The study aims to evaluate the effectiveness and safety of oral fixed-dose combination of bisoprolol/perindopril in patients with permanent atrial fibrillation

Start Date01 Aug 2020

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Aversi Clinic

100 Clinical Results associated with Aversi Clinic

0 Patents (Medical) associated with Aversi Clinic

Literatures (Medical) associated with Aversi Clinic

14 Jun 2024·Clinical Infectious Diseases

A Randomized, Double-Blind, Phase 3 Safety and Efficacy Study of Ridinilazole Versus Vancomycin for Treatment of Clostridioides difficile Infection: Clinical Outcomes With Microbiome and Metabolome Correlates of Response

Article

Author: Clow, Fong ; Dubberke, Erik R ; Wilcox, Mark ; Ramesh, Mayur S ; James, Danelle ; Louie, Thomas ; Duperchy, Esther ; Van Steenkiste, Christophe ; Montoya, Jose G ; Torre-Cisneros, Julian ; Styles, Lori ; Kiknadze, Nino ; Chang, Betty Y ; Stychneuskaya, Alena ; de Oliveira, Claudia Murta ; Li, Jianling ; Garcia-Diaz, Julia ; Sukbuntherng, Juthamas ; Okhuysen, Pablo C ; Garey, Kevin W

AbstractBackgroundExposure to antibiotics predisposes to dysbiosis and Clostridioides difficile infection (CDI) that can be severe, recurrent (rCDI), and life-threatening. Nonselective drugs that treat CDI and perpetuate dysbiosis are associated with rCDI, in part due to loss of microbiome-derived secondary bile acid (SBA) production. Ridinilazole is a highly selective drug designed to treat CDI and prevent rCDI.MethodsIn this phase 3 superiority trial, adults with CDI, confirmed with a stool toxin test, were randomized to receive 10 days of ridinilazole (200 mg twice daily) or vancomycin (125 mg 4 times daily). The primary endpoint was sustained clinical response (SCR), defined as clinical response and no rCDI through 30 days after end of treatment. Secondary endpoints included rCDI and change in relative abundance of SBAs.ResultsRidinilazole and vancomycin achieved an SCR rate of 73% versus 70.7%, respectively, a treatment difference of 2.2% (95% CI: −4.2%, 8.6%). Ridinilazole resulted in a 53% reduction in recurrence compared with vancomycin (8.1% vs 17.3%; 95% CI: −14.1%, −4.5%; P = .0002). Subgroup analyses revealed consistent ridinilazole benefit for reduction in rCDI across subgroups. Ridinilazole preserved microbiota diversity, increased SBAs, and did not increase the resistome. Conversely, vancomycin worsened CDI-associated dysbiosis, decreased SBAs, increased Proteobacteria abundance (∼3.5-fold), and increased the resistome.ConclusionsAlthough ridinilazole did not meet superiority in SCR, ridinilazole greatly reduced rCDI and preserved microbiome diversity and SBAs compared with vancomycin. These findings suggest that treatment of CDI with ridinilazole results in an earlier recovery of gut microbiome health.Clinical Trials Registration.Ri-CoDIFy 1 and 2: NCT03595553 and NCT03595566.

17 Jul 2023·EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve - DurAVR.

Article

Author: Meduri, Christopher U ; Settergren, Magnus R M ; Zhividze, Maia ; Katchakhidze, George ; Sorajja, Paul ; Feldt, Kari ; Kodali, Susheel K ; Rück, Andreas ; Cavalcante, João L ; Burns, Marcus R ; Bapat, Vinayak N ; Garg, Pankaj ; Poon, Karl K ; Shaburishvili, Tamaz ; Sathananthan, Janarthanan ; Zirakashvili, Teona ; Hamid, Nadira ; Zajarias, Alan

BACKGROUNDTAVI is a widely accepted treatment for patients with severe aortic stenosis (AS). Despite the adoption of diverse therapies, opportunities remain to develop technologies tailored to provide optimal acute and potential long-term benefits, particularly around haemodynamics, flow and durability.AIMSWe aimed to evaluate the safety and feasibility of the DurAVR transcatheter heart valve (THV), a first-in-class biomimetic valve, in the treatment of patients with symptomatic severe AS.METHODSThis was a first-in-human (FIH), prospective, non-randomised, single-arm, single-centre study. Patients with severe, symptomatic AS of any surgical risk and who were eligible for the DurAVR THV prosthesis were recruited; they were assessed at baseline, 30 days, 6 months, and 1 year post-procedure for implant success, haemodynamic performance, and safety.RESULTSThirteen patients (73.9±6.4 years old, 77% female) were enrolled. The DurAVR THV was successfully implanted in 100% of cases with no device-related complications. One access site complication, one permanent pacemaker implantation, and one case of moderate aortic regurgitation occurred. Otherwise, no deaths, stroke, bleeding, reinterventions, or myocardial infarction were reported during any of the follow-up visits. Despite a mean annulus size of 22.95±1.09 mm, favourable haemodynamic results were observed at 30 days (effective orifice area [EOA] 2.00±0.17 cm², and mean pressure gradient [MPG] 9.02±2.68 mmHg) and were sustained at 1 year (EOA 1.96±0.11 cm², MPG 8.82±1.38 mmHg), resulting in zero patients with any degree of prosthesis-patient mismatch. Additionally, new valve performance measures derived from cardiovascular magnetic resonance displayed restoration of laminar flow, consistent with a predisease state, in conjunction with a mean coaptation length of 8.3±1.7 mm.CONCLUSIONSPreliminary results from the FIH study with DurAVR THV demonstrate a good safety profile with promising haemodynamic performance sustained at 1 year and restoration of near-normal flow dynamics. Further clinical investigation is warranted to evaluate how DurAVR THV may play a role in addressing the challenge of lifetime management in AS patients.

01 Dec 2022·Epileptic Disorders

Leukoencephalopathy with calcifications and cysts: a case study with long‐term follow‐up

Article

Author: Kasradze, Sofia ; Gzirishvili, Nino ; Chutkerashvili, Gocha ; Lomidze, Giorgi ; Tskhvaradze, Svetlana

100 Deals associated with Aversi Clinic

100 Translational Medicine associated with Aversi Clinic

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