15 research outputs found
An open labeled, randomized, controlled clinical study to evaluate the efficacy of Torchnil capsules and Febcin tablet as add-on therapy for Covid-19 patients
No full textObjectives: This study was conducted to evaluate the efficacy and safety of Cap. Torchnil & Tab. Febcin when given as add-on therapy to Covid19 positive patients with moderate disease. Material and methods: Following written informed consent, patients were randomized to receive Cap. Torchnil & Tab. Febcin in addition to standard of care (SOC) [Add-on Group] or only SOC [SOC Group] for 14 days. Effect on clinical symptoms, WHO Clinical Assessment scale, hospital stay duration, time to Covid negative report, Sp02 levels and biomarkers was assessed during admission and relapse rate, if any, post discharge for 3 months. Results: 193 patients were screened and 150 completed the study, 77 in Add-on Group and 73 in SOC Group. Improvement in Covid related symptoms, WHO Assessment scale, time to covid negative report and duration of hospital stay was observed earlier in Add-on Group. Statistically significant fall in biomarker levels viz. CPK, D-dimer and IL-6 values at Day 14 and LDH levels at Days 7 & 14 was observed in Add-on Group. Improvement in Sp02 levels was also seen earlier in Add-on Group. Only 2 patients complained of acidity. Post discharge, 91 patients (49 from Add-on group and 42 from SOC group) came for physical visits. All these patients were clinically stable with no evidence of relapse. Conclusion: The study results thus showed that Cap. Torchnil and Tab. Febcin were effective and safe when given as add-on therapy to SOC in the clinical management of patients with moderate Covid-19 disease
Pharmacokinetic Profile of Subcutaneous C1-Esterase Inhibitor (C1-INH [SC]) in Adolescent and Adult Patients with Hereditary Angioedema (HAE)
No full textExposure-Response Model of Subcutaneous C1-Inhibitor Concentrate to Estimate the Risk of Attacks in Patients With Hereditary Angioedema
No full textSubcutaneous C1-inhibitor (HAEGARDA, CSL Behring), is a US Food and Drug Administration (FDA)-approved, highly concentrated formulation of a plasma-derived C1-esterase inhibitor (C1-INH), which, in the phase III Clinical Studies for Optimal Management in Preventing Angioedema with Low-Volume Subcutaneous C1-inhibitor Replacement Therapy (COMPACT) trial, reduced the incidence of hereditary angioedema (HAE) attacks when given prophylactically. Data from the COMPACT trial were used to develop a repeated time-to-event model to characterize the timing and frequency of HAE attacks as a function of C1-INH activity, and then develop an exposure-response model to assess the relationship between C1-INH functional activity levels (C1-INH(f)) and the risk of an attack. The C1-INH(f) values of 33.1%, 40.3%, and 63.1% were predicted to correspond with 50%, 70%, and 90% reductions in the HAE attack risk, respectively, relative to no therapy. Based on trough C1-INH(f) values for the 40 IU/kg (40.2%) and 60 IU/kg (48.0%) C1-INH (SC) doses, the model predicted that 50% and 67% of the population, respectively, would see at least a 70% decrease in the risk of an attack
Abstract 27: Physiologically based pharmacokinetic model for interactions of sorafenib and everolimus in mice
No full textPopulation pharmacokinetics of subcutaneous C1-inhibitor for prevention of attacks in patients with hereditary angioedema
No full textBackground: Long-term prophylaxis with subcutaneous (SC) administration of a highly concentrated plasma-derived C1-esterase inhibitor (C1-INH) formulation was recently approved by the Food and Drug Administration for hereditary angioedema (HAE) attack prevention. Objective: To characterize the population pharmacokinetics of C1-INH (SC) (HAEGARDA ® ; CSL Behring) in healthy volunteers and HAE patients, and assess the variability and influence of covariates on pharmacokinetics. Methods: C1-INH functional activity data obtained after administration of various C1-INH (intravenous; IV) and C1-INH (SC) doses from 1 study in healthy volunteers (n = 16) and 2 studies in subjects with HAE (n = 108) were pooled to develop a population pharmacokinetic model (NONMEM v7.2). Pharmacokinetic parameters derived from steady-state simulations based on the final model were also evaluated. Results: C1-INH functional activity following C1-INH (SC) administration was described by a linear one-compartment model with first-order absorption and elimination, with inter-individual variability in all parameters tested. The mean population bioavailability of C1-INH (SC), and pharmacokinetic parameters for clearance (CL), volume of distribution, and absorption rate were estimated to be ~43%, 1.03 mL/hour/kg, 0.05 L/kg and 0.0146 hour −1 , respectively. The effect of bodyweight on CL of C1-INH functional activity was included in the final model, estimated to be 0.74. Steady-state simulations of C1-INH functional activity vs time profiles in 1000 virtual HAE patients revealed higher minimum functional activity (C trough ) levels after twice-weekly dosing with 40 IU/kg (~40%) and 60 IU/kg (~48%) compared with 1000 IU IV (~30%). Based on the population pharmacokinetic model, the median time to peak concentration was ~59 hours and the median apparent plasma half-life was ~69 hours. Conclusions and Clinical Relevance: Twice-weekly bodyweight-adjusted dosing of C1-INH (SC) exhibits linear pharmacokinetics and dose-dependent increases in C trough levels at each dosing interval. In this analysis, SC dosing led to maintenance of higher C trough levels than IV dosing
Abstract 3681: Multi-scale analysis of everolimus and sorafenib combination in pancreatic cancer xenografts
No full textA Cross-Sectional Study to Assess Effects of Schoolbag Weight and Musculoskeletal Health Problems in Primary School Students of Kolhapur
No full textIntroduction: Musculoskeletal pain in school children is becoming new topic of health concern. Government recommendation of safe load limit of schoolbag is 10% of body weight. The study aimed to determine the prevalence of musculoskeletal health problems in primary school students of Kolhapur.
Methodology: This school based cross sectional study included 886 primary students (age 6-10 years). Institutional Ethical Com- mittee Consent, consent from School Authorities and parents was taken before conducting the study. Author-assisted questionnaire and a digital weighing scale were used as tools of assessment. Analysis was done using SPSS software and results were consid- ered significant when p < 0.05.
Results: Of the 886 primary school students, 82.7% (n=826) carried schoolbags >10% body weight. 64% (n= 567) complained of mus- culoskeletal discomfort related to carrying their schoolbag.
Conclusions: Prevalence of musculoskeletal symptoms in students from English medium schools and Marathi medium schools was 77.4% & 36.9% respectively; prevalence of musculoskeletal symp- toms is higher in CBSE (Central Board of Secondary Educa- tion)pattern schools (73%)than in SSC (Secondary School Certifi- cate) pattern schools (55%). The study provides practically feasible solutions to tackle the mus- culoskeletal health problems in primary school students and em- phasizes on securing ‘the health’ in a healthy childhood
Risk for Attacks in Hereditary Angioedema (HAE) Population Correlates with C1-inhibitor Functional Activity (C1-INHact)
No full textPlacebo-Controlled Trials of C1-Inhibitor (C1-INH) Replacement Therapy for Routine Prevention of Attacks in Patients with Hereditary Angioedema (HAE)
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