Amy Jacob

At AAPA 2017 in Las Vegas, Jennifer Carlquist PA-C, ER, CAQ said that she believed clinicians are trained in medicine to think heart disease is “an old person’s disease,” so they don’t have it on their radar for the young people (teen years through mid-30s). 

Carlquist wanted to address this myth that young people don’t get heart disease and explained that her lecture focused on cases of young people who actually either went into cardiac arrest from heart disease or had other congenital abnormalities that were never detected: like brugada syndrome and hypertrophic obstructive cardiomyopathy.

“While those are not technically heart disease as we think of on a day-to-day basis, because we think of HD as coronary artery disease, you can’t find the other symptoms unless you think about them.”

Carlquist touched on an interesting case of a 24-year-old who told her physician for months that she had chest pain, but she was told she’s young, “you can’t have heart disease; you’re fine, you’re probably just anxious.” As a result, no one did an EKG on her. Instead, her heart disease was discovered during a diabetic episode. She was given D50, because of her low blood sugar, and immediately said she had chest pain when she woke up. She received an EKG and went in with blood glucose level of 30 and ended up going home with two stents. Her patient history explained she was anemic, hypertensive, and a diabetic dialysis patient at 24, so this did make sense.

According to Carlquist, the advance in technology would spark an increase in reports of younger patients with heart disease.  Clinicians are also recommending more younger patients to get their calcium scores checked, which could potentially find the disease even before it happens.

With a calcium score, a patient with hyperlipidemia or hypertension can actually see a physical picture of what’s in his arteries and immediately change his lifestyle before his condition becomes serious.

Carlquist concluded, “I think we’re trying to focus on prevention more. I think we as providers, knowing that young people need stents, have to cast a wider net. The clinical likelihood that a 25-30-year-old with chest pain having a coronary event is low, but it’s still possible.” 

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At AAPA 2017 in Las Vegas, Jennifer Carlquist PA-C, ER, CAQ said that she believed clinicians are trained in medicine to think heart disease is "an old person's disease," so they don't have it on their radar for the young people (teen years through mid-30s).

Myth Busted: Young People Do Get Heart Disease

The US Food and Drug Administration (FDA) granted approval for sarilumab (Kevzara/ Sanofi, Regeneron) to treat adult patients with moderately-to-severely active rheumatoid arthritis who cannot tolerate one or more disease modifying antirheumatic drugs (DMARDs) like methotrexate (MTX).

The human monoclonal antibody, sarilumab, specifically works by binding to the interleukin-6 receptor (IL-6R) and inhibiting the “mediated signaling”.

Sarilumab’s approval was based on data from two pivotal phase III clinical trials of approximately 2900 adults with moderately-to-severely active rheumatoid arthritis that experienced “inadequate responses to previous treatment regimens”.

In both trials, sarilumab plus background DMARDs demonstrated statistically significant improvements in the patient cohort.

In the MOBILITY study, treatment with sarilumab combined with methotrexate reduced signs and symptoms, improved physical function, and demonstrated significantly less radiographic progression of structural damage, compared to placebo with methotrexate.

Results from the TARGET study indicated that treatment with sarilumab plus DMARD reduced signs and symptoms and improved physical function compared with placebo plus DMARD.

Researchers noted that sarilumab can be used as monotherapy, combined with MTX, or combined with other convention DMARDS. Experts’ recommended subcutaneous dosage of sarilumab is 200mg once ever two weeks — it can be self-administered.

The research team did point out that the dosage could be reduced from 200 to 150mg once every two weeks, if necessary, to manage certain laboratory abnormalities like neutropenia, thrombocytopenia, and liver enzyme elevations.

According to results, the most commonly reported adverse reactions of sarilumab were neutropenia, increased alanine aminotransferase, injection site erythema, upper respiratory infections, and urinary tract infections.

Officials stated in the press release that the US Wholesale Acquisition Cost (WAC) of sarilumab is $39,000/year for the 200mg and 150mg doses and is approximately 30% lower than the WAC for the 2 most widely used TNF-alpha inhibitors. “Actual costs to patients, payers, and health systems are anticipated to be lower as WAC does not reflect discounts, rebates, or copay support.”

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Sarilumab would be able to treat adult patients with moderately-to-severely active rheumatoid arthritis who cannot tolerate one or more disease modifying antirheumatic drugs like methotrexate.
 

Rheumatoid Arthritis Treatment Wins FDA Approval

The US Food and Drug Administration (FDA) today expanded the approved use of subcutaneous tocilizumab (Actemra) to treat adults with giant cell arteritis — a type of vasculitis that causes arteries to narrow and impede adequate blood flow.

With this indication, this is the first FDA-approved therapy specific to this form of vasculitis.

Subcutaneous tocilizumab was previously approved to treat moderate-to-severely active rheumatoid arthritis, and intravenous tocilizumab was also previously approved for moderate-to-severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis. 

According to Badrul Chowdhury, MD, PhD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, the team was able to expedite the development and review of the application given the critical need for patients with the serious condition that only had limited treatment options.

Standard treatment for giant cell arteritis involves high doses of corticosteroids that are tapered over time.

Researchers established the efficacy and safety of subcutaneous tocilizumab for giant cell arteritis in a double blind, placebo-controlled study with 251 patients with the condition. The primary efficacy endpoint was the proportion of patients that achieved sustained remission (the absence of symptoms, normalization of inflammatory laboratory tests, and tapering the use of prednisone) from Week 12 through Week 52.

According to results, more patients receiving subcutaneous tocilizumab with standardized prednisone regimens achieved sustained remission from Week 12 through Week 52 as compared to the patients administered placebo with standardized prednisone regimens. The cumulative prednisone dose was lower in treated patients with Actemra relative to placebo.

Researchers highlighted that the overall safety profile observed in the tocilizumab treatment groups appeared generally consistent with the known safety profile of tocilizumab.

Tocilizumab does carry a boxed warning for serious infections — patients treated with the drug that developed serious infections should discontinue treatment until the infection is controlled. Live vaccines should be avoided during treatment with Actemra, and laboratory monitoring is recommended due to potential consequences of treatment-related changes in neutrophils (type of white blood cell), platelets, lipids, and liver function tests.

The most commonly reported adverse events included hypersensitivity reactions, including anaphylaxis and death.

This is the first FDA-approved therapy specific to this form of vasculitis.

First Drug to Specifically Treat Giant Cell Arteritis Gains FDA Approval

AT AAPA 2017, Tatsiana Singh, MPAS, PA-C, Indiana State University Sycamore Center for Wellness, explained that despite a lack of reliable nationwide contemporary large-scale studies that could provide reliable statistics on medical errors, there has been some efforts of which healthcare providers are aware. 

Tatsiana highlighted the Institute of Medicine’s report in 1999, which estimated there are approximately 98,000 people dying annually from medical errors — this is 30-year-old data. There have been some attempts since then to review studies that were much lower scale (one that was published in the Journal of Patient Safety in 2013), and based on the results, the estimates have shown 200-400,000 people died annually from medical errors.

While these are deaths, there are still many people, 10-20-fold higher or 2-4 million people annually, — who suffer serious consequences as a result of medical errors.

“If you look at these numbers, medical errors would easily qualify for number 3 cause of death in the United States, and these numbers, in my opinion, are gross underestimates, because the majority of the studies that are available at this point are based on the review of medical charts.” Singh also noted that many medical errors do not get documented and never make it into the patient’s charts.

In fact, some studies show that 10-30% of autopsies actually discovered misdiagnoses. When regarding which errors are considered common, Singh noted they do depend on what studies are referred to; however, based on the data from the Joint Commission the leading medical errors are:

·      Reportable sentinel event is wrong surgery, wrong patient, and wrong body part. “It really is astounding that in this day and age; we still cannot operate on the right patient and take the correct organ or body part out.”

·      Unintentional retention of a foreign body, and that is again during surgery 

·      Delay in diagnosis; pediatric patients suffer from this greatly.

According to Singh, medication-related errors top the line and ICU patients are at the greatest risk for suffering from a medication-related error — a study that used direct observation of healthcare workers in ICU that found that 1 in 5 medicine dosages suffered from an error. Diagnosis–related errors are also very high, but are just very difficult to detect in research.  

200,000 to 400,000 people die annually from medical errors.