safe

Better Ways Needed to Track Drug Safety: Report

Title: Better Ways Needed to Track Drug Safety: Report
Category: Health News
Created: 5/1/2012 2:05:00 PM
Last Editorial Review: 5/2/2012 12:00:00 AM




safe

Study: Gene Therapy for HIV Safe, But Effectiveness Still Unclear

Title: Study: Gene Therapy for HIV Safe, But Effectiveness Still Unclear
Category: Health News
Created: 5/2/2012 4:05:00 PM
Last Editorial Review: 5/3/2012 12:00:00 AM




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HIV Drug Tenofovir Safe During Pregnancy, Study Suggests

Title: HIV Drug Tenofovir Safe During Pregnancy, Study Suggests
Category: Health News
Created: 5/3/2012 6:05:00 PM
Last Editorial Review: 5/4/2012 12:00:00 AM




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Water Pipe No Safer Than Cigarettes: Study

Title: Water Pipe No Safer Than Cigarettes: Study
Category: Health News
Created: 4/29/2013 2:35:00 PM
Last Editorial Review: 4/30/2013 12:00:00 AM




safe

Health Tip: Make Microwave Cooking Safe

Title: Health Tip: Make Microwave Cooking Safe
Category: Health News
Created: 5/1/2013 8:35:00 AM
Last Editorial Review: 5/1/2013 12:00:00 AM




safe

Keep Beauty Regimen Safe During Pregnancy, Doctor Advises

Title: Keep Beauty Regimen Safe During Pregnancy, Doctor Advises
Category: Health News
Created: 4/30/2013 2:35:00 PM
Last Editorial Review: 5/1/2013 12:00:00 AM




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Lung Cancer Surgery May Be Safest at High-Volume Hospitals, Study Finds

Title: Lung Cancer Surgery May Be Safest at High-Volume Hospitals, Study Finds
Category: Health News
Created: 4/29/2014 12:35:00 PM
Last Editorial Review: 4/30/2014 12:00:00 AM




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Many Pregnant Women Think E-Cigarettes 'Safer' Than Regular Cigarettes

Title: Many Pregnant Women Think E-Cigarettes 'Safer' Than Regular Cigarettes
Category: Health News
Created: 4/30/2015 12:00:00 AM
Last Editorial Review: 5/1/2015 12:00:00 AM




safe

Swim Safely This Summer

Title: Swim Safely This Summer
Category: Health News
Created: 4/23/2016 12:00:00 AM
Last Editorial Review: 4/25/2016 12:00:00 AM




safe

Let Safety Bloom in Your Garden This Season

Title: Let Safety Bloom in Your Garden This Season
Category: Health News
Created: 4/22/2016 12:00:00 AM
Last Editorial Review: 4/25/2016 12:00:00 AM




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Nipple-Preserving Mastectomies Appear Safe for High-Risk Women: Study

Title: Nipple-Preserving Mastectomies Appear Safe for High-Risk Women: Study
Category: Health News
Created: 4/25/2016 12:00:00 AM
Last Editorial Review: 4/26/2016 12:00:00 AM




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Contraception Safety Program for Acne Drug Failing in Canada

Title: Contraception Safety Program for Acne Drug Failing in Canada
Category: Health News
Created: 4/25/2016 12:00:00 AM
Last Editorial Review: 4/26/2016 12:00:00 AM




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When Grandparents Raise Grandkids, Are They Up to Date on Child Safety?

Title: When Grandparents Raise Grandkids, Are They Up to Date on Child Safety?
Category: Health News
Created: 5/4/2017 12:00:00 AM
Last Editorial Review: 5/4/2017 12:00:00 AM




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Health Tip: Be a Safe Driver for Your Kids

Title: Health Tip: Be a Safe Driver for Your Kids
Category: Health News
Created: 5/5/2017 12:00:00 AM
Last Editorial Review: 5/5/2017 12:00:00 AM




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Ecstasy May Help Some PTSD Sufferers, but Safety Issues Remain

Title: Ecstasy May Help Some PTSD Sufferers, but Safety Issues Remain
Category: Health News
Created: 5/1/2018 12:00:00 AM
Last Editorial Review: 5/2/2018 12:00:00 AM




safe

Make Your Amusement Park Visits Safe

Title: Make Your Amusement Park Visits Safe
Category: Health News
Created: 5/4/2018 12:00:00 AM
Last Editorial Review: 5/4/2018 12:00:00 AM




safe

Many Smokers Switch to Vaping While Pregnant, But Safety Issues Remain

Title: Many Smokers Switch to Vaping While Pregnant, But Safety Issues Remain
Category: Health News
Created: 4/29/2019 12:00:00 AM
Last Editorial Review: 4/30/2019 12:00:00 AM




safe

Navigating the Grocery Store Safely

Title: Navigating the Grocery Store Safely
Category: Health News
Created: 4/27/2020 12:00:00 AM
Last Editorial Review: 4/27/2020 12:00:00 AM




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There Aren't Enough Coronavirus Test Kits to Safely Reopen America, Experts Warn

Title: There Aren't Enough Coronavirus Test Kits to Safely Reopen America, Experts Warn
Category: Health News
Created: 4/27/2020 12:00:00 AM
Last Editorial Review: 4/27/2020 12:00:00 AM




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On Some Farms, Washing Machines Give Leafy Greens a Spin -- But Is That Safe?

Title: On Some Farms, Washing Machines Give Leafy Greens a Spin -- But Is That Safe?
Category: Health News
Created: 4/24/2020 12:00:00 AM
Last Editorial Review: 4/24/2020 12:00:00 AM




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Study Confirms Safety, Effectiveness of Children's Vaccines

Title: Study Confirms Safety, Effectiveness of Children's Vaccines
Category: Health News
Created: 4/23/2020 12:00:00 AM
Last Editorial Review: 4/24/2020 12:00:00 AM




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Your Doctor Wants to Reschedule That Surgery. But Is It Safe Now?

Title: Your Doctor Wants to Reschedule That Surgery. But Is It Safe Now?
Category: Health News
Created: 5/7/2020 12:00:00 AM
Last Editorial Review: 5/8/2020 12:00:00 AM




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An Expert's Guide to a Safe Run in Cold Weather

Title: An Expert's Guide to a Safe Run in Cold Weather
Category: Health News
Created: 3/14/2020 12:00:00 AM
Last Editorial Review: 3/16/2020 12:00:00 AM




safe

When Is Surgery Not Safe for Seniors?

Title: When Is Surgery Not Safe for Seniors?
Category: Health News
Created: 3/12/2020 12:00:00 AM
Last Editorial Review: 3/13/2020 12:00:00 AM




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Crafting With Dry Pasta, Play-Doh Safe for Kids With Gluten Sensitivity: Study

Title: Crafting With Dry Pasta, Play-Doh Safe for Kids With Gluten Sensitivity: Study
Category: Health News
Created: 2/4/2020 12:00:00 AM
Last Editorial Review: 2/5/2020 12:00:00 AM




safe

Women Are Much Safer Drivers Than Men, British Study Finds

Title: Women Are Much Safer Drivers Than Men, British Study Finds
Category: Health News
Created: 4/7/2020 12:00:00 AM
Last Editorial Review: 4/7/2020 12:00:00 AM




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Broiling in a Heat Wave? Wet T-shirt Can Safely Cool You Down

Title: Broiling in a Heat Wave? Wet T-shirt Can Safely Cool You Down
Category: Health News
Created: 4/13/2020 12:00:00 AM
Last Editorial Review: 4/14/2020 12:00:00 AM




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Is Electroconvulsive (ECT) Therapy Safe?

Title: Is Electroconvulsive (ECT) Therapy Safe?
Category: Procedures and Tests
Created: 3/6/2020 12:00:00 AM
Last Editorial Review: 3/6/2020 12:00:00 AM




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How Safe Is It to Fly?

Title: How Safe Is It to Fly?
Category: Health News
Created: 2/24/2020 12:00:00 AM
Last Editorial Review: 2/25/2020 12:00:00 AM




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Apparent Cause Analysis: A Safety Tool

Causal analysis is a core function of safety programs. Although established protocols exist for conducting root cause analysis for serious safety events, there is limited guidance for apparent cause analysis (ACA) in health care. At our institution, through a novel facilitated ACA approach, we aim to improve safety culture and provide a clear approach to address precursor safety events and near-miss safety events. We define facilitated ACA as limited investigation (scope and duration) of a safety event that resulted in little to no harm. These investigations require fewer resources and focus on preventive strategies. Our facilitated ACA model, with an operational algorithm and structured process, was developed and implemented at our tertiary-care, freestanding, urban pediatric hospital in 2018. Sixty-four ACAs were completed, and 83% were identified with the algorithm. Process measures, including time from event reporting to ACA launch (median 3 days; interquartile range 2–6 days), are tracked. Patient safety consultants averaged 5 hours to complete a facilitated ACA. A median of 3 disciplines or departments participated in each facilitated ACA. Through an iterative process, we implemented a structured process for facilitated ACA, and the model’s strength includes (1) right event, (2) right team, (3) right analysis, and (4) right action plans. This novel facilitated ACA model may support organizational cause analysis and improve safety culture with higher-reliability processes.




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Differential Response of the Chicken Trachea to Chronic Infection with Virulent Mycoplasma gallisepticum Strain Ap3AS and Vaxsafe MG (Strain ts-304): a Transcriptional Profile [Host Response and Inflammation]

Mycoplasma gallisepticum is the primary etiological agent of chronic respiratory disease in chickens. Live attenuated vaccines are most commonly used in the field to control the disease, but current vaccines have some limitations. Vaxsafe MG (strain ts-304) is a new vaccine candidate that is efficacious at a lower dose than the current commercial vaccine strain ts-11, from which it is derived. In this study, the transcriptional profiles of the trachea of unvaccinated chickens and chickens vaccinated with strain ts-304 were compared 2 weeks after challenge with M. gallisepticum strain Ap3AS during the chronic stage of infection. After challenge, genes, gene ontologies, pathways, and protein classes involved in inflammation, cytokine production and signaling, and cell proliferation were upregulated, while those involved in formation and motor movement of cilia, formation of intercellular junctional complexes, and formation of the cytoskeleton were downregulated in the unvaccinated birds compared to the vaccinated birds, reflecting immune dysregulation and the pathological changes induced in the trachea by infection with M. gallisepticum. Vaccination appears to protect the structural and functional integrity of the tracheal mucosa 2 weeks after infection with M. gallisepticum.




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Renal, Cardiovascular, and Safety Outcomes of Canagliflozin by Baseline Kidney Function: A Secondary Analysis of the CREDENCE Randomized Trial

Background

Canagliflozin reduced renal and cardiovascular events in people with type 2 diabetes in the CREDENCE trial. We assessed efficacy and safety of canagliflozin by initial estimated glomerular filtration rate (eGFR).

Methods

CREDENCE randomly assigned 4401 participants with an eGFR of 30 to <90 ml/min per 1.73 m2 and substantial albuminuria to canagliflozin 100 mg or placebo. We used Cox proportional hazards regression to analyze effects on renal and cardiovascular efficacy and safety outcomes within screening eGFR subgroups (30 to <45, 45 to <60, and 60 to <90 ml/min per 1.73 m2) and linear mixed effects models to analyze the effects on eGFR slope.

Results

At screening, 1313 (30%), 1279 (29%), and 1809 (41%) participants had an eGFR of 30 to <45, 45 to <60, and 60 to <90 ml/min per 1.73 m2, respectively. The relative benefits of canagliflozin for renal and cardiovascular outcomes appeared consistent among eGFR subgroups (all P interaction >0.11). Subgroups with lower eGFRs, who were at greater risk, exhibited larger absolute benefits for renal outcomes. Canagliflozin’s lack of effect on serious adverse events, amputations, and fractures appeared consistent among eGFR subgroups. In all subgroups, canagliflozin use led to an acute eGFR drop followed by relative stabilization of eGFR loss. Among those with an eGFR of 30 to <45 ml/min per 1.73 m2, canagliflozin led to an initial drop of 2.03 ml/min per 1.73 m2. Thereafter, decline in eGFR was slower in the canagliflozin versus placebo group (–1.72 versus –4.33 ml/min per 1.73 m2; between-group difference 2.61 ml/min per 1.73 m2).

Conclusions

Canagliflozin safely reduced the risk of renal and cardiovascular events, with consistent results across eGFR subgroups, including the subgroup initiating treatment with an eGFR of 30 to <45 ml/min per 1.73 m2. Absolute benefits for renal outcomes were greatest in subgroups with lower eGFR.

Clinical Trial registry name and registration number

Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy (CREDENCE), NCT02065791.




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Efficacy and safety of two doses of budesonide/formoterol fumarate metered dose inhaler in COPD

Inhaled corticosteroid/long-acting β2-agonist combination therapy is a recommended treatment option for patients with chronic obstructive pulmonary disease (COPD) and increased exacerbation risk, particularly those with elevated blood eosinophil levels. SOPHOS (NCT02727660) evaluated the efficacy and safety of two doses of budesonide/formoterol fumarate dihydrate metered dose inhaler (BFF MDI) versus formoterol fumarate dihydrate (FF) MDI, each delivered using co-suspension delivery technology, in patients with moderate-to-very severe COPD and a history of exacerbations.

In this phase 3, randomised, double-blind, parallel-group, 12–52-week, variable length study, patients received twice-daily BFF MDI 320/10 µg or 160/10 µg, or FF MDI 10 µg. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV1) at week 12. Secondary and other endpoints included assessments of moderate/severe COPD exacerbations and safety.

The primary analysis (modified intent-to-treat) population included 1843 patients (BFF MDI 320/10 µg, n=619; BFF MDI 160/10 µg, n=617; and FF MDI, n=607). BFF MDI 320/10 µg and 160/10 µg improved morning pre-dose trough FEV1 at week 12 versus FF MDI (least squares mean differences 34 mL [p=0.0081] and 32 mL [p=0.0134], respectively), increased time to first exacerbation (hazard ratios 0.827 [p=0.0441] and 0.803 [p=0.0198], respectively) and reduced exacerbation rate (rate ratios 0.67 [p=0.0001] and 0.71 [p=0.0010], respectively). Lung function and exacerbation benefits were driven by patients with blood eosinophil counts ≥150 cells·mm–3. The incidence of adverse events was similar, and pneumonia rates were low (≤2.4%) across treatments.

SOPHOS demonstrated the efficacy and tolerability of BFF MDI 320/10 µg and 160/10 µg in patients with moderate-to-very severe COPD at increased risk of exacerbations.




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Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial

OBJECTIVE

Most individuals with type 2 diabetes also have obesity, and treatment with some diabetes medications, including insulin, can cause further weight gain. No approved chronic weight management medications have been prospectively investigated in individuals with overweight or obesity and insulin-treated type 2 diabetes. The primary objective of this study was to assess the effect of liraglutide 3.0 mg versus placebo on weight loss in this population.

RESEARCH DESIGN AND METHODS

Satiety and Clinical Adiposity—Liraglutide Evidence (SCALE) Insulin was a 56-week, randomized, double-blind, placebo-controlled, multinational, multicenter trial in individuals with overweight or obesity and type 2 diabetes treated with basal insulin and ≤2 oral antidiabetic drugs.

RESULTS

Individuals were randomized to liraglutide 3.0 mg (n = 198) or placebo (n = 198), combined with intensive behavioral therapy (IBT). At 56 weeks, mean weight change was –5.8% for liraglutide 3.0 mg versus –1.5% with placebo (estimated treatment difference –4.3% [95% CI –5.5; –3.2]; P < 0.0001). With liraglutide 3.0 mg, 51.8% of individuals achieved ≥5% weight loss versus 24.0% with placebo (odds ratio 3.41 [95% CI 2.19; 5.31]; P < 0.0001). Liraglutide 3.0 mg was associated with significantly greater reductions in mean HbA1c and mean daytime glucose values and less need for insulin versus placebo, despite a treat-to-glycemic-target protocol. More hypoglycemic events were observed with placebo than liraglutide 3.0 mg. No new safety or tolerability issues were observed.

CONCLUSIONS

In individuals with overweight or obesity and insulin-treated type 2 diabetes, liraglutide 3.0 mg as an adjunct to IBT was superior to placebo regarding weight loss and improved glycemic control despite lower doses of basal insulin and without increases in hypoglycemic events.




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Efficacy and Safety of Use of the Fasting Algorithm for Singaporeans With Type 2 Diabetes (FAST) During Ramadan: A Prospective, Multicenter, Randomized Controlled Trial [Original Research]

PURPOSE

We aimed to evaluate the efficacy and safety of use of the Fasting Algorithm for Singaporeans with Type 2 Diabetes (FAST) during Ramadan.

METHODS

We performed a prospective, multicenter, randomized controlled trial. The inclusion criteria were age ≥21 years, baseline glycated hemoglobin (HbA1c) level ≤9.5%, and intention to fast for ≥10 days during Ramadan. Exclusion criteria included baseline estimated glomerular filtration rate <30 mL/min, diabetes-related hospitalization, and short-term corticosteroid therapy. Participants were randomized to intervention (use of FAST) or control (usual care without FAST) groups. Efficacy outcomes were HbA1c level and fasting blood glucose and postprandial glucose changes, and the safety outcome was incidence of major or minor hypoglycemia during the Ramadan period. Glycemic variability and diabetes distress were also investigated. Linear mixed models were constructed to assess changes.

RESULTS

A total of 97 participants were randomized (intervention: n = 46, control: n = 51). The HbA1c improvement during Ramadan was 4 times greater in the intervention group (–0.4%) than in the control group (–0.1%) (P = .049). The mean fasting blood glucose level decreased in the intervention group (–3.6 mg/dL) and increased in the control group (+20.9 mg/dL) (P = .034). The mean postprandial glucose level showed greater improvement in the intervention group (–16.4 mg/dL) compared to the control group (–2.3 mg/dL). There were more minor hypoglycemic events based on self-monitered blood glucose readings in the control group (intervention: 4, control: 6; P = .744). Glycemic variability was not significantly different between the 2 groups (P = .284). No between-group differences in diabetes distress were observed (P = .479).

CONCLUSIONS

Our findings emphasize the importance of efficacious, safe, and culturally tailored epistemic tools for diabetes management.




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Anticoagulants Safety and Effectiveness in General Practice: A Nationwide Prospective Cohort Study [Original Research]

PURPOSE

Most real-world studies on anticoagulants have been based on health insurance databases or performed in secondary care. The aim of this study was to compare safety and effectiveness between patients treated with vitamin K antagonists (VKAs) and patients treated with direct oral anticoagulants (DOACs) in a general practice setting.

METHODS

The CACAO study (Comparison of Accidents and their Circumstances with Oral Anticoagulants) is a multicenter prospective cohort study conducted among ambulatory patients taking an oral anticoagulant. Participants were patients from the study’s cross-sectional phase receiving oral anticoagulants because of nonvalvular atrial fibrillation, for secondary prevention of venous thromboembolism, or both. They were followed as usual for 1 year by their general practitioners, who collected data on changes in therapy, thromboembolic events, bleeding, and deaths. All events were adjudicated by an independent committee. We used a propensity score and a Cox regression model to derive hazard ratios.

RESULTS

Between April and December 2014, a total of 3,082 patients were included. At 1 year, 42 patients (1.7%) had experienced an arterial or venous event; 151 (6.1%) had experienced bleeding, including 47 (1.9%) who experienced major bleeding; and 105 (4.1%) had died. There was no significant difference between the VKA and DOAC groups regarding arterial or venous events, or major bleeding. The VKA group had a lower risk of overall bleeding (hazard ratio = 0.65; 95% CI, 0.43-0.98) but twice the risk of death (hazard ratio = 1.98; 95% CI, 1.15-3.42).

CONCLUSIONS

VKAs and DOACs had fairly similar safety and effectiveness in general practice. The substantially higher incidence of deaths with VKAs is consistent with known data from health insurance databases and calls for further research to understand its cause.




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On the Frontline of the COVID-19 Outbreak: Keeping Patients on Long-Term Dialysis Safe




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Additional safety consideration for azithromycin in the management of SARS-CoV-2 infection [Letters]




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Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Neuroendocrine Tumors: Results From the Phase II KEYNOTE-158 Study

Purpose:

KEYNOTE-158 (ClinicalTrials.gov identifier: NCT02628067) investigated the efficacy and safety of pembrolizumab across multiple cancers. We present results from patients with previously treated advanced well-differentiated neuroendocrine tumors (NET).

Patients and Methods:

Pembrolizumab 200 mg was administered every 3 weeks for 2 years or until progression, intolerable toxicity, or physician/patient decision. Tumor imaging was performed every 9 weeks for the first year and then every 12 weeks. Endpoints included objective response rate (ORR) per RECIST v1.1 by independent central radiologic review (primary) and duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety (secondary).

Results:

A total of 107 patients with NETs of the lung, appendix, small intestine, colon, rectum, or pancreas were treated. Median age was 59.0 years (range, 29–80), 44.9% had ECOG performance status 1, 40.2% had received ≥3 prior therapies for advanced disease, and 15.9% had PD-L1–positive tumors (combined positive score ≥1). Median follow-up was 24.2 months (range, 0.6–33.4). ORR was 3.7% (95% CI, 1.0–9.3), with zero complete responses and four partial responses (three pancreatic and one rectal) all in patients with PD-L1–negative tumors. Median DOR was not reached, with one of four responses ongoing after ≥21 months follow-up. Median PFS was 4.1 months (95% CI, 3.5–5.4); the 6-month PFS rate was 39.3%. Median OS was 24.2 months (95% CI, 15.8–32.5). Treatment-related adverse events (AE) occurred in 75.7% of patients, 21.5% of whom had grade 3–5 AEs.

Conclusions:

Pembrolizumab monotherapy showed limited antitumor activity and manageable safety in patients with previously treated advanced well-differentiated NETs.




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Efficacy and Safety of Duvelisib Following Disease Progression on Ofatumumab in Patients with Relapsed/Refractory CLL or SLL in the DUO Crossover Extension Study

Purpose:

In the phase III DUO trial, duvelisib, an oral dual PI3K-, inhibitor, demonstrated significantly improved efficacy versus ofatumumab [median (m) progression-free survival (PFS), 13.3 vs. 9.9 months (HR, 0.52; P < 0.0001); overall response rate [ORR], 74% vs. 45% (P < 0.0001)], with a manageable safety profile in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). We report results from patients with progressive disease (PD) after ofatumumab who crossed over to duvelisib in the DUO trial.

Patients and Methods:

Patients with radiographically confirmed PD after ofatumumab received duvelisib 25 mg twice daily in 28-day cycles until PD, intolerance, death, or study withdrawal. The primary endpoint was ORR per investigator. Secondary endpoints included duration of response (DOR), PFS, and safety.

Results:

As of December 14, 2018, 90 ofatumumab-treated patients in the DUO trial prior to crossover had an ORR of 29%, mDOR of 10.4 months, and mPFS of 9.4 months. After crossover, 77% of patients (69/90) achieved a response, with an mDOR of 14.9 months and mPFS of 15.7 months. Patients with del(17p) and/or TP53 mutations had similar outcomes [ORR, 77% (20/26); mPFS, 14.7 months]. Notably, 73% of patients (47/64) with disease previously refractory to ofatumumab achieved a response. The most frequent any-grade/grade 3/4 treatment-emergent adverse events were diarrhea (47%/23%), neutropenia (26%/23%), pyrexia (24%/4%), cutaneous reactions (23%/4%), and thrombocytopenia (10%/6%).

Conclusions:

Duvelisib demonstrated high response rates with good durability and a manageable safety profile in patients with R/R CLL/SLL who progressed on ofatumumab, including patients with high-risk disease and disease previously refractory to ofatumumab.




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Safety and Pharmacokinetic Characterization of Nacubactam, a Novel {beta}-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers [Clinical Therapeutics]

Nacubactam is a novel β-lactamase inhibitor with dual mechanisms of action as an inhibitor of serine β-lactamases (classes A and C and some class D) and an inhibitor of penicillin binding protein 2 in Enterobacteriaceae. The safety, tolerability, and pharmacokinetics of intravenous nacubactam were evaluated in single- and multiple-ascending-dose, placebo-controlled studies. Healthy participants received single ascending doses of nacubactam of 50 to 8,000 mg, multiple ascending doses of nacubactam of 1,000 to 4,000 mg every 8 h (q8h) for up to 7 days, or nacubactam of 2,000 mg plus meropenem of 2,000 mg q8h for 6 days after a 3-day lead-in period. Nacubactam was generally well tolerated, with the most frequently reported adverse events (AEs) being mild to moderate complications associated with intravenous access and headache. There was no apparent relationship between drug dose and the pattern, incidence, or severity of AEs. No clinically relevant dose-related trends were observed in laboratory safety test results. No serious AEs, dose-limiting AEs, or deaths were reported. After single or multiple doses, nacubactam pharmacokinetics appeared linear, and exposure increased in an approximately dose-proportional manner across the dose range investigated. Nacubactam was excreted largely unchanged into urine. Coadministration of nacubactam with meropenem did not significantly alter the pharmacokinetics of either drug. These findings support the continued clinical development of nacubactam and demonstrate the suitability of meropenem as a potential β-lactam partner for nacubactam. (The studies described in this paper have been registered at ClinicalTrials.gov under NCT02134834 [single ascending dose study] and NCT02972255 [multiple ascending dose study].)




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Efficacy and Safety of Flow-Diverter Therapy for Recurrent Aneurysms after Stent-Assisted Coiling [INTERVENTIONAL]

BACKGROUND AND PURPOSE:

Flow-diverter treatment for previously stented aneurysms has been reported to be less effective and prone to complications. In this study, we evaluated the effectiveness and safety of flow diverters for recurrent aneurysms after stent-assisted coiling.

MATERIALS AND METHODS:

Patients who underwent flow-diverter placement for recurrent aneurysms after stent-assisted coiling between March 2015 and March 2019 were recruited. Clinical and radiographic characteristics and clinical and angiographic outcomes were retrospectively evaluated.

RESULTS:

Among 133 patients who underwent flow-diverter insertion, 17 (male/female ratio = 5:12; mean age, 53.8 years) were treated for recurrent aneurysms after stent placement with (n = 16) or without (n = 1) coiling. Eight patients initially presented with subarachnoid hemorrhage; 7, with headache; and 2, with visual field defects. Angiographic morphology included large/giant saccular in 12 patients, dissecting in 2, fusiform in 1, traumatic pseudoaneurysm in 1, and ruptured blood blister-like aneurysm in 1. The duration between the first treatment and flow-diverter placement ranged from 2 weeks to 15 months (median, 6 months). Flow-diverter placement was successful in all cases without any complications. All patients had favorable outcomes (mRS, 0–2), without any newly appearing symptoms. Aneurysms were followed up with conventional angiography at least once in 6–18 months. Sixteen aneurysms showed complete occlusion, and 1 aneurysm was enlarged.

CONCLUSIONS:

Results from this case series investigating flow-diverter placement for recurrent aneurysms after stent-assisted coiling suggested that the procedure is safe and effective. Further study in a larger population may be warranted.




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3 options for safe investment when liquidity of land lot segment drops

Many investors have shifted their money into real estate for lease or short-term deposit in banks as the liquidity of land lot segment has declined sharply.




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Gold-coated fabric that emits own light could be ultimate safety gear

Clothes that light up by themselves could be a high-tech replacement to high-visibility gear worn by cyclists and construction workers




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Radar safety system protects only 7 per cent of UK smart motorways

The UK government has pledged to make smart motorways safer by rolling out a radar detection system within the next three years, but New Scientist can reveal that just 7 per cent of the roads are protected by the measure today




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COVIDSafe Still Has Bugs, According To Experts

There has been a lot of discussion surrounding the government's coronavirus tracing app, COVIDSafe, but at the forefront has been issues of privacy and its ability to work properly on devices. With the federal government tying the easing of social restrictions to app downloads, developers have reverse engineered the app to find out what's actually wrong with it. Here's what they've found. More »
    




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Oh Wow: Exploding A Hand Grenade Inside A Safe

This is a video of Youtuber Edward Sarkissian exploding an M67 frag grenade inside an 87-pound steel SentrySafe fire/waterproof home safe to see what will happen. What happens? It gets BLOWN UP. So, if you were wondering if "inside a home safe" would be a secure place to dispose of your extra grenades, the answer is not even for the first one, and definitely none after that. So while this safe may be fireproof, it certainly isn't *lobs dog toy like hand grenade, bounces off wall and back at my feet* fire-in-the-holeproof. Keep going for the video (everything up to 4:15 is prepping the grenade inside the safe), as well as a video of opening a safe with grenades taped to the outside (with $10,000 and a gold bar inside).



  • blowing things up
  • blown up sir
  • explosion
  • fire in all the holes!
  • fire in the hole!
  • fire in your hole!
  • great there go all my valuables
  • grenades
  • having a great time
  • kaboom
  • living the dream
  • safe
  • the opposite of safe
  • video
  • wait what
  • weapons of war

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Safely relaxing social distancing comes down to numbers

Your house number could be the key to the safe relaxation of COVID-19-related restrictions if governments follow a new exit strategy, which proposes the use of an 'odds-and-evens' approach to allowing people to head back to work and enjoy other activities after weeks of lockdown.




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Here are some coronavirus shopping tips to keep you safe at the supermarket

The more people we encounter, the higher the risk of virus transmission. So, how do we keep safe when going to the shops?




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John Legend: 'We're just hoping everybody stays safe and stays healthy'

John Legend joins Zane Lowe on Apple Music to run through his ‘At Home With’ playlist. He talks about how he’s coping at home