Charite Campus Benjamin Franklin

Berlin, Germany

Charite Campus Benjamin Franklin

Berlin, Germany
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Schaeffner E.S.,Charite Campus Virchow | Ebert N.,Charite Campus Virchow | Delanaye P.,University of Liège | Frei U.,Charite Campus Virchow | And 8 more authors.
Annals of Internal Medicine | Year: 2012

Background: In older adults, current equations to estimate glomerular filtration rate (GFR) are not validated and may misclassify elderly persons in terms of their stage of chronic kidney disease. Objective: To derive the Berlin Initiative Study (BIS) equation, a novel estimator of GFR in elderly participants. Design: Cross-sectional. Data were split for analysis into 2 sets for equation development and internal validation. Setting: Random community-based population of a large insurance company. Participants: 610 participants aged 70 years or older (mean age, 78.5 years). Intervention: Iohexol plasma clearance measurement as gold standard. Measurements: GFR, measured as the plasma clearance of the endogenous marker iohexol, to compare performance of existing equations of estimated GFR with measured GFR of the gold standard; estimation of measured GFR from standardized creatinine and cystatin C levels, sex, and age in the learning sample; and comparison of the BIS equations (BIS1: Creatinine-based; BIS2: Creatinine- and cystatin C-based) with other estimating equations and determination of bias, precision, and accuracy in the validation sample. Results: The new BIS2 equation yielded the smallest bias followed by the creatinine-based BIS1 and Cockcroft-Gault equations. All other equations considerably overestimated GFR. The BIS equations confirmed a high prevalence of persons older than 70 years with a GFR less than 60 mL/min per 1.73 m2 (BIS1, 50.4%; BIS2, 47.4%; measured GFR, 47.9%). The total misclassification rate for this criterion was smallest for the BIS2 equation (11.6%), followed by the cystatin C equation 2 (15.1%) proposed by the Chronic Kidney Disease Epidemiology Collaboration. Among the creatinine-based equations, BIS1 had the smallest misclassification rate (17.2%), followed by the Chronic Kidney Disease Epidemiology Collaboration equation (20.4%). Limitation: There was no validation by an external data set. Conclusion: The BIS2 equation should be used to estimate GFR in persons aged 70 years or older with normal or mild to moderately reduced kidney function. If cystatin C is not available, the BIS1 equation is an acceptable alternative. © 2012 American College of Physicians.

Stone G.W.,Columbia University Medical Center | Witzenbichler B.,Charite Campus Benjamin Franklin | Weisz G.,Columbia University Medical Center | Rinaldi M.J.,Sanger Heart and Vascular Institute | And 13 more authors.
The Lancet | Year: 2013

Background The relation between platelet reactivity and stent thrombosis, major bleeding, and other adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterised. We aimed to determine the relation between platelet reactivity during dual therapy with aspirin and clopidogrel and clinical outcomes after successful coronary drug-eluting stent implantation. Methods ADAPT-DES was a prospective, multicentre registry of patients successfully treated with one or more drugeluting stents and given aspirin and clopidogrel at 10-15 US and European hospitals. We assessed platelet reactivity in those patients after successful percutaneous coronary intervention using VerifyNow point-of-care assays, and assigned different cutoffs to define high platelet reactivity. The primary endpoint was definite or probable stent thrombosis; other endpoints were all-cause mortality, myocardial infarction, and clinically relevant bleeding. We did a propensity-adjusted multivariable analysis to determine the relation between platelet reactivity and subsequent adverse events. This study is registered with, number NCT00638794. Findings Between Jan 7, 2008, and Sept 16, 2010, 8665 patients were prospectively enrolled at 11 sites, of which 8583 were eligible. At 1-year follow-up, stent thrombosis had occurred in 70 (0·8%) patients, myocardial infarction in 269 (3·1%), clinically relevant bleeding in 531 (6·2%), and death in 161 (1·9%) patients. High platelet reactivity on clopidogrel was strongly related to stent thrombosis (adjusted HR 2·49 [95% CI 1·43-4·31], p=0·001) and myocardial infarction (adjusted HR 1·42 [1·09-1·86], p=0·01), was inversely related to bleeding (adjusted HR 0·73 [0·61- 0·89], p=0·002), but was not related to mortality (adjusted HR 1·20 [0·85-1·70], p=0·30). High platelet reactivity on aspirin was not significantly associated with stent thrombosis (adjusted HR 1·46 [0·58-3·64], p=0·42), myocardial infarction, or death, but was inversely related to bleeding (adjusted HR 0·65 [0·43-0·99], p=0·04). Interpretation The findings from this study emphasise the counter-balancing effects of haemorrhagic and ischaemic complications after stent implantation, and suggest that safer drugs or tailored strategies for the use of more potent agents must be developed if the benefits of greater platelet inhibition in patients with cardiovascular disease are to be realised.

Poddubnyy D.,Charite Campus Benjamin Franklin | Rudwaleit M.,Evangelisches Krankenhaus Hagen Haspe | Haibel H.,Charite Campus Benjamin Franklin | Listing J.,German Rheumatism Research Center | And 4 more authors.
Annals of the Rheumatic Diseases | Year: 2011

Objective: To assess the progression of radiographic sacroiliitis in a cohort of patients with early axial spondyloarthritis over a period of 2 years and to explore predictors of progression. Methods: 210 patients with axial spondyloarthritis from the German Spondyloarthritis Inception Cohort have been selected for this analysis based on availability of radiographs at baseline and after 2 years of follow-up. Radiographs were centrally digitised and the sacroiliac joints were scored independently according to the grading system of the modified New York criteria for ankylosing spondylitis (AS) by two trained readers. The readers scored both time points simultaneously but were blinded for the time point and for all clinical data. Results: 115 patients (54.8%) fulfilled the modified New York criteria for AS in their radiographic part in the opinion of both readers at baseline, while 95 patients (45.2%) were classified as non-radiographic axial spondyloarthritis. More patients with non-radiographic spondyloarthritis (10.5%) compared with AS (4.4%) showed an estimated 'true' progression by at least one grade according to both readers, although the difference between the two groups was statistically non-significant. The rate of progression from non-radiographic axial spondyloarthritis to AS was 11.6% over 2 years. An elevated level of C-reactive protein (CRP) at baseline was a strong positive predictor of radiographic sacroiliitis progression in non-radiographic axial spondyloarthritis and AS (OR 3.65 and 5.08, respectively, p<0.05). Conclusion: Progression of radiographic sacroiliitis by at least one grade after 2 years occurs only in a small percentage of patients with early axial spondyloarthritis. An elevated level of CRP was found to be a strong positive predictor of sacroiliitis progression.

Zeymer U.,Institute For Herzinfarktforschung Ludwighafen | Mochmann H.-C.,Charite Campus Benjamin Franklin | Mark B.,Klinikum Ludwigshafen | Arntz H.-R.,Charite Campus Benjamin Franklin | And 4 more authors.
JACC: Cardiovascular Interventions | Year: 2015

OBJECTIVES: This study compared the timing of onset of antiplatelet action after treatment with clopidogrel and prasugrel at first medical contact in patients with ST-segment elevation myocardial infarction (STEMI) scheduled for primary percutaneous coronary intervention (PPCI). BACKGROUND: Little is known about the timing of onset of antiplatelet action after a pre-percutaneous coronary intervention (PCI) loading dose of clopidogrel or prasugrel in patients with STEMI. METHODS: This double-blind, prospective study randomized 62 patients with STEMI scheduled for PPCI in the ambulance or the emergency department to 60 mg prasugrel (n = 31) or 600 mg clopidogrel (n = 31). The primary endpoint was the platelet reactivity index (PRI) measured with the vasodilator-stimulated phosphoprotein assay 2 h after intake of the study medication. Secondary endpoints were PRI after 4 h, TIMI (Thrombolysis In Myocardial Infarction) patency of the infarct-related artery before and after PCI, and clinical events until day 30. RESULTS: The PRI after 2 h (50.4 ± 32.7% vs. 66.3 ± 22.2%; p = 0.035) and after 4 h (39.1 ± 27.5% vs. 54.5 ± 49.3%; p = 0.038) were significantly lower with prasugrel compared with clopidogrel. In addition, the rate of patients with a PRI <50% tended to be higher with prasugrel compared with clopidogrel after 2 h (46.7% vs. 28.6%; p = 0.15) and after 4 h (63.0% vs. 38.9%; p = 0.06). There were no significant differences in TIMI 2/3 patency before PCI (39.2% vs. 31.0%; p = 0.43) and TIMI 3 patency after PCI (88.5% vs. 89.3%; p = 0.92). CONCLUSIONS: The pre-PCI administration of prasugrel in patients with STEMI undergoing PPCI was associated with a significant faster platelet inhibition compared with clopidogrel. Therefore, prasugrel should be preferred to clopidogrel in this setting. (ETAMI-Study: Early Thienopyridine Treatment to Improve Primary PCI in Patients With Acute Myocardial Infarction; NCT01327534) © 2015 by the American College of Cardiology Foundation.

Poddubnyy D.,Charite Campus Benjamin Franklin | Rudwaleit M.,Ev. Krankenhaus Hagen Haspe
Expert Opinion on Drug Safety | Year: 2011

Introduction: In the last couple of years, the number of patients with chronic inflammatory rheumatic diseases being treated with TNF α antagonist has increased dramatically. Adalimumab, a fully human monoclonal antibody against TNF α, is one of the most frequently administered TNF α antagonists. Yet, unresolved issues are the long-term safety of TNF α antagonists and high treatment costs. Areas covered: The authors summarize the available data on short- and long-term efficacy and safety of adalimumab in the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. The reader will find a comprehensive overview on the safety and efficacy of adalimumab for these conditions. Clinically relevant questions of adalimumab therapy are discussed. A special focus of this review is on the safety of adalimumab therapy. Expert opinion: Adalimumab is effective and reasonably safe in the short- and long-term treatment of patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis who do not respond to the standard therapy. It inhibits radiographic progression in rheumatoid and psoriatic arthritis. Treatment with a TNF α inhibitor such as adalimumab is associated with high treatment costs. © Informa UK, Ltd.

Poddubnyy D.A.,Charite Campus Benjamin Franklin | Rudwaleit M.,Charite Campus Benjamin Franklin | Listing J.,German Rheumatism Research Center | Braun J.,Ruhr University Bochum | Sieper J.,Charite Campus Benjamin Franklin
Annals of the Rheumatic Diseases | Year: 2010

Objective: This study was aimed at comparing high sensitivity C reactive protein (hsCRP) measurement with routine C reactive protein (CRP) evaluation as disease activity parameters in patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nrSpA). Methods: A total of 269 patients (153 with AS and 116 with nrSpA) were included. Level of hsCRP was measured using particle-enhanced immunoturbidimetric method with the lowest detected level of 0.1 mg/litre. The hsCRP values were compared to results of routine turbidimetric CRP test with the lowest detected level of 6 mg/litre. Results: In the whole group of patients with AS, hsCRP showed a better than routine CRP correlation with clinical parameters. In the whole group of patients with nrSpA, hsCRP correlated with the level of enthesitis-related tenderness only. In the AS subgroup with a negative routine CRP (<6 mg/litre) there was a clear trend for an increased level of pain, stiffness and functional impairment in patients with higher hsCRP concentration. Such a trend was less pronounced in patients with nrSpA. Conclusions: hsCRP correlates better than routine CRP with clinical disease activity parameters in patients with axial SpA, especially in AS. Therefore, hsCRP could be superior to standard CRP in assessing disease activity in axial SpA.

Dimeo F.,Charite Campus Benjamin Franklin | Pagonas N.,Charite Campus Benjamin Franklin | Seibert F.,Charite Campus Benjamin Franklin | Arndt R.,Charite Campus Benjamin Franklin | And 2 more authors.
Hypertension | Year: 2012

Regular physical exercise is broadly recommended by current European and American hypertension guidelines. It remains elusive, however, whether exercise leads to a reduction of blood pressure in resistant hypertension as well. The present randomized controlled trial examines the cardiovascular effects of aerobic exercise on resistant hypertension. Resistant hypertension was defined as a blood pressure ≥140/90 mm Hg in spite of 3 antihypertensive agents or a blood pressure controlled by ≥4 antihypertensive agents. Fifty subjects with resistant hypertension were randomly assigned to participate or not to participate in an 8-to 12-week treadmill exercise program (target lactate, 2.0±0.5 mmol/L). Blood pressure was assessed by 24-hour monitoring. Arterial compliance and cardiac index were measured by pulse wave analysis. The training program was well tolerated by all of the patients. Exercise significantly decreased systolic and diastolic daytime ambulatory blood pressure by 6±12 and 3±7 mm Hg, respectively (P=0.03 each). Regular exercise reduced blood pressure on exertion and increased physical performance as assessed by maximal oxygen uptake and lactate curves. Arterial compliance and cardiac index remained unchanged. Physical exercise is able to decrease blood pressure even in subjects with low responsiveness to medical treatment. It should be included in the therapeutic approach to resistant hypertension. © 2012 American Heart Association, Inc.

Haibel H.,Charite Campus Benjamin Franklin | Sieper J.,Charite Campus Benjamin Franklin
Current Opinion in Rheumatology | Year: 2010

Purpose of review: Therapy of ankylosing spondylitis with tumor necrosis factor (TNF)-blockers is very effective in about 50% of patients. The focus of this review is to discuss how early in the course of the disease patients with axial spondyloarthritis should be treated with TNF-blockers. Recent findings: During the last 10 years TNF-blockers were investigated in established ankylosing spondylitis. More recently clinical trials focused on early treatment including patients with axial nonradiographic spondyloarthritis. It could be shown that TNF-blockers are at least as effective in patients with axial nonradiographic spondyloarthritis when compared with established ankylosing spondylitis and that TNF-blockers are even more effective when used earlier in the course of the disease and in younger age. Some data even indicate that drug-free remission might be achieved if patients are treated earlier. Active inflammation as seen by MRI can effectively be suppressed during therapy with TNF-blockers. It has been hypothesized that early anti-inflammatory treatment is the best way to prevent ankylosis, which has to be proven in future studies. Summary: TNF-blockers can achieve a higher clinical response if ankylosing spondylitis patients and patients with nonradiographic axial spondyloarthritis are treated earlier. Whether very early treatment affects ankylosis has to be further investigated. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Missner S.,Charite Campus Benjamin Franklin | Kellner U.,Charite Campus Benjamin Franklin
Graefe's Archive for Clinical and Experimental Ophthalmology | Year: 2012

Purpose To compare various screening methods for the early diagnosis of retinal dysfunction in patients with long-term chloroquine (CQ) and hydroxychloroquine (HCQ) treatment. Methods Twenty patients with long-term CQ/HCQ treatment underwent ophthalmologic evaluation including visual acuity testing, ophthalmoscopy, fluorescein angiography, color vision tests, visual field and multifocal electroretinography (mfERG). Results In 14 patients, retinal dysfunction was indicated in the mfERG (reduced amplitudes and/or delayed implicit times) in the parafoveal area. Towards the periphery, the function was normal or only moderately reduced. Ophthalmoscopy and fluorescein angiography identified pathologic retinal changes in seven of these 14 patients. Six patients had normal mfERG, ophthalmoscopy, and fluorescein angiography. Results of color vision and visual field testing were variable even in patients with morphologic alterations. Conclusion The use of mfERG may detect retinal dysfunction in a considerable number of eyes with normal ophthalmocopy and fluorescein angiography. The higher variability of color vision and visual field testing results suggests the use of mfERG as primary screening tool for retinal dysfunction in long-term CQ/HCQ treatment. © 2011 Springer-Verlag.

Dougados M.,University of Paris Descartes | Simon P.,University of Paris Descartes | Braun J.,Rheumazentrum Ruhrgebeit | Burgos-Vargas R.,Hospital General Of Mexico | And 3 more authors.
Annals of the Rheumatic Diseases | Year: 2011

The amount of NSAID intake could be considered as a clinically relevant outcome measure in ankylosing spondylitis. The information should include at least the following: (1) the type of NSAID; (2) the dose; (3) the number of days taking NSAID during the period of interest. The objectives of this initiative were to propose both an NSAID equivalent score and a way of collecting and analysing this information in longitudinal clinical studies/trials. For the NSAID equivalent scoring system, the recommendations are (1) to refer to a scale in which 0 = no intake, 100 = 150 mg diclofenac, 1000 mg naproxen, 200 mg aceclofenac, 400 mg celecoxib, 600 mg etodolac, 90 mg etoricoxib, 200 mg flurbiprofen, 2400 mg ibuprofen, 150 mg indometacin, 200 mg ketoprofen, 15 mg meloxicam, 400 mg phenylbutazone, 20 mg piroxicam, 20 mg tenoxicam; (2) to present the results as mean daily intake by considering the number of days on which NSAID has been taken during a period of interest. This initiative should facilitate the conduct and analysis of clinical studies/trials.

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