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Maisano F.,San Raffaele Scientific Institute | Franzen O.,Rigshospitalet | Baldus S.,University of Hamburg | Hausleiter J.,Deutsches Herzzentrum Munich | And 8 more authors.
Journal of the American College of Cardiology | Year: 2013

Objectives The purpose of this article is to report early and mid-term outcomes of the ACCESS-EU study (ACCESS-Europe A Two-Phase Observational Study of the MitraClip System in Europe), a European prospective, multicenter, nonrandomized post-approval study of MitraClip therapy (Abbott Vascular, Inc., Santa Clara, California). Background MitraClip has been increasingly performed in Europe after approval; the ACCESS-EU registry provides a snapshot of the real-world clinical demographic data and outcomes. Methods A total of 567 patients with significant mitral valve regurgitation (MR) underwent MitraClip therapy at 14 European sites. Mean logistic European System for Cardiac Operative Risk Evaluation at baseline was 23.0 ± 18.3; 84.9% patients were in New York Heart Association functional class III or IV, and 52.7% of patients had an ejection fraction ≤40%. Results The MitraClip implant rate was 99.6%. A total of 19 patients (3.4%) died within 30 days after the MitraClip procedure. The Kaplan-Meier survival at 1 year was 81.8%. Intensive care unit and hospital length of stay was 2.5 ± 6.5 days and 7.7 ± 8.2 days, respectively. Single leaflet device attachment was reported in 27 patients (4.8%). There were no MitraClip device embolizations. Thirty-six subjects (6.3%) required mitral valve surgery within 12 months after the MitraClip implant procedure. There was improvement in the severity of MR at 12 months, compared with baseline (p < 0.0001), with 78.9% of patients free from MR, severity of >2+ at 12 months. At 12 months, 71.4% of patients had New York Heart Association functional class II or class I. Six-min-walk-test improved 59.5 ± 112.4 m, and Minnesota-living-with-heart-failure score improved 13.5 ± 20.5 points. Conclusions In the real-world, post-approval experience in Europe, patients undergoing the MitraClip therapy are high-risk, elderly patients, mainly affected by functional MR. In this patient population, the MitraClip procedure is effective with low rates of hospital mortality and adverse events. © 2013 by the American College of Cardiology Foundation Published by Elsevier Inc.


NUR FÜR MEDIEN AUS EMEA: NICHT FÜR JOURNALISTEN AUS DER SCHWEIZ/ÖSTERREICH Eribulin von Eisai zeigte in Phase III-Zulassungsstudien einen noch nie dagewesenen Überlebensvorteil beim fortgeschrittenen Liposarkom[1] Der Gemeinsame Bundesausschuss (G-BA) hat den beträchtlichen Zusatznutzen von Halaven® (Eribulin) bei der Behandlung des nicht resezierbaren, fortgeschrittenen oder metastasierten Liposarkoms gegenüber Dacarbazin am 1. Dezember 2016 bestätigt.[2] In seiner Bewertung hat der G-BA insbesondere die Ergebnisse zur Gesamtmortalität, Symptomatik und zur Lebensqualität, die einen Zusatznutzen gegenüber dieser zweckmäßigen Vergleichstherapie zeigen, als entscheidungsrelevant hervorgehoben. Mit seiner Entscheidung wich der G-BA von der Empfehlung des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) vom September dieses Jahres ab. Das IQWiG hatte aus formalen bzw. methodischen Gründen die von Eisai vorgelegten Daten nicht bewertet und einen Zusatznutzen als nicht belegt erachtet. Der G-BA hingegen hat den deutlichen Überlebensvorteil von Eribulin bei Patienten mit fortgeschrittenem Liposarkom als klinisch relevante und als beträchtliche Verbesserung des therapierelevanten Nutzens gewertet.[2] Eribulin ist in der Europäischen Union indiziert für die Behandlung von erwachsenen Patienten mit nicht resezierbarem Liposarkom, die wegen einer fortgeschrittenen oder metastasierten Tumorerkrankung eine Vorbehandlung mit einer Anthrazyklin enthaltenden Therapie (sofern sie geeignet war) erhalten haben.[3] Liposarkome zählen zu den häufigsten Subtypen des Weichteilsarkoms.[4],[5] Weichteilsarkome entwickeln sich aus Zellen wichtiger Gewebe wie Muskeln, Nerven, Bindegewebe und Blut,[6] wobei Liposarkome aus Fettzellen entstehen und potenziell überall im Körper auftreten können.[6] "Es ist sehr ermutigend, dass der G-BA den Nutzen, den Eribulin Patienten mit fortgeschrittenem Liposarkom bietet, anerkannt hat. Angesichts der begrenzten Behandlungsoptionen für diese Erkrankung sind neue und wirksame Therapien dringend notwendig. Eribulin kann diesen Bedarf decken, da es einen statistisch signifikanten und bedeutenden Überlebensvorteil gegenüber Dacarbazin, einer etablierten und international akzeptierten Behandlungsoption des fortgeschrittenen Weichteilsarkoms, gezeigt hat", kommentiert Prof. Dr. med Viktor Grünwald, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover. Die Entscheidung des G-BA basiert auf den Daten der Studie 309,[1] die zeigten, dass Eribulin das Gesamtüberleben im Vergleich zu Dacarbazin bei Patienten mit fortgeschrittenem Liposarkom signifikant verlängert. In dieser Studie zeigte sich für Patienten mit nicht resezierbarem, fortgeschrittenem oder metastasiertem Liposarkom, die mit Eribulin behandelt wurden, ein um 7,2 Monate verlängertes medianes Gesamtüberleben im Vergleich zu Patienten, die mit Dacarbazin behandelt wurden (15,6 Monate vs. 8,4 Monate medianes Gesamtüberleben, Hazard Ratio (HR) = 0,511; 95%-KI 0,346-0,753; p = 0,0006).[1] Die häufigsten unerwünschten Ereignisse mit Grad 3 oder 4 (über 5 %) waren Neutropenie, Anämie und Leukopenie unter Eribulin sowie Anämie, Neutropenie und Thrombozytopenie unter Dacarbazin.[1] "Wir freuen uns, dass der G-BA - das oberste Beschlussgremium der gemeinsamen Selbstverwaltung im deutschen Gesundheitswesen - den beträchtlichen Zusatznutzen von Eribulin gegenüber Dacarbazin für Patienten mit nicht resezierbarem, fortgeschrittenem oder metastasiertem Liposarkom anerkannt hat. Das fortgeschrittene Liposarkom ist bereits der zweite Tumortyp, bei dem Eribulin einen Gesamtüberlebensvorteil gezeigt hat. Wir glauben, dass Eribulin einen noch nie dagewesenen Nutzen für Patienten in Deutschland bietet und freuen uns auf gute Gespräche mit dem GKV-Spitzenverband, um basierend auf dieser positiven Entscheidung einen Erstattungspreis zu verhandeln", kommentiert Dr. Patrik Höller, Leiter der Oncology Business Group, Eisai GmbH, Frankfurt. Eribulin ist in der Europäischen Union ebenfalls für die Behandlung von erwachsenen Patienten mit lokal fortgeschrittenem oder metastasiertem Brustkrebs zugelassen, bei denen nach mindestens einer Chemotherapie zur Behandlung einer fortgeschrittenen oder metastasierten Brustkrebserkrankung eine weitere Progression eingetreten ist. Die Vortherapien sollen ein Anthrazyklin und ein Taxan entweder als adjuvante Therapie oder im Rahmen der metastasierten Situation enthalten haben, es sei denn, diese Behandlungen waren ungeeignet für den Patienten.[3] Eisai widmet sich der Erforschung, Entwicklung und Herstellung innovativer onkologischer Therapien, die einen echten Unterschied ausmachen und sich positiv auf das Leben der Patienten und ihrer Familien auswirken können. Dieses leidenschaftliche Interesse am Menschen ist Teil der Unternehmensphilosophie human health care (hhc) von Eisai, die zum Ziel hat, ein besseres Verständnis für die Bedürfnisse von Patienten und ihren Familien zu entwickeln und so deren Lebensqualität zu verbessern. Eribulin ist der erste Wirkstoff mit neuartigem Wirkmechanismus aus der Klasse der Halichondrine. Strukturell handelt es sich bei Eribulin um eine vereinfachte, synthetisch hergestellte Version von Halichondrin B, einem Naturprodukt, das aus dem Meeresschwamm Halichondria okadai isoliert wird. Es wird angenommen, dass Eribulin die Wachstumsphase der Mikrotubuli-Dynamik hemmt und so die Zellteilung verhindert. Studie 309 war eine randomisierte, offene, multizentrische Phase-III-Studie zum Vergleich der Wirksamkeit und Sicherheit von Eribulin (1,23 mg/m2, i.v. an Tag 1 und 8) mit Dacarbazin (850, 1000 oder 1200 mg/m2, i.v. an Tag 1) bei Verabreichung beider Medikamente in einem 21-Tageszyklus. 452 Patienten (ab dem Alter von 18 Jahren) mit Weichteilsarkom wurden randomisiert. Der primäre Endpunkt der Studie war das Gesamtüberleben. Zu den weiteren Endpunkten zählten u.a. progressionsfreies Überleben und Lebensqualität. Über Eisai EMEA in der Onkologie Eisai engagiert sich in der Entwicklung und Bereitstellung neuer Behandlungen mit hohem Nutzen für Menschen mit Krebs. Die Entwicklung therapeutischer Optionen in der Onkologie ist ein strategisch wichtiges Geschäftsfeld von Eisai in Europa, Nahost, Afrika, Russland und Ozeanien (EMEA). In der Europäischen Union bietet Eisai aktuell drei zugelassene Präparate in vier Indikationen an: Eisai Co., Ltd. ist ein führendes, weltweit agierendes forschungs- und entwicklungsorientiertes (F&E) Pharmaunternehmen mit Hauptsitz in Japan. Eisai hat sein Unternehmensleitbild wie folgt definiert: Im Mittelpunkt stehen die Patienten und ihre Angehörigen sowie die Verbesserung der Gesundheitsfürsorge - wir nennen dies unsere "human health care (hhc)"-Philosophie. Mit über 10.000 Mitarbeiterinnen und Mitarbeitern in unserem weltweiten Netzwerk von Forschungs- und Entwicklungseinrichtungen, Produktionsstätten und Vertriebsniederlassungen arbeiten wir an der Verwirklichung unserer hhc-Philosophie, indem wir innovative Produkte in verschiedenen therapeutischen Bereichen anbieten, in denen ein hoher ungedeckter medizinischer Bedarf besteht, wie etwa der Onkologie und der Neurologie. Als global tätiges pharmazeutisches Unternehmen engagieren wir uns gemäß unserem Unternehmensleitbild für Patienten überall auf der Welt - durch Investitionen und Beteiligungen an partnerschaftlichen Initiativen zur Verbesserung des Zugangs zu Arzneimitteln in Entwicklungs- und Schwellenländern. Weitere Informationen zu Eisai Co., Ltd. finden Sie unter: http://www.eisai.com. 2. Beschluss und Tragende Gründe des G-BA verfügbar unter: https://www.g-ba.de/informationen/beschluesse/2775/. Zugriff im Dezember 2016 5. Macmillan. Types of soft tissue sarcoma. Abrufbar unter: http://www.macmillan.org.uk/cancerinformation/cancertypes/softtissuesarcomas/aboutsofttissuesarcomas/typesofsofttissuesarcoma.aspx Zugriff im Dezember 2016


FOR EMEA MEDIA ONLY: NOT FOR SWISS/AUSTRIAN JOURNALISTS The German Federal Joint Committee (G-BA) has confirmed the considerable additional benefit for Halaven® (eribulin) compared to dacarbazine in the treatment of unresectable advanced or metastatic liposarcoma.[2] In its assessment, the G-BA found the data for mortality, symptoms and quality of life, which showed an additional benefit over the appropriate comparator, to be decisive. With its decision, the G-BA did not follow the recommendation of the German Institute for Quality and Efficiency in Health Care (IQWiG) - put forward in September this year - to not grant an additional benefit based on formal grounds only which resulted in the IQWiG not evaluating the clinical data provided by Eisai initially. In contrast, the G-BA judged the substantial survival benefit eribulin offers to patients with advanced liposarcoma to be a clinically relevant and considerable improvement of the therapy-relevant benefit.[2] Eribulin is indicated in the European Union for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.[3] Liposarcomas are one of the most common subtypes of soft tissue sarcomas (STS).[4],[5] STS develop from cells in essential tissues such as muscle, nerves, fibrous tissues and blood,[6] with liposarcomas arising from fat cells and potentially occurring anywhere in the body.[6] "It is very encouraging that the G-BA has recognised the benefit eribulin offers to patients with advanced liposarcoma. Given the limited treatment options for this condition, new and effective therapies are urgently needed. Eribulin clearly addresses this need as it has demonstrated a statistically significant and relevant survival advantage over dacarbazine, an established and internationally accepted treatment option for advanced soft tissue sarcoma," comments Prof. Dr. Viktor Grünwald, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover. The G-BA assessment was supported by data from study 309, a randomized phase III trial in unresectable advanced or metastatic pretreated leiomyosarcoma or liposarcoma patients. The results showed that eribulin significantly improves overall survival (OS) versus dacarbazine in a preplanned subgroup analysis of patients with advanced liposarcoma. In this study, patients with liposarcoma that were treated with eribulin had a 7.2 months longer median overall survival than those treated with dacarbazine (15.6 months versus 8.4 months median OS, HR = 0.511; 95% CI 0.346-0.753; p=0.0006).[1] The most common (above 5%) adverse events of Grade 3 or 4 observed in the eribulin arm were neutropenia, anaemia and leukopenia, and in the dacarbazine arm were anaemia, neutropenia and thrombocytopenia.[1] "We are pleased that the G-BA - the supreme decision making body in German statutory healthcare - recognised the considerable value eribulin brings to people with unresectable advanced or metastatic liposarcoma compared to dacarbazine. Advanced liposarcoma is the second tumour type in which eribulin has demonstrated an overall survival benefit. We believe eribulin offers an unprecedented benefit to patients in Germany, and look forward to positive talks with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) to negotiate reimbursement prices based on this favourable G-BA decision," comments Dr. Patrik Höller, Director Oncology Business Group, Eisai GmbH, Frankfurt, Germany. Eribulin is also licensed in the European Union for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.[3] Eisai is dedicated to the discovery, development and production of innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives to better understand the needs of patients and their families to increase the benefits health care provides. Halaven® (eribulin)    Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally, eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. Global Phase III Clinical Study 309[1] Study 309 is a randomised, open-label multicentre phase III study to compare the efficacy and safety of eribulin mesylate (1.4 mg/m2, IV on days 1 and 8) to dacarbazine (850, 1,000 or 1,200 mg/m2, IV on day 1) with both drugs administered in a 21-day cycle. 452 patients (aged 18 or over) with soft tissue sarcomas of leiomyosarcoma or liposarcoma subtype were randomized 1:1. The primary endpoint of the study was overall survival. Additional endpoints included progression-free survival and quality of life. About Eisai EMEA in Oncology Eisai is committed to the development and delivery of highly beneficial new treatments for people with cancer. The development of therapeutic options in oncology is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA). In the European Union, Eisai currently has three marketed treatments across four indications: About Eisai Co., Ltd. Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With close to 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology. As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries. For more information about Eisai Co., Ltd., please visit http://www.eisai.com. 1. Schöffski P et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. The Lancet. 2016 6. Macmillan. What are soft tissue sarcomas? Available at:   http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Softtissuesarcomas/Aboutsofttissuesarcomas/Softtissuesarcomas.aspx. Accessed: December 2016


Rummel M.J.,Justus Liebig University | Niederle N.,Klinikum Leverkusen | Maschmeyer G.,Ernst von Bergmann Klinikum | Banat G.A.,Justus Liebig University | And 16 more authors.
The Lancet | Year: 2013

Background: Rituximab plus chemotherapy, most often CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), is the first-line standard of care for patients with advanced indolent lymphoma, and for elderly patients with mantle-cell lymphoma. Bendamustine plus rituximab is effective for relapsed or refractory disease. We compared bendamustine plus rituximab with CHOP plus rituximab (R-CHOP) as first-line treatment for patients with indolent and mantle-cell lymphomas. Methods: We did a prospective, multicentre, randomised, open-label, non-inferiority trial at 81 centres in Germany between Sept 1, 2003, and Aug 31, 2008. Patients aged 18 years or older with a WHO performance status of 2 or less were eligible if they had newly diagnosed stage III or IV indolent or mantle-cell lymphoma. Patients were stratified by histological lymphoma subtype, then randomly assigned according to a prespecified randomisation list to receive either intravenous bendamustine (90 mg/m2 on days 1 and 2 of a 4-week cycle) or CHOP (cycles every 3 weeks of cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and vincristine 1·4 mg/m2 on day 1, and prednisone 100 mg/day for 5 days) for a maximum of six cycles. Patients in both groups received rituximab 375 mg/m2 on day 1 of each cycle. Patients and treating physicians were not masked to treatment allocation. The primary endpoint was progression-free survival, with a non-inferiority margin of 10%. Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00991211, and the Federal Institute for Drugs and Medical Devices of Germany, BfArM 4021335. Findings: 274 patients were assigned to bendamustine plus rituximab (261 assessed) and 275 to R-CHOP (253 assessed). At median follow-up of 45 months (IQR 25-57), median progression-free survival was significantly longer in the bendamustine plus rituximab group than in the R-CHOP group (69·5 months [26·1 to not yet reached] vs 31·2 months [15·2-65·7]; hazard ratio 0·58, 95% CI 0·44-0·74; p<0·0001). Bendamustine plus rituximab was better tolerated than R-CHOP, with lower rates of alopecia (0 patients vs 245 (100%) of 245 patients who recieved ≥3 cycles; p<0·0001), haematological toxicity (77 [30%] vs 173 [68%]; p<0·0001), infections (96 [37%] vs 127 [50%]); p=0·0025), peripheral neuropathy (18 [7%] vs 73 [29%]; p<0·0001), and stomatitis (16 [6%] vs 47 [19%]; p<0·0001). Erythematous skin reactions were more common in patients in the bendamustine plus rituximab group than in those in the R-CHOP group (42 [16%] vs 23 [9%]; p=0·024). Interpretation: In patients with previously untreated indolent lymphoma, bendamustine plus rituximab can be considered as a preferred first-line treatment approach to R-CHOP because of increased progression-free survival and fewer toxic effects. Funding: Roche Pharma AG, Ribosepharm/Mundipharma GmbH.


Poddubnyy D.,Charité - Medical University of Berlin | Rudwaleit M.,Endokrinologikum | Haibel H.,Charité - Medical University of Berlin | Listing J.,German Rheumatism Research Center | And 4 more authors.
Annals of the Rheumatic Diseases | Year: 2012

Objective: To investigate the influence of non-steroidal anti-inflammatory drugs (NSAIDs) intake on radiographic spinal progression over 2 years in patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (SpA). Methods: 164 patients with axial SpA (88 with AS and 76 with non-radiographic axial SpA) were selected for this analysis based on availability of spinal radiographs at baseline and after 2 years of follow-up and the data on NSAIDs intake. Spinal radiographs were scored by two trained readers in a concealed randomly selected order according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) system. An index of the NSAID intake counting both dose and duration of drug intake was calculated. Results: High NSAIDs intake (NSAID index≥50) in AS was associated with lower likelihood of significant radiographic progression defined as an mSASSS worsening by ≥2 units: OR=0.15, 95% CI 0.02 to 0.96, p=0.045 (adjusted for baseline structural damage, elevated C reactive protein (CRP) and smoking status) in comparison with patients with low NSAIDs intake (NSAID index<50). This effect was most pronounced in patients with baseline syndesmophytes plus elevated CRP: mean mSASSS progression was 4.36±4.53 in patients with low NSAIDs intake versus 0.14±1.80 with high intake, p=0.02. In non-radiographic axial SpA, no significant differences regarding radiographic progression between patients with high and low NSAIDs intake were found. Conclusion: A high NSAIDs intake over 2 years is associated with retarded radiographic spinal progression in AS. In non-radiographic axial SpA this effect is less evident, probably due to a low grade of new bone formation in the spine at this stage..


Torres A.,University of Barcelona | Blasi F.,University of Milan | Peetermans W.E.,University Hospital | Viegi G.,CNR Institute of Clinical Physiology | And 2 more authors.
European Journal of Clinical Microbiology and Infectious Diseases | Year: 2014

The purpose of this paper was to generate up-to-date information on the aetiology of community-acquired pneumonia (CAP) and its antibiotic management in adults across Europe. Structured searches of PubMed identified information on the aetiology of CAP and its antibiotic management in individuals aged >15 years across Europe. We summarise the data from 33 studies published between January 2005 and July 2012 that reported on the pathogens identified in patients with CAP and antibiotic treatment in patients with CAP. Streptococcus pneumoniae was the most commonly isolated pathogen in patients with CAP and was identified in 12.0-85.0 % of patients. Other frequently identified pathogens found to cause CAP were Haemophilus influenzae, Gram-negative enteric bacilli, respiratory viruses and Mycoplasma pneumoniae. We found several age-related trends: S. pneumoniae, H. influenzae and respiratory viruses were more frequent in elderly patients aged ≥65 years, whereas M. pneumoniae was more frequent in those aged <65 years. Antibiotic monotherapy was more frequent than combination therapy, and beta-lactams were the most commonly prescribed antibiotics. Hospitalised patients were more likely than outpatients to receive combination antibiotic therapy. Limited data on antibiotic resistance were available in the studies. Penicillin resistance of S. pneumoniae was reported in 8.4-20.7 % of isolates and erythromycin resistance was reported in 14.7-17.1 % of isolates. Understanding the aetiology of CAP and the changing pattern of antibiotic resistance in Europe, together with an increased awareness of the risk factors for CAP, will help clinicians to identify those patients most at risk of developing CAP and provide guidance on the most appropriate treatment. © 2014 The Author(s).


Introduction: Academisation, as intended by the health allied professions (i. e., physiotherapy, occupational therapy, speech and swallowing therapy), is not restricted to an education at a higher level, but also includes the claim for active research in separate and independent university institutes. Focussed on the situation in Germany, the present study examines the advantages and drawbacks of this development from the perspective of the medical specialty of Physical Medicine and Rehabilitation (PMR) in order to find adequate strategies to cope with future challenges. Methods: Based on available literature including comments and position papers, the pros and cons of academisation were critically examined, separately regarding objective medical and economic arguments and consequences as well as specific interests of the different health care professions. Results: An academic education of at least a portion of all therapists may lead to a more reflective clinical use of therapies according to the principles of evidence based medicine, although there is currently no clear-cut evidence for its superiority when compared with conventional college education. Other advantages are an improved qualification of college teachers, the acquisition of management skills, and the education of motivated and well educated therapists who may participate in scientific projects. Objections may be raised towards a direct access of patients to therapists as well as a general need for separate university institutes for the therapeutic professions in parallel to existing PRM units. Besides an improved quality of professional practice, the attempt to gain autonomy from physicians seems to be a strong motive for academisation of the health allied professions. Discussion: On the long term, there is a risk of a complete transfer of responsibilities for physical therapy and rehabilitation to the therapeutic professions with a corresponding reduced representation of the German PRM specialty at the university level. However, there are also chances inherent in this process, such as the education of qualified therapists to join scientific projects. Hence, deliberate strategies have to be elaborated to respond to these developments. © Georg Thieme Verlag KG Stuttgart · New York.


Introduction: In the last decade, an increasing number of randomized-controlled trials dealing with innovative new physiotherapeutic approaches for the treatment of Parkinsons disease have been published. Recent meta-analyses reflect this development by providing a much broader basis to evaluate their clinical effects. However, some discrepancies exist between these reports when regarding the selection of clinical trials and the estimation of therapeutic effects. The purpose of this review is to present an updated compilation of available evidence for beneficial effects of the different therapies and their clinical application. Methods: An electronic search was performed in the databases Medline, PubMed, and Google Scholar for meta-analyses, published between January 2000 and March 2014. Results: 8 meta-analyses could be identified. Level Ia evidence can be found for the efficacy of exercise, dance and cueing therapy. Also treadmill training reached level Ia evidence, although there are some discrepancies between 2 meta-analyses with different criteria for study selection. Tai Chi/Qigong and LSTV-BIG therapy reached Ib level, positive effects of a repetitive training of compensatory steps could be demonstrated on IIb level. No long lasting effect could be ascertained for whole-body vibration therapy. Positive effects of conventional physiotherapy on flexibility, and motor- and ADL functions are reported in only 3 studies. Effects sizes were always low to moderate, reaching up to 0.56. Almost all patients tested were in less advanced stages of their disease (i.e., Hoehn Yahr 2-3). General problems for an evaluation are a variable content, intensity and duration of tested treatments, as well as control groups with and without any therapy. Conclusion: The new physiotherapeutic concepts offer a promising new approach for treating symptoms of Parkinsons disease. Best effects can be expected in the treatment of bradykinesia and postural instability, so that the tested methods can be considered as a complementary approach to treat symptoms not sufficiently ameliorated by drug therapy or surgical intervention. Considering all published studies, a best practice concept is not yet available. © Georg Thieme Verlag KG Stuttgart, New York.


Menne J.,Medizinische Hochschule | Chatzikyrkou C.,Medizinische Hochschule | Haller H.,Medizinische Hochschule
Journal of Hypertension | Year: 2010

Microalbuminuria, the increase in urinary albumin excretion, has most often been linked with renal disease in diabetic patients. However, accumulating data demonstrate a link between albuminuria and cardiovascular disease in both diabetic and nondiabetic patients, even at very low levels of urinary albumin excretion once considered to be 'normal'. The reasons for the increase in cardiovascular risk may be linked to generalized vascular and endothelial dysfunction, mediated by the renin-angiotensin system and the angiotensin II type 1 receptor. Accordingly, angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers have demonstrated some success in treating microalbuminuria. With the prevalence of microalbuminuria at around 7% in the general population, and as high as 39% in diabetic patients, reducing and preventing microalbuminuria is becoming of increasing interest in helping to reduce cardiovascular risk. Subsequently, international guidelines have recommended screening for the presence of microalbuminuria in all patients with hypertension, diabetes or both. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Torresi J.,Austin Hospital | Torresi J.,University of Melbourne | Johnson D.,Austin Hospital | Johnson D.,University of Melbourne | Wedemeyer H.,Medizinische Hochschule
Journal of Hepatology | Year: 2011

Hepatitis C virus (HCV) is a blood borne disease estimated to chronically infect 3% of the worlds' population causing significant morbidity and mortality. Current medical therapy is curative in approximately 50% of patients. While recent treatment advances of genotype 1 infection using directly acting antiviral agents (DAAs) are encouraging, there is still a need to develop vaccine strategies capable of preventing infection. Moreover, vaccines may also be used in future in combination with DAAs enabling interferon-free treatment regimens. Viral and host specific factors contribute to viral evasion and present important impediments to vaccine development. Both, innate and adaptive immune responses are of major importance for the control of HCV infection. However, HCV has evolved ways of evading the host's immune response in order to establish persistent infection. For example, HCV inhibits intracellular interferon signalling pathways, impairs the activation of dendritic cells, CD8+ and CD4+ T cell responses, induces a state of T-cell exhaustion and selects escape variants with mutations CD8+ T cell epitopes. An effective vaccine will need to produce strong and broadly cross-reactive CD4+, CD8+ T cell and neutralising antibody (NAb) responses to be successful in preventing or clearing HCV. Vaccines in clinical trials now include recombinant proteins, synthetic peptides, virosome based vaccines, tarmogens, modified vaccinia Ankara based vaccines, and DNA based vaccines. Several preclinical vaccine strategies are also under development and include recombinant adenoviral vaccines, virus like particles, and synthetic peptide vaccines. This paper will review the vaccines strategies employed, their success to date and future directions of vaccine design. © 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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