2018 Year in review

EBM Focus - Volume 13, Issue 43

In 2018, the DynaMed Editors considered 23,223 articles and 9,131 articles were included in DynaMed Plus. Each week, DynaMed EBM Focus writers and editors selected articles that were considered “most likely to inform clinical practice.

As a “Year in Review,” the EBM Focus presents the 5 most important articles from 2018. We welcome your comments on how your clinical practice was affected by the information presented. Comments can be sent to dynamededitor@ebsco.com.

We would like to thank our readers for their support and input throughout the year. Your feedback helps improve the DynaMed EBM Focus for the global DynaMed Community.

With our very best wishes for a joyous and peaceful New Year,
The DynaMed EBM Focus Newsletter Editors

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

Reference: JAMA Intern Med 2018 Oct 29 (level 2 [mid-level] evidence)

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. Of particular concern is the recommendation by the AHA/ACC to treat to a blood pressure of < 130/80 in all comers once the decision to initiate pharmacotherapy is made, considering they only evaluated outcomes in patients at moderate to high risk of cardiovascular disease (CVD). Low outcome event rates in a low-risk population would necessitate such a large number of participants in order to adequately power a prospective trial that, to date, no trial data evaluating the benefit of antihypertensive treatment in a low-risk population exist. 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.

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

Reference: N Engl J Med 2018 Sep 16 early online (level 1 [likely reliable] evidence)

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 over 19,000 community dwelling adults over age 70 living in Australia or the United States to either 100 mg of aspirin daily or placebo. After three years of data collection, the researchers added Black and Hispanic patients aged ≥ 65 in the US as inclusion criteria given the higher predicted event rates in this patient population. Patients with diabetes, dyslipidemia, and hypertension were included in the trial. Those with an indication for aspirin, anemia, limited life expectancy, dementia, or significant disability were excluded. The aspirin and placebo groups had similar baseline characteristics, with a median age 74 years at enrollment. Nearly ¾ of participants had hypertension and 65% of participants were diagnosed with dyslipidemia. The primary endpoint was disability free survival, defined as survival at the end of the trial free from dementia or physical disability.

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

Reference: JAMA 2017 Dec 26;318(24):2466 (level 2 [mid-level] evidence)

In order to reduce the risk of fracture and falls in older adults living in institutionalized settings and community-dwelling adults ≥ 65 years old, the American Geriatrics Society Workgroup on Vitamin D Supplementation suggests supplementation with ≥ 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 > 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 duration of treatment which ranged from 3 months to 7 years.

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

Reference: ARRIVE trial (N Engl J Med 2018; 379:513) (level 2 [mid-level] evidence)

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 0 days to 39 weeks and 4 days. Induction was with oxytocin as well as cervical ripening if modified Bishop score was < 5. Women assigned to expectant management were asked to forego delivery until 40 weeks and 5 days and if still pregnant, were induced by at least 42 weeks and 2 days. Baseline characteristics of both groups were similar with the exception that a significantly higher proportion of women in the expectant management group had a history of previous pregnancy loss. A similar number of patients in each group (4.6-6 %) crossed over due to patient or provider preference. Participants, including those women in the expectant management group who underwent induction of labor after 40 weeks and 5 days, were analyzed using intention-to-treat.

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

Reference: SYGMA 2 trial (N Engl J Med 2018 May 17;378(20):1877) (level 2 [mid-level] evidence)

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 1 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 ≥ 3 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 a ≥ 0.5 point decrease from baseline. Ninety-one percent of patients completed treatment, and 99% were included in the analyses.

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DynaMed Plus EBM Focus Editorial Team
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