Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: Twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study
Dake M.D.,Stanford University |
Scheinert D.,Park Hospital |
Tepe G.,Klinikum Rosenheim |
Tessarek J.,St Bonifatius Hospital |
And 7 more authors.
Journal of Endovascular Therapy | Year: 2011
Purpose: To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov). Methods: The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites. Results: Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5682.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months. Conclusions: These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy. © 2011 by the International Society of Endovascular Specialists.
Parker C.,National Health Research Institute |
Nilsson D Heinrich S.,Karolinska University Hospital |
Nilsson D Heinrich S.,Akershus University Hospital |
Helle S.I.,University of Bergen |
And 27 more authors.
New England Journal of Medicine | Year: 2013
Background: Radium-223 dichloride (radium-223), an alpha emitter, selectively targets bone metastases with alpha particles. We assessed the efficacy and safety of radium-223 as compared with placebo, in addition to the best standard of care, in men with castration-resistant prostate cancer and bone metastases. Methods: In our phase 3, randomized, double-blind, placebo-controlled study, we randomly assigned 921 patients who had received, were not eligible to receive, or declined docetaxel, in a 2:1 ratio, to receive six injections of radium-223 (at a dose of 50 kBq per kilogram of body weight intravenously) or matching placebo; one injection was administered every 4 weeks. In addition, all patients received the best standard of care. The primary end point was overall survival. The main secondary efficacy end points included time to the first symptomatic skeletal event and various biochemical end points. A prespecified interim analysis, conducted when 314 deaths had occurred, assessed the effect of radium-223 versus placebo on survival. An updated analysis, when 528 deaths had occurred, was performed before crossover from placebo to radium-223. Results: At the interim analysis, which involved 809 patients, radium-223, as compared with placebo, significantly improved overall survival (median, 14.0 months vs. 11.2 months; hazard ratio, 0.70; 95% confidence interval [CI], 0.55 to 0.88; two-sided P = 0.002). The updated analysis involving 921 patients confirmed the radium-223 survival benefit (median, 14.9 months vs. 11.3 months; hazard ratio, 0.70; 95% CI, 0.58 to 0.83; P<0.001). Assessments of all main secondary efficacy end points also showed a benefit of radium-233 as compared with placebo. Radium-223 was associated with low myelosuppression rates and fewer adverse events. Conclusions: In this study, which was terminated for efficacy at the prespecified interim analysis, radium-223 improved overall survival. Copyright © 2013 Massachusetts Medical Society.
PubMed | Praxis Dr. Krause, Zentrum fur HIV und Hepatogastroenterologie, University of Hamburg, Gemeinschaftspraxis and 8 more.
Type: Journal Article | Journal: Digestive diseases and sciences | Year: 2016
Multiple clinical trials have demonstrated the efficacy and safety of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB). However, long-term efficacy and safety data for TDF in real-life clinical practice are limited.Prospective German field practice study in CHB-mono-infected patients. Patients were TDF-nave but could have been treated previously with other HBV antivirals.Efficacy analysis included 400 patients; 301 (75%) completed 36months of TDF treatment. Both treatment-nave and treatment-experienced patients showed a rapid decline in HBV DNA within 3months of TDF initiation. After 36months, HBV DNA<69IU/mL was achieved by 91% of treatment-nave patients (90 and 92% in hepatitis B e antigen [HBeAg]-positive and [HBeAg]-negative, respectively) and 96% of treatment-experienced patients (93 and 97%, respectively). Three patients experienced virologic breakthrough, all with reported non-compliance. Overall, 5.7% HBeAg-positive and 2.2% HBeAg-negative patients lost hepatitis B surface antigen. Safety data were consistent with the known TDF safety profile; the most commonly reported adverse events possibly related to TDF were fatigue (2.0%) and headache (2.0%). Few patients (1.3%) experienced renal-related adverse reactions. Creatinine clearance remained relatively stable over time; patients responded favorably where TDF was dose adjusted per label for decreased creatinine clearance.TDF showed a favorable tolerability profile and induced rapid and sustained suppression of HBV DNA in patients with CHB treated for up to 3years in routine clinical practice, irrespective of treatment history. Efficacy and safety in this heterogeneous patient population were consistent with data from clinical trials.
Gluer C.-C.,Universitatsklinikum Schleswig Holstein |
Marin F.,Lilly Research Center |
Ringe J.D.,Klinikum Leverkusen |
Hawkins F.,Hospital 12 Of Octubre |
And 17 more authors.
Journal of Bone and Mineral Research | Year: 2013
Data on treatment of glucocorticoid-induced osteoporosis (GIO) in men are scarce. We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations. Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months. Primary objective was to compare lumbar spine (L1-L3) BMD measured by quantitative computed tomography (QCT). Secondary outcomes included BMD and microstructure measured by high-resolution QCT (HRQCT) at the 12th thoracic vertebra, biomechanical effects for axial compression, anterior bending, and axial torsion evaluated by finite element (FE) analysis from HRQCT data, aBMD by dual X-ray absorptiometry, biochemical markers, and safety. Computed tomography scans were performed at 0, 6, and 18 months. A mixed model repeated measures analysis was performed to compare changes from baseline between groups. Mean age was 56.3 years. Median GC dose and duration were 8.8 mg/d and 6.4 years, respectively; 39.1% of subjects had a prevalent fracture, and 32.6% received prior bisphosphonate treatment. At 18 months, trabecular BMD had significantly increased for both treatments, with significantly greater increases with teriparatide (16.3% versus 3.8%; p = 0.004). HRQCT trabecular and cortical variables significantly increased for both treatments with significantly larger improvements for teriparatide for integral and trabecular BMD and bone surface to volume ratio (BS/BV) as a microstructural measure. Vertebral strength increases at 18 months were significant in both groups (teriparatide: 26.0% to 34.0%; risedronate: 4.2% to 6.7%), with significantly higher increases in the teriparatide group for all loading modes (0.005 < p < 0.015). Adverse events were similar between groups. None of the patients on teriparatide but five (10.6%) on risedronate developed new clinical fractures (p = 0.056). In conclusion, in this 18-month trial in men with GIO, teriparatide showed larger improvements in spinal BMD, microstructure, and FE-derived strength than risedronate. Copyright © 2013 American Society for Bone and Mineral Research.
Gold R.,Ruhr University Bochum |
Comi G.,San Raffaele Scientific Institute |
Palace J.,University of Oxford |
Siever A.,Gemeinschaftspraxis |
And 5 more authors.
Journal of Neurology | Year: 2014
The aim of this study was to evaluate short-term safety and tolerability of fingolimod in a real-world population with relapsing multiple sclerosis, focusing on cardiac safety during treatment initiation. Patients received fingolimod 0.5 mg once daily for four months. Patients excluded from the pivotal studies with certain pre-existing cardiac conditions or baseline cardiac findings (PCCs), and those receiving beta blockers (BBs) and/or calcium channel blockers (CCBs), were eligible. Heart rate (HR) and electrical conduction events were monitored using ambulatory electrocardiography for at least 6 h after the first dose. Of 2,417 enrolled patients, 2,282 (94.4%) completed the study. Fingolimod initiation was associated with a transient, mostly asymptomatic decrease in HR. Bradycardia adverse events occurred in 0.6% of patients and were more frequent in individuals receiving BBs/CCBs (3.3%) than in other patient subgroups (0.5-1.4%); most events were asymptomatic, and all patients recovered without pharmacological intervention. In the 6 h post-dose, the incidences of Mobitz type I second-degree atrioventricular block (AVB) and 2:1 AVB were higher in patients with PCCs (4.1 and 2.0%, respectively) than in those without (0.9 and 0.3%, respectively); at pre-dose screening, patients with PCCs had the same incidence of Mobitz type I second-degree AVB (4.1%) and a slightly lower incidence of 2:1 AVB (0.7%) than 6 h post-dose. All recorded conduction abnormalities were asymptomatic. This study adds to the evidence showing that cardiac effects during fingolimod initiation remain consistent with those known from previous, controlled studies, even if patients with PCCs are included. © The Author(s) 2013.
The hidradenocarcinoma of the wrist - An extremely rare malignant carcinoma: Case presentation and literature review [Das Hidradenokarzinom des Handgelenkes - ein extrem seltener maligner Tumor: Falldarstellung und Literaturübersicht]
Arsalan-Werner A.,Hand Trauma Center |
Mentzel T.,Gemeinschaftspraxis |
Kempf B.,Institute For Pathologie Und Zytodiagnostik Main Taunus |
Sauerbier M.,Hand Trauma Center
Handchirurgie Mikrochirurgie Plastische Chirurgie | Year: 2013
Hidradenocarcinomas are rare, yet highly malignant tumors of eccrine sweat gland origin. Due to its locally aggressive growth and likelihood for metastasis it should be considered as a differential diagnosis especially in case of suspicious intraoperative findings. We report the case of a 73-year-old female patient presenting with a hidradenocarcinoma of the wrist. Treatment of hidradenocarcinomas is similar to the treatment of sarcomas: The first step is an incisional biopsy and obtaining an expert second opinion on the histopathological diagnosis as well as staging. The second step is a clear margin resection of the tumor and the plastic-surgical reconstruction. A long-term follow-up is mandatory to detect potential recurrence or metastasis. © Georg Thieme Verlag KG Stuttgart.
Pneumologie | Year: 2014
After 8 years the Global Initiative for Asthma (GINA) presented a fully revised report. In May 2014 the new GINA was published online [www.ginasthma.org]. On a live GINA Session at the European Respiratory Society (ERS) conference 2014 in Munich members of the board of directors and of the science committee presented the new contents, e.g. the GINA statement from page one, that GINA is Not a guideline, but a practical approach to managing asthma in clinical practice - was explicitly emphasized on the ERS. This may reflect a changing claim towards a more pragmatic attempt (but probably also the fear of liability). © Georg Thieme Verlag KG Stuttgart.
Muller U.,Justus Liebig University |
Winter P.,Justus Liebig University |
Bolender C.,Gemeinschaftspraxis |
Nolte D.,Justus Liebig University
Journal of Alzheimer's Disease | Year: 2014
Mutations in the gene PSEN2 are a rare cause of early onset Alzheimer's disease (EOAD). PSEN2 sequence variants are often only found in one patient and pathogenicity cannot be formally documented. Here we describe a previously unrecognized sequence change (c.376G>A) in PSEN2 in an EOAD patient and her likewise affected mother. This change results in the exchange of amino acid glutamic acid (E) by lysine (K) at position 126 of the protein (p.E126K). Pathogenicity of the mutation is shown by segregation with disease, evolutionary conservation of E126, and in silico analysis of the mutation. © 2014 - IOS Press and the authors. All rights reserved.
Manual treatment of postural asymmetry in infants: A practice-accompanying therapy study [Die manualmedizinische Behandlung von Haltungs- und Bewegungsasymmetrien im Säuglingsalter: Eine praxisbegleitende Therapiestudie]
Bullinger H.M.,Gemeinschaftspraxis |
Sacher R.,Gemeinschaftspraxis |
Manuelle Medizin | Year: 2012
In a non-randomized, interventional trial the results of a single manual treatment of 812 infants with kinematic imbalance due to suboccipital strain were followed up after 4 weeks. In 88% of the cases no restricted cervical movements and dysfunctions in the upper cervical region were found. Further diagnostic or functional orthopedic treatment of the infantile postural asymmetry was not indicated. The effects of a single treatment with manual techniques seem to be effective. The frequency of manual interventions will be discussed. © 2012 Springer-Verlag.
Manuelle Medizin | Year: 2011
Motoric disorders in children are often associated with problems in normal speech development. Improvements in speech development can be seen after treating functional disorders of the craniovertebral joints, in particular where logopedic therapy has not been successful. Manual medicine seems to be a good additional therapy, especially in therapy-refractive patients and can prevent long therapy careers. Success of manual techniques does not seem to follow a regular scheme and cannot be validated because qualified screening methods and studies with suitable numbers do not yet exist. Diagnostic and therapeutic concepts will be presented. © 2011 Springer-Verlag.