A special episode focuses on the issue of insulin accessibility and affordability in the United States, with four experts in the diabetes arena weighing in on the topic.

Crisis Point: Insulin Access in the United States

, Ian W. Flinn, MD, PhD, Director, Lymphoma Research, Sarah Cannon Research Institute at Tennessee Oncology, spoke on the US Food and Drug Administration's (FDA) 

 of zanubrutinib (Brukinsa) and its importance for patients and providers dealing with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), 

Supporting data from the SEQUOIA and ALPINE trials assessed the efficacy of zanubrutinib in these populations.

The phase 3 SEQUOIA study evaluated treatment-naïve patients with CLL/SLL in randomized and non-randomized cohorts. In the randomized cohort, 479 patients, including patients without 17p deletion, underwent treatment of zanubrutinib until disease progression, or 6 cycles of bendamustine alongside rituximab. Progression-free survival was the main efficacy outcome.

In ALPINE, the second clinical trial, a total of 652 patients with relapsed or refractory CLL/SLL received either zanubrutinib or ibrutinib following randomization. The median amount of prior lines of therapy was 1, and ranged from 1-8. The overall response rate, and duration of response, were measures for the main efficacy outcome.

As a Bruton's tyrosine kinase (BTK) therapy, zanubrutinib provides an option with reduced adverse events, as opposed to chemotherapy treatments like venetoclax, which is usually combined with a monoclonal antibody, Flinn explained.

"Patients get that therapy for about a year, and then they can come off. They only have to stay on it for about a year because they get very deep remissions. Many patients have undetectable, minimal residual disease," he said. "It's a little bit of pain to give that therapy because it's it's very intensive."

Because the therapy involves 5 weeks of dose escalation, which means patients are visiting their treatment center multiple times per week to avoid tumor lysis syndrome (TLS), the approval of zanubrutinib as an option was significant. Flinn shared that many patients opt for Bruton's tyrosine kinase (BTK) over this combination therapy. 

Videos

Dr. Ian Flinn explains that as a Bruton's tyrosine kinase (BTK) therapy, zanubrutinib provides an option with reduced adverse events compared with chemotherapy treatments like venetoclax.

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Ian Flinn, MD, PhD: Bruton's Tyrosine Kinase Therapy Offers Fewer Adverse Events for CLL, SLL

Connor Iapoce is an associate editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

 in the United States surged during the first year of the 

, with particularly high numbers for Asian, Black, and Hispanic populations.

(AHA) 2023 Statistical Update reported more people died from cardiovascular-related causes in 2020, the first year of the COVID-19 pandemic, than in any year since 2003.

The data show CVD-related deaths swelled from 874,612 in 2019 to 928,741 in 2020, the largest single-year increase since 2015. This surpassed the previous high death rate of 910,000 recorded in 2003.

“The age-adjusted mortality rate takes into consideration that the total population may have more older adults from one year to another, in which case you might expect higher rates of death among older people,” said writing committee volunteer chair Connie W. Tsao, MD, MPH, Assistant Professor of Medicine, Harvard Medical School in a 

. “So even though our total number of deaths have been slowly increasing over the past decade, we have seen a decline each year in our age-adjusted rates – until 2020.”

Overall, CVD consists of coronary heart disease, stroke, heart failure and hypertension/high blood pressure. Coronary heart disease remains the number one cause of death in the United States, while stroke continued to rank fifth among all causes of death. In 2020, COVID-19 appeared in the list of leading causes of death for the first time.

The update clarified the mechanisms by which COVID-19 impacts cardiovascular health. This included its relationships to risk factors for heart disease and stroke, such as diabetes and high blood pressure putting individuals at greater risk for more severe COVID-19 illness.

The current report indicated the greatest increases in CVD deaths seen in Asian, Black, and Hispanic communities represented ongoing structural and societal disparities, as these populations were most impacted in the early days of the COVID-19 pandemic. Committee authors cited the disproportionate burden of cardiovascular risk factors in these populations, including hypertension and obesity.

“COVID-19 has both direct and indirect impacts on cardiovascular health,” added Michelle A. Albert, MD, MPH, volunteer president of the American Heart Association and the Walter A. Haas-Lucie Stern Endowed Chair in Cardiology at the University of California at San Francisco (UCSF) in a 

. “As we learned, the virus is associated with new clotting and inflammation. We also know that many people who had new or existing heart disease and stroke symptoms were reluctant to seek medical care, particularly in the early days of the pandemic. This resulted in people presenting with more advanced stages of cardiovascular conditions and needing more acute or urgent treatment for what may have been manageable chronic conditions. And, sadly, appears to have cost many their lives.”

Study authors further cited disparities related to gender, race, and ethnicity that occurred in the research. However, a special commentary by members of the update’s writing committee noted a lack of data from other underrepresented populations, including LGBTQ people and those living in rural versus urban areas of the United States.

In doing so, they aimed to “better recognize and understand the unique experiences of individuals and populations” and gather information on specific social factors related to health risk and outcomes.

“However, the data are still lacking because these communities are grossly underrepresented in clinical and epidemiological research,” Tsao said. “We are hopeful that this gap in literature will be filled in coming years as it will be critical to the American Heart Association’s goal to achieve cardiovascular health equity for all in the US and globally.”

Global and regional trends in death were addressed in the statistical update, related to different cardiovascular diagnoses and risk factors. CVD continued to be the top killer globally and took the lives of more than 19 million people around the world each year.

The trends show that globally, coronary heart disease and stroke are the top two causes of death linked to CVD. Study authors noted the rates were shown to rise around the world in the past decade in all but two regions, North America, and Europe/Central Asia.

Data on North America show heart disease death rates have been falling in recent decades, from 28.2% of all deaths in 1990 to 18.7% in 2019. Stroke deaths fell from 7.3% of all deaths in 1990 to 6.4% in 2019. In Europe and Asia, heart disease death rates fell from 27.2% of all deaths in 1990 to 24.4% in 2019, with stroke death rates falling from 15.1% to 12.5% in the same period.

Study authors emphasized the importance of the report as a critical resource for policymakers, clinicians, researchers, health advocates, and others seeking the best available data on these conditions and their risk factors.

"As the U.S. prepares to celebrate the 60th annual Heart Month in February, it's critical that we recognize and redouble the lifesaving progress we've made in nearly a century of researching, advocating, and educating, while continuing to identify and understand those barriers that still put certain people at increased risk for cardiovascular disease," Albert said.

Heart Disease and Stroke Statistics—2023 Update: A Report from the American Heart Association

Articles

New data from the AHA 2023 Statistical Update suggest more people died from cardiovascular-related causes in 2020 than in any year since 2003. 

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

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CVD-Related Deaths Surged During First Year of COVID-19 Pandemic 

Lana Dykes is the editor of HCPLive Rheumatology. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. In her free time, she enjoys cooking, yoga, listening to podcasts, and drawing. She can be reached via email at LDykes@mjhlifesciences.com.

, Virginia Byers Kraus, MD, PhD, professor in the departments of Medicine, Pathology, and Orthopedic Surgery at Duke University School of Medicine and lead investigator of the study, “

A “best-in-class” systemic biomarker predictor of clinically relevant knee osteoarthritis structural and pain progression

,” discusses the multi-biomarker blood tests that could be used to predict which individuals are at a greater risk of worsening knee osteoarthritis.

“Our primary motivation was to help develop treatments for people with osteoarthritis that would slow or prevent the disease and be more than painkillers- actually affect the disease process itself,” Kraus explains.

Through a blood test that used multiple biomarkers, investigators were able to predict, with 74% accuracy, which patients at baseline were more likely to progress within the next 2 to 4 years. However, while some of the proteins were able to positively predict those at higher risk, other proteins indicated lower risk. For example, parts of the vitamin D binding protein both predicted progression and non-progression.

“The immediate application and significance is that we could partner with companies doing trials to identify the people that are most appropriate for the trials so that we could reduce the costs and the time it takes to do the trials,” Kraus emphasized. “We could get to a treatment that's really effective faster and at a much lower cost. Therefore, it would be more likely that more companies would test things and that we would get to a positive result… Having a biomarker in your drug development program increases the chance that you're going to be successful.”

Kraus emphasizes that patients with osteoarthritis should continue to be optimistic regarding possible breakthroughs in treatment. “We've seen recent breakthroughs with Alzheimer's disease, another chronic disabling condition, so I take that all with great enthusiasm and optimism that osteoarthritis will soon follow.”

“Our primary motivation was to help develop treatments for people with osteoarthritis that would slow or prevent the disease and be more than painkillers- actually affect the disease process itself,” Virginia Kraus, MD, explains. 

Osteoarthritis

On the HCPLive osteoarthritis page, resources on the topics of medical news and expert insight into OA can be found. Content includes articles, interviews, videos, podcasts, and breaking news on degenerative joint disease, and more.

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Biomarker Predicts Patients at Greater Risk of Worsening Knee Osteoarthritis 

A recent investigation revealed associations between outdoor air pollution in urban areas and non-viral 

 exacerbations, as well as specific inflammatory pathways in the airways of children with asthma. 

The prevalence and severity of asthma increased with the rise of urbanization, and according to the study, children in low-income urban centers have the highest rates of asthma. While the relationship has been observed in previous literature, the mechanisms involved are not understood, especially in comparison to those that facilitate the relationship between respiratory viruses and asthma exacerbation. 

In the study, Matthew Altman, MD, Systems Immunology Division, Benaroya Research Institute, and investigators, focused on asthma exacerbations without the presence of respiratory virus, but the team also aimed to examine regional air pollutant concentrations, respiratory illnesses, lung function, and upper airway transcriptional signatures in children with asthma.

The Specific Inflammatory Pathways and Air Pollutants

The retrospective analysis evaluated data from the MUPPITS1 cohort from 2017, which enrolled 208 children aged 6-17 years from urban areas across 9 cities. The participating patients had exacerbation-prone asthma and were recruited between October 2015-October 2016, then their respiratory status was monitored. The final visit of the investigation took place in January 2017.

Investigators then validated their findings with the ICATA cohort, which recuited 419 patients with persistent allergic asthma, aged 6-20 years, that lived in urban areas across 8 US cities. Enrollment occurred from October 2006-March 2008, with the final visit dated December 2009. 

For this assessment, investigators included patients who reported respiratory illness within the MUPPITS1 study duration. Patient data from the ICATA cohort were included if they had nasal samples collected at the time of respiratory illness or a scheduled visit. 

Air quality index values and air pollutant concentrations for PM

, CO, and Pb from the US Environmental Protection Agency spanning the years of both cohorts, were used to match values and concentrations of each illness for each participant. Then, investigators utilized an amalgamation of generalized additive models, case crossover analyses, and generalized linear mixed-effects models in order to identify associations between regional air pollutant concentrations and respiratory illnesses and asthma exacerbations, pulmonary function, and upper airway transcriptional signatures.

Influences of Asthma Without Viral Infection 

The data demonstrated a rise in air quality index values, that resulted from increased PM

 concentrations, showed a significant association with decreased pulmonary functions and the presence of asthma exacerbations without viral infection. The analysis consisted of 168 patients from MUPPITS1 (98 males; 70 females), and 189 patients from ICATA (115 males; 74 females).

Evidence of altered gene expression in coordinated inflammatory pathways was significantly linked to individual pollutants. This observation related to PM

 with increased epithelial induction of tissue kallikreins, mucus hypersecretion, barrier functions and O

 with increased type-2 inflammation, the team reported.

"Our findings suggest that air pollution is an important independent risk factor for asthma exacerbations in children living in urban areas and is potentially linked to exacerbations through specific inflammatory pathways in the airway," investigators wrote. "Further investigation of these potential mechanistic pathways could inform asthma prevention and management approaches."

Associations between outdoor air pollutants and non-viral asthma exacerbations and airway inflammatory responses in children and adolescents living in urban areas in the USA: a retrospective secondary analysis

The specific mechanisms involved in associations between air pollution and respiratory illness without viral infection are not understood, especially compared with those of respiratory viruses and asthma exacerbation. 

Pulmonology

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Family Medicine

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Air Pollution in Urban Areas Linked to Asthma, Inflammatory Responses in Children

A 12-month vigorous or moderate aerobic exercise program could generate long-term benefit on 

, according to 10-year follow-up of a randomized clinical trial.

Similar trials have reported beneficial results of lifestyle intervention for the prevention of diabetes, but these trials combined exercise with diet and included individual or group consulting. In contrast, the current trial performed strict coaching in the exercise programs during the 1-year intervention and all participants were instructed not to change their diet.

“Regarding the importance of obesity management in the prevention of T2D addressed by the latest American Diabetes Association guideline, our results are supportive of physical exercise as an effective scheme for obesity management to delay the progression of T2D, and vigorous and moderate aerobic exercise programs could be implemented for prevention of T2D in people with obesity,” wrote corresponding author Xiaoying Li, MD, PhD, Ministry of Education Key Laboratory of Metabolism and Molecular Medicine, Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University.

Lifestyle interventions including diet and exercise play a key role in the prevention of T2D in at-risk individuals, but the isolated effects of vigorous and moderate exercise are uncertain. Li and colleagues performed a 10-year follow-up study based on their previous RCT to assess long-term effects of exercise on the prevention of diabetes between July 2021 and May 2022.

The trial consisted of vigorous aerobic exercise (n = 73), moderate aerobic exercise (n = 73), and nonexercise control groups (n = 74) in individuals with central obesity and nonalcoholic fatty liver disease. At the end of the 12-month intervention, all participants were encouraged to continue with a healthy lifestyle and moderate intensity aerobic exercise.

They were then followed up with at 2-year and 10-year visits to assess the incidence of T2D and the changes in body weight, waist circumference, and metabolic risk factors. The study defined incident diabetes as fasting plasma glucose of 126 mg/dL or greater, hemoglobin A1c (HbA1c) levels of 6.5% or greater, and/or the use of antidiabetic medication.

From 220 eligible participants in the original RCT, 208 (94.5%) participants finished the 1-year exercise intervention. At the 2-year and 10-year follow-up visits, 195 (88.6%) and 179 participants (81.4%) continued with the assessment of incident diabetes, respectively.

Similar metabolic equivalents of leisure time physical activity among the 3 groups were observed at baseline but were found higher in moderate and vigorous exercise groups than in the nonexercise group at the end of 1-year intervention. No significant differences were reported among the 3 groups at the 10-year follow-up, but there was a trend of higher levels of leisure time physical activity in the exercise group than the nonexercise group.

In the 10-year follow-up, data show the cumulative incidence of T2D was 2.1 per 100 person-years (PYs) in the vigorous group, compared to 1.9 per 100 PYs in the moderate group, and 4.1 per 100 PYs in the nonexercise groups.

The risk of diabetes was reduced by 49% in the vigorous aerobic exercise group and by 53% in the moderate aerobic exercise group compared with the non-exercise group. Investigators reported similar results of moderate and vigorous aerobic exercise in those who completed 12-month interventions.

Further results show HbA1c and waist circumference to be significantly reduced in the vigorous and moderate exercise groups compared with the nonexercise group. Meanwhile, fasting plasma glucose levels and weight regain were lower in the exercise groups, although significant differences were not detected.

Effect of Moderate and Vigorous Aerobic Exercise on Incident Diabetes in Adults with Obesity: A 10-Year Follow-up of a Randomized Clinical Trial

The risk of diabetes was reduced by approximately 50% in both the vigorous and moderate aerobic exercise groups compared with the nonexercise group. 

Obesity Management

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Type 2 Diabetes

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Aerobic Exercise Programs May Help Prevent Diabetes in Individuals with Obesity 

. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with 

. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

SARS-CoV-2 infections cause microbiome dysbiosis in patient and possibly an increase in opportunistic pathogens and a decrease in beneficial bacteria.

C Difficile Infection

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Significant Gut Microbiota Differences Found in COVID-19 Patients, Healthy Individuals

Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

The January 2023 cardiology month in review features a trio of articles related to management of atrial fibrillation, the FDA approval of Abbott’s Navitor system, and a study spotlighting the prevalence of mental health conditions among cardiologists.

Cardiology Month in Review: January 2023

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

In this recent study, mental health conditions associated with alopecia areata were assessed by the study’s investigators.

Dermatology

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Anxiety, Depressive Disorder Prevalence Greater Among Alopecia Areata Patients

A sugary drinks tax in England may have prevented over 5,000 cases of obesity a year in older girls, but had no significant association with obesity levels in year six boys or younger children. 


Sugary Drinks Tax May Be Effective In Preventing Childhood Obesity 

The approval of the adalimumab biosimilar, adalimumab-aacf, signals the beginning of Fresenius Kabi's long-term dedication to biosimilars.


Biosimilars

Biosimilar Adalimumab-aacf Gains FDA Approval, Marks Growing Interest in Biosimilar Development 

The clinical trials that supported the FDA decision, SEQUOIA and ALPINE, evaluated the efficacy of zanubrutinib and findings paved the way to add the therapy as a treatment option.

Ian Flinn, MD, PhD: Zanubrutinib for Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

A ED screening program identified a substantial number of patients with undiagnosed prediabetes and T2D or undermanaged disease, particularly racial and ethnic minorities. 

Emergency Department Screening Program Useful in Identifying Undiagnosed Diabetes 

The latest HCPLive interview segment with Karan Lal, DO, discussing his views on what can go wrong during cosmetic procedures.

Karan Lal, DO: Cosmetic Complications and Safety Regulations in Dermatology

The study population consists of patients who received 1-3 prior lines of therapy for relapsed and lenalidomide-refractory multiple myeloma.

Hospital Medicine

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Cilta-cel Improves Progression-Free Survival as Multiple Myeloma Therapy in Phase 3 Data 

Glucocorticoids are sometimes used as “bridging” therapy to alleviate symptoms in newly diagnosed patients with rheumatoid arthritis until a disease-modifying antirheumatic drug (DMARD) kicks in. Test your knowledge of bridging therapy with this quiz. 

Latest News

Ian Flinn, MD, PhD: Bruton's Tyrosine Kinase Therapy Offers Fewer Adverse Events for CLL, SLL

CVD-Related Deaths Surged During First Year of COVID-19 Pandemic

Biomarker Predicts Patients at Greater Risk of Worsening Knee Osteoarthritis

Air Pollution in Urban Areas Linked to Asthma, Inflammatory Responses in Children

Aerobic Exercise Programs May Help Prevent Diabetes in Individuals with Obesity