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Noninferiority

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https://www.readbyqxmd.com/read/28081304/comparison-of-an-ac-taxane-versus-ac-free-regimen-and-paclitaxel-versus-docetaxel-in-patients-with-lymph-node-positive-breast-cancer-final-results-of-the-national-surgical-adjuvant-study-of-breast-cancer-02-trial-a-randomized-comparative-phase-3-study
#1
Toru Watanabe, Masaru Kuranami, Kenichi Inoue, Norikazu Masuda, Kenjiro Aogi, Shinji Ohno, Hiroji Iwata, Hirofumi Mukai, Yukari Uemura, Yasuo Ohashi
BACKGROUND: In postoperative patients with breast cancer, the combination of an anthracycline and cyclophosphamide (AC) followed by a taxane is a standard regimen. In the current study, the authors examined whether AC could be safely omitted, and compared the effectiveness of paclitaxel versus docetaxel. METHODS: Female postoperative patients with axillary lymph node-positive breast cancer were eligible for enrollment in this phase 3, open-label, randomized controlled trial at 84 centers in Japan...
January 12, 2017: Cancer
https://www.readbyqxmd.com/read/28079812/the-efficacy-of-elastomeric-patient-control-module-when-connected-to-a-balloon-pump-for-postoperative-epidural-analgesia-a-randomized-noninferiority-trial
#2
Myung Hwa Kim, Yon Hee Shim, Min-Soo Kim, Yang-Sik Shin, Hyun Joo Lee, Jeong Soo Lee
When considering the principles of a pain control strategy by patients, reliable administration of additional bolus doses is important for providing the adequate analgesia and improving patient satisfaction. We compared the efficacy of elastomeric patient-control module (PCM) with conventional PCM providing epidural analgesia postoperatively.A noninferiority comparison was used. Eighty-six patients scheduled for open upper abdominal surgery were randomized to use either an elastomeric or conventional PCM connected to balloon pump...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28079554/latest-evidence-on-transcatheter-aortic-valve-implantation-vs-surgical-aortic-valve-replacement-for-the-treatment-of-aortic-stenosis-in-high-and-intermediate-risk-patients
#3
Fabien Praz, George C M Siontis, Subodh Verma, Stephan Windecker, Peter Jüni
PURPOSE OF REVIEW: The goal of this review is to summarize the current evidence supporting the use of transcatheter aortic valve implantation (TAVI) in high and intermediate-risk patients. The focus is on the five randomized controlled trials comparing TAVI with surgical aortic valve replacement (SAVR) published to date, as well as two recent meta-analyses. RECENT FINDINGS: TAVI has profoundly transformed the treatment of elderly patients presenting with symptomatic severe aortic stenosis...
January 11, 2017: Current Opinion in Cardiology
https://www.readbyqxmd.com/read/28078647/sitagliptin-a-review-in-type-2-diabetes
#4
Lesley J Scott
The dipeptidyl peptidase-4 inhibitor sitagliptin (Januvia(®); Glactiv(®); Tesavel(®); Xelevia™) is approved in more than 130 countries worldwide as monotherapy and in combination with other antihyperglycaemic drugs for the treatment of adult patients with type 2 diabetes (T2D). Extensive clinical experience has firmly established the glycaemic efficacy of oral sitagliptin (±other antihyperglycaemic drugs) in a broad spectrum of patients with T2D, including obese, elderly and renally impaired patients and those with established cardiovascular (CV) disease (CVD)...
January 11, 2017: Drugs
https://www.readbyqxmd.com/read/28077507/stroke-and-mortality-risk-in-patients-with-various-patterns-of-atrial-fibrillation-results-from-the-engage-af-timi-48-trial-effective-anticoagulation-with-factor-xa-next-generation-in-atrial-fibrillation-thrombolysis-in-myocardial-infarction-48
#5
Mark S Link, Robert P Giugliano, Christian T Ruff, Benjamin M Scirica, Heikke Huikuri, Ali Oto, Andrea E Crompton, Sabina A Murphy, Hans Lanz, Michele F Mercuri, Elliott M Antman, Eugene Braunwald
BACKGROUND: Whether the pattern of atrial fibrillation (AF) modifies the risk/benefit of anticoagulation is controversial. In ENGAGE AF-TIMI 48 trial (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48), the factor Xa inhibitor edoxaban was noninferior to warfarin in preventing stroke or systemic embolic events and significantly reduced bleeding and cardiovascular mortality. However, detailed analyses by AF pattern have not been reported...
January 2017: Circulation. Arrhythmia and Electrophysiology
https://www.readbyqxmd.com/read/28077046/rational-use-of-rasburicase-for-the-treatment-and-management-of-tumor-lysis-syndrome
#6
Suhail A Shaikh, Bernard L Marini, Shannon M Hough, Anthony J Perissinotti
Purpose There is a lack of high-level evidence identifying meaningful outcomes and the optimal place in therapy of rasburicase in patients with, or at high risk for tumor lysis syndrome. The primary objective of this study was to evaluate and characterize outcomes resulting from an institution-specific guideline emphasizing supportive care, xanthine oxidase inhibitors, and lower doses of rasburicase. Methods In this retrospective chart review, we compared conservative rasburicase dosing, in accordance with newly developed UMHS tumor lysis syndrome guidelines, with aggressive rasburicase in adult patients (≥ 18 years of age) with hematological or solid tumor malignancies, and a uric acid level between 8 and 15 mg/dL...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28076247/5-day-versus-10-day-course-of-fluoroquinolones-in-outpatient-males-with-a-urinary-tract-infection-uti
#7
Geoffrey A Mospan, Kurt A Wargo
INTRODUCTION: Current guidelines classify urinary tract infections (UTIs) in males as complicated and recommend longer treatment than for UTIs in females. The objective of this study is to demonstrate that males with UTIs may be successfully treated with an outpatient 5-day course of levofloxacin. METHODS: Data were obtained from a previously conducted clinical trial (www.clinicaltrials.gov identifier NCT00210886), a multicenter, double-blind, randomized, noninferiority study comparing levofloxacin 750 mg intravenously/by mouth once daily for 5 days and ciprofloxacin 400/500 mg intravenously/by mouth twice daily for 10 days in complicated UTI (cUTI)...
November 2016: Journal of the American Board of Family Medicine: JABFM
https://www.readbyqxmd.com/read/28073858/boosting-immune-responses-following-fractional-dose-inactivated-poliovirus-vaccine-a-randomized-controlled-trial
#8
Sonia Resik, Alina Tejeda, Manuel Diaz, Hiromasa Okayasu, Carolyn Sein, Natalie A Molodecky, Magile Fonseca, Nilda Alemany, Gloria Garcia, Lai Heng Hung, Yenisleydis Martinez, Roland W Sutter
BACKGROUND:  Fractional-dose administration of inactivated poliovirus vaccine (fIPV) could increase IPV affordability and stretch limited supplies. We assessed immune responses following fIPV administered intradermally, compared with full-dose IPV administered intramuscularly, among adults with a history of oral poliovirus vaccine (OPV) receipt. METHODS:  We conducted a randomized, controlled noninferiority trial in Cuba. fIPV or IPV were administered on days 0 and 28; serum was collected on days 0, 7, 28, and 56 for analysis by a neutralization assay...
January 9, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28069068/the-sygma-programme-of-phase-3-trials-to-evaluate-the-efficacy-and-safety-of-budesonide-formoterol-given-as-needed-in-mild-asthma-study-protocols-for-two-randomised-controlled-trials
#9
Paul M O'Byrne, J Mark FitzGerald, Nanshan Zhong, Eric Bateman, Peter J Barnes, Christina Keen, Gun Almqvist, Kristine Pemberton, Carin Jorup, Stefan Ivanov, Helen K Reddel
BACKGROUND: In many patients with mild asthma, the low frequency of symptoms and the episodic nature of exacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance on short-acting β2-agonist (SABA) reliever medication and under-treatment of the underlying inflammation, with poor control of asthma symptoms and increased risk of exacerbations. The use of budesonide/formoterol 'as needed' in response to symptoms may represent an alternative treatment option for patients with mild asthma...
January 10, 2017: Trials
https://www.readbyqxmd.com/read/28066111/clinical-effectiveness-and-safety-of-low-cost-versus-innovator-brand-amlodipine-in-hypertension-a-single-blinded-randomized-crossover-noninferiority-trial
#10
Alak Kumar Das, Suparna Chatterjee, Jyotirmoy Pal
OBJECTIVES: A single-blinded, randomized, crossover, noninferiority trial was conducted to evaluate clinical effectiveness and safety of low-cost brand (LCB) versus innovator brand (IB) amlodipine in essential hypertension. MATERIALS AND METHODS: The primary end-point was change of systolic blood pressure (BP) from baseline to study end. Adult patients with Stage 1 hypertension or isolated systolic hypertension were randomized to receive 5 mg amlodipine LCB or IB once daily for 6 weeks in each period in a 2 × 2 crossover manner with three follow-up visits in each sequence...
November 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28063718/second-date-appendectomy-operating-for-failure-of-nonoperative-treatment-in-perforated-appendicitis
#11
Marco Lotti
BACKGROUND: Nonoperative treatment of acute appendicitis is embraced by many surgical teams, driven by low to moderate quality randomized studies that support noninferiority of antibiotics versus appendectomy for treatment of acute uncomplicated appendicitis. Several flaws of these studies have emerged, especially in the recruitment strategy and in the diagnostic criteria that were used. The growing confidence given to antibiotics, together with the lack of reliable criteria to distinguish between uncomplicated and perforated appendicitis, exposes patients with perforated appendicitis to the likelihood to be treated with antibiotics instead of surgery...
January 2, 2017: American Journal of Emergency Medicine
https://www.readbyqxmd.com/read/28062552/time-to-change-dosing-of-inactivated-quadrivalent-influenza-vaccine-in-young-children-evidence-from-a-phase-iii-randomized-controlled-trial
#12
Varsha K Jain, Joseph B Domachowske, Long Wang, Opokua Ofori-Anyinam, Miguel A Rodríguez-Weber, Michael L Leonardi, Nicola P Klein, Gary Schlichter, Robert Jeanfreau, Byron L Haney, Laurence Chu, Jo-Ann S Harris, Kwabena O Sarpong, Amanda C Micucio, Jyoti Soni, Vijayalakshmi Chandrasekaran, Ping Li, Bruce L Innis
BACKGROUND: Children under 3 years of age may benefit from a double-dose of inactivated quadrivalent influenza vaccine (IIV4) instead of the standard-dose. METHODS: We compared the only United States-licensed standard-dose IIV4 (0.25 mL, 7.5 µg hemagglutinin per influenza strain) versus double-dose IIV4 manufactured by a different process (0.5 mL, 15 µg per strain) in a phase III, randomized, observer-blind trial in children 6-35 months of age (NCT02242643). The primary objective was to demonstrate immunogenic noninferiority of the double-dose for all vaccine strains 28 days after last vaccination...
January 6, 2017: Journal of the Pediatric Infectious Diseases Society
https://www.readbyqxmd.com/read/28058589/assessment-of-effects-of-atomoxetine-in-adult-patients-with-adhd-consistency-among-three-geographic-regions-in-a-response-maintenance-study
#13
Yoko Tanaka, Rodrigo Escobar, Himanshu P Upadhyaya
A previous study (Upadhyaya et al. in Eur J Psychiatry 2013b; 27:185-205) reported that adults with attention-deficit/hyperactivity disorder (ADHD) demonstrated maintenance of response for up to 25 weeks after initially responding to atomoxetine treatment. In the present report, the consistency of treatment effect across three geographic regions (Europe, United States/Canada [US/Can], and Latin America [Latin Am]) was explored. Data were analyzed from a phase 3, multicenter, randomized, double-blind, maintenance-of-response (randomized withdrawal) trial of atomoxetine versus placebo in adults with ADHD...
January 6, 2017: Attention Deficit and Hyperactivity Disorders
https://www.readbyqxmd.com/read/28056202/trastuzumab-emtansine-with-or-without-pertuzumab-versus-trastuzumab-plus-taxane-for-human-epidermal-growth-factor-receptor-2-positive-advanced-breast-cancer-primary-results-from-the-phase-iii-marianne-study
#14
Edith A Perez, Carlos Barrios, Wolfgang Eiermann, Masakazu Toi, Young-Hyuck Im, Pierfranco Conte, Miguel Martin, Tadeusz Pienkowski, Xavier Pivot, Howard Burris, Jennifer A Petersen, Sven Stanzel, Alexander Strasak, Monika Patre, Paul Ellis
Purpose Trastuzumab and pertuzumab are human epidermal growth factor receptor 2 (HER2) -targeted monoclonal antibodies, and trastuzumab emtansine (T-DM1) is an antibody-drug conjugate that combines the properties of trastuzumab with the cytotoxic activity of DM1. T-DM1 demonstrated encouraging efficacy and safety in a phase II study of patients with previously untreated HER2-positive metastatic breast cancer. Combination T-DM1 and pertuzumab showed synergistic activity in cell culture models and had an acceptable safety profile in a phase Ib and II study...
January 10, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28053508/critical-role-of-tedizolid-in-the-treatment-of-acute-bacterial-skin-and-skin-structure-infections
#15
REVIEW
Olivia Ferrández, Olatz Urbina, Santiago Grau
Tedizolid phosphate has high activity against the Gram-positive microorganisms mainly involved in acute bacterial skin and skin structure infections, such as strains of Staphylococcus aureus (including methicillin-resistant S. aureus strains and methicillin-sensitive S. aureus strains), Streptococcus pyogenes, Streptococcus agalactiae, the Streptococcus anginosus group, and Enterococcus faecalis, including those with some mechanism of resistance limiting the use of linezolid. The area under the curve for time 0-24 hours/minimum inhibitory concentration (MIC) pharmacodynamic ratio has shown the best correlation with the efficacy of tedizolid, versus the time above MIC ratio and the maximum drug concentration/minimum inhibitory concentration ratio...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28035545/dtap5-hb-ipv-hib-vaccine-vaxelis-%C3%A2-a-review-of-its-use-in-primary-and-booster-vaccination
#16
Yahiya Y Syed
Vaxelis(®) is a fully liquid, ready-to-use, hexavalent vaccine approved in the EU for primary and booster vaccination in infants and toddlers from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b (Hib). It contains diphtheria and tetanus toxoids, five acellular pertussis antigens, recombinant hepatitis B virus surface antigen produced in the yeast, Saccharomyces cerevisiae, inactivated poliovirus, and the Hib polysaccharide (polyribosylribitol phosphate) conjugated to the outer membrane protein complex of Neisseria meningitidis...
December 29, 2016: Paediatric Drugs
https://www.readbyqxmd.com/read/28033291/adductor-canal-block-versus-femoral-nerve-block-combined-with-sciatic-nerve-block-as-an-anesthetic-technique-for-hindfoot-and-ankle-surgery-a-prospective-randomized-noninferiority-trial
#17
Han Bum Joe, Ho Sik Choo, Ji Sang Yoon, Sang Eon Oh, Jae Ho Cho, Young Uk Park
BACKGROUND: A femoral nerve block (FNB) in combination with a sciatic nerve block (SNB) is commonly used for anesthesia and analgesia in patients undergoing hindfoot and ankle surgery. The effects of FNB on motor function, related fall risk, and rehabilitation are controversial. An adductor canal block (ACB) potentially spares motor fibers in the femoral nerve, but the comparative effect on hindfoot and ankle surgeries between the 2 approaches is not yet well defined. We hypothesized that compared to FNB, ACB would cause less weakness in the quadriceps and produce similar pain scores during and after the operation...
December 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28030724/a-propensity-score-matched-analysis-of-robotic-vs-open-pancreatoduodenectomy-on-incidence-of-pancreatic-fistula
#18
Matthew T McMillan, Amer H Zureikat, Melissa E Hogg, Stacy J Kowalsky, Herbert J Zeh, Michael H Sprys, Charles M Vollmer
Importance: The adoption of robotic pancreatoduodenectomy (RPD) is gaining momentum; however, its impact on major outcomes, including pancreatic fistula, has yet to be adequately compared with open pancreatoduodenectomy (OPD). Objective: To demonstrate that use of RPD does not increase the incidence of clinically relevant pancreatic fistula (CR-POPF) compared with OPD. Design, Setting, and Participants: Data were accrued from 2846 patients who underwent pancreatoduodenectomies (OPDs, n = 2661; RPDs, n = 185), performed by 51 surgeons at 17 institutions worldwide (2003-2015)...
December 28, 2016: JAMA Surgery
https://www.readbyqxmd.com/read/28030702/effect-of-longer-interval-vs-standard-dosing-of-zoledronic-acid-on-skeletal-events-in-patients-with-bone-metastases-a-randomized-clinical-trial
#19
Andrew L Himelstein, Jared C Foster, James L Khatcheressian, John D Roberts, Drew K Seisler, Paul J Novotny, Rui Qin, Ronald S Go, Stephen S Grubbs, Tracey O'Connor, Mario R Velasco, Douglas Weckstein, Ann O'Mara, Charles L Loprinzi, Charles L Shapiro
Importance: Zoledronic acid, a third-generation aminobisphosphonate, reduces the incidence of skeletal-related events and pain in patients with bone metastases. The optimal dosing interval for zoledronic acid is uncertain. Objective: To determine whether zoledronic acid administered every 12 weeks is noninferior to zoledronic acid administered every 4 weeks. Design, Setting, Participants: Randomized, open-label clinical trial conducted at 269 academic and community sites in the United States...
3, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28027075/single-use-and-disposable-flexible-ureteroscopes
#20
Esteban Emiliani, Olivier Traxer
PURPOSE OF REVIEW: Flexible ureteroscopy has been widely developed in the last decade been nowadays one of the first line treatment options for urolithiasis and conservative management for upper tract urothelial tumors. Even though some unfavorable features of the reusable flexible scopes can limit the surgical procedure such as their availability, lack of sterilization or costly repairs. Disposable scopes have been developed with the intention of improving such problems. RECENT FINDINGS: To our knowledge, seven devices have been developed...
December 23, 2016: Current Opinion in Urology
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