Search results for "dosing"
showing 10 items of 128 documents
Separating efficacy and sedative effects of guanfacine extended release in children and adolescents with ADHD from four randomized, controlled, phase…
2016
IntroductionGuanfacine extended release (GXR) is a non-stimulant treatment for attention-deficit/hyperactivity disorder (ADHD).ObjectiveTo separate efficacy and sedative treatment-emergent adverse events (TEAEs) associated with GXR in four randomized, controlled trials in children (6–12 years) and adolescents (13–17 years) with ADHD.MethodsSPD503-301 (n = 345) and SPD503-304 (n = 324) were 8 and 9 week studies of fixed-dose GXR (≤ 4 mg/day). SPD503-312 (n = 314; adolescents only) and SPD503-316 (n = 338) were 10–13 week studies of dose-optimized GXR (1–7 mg/day).ResultsIn fixed-dose studies, pooled incidences of sedative TEAEs with GXR were highest at week 1 (GXR, 13.9–18.7%; placebo, 8.7%)…
Zotepin versus Perazin bei Patienten mit paranoider Schizophrenie: eine doppelblind-kontrollierte Wirksamkeitsprüfung
1991
The dibenzothiepine zotepine is a new potential "atypical" neuroleptic exhibiting powerful antiserotonergic and antidopaminergic properties. The efficacy of zotepine was evaluated in a double-blind controlled trial versus the tricyclic neuroleptic perazine in 41 patients suffering mainly from the paranoid-hallucinatory type of schizophrenia. The key outcome variable was the extent of mental disturbance as defined by the total score of the BPRS. Additional outcome variables were GAS and CGI. In addition, adverse reactions and extrapyramidal side effects were assessed according to the FSUCL scale and the Gerlach and AIMS rating scale, respectively. Additional variables recorded were blood pre…
A systematic overview of the first pasteurised VWF/FVIII medicinal product, Haemate P/Humate -P: history and clinical performance
2008
Patients with von Willebrand disease (VWD) and haemophilia A (HA) lack, to varying degrees, the von Willebrand factor (VWF) and coagulation factor VIII (FVIII) that are critical for normal haemostasis. These conditions in turn make patients prone to uncontrolled bleeding. Historically, patients with severe forms of VWD or HA were crippled before adulthood and their life expectancy was significantly reduced. Over the past decades, specific coagulation factor replacement therapies including Haemate P, have been developed to help patients achieve and maintain normal haemostasis. Haemate P is a human, plasma-derived VWF/FVIII medicinal product, which was first licensed in Germany in 1981 for th…
Results of a Prospective, Open-Label Trial to Assess the Efficacy, Safety and Immunogenicity of Wilate® in Children Under 6 Years of Age with Inherit…
2011
Abstract Abstract 3330 Introduction: Wilate® is a new-generation plasma-derived concentrate of von Willebrand factor (VWF) and factor VIII (FVIII) developed for treatment of patients with von Willebrand disease (VWD) and haemophilia A. The objective of this study was to assess efficacy, safety and immunogenicity of Wilate in children below 6 years of age with inherited VWD. Methods: The prospective, multi-centre trial included patients with inherited VWD of any type below 6 years of age with insufficient response to DDAVP. Any clinical event requiring VWF/FVIII concentrate treatment within 1 year was treated with Wilate. Efficacy was recorded by using a 4-point VRS and in vivo recovery of F…
Factors Associated with Decisions for Initial Dosing, Up-Titration of Propiverine and Treatment Outcomes in Overactive Bladder Syndrome Patients in a…
2021
Two doses of propiverine ER (30 and 45 mg/d) are available for the treatment of overactive bladder (OAB) syndrome. We have explored factors associated with the initial dosing choice (allocation bias), the decision to adapt dosing (escalation bias) and how dosing relative to other factors affects treatment outcomes. Data from two non-interventional studies of 1335 and 745 OAB patients, respectively, receiving treatment with propiverine, were analyzed post-hoc. Multivariate analysis was applied to identify factors associated with dosing decisions and treatment outcomes. Several parameters were associated with dose choice, escalation to higher dose or treatment outcomes, but only few exhibited…
Fluence rate or cumulative dose? : Vulnerability of larval northern pike (Esox lucius) to ultraviolet radiation
2007
Newly hatched larvae of northern pike were exposed in the laboratory to four fluence rates of ultraviolet radiation (UVR; 290–400 nm) over three different time periods, resulting in total doses ranging from 3.0 ± 0.2 to 63.0 ± 4.4 kJ·m−2. Mortality and behavior of the larvae were followed for 8–12 days, and growth measured at the end of the experiment. Also, the principle of reciprocity—that the UVR-induced mortality depends on the cumulative dose, independent of fluence rate—was tested. Fluence rates higher than 1480 ± 150 mW·m−2 caused mortality and growth retardation. The highest fluence rate (3040 ± 210 mW·m−2) caused 100% mortality in 5 days. All fluence rates caused behavioral disorde…
External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical set…
2012
AimsVancomycin is one of the most evaluated antibiotics in neonates using modeling and simulation approaches. However no clear consensus on optimal dosing has been achieved. The objective of the present study was to perform an external evaluation of published models, in order to test their predictive performances in an independent dataset and to identify the possible study-related factors influencing the transferability of pharmacokinetic models to different clinical settings.MethodPublished neonatal vancomycin pharmacokinetic models were screened from the literature. The predictive performance of six models was evaluated using an independent dataset (112 concentrations from 78 neonates). T…
Subcutaneous C1 inhibitor for prevention of attacks of hereditary angioedema: additional outcomes and subgroup analysis of a placebo-controlled rando…
2019
Abstract Background Hereditary angioedema (HAE) is a debilitating disorder resulting from C1-esterase inhibitor (C1-INH) deficiency. In the COMPACT phase 3 study the prophylactic use of a subcutaneous C1 inhibitor (C1-INH [SC], HAEGARDA®, CSL Behring) twice weekly significantly reduced the frequency of acute edema attacks. Analysis of treatment effects by subgroups, onset of effect, and other exploratory analysis have not been reported. Methods This is a post hoc exploratory analysis on data from the randomized, placebo-controlled COMPACT study. 90 patients with C1-INH-HAE were randomized to 1 of 4 treatment sequences: C1-INH (SC) 40 or 60 IU/kg of body weight twice weekly for 16 weeks, pre…
Distribution and depletion of sulfadiazine after a multiple per os dosing in gilthead sea bream (Sparus aurata) fed two different diets
2013
The distribution and depletion profile of sulfadiazine (SDZ) were investigated in gilthead sea bream (Sparus aurata) fed on fish oil (FO) or plant oil-based (PO) diets. Fish averaging 230 g were given medicated feed containing 25 mg SDZ kg-1 fish for 5 days at 24-26°C. Blood and muscle plus skin were sampled on days 1, 3, 5, 6, 8 and 9. Differences in plasma and fillet SDZ levels between the two groups were statistically insignificant. The maximum drug concentrations in plasma were 3.2 ± 1.9 μg mL-1 and 2.9 ± 1.2 μg mL-1 in the PO and FO groups, respectively. In post-medicated samples depletion rapidly reached concentrations close to the level of quantification at 72 h post medication. With…
Improving adherence in osteoporosis: a new management algorithm for the patient with osteoporosis
2011
Introduction: Bisphosphonates are the first-choice treatment for osteoporosis. They effectively increase bone mineral density, reduce markers of bone resorption, and lower the incidence of new fractures in patients with osteoporosis-related fracture. However, the efficacy observed in clinical trials may not be realized in a real-life setting, partly due to poor adherence to therapy, with a significant worsening of clinical outcomes. Several issues contribute to poor adherence to osteoporosis medication, including inconvenient dosing regimens and concerns about possible adverse events. Although strategies to improve adherence have been investigated, new approaches are required. Areas covered…