scholarly journals Impact of early vs. delayed initiation of dutasteride/tamsulosin combination therapy in LUTS/BPH patients with moderate-severe symptoms at risk of disease progression: Results from clinical trial simulations using risk of AUR or BPH-related surgery

2020 ◽  
Vol 19 ◽  
pp. e636-e637
Author(s):  
J.M. Palacios Moreno ◽  
S. D’agate ◽  
C. Chandrashekhar ◽  
M. Manyak ◽  
M. Oelke ◽  
...  
Keyword(s):  
Clinical Trial ◽  
At Risk ◽  
Combination Therapy ◽  
Disease Progression ◽  
Clinical Trial Simulations ◽  
Delayed Initiation ◽  
Risk Of Disease

scholarly journals Impact of early vs. delayed initiation of dutasteride/tamsulosin combination therapy on the risk of acute urinary retention or BPH-related surgery in LUTS/BPH patients with moderate-to-severe symptoms at risk of disease progression

2020 ◽  
Author(s):  
Salvatore D’Agate ◽  
Chandrashekhar Chavan ◽  
Michael Manyak ◽  
Juan Manuel Palacios-Moreno ◽  
Matthias Oelke ◽  
...  
Keyword(s):  
At Risk ◽  
Combination Therapy ◽  
Disease Progression ◽  
Urinary Retention ◽  
Acute Urinary Retention ◽  
Treatment Algorithm ◽  
Phase Iii ◽  
Rank Test ◽  
Survival Curves ◽  
Risk Of Disease

Abstract Purpose To evaluate the effect of delayed start of combination therapy (CT) with dutasteride 0.5 mg and tamsulosin 0.4 mg on the risk of acute urinary retention or benign prostatic hyperplasia (BPH)-related surgery (AUR/S) in patients with moderate-to-severe lower urinary tract symptoms (LUTS) at risk of disease progression. Methods Using a time-to-event model based on pooled data from 10,238 patients from Phase III/IV dutasteride trials, clinical trial simulations (CTS) were performed to assess the risk of AUR/S up to 48 months in moderate-to-severe LUTS/BPH patients following immediate and delayed start of CT for those not responding to tamsulosin monotherapy. Simulation scenarios (1300 subjects/arm) were investigated, including immediate start (reference) and alternative delayed start (six scenarios 1–24 months). AUR/S incidence was described by Kaplan–Meier survival curves and analysed using log-rank test. The cumulative incidence of events as well as the relative and attributable risks were summarised stratified by treatment. Results Survival curves for patients starting CT at month 1 and 3 did not differ from those who initiated CT immediately. By contrast, significant differences (p < 0.001) were observed when switch to CT occurs ≥ 6 months from the initial treatment. At month 48, AUR/S incidence was 4.6% vs 9.5%, 11.0% and 11.3% in patients receiving immediate CT vs. switchers after 6, 12 and 24 months, respectively. Conclusions Start of CT before month 6 appears to significantly reduce the risk of AUR/S compared with delayed start by ≥ 6 months. This has implications for the treatment algorithm for men with LUTS/BPH at risk of disease progression.

scholarly journals How to Monitor Patients with Chronic Myelogenous Leukemia

2003 ◽  
Vol 1 (4) ◽  
pp. 513-517
Author(s):  
Michael E O'Dwyer
Keyword(s):  
At Risk ◽  
Disease Progression ◽  
Chronic Myelogenous Leukemia ◽  
Treatment Options ◽  
Myelogenous Leukemia ◽  
Newly Diagnosed ◽  
Optimal Response ◽  
Risk Of Disease

The introduction of imatinib has radically altered the treatment options and, perhaps, prognosis for patients with newly diagnosed chronic myelogenous leukemia (CML). However, although the majority of patients appear to benefit from this agent, it is important to recognize as early as possible the patients who experience a sub-optimal response and those who may be at risk of disease progression. This article reviews current available methods of monitoring and provides recommendations for appropriate follow up of imatinib-treated patients.

Abstract 17722: Does Aortic Resection without an Open Distal and Hemi-Arch Procedure Address all Regions at Risk of Progression in Bicuspid Aortopathy?

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Alex J Barker ◽  
Pim van Ooij ◽  
Paul W Fedak ◽  
Robert O Bonow ◽  
S. Chris Malaisrie ◽  
...  
Keyword(s):  
At Risk ◽  
Disease Progression ◽  
Severe Aortic Stenosis ◽  
Preoperative Imaging ◽  
Patient Specific ◽  
4D Flow Mri ◽  
4D Flow ◽  
Flow Mri ◽  
Risk Of Disease ◽  
Resection Area

Introduction: Aggressive aortic resection strategies for bicuspid aortic valve (BAV) patients with significant aortopathy are sometimes warranted. 4D flow MRI can identify regions of the aorta with elevated wall shear stress (WSS) that may be at risk of disease progression and thus should be resected during aneurysm repair. This study assesses the efficacy of standard aortic resection practices to include areas at risk as determined by preoperative imaging. Methods: 13 BAV patients (51±17 yrs) undergoing ascending aortic repair received preoperative 4D flow MRI. 10 age-matched normal subjects (50±14 yrs) with healthy tricuspid aortic valves were used to determine the range of physiologically normal WSS. Patient WSS above the healthy 95% confidence interval classified tissue at risk. The surgeon was blinded to the results and postoperative MRI identified the exact region of resection. Results: Preoperative mean aortic diameter was 4.7±0.7 cm; the age-matched control diameter was 2.9±0.5 cm (P<0.001). 38% of patients had severe aortic stenosis. All patients had WSS above the physiologic norm. All 5 patients with open distal and hemi-arch repair had complete removal of “at-risk” tissue as defined by elevated WSS. In all 5 cases, resection with the clamp on would have resulted in residual at risk regions. Of the 8 patients with the occluding clamp left on: 4 had regions at risk that matched/were smaller than the resected regions (-9±6% of resection area) while 4 had remaining tissue at risk (36±22% of resection area). The average at risk region remaining was 14±28% of the resection area. Conclusions: In selected patients with BAV, aggressive resection using open distal/hemi-arch repair is necessary for complete resection of tissue at risk of disease progression. Less aggressive resections without an open distal anastomosis does not always completely remove “at risk” regions. With further validation, 4D flow MRI could be used to guide patient-specific resection strategies.

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