DynaMed EBM Focus: 2016 Year in Review Part I

EBM Focus - Volume 11, Issue 51

Read the full EBM Focus and earn CME credit.

In 2016, the DynaMed Editors considered 39,345 articles and 9,013 articles were included in DynaMed Plus. Each week, from an average of 180 articles added to DynaMed Plus, editors selected articles that were considered “most likely to inform clinical practice.”

As a “Year in Review,” the EBM Focus presents the 10 most important articles from 2016. The top 5 are shown in this issue and the next 5 will be presented in the next issue. We welcome your comments on how your clinical practice was affected by the information presented. Comments can be sent to dynameder@ebsco.com.

We would like to thank our readers for their support and input throughout the year. Your feedback helps improve the DynaMed Plus EBM Focus for the global DynaMed Community.
With our very best wishes for a joyous and peaceful New Year,

The DynaMed Editors

Active monitoring has similar 10-year mortality outcomes as prostatectomy and radiotherapy in men aged 50-69 years with newly diagnosed localized prostate cancer

Reference - Prostate Testing for Cancer and Treatment (ProtecT) trial (N Engl J Med 2016 Oct 13;375(15):1415) (level 1 [likely reliable] evidence)

Prostate cancer has a lifetime risk in the United States of about 15% (CA Cancer J Clin 2014 Jan-Feb;64(1):9), but localized prostate cancer identified by PSA screening generally has a slow progression. It is unclear how to best weigh the possible beneficial effects of prostatectomy or radiotherapy against their complications. The recent National Comprehensive Cancer Network (NCCN) guidelines recommend active surveillance for many men with low-risk prostate cancer, but this recommendation is based on lower-level evidence, albeit with uniform consensus (NCCN website). The recent ProtecT trial, conducted in the United Kingdom, randomized 1,643 men (98% white, aged 50-69 years) with localized prostate cancer diagnosed after PSA screening to active monitoring versus radical prostatectomy versus radiotherapy (with neoadjuvant androgen deprivation therapy), and followed them for a median of 10 years with regular PSA monitoring. The diagnosed cancers were mostly low-risk: 76% had stage T1c, 77% had a Gleason score = 6, and 90% had PSA levels

< 10 ng/mL. Patients in the active monitoring group with a 50% or greater increase in the PSA level over one year during follow-up were managed at physician’s discretion (54% eventually had treatment).

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Blood Pressure Targets

< 130 mm Hg Might Not Benefit Patients with Diabetes Reference - BMJ 2016 Feb 24;352:i717 (level 2 [mid-level] evidence)

Much attention has been generated surrounding optimal blood pressure targets in patients with hypertension. Recent trials have suggested that systolic blood pressure targets as low < 120 mm Hg may decrease mortality and cardiovascular events compared to the currently recommended target of < 140 mm Hg (N Engl J Med 2015 Nov 26;373(22):2103, Lancet 2009 Aug 15;374(9689):525). However, patients with diabetes were excluded from these trials. There is some evidence suggesting lower blood pressure targets may improve the risk of stroke and nephropathy in patients with hypertension and diabetes (Circulation 2011 Jun 21;123(24):2799, N Engl J Med 2010 Apr 29;362(17):1575), and the Canadian Hypertension Education Program recommends systolic blood pressure targets < 130 mm Hg for patients with diabetes (Hypertension Canada 2015). To try to determine the optimum blood pressure target in patients with diabetes, a recent systematic review analyzed 49 randomized trials assessing antihypertensive treatments in 73,738 patients with diabetes (mostly type 2 diabetes).

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Long-term oxygen therapy may not reduce mortality in patients with stable COPD and non-severe resting hypoxemia or exercise-induced hypoxemia
Reference – N Engl J Med 2016 Oct 27;375(17):1617 (level 2 [mid-level] evidence)

For patients with COPD and severe resting hypoxemia, LTOT increases survival (Ann Intern Med 1980 Sep;93(3):391, Lancet 1981 Mar 28;1(8222):681) and is recommended by professional organizations (Global Initiative for Chronic Obstructive Lung Disease 2016, Ann Intern Med. 2011 Aug 2;155(3):179-91). However, for patients with non-severe hypoxemia, LTOT has not been shown to increase survival (Eur Respir J 1999 Nov;14(5):1002, Thorax 1997 Aug;52(8):674, Am Rev Respir Dis 1992 May;145(5):1070), though all of these trials were small. Based on this evidence, recommendations regarding LTOT for patients with non-severe hypoxemia have not been made. The recent Long-Term Oxygen Treatment Trial randomized 738 adults ≥ 40 years old with stable COPD and resting oxygen SpO2 89%-93% or exercise-induced SpO2 80%-89% to LTOT vs. no oxygen therapy for 1-6 years. Patients were excluded for recent COPD exacerbations requiring antibiotics or systemic corticosteroids, recent thoracic surgery or other possible causes of pulmonary instability, serious comorbidities that may lead to death during the trial, other conditions that may affect oxygenation, and < 10 pack-years of cigarette smoking history. Patients in the LTOT group received either 24-hour therapy or oxygen during sleep and exercise, depending on their specific condition. Patients in the no oxygen therapy group received supplemental oxygen if they developed severe hypoxemia; these patients were reevaluated after 30 days.

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Intensive Blood Pressure Therapy May Reduce Adverse Cardiovascular Outcomes and Mortality in Patients ≥ 75 years old with Hypertension
Reference - JAMA 2016 Jun 28;315(24):2673 (level 2 [mid-level] evidence)

Approximately 75% of Americans ≥ 75 years old have hypertension (Circulation 2015 Jan 27;131(4):e29), but guidelines for optimal blood pressure control in this population vary. Some guidelines recommend antihypertensive treatment for elderly patients with SBP ≥ 160 mm Hg, while others suggest the threshold for initiation of treatment be a SBP of 150 mm Hg or even 140 mm Hg (Eur Heart J 2013 Jul;34(28):2159, JAMA 2014 Feb 5;311(5):507, Can J Cardiol 2015 May;31(5):549, NICE 2011 Aug:CG127). SBP targets during antihypertensive therapy also vary, but most recommend treatment targets of 140 mm Hg to 150 mm Hg. The SPRINT trial recently found SBP targets < 120 mm Hg decreased cardiovascular adverse events and all-cause mortality in patients ≥ 50 with hypertension, increased cardiovascular risk, and without diabetes (N Engl J Med 2015 Nov 26;373(22):2103, EBM focus Volume 10, Issue 45) and while consistent results were reported for the subgroup of patients ≥ 75 years old, the details of those results were not reported. These details have now been reported in a prespecified subgroup analysis of the 2,636 community-dwelling patients ≥ 75 years old in the SPRINT trial randomized to antihypertensive treatment with an SBP target < 120 mm Hg (intensive therapy) vs. an SBP target < 140 mm Hg (standard therapy).

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Azithromycin may not improve symptoms or lung function in adults with acute asthma exacerbation requiring systemic corticosteroids
Reference - AZALEA trial (JAMA Intern Med 2016 Nov 1;176(11):1630) (level 2 [mid-level] evidence)

Asthma exacerbations in adults are usually caused by viral respiratory infections, but bacterial infections, allergens, pollutants, and other causes may also trigger them. Despite the relatively low likelihood of a bacterial etiology, and guideline recommendations against routine antibiotic therapy (British Guideline on Acute Asthma 2016, National Heart, Lung, and Blood Institute Guidelines for the Diagnosis and Management of Asthma 2007), antibiotics are often prescribed for asthma exacerbations, including 22% of emergency room visits in the United States (Acad Emerg Med 2008 Aug;15(8):736). Evidence directly assessing antibiotic efficacy for asthma exacerbations is limited (Cochrane Database Syst Rev 2001;(3):CD002741), and in the highest quality trial to date that does show a benefit, treatment with telithromycin 800 mg/day for 10 days reduced symptom severity by only a mean of 0.3 points on a 6 point scale (N Engl J Med 2006 Apr 13;354(15):1589). To better investigate the possible efficacy of antibiotic use for asthma exacerbation, the AZALEA trial (JAMA Intern Med 2016 Sep 19 early online) randomized 199 adults presenting to the emergency department in the United Kingdom for acute asthma exacerbation to azithromycin 500 mg vs. placebo once daily for 3 days and followed them until day 10. Only patients requiring systemic corticosteroids for the exacerbation were included in this trial, and patients were excluded if they had any systemic antibiotic therapy during the previous 28 days or had other serious cardiopulmonary conditions.

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