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Konstanz, Germany

Zanchetta J.R.,Institute Investigaciones Metablicas | Bogado C.E.,Institute Investigaciones Metablicas | Cisari C.,University of Piemonte Orientale | Aslanidis S.,Hippokration General Hospital | And 3 more authors.
Current Medical Research and Opinion | Year: 2010

Objective: To determine the safety and efficacy of full-length parathyroid hormone, PTH(184), treatment for up to 36 months by evaluating bone mineral density (BMD) changes, bone histomorphometric indices, and clinical fracture incidence in postmenopausal women with osteoporosis. Background: The TOP trial demonstrated increased lumbar spine BMD (6.9) versus placebo after 18 months of PTH(184) treatment and reduced the incidence of new vertebral fractures (61; p0.001). The therapeutic benefits of long-term treatment of postmenopausal women with PTH(184) are unknown. Methods: The safety and efficacy of 36 months of once-daily dosing with 100g PTH(184) in postmenopausal women with osteoporosis were assessed. Women receiving placebo during the TOP trial were eligible for PTH(184) in the extension study. Clinical trial registration: NCT00172120. Results: Lumbar spine BMD increased by 8.5 above baseline (p<0.001) at 36 months of PTH(184) treatment, remaining stable during the last 12 months of treatment. Increases in total hip and femoral neck BMD occurred more slowly, reaching 3.2 and 3.4, respectively above baseline at 36 months (p<0.001). The total hip BMD showed no signs of reaching a limiting value although the femoral neck plateaued from months 24 to 36. Seven patients had vertebral fractures during the placebo phase of the TOP trial and before entering the extension study, but this rate decreased with the introduction of PTH(184) therapy, resulting in a single worsened vertebral fracture in the first 6 months and no further vertebral fractures from months 6 to 36. Treatment over 36 months with PTH(184) was well-tolerated and iliac crest biopsies showed no adverse effects on bone. Limitations: There was no placebo group for BMD comparisons. The number of patients assessed for fracture incidence was small. Conclusions: PTH(184) treatment for 36 months resulted in significant increases in BMD at the lumbar spine and hip, was associated with a lower incidence of vertebral fracture when compared to before therapy initiation, and was well-tolerated. The continuous increases in total hip BMD suggest that prolonged PTH(184) treatment may be beneficial for postmenopausal osteoporosis. Increased BMD at the femoral neck and lumbar spine also showed favourable changes but plateaued between 24 and 36 months. Long-term treatment was not associated with abnormalities in bone biopsies. © 2010 Informa UK Ltd All rights reserved. Source


Viborg Mortensen F.,University Hospital | Birth M.,Klinik fur Allgemein | Gunther K.,Hauptabteilung fur Allgemein und Viszeralchirurgie | Habicht A.,Signifikans ApS | And 2 more authors.
Gesundheitsokonomie und Qualitatsmanagement | Year: 2012

Aim: The aim of this study was to evaluate treatments for haemostasis and the potential hospital resource use implications of these treatments by way of expert assessment. Methods: This analysis was based on data from a non-interventional surveillance study, which enrolled 3098 patients at 227 centres in 12 European countries. All patients received a haemostatic sealing patch (TachoSil®, Nycomed GmbH, Zurich, Switzerland), with the decision to use TachoSil made by the surgeon. Data on duration of surgery, hospital length of stay (LOS) and use of blood products were collected. Surgeons were asked to compare TachoSil with products or procedures they would otherwise have used. Results: Mean duration of surgery was 192.1 minutes and mean hospital LOS was 17.5 days. According to surgeons, operating time would have been significantly reduced with TachoSil versus the potential alternative in 55.5% of patients (p<0.001). Surgeons predicted that the use of TachoSil would reduce duration of surgery by 12.2 minutes. Choice of alternative treatment, type of surgery and country had a significant effect on surgeons assessment. TachoSil was thought to offer greater benefits in anti-coagulated patients with a normal pre-operative coagulation test and in emergency surgery. Conclusion: The use of topical haemostatic agents such as TachoSil may offer benefits with regard to hospital resource use. copy; Georg Thieme Verlag KG · Stuttgart · New York. Source


Vissers D.,Mapi Values | Stam W.,Mapi Values | Nolte T.,Schmerz und Palliativzentrum | Lenre M.,Nycomed | Jansen J.,Mapi Values
Current Medical Research and Opinion | Year: 2010

Objective: To compare the efficacy of intranasal fentanyl spray (INFS), oral transmucosal fentanyl citrate (OTFC), fentanyl buccal tablet (FBT) and oral morphine (OM) for the treatment of breakthrough cancer pain (BTCP). Methods: A systematic literature review (Medline, EMBASE, BIOSIS; 19962007) identified six randomised controlled trials (RCTs) investigating the effects of INFS, OTFC, FBT and OM for the treatment of BTCP. The endpoint of interest was pain intensity difference (PID, reported on a 010 numeric rating scale [NRS]) up to 60 minutes after intake. Results of all trials were analysed simultaneously with a mixed treatment comparison (extended meta-analysis). MTC can be considered a valid method when included studies are comparable regarding effect modifying baseline patient and study characteristics. Results: INFS provided the greatest reduction in pain relative to placebo: PID 1.7 points (95 CrI: 1.4; 1.9) at 15 minutes, 2.0 (1.6; 2.3) at 30 minutes, 2.0 (1.5; 2.4) at 45 minutes and 1.9 (1.5; 2.4) at 60 minutes. PID for OTFC and FBT relative to placebo were 0.4 (0.0; 0.8) and 0.5 (0.3; 0.7) at 15 minutes. Both treatments provided a reduction in pain superior to placebo at other time points. INFS displayed a more than 99 probability of providing the greatest pain reduction out of all interventions compared at 15 minutes after intake. This was maintained for any measured time point before 45 minutes when compared to FBT and for any measured time point before 60 minutes when compared to OTFC. Only from 45 minutes onwards did OM show a greater pain reduction than placebo. Conclusion: Based on currently available evidence, INFS is expected to provide the greatest improvement in the treatment of BTCP. Due to its slow onset to effect OM cannot be considered an efficacious treatment for BTCP. © 2010 Informa UK Ltd All rights reserved. Source


Marta G.M.,Vienna University Hospital | Facciolo F.,Italian National Cancer Institute | Ladegaard L.,University of Southern Denmark | Dienemann H.,University of Heidelberg | And 6 more authors.
European Journal of Cardio-thoracic Surgery | Year: 2010

Objectives: Alveolar air leakage remains a serious problem in lung surgery, being associated with increased postoperative morbidity, prolonged hospital stay and greater health-care costs. The aim of this study was to evaluate the sealing efficacy and safety of the surgical patch, TachoSil®, in lung surgery. Methods: Patients undergoing elective pulmonary lobectomy who had grade 1 or 2 air leakage (evaluated by the water submersion test) after primary stapling and limited suturing were randomised at 12 European centres to open-label treatment with TachoSil® or standard surgical treatment (resuturing, stapling or no further treatment at the surgeons' discretion). Randomisation was performed during surgery using a centralised interactive voice response system. Duration of postoperative air leakage (primary end point), reduction of intra-operative air leakage intensity (secondary end point) and adverse events (AEs), including postoperative complications, were assessed. Results: A total of 486 patients were screened and 299 received trial treatment (intent-to-treat (ITT) population: TachoSil®, n=148; standard treatment, n=151). TachoSil® resulted in a reduction in the duration of postoperative air leakage (p=0.030). Patients in the TachoSil® group also experienced a greater reduction in intra-operative air leakage intensity (p=0.042). Median time until chest drain removal was 4 days with TachoSil® and 5 days in the standard group (p=0.054). There was no difference between groups in hospital length of stay. AEs were generally similar in both groups, including postoperative complications. Conclusions: TachoSil® was superior to standard surgical treatment in reducing both postoperative air leakage duration and intra-operative air leakage intensity in patients undergoing elective pulmonary lobectomy. © 2010 European Association for Cardio-Thoracic Surgery. Source


Vollert S.,Nycomed A Takeda Company | Kaessner N.,Nycomed | Heuser A.,Nycomed A Takeda Company | Hanauer G.,Nycomed | And 5 more authors.
Diabetologia | Year: 2012

Aims/hypothesis: The cAMP-degrading phosphodiesterase 4 (PDE4) enzyme has recently been implicated in the regulation of glucagon-like peptide-1 (GLP-1), an incretin hormone with glucose-lowering properties. We investigated whether the PDE4 inhibitor roflumilast elevates GLP-1 levels in diabetic db/db mice and whether this elevation is accompanied by glucose-lowering effects. Methods: Plasma GLP-1 was determined in db/db mice after single oral administration of roflumilast or its active metabolite roflumilast-N-oxide. Diabetes-relevant variables including HbA1c, blood glucose, serum insulin, body weight, food and water intake, and pancreas morphology were determined in db/db mice treated daily for 28 days with roflumilast or roflumilast-N-oxide. Pharmacokinetic/pharmacodynamic analysis clarified the contribution of roflumilast vs its metabolite. In addition, the effect of roflumilast-N-oxide on insulin release was investigated in primary mouse islets. Results: Single treatment of db/db mice with 10 mg/kg roflumilast or roflumilast-N-oxide enhanced plasma GLP-1 2.5- and fourfold, respectively. Chronic treatment of db/db mice with roflumilast or roflumilast-N-oxide at 3 mg/kg showed prevention of disease progression. Roflumilast-N-oxide abolished the increase in blood glucose, reduced the increment in HbA1c by 50% and doubled fasted serum insulin compared with vehicle, concomitant with preservation of pancreatic islet morphology. Furthermore, roflumilast-N-oxide amplified forskolin-induced insulin release in primary islets. Roflumilast-N-oxide showed stronger glucose-lowering effects than its parent compound, consistent with its greater effect on GLP-1 secretion and explainable by pharmacokinetic/pharmacodynamic modelling. Conclusions/interpretation: Our results suggest that roflumilast and roflumilast-N-oxide delay the progression of diabetes in db/db mice through protection of pancreatic islet physiology potentially involving GLP-1 and insulin activities. © 2012 Springer-Verlag. Source

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