Rheumatoid arthritis (RA) is a complex, systemic autoimmune disease that is well known but not well understood. One related consequence – 

many people living with RA do not achieve remission.

Many continue to struggle daily through painful joints and fatigue, unable to do many of the things that they used to.

The good news? The heightened community focus on research and development can help change this storyline.

Remission or low disease activity are the primary goals of RA treatment as defined by the American College of Rheumatology (ACR) guidelines.

But not all patients can get there despite the progress in the management of RA over the last couple of decades. This challenge is what drives all of us who work in this field each day.

Early in my career as a rheumatologist, there were fewer treatment options available for moderate to severe RA. For many patients who had an RA diagnosis, chronic pain, irreversible joint deformities and loss of function are what slowly unfolded before their eyes over time. Fortunately, tumor necrosis factor (TNF) inhibitors soon came to the clinic, which helped to address these challenges. As a physician, I went from managing recurrent flares and having the difficult conversation about joint damage, to counseling patients that with these new biologic therapies, they may have a better chance of managing their RA symptoms. Having seen how achieving remission affected the lives of some of my patients, I knew the work was not done until this became a reality for more RA patients.

When I decided to join AbbVie, I was in search of an opportunity to do clinical research that would advance the care of rheumatology patients. Today, I lead a team of physicians and scientists who design and execute clinical trials that evaluate investigational new compounds to treat immune-mediated inflammatory diseases. Our mission is focused on advancing the standard of care for the treatment of the diseases for which we work. The challenge in RA was to develop a new therapy that could elevate treatment expectations and help more patients reach their treatment goals. We knew that different patients respond differently to any given therapy so we needed to better understand what new pathways we could target.

My colleagues in drug discovery focused on the hypothesis that inhibition of certain Janus Kinases (JAK) could deliver a positive benefit-risk profile in RA patients. Years of diligent work led to the discovery of upadacitinib, now known as RINVOQ™, an oral JAK inhibitor that was approved by the U.S. Food and Drug Administration (FDA) in August 2019 for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate.

In developing RINVOQ to treat moderate to severe RA, we knew it was necessary to design a comprehensive program so we could have a good understanding of the optimal use of this compound for various types of patients. Our team evaluated RINVOQ in one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across all treatment arms in five studies. The SELECT studies included assessments of efficacy, safety and tolerability across a variety of patients with moderate to severe disease from those who were naïve* or intolerant to methotrexate, to patients who had failed or were intolerant to biologic disease-modifying anti-rheumatic drugs. Results from the five pivotal trials showed:

RINVOQ met all primary (ACR20 or ACR50 at Week 12 or 14) and ranked secondary endpoints in all five studies

Remission rates with RINVOQ (as assessed by DAS28-CRP<2.6†) were observed at week 12 or 14 with durable rates through week 26

RINVOQ significantly inhibited radiographic progression with or without methotrexate at week 24 or 26*

We have made progress in our understanding of RA and in our ability to develop new effective medicines for patients living with this disease. With the multiple therapies available today, rheumatologists can better address each patient’s unique needs and more patients can reach their individual treatment goals, something I hoped for when I was still in clinic. I am fortunate and proud to have been a part of making RINVOQ a viable treatment option for many patients.

* RINVOQ is not indicated for MTX-naive patients.

†Does not mean drug-free remission or complete absence of disease.

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is controlled.

Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent infection prior to RINVOQ use.

Invasive fungal infections, including cryptococcosis and pneumocystosis.

Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Lymphoma and other malignancies have been observed in patients treated with RINVOQ. 

Consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or in patients who develop a malignancy. NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk.Patients with symptoms of thrombosis should be promptly evaluated.

Gastrointestinal perforations have been reported in clinical studies with RINVOQ, although the role of JAK inhibition in these events is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). RINVOQ should be used with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation.

Treatment with RINVOQ was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts at baseline and thereafter according to routine patient management.

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical studies. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ clinical studies. Treatment should not be initiated or should be interrupted in patients with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

Treatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Manage patients according to clinical guidelines for the management of hyperlipidemia. Evaluate 12 weeks after initiation of treatment and thereafter according to the clinical guidelines for hyperlipidemia.

Treatment with RINVOQ was associated with increased incidence of liver enzyme elevation compared to placebo. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

Based on animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose. Verify pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ.

Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines.

There are no data on the presence of RINVOQ in human milk, the effects on the breastfed infant, or the effects on milk production. Available data in animals have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding is not recommended during treatment with RINVOQ and for 6 days after the last dose.

RINVOQ is not recommended in patients with severe hepatic impairment.

The most common adverse reactions in RINVOQ clinical trials (≥1%) were: upper respiratory tract infection, nausea, cough, and pyrexia.

 Medicines Matter Rheumatology. JAK inhibitors: The next generation of drugs for treating rheumatoid arthritis? 

https://rheumatology.medicinematters.com/rheumatoid-arthritis-/jak-inhibitors/jak-inhibitors-the-next-generation-of-drugs-for-treating-rheumat/12336972

 American College of Rheumatology. Rheumatoid Arthritis. Available at: 

https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis

American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. 

https://www.rheumatology.org/Portals/0/Files/ACR%202015%20RA%20Guideline.pdf

RINVOQ™ [Package Insert]. North Chicago, Ill.: AbbVie Inc.

Articles

Elevating RA Treatment Expectations

Given the various health challenges that parents and health care practitioners are dealing with today, hepatitis A may not be the first infectious disease that comes to mind for parents grappling with how to best protect their children. What many people don’t know is that there is a widespread outbreak of hepatitis A that has been sweeping the U.S. since 2016.  

This rise in hepatitis A cases has predominantly resulted from adult-to-adult contact, with infection occurring mostly among adults using drugs or experiencing homelessness. However, children under 18 years of age are also at risk for hepatitis A and require vaccination, a fact many parents may not understand. And what’s more, preventative measures among certain risk groups can have a significant impact on protecting the health of the overall community. Health care practitioners therefore have an obligation to discuss — and encourage, when appropriate – hepatitis A vaccination their families.  

The U.S. Centers for Disease Control and Prevention (CDC) supports routine hepatitis A vaccination in children 1-18 years of age. While the CDC has recommended all one-year-olds (i.e., 12-23 months) in the U.S. routinely receive the hepatitis A vaccine since 2006 (in addition to certain high-risk adults), the CDC went even further in July 2020. As an update on their official guidance, the CDC now recommends that all children and adolescents aged 2-18 years should be vaccinated against hepatitis A if they haven’t been already, known as “catch-up vaccination.” 

Why the change after nearly fifteen years? By increasing vaccination rates for this at-risk age group, we can build a herd immunity that can help reduce the spread of infection among the larger population and, in particular, vulnerable adults. Currently only 62% of children receive two or more doses of hepatitis A vaccine by the age of 19-35 months, well below the Healthy People 2020 goal of 85%. This does however increase to 68% when looking at adolescents aged 13-17 years, as the 2006 universal cohort has reached adolescence.  

Making the Case for Hepatitis A Vaccination to Parents 

In order to achieve this vision, the CDC guidelines need to be put swiftly into action. This will first require a review of existing practice protocols and processes to ensure patients aged 2-18 years are routinely assessed for hepatitis A vaccination and then followed up on to receive a complete series. 

This pre-identification will help prepare for these important conversations with parents as routine pediatric visits offer vital opportunities to get children aged 2-18 years fully vaccinated and convey valuable information. Pediatricians can help explain to parents what the new CDC recommendations mean for their child and discuss the benefits of vaccination. 

When speaking to parents who may not be familiar with children’s risk for hepatitis A, start with a question that is likely top of mind: how their child could contract the virus. Hepatitis A may often be associated with contaminated food or water, but kids are actually much more likely to be infected through human contact or contaminated surfaces. Taking precautions to protect children from hepatitis A is just as important as protecting them from any other vaccine-preventable diseases. 

We should not overlook hepatitis A as a highly-contagious infection with rapidly-increasing incidence in the U.S., including among children under 6 years of age who can appear asymptomatic and be transmitters of the virus. It’s important to remain vigilant in vaccination and protection against all preventable diseases that continue to affect us. 

Now more than ever, it is critical that we proactively address hepatitis A with parents, improve education about CDC guidelines for protection against all infectious diseases and share resources for people to learn more about how they can protect themselves. For more information, visit 

https://www.vaccines.gov/diseases/hepatitis_a. 

The Importance of Understanding the CDC Hepatitis A Vaccine Guidelines

Dr. Mitesh Borad, Oncologist, Associate Professor of Medicine at Mayo Clinic College of Medicine and Science

Cholangiocarcinoma (CCA) is a rare and often overlooked cancer that forms in the bile duct. Rare in that it affects fewer than 10,000 people in the U.S.,

 but overlooked likely because of its non-specific symptoms — including abdominal pain, night sweats, fatigue, jaundice, general discomfort and weakness – which can make it difficult for physicians to identify.

 Too often, CCA becomes a diagnosis of exclusion, only determined after physicians undergo rigorous processes to rule out other potential explanations to reach a diagnosis. As such, CCA is often diagnosed at an advanced stage when curative modalities such as surgery are not feasible and the prognosis is poor.

Given the non-specific nature of symptoms associated with the diagnosis of CCA, other than jaundice, early detection is uncommon. In my own practice, I have found that a growing number of patients are being incidentally diagnosed by the presence of lesions, which are identified through imaging in the absence of other typical CCA symptoms.

Historically, the only potentially curative treatment for CCA has been surgery, but even after surgery, relapse rates are high, and patients have a median survival of only about 12 months.

 More recently, technological interventions are making it possible to more efficiently evaluate CCA by allowing researchers to look closely inside each person’s tumors to see exactly which mutations are present. 

This type of testing, called molecular profiling, pinpoints driver mutations, or genomic abnormalities.

 Molecular profiling can help detect these abnormalities earlier on in disease progression.

For example, FGFR2 fusion or rearrangement is observed in 10 — 15% of patients whose CCA originates in the bile ducts within the liver, known as intrahepatic CCA.

While a variety of molecular profiling methods are now available, next-generation sequencing (NGS) and fluorescence in situ hybridization (FISH) are among the most common. NGS allows us to analyze a tissue sample for multiple alterations at the same time, while FISH tests are conducted to identify one specific, predetermined alteration at a time.

Molecular profiling isn’t consistently conducted, and it often isn’t even considered until after first-line chemotherapy has failed. Knowing that, I encourage patients within my practice to undergo molecular profiling early on in a patient’s CCA diagnosis, and I urge my hepatology and gastroenterology colleagues to do the same.

It is critical that physicians understand the importance of early molecular profiling when it comes to treating patients with CCA. More broadly, molecular profiling has helped scientists and physicians better understand how cancer can start, grow and spread in the body.

For more information on FGFR2 fusions and next generation sequencing in cholangiocarcinoma, visit 

[i] Key Statistics for Bile Duct Cancer. American Cancer Society. 

https://www.cancer.org/cancer/bile-duct-cancer/about/key-statistics.html

[ii] Banales JM, et al. Nat Rev Gastroenterol Hepatol. 2016;13:261&#8210;280.

[iii] Uhlig J, et al. Ann Surg Oncol. 2019;26:1993—2000.

[iv] Bridgewater J, et al. J Hepatol. 2014;60(6):1268-1289.

[v] Lowery M, et al. Clin Cancer Res. 2018;24(17):4154-4161.

[vi] Graham RP, et al. Hum Pathol. 2014;45:1630&#8210;1638.

[vii] Farshidfar F, et al. Cell Rep. 2017;18(11):2780—2794.

[viii] Damodaran S, Berger MF, Roychowdhury S. Am Soc Clin Oncol Educ Book. 2015;e175-e182.

[ix] Hu L, Ru K, Zhang L, et al. Biomark Res. 2014;2(1):3.

Disclosures: Dr. Borad reports financial ties to Incyte, ADC Therapeutics, Exelixis Pharmaceuticals, G1 Therapeutics, Immunovative Therapies, Inspyr Therapeutics, Lynx Group, OncBioMune Pharmaceuticals, Western Oncolytics

The Critical Role of Molecular Profiling in Cholangiocarcinoma 

As recently as 2015, over 30 million people in the US had diabetes—a rate equivalent to 9.4% of the US population.

 Of these cases, a rate of 90%-95% are type 2 diabetes (T2D).

 The prevalence of T2D has been on the rise.

Patients are advised to work closely with their physicians to set and achieve long-term strategies, including diet modifications and improvements to exercise routines. Lifestyle management is a fundamental aspect of diabetes care and healthcare providers may recommend pharmacotherapy for patients when target blood sugar levels have not been achieved with diet and exercise alone.

 Diabetes care should be individualized for each patient, which may include determining the appropriate pharmacologic treatment.

A significant milestone in the area of T2D therapies was the approval of the first glucagon-like peptide-1 receptor agonist (GLP-1 RA), in the U.S., in 2005.

 In 2017, the FDA approved the GLP-1 RA BYDUREON BCise

 (exenatide extended-release)&lrm; injectable suspension 2 mg.

 Indicated for the lowering of glycated hemoglobin (HbA1c) as an adjunct to diet and exercise in adults with T2D who are uncontrolled on antidiabetic agent(s), BYDUREON BCise features convenient once-weekly dosing and an easy to use device for patients working to manage their T2D.

Medication adherence plays an essential role in overall glycemic control. Unfortunately, the adherence rate among patients with T2D is as low as 45%, with nearly one-third of patients with T2D failing to fill even their first prescription of a glucose-lowering agent.

But more convenient options and advances in formulations and delivery devices may help improve adherence.

One option for healthcare providers to consider is the single-dose autoinjector BYDUREON BCise. This once-weekly autoinjector device was deemed “easy” or “very easy” to use by 86% of patients in a clinical study.

The non-insulin therapy was designed to be simple to use, being administered subcutaneously in 4 steps following preparation: mix, unlock, unscrew and inject. The injection contains a unique continuous-release microsphere technology that releases the medicine into the body over time, reaching a steady state at 10 weeks with continued once-weekly dosing.

 In turn, BYDUREON BCise helps the body release its own insulin to help lower blood sugar specifically when the body needs it.

BYDUREON BCise is not recommended as a first therapy for type 2 diabetes and should not be used to treat type 1 diabetes. It causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON BCise causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined. It is contraindicated in patients with a personal or family history of medullary thyroid cancer, or in patients with Multiple Endocrine Neoplasia syndrome type 2, or with a prior serious hypersensitivity reaction to any of the product components.

The most common adverse reactions are injection site reaction (10.5%) and nausea (8.2%).

 Please refer to the IMPORTANT SAFETY INFORMATION below for more details.

Effective T2D medication therapy delivers the right drug at the right dose, through the right route, at the right time, for the right patient. Though the sheer breadth of available antihyperglycemic therapies—available across different drug classes, in combination or as lone therapy&mdash;is overwhelming, the base of knowledge informing treatment decisions is still growing.

Some decisions may be simplified by a proven, easy-to-use device such as BYDUREON BCise.

Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON BCise causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined 

BYDUREON BCise is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of BYDUREON BCise and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with BYDUREON BCise

Personal or family history of MTC, patients with MEN 2

Patients with prior serious hypersensitivity reactions to exenatide or product components

including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis

Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider lowering the dose of these agents when coadministered with BYDUREON BCise

May induce nausea and vomiting with transient hypovolemia and may worsen renal function. Increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. Not recommended in patients with eGFR <45 mL/min/1.73 m

Because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe gastrointestinal disease (eg, gastroparesis)

Patients may develop antibodies to exenatide. Patients with higher titer antibodies may have an attenuated HbA1c response. In clinical trials, attenuated glycemic response was associated with BYDUREON BCise-treated patients. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy

Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON BCise and promptly seek medical advice

Serious reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, have been reported

 has been reported in GLP-1 receptor agonist trials, including exenatide. If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated

Most common (≥5%) in clinical trials: injection-site nodule (10.5%), nausea (8.2%).

BYDUREON BCise slows gastric emptying and may reduce the rate of absorption of orally administered drugs

Increased international normalized ratio (INR) sometimes associated with bleeding has been reported with concomitant use of exenatide with warfarin. Monitor INR frequently until stable upon initiation of BYDUREON BCise

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

BYDUREON BCise is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Not recommended as first-line therapy for patients inadequately controlled on diet and exercise

Not a substitute for insulin. Should not be used to treat type 1 diabetes or diabetic ketoacidosis

Use with prandial insulin has not been studied

Do not coadminister with other exenatide-containing products

Not studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis

 for Medication Guide for BYDUREON BCise 2 mg, including Boxed WARNING.

National Diabetes Statistics Report, 2017.

 Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2017.

https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

2. Centers for Disease Control. Long-Term Trends in Diabetes, April 2017.

https://www.cdc.gov/diabetes/statistics/slides/long_term_trends.pdf

3. American Diabetes Association. Standards of Medical Care in Diabetes — 2019. 

https://care.diabetesjournals.org/content/42/Supplement_1

4. Mayo Clinic. Type 2 Diabetes-Diagnosis & treatment.

https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/diagnosis-treatment/drc-20351199

5. Trujillo JM, Nuffer W, Ellis SL. GLP-1 receptor agonists: a review of head-to-head clinical studies. 

6. AstraZeneca US press release. US FDA approves new easy-to-use, once-weekly BYDUREON® BCise

 injectable medicine for patients with type-2 diabetes.

https://www.astrazeneca-us.com/content/az-us/media/press-releases/2017/us-fda-approves-new-easy-to-use-once-weekly-bydureon-bcise-injectable-medicine-for-patients-with-type-2-diabetes-10232017.html

 ([exenatide extended-release] injectable suspension) [prescribing information].  Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.

8. Curkendall SM, Thomas N, Bell KF, Juneau PL, Weiss AJ. Predictors of medication adherence in patients with type 2 diabetes mellitus. 

9. Fischer MA, Stedman MR, Lii J, et al. Primary medication non-adherence: analysis of 195,930 electronic prescriptions. 

10. Giorgino F, Penfornis A, Pechtner V, Gentilella R, Corcos A. Adherence to antihyperglycemic medications and glucagon-like peptide-1 receptor agonists in type 2 diabetes: clinical consequences and strategies for improvement. 

11. Data on File, REF-14053, AstraZeneca Pharmaceuticals.

https://www.bydureonhcp.com/bydureon-bcise/pk-profile.html

How a Once-Weekly Injection Can Help Manage Type 2 Diabetes

This ad was supported by Church & Dwight Co. Inc, featuring Feryal Hajee, MD.

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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

 as a Professional Member and be part of our relentless force as we build a world of longer, healthier lives!

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.

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