A Phase II randomized controlled trial evaluated antithrombotic treatment with fesomersen in patients with kidney failure on hemodialysis.

Patients with kidney failure on hemodialysis (KF-HD) are at high risk for both atherothrombotic events and bleeding. This Phase IIb study evaluated the dose-response of fesomersen, an inhibitor of hepatic Factor XI expression, versus placebo, for bleeding and atherothrombosis in patients with KF-HD. Patients were randomized to receive fesomersen 40, 80, or 120 mg once-monthly, or matching placebo, for up to 12 months. The primary safety endpoint was a composite of major bleeding and clinically relevant non-major bleeding (MB/CRNMB). Exploratory endpoints included post-dialysis arterio-venous (AV)-access bleeding, major atherothrombotic events (composite of fatal or non-fatal myocardial infarction, ischemic stroke, acute limb ischemia/major amputation, systemic embolism, symptomatic venous thromboembolism), AV-access thrombosis, and clotting of the hemodialysis circuit. Of 308 participants randomized, 307 received study treatment and were analyzed. Fesomersen led to a dose-dependent and sustained reduction of steady-state median FXI levels by 53.6% (40 mg group), 71.3% (80 mg group), 86.0% (120 mg group), versus 1.9% in the placebo group. MB/CRNMB events occurred in 6.5% (40 mg group), 5.1% (80 mg group), 3.9% (120 mg group), and in 4.0% of those receiving placebo (pooled fesomersen versus placebo P = 0.78). Major atherothrombotic events occurred in 1 patient (1.3%) in each treatment arm. MB/CRNMB bleeding and post-dialysis AV-access bleeding were not related to predicted FXI levels. Lower predicted FXI levels were associated with reductions in hemodialysis circuit clotting (P = 0.002) and AV-access thrombosis (P = 0.014). In patients with KF-HD, fesomersen produced a dose-dependent reduction in FXI levels associated with similar rates of major bleeding compared with placebo. REGISTRATION: URL: https://www.clinicaltrials.gov; unique identifier: NCT04534114.

A Further Decrease in the Rates of Administration of Electroconvulsive Therapy in England.

OBJECTIVES: Electroconvulsive therapy (ECT) is an effective treatment of major depression, and there have been consistent improvements in the administration of ECT in the past decade. However, studies have reported a steady decline in the rates of use of ECT in the United Kingdom and Ireland. Despite this, there has been no consistent record of how much ECT is being given or to whom it is given, for more than 20 years. The purpose of this study is to estimate the change in frequency of ECT use, the length of courses, patient demographics, and clinical outcomes between 2006 and 2 periods of 2012/2013 and 2014/2015. METHODS: In 2012/2013, clinics were asked to complete an online survey giving details of every patient who started a course of ECT between April 1, 2012, and March 31, 2013. This was repeated for the same period in 2014/2015. RESULTS: There continues to be a striking decline in the number of courses of ECT prescribed. Course length has increased. Women are twice as likely to be prescribed ECT as men. Modal age is 60 to 80 years, and the most common diagnosis is depression. Most courses were rated as clinically effective, especially for people with severe illnesses. Maintenance ECT is used at half the clinics surveyed. CONCLUSIONS: The use of ECT in England continues to decline. The reasons for this are unclear and need investigation.

Patients' and carers' experiences of UK memory services.

OBJECTIVE: The objective of this study is to test the validity of an accreditation programme for memory services in the UK by investigating whether different levels of accreditation status (excellent compared with accredited) are reflected in patients' and carers' reported satisfaction. METHOD: A comparison of survey data from patient and carer feedback questionnaires collected from services as part of the accreditation process. RESULTS: Five hundred and eighty-three patient questionnaires and 663 carer questionnaires were returned from 41 services. Patients and carers who attended memory services which were later 'accredited as excellent', were more likely than those who had visited 'accredited' services to have: been given written information about a variety of topics; been asked for feedback about using the memory service; and had found it easier to get to their appointments. Carers attending services accredited as excellent were more likely to have been offered an assessment of their needs. CONCLUSION: Patients and carers had very good experiences of memory services overall whether they had standard or excellent accreditation. However, 'excellent' services were consistently better on a number of factors. This provides further support that the accreditation process is an important indicator of the quality of memory services.