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It’s no secret that unmanaged high cholesterol is a major health threat, potentially increasing patients’ risk of heart disease, which can lead to a heart attack, stroke or even death. While the safety and benefits of statins are well-documented,

 studies show that at least 50% of people stop taking their statin within one year of treatment initiation, despite those proven benefits.

Many patients discontinue their statin treatment without first consulting their doctors, often citing muscle aches,

 potentially not realizing that there are other statins available that may be better suited for them. A 2017 Lancet study also found that patients were more likely to report side effects when they knew they were taking statins, but when they had no idea, there was no increase in muscle-related effects — a phenomenon sometimes referred to as a “nocebo” effect.

Dr. Shawn Dhillon, Chief Medical Officer of AnytimeDRs in Baltimore, MD, believes that ongoing patient education and an open doctor-patient dialogue could be key to solving this problem. According to Dr. Dhillon, patients are often unaware of the other risk factors that can contribute to high cholesterol, assuming that once they modify their diet and exercise routine, statin use is no longer needed. In this case, patient education could mean the difference between prevention and vulnerability to serious risk factors.

“When it comes to helping patients understand the gravity of a high cholesterol diagnosis and the role of statin treatment, I think it's critical for the doctor to be proactive and consistent. All too often the patient is not receiving a full picture of what it means to have high cholesterol, or not having this message reinforced after diagnosis,” said Dr. Dhillon. “When patients come in, they are not necessarily saying, ‘I need to have my cholesterol monitored and I'm really worried about it.’ It's up to the doctor to really drive that awareness and educate the patient as to why the numbers matter, and the importance of maintaining statin use in tandem with healthy lifestyle changes.”

With such a high rate of statin discontinuation, Dr. Dhillon also believes that maintaining an open dialogue will empower patients to speak up when they have a complaint about their statin treatment, such as muscle pain, and that doctors should take an individualized approach to 

making sure each patient is on the right statin for them.

For example, some statins may cause changes to blood glucose levels in patients with high cholesterol and type 2 diabetes (T2D),

 and this is something Dr. Dhillon takes careful note of when treating patients. A staggering 30.3 million people in the U.S. have diabetes, with type 2 diabetes accounting for approximately 90-95% of cases, according to the Centers for Disease Control and Prevention (CDC).

With this in mind, it’s important that these patients are not exposing themselves to the risk of increased blood glucose levels due to their statin treatment. “With the statin medication LIVALO in particular, we often do not see the same elevation in overall glucose levels that we see with other statins,” said Dr. Dhillon. In a study in patients with dyslipidemia and type 2 diabetes, LIVALO® (pitavastatin) 4mg demonstrated a non-significant change in fasting glucose levels whereas Lipitor® (atorvastatin) 20mg demonstrated a significant increase over 12 weeks. Moreover, both LIVALO 4mg and Lipitor 20mg achieved potent LDL-C reduction of 41% and 43%, respectively.

LIVALO has been proven to reduce bad (LDL) cholesterol by up to mean 45% and with a reduction of Apo B up to a mean of 37% both at the 4 mg dose, and in clinical trials has low rates of certain side effects. Compared to most other statins, 

 also has a reduced potential to interact with other medications that a patient may be taking.

Dr. Dhillon brings a distinctive view to the statin discussion, having personally taken a statin for close to two decades.

“I take LIVALO to manage my high cholesterol, and I will often recommend it to my patients because it comes from personal experience,” said Dr. Dhillon. “I did experience myalgias with other statins and then switched. Since my switch to LIVALO, I've had good cholesterol numbers, and feel better than I did before. Once I share this with my patients, it hits home for them and reminds them I wouldn’t prescribe them anything I wouldn’t take myself.”

Dr. Dhillon continues, “Ultimately, I believe that patient success with the right statin is enhanced through an open relationship between the doctor and patient. If you have just a quick discussion to explain high cholesterol treatment, your patient may not fully grasp the importance of taking their statin in combination with lifestyle changes, or realize that if they experience a side effect, there are other options to try. Take an extra few minutes to educate them at diagnosis, and ‘go beyond the numbers’ to encourage them to speak up about how they’re feeling at each appointment, and it will pay off in spades.”

LIVALO is not right for everyone. Do not take LIVALO if:

 You have a known allergy to LIVALO or any of its ingredients.

 You have active liver problems, including some abnormal liver test results.

 You are nursing, pregnant or may become pregnant, as it may harm the baby.

 You are currently taking cyclosporine or gemfibrozil.

What is the most important information I should know and talk to my doctor about?

Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, itching, or hives.

Muscle problems may be an early sign of rare, serious conditions. Tell your doctor right away if you have any unexplained muscle pain, weakness, or tenderness, particularly if accompanied by malaise or fever, or if these muscle signs or symptoms persist after discontinuing LIVALO.

Serious liver problems have been reported rarely in patients taking statins, including LIVALO. Your doctor should do liver tests before you start, and if you have symptoms of liver problems while you are taking LIVALO. Tell your healthcare provider right away if you feel more tired than usual, have a loss of appetite, upper belly pain, dark-colored urine, or yellowing of the skin or eyes.

Tell your doctor about all your medical conditions and medications you take including nonprescription medicines, vitamins, or herbal supplements.

Increases in blood sugar levels have been reported with statins, including LIVALO.

Tell your healthcare provider of a known or suspected pregnancy.

What are the most common side effects of LIVALO?

The most common side effects of LIVALO in clinical studies were:

This is not a complete list of side effects. Talk to your healthcare provider for more information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Store LIVALO tablets at room temperature, in a dry place, and out of the reach of children. • LIVALO can be taken at any time of day, with or without food.

Swallow the tablet whole. Do not split, crush, dissolve, or chew.

Do not exceed 4 mg once daily dosing of LIVALO.

Other important information I should know about LIVALO.

LIVALO has not been studied to evaluate its effect on reducing heart-related disease or death.

LIVALO is available by prescription only.

For additional information, please see the full Prescribing Information or visit www.LivaloRx.com

Safety of statins emphasized in new report. www.heart.org. https://www.heart.org/en/news/2018/12/10/safety-of-statins-emphasized-in-new-report. Published December 2018. Accessed April 2019.

Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding statin use in America and gaps in patient education (USAGE): an internet-based survey of 10,138 current and former statin users. J. Clin Lipidol. 2012;6(3):208-215.

Zhang H, Plutzky J, Shubina M, Turchin A. Continued Statin Prescriptions After Adverse Reactions and Patient Outcomes. Annals of Internal Medicine. 2017;167(4):221. doi:10.7326/m16-0838.

Pedro-Botet J, Rubie&#769;s-Prat J. Statin-associated muscle symptoms: beware of the nocebo effect. The Lancet. 2017;389(10088):2445-2446. doi:10.1016/s0140-6736(17)31163-7.

Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2018; https://www.ahajournals.org/doi/suppl/10.1161/CIR.0000000000000625.

LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals American, Inc.; November 2016.

Gumprecht J, Gosho M, Budinski D, Hounslow N. Comparative long-term efficacy and tolerability of pitavastatin 4 mg and atorvastatin 20-40 mg in patients with type 2 diabetes mellitus and combined (mixed) dyslipidaemia. Diabetes Obes Metab. 2011;13(11):1047-1055.

The Importance of Open Doctor-Patient Dialogue about Statin Treatment

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Cardiovascular diseases continue to be the leading cause of death in the United States, though many risk factors for these diseases have been known for decades.

Today, researchers and clinicians are continuing to take a much deeper look at the story behind those risk factors. Why do some populations suffer disproportionately? What is the role of environment? Safe housing? Race? Ethnicity? Socioeconomic status? Education? Access to healthy food? Access to health care?

The answers to all of these questions paint a troubling picture: Great disparities in health in the United States remain. People don’t live as healthy, or as long, based on factors known collectively as social determinants of health. These determinants—which could be summarized very simply as environmental, financial and societal factors&mdash;are taking a terrible toll on the health of vulnerable populations all over the country. 

The American Heart Association (AHA) is dedicated to changing this picture. The organization has worked for years to understand the barriers to health experienced by populations and to find solutions so that all Americans can enjoy longer, healthier lives.

Addressing health disparities in communities across America is a major priority for the AHA, which is collaborating to do so with government agencies and organizations nationwide. Most recently, with support from the Bristol-Myers Squibb Foundation, the AHA is piloting a multi-faceted initiative in Baltimore to improve health outcomes for at-risk populations.

The American Heart Association concurs with the current definition of health disparity provided by The Office for Disease Prevention and Health Promotion: “…a particular type of health difference that is closely linked with social, economic, and/or environmental disadvantage.”

Their definition continues to state that health disparities “adversely affect groups of people who have systematically experienced greater obstacles to health based on their racial or ethnic group; religion; socioeconomic status; gender; age; mental health; cognitive, sensory, or physical disability; sexual orientation or gender identity; geographic location; or other characteristics historically linked to discrimination or exclusion

. The determinants include a wide variety of issues affecting environment, including race bias, income level, education level, stress, pollution, housing availability, access to healthy foods and access to safe ways to exercise.

The World Health Organization (WHO) defines the determinants quite broadly as “the circumstances in which people are born, grow, live, work, and age, and the systems put in place to deal with illness.

” Social determinants of health are identified by

Three measures of socioeconomic position have been explored extensively with regard to their relationship to cardiovascular health: education, income and occupation. Broadly speaking, lower socioeconomic position in the United States is associated with a greater prevalence of cardiovascular disease risk factors, and a higher incidence of mortality resulting from those diseases

There is a common belief that the United States outperforms other developed countries in health status. But that is not the case. In fact, for several decades, the US has not kept pace with other high-income countries in terms of life expectancy.

Recent research indicates that worsening social, economic and environmental factors are affecting health in serious ways. According to the Organization for Economic Co-operation and Development, the growing racial and ethnic diversity in the US, coupled with conditions that lead to disadvantages early in life, have serious implications for future health and productivity

Research has shown low-income populations, particularly those in rural and inner-city settings, experience suboptimal access to quality health care. Some groups are at greater disadvantage than others. The latest data from the CDC indicates African-Americans have fewer years limitation-free activity than white people

Eliminating health disparities for minorities would have reduced indirect costs associated with illness and premature death by more than $1 trillion between 2003 and 2006, according to a report from the AHA's Community Health in Action initiative. It is estimated that between 2009 and 2018, racial disparities in health will cost US health insurers approximately $337 billion. Obtaining care late in the course of a disease increases cost of care exponentially.

From a business perspective, a healthy, productive workforce is a prerequisite to a thriving economy. The health status of adults can impact productivity and generate higher health care costs.

It is clear that even better health insurance coverage alone will not address health disparities associated with race, ethnicity, socioeconomic status and geography

. What then is the solution to this problem? How do primary and secondary care providers, in their capacity as individuals, ensure equitable access to health care to underserved populations? What can be done at the institutional level, and as members of the community and society at large?

There are many approaches, in communities, in clinics and elsewhere. “Our increasing cultural and ethnic diversity as a nation also brings with it a unique set of opportunities and challenges related to providing equitable health care for all in the name of eliminating health disparities,” noted Eduardo Sanchez, MD, the AHA’s Chief Medical Officer for Prevention and Chief for the Center of Health Metrics and Evaluation.

Taking action in communities of need is crucial. Baltimore is a prime example of a community where environmental problems are associated with poor health. Its poorest areas face a 40% greater age-adjusted mortality than the rest of the city. “This reality is compounded by systemic social, political, economic, and environmental obstacles,” according to a report from the AHA’s Community Health in Action initiative.

The three-year initiative, which is slated to wrap up in 2020, aims to increase equity and improve systems of care across the community. There are several facets to it. The initiative seeks to develop networks and trust; strengthen communication channels; implement city-wide protocols and practices to improve access to care; and coordination of care between primary care providers and specialists.

Rhonda Ford Chatmon, AHA's Vice President of Health Strategies for the Greater Maryland area, highlighted the importance of addressing the entire community: “

, a recent article in the Stanford Social Innovation Review, suggests to us that we need to move beyond “isolated strategies” that don’t always reflect authentic community engagement and often are strategies that are “created for them without them.”” 

The AHA, through the work of the Community Health in Action Task Force, is utilizing input from diverse stakeholders representing clinical, community and patients to develop resources and drive policy, system and environmental changes that create “equitable” access and outcomes for all. In addition, the AHA will collaborate on a collective impact approach that is designed to address disparities and social influences that impact a patient’s ability to navigate complex healthcare systems and achieve optimal health outcomes. 

>>> To learn more about strategies to tackle health care disparities, visit 

. This free resource will guide you to reflect on how best to handle interventions to improve health outcomes in communities disproportionately affected by cardiovascular disease.

Aside from our efforts in the community, a key part of this project includes the development of two curricula to address health care disparities: one each for clinicians and community health care workers. Both programs will be available to people from all backgrounds, including those without medical experience.

 includes an overview of health disparities spanning from the trailblazing research that gave birth to the Office of Minority Health in 1986 to the latest developments. This program was developed by a group of experts, including 

Sarah Alexander, MD, FACC; Linda P. Bolin, PhD, RN, ANP, FAHA; Natalie Evans, MD, MS and Katherine Tucker, DNP, RN, APRN-BC, NE-BC, with the input of Kimberly Ketter, MSN, AGNP-C, CDE, African American 

Cardiomyopathy and Heart Failure Patient from the Baltimore area.

This group of individuals from Yale Health, East Carolina University, Rush Medical Center and Cleveland Clinic has experience in 

definition of risk assessments and counseling, research on improvement of clinical conditions in minorities, and research on cardiovascular health. 

A key development in the work on disparities is the 2015 scientific statement from the AHA titled 

Social Determinants of Risk and Outcomes for Cardiovascular Disease

. And now, as part of the Community Health in Action initiative, the AHA is adding some measures of disparities to two interventions that improve access to evidence-based care: 

. Both of these tools deliver clinical resources and track process of care measures and outcomes data in care delivery.

GWTG is an in-patient registry focusing on the emergency and specialty care setting, and Target: BP is a programmatic tool focusing on the primary care setting. Using these programs for data tracking will create additional measures within the GWTG Registry and Target: BP quality improvement program.

The program also increases access and equity through engagement of Baltimore’s safety net populations using 

online and event-based educational series designed to help communities and their leaders understand their health, risk factors and healthy living.

“The main challenge in serving all populations equitably isn’t a lack of medical expertise,” Sanchez said. “Rather, it lies in overcoming preconceptions of cultural barriers and being better able to connect with our patients to serve them better. To do that, we need to understand our patients’ varied backgrounds and perspectives, their beliefs and concerns related to health, and how all of these shape behaviors and interactions.”

Failure to understand these perspectives, Sanchez explained, could result in worsened health outcomes, more disparities, and sometimes, “even serious consequences.”

Shawna D. Nesbitt MD, MS, Associate Dean of Student Affairs for the Office of Student Diversity and Inclusion at UT Southwestern Medical Center in Dallas, noted the importance of strengthening cultural competencies in clinical settings.“At an intuitive and experiential level, many health care experts have found that cultural competence does indeed play a role in reducing disparities.” Nesbitt said.

She described a recent incident that illustrates the importance of improving health literacy among patients.

“A 66-year-old from an ethnic minority was diagnosed with atrial fibrillation, prescribed medicines, and given detailed instructions for the medication regimen and follow-up visits,” she said. “However, in 2 months, he came back with internal bleeding because he didn’t follow the instructions on his medicine.”

“When asked why he hadn’t followed instructions, he admitted he couldn’t follow the complicated instructions that were given, felt foolish to voice his doubts, and didn’t want to bother the ‘busy doctor,'” Nesbitt said. “This incident highlights the importance of improving health literacy, but it is key to note that this is not the responsibility of the provider alone.”

Linda P. Bolin, PhD, RN, ANP, FAHA, Assistant Professor at the Department of Nursing Science in East Carolina University — College of Nursing, added that efforts are being made at the provider and system level to improve cultural competence.

“Interventions that lie within the cultural competence circle are those that prompt equitable preventive care or treatment for chronic disease, addressing physical barriers to access, improving our ability as providers to provide health care services, helping us better understand cultural components of clinical encounters with different populations and their own inherent biases, and assisting patients from a population of interest to competently navigate the patient-provider relationship and the larger health system,” Bolin said. 

Sanchez said measures to advance care vary from clinic to clinic, but noted some best practices to improve care for underserved population:

“Improve efforts to attract and retain students from rural, inner-city, or underserved and underrepresented minority backgrounds. They are more likely to provide care in these settings after completing their training.”

“Provide training about social determinants of health and how to assess them and address them as a treatment plan is developed.”

"Provide training about implicit biases.”

“Increase emphasis on achieving the “Quadruple Aim” — which is a variation of the Institute for Healthcare Improvement’s Triple Aim

 — a framework that serves as a foundation for optimizing health. It focuses on improving the health of populations, enhancing the experience of care for individuals, and reducing the per capita cost of health care. Some organizations have added pursuing health equity as the fourth aim.”

“Develop partnerships with patients, communities, public health providers and social service agencies.”

“Implement highly effective collaborative interprofessional teams in primary care.”

“Expand the use of technology to increase access to specialty care services and support clinicians in low resource areas.”

An understanding of implicit bias plays a key role in addressing disparities. Implicit biases are unintentional and automatically activated, and can help perpetuate discrimination and lead to differential outcomes for certain racial and ethnic groups.

Research demonstrates people who endorse values opposed to prejudice are motivated to inhibit the expression of implicit bias. It is heartening to note that about 53% of white Americans agree on the need to keep on making changes to make sure minorities have equal rights. However, this figure is far from ideal

Although tools to help clinicians reduce implicit bias are diverse, a conversation about how the social determinants of health might impact patients can go a long way. This conversation doesn’t need to be a chore, but rather a way to discover what the patient is all about.

An attitude of cultural humility is very useful here, and it can be

implemented by emphasizing how providers would benefit from understanding cultural components of clinic encounters and inherent biases, understanding how patient’s perception of physician’s cultural competency affects care and guiding patients to understand how to navigate the health care system.

While there is a perception that not enough is being done, multiple research-focused organizations have actually impacted the development of knowledge and understanding of health disparities over the past few decades.

Some examples include the Agency for Healthcare Research & Quality, the National Institutes of Health, the Henry J. Kaiser Family Foundation, the Robert Wood Johnson Foundation, as well as programs dedicated to study health disparities at universities such as John Hopkins, Chicago Medical School at Rosalind Franklin University of Medicine and Science, Hackensack University Health Network, and the University of Colorado School of Medicine.

The scope of interventions has shifted the paradigm to a forward-looking venture that promotes community-based health measures for both the current and future generations. Examples of multi-generational efforts include the Three Generational Approach

,  which strengthens families and builds children’s skills through adulthood to reach their potential to be a healthy, engaged, productive citizen with full potential to plan for and parent the next generation. An example of a community wide approach is the 

 initiative currently managed by the AHA with the support of 

In addition to educating the clinician population, the AHA just published a course for 

 designed to provide knowledge that will empower them to become active members of the care team of patients impacted by cardiovascular diseases.

 and your thoughts on disparities that can be provided in the evaluation will contribute to this important initiative.

 Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services (2019, February 15). Disparities. Retrieved February 15, 2019, from https://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities

 World Health Organization. (2018). Social Determinants of Health. Retrieved September 12, 2018, from http://www.who.int/social_determinants/en/

 Havranek EP, Mujahid MS, Barr DA, et al. Social determinants of risk and outcomes for cardio-vascular disease: a scienti&#64257;c statement from the American Heart Association. Circulation. 2015;132:873—98.

As cited in Baciu A, Negussie Y, Geller A, et al., editors. Communities in Action: Pathways to Health Equity. Washington (DC): National Academies Press (US); 2017 Jan 11. 1, The Need to Promote Health Equity. Available from: https://www.ncbi.nlm.nih.gov/books/NBK425853/

 Centers for Disease Control and Prevention. (2013, November 22). CDC Health Disparities and Inequalities Report - United States, 2013, p.89. Retrieved September 12, 2018, from 

https://www.cdc.gov/mmwr/pdf/other/su6203.pdf

 National Academies of Sciences, Engineering, and Medicine. 2017. Communities in action: Pathways to health equity. Washington, DC: The National Academies Press. doi: 10.17226/24624, p.7

 Institute for Healthcare Improvement. (2019). The IHI Triple Aim. Retrieved February 15, 2019, from http://www.ihi.org/Engage/Initiatives/TripleAim/Pages/default.aspx

 Pew Research Center. (2017, June 27). On Views of Race and Inequality, Blacks and Whites Are Worlds Apart. Retrieved March 5, 2019, from http://www.pewsocialtrends.org/2016/06/27/on-views-of-race-and-inequality-blacks-and-whites-are-worlds-apart/

 Cheng, T. L., Johnson, S. B., & Goodman, E. (2016). Breaking the Intergenerational Cycle of Disadvantage: The Three Generation Approach. 

(6), e20152467. http://doi.org/10.1542/peds.2015-2467

The learning activity referred to in this article offers continuing education credit for physicians, nurses and pharmacists, as well as ABIM MOC points and ethics credit. The development of this activity is supported by an independent grant from the Bristol-Myers Squibb Foundation. For questions about this program, contact Marcela Iannini, Program Manager with the Lifelong Learning Division of the AHA at 

The Dangers of Health Disparities and the Urgent Need to Address Them

Over the last 20 years that I’ve been practicing medicine as both a clinician and as a researcher, I’ve treated countless patients with psoriasis. An estimated 7.5 million Americans are affected by psoriasis,

 of whom 80 to 90 percent suffer from plaque psoriasis, the most common form.

 What many patients, clinicians and even dermatologists fail to recognize is that psoriasis isn’t just a skin condition. It’s a chronic immune-mediated disease that has an impact on patients and their families far beyond the skin. Living with plaque psoriasis can affect patients physically, emotionally and socially, causing severe psychosocial distress that adversely impacts their quality of life. More recently, it has been identified that more severe psoriasis — when over 10 percent of the body is affected

 — can increase the incidence of depression, cardiovascular disease and even increase mortality in those who suffer.

When I began practicing, we had limited options to offer psoriasis patients who had more extensive disease. Many patients didn’t respond to the therapies available or achieve the results they desired. Moreover, due to perceived side effects, some clinicians were very hesitant to use available systemic treatments. In recent years, the number of, U.S. Food and Drug Administration (FDA)-approved treatments has grown substantially. Advances in our understanding of the immune system and the role of proteins, such as tumor necrosis factor-alpha (TNF-alpha), interleukin (IL)-17, IL-12 and IL-23,

 have made the discovery and development of biologics that target the underlying cause of psoriasis possible. With a more targeted approach, many patients demonstrate meaningful improvements in their condition.

Yet, even with advances in therapy, challenges remain, in part because psoriasis is a complex condition and patients can have a variable response to different treatments. Therefore, a continued need exists for research that will lead to new options that offer high rates of lasting skin response for patients.

Acknowledging the Psychosocial Burden of Psoriasis

Dermatologists who treat patients with psoriasis often focus on treating the physical symptoms of the disease — addressing the inflamed, scaly and erythematous patches – but the impact of psoriasis goes well beyond clinical severity. For many patients, psoriasis interferes significantly with daily life, negatively impacting relationships at home, school or work.

 Nearly 90 percent of psoriasis patients indicate that the disease impacts their overall emotional well-being and report feeling helpless and embarrassed.

 Additionally, nearly 80 percent of patients report symptoms of depression and anxiety, and more than half experience significant stress.

While patients living with psoriasis may feel self-conscious, ashamed and depressed, they often do not discuss these emotions with their dermatologist. Likewise, dermatologists may only superficially ask their patients about the impact psoriasis may be having on their quality of life. As the clinical severity of psoriasis may not accurately reflect the degree of its emotional impact, it’s critical that dermatologists assess the psychosocial aspects of the disease when meeting with their patients.

Dermatologists must deeply understand their patients’ treatment goals. More recently, treatment advances have led to greater numbers of patients achieving high levels of clinical response and even completely clear skin, as measured by a Psoriasis Area and Severity Index (PASI) of 100. Unfortunately, psoriasis is unpredictable. Not all patients achieve high levels of skin clearance, and if they do, it sometimes doesn’t last. Today, patients still cycle through various treatment modalities, including topical and oral treatments, experiencing response followed by flare-ups, which can be frustrating for both the patient and their dermatologist.

Each year, the global dermatology community comes together at the American Academy of Dermatology (AAD) Annual Meeting to share new research that can lead to improved care and management of psoriasis as well as other serious dermatologic conditions. While attending this year’s meeting in Washington, DC, I was pleased to see new data, including long-term results, from clinical trials in psoriasis that demonstrated high rates of skin clearance. Additionally, there were several sessions focused on helping physicians select the appropriate course of care for psoriasis patients in an era of multiple treatment options — a critical topic as the treatment landscape continues to grow and evolve. I left the meeting feeling optimistic about the available information and potential research advances on the horizon that may help dermatologists meet the treatment expectations of their patients.

As the psoriasis treatment landscape continues to change, it’s important we keep abreast of scientific developments. We also must maintain an open dialogue with patients about the full impact of this chronic disease on their quality of life and ensure an accurate understanding of their treatment goals. By establishing a solid partnership with our patients and gaining a better understanding of their individual challenges, we can determine the most appropriate course of care and help them achieve their goals, ultimately improving outcomes.

DISCLOSURE: Gordon reports financial ties to AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corporation, Demira, Dermavant Sciences, Eli Lilly and Company, Genzyme, Janssen Pharmaceuticals, Kyowa Hakko Kirin Pharma, Leo Pharma, Merck & Co, Novartis Pharmaceuticals, Ortho Dermatologics, Pfizer, Sun Pharmaceuticals and UCB.

 American Academy of Dermatology. Skin conditions by the numbers.  

https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers

 National Psoriasis Foundation. About Psoriasis. 

https://www.psoriasis.org/about-psoriasis

 American Academy of Dermatology Association. Psoriasis is more than skin deep. 

https://www.aad.org/media/news-releases/psoriasis-is-more-than-skin-deep

 National Psoriasis Foundation. Comorbidities associated with psoriatic disease. 

https://www.psoriasis.org/about-psoriasis/related-conditions

 National Psoriasis Foundation. Moderate to Severe Psoriasis and Psoriatic Arthritis: Biologic Drugs. 

https://www.psoriasis.org/about-psoriasis/treatments/biologics

 Global Report On Psoriasis. World Health Organization. 2016. Available at: 

An examination of the physical, emotional and social burden of psoriasis, and the continued need for research to advance care for patients.

Addressing Treatment Challenges and Advancing Care in Psoriasis

Frank Trudo, MD, MBA, was recently appointed as VP, US Respiratory Medical Affairs at AstraZeneca.

You’ve had an interesting career in that you’ve been both a practicing pulmonologist seeing patients every day and a medical expert involved in drug development at AstraZeneca. Take me through your career path and what led you to your current role as VP of US Respiratory, Medical Affairs at AstraZeneca.

I decided to go into pulmonary medicine because I was interested in the multifaceted approach of the specialty across immunology, infectious disease, and oncology. I did my pulmonology specialty training at the University of Pennsylvania and then joined a practice. After 13 years as a practicing pulmonologist, I joined AstraZeneca in 2011 as the Associate Director of Clinical Research, Respiratory and Inflammation. My new role allowed me to pursue my desire to help patients on a different level by guiding the development of medications. Some of the most rewarding parts about working at AstraZeneca are being able to drive the science that helps advance patient care and being at the forefront of advancements in respiratory disease therapies. Over the course of my career, I’ve been involved in numerous projects, including several respiratory clinical trials.

Shifting to a more general treatment landscape question, what do you think is on the horizon for the Inhaled space?

It’s an exciting time in pulmonary medicine. We're recognizing that asthma and COPD are heterogeneous diseases

, meaning that there’s not just one type of inflammation driving these diseases.

Our aim at AstraZeneca is to transform asthma and COPD treatment through Inhaled combinations at the core of care, precision biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. Because of the complexity of respiratory disease, we need different treatment and device options for patients. The use of such targeted therapies, on top of controller medication, may lead to better asthma control and less exacerbation risks in patients with asthma.

Switching gears, one of the brands you worked on over the course of your career is SYMBICORT

(budesonide/formoterol fumarate dihydrate) Inhalation Aerosol.

Can you tell us about this treatment option? 

Combination products that contain an inhaled corticosteroid (ICS) and a long-acting beta

 adrenergic agonist (LABA), including SYMBICORT, are important medications for many patients

 and are a mainstay of inhalational therapy for asthma and COPD. AstraZeneca’s investment to fully explore indications in different populations shows our continued commitment to the respiratory space.

SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older.

 SYMBICORT should be used for patients not adequately controlled on a long-term asthma-control medication such as an ICS or whose disease warrants initiation of treatment with both an ICS and LABA.

SYMBICORT 160/4.5 µg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce COPD exacerbations.

SYMBICORT is not indicated for the relief of acute bronchospasm.

What are some milestones that speak to SYMBICORT’s evolution over the past several years? 

Last year was an important year of milestones for SYMBICORT because the FDA approved three label updates, made possible through several clinical trials. These included a safety/efficacy pediatric asthma indication trial in patients 6 to <12 years of age, a Phase 3b trial designed to support approval of the COPD exacerbation indication, which I helped design and execute, and a LABA post marketing safety study in asthma patients ≥12 years of age, which was part of an FDA-required class-wide clinical trial program conducted by manufacturers of ICS/LABAs that evaluated the risk of serious asthma-related events with ICS/LABA versus ICS alone.

In January 2017, SYMBICORT 80/4.5 µg was approved for the treatment of asthma in patients aged six up to 12 years. SYMBICORT 80/4.5 µg and 160/4.5 µg were already approved in the US to treat asthma in patients 12 years and older.

In September 2017, SYMBICORT 160/4.5 µg was approved for reducing exacerbations in patients with COPD. This added to the previously approved indication of maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and/or emphysema.

In December 2017, the US Food and Drug Administration (FDA) approved updates to the labeling for all ICS/LABA products, including SYMBICORT. These updates included removal of the Boxed WARNING for serious asthma-related outcomes.

 The ICS/LABA labels all retain a Warning and Precaution related to an increased risk of asthma-related death when LABAs are used without an ICS in the treatment of asthma.

 These label updates were a result of an FDA review of 4 post-marketing LABA safety studies conducted with ICS/LABA products, including the study with SYMBICORT.

IMPORTANT SAFETY INFORMATION FOR SYMBICORT

-adrenergic agonists (LABA) as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA. When LABA are used in fixed dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

SYMBICORT should not be initiated in patients during rapidly deteriorating episodes of asthma or COPD

Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason

Localized infections of the mouth and pharynx with 

 has occurred in patients treated with SYMBICORT. Patients should rinse the mouth after inhalation of SYMBICORT

Lower respiratory tract infections, including pneumonia, have been reported following the administration of ICS

Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to ICS. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available ICS

Caution should be exercised when considering administration of SYMBICORT in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors

As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT

Immediate hypersensitivity reactions may occur, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm

Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension

Frank Trudo, MD, MBA, was recently appointed as VP, US Respiratory, Medical Affairs, at AstraZeneca.

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