Πέμπτη 2 Ιουνίου 2022

Effectiveness and safety of sacubitril/valsartan for patients with hypertension and heart failure in the real‐world setting: A retrospective study in China

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Effectiveness and safety of sacubitril/valsartan for patients with hypertension and heart failure in the real-world setting: A retrospective study in China

This study provided real-world evidence on the effectiveness and safety of sacubitril/valsartan (sac/val), among adult patients diagnosed with hypertension and heart failure (or cardiac insufficiency). Patients who discontinued therapy throughout 12 months due to sac/val related adverse events were defined as severe adverse event (SAE) group, and the others were defined as non-SAE group. Noticeably, a history of atrial fibrillation or chronic kidney disease, as well as higher baseline levels of serum creatinine, uric acid and NT-proBNP, was more likely to lead to the discontinuation of sac/val caused by its AEs. In addition, among patients who maintained sac/val therapy throughout 3–12 months, the latest values of clinic blood pressure (BP) and parameters on cardiac function significantly improved compared with those at baseline (p < 0.0001).


Abstract

What Is Known and Objective

Hypertension (HP) is associated with heart failure (HF). Sacubitril/valsartan (sac/val) has been approved for primary HP by China Food and Drug Administration (CFDA) in June 2021. The present study aimed to provide evidence on the effectiveness and safety of sac/val in Chinese patients complicated with HP and HF.

Methods

This retrospective study was conducted on adult patients diagnosed with HP and HF and treated with sac/val between July 2020 and December 2020. The potential risk factors for the discontinuation events caused by sac/val-related adverse events (AEs) were explored. The data, including blood pressure (BP), cardiac indicators, corresponding values on echocardiographic parameters, unplanned visits, and AEs throughout 3–12 months, were collected.

Results and Discussion

A total of 446 eligible patients were included in this study. The discontinuation events of sac/val were mainly attributed to its AEs (hypotension, hyperkalemia, and deterioration in kidney function). Univariate analysis revealed that history of chronic kidney disease, atrial fibrillation, higher values of serum creatinine, serum uric acid, serum N-terminal pro B-type natriuretic peptide, and lower estimated glomerular filtration rate were potential risk factors for discontinuation. Patients who maintained sac/val therapy throughout 3–12 months showed significantly improved values of clinical BP, cardiac indicators, and echocardiographic parameters compared to those at baseline (p < 0.0001).

What Is New and Conclusion

Sac/val was effective on BP and improved cardiac function in patients complicated with HP and HF. The physicians should focus on patients with renal dysfunction to take timely precautions to improve tolerability for sac/val.

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The microbiome of cryospheric ecosystems

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Identification of exosomal hsa-miR-483-5p as a potential biomarker for hepatocellular carcinoma via microRNA expression profiling of tumor-derived exosomes

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Publication date: Available online 1 June 2022

Source: Experimental Cell Research

Author(s): Jie Lin, Wansong Lin, Yannan Bai, Yanling Liao, Qiaoyan Lin, Lingfeng Chen, Yijuan Wu

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Hippocampal avoidance prophylactic cranial irradiation (HA-PCI) for small cell lung cancer reduces hippocampal atrophy compared to conventional PCI

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Abstract
Background
Reducing radiation dose to the hippocampus with hippocampal avoidance prophylactic cranial irradiation (HA-PCI) is proposed to prevent cognitive decline. It has, however, not been investigated whether hippocampal atrophy is actually mitigated by this approach. Here, we determined whether HA-PCI reduces hippocampal atrophy. Additionally we evaluated neurotoxicity of (HA-)PCI to other brain regions. Finally, we evaluated associations of hippocampal atrophy and brain neurotoxicity with memory decline.
Methods
High quality research MRI scans were acquired in the multicenter, randomized phase 3 trial NCT01780675. Hippocampal atrophy was evaluated 4 months (57 HAPCI patients and 46 PCI patients) and 12 months (28 HAPCI patients and 27 PCI patients) after (HA-)PCI. We additionally studied multimodal indices of brain injury. Memory was assessed with the Hopkins Verbal Learning Test Revised (HVLT-R).
Results
HA-PCI r educed hippocampal atrophy at 4 months (1.8% for HA-PCI and 3.0% for PCI) and at 12 months (3.0% for HA-PCI and 5.8% for PCI). Both HA-PCI and PCI were associated with considerable reductions of gray matter and normal appearing white matter, increases of white matter hyperintensities and brain aging. There were no significant associations between hippocampal atrophy and memory.
Conclusions
HA-PCI reduces hippocampal atrophy at 4 and 12 months compared to regular PCI. Both types of radiotherapy are associated with considerable brain injury. We did not find evidence for excessive brain injury after HA-PCI relative to PCI. Hippocampal atrophy was not associated with memory decline in this population as measured with HVLT-R. The usefulness of HA-PCI is still subject to debate.
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Phase II study of alisertib as a single agent for treating recurrent or progressive atypical teratoid/rhabdoid tumor

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Abstract
Background
Recurrent atypical teratoid/rhabdoid tumor (AT/RT) is, most often, a fatal pediatric malignancy with limited curative options.
Methods
We conducted a phase II study of Aurora kinase A inhibitor alisertib in patients aged <22 years with recurrent AT/RT. Patients received alisertib once daily (80 mg/m 2 as enteric-coated tablets or 60 mg/m 2 as liquid formulation) on Days 1–7 of a 21-day cycle until progressive disease (PD) occurred. Alisertib plasma concentrations were measured in cycle 1 on Days 1 (single dose) and 7 (steady state) and analyzed with noncompartmental pharmacokinetics. Trial efficacy end point was ≥10 participants with stable disease (SD) or better at 12 weeks.
Results
SD (n=8) and partial response (PR) (n=1) were observed among 30 evaluable patients. Progression-free survival (PFS) was 30.0% ± 7.9% at 6 months and 13.3% ± 5.6% at 1 year. One-year overa ll survival (OS) was 36.7% ± 8.4%. Two patients continued treatment for >12 months. PFS did not differ by AT/RT molecular groups. Neutropenia was the most common adverse effect (n=23/30, 77%). The 22 patients who received liquid formulation had a higher mean maximum concentration (Cmax) of 10.1 ± 3.0 µM and faster time to Cmax (Tmax = 1.2 ± 0.7 h) than those who received tablets (Cmax = 5.7 ± 2.4 µM, Tmax = 3.4 ± 1.4 h).
Conclusions
Although the study did not meet pre-determined efficacy end point, single agent alisertib was well tolerated by children with recurrent AT/RT, and SD or PR was observed in approximately a third of the patients.
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Overexpression of TIGAR and HO-1 in peripheral blood mononuclear cells (PBMCs) of breast cancer patients treated with radiotherapy

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Dedicated isotropic 3-D T1 SPACE sequence imaging for radiosurgery planning improves brain metastases detection and reduces the risk of intracranial relapse

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Publication date: Available online 2 June 2022

Source: Radiotherapy and Oncology

Author(s): Tugce Kutuk, Kevin J. Abrams, Martin C. Tom, Muni Rubens, Haley Appel, Charif Sidani, Matthew D. Hall, Ranjini Tolakanahalli, D. Jay J. Wieczorek, Alonso N. Gutierrez, Michael W. McDermott, Manmeet S. Ahluwalia, Minesh P. Mehta, Rupesh Kotecha

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Depolarization of echo chambers by random dynamical nudge

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Effectiveness of Paxlovid in Reducing Severe COVID-19 and Mortality in High Risk Patients

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Abstract
Background
Paxlovid was granted emergency use authorization for the treatment of mild to moderate COVID-19, based on the interim analysis of EPIC-HR trial. Paxlovid effectiveness needs to be assessed in a noncontrolled setting. In this study we used population-based real world data to evaluate the effectiveness of Paxlovid.
Methods
The database of the largest healthcare provider in Israel was used to identify all adults aged 18 years or older with first ever positive test for SARS-CoV-2 between January and February 2022, who were at high risk for severe COVID-19 and had no contraindications for Paxlovid use. Patients were included irrespective of their COVID-19 vaccination status. Cox hazard regression was used to estimate the 28 day HR for severe COVID-19 or mortality with Paxlovid examined as time-dependent variable.
Results
Overall, 180,351 eligible were included, of them only 4,737 (2.6%) were treated with Paxlovid , and 135,482 (75.1%) had adequate COVID-19 vaccination status. Both Paxlovid and adequate COVID-19 vaccination status were associated with significant decrease in the rate of severe COVID-19 or mortality with adjusted HR 0.54 (95% CI, 0.39-0.75) and 0.20 (95% CI, 0.17-0.22), respectively. Paxlovid appears to be more effective in older patients, immunosuppressed patients, and patients with underlying neurological or cardiovascular disease (interaction p-value <0.05 for all). No significant interaction was detected between Paxlovid treatment and COVID-19 vaccination status.
Conclusions
This study suggests that in the era of omicron and in real life setting Paxlovid is highly effective in reducing the risk of severe COVID-19 or mortality.
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