In this section, we will highlight the key high-impact studies, updates, and analyses published in medicine during the past week.
Factor Xa inhibitors have been shown to be noninferior to warfarin for prevention of venous thromboembolism, and dabigatran has been compared for anticoagulation in patients with non-valvular atrial fibrillation. In this large randomized, double-blind, double-dummy trial 21,105 patients with non-valvular atrial fibrillation were randomized to receive warfarin, low-dose edoxaban, or high-dose edoxaban. The primary outcomes were time to stroke or systemic embolism and drug safety (major bleeding). Both edoxaban groups were noninferior to warfarin, and high-dose edoxaban was more effective in preventing embolic events than warfarin. The rate of stroke or systemic embolism was 1.50% per year in the warfarin group, 1.18% in the high-dose edoxaban group (p<0.0001 for noninferiority, p=0.02 for superiority), and 1.61% in the low-dose edoxaban group (p=0.005 for noninferiority, p=0.44 for superiority). Participants on edoxaban also had significantly less bleeding (high dose 2.75%, low dose 1.61%) than those on warfarin (3.43%, HR 0.80 and 0.47 for high- and low-dose edoxaban, respectively, p<0.0001).
Induced hypothermia reduces brain injury in conditions with global cerebral hypoxia. No randomized trials have been done assessing the safety and efficacy of induced hypothermia in bacterial meningitis, though experimental studies are promising. Investigators at multiple centers in France randomized 98 comatose adults with bacterial meningitis to receive cooling to 32-34°C for 48 hours or standard care to study the impact on the patient’s Glasgow Outcome Scale score after 3 months. The study was stopped early due to higher mortality at 3 months in the intervention group than the control group (51% vs 31%, RR 1.99, 95% CI 1.05-3.77, p=0.04). Post-hoc analysis showed it would be highly unlikely to find that moderate hypothermia would improve outcomes in patients with bacterial meningitis (probability = 0.023, probability to conclude in favor of futility = 0.977). There was no significant difference in mortality or unfavorable outcome (Glasgow Outcome Score <5) between intravenous or other forms of cooling (p=0.36 and p=0.46 respectively).
Pediatric Crohn’s disease is often more severe and refractory than adult-onset Crohn’s disease, and insufficient disease control can result in delayed development and a need for surgery. In this randomized, double-blind trial, 56 children with refractive Crohn’s disease were randomized to receive low-dose thalidomide or placebo to study the effect on clinical remission, defined as a Pediatric Crohn Disease Activity Index score less than 10, at 8 weeks. A greater proportion of children in the thalidomide group (46%) reached clinical remission compared to the placebo group (11%, RR 4.0, p=0.01) at 8 weeks, though the effect was not significantly different at 4 weeks. Mean remission time was 181.1 weeks in those who achieved remission. This study included children who had previously failed treatment with infliximab and suggests that thalidomide may be used effectively in refractory Crohn’s disease.
Bariatric surgery is an increasingly common treatment for obesity, and has positive effects on diabetes and cardiovascular outcomes, but long-term cancer risk is not well-studied, and investigators have observed an unexpected increase in colorectal cancer incidence after such surgery. In this retrospective cohort study, the records of 15,095 Swedish patients who had undergone obesity surgery and 62,016 obese patients who had not had surgery were reviewed for occurrence of colon cancer. The standardized incidence ratio (SIR) in the surgery cohort was 1.60 (95%CI 1.25-2.02), compared to 1.26 in the no surgery cohort. In addition, the risk of colorectal cancer increased with longer follow up in the surgery group (SIR=2.0 at 10 years follow up, p=0.05 for trend), but not in the cohort without obesity surgery (SIR=1.27 at 10 years, p=0.66 for trend). It is unclear why bariatric surgery would increase the risk of colorectal cancer.
Delayed surgical treatment is related to decreased survival in many types of cancer, though it has not been studied specifically for uterine cancer, and delayed access to surgery is a problem in many places. Researchers in Ontario conducted a retrospective analysis of 9,417 women diagnosed with uterine cancer from 2000 to 2009 to study the association between wait time between diagnosis and surgery and survival time between surgery and death. Decreased survival was associated with surgery <2 weeks after diagnosis and those who waited longer than 12 weeks for surgery. Compared to women who waited longer than 12 weeks for surgery, those who waited 2-6 or 6-12 weeks had significantly decreased mortality (HR 0.0.79, 95%CI 0.7-0.91 and HR 0.80, 95%CI 0.71-0.91 respectively, p<0.001). Worse survival associated with wait times <2 weeks may be due to the acuity of the patient’s condition necessitating surgery.
By Kathleen Li and David Ouyang
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