EBM Focus: 2018 Year in Review

Medical | DynaMed Plus EBM Focus Editorial Team| January 14, 2019

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The EBM Focus series is a collection of the most meaningful research findings relevant to the point-of-care, curated by the DynaMed Plus® editorial team. Check out the team’s five most important articles from 2018.

DynaMed Plus® editors monitor a large volume of research information on a daily basis through the process of Systematic Literature Surveillance, which includes monitoring over 500 medical journals, systematic review collections, and guideline organizations. New evidence is integrated into existing content every day, and overall conclusions are modified as appropriate, representing a synthesis of the best available evidence. By using DynaMed Plus®, busy practicing clinicians can focus on applying clinical evidence to direct patient care. Each week, research articles are selected that are “most likely to inform clinical practice” and the EBM Focus highlights those studies.

Here are five of the most important studies in 2018 and links to the EBM Focus highlighting the articles.

Antihypertensive treatment for low-risk patients with mild hypertension does not appear to be beneficial

How can clinicians keep up with hypertension management when guidelines across the world vary and thresholds and stages of hypertension are constantly changing? The recent American Heart Association/American College of Cardiology (AHA/ACC) hypertension guideline lowered the threshold for labeling patients as hypertensive and initiating therapy, raising concerns. The American College of Physicians and the American Academy of Family Physicians declined to endorse these recommendations. To explore this question, a group of investigators designed a cohort study to examine the benefits and harms of treating patients with mild hypertension and low risk of CVD.

Reference: JAMA Intern Med 2018 Oct 29
Click here to read the full EBM Focus

Aspirin for primary prevention does not reduce vascular events in adults aged ≥ 70 years and may increase rates of death and major bleeding

On the heels of the ASCEND trial that suggested aspirin for primary prevention in diabetic patients may slightly reduce serious vascular events at the cost of increased rates of major bleeding, a group of researchers conducted a randomized, double-blind, placebo-controlled trial to examine the benefits of aspirin for primary prevention among older adults. In the ASPREE trial (Aspirin in Reducing Events in the Elderly), researchers randomized more than 19,000 community dwelling adults over age 70 to either 100 mg of aspirin daily or placebo. The primary endpoint was disability-free survival, defined as survival at the end of the trial free from dementia or physical disability.

Reference: ASPREE trial (N Engl J Med 2018 Sep 16)
Click here to read the full EBM Focus

Vitamin D plus calcium supplementation might not reduce the risk of hip fracture in unselected community-dwelling adults > 50 years old

To reduce the risk of fracture and falls in older adults living in institutionalized settings and community-dwelling adults at least 65 years old, the American Geriatrics Society Workgroup on Vitamin D Supplementation suggests supplementation with at least 1,000 units/day (25 mcg/day) vitamin D plus calcium commonly given at 1,000-1,200 mg/day (J Am Geriatr Soc 2014). A recent systematic review was conducted to evaluate the potential benefit of supplementation to prevent fractures in community-dwelling adults. This review included 33 randomized trials comparing supplementation with vitamin D plus calcium, vitamin D alone, or calcium alone vs. placebo or no treatment in 51,145 community-dwelling adults over 50 years old, with or without osteoporosis (trials in patients with corticosteroid-induced osteoporosis were excluded). The dose and frequency of supplementation varied across the trials, as well as the duration of treatment which ranged from three months to seven years.

Reference: JAMA 2017 Dec 26
Click here to read the full EBM Focus

Could elective inductions at 39 weeks in low-risk nulliparous women help neonates ARRIVE more quickly and more safely?

There have been concerns, based primarily on observational data, that induction of labor was associated with worse maternal and fetal outcome. In the ARRIVE multicenter randomized unblinded trial, low risk nulliparous women were randomized at the 38 week visit to either expectant management (3,044 women) or induction of labor (3,062 women) between 39 weeks and zero days to 39 weeks and four days. Induction was with oxytocin, as well as cervical ripening if modified Bishop score was less than five. Women assigned to expectant management were asked to forego delivery until 40 weeks and five days and if still pregnant, were induced by at least 42 weeks and two days. A similar number of patients in each group (4.6-6%) crossed over due to patient or provider preference. Induction of labor for low risk nulliparous women at 39 weeks appeared to reduce the risk of cesarean delivery compared to expectant management with similar neonatal outcomes.

Reference: ARRIVE trial (N Engl J Med 2018; 379:513)
Click here to read the full EBM Focus

As-needed budesonide/formoterol for mild persistent asthma may prevent serious exacerbations as well as twice-daily maintenance budesonide

Regularly administered low-dose inhaled corticosteroids are recommended as maintenance therapy for mild persistent asthma (GINA 2018, Lancet 2018). However, patient adherence to maintenance therapy is low (Curr Opin Pulm Med 2013) and using only an as-needed combined corticosteroid/beta agonist inhaler may be attractive to many patients. In the SYGMA 2 noninferiority trial, 4,215 patients with mild persistent asthma were randomized to as-needed combination budesonide 200 mcg / formoterol 6 mcg inhaler (Symbicort Turbuhaler) vs. maintenance budesonide 200 mcg inhaler (Pulmicort Turbuhaler) twice-daily for one year. The as-needed budesonide/formoterol regimen also included twice-daily placebo doses, and the maintenance budesonide regimen also included an as-needed terbutaline 0.5 mg inhaler. The criterion for noninferiority was < 1.2 for the upper limit of the 1-sided 95% CI for the rate ratio for severe exacerbations with as-needed budesonide/formoterol compared to maintenance budesonide. Exacerbations were considered severe if they required systemic corticosteroids for at least three days, an emergency department visit leading to systemic corticosteroids, or hospitalization. Overall symptom severity was assessed with the Asthma Control Questionnaire-5 score (total score range 0-6), with symptom improvement defined as at least 0.5-point decrease from baseline.

Reference: SYGMA 2 trial (N Engl J Med 2018 May 17;378(20):1877)
Click here to read the full EBM Focus

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DynaMed Plus EBM Focus Editorial Team

The DynaMed Plus EBM Focus editorial team consists of the following members:

Alan Ehrlich, MD: Executive Editor at DynaMed Plus and Associate Professor in Family Medicine at the University of Massachusetts Medical School

Monica Zangwill, MD, MPH: Associate Deputy Editor at DynaMed Plus

Katharine DeGeorge, MD, MS: Clinical Editor at DynaMed Plus and Assistant Professor in Family Medicine at University of Virginia School of Medicine

Carina Brown, MD: Fellow at University of Virginia School of Medicine

Sarah Dalrymple, MD: Fellow at University of Virginia School of Medicine

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