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Clinical Trial News

Aficamten Shows Long-Term Safety and Cardiac Benefits in HCM Patients

  • Integrated safety analysis of aficamten across three clinical trials reinforces its robust safety profile, with adverse events similar to placebo.
  • FOREST-HCM analysis demonstrates successful withdrawal of standard of care medications in obstructive HCM patients treated with aficamten.
  • SEQUOIA-HCM data shows aficamten improves cardiac remodeling, structure, function, and biomarkers, suggesting potential disease modification.
  • Aficamten significantly improves symptom burden and quality of life in patients with obstructive HCM, as measured by KCCQ-OSS and SAQ-SS.

Ozempic Shows Promise in Reducing Heart Failure Risk in Diabetes Patients with Chronic Kidney Disease

  • Semaglutide, the active ingredient in Ozempic, demonstrates a 27% reduction in heart failure events among diabetes patients with chronic kidney disease.
  • The study also found a 29% decrease in the risk of cardiovascular death in the same patient population treated with semaglutide.
  • These findings from the FLOW trial highlight the potential of Ozempic to address heart disease, a leading cause of death, in vulnerable patients.
  • Further research is needed to understand the mechanisms behind semaglutide's cardioprotective effects in this specific patient group.

RHEIA Trial: TAVI Superior to Surgery for Aortic Stenosis in Women

  • The RHEIA trial demonstrated that transcatheter aortic valve implantation (TAVI) is superior to surgical aortic valve replacement in women with severe aortic stenosis.
  • TAVI significantly reduced the composite endpoint of all-cause mortality, stroke, and rehospitalization compared to surgery at one year.
  • The primary driver for TAVI's superiority was a notable reduction in rehospitalizations for valve-related symptoms or worsening heart failure.
  • TAVI was associated with shorter hospital stays and lower rates of new-onset atrial fibrillation, suggesting it could be the preferred therapy for women with severe aortic stenosis.

Mindfulness Training Shows Promise in Managing Chronic Pain: LAMP Trial Results

  • The LAMP pragmatic clinical trial evaluated the effectiveness of mindfulness training for chronic pain management.
  • The study compared two different approaches to mindfulness training in a multisite trial.
  • Results from the LAMP trial, presented by Dr. Diana Burgess, offer insights into non-pharmacological pain management strategies.
  • The findings contribute to the growing body of evidence supporting mindfulness-based interventions for chronic pain.

RAS Inhibitors: No Clear Advantage to Stopping or Continuing Before Noncardiac Surgery

  • The Stop-or-Not trial found no significant difference in death or major complications at 28 days between continuing or discontinuing RAS inhibitors before noncardiac surgery.
  • Intra-operative hypotension was more frequent with continued RAS inhibitors, but did not translate to increased serious complications.
  • Experts suggest individualizing care based on patient factors, hemodynamics, and the specifics of the surgery, offering clinicians greater flexibility.
  • Current guidelines weakly suggest either strategy is reasonable, highlighting the need for more research, especially in heart failure patients.

Aggressive Supportive Care May Reduce Infection Risk Following Linvoseltamab Treatment in Multiple Myeloma

  • Aggressive supportive care is crucial following linvoseltamab and BCMA bispecific antibody treatments to prevent high-grade infections, especially in community settings.
  • Intravenous immunoglobulin and infection prophylaxis are essential components of supportive care to mitigate the risk of severe infections post-immunotherapy.
  • Reducing the dosing frequency of bispecific antibodies, as seen with teclistamab, may also decrease the risk of infections over time.
  • Phase 1/2 LINKER-MM1 trial data highlights the efficacy of linvoseltamab but also underscores the importance of managing treatment-related infection incidence.

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04557098Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/17/2020

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

NCT03761108RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 1/23/2019

Mirdametinib's NDA for NF1-PN Granted Priority Review by FDA

• The FDA has granted priority review to SpringWorks Therapeutics' NDA for mirdametinib in treating Neurofibromatosis Type 1-associated plexiform neurofibromas (NF1-PN). • The PDUFA target action date is set for February 28, 2025, with the FDA indicating no current plans for an advisory committee meeting. • Mirdametinib's MAA for NF1-PN has also been validated by the European Medicines Agency, potentially offering a new treatment option in Europe. • The NDA and MAA submissions include data from the Phase 2b ReNeu trial, demonstrating significant objective response rates and improved quality of life.

MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

NCT03962543Active, Not RecruitingPhase 2
SpringWorks Therapeutics, Inc.
Posted 9/29/2019

Novel Drug Development Advances in Metastatic Colorectal Cancer: Focus on KRAS Targeting and Immunotherapy

  • Recent therapeutic advances including trifluridine/tipiracil plus bevacizumab and fruquintinib have expanded treatment options for refractory metastatic colorectal cancer patients.
  • Significant progress is being made in targeting previously "undruggable" mutations, with promising developments in KRAS G12C inhibition and emerging pan-KRAS inhibitors.
  • While immunotherapy use remains limited to microsatellite instability-high patients, new approaches combining checkpoint inhibitors with VEGF TKIs show potential for broader application.

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

NCT04737187CompletedPhase 3
Taiho Oncology, Inc.
Posted 11/25/2020

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer

NCT04322539CompletedPhase 3
Hutchison Medipharma Limited
Posted 8/12/2020

Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer

A Phase III clinical trial is set to evaluate the efficacy and safety of Socazolimab combined with chemotherapy, with or without bevacizumab, as a first-line treatment for persistent, recurrent, or metastatic cervical cancer. The study aims to determine if this combination offers better patient outcomes compared to placebo combined with chemotherapy with or without bevacizumab.

Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer

NCT06459687RecruitingPhase 3
Lee's Pharmaceutical Limited
Posted 11/28/2024

Prucalopride Shows Favorable Safety Profile in Chronic Idiopathic Constipation Treatment

  • Prucalopride, a selective 5-HT4 receptor agonist, demonstrates a manageable safety profile in treating chronic idiopathic constipation (CIC) based on clinical trial data.
  • Common adverse reactions reported in prucalopride-treated patients include headache, abdominal pain, nausea, and diarrhea, with most cases resolving within a few days.
  • Cardiovascular safety analysis from clinical trials and an observational cohort study did not indicate an increased risk of major adverse cardiovascular events (MACE) with prucalopride use.
  • Discontinuation rates due to adverse reactions were slightly higher in the prucalopride group compared to placebo, with nausea being the most common reason.

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