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Battelino T.,University of Ljubljana | Conget I.,Hospital Clinici Universitari | Olsen B.,Glostrup Hospital | Schutz-Fuhrmann I.,Hospital Hietzing | And 5 more authors.
Diabetologia | Year: 2012

Aims/hypothesis The aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitorin (CGM) to insulin pump therapy (CSII) in type 1 diabetes. Methods Children and adults (n=153) on CSII with HbA1c 7.5-9.5% (58.5-80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months. After 4 months' washout, participants crossed over to the other arm for 6 months. Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres. The primary outcome was the difference in HbA1c levels between arms after 6 months. Results Seventy-seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis. The mean difference in HbA1c was -0.43% (-4.74 mmol/mol) in favour of the Sensor On arm (8.04% [64.34 mmol/mol] vs 8.47% [69.08 mmol/mol]; 95% CI -0.32%, -0.55% [-3.50, -6.01 mmol/mol]; p<0.001). Following cessation of glucose sensing, HbA 1c reverted to baseline levels. Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p=0.009). The mean number of daily boluses increased in the Sensor On arm (6.8±2.5 vs 5.8±1.9, p<0.0001), together with the frequency of use of the temporary basal rate (0.75± 1.11 vs 0.26±0.47, p<0.0001) and manual insulin suspend (0.91±1.25 vs 0.70±0.75, p<0.018) functions. Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively (p=0.40). Conclusions/interpretation Continuous glucose monitoring was associated with decreased HbA1c levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self-adjustments of insulin therapy may have contributed to these effects.Trial registration ClinicalTrials.gov registration no. NCT00598663. Funding The study was funded by Medtronic International Trading Sarl Switzerland. © Springer-Verlag 2012.

Gnant M.,Medical University of Vienna | Pfeiler G.,Medical University of Vienna | Dubsky P.C.,Medical University of Vienna | Hubalek M.,Innsbruck Medical University | And 24 more authors.
The Lancet | Year: 2015

Background Adjuvant endocrine therapy compromises bone health in patients with breast cancer, causing osteopenia, osteoporosis, and fractures. Antiresorptive treatments such as bisphosphonates prevent and counteract these side-effects. In this trial, we aimed to investigate the effects of the anti-RANK ligand antibody denosumab in postmenopausal, aromatase inhibitor-treated patients with early-stage hormone receptor-positive breast cancer. Methods In this prospective, double-blind, placebo-controlled, phase 3 trial, postmenopausal patients with early hormone receptor-positive breast cancer receiving treatment with aromatase inhibitors were randomly assigned in a 1:1 ratio to receive either denosumab 60 mg or placebo administered subcutaneously every 6 months in 58 trial centres in Austria and Sweden. Patients were assigned by an interactive voice response system. The randomisation schedule used a randomly permuted block design with block sizes 2 and 4, stratified by type of hospital regarding Hologic device for DXA scans, previous aromatase inhibitor use, and baseline bone mineral density. Patients, treating physicians, investigators, data managers, and all study personnel were masked to treatment allocation. The primary endpoint was time from randomisation to first clinical fracture, analysed by intention to treat. As an additional sensitivity analysis, we also analysed the primary endpoint on the per-protocol population. Patients were treated until the prespecified number of 247 first clinical fractures was reached. This trial is ongoing (patients are in follow-up) and is registered with the European Clinical Trials Database, number 2005-005275-15, and with ClinicalTrials.gov, number NCT00556374. Findings Between Dec 18, 2006, and July 22, 2013, 3425 eligible patients were enrolled into the trial, of whom 3420 were randomly assigned to receive denosumab 60 mg (n=1711) or placebo (n=1709) subcutaneously every 6 months. Compared with the placebo group, patients in the denosumab group had a significantly delayed time to first clinical fracture (hazard ratio [HR] 0·50 [95% CI 0·39-0·65], p<0·0001). The overall lower number of fractures in the denosumab group (92) than in the placebo group (176) was similar in all patient subgroups, including in patients with a bone mineral density T-score of -1 or higher at baseline (n=1872, HR 0·44 [95% CI 0·31-0·64], p<0·0001) and in those with a bone mineral density T-score of less than -1 already at baseline (n=1548, HR 0·57 [95% CI 0·40-0·82], p=0·002). The patient incidence of adverse events in the safety analysis set (all patients who received at least one dose of study drug) did not differ between the denosumab group (1366 events, 80%) and the placebo group (1334 events, 79%), nor did the numbers of serious adverse events (521 vs 511 [30% in each group]). The main adverse events were arthralgia and other aromatase-inhibitor related symptoms; no additional toxicity from the study drug was reported. Despite proactive adjudication of every potential osteonecrosis of the jaw by an international expert panel, no cases of osteonecrosis of the jaw were reported. 93 patients (3% of the full analysis set) died during the study, of which one death (in the denosumab group) was thought to be related to the study drug. Interpretation Adjuvant denosumab 60 mg twice per year reduces the risk of clinical fractures in postmenopausal women with breast cancer receiving aromatase inhibitors, and can be administered without added toxicity. Since a main side-effect of adjuvant breast cancer treatment can be substantially reduced by the addition of denosumab, this treatment should be considered for clinical practice. Funding Amgen. © 2015 Elsevier Ltd.

Czerny M.,University Hospital Berne | Funovics M.,Medical University of Vienna | Schoder M.,Medical University of Vienna | Loewe C.,Medical University of Vienna | And 5 more authors.
Journal of Thoracic and Cardiovascular Surgery | Year: 2013

Thoracic endovascular aortic repair has broadened the spectrum of treatment options for various acute and chronic thoracic aortic diseases. In clinical practice, aneurysms of the descending aorta are rarely limited to 1 segment. Thus, various surgical and endovascular options have been developed to offer treatment to those patients with more extended descending thoracic aortic disease. We have summarized the most common methods of arch rerouting, depending on the aortic involvement, emphasizing that these techniques should be used very selectively by experienced cardiovascular surgery teams. Copyright © 2013 Published by Elsevier Inc. on behalf of The American Association for Thoracic Surgery.

Bracher A.,Medical University of Vienna | Cardona A.S.,Medical University of Vienna | Tauber S.,Medical University of Vienna | Tauber S.,Center for Integrative Bioinformatics Vienna | And 7 more authors.
Journal of Investigative Dermatology | Year: 2013

Alterations in epidermal growth factor (EGF) expression are known to be of prognostic relevance in human melanoma, but EGF-mediated effects on melanoma have not been extensively studied. As lymph node metastasis usually represents the first major step in melanoma progression, we were trying to identify a potential role of primary tumor-derived EGF in the mediation of melanoma lymph node metastases. Stable EGF knockdown (EGFkd) in EGF-high (M24met) and EGF-low (A375) expressing melanoma cells was generated. Only in EGF-high melanoma cells, EGFkd led to a significant reduction of lymph node metastasis and primary tumor lymphangiogenesis in vivo, as well as impairment of tumor cell migration in vitro. Moreover, EGF-induced sprouting of lymphatic but not of blood endothelial cells was abolished using supernatants of M24met EGFkd cells. In addition, M24met EGFkd tumors showed reduced vascular endothelial growth factor-C (VEGF-C) expression levels. Similarly, in human primary melanomas, a direct correlation between EGF/VEGF-C and EGF/Prox-1 expression levels was found. Finally, melanoma patients with lymph node micrometastases undergoing sentinel node biopsy were found to have significantly elevated EGF serum levels as compared with sentinel lymph node-negative patients. Our data indicate that tumor-derived EGF is important in mediating melanoma lymph node metastasis. © 2013 The Society for Investigative Dermatology.

Weiss G.,Hospital Hietzing | Tsagakis K.,University of Duisburg - Essen | Jakob H.,University of Duisburg - Essen | Di Bartolomeo R.,University of Bologna | And 6 more authors.
European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery | Year: 2015

OBJECTIVES: Providing effective treatment for complicated type B aortic dissection (AD) with concomitant pathologies of the aortic arch or ascending aorta is challenging, especially if the aortic anatomy is contraindicated for thoracic endovascular aortic repair (TEVAR). We present the early results of a multicentre study using the frozen elephant trunk (FET) technique for type B AD.METHODS: From January 2005 to March 2013, data from 465 patients who had undergone treatment with the FET technique were collected in the database of the International E-vita Open Registry. From this cohort, 57 patients who had a primary indication for surgery for type B AD were included in the present study. Their mean age was 58±12 years, and 72% had a chronic dissection. All operations were performed in circulatory arrest and bilateral antegrade cerebral perfusion. Computed aortic imaging was performed for false lumen (FL) evaluation during the follow-up.RESULTS: The in-hospital mortality rate was 14% (8/57). Stroke and spinal cord injury occurred in 6 (10%) and 2 patients (4%), respectively. The rate of immediate FL thrombosis at the level of the stent graft was 75% (40/53) and increased to 97% (41/42) during the follow-up period (23±19 months). Distally, at the level of the abdominal aorta, the FL remained patent in 50% (21/42) of patients. The 1- and 3-year survival was 81 and 75%, respectively.CONCLUSION: The FET technique is a feasible therapeutic option for complicated type B AD with involvement of the aortic arch if TEVAR is contraindicated. In contrast to conventional aortic surgery via a lateral thoracotomy, the FET procedure can provide simultaneous treatment of the ascending aorta and aortic arch. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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