High- vs Low-Dose Tranexamic Acid Infusion and Need for Red Blood Cell Transfusion and Adverse Events in Cardiac Surgery—Reply

In Reply In response to the comments by Dr Koster and colleagues, the OPTIMAL trial enrolled patients aged 18 to 70 years, which is the age range of most patients undergoing adult cardiac bypass surgery in China. We agree that our study results, especially regarding seizures, should be interpreted with caution for patients older than 70 years.

Leggi
Gennaio 2023

Antiandrogen Treatment vs Active Surveillance for Patients With Prostate Cancer

To the Editor We applaud Shore et al for their work with the ENACT randomized clinical trial to improve progression-free survival among men on active surveillance (AS) for prostate cancer (PCa). Their addition of enzalutamide monotherapy to the AS regimen represents the latest pharmacological intervention aimed at delaying PCa progression, mirroring previous attempts including use of dutasteride, bicalutamide, and other drugs that disrupt the androgen axis.

Leggi
Gennaio 2023

Antiandrogen Treatment vs Active Surveillance for Patients With Prostate Cancer

To the Editor In a recent issue of JAMA Oncology, Shore et al present the results of ENACT, a phase 2 clinical trial randomizing patients with low and favorable intermediate-risk prostate cancer on active surveillance (AS) to receive or not to receive 1 year of antiandrogen treatment with enzalutamide. Findings of this trial suggest a decreased rate of pathologic or therapeutic progression, cancer-positive core rate, and biochemical progression-free survival (bPFS) in the enzalutamide group at 1 year, although no difference in these end points was observed between the groups at 2 years. Based on these results, the authors propose adding enzalutamide to AS for this patient population.

Leggi
Gennaio 2023

Antiandrogen Treatment vs Active Surveillance for Patients With Prostate Cancer—Reply

In Reply Active surveillance (AS) is the preferred management strategy for low-risk prostate cancer. While AS rates are increasing in clinical practice, its adoption remains suboptimal and is highly variable in the US. The potential benefits of treatments that might provide a durable effect on pathology and delay disease progression in the favorable-risk prostate cancer setting have not been fully elucidated.

Leggi
Gennaio 2023

Antiandrogen Treatment vs Active Surveillance for Patients With Prostate Cancer

To the Editor I read with great interest the ENACT randomized clinical trial by Shore et al. This study has recapitulated the same error as the REDEEM study, which is referenced in the Discussion. REDEEM compared dutasteride, a known prostate cytoreductive drug, with placebo in men on active surveillance. The end point of progression included an increase in the volume of grade group 1 (GG1) cancer. The study showed a 38% reduction in progression, but 100% of this was due to differences in volume progression of GG1 disease. In fact, there was a slightly higher rate of grade progression in the dutasteride arm. Rightly, this progression benefit was not considered meaningful by the prostate cancer community. Guidelines do not recommend 5α-reductase inhibitors for men on surveillance to reduce disease progression rates.

Leggi
Gennaio 2023

COVID-19 vs Influenza for Risk of Thrombotic Events in Hospitalized Patients—Reply

In Reply We appreciate the interest in our recent study and the opportunity to share our responses to the comments by Dr Yii and colleagues. We sought to assess whether the risk of arterial and venous thromboembolism among patients hospitalized with COVID-19 differed from those hospitalized with another respiratory viral infection. Patients with influenza in 2018-2019 were selected as the comparator because this pathogen also causes pandemics, results in hospitalization when severe, and is associated with increased risk of acute myocardial infarction, ischemic stroke, and venous thromboembolism. Evaluating outcomes of COVID-19 within the broader context of other respiratory viruses is important, and we therefore think that patients hospitalized with influenza represented an appropriate comparator group.

Leggi
Dicembre 2022

Remote Ischemic Conditioning vs Usual Care and Neurologic Function in Acute Moderate Ischemic Stroke

To the Editor The Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke (RICAMIS) randomized clinical trial shed new light on remote ischemic conditioning (RIC) as a potential treatment in acute ischemic stroke, although there was a 5.4% absolute risk improvement in excellent outcome with a power of 66%. To reproduce these findings with the same protocol using a power of 80%, a sample size of 2458 patients would be required. Previous trials in acute brain infarction and myocardial infarction have delivered 1 cycle of RIC in the first 6 hours of ischemia with the underlying hypothesis of enhanced penumbra salvage. However, the RICAMIS study investigators started this treatment within the first 48 hours, with a mean onset-to-treatment delay of 24.8 hours, and performed RIC twice a day over a mean of 11 days in patients with acute moderate ischemic stroke.

Leggi
Dicembre 2022

Remote Ischemic Conditioning vs Usual Care and Neurologic Function in Acute Moderate Ischemic Stroke—Reply

In Reply We appreciate the interest shown by Dr Pico and colleagues about our trial that investigated the effect of RIC on neurologic function in patients with acute moderate ischemic stroke. A dose-response relationship between the number of days of RIC (or the number of RICs delivered) and excellent outcomes is important information to determine the best protocol for in-hospital RIC. These data will be investigated in our secondary analysis of the RICAMIS study.

Leggi
Dicembre 2022