The Vitals - March 2016

Examining the News Affecting Pharmacy & Clinics
March 2016, Vol 4, No 3 - The Vitals

In This Article

High-Cholesterol Foods May Not Increase Risk for Coronary Artery Disease

Although the effects of dietary cholesterol on blood cholesterol concentrations are largely modest, the influence is stronger in patients who have a ε4 allele in the apolipoprotein E gene (ApoE4). Little is known about the association between cholesterol intake and the risk for coronary artery disease (CAD) in this patient population.

To further explore this association, Jyrki K. Virtanen, PhD, Adjunct Professor, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland, and colleagues investigated the relationship between intake of cholesterol and eggs—which are a main source for dietary cholesterol—and the risk for incident CAD in men. The study included 1032 men who were aged 42 to 60 years at the baseline examinations of the prospective, population-based Kuopio Ischaemic Heart Disease Risk Factor Study.

“The ApoE4 phenotype was found in 32.5% of the men. During the average follow-up of 20.8 years, 230 CAD events occurred,” the study authors noted. “Egg or cholesterol intakes were not associated with the risk of CAD.”

The study authors concluded that egg or cholesterol intakes were not associated with an increased risk for CAD, even in carriers of ApoE4.

  1. Virtanen JK, Mursu J, Virtanen HEK, et al. Associations of egg and cholesterol intakes with carotid intima-media thickness and risk of incident coronary artery disease according to apolipoprotein E phenotype in men: the Kuopio Ischaemic Heart Disease Risk Factor Study. Am J Clin Nutr. 2016 Feb 10. Epub ahead of print.

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New Liquid Biopsy Detects NSCLC Biomarkers

Personalized medicine has changed cancer treatment with the introduction of molecular targeted therapies. Although biopsy-based genotyping is the current clinical practice, biopsy procedures can result in morbidity, according to a presentation by David T. W. Wong, DMD, DMSc, Professor, University of California, Los Angeles, and colleagues at the 2016 American Association for the Advancement of Science Annual Meeting.

“To overcome these issues, technologies are needed for rapid, cost-effective, and noninvasive identification of biomarkers at various time points during the course of disease,” explained Dr Wong and colleagues.

Liquid biopsy is an emerging method that can address the need for this type of technology. The use of cell-free circulating tumor DNA through liquid biopsies will facilitate an analysis of tumor genomics, which is urgently required for molecular targeted therapy. Most existing targeted approaches are based on a polymerase chain reaction and/or next-generation sequencing for liquid biopsy applications.

“We have developed a liquid biopsy technology, ‘electric field induced release and measurement (EFIRM) liquid biopsy (eLB),’ [which] provides the most accurate detection that can assist clinical treatment decisions for the most common subtype of lung cancer, non–small-cell lung cancer (NSCLC),” Dr Wong and colleagues stated.

The study authors explained that eLB can detect actionable epidermal growth factor (EGFR) gene mutations in patients with NSCLC, in 100% agreement with biopsy-based genotyping. Minimally/noninvasive, eLB detects the most common EGFR gene mutations treatable with tyrosine kinase inhibitors to effectively extend the progression-free survival of patients with NSCLC.

  1. Wong D. Saliva liquid biopsy for cancer detection. Presented at: 2016 American Association for the Advancement of Science Annual Meeting; February 11-15, 2016; Washington, DC.

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Marijuana Use Associated with Worse Verbal Memory, Has No Effect on Other Cognitive Domains

Marijuana use has increased in the United States, but its long-term effects on memory and other aspects of cognitive function are uncertain. In their study, Reto Auer, MD, MAS, Postdoctoral Scholar, Department of Epidemiology and Biostatistics, University of California San Francisco, and colleagues examined the association between lifetime exposure to marijuana use and cognitive performance.

They used data from the Coronary Artery Risk Development in Young Adults study, which included a cohort of 5115 black and white men and women aged 18 to 30 years at baseline, and followed up with them for >25 years to assess associations between cumulative years of marijuana exposure and cognitive function. At year 25, the 3 domains of cognitive function that were assessed were verbal memory, processing speed, and executive function.

“Current use of marijuana was associated with worse verbal memory and processing speed; cumulative lifetime exposure was associated with worse performance in all 3 domains of cognitive function,” Dr Auer and colleagues explained. “After excluding current users and adjusting for potential confounders, cumulative lifetime exposure to marijuana remained significantly associated with worse verbal memory.”

As a result, the study authors concluded that although previous exposure to marijuana is associated with worse verbal memory, marijuana use does not seem to affect processing speed or executive function.

  1. Auer R, Vittinghoff E, Yaffe K, et al. Association between lifetime marijuana use and cognitive function in middle age: the coronary artery risk development in young adults (CARDIA) study. JAMA Intern Med. 2016 Feb 1. Epub ahead of print.

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FDA Reveals Exhaustive Opioid Policy Changes

According to a special US Food and Drug Administration (FDA) report published in The New England Journal of Medicine, physicians have witnessed devastating results of opioid abuse and misuse in people, including addicted patients who had been prescribed opioids for pain treatment, as well as those who have not received a prescription for the drugs.

“Many Americans are now addicted to prescription opioids, and the number of deaths due to prescription opioid overdose is unacceptable,” stated Robert M. Califf, MD, Commissioner of Food and Drugs, FDA, Silver Spring, MD, and colleagues. “We are launching this renewed effort in the context of a broad national campaign that includes a major initiative led by the Department of Health and Human Services…designed to attack the problem from every angle.”

The FDA plans to begin with broadly re-examining their approach, including thinking about how to best apply existing policies, which policies need to be updated, and whether new policies must be developed. This includes consulting with the National Academy of Medicine to create a framework for opioid reviews, approvals, and monitoring. In addition, the FDA Science Board will convene in March to advise the development of alternative pain medications and postmarketing surveillance activities.

The FDA has also promised to expand requirements for drug companies to generate postmarketing data on the long-term impact of extended-release/long-acting opioid use to provide better data on the risks for misuse and abuse. The agency is working with the industry and the National Institutes of Health to develop alternative medications without opioids’ addictive properties. The Department of Health & Human Services’ agencies and FDA program for mandated industry-funded studies are also developing a plan to conduct evidence-based research that will guide opioid use and consider new approaches to pain prevention and management.

“Regardless of whether we view these issues from the perspective of patients, physicians, or regulators, the status quo is clearly not acceptable,” Dr Califf and colleagues stated. “As the public health agency responsible for oversight of pharmaceutical safety and effectiveness, we recognize that this crisis demands solutions.”

  1. Califf RM, Woodcock J, Ostroff S. A proactive response to prescription opioid abuse. N Engl J Med. 2016 Feb 4. Epub ahead of print.

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New Due Date Calculator Application Replaces Pregnancy Wheel

The American College of Obstetricians and Gynecologists (ACOG) recently launched a new Estimated Due Date (EDD) Calculator for determining pregnancy due dates. This is the first mobile application based on joint recommendations from ACOG, the American Institute of Ultrasound in Medicine, and the Society for Maternal-Fetal Medicine. The EDD Calculator is the only obstetrics/gynecology-related application that reconciles the inaccuracy in due dates that occurs between the first ultrasound and the date of the patient’s last menstrual period.

The EDD Calculator can also recalculate due dates based on an ultrasound, or assisted reproductive technology, which helps healthcare providers with patients who undergo embryo transfers in adherence to the Committee Opinion. In addition, the application has functionality that allows the user to determine the gestational age of the fetus.

“The EDD Calculator has ACOG guidelines built into the logic, therefore it is the most accurate tool available for [obstetricians/gynecologists] and their staff,” explained Nathaniel DeNicola, MD, MSHP, FACOG, ACOG Digital & Social Media Expert Consultant, and Senior Fellow, Penn Social Media & Health Innovation Lab, Penn Medicine Center for Health Care Innovation, Philadelphia, PA, in a statement released by ACOG. “This is the only app that is based on ACOG guidelines and was beta tested by [obstetrics/gynecology] experts.”

Although the EDD Calculator is geared toward obstetric providers, its simple format is easy to use for other members of the healthcare team, and even patients. According to a press release by ACOG, the organization will phase out the physical plastic wheel in favor of the EDD Calculator.

The new EDD Calculator is part of the primary ACOG application, which can be downloaded for free on Apple Inc and Android devices.

  1. ACOG reinvents the pregnancy wheel [news release]. Washington, DC; The American College of Obstetricians and Gynecologists; January 22, 2016. Accessed March 1, 2016.

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Last modified: March 25, 2016
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