A pilot study of vidofludimus calcium for treatment of primary sclerosing cholangitis.

The purpose of this pilot study was to explore the efficacy, safety, and tolerability of vidofludimus calcium (VC) in the treatment of primary sclerosing cholangitis (PSC). This was a single-arm open-label pilot study with a cohort of 18 patients with PSC. Study patients received VC for a period of 6 months. The study was undertaken at two sites, Mayo Clinic, Rochester, MN, and Mayo Clinic, Phoenix, AZ. The primary endpoint of the study was improvement of serum alkaline phosphatase (ALP) at the end of the study. Secondary endpoints included assessment of other liver biomarkers (bilirubin, alanine aminotransferase, and aspartate aminotransferase). Of 18 patients enrolled, 11 completed the 6 months of study treatment. Patients who completed treatment versus those who did not were similar other than a significantly higher direct bilirubin at baseline in the group that completed treatment (mean ± SD, 0.4 ± 0.3 versus 0.1 ± 0.1, p = 0.04). By intent to treat analysis, the primary outcome was met in 16.7% (3/18) of patients. By per-protocol analysis, including only patients who completed treatment, normalization of ALP occurred in 27.7% (3/11) at week 24 (95% confidence interval, 6.0% to 61.0%). VC was well tolerated with no drug-related serious adverse events. Conclusion: This proof of concept study provides support for further exploration of VC in patients with PSC.

A Successful Quality Improvement Project for Detection and Management of Acute Stroke in Hospitalized Patients.

BACKGROUND: The incidence rate of stroke in hospitalized patients ranges between 2% and 17% of all strokes-a higher rate than in the community. Delays in recognition and management of stroke in hospitalized patients lead to worse outcomes. At our hospital, the existing in-hospital stroke (IHS) code showed low usage and effectiveness. In a quality improvement (QI) project, we aimed to improve the identification of and the quality of care for inpatient strokes. METHODS: A nurse-driven IHS protocol was implemented, which alerted a specialized stroke team and cleared the computed tomography (CT) scanner. The protocol focused on prioritizing staff education, simplifying the process, empowering staff to activate an IHS code, ensuring adequate support and teamwork, identifying well-defined quality metrics (eg, time to CT and documentation tool use), and providing feedback communication. We analyzed 2 years of postimplementation IHS data for impact on stroke detection and outcomes. RESULTS: In the 2 years post QI, there was a more than 10-fold increase in IHS (pre-QI, n = 8; first year post QI, n = 94; second year post QI, n = 123). In the post-QI cohort, after excluding patients with missing information (n = 26), 69 cases had new stroke diagnoses (63 ischemic, 6 hemorrhagic), and 148 were stroke mimics. The mean (SD) time from IHS to CT was 18.7 (7.0) minutes. Of the 63 new ischemic stroke cases, 25 (39.7%) were treated with thrombolytic therapy and/or mechanical thrombectomy. CONCLUSION: The new IHS protocol has led to a marked increase in cases identified, rapid evaluation, and high utilization rate of acute stroke therapies.