One of the most persistent burdens surrounding 

 is the frequently delay in diagnosis by clinicians and initiated care for affected patients. It’s critical for caregivers and at-risk persons alike to identify the telling signs and symptoms of apnea risk—and the initial steps necessary to begin managing the chronic disease.

, Reena Mehra, MD, MS, director of sleep disorders research at the Cleveland Clinic, spoke with American Lung Association (ALA) chief medical officer Albert Rizzo, MD, on the most common or undercooked symptoms in obstructive sleep apnea. She noted how often patients present to her clinic with symptoms of excessive daytime sleepiness and general fatigue.

“That is by far and away the most common symptoms of obstructive sleep apnea, and it’s by virtue of the disruptive sleep that’s introduced from these repetitive episodes of stopped breathing—and probably some other pathways by which hypoxia may alter certain areas of the brain and lead to that sleepiness as well,” Mehra said.

Mehra additionally highlighted the importance of identifying persistent snoring, drowsing driving—an “important one” to quickly address—altered mood, or even nocturia as signs of untreated sleep apnea.

Rizzo and Mehra additionally discussed the misconception that obesity is a direct correlation with sleep apnea, highlighting the risk persons with unique airway anatomy and tissue accumulation face with the disease.

“It’s not everyone who is obese has sleep apnea, and not everyone who has sleep apnea is obese,” Mehra said.

Lastly, the pair reviewed differences in use of at-home and in-lab testing for sleep apnea.

“There’s a lot that’s monitored during an in-lab, attended polysomnogram,” Mehra said. ”It’s great from the standpoint of being able to collect a lot of helpful, important information about the degree of severity of sleep apnea…it allows us to more carefully and in a detailed way characterize the sleep-disordered breathing.”

“There can be some underestimation of the true degree of sleep apnea with home sleep apnea tests, so it’s important to recognize if you have high test probability, you’re doing the home sleep apnea test but it’s not conclusive nor revealing of a diagnosis, then one should pursue in-lab diagnostic testing to really confirm if there’s presence of sleep apnea,” she added.

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Reena Mehra, MD, MS, reviews telling signs, the role of obesity, and the importance of proper testing for sleep apnea.

Obstructive Sleep Apnea: Common Symptoms and Misconceptions

 US Food and Drug Administration (FDA) approval of roflumilast cream

 (ZORYVE) for adults and adolescents with 

 last week, opportunity is now more reasonable to consider the once-daily topical PDE-4 inhibitor agent for use and marketing in other fields of skin health.

One prominent investigator behind the drug supports the possibility that it may have safe and effective benefit in other patients from different ages and with different diseases; what matters most is it remains a proven benefit and an accessible option for patients.

In the second segment of an interview with 

, pivotal phase 3 DERMIS trial author Mark Lebwohl, MD, chair of the department of dermatology at Icahn School of Medicine at Mount Sinai, discussed next steps for assessment of roflumilast cream, including its potential use in atopic dermatitis.

“I’m sure that the manufacturers would be interested in any other steroid-responsive dermatoses,” Lebwohl said. “If it works for psoriasis, there’s a good chance it works for other dermatoses as well.”

Regarding long-term psoriasis benefit, Lebwohl expressed confidence that the agent may be “completely safe for long-term use,” though extended-use analyses are still ongoing. He noted the medical field’s familiarity with PDE-4 inhibitor drugs—already indicated for and well-tested with various chronic disease patients at ample durations of treatment.

“It does look like the benefits are sustained, and we know you can continue it without side effects,” he said. “And in a chronic disease, a set of agents like topical steroids that are very effective but start to thin the skin and cause side effects the longer you use them is not ideal. So we now do have something that I think would be ideal.”

Lastly, Lebewohl stressed the importance of patient access to roflumilast cream, alluding to the familiar burden prescribing clinicians face when an eligible patient its met with a high price tag or formulary rejection at the pharmacy.

“I would look to small specialty pharmacies that actually don’t take payments from insurance companies to take drugs off their formulary,” he said. “It’s a great drug, and make sure patients have access to it by making sure they go to the right pharmacy for it.”

The pivotal DERMIS trial author discusses extended assessment and prescribing strategies for the latest psoriasis agent.

Mark Lebwohl, MD: Optimizing Roflumilast Cream in Dermatology

Despite recent advancements in medicine, there are still barriers and hurdles that prevent better care in all fields of medicine, including 

The effectiveness of treatments, whether or not a payer will in fact pay for the treatments, and the balance of patient needs and knowledge are all things that really hamper proper care for many with diseases like major depressive disorder (MDD) and generalized anxiety disorder (GAD).

These questions might only get more complicated in the next few years as more and more non-traditional treatments like esketamine become more commonly used to treat depression and other psychiatric disorders.

Rethinking Psychiatry with Dr. Steve Levine

, Dr. Levine is joined by Lisa Harding, MD, a clinical instructor with the Yale University School of Medicine, for a lively conversation with what is currently lacking in psychiatric care, particularly what do patients need and how do doctors properly gauge patient progress.

The discussion largely centered on how scaling patient needs ultimately can be improved in the future and why it is important for doctors to set realistic expectations for what a certain treatment will do and how fast.

While all doctors can be frustrated from time-to-time with the system, the 2 were hopeful that new treatments and better communication will ultimately have a positive impact on patients.

Dr. Levine talks with Dr. Lisa Harding about how clinicians can best improve patient care in psychiatry. 

Rethinking Psychiatry With Dr. Steve Levine: Episode 4

The emergence of biologics have transformed care in 

Whether it is ustekinumab, rizankizumab, or vedolizumab, patients with either Crohn’s disease or ulcerative colitis now have a bevy of treatment options boosting impressive safety and efficacy data.

But is a clear hierarchy emerging and where is drug development going to go in the next few years?

, David P. Hudesman, MD, Medical Director of the Inflammatory Bowel Disease Center at NYU Langone Health, explained where he believes drug development will move toward in the coming years and how new biologics are most likely on the table.

“I think there will be in the next 1-5 years more biologics that come to market,” Hudesman said. “A lot of them are going to be similar mechanisms of action and different options for the patient, as well as biosimilars.”

Hudesman also said a lot of the current early phase studies in IBD have focused more on oral small molecules.

Another area likely to see some action in the next few years is with interleukin-23 inhibitors. Earlier this year, the US Food and Drug Administration (FDA) approved Risankizumab, the first and only IL-23 treatment for patients with Crohn’s disease.

Hudesman said he expects future research to focus on IL-23’s for patients with IBD.

Dr. David Hudesman expects drug developers to continue to target biologics for the treatment of IBD. 

David Hudesman, MD: Where Drug Development is Going in IBD

The Foundation of Sarcoidosis Research (FSR)

 tomorrow, August 3 at 5pm ET, to expand on a recent 

 on pulmonary sarcoidosis that the foundation conducted with the US Food and Drug Administration (FDA). In the non-regulatory, non-public session, challenges of sarcoidosis were shared by patients and caregivers impacted by the disease.

 that affects various areas of the body including the 

, lymph nodes, eyes, and skin, simultaneously at times. The development of granulomas in these organs lead to multiple complications that individuals with the condition must live with, and while there have been many advances in research, treatment and diagnosis can be difficult.

, Mary McGowan, CEO of the Foundation for Sarcoidosis Research, detailed the premise and the primary takeaways from the listening session, where speakers explained to the FDA the critical need for more flexibility in clinical trials and approval pathways, as well as the urgency for more drug development. 

"It is commonly misdiagnosed," McGowan explained. "Sarcoidosis is extremely challenging to diagnose. In fact, sarcoidosis is a diagnosis of exclusion, which means that clinicians must effectively rule out any other conditions before providing a clear diagnosis for sarcoidosis." 

It can take months, or even years, before a patient finally receives a diagnosis of the disease. McGowan shared that patients may even undergo serious treatments for inaccurate diagnoses, such as advanced cancer treatment, before their ultimate diagnosis of sarcoidosis. 

As a progressive disease, time spent without proper treatment can greatly impact the outcome of each patient, in addition to their quality of life.

"Pulmonary sarcoidosis, the topic of this particular patient listening session, can also often be misdiagnosed as asthma and even COPD," she continued. "Delayed diagnosis, of course, not only means that patients can be exposed to harmful therapies that will not improve their condition, but time lost is also lung function lost, and this can't be rebuilt."

To learn more about the listening session on pulmonary sarcoidosis, read the 

Prior to the launch of FSR's webinar on pulmonary sarcoidosis, Mary McGowan, CEO, discusses the private listening session held with the FDA that addressed the critical needs in the field.

Mary McGowan: Pulmonary Sarcoidosis Listening Session with the FDA

The role of prevention is paramount in treating 

, but the economic impact of the treatment is staggering.

Data suggest an excess of $200 billion in direct costs is spent on an annual basis on CVD in the United States alone, not inclusive of indirect costs or the toll of the disease. 

, Ty Gluckman, MD, Providence St. Joseph Health, called to mind a concept that Benjamin Franklin coined in 1736, noting "an ounce of prevention is worth a pound of cure."

He presented a talk on the subject of CVD prevention at the 2022 American Society for Preventive Cardiology meeting in Louisville, Kentucky. 

"The talk focuses on the concept and how we begin to move towards greater investment in preventive efforts up front to reduce the downstream impact, really looking from a population health perspective overall," Gluckman said. 

He noted that the way care is reimbursed, particuarly through a fee-for-service model, is based upon patients undergoing events and treating events post-occurrence. The talk additionally discusses on focusing efforts where the money is being spent, regarding economic costs in individuals who have higher baseline risk. 

"Those individuals have a greater spend on an annualized basis in terms of cardiovascular disease than those individuals that are low risk," he added. 

Gluckman discussed challenges in the cost-effectiveness of common interventions, including reducing weight for those with increased body mass index (BMI), lowering blood pressure, and addressing appropriate interventions for those with coronary disease, diabetes, and ongoing tobacco use.  

"Historically, while many of our therapies have been generic, in terms of pharmacotherapies, an increased number of our newer pharmacotherapies are now branded agents not generic and therefore associated with higher costs," Gluckman said. 

The presentation additionally focused on national guidelines and their methodology to incorporate cost effectiveness and the incorporation of value into guidelines. 

"Moving away from a one-size-fits-all approach that begins to individualize our treatment approaches to better match what may be more costly interventions in those individuals who are most likely to benefit from them," Gluckman said. 

Moreover, he discussed the concept of value-based insurance design and communicating with the payer community to make investments and subsidize costly therapies in patients who are more likely to benefit from them.

In the interview, Gluckman additionally discussed the timeline of preventive efforts, the cost of medication, and what the long-term future looks like for this discussion overall.  

For more from Dr. Gluckman, watch the above video.

At the 2022 ASPC annual meeting, Dr. Gluckman highlights the overall impact of the economic cost of cardiovascular disease and the role of prevention. 

Ty Gluckman, MD: The Staggering Cost of Cardiovascular Disease Prevention

Obesity is a risk factor for cardiovascular disease, but preventive cardiologists may face challenges in counseling a patient on a healthy body weight and strategies to achieve this goal.

2022 American Society for Preventive Cardiology Meeting

, Robert Kushner, MD, Feinberg School of Medicine, Northwestern University, presented a talk on how to treat obesity as a cardiovascular risk factor, referring to it as ‘the one that got away.’

The talk highlighted data that support obesity as a risk factor, including disability-adjusted life years (DALYs) and the effects on the heart, such as heart failure with preserved ejection fraction (HFpEF).

“I am also talking about the benefits of weight loss, not only on reducing cardiovascular risk, but also improving metabolism as it relates to insulin sensitivity and reducing insulin resistance as it relates to metabolic syndrome,” Kushner added.

He additionally discussed how clinicians can better help patients manage their weight by using targeted strategies, such as self-monitoring, meal plans, support and accountability. Kushner described the foundation of obesity treatment as lifestyle management, including diet and exercise, as well as stress reduction and lack of substance abuse.

However, the excitement for Kushner has come in the form of adjunctive pharmacotherapy. He noted that the field is at the verge of a second generation of medicines for obesity, primarily mimicking gut hormones, such as GLP-1s. In addition to treating diabetes and lowering blood sugar, the effects of these agents on appetite have led to double digit weight loss, including up to 20% weight loss, Kushner noted.

“It's not only an incretin hormone for diabetes, but in improving appetite, but also affecting other cardiovascular risk factors, effects on the kidney blood pressure and blood clotting,” Kushner added.

Kushner discussed the continuum of options in obesity management, from lifestyle changes to diet and exercise, but also noted the more aggressive treatments for obesity. The first, as noted above, is pharmacotherapy, but the other is bariatric surgery. He added that the surgery is the most effective treatment for patients with obesity, and that typically leads to significant endurable weight loss.

“I think it's important when we see individuals and we present all the options to them really from the very beginning about what is going to be the most effective treatment,” he said.

For a patient with high risk of cardiovascular disease and a corresponding body mass index (BMI) of ≥40, Kushner is potentially thinking about bariatric surgery for that individual.

“They don't have to fail lifestyle management and then fail pharmacotherapy to then bring up bariatric surgery,” he added. “We want to bring the most effective treatment for that patient as early as possible.”

Kushner further discussed the awareness of social determinants of health in obesity treatment. These social determinants are particularly affecting those who suffer from obesity or excessive weight due to a lack of resources, access to healthy foods, and others necessary to promote health in a community.

He noted that those who are most affected are often of lower socioeconomic status, particularly African-American females who have the highest prevalence of severe obesity in the United States.

“When we make recommendations to individuals and minority groups, we have to think about access and affordability when we're recommending treatments,” Kushner said. “Unfortunately, due to health care resources, a lot of the exciting medications that are being developed, are not affordable or not covered under certain health plans, so we have to be very aware of that and sensitive to the needs.”

Dr. Kushner discusses obesity as a risk factor for CVD and how preventive cardiologists can better target weight management to support patient health. 

Robert Kushner, MD: An Emphasis on Obesity as CV Risk Factor 

The need for ongoing, continuous data is important for studying virtually any disease, including 

 (NAFLD) and nonalcoholic steatohepatitis (NASH), neither of which have treatments approved by the US Food and Drug Administration (FDA).

That is why a study like TARGET-NASH is important because it allows investigators to collect data on a longer period of time and monitor different attributes and data points from patients with NASH or NAFLD.

, Arun J. Sanyal, MBBS, MD, Director of Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Interim Chair of Division of Gastroenterology, Hepatology, and Nutrition, Z. Reno Vlahcevic Professor of Medicine, Physiology, and Molecular Pathology, Virginia Commonwealth University School of Medicine, discussed how important it will be to continue to study and examine patients with these liver disorders and discover how patients ultimately change over time in an effort to improve treatments, screenings, and care.

“You have to remember, to do these types of things you have to have a lot of data and in usual clinical practice people might come in once a year,” Sanyal said. “There’s a paucity of data and here we have patients across a spectrum of clinical centers and data will be collected as part of real-world evidence.”

Recently, investigators presented new results as part of TARGET-NASH showing longitudinal trajectories of alanine aminotransferase (ALT), a common liver biomarker, were stable among patient with NAFLD.

The data was presented at the International Liver Congress (ILC) 2022 in London and is part of TARGET-NASH, an observational study of participants with NAFLD and/or NASH in usual clinical practice.

Dr. Sanyal talks about the importance in having ongoing real-world data for NAFLD and NASH. 

Arun Sanyal, MD: The Importance of Continuous Data for NAFLD

 field celebrated the 100th anniversary of the insulin discovery last year—a landmark innovation not only in endocrinology and cardiometabolic disease, but medicine overall. A full century later, the impact of insulin therapy is ineffable in diabetes management.

That is not to say the field is deprived of any other innovations.

Last month, diabetes experts and specialists from the Duke Health collaborated with 

 on a State of the Science Summit program titled, “Institutional Perspectives in Type 2 Diabetes: Contemporary Approaches to Insulin Treatment.”

The paneled presentation was led by chair Jennifer Green, MD, diabetologist and professor of medicine at Duke University Medical Center.

, Green discussed the 3 classes of technology that have delivered innovation for modern type 2 diabetes care.

Starting with insulin pumps, Green described the needs of the various patients with unstable or inadequate glycemic control, despite use of an intensive subacute insulin regimen. “Particularly if they have problems with hypoglycemia at transition to insulin, delivery through an insulin pump would always be a reasonable consideration,” Green said.

Green also praised the accessibility and benefit of continuous glucose monitoring devices for patients with ≥1 daily insulin injection. “I do think in many circumstances these are incredibly important from a safety perspective,” she said. “But I think the real advantage is in alerting people to hypoglycemia, particularly in patients who don’t manage hypoglycemia well. They can be life-saving devices, frankly.”

Lastly, Green described smart insulin pens as capable of working in concert with glucose sensors to provide real-time, accurate insulin doses. “That can be very, very helpful in reviewing someone’s data to really understand what was administered and what might not have been administered so that the regimen can be changed safely and effectively,” she said.

Finally, on the subject of navigating these armaments for the appropriate patient, Green discussed the benefit of the American Diabetes Association (ADA) Standards of Care.

“They do offer a condensed version which is geared toward primary care doctors in general,” Green said. “I would also say to really discuss your patients who have a need for diabetes specialty care with those diabetologists, endocrinologists or other specialists who they go to to provide that care so that it’s a learning experience.”

Jennifer Green, MD, discusses the benefit of relatively new innovations including continuous glucose monitoring and smart insulin pens.

Advancing Insulin Care in Diabetes: Tech and Tips

Last month, diabetes experts and specialists from the Duke Health collaborated with 

 on a State of the Science Summit program titled, “Institutional Perspectives in Type 2 Diabetes: Contemporary Approaches to Insulin Treatment.”

The paneled presentation was led by chair Jennifer Green, MD, diabetologist and professor of medicine at Duke University Medical Center. In an interview with 

, Green discussed some of the key topics of discussion at the program, including the role of insulin as a “foundation or fundamental of care in type 2 diabetes” amid an era of evolving care strategies and advancing treatment options.

“I think it’s really important to remember that people are developing type 2 diabetes at younger and younger ages, and they are living many more years with type 2 diabetes than we have seen in the past,” Green said. “And we know that the longer a person has type 2 diabetes, the greater the chances are they’re going to need insulin at least as a component of their glucose management regimen.”

Green also discussed initiating insulin treatment, and the specificity of parameters that go into such a decision for the average patient.

“Many people, by the time they are diagnosed with type 2 diabetes, have a very high hemoglobin A1C, they have symptoms related to hyperglycemia, and it is always appropriate to think of insulin therapy right off the bat for someone in that situation,” she said.

After reviewing specific cases of patients with acute illness, pregnancy or concomitant steroid treatment, Green reviewed access and cost-effective strategies for the costly drug, as well as the rationale behind treatment intensification or modification.

“I don’t think there’s a one-size-fits-all, but when you’re talking about outpatient, usual clinical care where there isn’t an urgent need to start insulin, you can always think about…incorporating insulin as part of your approach to getting that person’s control much closer to what’s optimal to them,” Green said. “But there’s really no hard and fast rule.”

The Duke expert reviews key strategies for starting and continuing care with the pivotal glycemic control agent.

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