Age at Onset of Type 2 Diabetes Could Help Predict Risk of Dementia

: A middle-aged woman with a history of diabetes and hypertension is brought to the emergency department by paramedics as a field-activated ST-elevation MI. They report that about 40 minutes ago she fainted and when she came to she had anxiety, chest pain, and shortness of breath. There was no head injury.

Medics gave aspirin plus 3 doses of nitroglycerin en route without relief.

: On exam, the patient is obese, diaphoretic, and appears very anxious bordering on delirious. She is unable to give much history and is thrashing around.

: Pulse 131, BP 95/58, pulse ox 98% on oxygen. Lungs are clear and heart is tachycardic with normal heart sounds. Abdomen is rotund and non-tender. Legs have no edema, chords, tenderness, or erythema. Pulses are symmetric.


Our latest case report from Brady Pregerson, MD, features a middle-aged woman brought to the emergency department by paramedics as a field-activated ST-elevation MI. Check out the EKG and see if you can determine the correct diagnosis.

Endocrinology Case Report: Syncope and ST-Elevation

Researchers from UCLA are hopeful their recent study can serve as a warning for clinicians treating postmenopausal women and help inform guidelines in the future.

While previous research points to an increased risk of subsequent fracture following a hip or spine fracture, the UCLA-led analysis of more than 150,000 patients suggests any fracture, no matter the location, was associated with increased risk of any fracture in the future.

"Current clinical guidelines have only been emphasizing hip and spine fractures, but our findings challenge that viewpoint," said lead investigator Carolyn Crandall, MD, professor of medicine at the David Geffen School of Medicine at UCLA, 

. "By not paying attention to which types of fractures increase the risk of future fractures, we are missing the opportunity to identify people at increased risk of future fracture and counsel them regarding risk reduction.”

Despite posing a significant threat to overall health and quality of life, Crandall and colleagues noted a gap in research related colocations of subsequent fracture after initial fracture among postmenopausal women. With an interest in filling this apparent knowledge gap, investigators designed the current study as a prospective analysis of patients who were enrolled in the Women’s Health Initiative (WHI) from 1993-1998.

From the WHI, investigators obtained data related to more than 161,000 postmenopausal women aged 50-79 years from 40 centers across the US. After excluding women based on missing information and use of bisphosphonates, calcitonin, and/or raloxifene at baseline, investigators identified a cohort of 157,282 women for inclusion in the current study. Of these, 137,412 had complete covariate information.

Overall, the mean participant age was 63.1 (SD, 7.2) years, the mean BMI was 28.0 (SD, 5.9) kg/m2, and the mean follow-up duration was 15.4 (SD, 6.2) years. Investigators also noted 83% of participants self-identified as White.

In total, 47,126 (30%) participants experienced a fracture during the follow-up period. Compared to those who did not experience a fracture, those with incident fracture were older (

 <.0001), less likely to be using hormone therapy at baseline (

=.001), more likely to have experienced falls during the 12 months prior to baseline (

 <.0001), and were more likely to report a prevalent fracture at baseline (

Upon analysis, investigators found risk of each type of subsequent fracture was increased after each type of initial fracture. Results suggested incident lower arm/wrist fracture was associated with significantly increased risk of subsequent fractures at upper arm/shoulder, upper leg, knee, lower leg/ankle, hip/pelvis, and spine, with adjusted hazard ratios ranging from 2.63 to 5.68.

Additionally, results indicated hip fracture risk was increased following a lower arm or wrist fracture (aHR, 4.80; 95% CI, 4.29-5.36), initial upper arm or shoulder fracture (aHR, 5.06; 95% CI, 4.39-5.82), initial upper leg fracture (aHR, 5.11; 95% CI, 3.91-6.67), initial knee fracture (aHR, 5.03; 95% CI, 4.20-6.03), initial lower leg/ankle fracture (aHR, 4.10; 95% CI, 3.58-4.68), and initial spine fracture (aHR, 6.69; 95% CI, 5.95-7.53).

Further analysis demonstrated the observed increases in risk were significant across all age groups. Investigators also pointed out risk of subsequent fracture appeared to be more pronounced among women self-identifying as non-Hispanic Black, Hispanic/Latina, and Asian/Pacific Islander compared to those self-identifying as non-Hispanic White.

Investigators cautioned clinicians to consider the limitations of their study before overinterpretation of its findings. These limitations included reliance on self-reporting of fractures, lack of information related to rib fractures, and limited availability of data related to bone mineral density.

After the initial fracture in postmenopausal women, where do subsequent fractures occur?

A new study is challenging the notion that certain types of fractures, such as lower arm or wrist fractures, do not signal increased risk of subsequent fractures among postmenopausal women. 

Any Fracture, Regardless of Location, Signals Increased Risk of Subsequent Fracture in Postmenopausal Women

Data from a cohort study of nearly 7 million patients in England is offering an overview of the impact BMI, type 2 diabetes, and other health conditions have had on COVID-19 severity during the pandemic.

Using information obtained from a database of more than 35 million patients, results of the study suggest a linear association exists between increasing BMI when exceeding 23 kg/m2 and risk of severe COVID-19, with this risk being most notable among patients younger than 40 years of age and Black patients.

“Our findings from this large population-based cohort emphasize that excess weight is associated with substantially increased risks of severe COVID-19 outcomes, and one of the most important modifiable risk factors identified to date,” wrote investigators.

With an interest in further exploration of associations between clinical characteristics and severity of COVID-19, a University of Oxford-led team designed the current study as a prospective, community-based cohort study of patient-level data from the QResearch database of general practices in England. Combining information from this database with linked data from Public Health England, investigators hoped to perform an analysis using Cox proportional hazard models to estimate risk of severe COVID-19 according to BMI.

With January 24, 2020-April 30, 2020 defined as the period of interest, investigators identified 6,910,695 patients 20-99 years of age with at least one BMI measurement for inclusion in their study. The overall study cohort had a mean BMI of 26.78 (SD, 5.9) kg/m

, more than 50% of patients had a BMI greater than 25 kg/m

, and approximately 70% were 59 years of age or younger. Outcomes of interest in the study were admission to a hospital, admission to an intensive care unit (ICU), and death from COVID-19.

Of the 6,910,695 patients included in the analyses, 13,503 were hospitalized with COVID-19, 1601 required ICU admission, and 5479 died from COVID-19. Investigators noted approximately 33% of patients with severe COVID-19 outcomes had type 2 diabetes and most people with severe COVID-19 were aged 60 years or older.

, results of the analyses indicated the presence of a J-shaped association between BMI and admission to the hospital (adjusted hazard ratio [aHR] per kg/m² from the nadir: 1.05; 95% CI, 1.05-1.05) and death (aHR, 1.04; 95% CI, 1.04-1.05). Investigators also pointed out a linear association with ICU admission was observed across the whole BMI range (aHR, 1.10; 95% CI, 1.09-1.10).

Further analysis suggested there was a significant interaction between BMI and age and ethnicity. Specifically, a greater risk per kg/m

 above the nadir was seen in patients 20-39 years of age (aHR, 1.09; 95% CI, 1.08-1.10) compared to those 80-100 years of age (aHR and among Black patients (aHR 1.07; 95% CI, 1.06-1.06) compared to White patients (aHR, 1.04; 95% CI, 1.04-1.05). Investigators noted the risk of hospital admission and ICU admission due to COIVD-19 associated with each unit increase of BMI was lower in patients with type 2 diabetes, hypertension, and cardiovascular disease than in those without these morbidities.

“Although as yet unproven, interventions that reduce weight might reduce the risk of severe COVID-19 outcomes in individuals. In the longer term, our findings highlight the need to work towards a healthy weight at a population level,” investigators wrote.

Associations between body-mass index and COVID-19 severity in 6.9 million people in England: a prospective, community-based, cohort study

Data from more than 1500 general practices are providing a comprehensive overview of the impact of obesity on risk of severe COVID-19 outcomes in England—suggesting each BMI increase beyond 23 kg/m2 increased risk of hospital admission and death. 

Impact of Obesity on Risk of Severe COVID-19 Among Patients in England

Data from a phase 3 trial used as part of the agent's approval is providing clinicians with insight into the use of dasiglucagon (Zegalogue) in patients with type 1 diabetes and severe hypoglycemia. 

The trial, which randomized 170 adult patients and compared dasiglucagon against placebo and reconstituted glucagon, found the ready-to-use, next-generation glucagon analog from Zealand Pharma helped 99% of patients achieve plasma glucose recovery within 15 minutes.

"The results of this trial add significantly to the clinical evidence supporting the use of dasiglucagon for the treatment of severe hypoglycemia, and these data build upon the strong clinical data reported throughout dasiglucagon’s clinical trial program in this indication," said Thomas Pieber, MD, Head of the Division of Endocrinology and Metabolism and Chairman of the Department of Internal Medicine at Medical University of Graz, Austria, 

. "This study provides convincing evidence of the potential of dasiglucagon as a treatment that can help patients and their caregivers to address severe hypoglycemia.”

With the US Food and Drug Administration awarding 

approval to dasiglucagon for treatment of severe hypoglycemia

 in pediatric and adult patients with diabetes aged 6 years and older, this most recent article, which was published in 

 offer clinicians some of the best insight yet into use of the injectable. Of note, this phase 3 trial was used as part of the approval of dasiglucagon.

A randomized, double-blind trial, the study enrolled 170 patients with type 1 diabetes and randomized them in 2:1:1 ratio to 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon during controlled insulin-induced hypoglycemia. In total, 84 patients were randomized to dasiglucagon and 43 were randomized to both placebo and reconstituted glucagon.

The trial’s primary end point was time to plasma glucose recovery, which was defined as an increase of 20 mg/dL or more from baseline without rescue intravenous glucose. Investigators noted the primary comparison of interest was dasiglucagon against placebo and reconstituted lyophilized glucagon was included as a reference.

At the end of the trial, the median time to recovery was 10 (95% CI, 10-10) minutes among patients receiving dasiglucagon compared to 40 (95% CI, 30-40) minutes among patients receiving placebo (

 <.001). Investigators noted the corresponding result for patients receiving reconstituted glucagon was 12 (95% CI, 10-12) minutes.

Overall, plasma glucose recovery was achieved within 15 in all but one patient, which investigators noted was superior to placebo (2%; 

 <.001) and similar to glucagon (95%). Additionally, similar outcomes were noted when assessing time to plasma glucose recovery at 10, 20, and 30 minutes after dosing. Investigators also pointed out all patients in the study achieved recovery with a single dose.

In safety analyses, the most frequent adverse effects, defined as occurring in 2% of patients or more, were nausea and vomiting. Of note, both of these are listed as potential adverse reactions within the prescribing information for dasiglucagon.

“The outcomes from this study are clinically meaningful and offer patients impacted by severe hypoglycemia an additional treatment option,” said Frank Sanders, President of Zealand Pharma US, in the aforementioned statement. “As minutes matter in severe hypoglycemia, this is an incredibly promising and exciting moment for both patients and Zealand.”

Dasiglucagon: A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia Results of Phase 3 Randomized Double-Blind Clinical Trial,

New information from a phase 3 trial used as part of the FDA approval is providing insight into the safety and efficacy of dasiglucagon for treatment of severe hypoglycemia in adult patients with type 1 diabetes.

Dasiglucagon Demonstrates Superiority to Placebo for Severe Hypoglycemia in Phase 3 Trial

The US Preventive Services Task Force (USPSTF) is reaffirming the organization’s 2015 recommendation related to 

 for adults in their latest recommendation statement.

recommends screening adults 18 years or older with office blood pressure measurement and obtaining blood pressure measurements outside of a clinical setting for diagnostic confirmation before starting treatment. Further supporting their stance, the statement’s authors reported finding no new substantial evidence the could change its recommendation.

“Without screening, most people wouldn’t know they have hypertension and could be at risk for a heart attack or stroke,” said Task Force member John B. Wong, MD, of the Tufts Medical Center, 

. “Clinicians can improve their patients’ health by screening all adults for hypertension.”

investigators also provide clinicians with the evidence base for their latest recommendation. To assess the benefits and harms of screening and confirmatory blood pressure measurements, the Task Force conducted a systematic review and meta-analysis of the information published within the MEDLINE, PubMed, Cochrane Collaboration Central Registry of Controlled Trials, and CINAHL databases through March 26, 2021.

Of note, the investigators' search included randomized clinical trials and nonrandomized controlled intervention studies for the effectiveness of screening and accuracy studies for screening and confirmatory measurements. Additionally, RCTs, nonrandomized controlled intervention studies, and observational studies were used for potential harms of screening and confirmation.

Supporting Data

Screening for Hypertension in Adults US Preventive Services Task Force Reaffirmation Recommendation Statement

Screening for Hypertension in Adults Updated Evidence Report and Systematic Review for the US Preventive Services Task Force

The USPSTF recommendation reaffirms their 2015 stance, which calls for screening adults 18 years or older with office blood pressure measurement and obtaining measurements outside of a clinical setting for diagnostic confirmation before starting treatment.

US Preventive Services Task Force Reinforces 2015 Blood Pressure Screening Guidelines

Dapagliflozin (Farxiga) has received a historic approval from the US Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD), according to a 

Almost a year to the date after receiving approval for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes, dapagliflozin now becomes the first SGLT2 inhibitor to receive approval for treatment of CKD.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Aliza Thompson, MD, MS, deputy director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, in the aforementioned statement. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”

Few agents have captured the attention of the masses in recent years in the same manner as dapagliflozin. With the SGLT2 inhibitor class blazing trails in heart failure and chronic kidney disease, many expected it was only a matter of time until today’s approval became reality based on data from multiple clinical trials.

In their own statement, AstraZeneca referred to the approval as "the most significant advancement in the treatment of chronic kidney disease in more than 20 years". 

"We’ve shown impressive efficacy for 

 in type-2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the US," added Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, in the 

Based on the results of the DAPA-CKD trial, which was originally presented at ESC 2020, the latest approval for dapagliflozin is for reducing the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. In the phase 3 trial, 4304 patients were randomized in a 1:1 ratio to either dapagliflozin or placebo.

Designed with a primary composite endpoint that included a 50% reduction in kidney function, progression to kidney failure, or cardiovascular or kidney death, results of the study indicated dapagliflozin was associated with a 39% reduction in the study’s primary endpoint. Trial investigators noted this reduction was seen in patients with and without diabetes, with reductions of 36% in patients with diabetes and 50% in patients without.

For more on the results of DAPA-CKD and how it informs the use of dapagliflozin, check out this interview from ESC 2020 with the trial's principal investigator Hiddo Heerspink, PhD, PharmD, Professor of Clinical Trials and Personalized Medicine at University Medical Center Groningen.

With approval in late April, dapagliflozin becomes the first SGLT2 inhibitor to receive approval for treatment of chronic kidney disease, heart failure, and type 2 diabetes. 

Any Fracture, Regardless of Location, Signals Increased Risk of Subsequent Fracture in Postmenopausal Women

Impact of Obesity on Risk of Severe COVID-19 Among Patients in England

Dasiglucagon Demonstrates Superiority to Placebo for Severe Hypoglycemia in Phase 3 Trial

US Preventive Services Task Force Reinforces 2015 Blood Pressure Screening Guidelines

FDA Approves Dapagliflozin for Treatment of Chronic Kidney Disease