Publications by authors named "A S Edelman"
Objective: We sought to develop consensus recommendations for measurement and analysis of data on contraceptive-induced menstrual changes (CIMCs) in contraceptive clinical trials. We built upon previous standardization efforts over the last 50 years and prioritized input from a variety of global experts and current regulatory authority guidance on patient-reported outcomes.
Study Design: We completed a formal consensus-building process with an interdisciplinary group of 57 experts from 30 organizations and 14 countries in five global regions who work across academia, nonprofit research organizations, the pharmaceutical industry, and funding agencies.
Déjà vu all over again: a recurrent flaw in anticoagulant study design.
J Thromb Haemost
January 2025
Article Synopsis
- The introduction of direct oral anticoagulants (DOACs) since 2010 has significantly changed blood-thinning treatments, shown to be effective and often safer than warfarin for patients of all ages.
- Postmarketing data revealed a higher incidence of heavy menstrual bleeding (HMB) with rivaroxaban, an issue that wasn't evident during clinical trials.
- Current research is exploring Factor XI inhibitors as a new anticoagulant option, but a systematic review found a lack of studies focusing on menstruating individuals and uterine bleeding, indicating a gap in clinical trial designs.
Article Synopsis
- - The Cochrane Review protocol focuses on evaluating how hormonal contraception for pregnancy prevention impacts fracture risk.
- - It aims to study individuals who are currently or were previously able to become pregnant.
- - The review will analyze existing data to provide insights on the safety of hormonal contraceptives concerning bone health.
Article Synopsis
- CFTR is an anion channel that evolved from ABC transporters and has a unique structure with a lateral portal that attracts anions from the cytoplasm to its interior.
- Using molecular dynamics simulations and biochemical assays, the study examines specific amino acids involved in CFTR regulation, particularly focusing on R1158, R1030, and W846.
- Mutating these amino acids boosts channel activity and allows opening by potentiators without needing increased cAMP levels, highlighting a new critical area in CFTR's regulatory mechanism located in its membrane-spanning domain 2.