Inpatient Insights
APhA Staff
Apixaban effective for extended treatment of provoked VTE
The appropriate duration of anticoagulation for venous thromboembolism (VTE) in the population of patients with provoked VTE and concomitant enduring risk factors (e.g., autoimmune disorders, chronic lung disease, or obesity) is unclear. Researchers at Brigham and Women’s Hospital–Harvard Medical School conducted the HI-PRO trial to assess the efficacy and safety of oral apixaban, as compared with placebo, for the prevention of recurrence in patients with provoked VTE and at least one enduring risk factor.
In the single-center, double-blind, randomized trial, published on August 30, 2025, in NEJM, 600 adults with VTE after the occurrence of a transient provoking factor who had at least one enduring risk factor and had completed at least 3 months of anticoagulation were assigned to receive oral apixaban (at a dose of 2.5 mg twice daily) or placebo for 12 months. The primary outcome was the first symptomatic recurrent VTE.
Symptomatic recurrent VTE occurred in 4 patients (1.3%) in the apixaban group and in 30 patients (10.0%) in the placebo group, while major bleeding occurred in one patient in the apixaban group and none in the placebo group. Clinically relevant nonmajor bleeding was observed in 14 of 294 patients (4.8%) in the apixaban group and in 5 of 294 patients (1.7%) in the placebo group. One patient in the apixaban group and three patients in the placebo group died, with no deaths attributed to cardiovascular or hemorrhagic causes. Nonhemorrhagic adverse events occurred in six patients (2.0%) in each group.
The authors concluded that among patients with provoked VTE and enduring risk factors, low-intensity therapy with apixaban for 12 months resulted in a lower risk of symptomatic recurrent VTE than placebo, with a low risk of major bleeding. ■
Groups release best practices for critical care pharmacists
Achieving optimal outcomes for critically ill patients requires an interprofessional team approach, with critical care pharmacists as essential members of the team. An interprofessional expert panel representing the American Association of Critical-Care Nurses, American College of Clinical Pharmacy, American Society of Health-System Pharmacists, Institute for Safe Medication Practices, Society of Critical Care Medicine, The Joint Commission, and U.S. Public Health Service developed consensus recommendations to present standards and guidance for individual pharmacists, institutions, and standard-setting bodies regarding best practices for the team integration of critical care pharmacists.
A total of 10 consensus recommendation statements were published in the Journal of the American College of Clinical Pharmacy on August 4, 2025, along with implementation guidance, process and outcome metrics, and a future agenda for research and advocacy. The recommendations addressed professional engagement, standards, patient care (both direct and indirect), finances, and needed research.
The group concluded that team-based care of critically ill patients, which has been embraced by health care professionals who work in the ICU setting, requires intentionality regarding the presence, collaborative work environment, and workload of its individual members. ■
Is dalbavancin superior for treatment of complicated Staphylococcus aureus bacteremia?
Staphylococcus aureusStaphylococcus aureus is the leading bacterial cause of bloodstream infection worldwide, but the number of randomized clinical trials informing management of S. aureus bacteremia is limited. Treatment generally requires prolonged administration of I.V. antibiotics, which can be associated with complications. Dalbavancin, a long-acting I.V. lipoglycopeptide may be effective for treatment of complicated S. aureus bacteremia without requiring long-term I.V. treatment. Members of the Antibacterial Resistance Leadership Group evaluated the efficacy and safety of dalbavancin versus standard therapy for completion of treatment of complicated S. aureus bacteremia. The study was published online in JAMA on August 13, 2025.
The open-label randomized clinical trial was conducted from April 2021 to December 2023 at 23 medical centers in the United States and Canada. Participants were randomly assigned to receive either two doses of I.V. dalbavancin (1,500 mg on days 1 and 8) or 4 to 8 total weeks of standard I.V. therapy (cefazolin or penicillin if methicillin susceptible; vancomycin or daptomycin if methicillin resistant). The primary outcome was the desirability of outcome ranking at day 70, which involved five components (clinical success, infectious complications, safety complications, mortality, and health-related quality of life). Secondary outcomes included clinical efficacy at day 70 (prespecified noninferiority margin of 20%) and safety.
Results of the study showed that among participants with complicated S. aureus bacteremia who achieved blood culture clearance, the probability of a more desirable outcome at day 70 with dalbavancin versus standard therapy was 47.7%, which did not achieve the prespecified criterion for superiority. The authors concluded that when considered with other efficacy and safety outcomes, these findings may help inform use of dalbavancin in clinical practice. ■
Are shorter durations of antibiotic prophylaxis effective for preventing upper GI bleeding in patients with cirrhosis?
Multiple guidelines recommend administering antibiotic prophylaxis to patients with cirrhosis who present with acute upper GI bleeding. Fluoroquinolones were initially used, but because of increased resistance, most guidelines now recommend a 5 to 7 day regimen of a third-generation cephalosporin. Researchers from McGill University conducted a systematic review and meta-analysis to determine whether current evidence continues to support this recommendation.
The study, which was published online in JAMA Internal Medicine on August 11, 2025, included randomized clinical trials from the Embase, MEDLINE, and CENTRAL databases that included the keywords “GI bleeding” and “prophylactic antibiotics.” The primary outcome was all-cause mortality with a prespecified 5% noninferiority margin on the risk difference scale. Early rebleed and bacterial infections were secondary outcomes. Study quality was low to moderate, bacterial infections were heterogeneously defined, and no studies reported adverse events.
Results of the analysis showed that shorter durations (including no antibiotics) had a 97.3% probability of noninferiority for all-cause mortality and a 73.8% probability of noninferiority for early rebleeding but were associated with more study-defined bacterial infections. The authors suggested that higher quality randomized clinical trial data are needed and that guideline recommendations for routine antibiotic prophylaxis in patients with cirrhosis and upper GI bleeding should be reassessed. ■