Fluoxetine in progressive multiple sclerosis: The FLUOX-PMS trial

2019 ◽  
Vol 25 (13) ◽  
pp. 1728-1735 ◽  
Author(s):  
Melissa Cambron ◽  
Jop Mostert ◽  
Marie D’Hooghe ◽  
Guy Nagels ◽  
Barbara Willekens ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Statistical Power ◽  
Primary Outcome ◽  
Cox Regression ◽  
Neuroprotective Effect ◽  
Brain Magnetic Resonance Imaging ◽  
Rank Test ◽  
Cox Regression Analysis ◽  
Significant Difference ◽  
Secondary Outcomes

Background: Preclinical studies suggest that fluoxetine has neuroprotective properties that might reduce axonal degeneration in multiple sclerosis (MS). Objective: To determine whether fluoxetine slows accumulation of disability in progressive MS. Methods: In a double-blind multicenter phase 2 trial, patients with primary or secondary progressive MS were randomized to fluoxetine 40 mg/day or placebo for a period of 108 weeks. Clinical assessments were performed every 12 weeks by trained study nurses who visited the patients at their home. The primary outcome was the time to a 12-week confirmed 20% increase in the Timed 25 Foot Walk or 9-Hole Peg test. Secondary outcomes included the Hauser ambulation index, cognitive tests, fatigue, and brain magnetic resonance imaging (MRI). Results: In the efficacy analysis, 69 patients received fluoxetine and 68 patients received placebo. Using the log-rank test ( p = 0.258) and Cox regression analysis ( p = 0.253), we found no significant difference in the primary outcome between the two groups. Due to an unexpected slow rate of progression in the placebo group, there was insufficient statistical power to detect a potential benefit of fluoxetine. We found no differences between the two groups for secondary outcomes. Conclusion: The trial failed to demonstrate a neuroprotective effect of fluoxetine in patients with progressive MS.

Effect of BRCA Mutations on the Length of Survival in Epithelial Ovarian Tumors

2002 ◽  
Vol 20 (2) ◽  
pp. 463-466 ◽  
Author(s):  
Y. Ben David ◽  
A. Chetrit ◽  
G. Hirsh-Yechezkel ◽  
E. Friedman ◽  
B.D. Beck ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Survival ◽  
Cox Regression ◽  
Ovarian Tumors ◽  
Early Years ◽  
Rank Test ◽  
Brca Mutations ◽  
Blood Samples ◽  
Cox Regression Analysis ◽  
Significant Difference

PURPOSE: To study the role of BRCA mutations in ovarian cancer survival. PATIENTS AND METHODS: Blood samples and specimens of ovarian tumors (whenever blood samples were not available) at the time of the primary surgery were obtained in the course of a nationwide case-control study of women with ovarian cancer in Israel. The three common BRCA mutations in Israel (185delAG, 5382insC, and 6174delT) were analyzed with a multiplex polymerase chain reaction to amplify the exons containing the three mutations using fluor-labeled primers in a single reaction. Because each mutation is a small insertion or deletion, they can be detected as length polymorphisms. Patients were followed for up to 5 years (range, 20 to 64 months). Statistical analysis was performed using the Kaplan-Meier method and the log-rank test. Stepwise Cox regression analysis was used for determination of independent prognostic factors. RESULTS: This report is based on 896 blood or tumor specimens analyzed for the presence of the BRCA mutations. Of these, 234 women (26.1%) were found to be positive. A significant difference in survival pattern was found between BRCA1/BRCA2 carriers and noncarriers among the women with invasive ovarian cancer (median survival, 53.4 months v 37.8 months; 3-year survival, 65.8% v 51.9%, respectively). These differences were independent of age at diagnosis or stage of the disease. CONCLUSION: Our data indicate that the survival of patients with ovarian cancer is affected by BRCA germline mutation, at least in the early years after diagnosis.

Multicenter comparison of outcomes for clinical and pathologic T3a renal cell carcinoma.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 758-758
Author(s):  
Aaron Bradshaw ◽  
Fady Ghali ◽  
Nathan Miller ◽  
Cathrine Keiner ◽  
Raksha Dutt ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Primary Outcome ◽  
Cox Regression ◽  
Multivariable Analysis ◽  
Rank Test ◽  
Similar Proportion ◽  
Secondary Outcomes

758 Background: The identification of venous thrombus in patients with renal cell carcinoma (RCC) is particularly challenging, with a substantial number upstaged to pathologic T3a following intervention. We compared survival outcomes between patients with initial cT3a status versus those upstaged to pT3a. Methods: This is a retrospective, multicenter analysis of patients with cT3a or pT3a RCC who underwent operative management. Primary outcome was recurrence-free survival (RFS). Secondary outcomes were overall survival (OS) and cancer-specific survival (CSS). Cox regression multivariable analysis (MVA) was utilized for primary outcome. Kaplan-Meier analyses (KMA) were conducted to describe RFS, OS, and CSS with log-rank test comparing clinical and upstaged pathologic T3a groups. Results: 770 patients were analyzed (cT3a 184, pT3a 586, median follow-up 28 months). Average pathologic tumor size was smaller in pT3a (7.2 cm vs 8.7 cm, p < 0.01), with no significant differences in clinical variables. A similar proportion underwent radical nephrectomy (vs. partial) (89.7% cT3a and 85.0% pT3a, p = 0.11) with no significant different in positive margin rate (3.8% cT3a, 4.8% pT3a, p = 0.23). However, a higher proportion of patients with cT3a disease were pathologically node positive (19.0% vs. 10.8%, p < 0.01) and demonstrated a higher rate of recurrence (cT3a 51.1% vs. pT3a 34.1%, p < 0.01) despite shorter mean follow-up (cT3a 33.0 vs. pT3a 50.7 mo, p < 0.01). MVA for RFS revealed cT3a staging (pT3a referent, HR 1.72, p < 0.01), positive margins (HR 2.85, p < 0.01), and clear cell histology (HR 1.68, p < 0.01) to be independently associated with higher recurrence rate, while partial nephrectomy (radical referent, HR 0.259, p < 0.01) was associated with a decreased rate. KMA revealed 5-year RFS of 34.4% and 60.6% for cT3a and pT3a respectively (p < 0.01). KMA for secondary outcomes revealed 5-year OS rates of 56.7% and 62.0% (p = 0.02) and 5-year CSS of 74.4% and 67.7% for cT3a and pT3a respectively (p = 0.01). Conclusions: Patients with cT3a RCC have poorer oncologic outcomes than those with upstaged pT3a RCC. Suspected venous involvement on pre-operative imaging may indicate more aggressive or advanced disease than that found during surgery.

scholarly journals Impact of catheter ablation for atrial flutter on mortality and hospital readmission rates in patients with heart failure and reduced ejection fraction

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Arora ◽  
H P Patel ◽  
C Jani ◽  
S Thakkar ◽  
J Gonzalez ◽  
...  
Keyword(s):  
Heart Failure ◽  
Catheter Ablation ◽  
Ejection Fraction ◽  
Atrial Flutter ◽  
Primary Outcome ◽  
Cox Regression Analysis ◽  
Reduced Ejection Fraction ◽  
Significant Difference ◽  
All Cause Mortality ◽  
Secondary Outcomes

Abstract Background The effectiveness of catheter ablation as a management modality amongst patients with coexisting atrial flutter (AFL) and heart failure with reduced ejection fraction (HFrEF) is scarcely studied. Methods Appropriate ICD 10 codes were applied to the 2016 and 2017 National Readmission Database (NRD) to isolate patients having coexistent AFL and HFrEF including who had undergone an ablation. All-cause mortality at the end of 1 year was used as a primary outcome. Readmission due to AFL, heart failure (HF) and other causes were secondary outcomes. The hazard ratios were generated using Cox regression analysis while the time to event analysis was demonstrated with the Kaplan Meier curves. Results Out of a total of 9966 patients with AFL and HFrEF, 1980 (24.79%) patients underwent catheter ablation. The primary outcome, all-cause mortality (2.8% vs. 4.6%, HR: 0.610, 95% CI: 0.460–0.808, p=0.001) at the end of 1 year was significantly lower. Significant difference was also noted amongst two groups when it came to secondary outcomes such as readmissions due to AFL (1.6% vs. 6.3%, HR: 0.247, 95% CI: 0.173–0.354, p&lt;0.001), HF (8.2% vs. 11.4%, HR: 0.693, 95% CI: 0.587–0.819, p&lt;0.001) and other causes (29.4% vs. 37.1%, HR: 0.735, 95% CI: 0.673–0.804, p&lt;0.001) Conclusion Ablative intervention amongst AFL patients with concomitant HFrEF showed a significant reduction in all-cause mortality. It also leads to significant reductions in readmissions due to AFL, HF and other causes at the end of one year. Outcomes of AFL and HFrEF Funding Acknowledgement Type of funding source: None

Continuous daily use of cilostazol prevents in-stent restenosis following carotid artery stenting: serial angiographic investigation of 229 lesions

2015 ◽  
Vol 8 (5) ◽  
pp. 471-475 ◽  
Author(s):  
Yuichi Miyazaki ◽  
Takahisa Mori ◽  
Tomonori Iwata ◽  
Yoshinori Aoyagi ◽  
Yuhei Tanno ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Carotid Artery Stenting ◽  
Cox Regression ◽  
Rank Test ◽  
Adjusted Relative Risk ◽  
Cox Regression Analysis ◽  
Stent Restenosis ◽  
Significant Difference ◽  
In Stent Restenosis

BackgroundSeveral studies have reported that cilostazol (CLS) may reduce in-stent restenosis (ISR) after carotid artery stenting (CAS). However, it is not known for how long CLS must be continued to prevent ISR.MethodsWe retrospectively reviewed a prospectively collected database of patients who underwent elective CAS and follow-up angiography at 3 months and 1 year after the procedure. ISR was defined as stenosis of 50% or greater on digital subtraction angiography. The cumulative incidence rates of angiographic ISR were compared between the three groups, divided according to duration of CLS use : (1) patients who were maintained on CLS for 12 months or more after CAS (12M CLS group, n=70), (2) patients who were treated with CLS for the first 3 months after CAS (3M CLS group, n=23), and (3) patients who did not receive CLS (no CLS group, n=136).ResultsA total of 229 lesions in 199 patients were included in our analysis. During a median follow-up of 365 days, ISR was detected in 15 lesions. The cumulative ISR rates overall and in the 12M CLS, 3M CLS, and no CLS groups were 5.6%, 0%, 5.0%, and 8.4%, respectively, at 1 year, and the log rank test showed that there was a significant difference between the three groups (p<0.05). Cox regression analysis demonstrated that the 12M CLS group had a significantly lower risk of ISR than the 3M CLS group (adjusted relative risk (aRR) 3.06e-10, 95% CI 0 to 0.51, p<0.05) and the no CLS group (aRR 1.41e-10, 95% CI 0 to 0.15, p<0.001), whereas no difference was found between the 3M CLS group and the no CLS group.ConclusionsAn overall cumulative ISR rate of 5.6% was documented angiographically at 1 year after CAS. Continuous daily use of CLS (for at least 1 year) may have a beneficial effect on long term prevention of ISR.

Similar cardiovascular outcomes in patients with diabetes and established or high risk for coronary vascular disease treated with dulaglutide with and without baseline metformin

2020 ◽  
Author(s):  
Giulia Ferrannini ◽  
Hertzel Gerstein ◽  
Helen Martina Colhoun ◽  
Gilles R Dagenais ◽  
Rafael Diaz ◽  
...  
Keyword(s):  
Heart Failure ◽  
Type 2 Diabetes ◽  
High Risk ◽  
Primary Outcome ◽  
Cox Regression ◽  
Composite Endpoint ◽  
Metformin Therapy ◽  
Significant Difference ◽  
Secondary Outcomes

Abstract Objective  Recent European Guidelines for Diabetes, Prediabetes and Cardiovascular Diseases introduced a shift in managing patients with type 2 diabetes at high risk for or established cardiovascular (CV) disease by recommending GLP-1 receptor agonists and SGLT-2 inhibitors as initial glucose-lowering therapy. This is questioned since outcome trials of these drug classes had metformin as background therapy. In this post hoc analysis, the effect of dulaglutide on CV events was investigated according to the baseline metformin therapy by means of a subgroup analysis of the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial. Research design and methods  Patients in REWIND (n = 9901; women: 46.3%; mean age: 66.2 years) had type 2 diabetes and either a previous CV event (31%) or high CV risk (69%). They were randomized (1:1) to sc. dulaglutide (1.5 mg/weekly) or placebo in addition to standard of care. The primary outcome was the first of a composite of nonfatal myocardial infarction, nonfatal stroke, and death from cardiovascular or unknown causes. Key secondary outcomes included a microvascular composite endpoint, all-cause death, and heart failure. The effect of dulaglutide in patients with and without baseline metformin was evaluated by a Cox regression hazard model with baseline metformin, dulaglutide assignment, and their interaction as independent variables. Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by a Cox regression model with adjustments for factors differing at baseline between people with vs. without metformin, identified using the backward selection. Results  Compared to patients with metformin at baseline (n = 8037; 81%), those without metformin (n = 1864; 19%) were older and slightly less obese and had higher proportions of women, prior CV events, heart failure, and renal disease. The primary outcome occurred in 976 (12%) participants with baseline metformin and in 281 (15%) without. There was no significant difference in the effect of dulaglutide on the primary outcome in patients with vs. without metformin at baseline [HR 0.92 (CI 0.81–1.05) vs. 0.78 (CI 0.61–0.99); interaction P = 0.18]. Findings for key secondary outcomes were similar in patients with and without baseline metformin. Conclusion  This analysis suggests that the cardioprotective effect of dulaglutide is unaffected by the baseline use of metformin therapy.

Predictive Model for Live Birth at 12 Months After Starting In-Vitro Fertilization Treatment

MedPharmRes ◽  
2018 ◽  
Vol 2 (2) ◽  
pp. 5-20
Author(s):  
Vu Ho ◽  
Toan Pham ◽  
Tuong Ho ◽  
Lan Vuong
Keyword(s):  
In Vitro Fertilization ◽  
Live Birth ◽  
Cox Regression ◽  
Financial Burden ◽  
Oocyte Retrieval ◽  
Operating Characteristics ◽  
Vitro Fertilization ◽  
Cox Regression Analysis ◽  
Significant Difference

IVF carries a considerable physical, emotional and financial burden. Therefore, it would be useful to be able to predict the likelihood of success for each couple. The aim of this retrospective cohort study was to develop a prediction model to estimate the probability of a live birth at 12 months after one completed IVF cycle (all fresh and frozen embryo transfers from the same oocyte retrieval). We analyzed data collected from 2600 women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) at a single center in Vietnam between April 2014 and December 2015. All patients received gonadotropin-releasing hormone (GnRH) antagonist stimulation, followed by fresh and/or frozen embryo transfer (FET) on Day 3. Using Cox regression analysis, five predictive factors were identified: female age, total dose of recombinant follicle stimulating hormone used, type of trigger, fresh or FET during the first transfer, and number of subsequent FET after the first transfer. The area under the receiver operating characteristics curve for the final model was 0.63 (95% confidence interval [CI] 0.60‒0.65) and 0.60 (95% CI 0.57‒0.63) for the validation cohort. There was no significant difference between the predicted and observed probabilities of live birth (Hosmer-Lemeshow test, p > 0.05). The model developed had similar discrimination to existing models and could be implemented in clinical practice.

scholarly journals The prognostic and diagnostic significance of the neutrophil-to-lymphocyte ratio in hepatocellular carcinoma: a prospective controlled study

2021 ◽  
Author(s):  
Philip J. Johnson ◽  
Sofi Dhanaraj ◽  
Sarah Berhane ◽  
Laura Bonnett ◽  
Yuk Ting Ma
Keyword(s):  
Hepatocellular Carcinoma ◽  
Regression Analysis ◽  
Prognostic Factor ◽  
Cox Regression ◽  
Prognostic Models ◽  
Controlled Study ◽  
Cox Regression Analysis ◽  
Neutrophil Lymphocyte Ratio ◽  
Lymphocyte Ratio ◽  
Significant Difference

Abstract Background The neutrophil–lymphocyte ratio (NLR), a presumed measure of the balance between neutrophil-associated pro-tumour inflammation and lymphocyte-dependent antitumour immune function, has been suggested as a prognostic factor for several cancers, including hepatocellular carcinoma (HCC). Methods In this study, a prospectively accrued cohort of 781 patients (493 HCC and 288 chronic liver disease (CLD) without HCC) were followed-up for more than 6 years. NLR levels between HCC and CLD patients were compared, and the effect of baseline NLR on overall survival amongst HCC patients was assessed via multivariable Cox regression analysis. Results On entry into the study (‘baseline’), there was no clinically significant difference in the NLR values between CLD and HCC patients. Amongst HCC patients, NLR levels closest to last visit/death were significantly higher compared to baseline. Multivariable Cox regression analysis showed that NLR was an independent prognostic factor, even after adjustment for the HCC stage. Conclusion NLR is a significant independent factor influencing survival in HCC patients, hence offering an additional dimension in prognostic models.

scholarly journals Single modality radical radiotherapy is an acceptable alternative for the older patient with squamous cell carcinoma of the oesophagus

2021 ◽  
Vol 8 (1) ◽  
pp. e000492
Author(s):  
Sarah Derby ◽  
Matthew Forshaw ◽  
Caroline Lowrie ◽  
Derek Grose ◽  
Husam Marashi ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Cox Regression ◽  
Multimodality Treatment ◽  
Radical Radiotherapy ◽  
Older Patient ◽  
Older Population ◽  
Cox Regression Analysis ◽  
Significant Difference

BackgroundOesophageal cancer remains a common cause of cancer mortality worldwide. Increasingly, oncology centres are treating an older population and comorbidities may preclude multimodality treatment with chemoradiotherapy (CRT). We review outcomes of radical radiotherapy (RT) in an older population treating squamous cell carcinoma (SCC) oesophagus.MethodsPatients over 65 years receiving RT for SCC oesophagus between 2013 and 2016 in the West of Scotland were identified. Kaplan-Meier and Cox-regression analysis were used to compare overall survival (OS) between patients treated with radical RT and radical CRT.ResultsThere were 83 patients over 65 years treated with either RT (n=21) or CRT (n=62). There was no significant difference in median OS between CRT versus RT (26.8 months vs 28.5 months, p=0.92). All patients receiving RT completed their treatment whereas 11% of CRT patients did not complete treatment.ConclusionSurvival in this non-trial older patient group managed with CRT is comparable to that reported in previous trials. RT shows better than expected outcomes which may reflect developments in RT technique. This review supports RT as an alternative in older patients, unfit for concurrent treatment.

Impact of Hybrid Operating Rooms on Long-Term Clinical Outcomes Following Fenestrated and Branched Endovascular Aortic Repair

2021 ◽  
pp. 152660282199672
Author(s):  
Giovanni Tinelli ◽  
Marie Bonnet ◽  
Adrien Hertault ◽  
Simona Sica ◽  
Gian Luca Di Tanna ◽  
...  
Keyword(s):  
Operating Room ◽  
Clinical Outcomes ◽  
Cox Regression ◽  
Statistical Significance ◽  
Aortic Aneurysms ◽  
Study Patient ◽  
Cox Regression Analysis ◽  
Significant Difference ◽  
The Impact

Purpose: Evaluate the impact of hybrid operating room (HOR) guidance on the long-term clinical outcomes following fenestrated and branched endovascular repair (F-BEVAR) for complex aortic aneurysms. Materials and Methods: Prospectively collected registry data were retrospectively analyzed to compare the procedural, short- and long-term outcomes of consecutive F-BEVAR performed from January 2010 to December 2014 under standard mobile C-arm versus hybrid room guidance in a high-volume aortic center. Results: A total of 262 consecutive patients, including 133 patients treated with a mobile C-arm equipped operating room and 129 with a HOR guidance, were enrolled in this study. Patient radiation exposure and contrast media volume were significantly reduced in the HOR group. Short-term clinical outcomes were improved despite higher case complexity in the HOR group, with no statistical significance. At a median follow-up of 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group, and 44.9 months (Q1 25.1, Q3 53.5, p=0.53) in the HOR group, there was no statistically significant difference in terms of target vessel occlusion and limb occlusion. When the endograft involved 3 or more fenestrations and/or branches (complex F-BEVAR), graft instability (36% vs 25%, p=0.035), reintervention on target vessels (20% vs 11%, p=0.019) and total reintervention rates (24% vs 15%, p=0.032) were significantly reduced in the HOR group. The multivariable Cox regression analysis did not show statistically significant differences for long-term death and aortic-related death between the 2 groups. Conclusion: Our study suggests that better long-term clinical outcomes could be observed when performing complex F-BEVAR in the latest generation HOR.

scholarly journals Predictive impact of PVL assessments on clinical outcomes in patients undergoing TAVR

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Matsushita ◽  
B Marchandot ◽  
M Kibler ◽  
C Sato ◽  
J Heger ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Cox Regression ◽  
Adenosine Diphosphate ◽  
Rank Test ◽  
Multicenter Studies ◽  
Cox Regression Analysis ◽  
Paravalvular Leakage ◽  
Transcatheter Aortic Valve ◽  
Log Rank Test ◽  
Cerebrovascular Events

Abstract Introduction Paravalvular leakage (PVL) following transcatheter aortic valve replacement (TAVR) is associated with greater mortality. In clinical practice, determining PVL severity after TAVR remains challenging and often requires multiparametric assessment. Purpose This study sought to evaluate the respective value of various modalities of PVL assessments, including transthoracic echocardiography (TTE), cine-angiography, aortic regurgitation index (ARI), and closure time with adenosine diphosphate (CT-ADP), in the prediction of adverse clinical outcomes. Methods We included 1044 patients from our prospective TAVR registry between February 2010 and May 2019. Major adverse cardiac and cerebrovascular events (MACCE) was defined as a composite of all-cause death, myocardial infarction, stroke, and heart failure hospitalization within 1-year. Established cutoff values of ARI (&lt;25) and CT-ADP (&gt;180 sec) were used to assess the presence of PVL after TAVR. Results Moderate to severe PVL occurred in 14.2% and 5.2% of patients as measured by TTE and angiography. The rate of patients with ARI &lt;25 and CT-ADP &gt;180 sec were 36.5% and 24.9%, respectively. Among the four modalities, PVL evaluated by angiography predicted poorer clinical outcomes (Log rank test; p=0.001), whereas TTE, ARI &lt;25, and CT-ADP &gt;180 sec were not associated with 1-year MACCE. By multivariate Cox regression analysis, moderate to severe PVL by angiography was an independent predictor of 1-year MACCE (hazard ratio: 1.96; 95% confidence interval: 1.22–3.00; p=0.007). Conclusions Paravalvular leakage measured by angiography was evidenced as the most meaningful modality in the prediction of adverse clinical outcomes. Future multicenter studies are warranted to ensure these findings in the current TAVR era. Figure 1 Funding Acknowledgement Type of funding source: None

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