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Surrogate endpoint

George A Fisher, Edward M Wolin, Nilani Liyanage, Susan Pitman Lowenthal, Beloo Mirakhur, Rodney F Pommier, Montaser Shaheen, Aaron I Vinik
OBJECTIVE: This ELECT prospective analysis examined lanreotide depot/autogel for carcinoid syndrome (CS) symptom control in patients with neuroendocrine tumors (NETs) who were responsive to prior octreotide (prior octreotide group) compared with patients who were naïve to prior somatostatin analogue treatment (de novo group). METHODS: Adults with histopathologically confirmed NET and stable CS (diarrhea and/or flushing) were randomized to subcutaneous (SC) lanreotide 120 mg or placebo every 4 weeks for 16 weeks...
March 2018: Endocrine Practice
Stuart G Baker
No abstract text is available yet for this article.
April 15, 2018: Statistics in Medicine
Ray Y Chen, Laura E Via, Lori E Dodd, Gerhard Walzl, Stephanus T Malherbe, André G Loxton, Rodney Dawson, Robert J Wilkinson, Friedrich Thienemann, Michele Tameris, Mark Hatherill, Andreas H Diacon, Xin Liu, Jin Xing, Xiaowei Jin, Zhenya Ma, Shouguo Pan, Guolong Zhang, Qian Gao, Qi Jiang, Hong Zhu, Lili Liang, Hongfei Duan, Taeksun Song, David Alland, Michael Tartakovsky, Alex Rosenthal, Christopher Whalen, Michael Duvenhage, Ying Cai, Lisa C Goldfeder, Kriti Arora, Bronwyn Smith, Jill Winter, Clifton E Barry Iii
Background : By the early 1980s, tuberculosis treatment was shortened from 24 to 6 months, maintaining relapse rates of 1-2%. Subsequent trials attempting shorter durations have failed, with 4-month arms consistently having relapse rates of 15-20%. One trial shortened treatment only among those without baseline cavity on chest x-ray and whose month 2 sputum culture converted to negative. The 4-month arm relapse rate decreased to 7% but was still significantly worse than the 6-month arm (1.6%, P<0.01).  We hypothesize that PET/CT characteristics at baseline, PET/CT changes at one month, and markers of residual bacterial load will identify patients with tuberculosis who can be cured with 4 months (16 weeks) of standard treatment...
November 6, 2017: Gates Open Res
Helen M Colhoun, M Loredana Marcovecchio
Diabetic kidney disease (DKD) remains one of the leading causes of reduced lifespan in diabetes. The quest for both prognostic and surrogate endpoint biomarkers for advanced DKD and end-stage renal disease has received major investment and interest in recent years. However, at present no novel biomarkers are in routine use in the clinic or in trials. This review focuses on the current status of prognostic biomarkers. First, we emphasise that albuminuria and eGFR, with other routine clinical data, show at least modest prediction of future renal status if properly used...
March 8, 2018: Diabetologia
Fahim Ebrahimi, Stavros Giaglis, Sinuhe Hahn, Claudine A Blum, Christine Baumgartner, Alexander Kutz, Shane Vontelin van Breda, Beat Mueller, Philipp Schuetz, Mirjam Christ-Crain, Paul Hasler
Neutrophil extracellular traps (NETs) are a hallmark of the immune response in inflammatory diseases. However, the role of NETs in community-acquired pneumonia is unknown. This study aims to characterise the impact of NETs on clinical outcomes in pneumonia.This is a secondary analysis of a randomized-controlled, multicentre trial. Patients with community-acquired pneumonia were randomly assigned to either prednisone 50 mg or placebo for 7 days. The primary endpoint was time to clinical stability; main secondary endpoints were length of hospital stay and mortality...
March 8, 2018: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
Yan Zhang, Kai-Uwe Saum, Ben Schöttker, Bernd Holleczek, Hermann Brenner
Survival predictors are of potential use for informing on biological age and targeting prevention of aging-related morbidity. We assessed associations of 2 novel methylomic survival indicators, a methylation-based mortality risk score (MRscore) and the epigenetic clock-derived age acceleration (AA), with a well-known survival predictor, frailty index (FI), and compared the 3 indicators in mortality prediction. In a large population-based cohort with 14-year follow-up, we found both MRscore and AA to be independently associated with FI, but the association was much stronger for MRscore than for AA...
March 6, 2018: Aging
Federico Rotolo, Xavier Paoletti, Stefan Michiels
BACKGROUND AND OBJECTIVE: Surrogate endpoints are attractive for use in clinical trials instead of well-established endpoints because of practical convenience. To validate a surrogate endpoint, two important measures can be estimated in a meta-analytic context when individual patient data are available: the Rindiv 2 or the Kendall's τ at the individual level, and the Rtrial 2 at the trial level. We aimed at providing an R implementation of classical and well-established as well as more recent statistical methods for surrogacy assessment with failure time endpoints...
March 2018: Computer Methods and Programs in Biomedicine
Paul R Scully, Gorka Bastarrika, James C Moon, Thomas A Treibel
PURPOSE OF REVIEW: This review article discusses the evolution of extracellular volume (ECV) quantification using both cardiovascular magnetic resonance (CMR) and computed tomography (CT). RECENT FINDINGS: Visualizing diffuse myocardial fibrosis is challenging and until recently, was restricted to the domain of the pathologist. CMR and CT both use extravascular, extracellular contrast agents, permitting ECV measurement. The evidence base around ECV quantification by CMR is growing rapidly and just starting in CT...
March 6, 2018: Current Cardiology Reports
A Popa-Cherechenau, D Schmidl, G Garhöfer, L Schmetterer
BACKGROUND: Structural endpoints have been discussed as surrogate endpoints for the approval of neuroprotective drugs in glaucoma. OBJECTIVE: Is the evidence strong enough to establish structural endpoints as surrogate endpoints? MATERIAL AND METHODS: Review of current understanding between structure and function in glaucoma. RESULTS: The introduction of optical coherence tomography has revolutionized imaging in glaucoma patients...
March 6, 2018: Der Ophthalmologe: Zeitschrift der Deutschen Ophthalmologischen Gesellschaft
Peter P Swoboda, Bara Erhayiem, Rachel Kan, Adam K McDiarmid, Pankaj Garg, Tarique A Musa, Laura E Dobson, Klaus K Witte, Mark T Kearney, Julian H Barth, Ramzi Ajjan, John P Greenwood, Sven Plein
BACKGROUND: We aimed to investigate in patients with type 2 diabetes whether aortic stiffness is: (i) associated with glycaemic control, (ii) associated with adverse outcomes and (iii) can be reversed on treatment with RAAS inhibition. METHODS: Patients with type 2 diabetes (N = 94) and low vascular risk underwent assessment of cardiovascular risk and CMR assessment of ascending aortic distensibility (AAD), descending aortic distensibility (DAD) and aortic pulse wave velocity (PWV)...
March 5, 2018: Cardiovascular Diabetology
James L Januzzi
No abstract text is available yet for this article.
March 4, 2018: JACC. Heart Failure
Veronika Brixner, Arndt-Holger Kiessling, Katharina Madlener, Markus M Müller, Johannes Leibacher, Sarah Dombos, Iuliia Weber, Hans-Ulrich Pfeiffer, Christof Geisen, Michael Schmidt, Reinhard Henschler, Anne North, Norman Huang, Nina Mufti, Anna Erickson, Christine Ernst, Salvador Rico, Richard J Benjamin, Laurence M Corash, Erhard Seifried
BACKGROUND: Nucleic acid-targeted pathogen inactivation technology using amustaline (S-303) and glutathione (GSH) was developed to reduce the risk of transfusion-transmitted infectious disease and transfusion-associated graft-versus-host disease with red blood cell (RBC) transfusion. STUDY DESIGN AND METHODS: A randomized, double-blind, controlled study was performed to assess the in vitro characteristics of amustaline-treated RBCs (test) compared with conventional (control) RBCs and to evaluate safety and efficacy of transfusion during and after cardiac surgery...
March 1, 2018: Transfusion
Manuel E Ortiz-Santaliestra, Joao P Maia, Andrés Egea-Serrano, Isabel Lopes
Amphibians and reptiles are the two most endangered groups of vertebrates. Environmental pollution by pesticides is recognised as one of the major factors threatening populations of these groups. However, the effects of pesticides on amphibians and reptiles have been studied for few substances, which is partly related to the fact that these animals are not included in the mandatory toxicity testing conducted as part of environmental risk assessments of pesticides. Whether risks of pesticides to amphibians and reptiles are addressed by surrogate taxa used in risk assessment is currently under debate...
February 28, 2018: Ecotoxicology
Antonella Palazzo, Silvia Dellapasqua, Elisabetta Munzone, Vincenzo Bagnardi, Manuelita Mazza, Giuseppe Cancello, Raffaella Ghisini, Monica Iorfida, Emilia Montagna, Aaron Goldhirsch, Marco Colleoni
BACKGROUND: Inflammatory breast cancer (IBC) is a rare and highly aggressive disease. A neoadjuvant regimen with chemotherapy and an antiangiogenic strategy was investigated. PATIENTS AND METHODS: Patients with primary or recurrent IBC who were candidates for neoadjuvant treatment received weekly carboplatin and paclitaxel plus bevacizumab every 3 weeks and oral metronomic cyclophosphamide for 6 months. Trastuzumab was added for patients with HER2+ tumors and endocrine therapy was added for patients with estrogen receptor and/or progesterone receptor ≥ 10% tumors...
February 2, 2018: Clinical Breast Cancer
Gudmundur Johannsson, Martin Bidlingmaier, Beverly Biller, Margaret Boguszewski, Felipe F Casanueva, Philippe Chanson, Catherine S Choong, Peter E Clayton, David Clemmons, Mehul Dattani, Jan Frystyk, Ken K Y Ho, Andrew Hoffman, Reiko Horikawa, Anders Juul, John Kopchick, Xiaoping Luo, Sebastian Neggers, Irène Netchine, Daniel S Olsson, Sally Radovick, Ron G Rosenfeld, Richard J Ross, Katharina Schilbach, Paulo Ferrez Collett-Solberg, Christian J Strasburger, Peter J Trainer, Kerstin Wickstrom, Kevin Cj Yuen, Jens Otto Lunde Jørgensen
OBJECTIVE: The Growth Hormone Research Society (GRS) convened a Workshop in 2017 to evaluate clinical endpoints, surrogate endpoints and biomarkers during GH treatment of children and adults, and in patients with acromegaly. PARTICIPANTS: GRS invited 34 international experts including clinicians, basic scientists, a regulatory scientist and physicians from the pharmaceutical industry. EVIDENCE: Current literature was reviewed and expert opinion was utilized to establish the state of the art, and identify current gaps and unmet needs...
February 26, 2018: Endocrine Connections
Marion Savina, Sophie Gourgou, Antoine Italiano, Derek Dinart, Virginie Rondeau, Nicolas Penel, Simone Mathoulin-Pelissier, Carine Bellera
BACKGROUND: In cancer randomized controlled trials (RCT), alternative endpoints are increasingly being used in place of overall survival (OS) to reduce sample size, duration and cost of trials. It is necessary to ensure that these endpoints are valid surrogates for OS. Our aim was to identify meta-analyses that evaluated surrogate endpoints for OS and assess the strength of evidence for each meta-analysis (MA). MATERIALS AND METHODS: We performed a systematic review to identify MA of cancer RCTs assessing surrogate endpoints for OS...
March 2018: Critical Reviews in Oncology/hematology
Ergun Velidedeoglu, Marc W Cavaillé-Coll, Shukal Bala, Ozlem A Belen, Yan Wang, Renata Albrecht
BACKGROUND: Despite major advances in understanding the pathophysiology of antibody mediated rejection (AMR); prevention, diagnosis and treatment remain unmet medical needs. It appears that early T-cell mediated rejection (TCMR), de novo donor specific antibody (dnDSA) formation and AMR result from patient or physician initiated suboptimal immunosuppression, and represent landmarks in an ongoing process rather than separate events. METHODS: On April 12-13, 2017, the Food and Drug Administration (FDA) sponsored a public workshop on AMR in kidney transplantation to discuss new advances, importance of immunosuppressive medication nonadherence in dnDSA formation, associations between AMR, cellular rejection, changes in GFR, and challenges of clinical trial design for the prevention and treatment of AMR...
February 20, 2018: Transplantation
David Jiménez, Carlos Andrés Quezada, Pilar Escribano
No abstract text is available yet for this article.
February 20, 2018: Journal of the American College of Cardiology
Edward L Korn, Boris Freidlin
Establishing trial-level surrogacy of an intermediate endpoint for predicting survival benefit in future trials is extremely challenging because of the extrapolations required, but there are other useful drug development and patient management applications of intermediate endpoints.
February 12, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Janusz Sledz, Michal Labus, Mariusz Mazij, Monika Klank-Szafran, Dariusz Karbarz, Bartosz Ludwik, Jacek Kusa, Karol Deutsch, Leslaw Szydlowski, Adrian Mscisz, Jerzy Spikowski, Aleksandra Morka, Tomasz Kameczura, Aleksandra Swietoniowska-Mscisz, Sebastian Stec
PURPOSE: During incremental atrial pacing in patients with atrioventricular nodal reentrant tachycardia, the PR interval often exceeds the RR interval (PR > RR) during stable 1:1 AV conduction. However, the PR/RR ratio has never been evaluated in a large group of patients with pacing from the proximal coronary sinus and after isoproterenol challenge. Our study validates new site of pacing and easier method of identification of PR > RR. MATERIAL AND METHODS: A prospective protocol of incremental atrial pacing from the proximal coronary sinus was carried out in 398 patients (AVNRT-228 and control-170)...
February 10, 2018: Advances in Medical Sciences
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