Publications by authors named "Elaine K Kowalewski"
Article Synopsis
- The study examined the effectiveness and safety of berdazimer gel, a topical antiviral treatment, in controlling molluscum contagiosum (MC) infections in patients with and without atopic dermatitis (AD).
- It involved a combined analysis of three Phase 3 clinical trials, where patients applied berdazimer or a placebo daily for 12 weeks, measuring the complete clearance of lesions as the primary outcome.
- Results indicated higher clearance rates for berdazimer compared to the placebo in both subgroups, though some application-site adverse effects were noted, particularly in patients with concurrent AD.
Article Synopsis
- Molluscum contagiosum (MC) is a contagious skin condition with no approved medications in the US; a study looked at berdazimer gel as a treatment option.
- The trial involved 891 participants across 55 clinics, where they either received berdazimer gel or a placebo vehicle gel applied daily for 12 weeks.
- Results showed that 32.4% of those using berdazimer gel achieved complete clearance of MC lesions compared to 19.7% in the placebo group, indicating that the gel is effective.
Background/aim: DARE-19 (NCT04350593) was a randomized trial studying the effects of dapagliflozin, an SGLT2 inhibitor, in hospitalized patients with COVID-19 pneumonia and cardiometabolic risk factors. The conduct of DARE-19 offered the opportunity to define an innovative and clinically meaningful endpoint in a new disease that would best reflect the known profile of dapagliflozin, accompanied by the statistical challenges of analysis and interpretation of such a novel endpoint.
Methods: Hierarchical composite endpoints (HCEs) are based on clinical outcomes which, unlike traditional composite endpoints incorporate ranking of components according to clinical importance.
Article Synopsis
- The study examines how removing amyloid plaques in the brain can potentially treat Alzheimer's disease, highlighting the need to understand the relationship between plaque removal, ARIA rates, and treatment effectiveness.
- It uses meta-analyses and statistical models to evaluate data from clinical trials involving various amyloid therapies (like aducanumab and lecanemab), focusing on how different doses affect amyloid reduction and cognitive changes.
- Results indicate that the degree of amyloid removal differs by therapy and dosage but shows a strong correlation with ARIA-E rates and improvements in dementia-related cognitive functions over time.
The win odds is a distribution-free method of comparing locations of distributions of two independent random variables. Introduced as a method for analyzing hierarchical composite endpoints, it is well suited to be used in the analysis of ordinal scale endpoints in COVID-19 clinical trials. For a single outcome, we provide power and sample size calculation formulas for the win odds test.
View Article and Find Full Text PDF