Validated HPLC-UV method for amphotericin B quantification in a critical patient receiving AmBisome and treated with extracorporeal replacement therapies.

Amphotericin B (AMB) is a polyene macrolide antifungal agent used for treating invasive fungal infections. Liposomal AMB is a lipid dosage form, available as AmBisome, which reduces the toxicity of the drug. A simple HPLC-UV method was developed for the determination of AMB in plasma to study its pharmacokinetic profile in a critical patient receiving AmBisome and treated with extracorporeal replacement therapies.

Stability of tedizolid phosphate-sodium rifampicin and tedizolid phosphate-meropenem admixtures in intravenous infusion bags stored at different temperatures.

This is a report on the chemical stability and physical compatibility of intravenous tedizolid phosphate 0.8 mg/mL-sodium rifampicin 2.4 mg/mL and tedizolid phosphate 0.

Pharmacokinetic/Pharmacodynamic Analysis of Voriconazole Against Candida spp. and Aspergillus spp. in Allogeneic Stem Cell Transplant Recipients.

Background: To evaluate the adequacy of different dosing regimens of voriconazole for the prophylaxis of invasive candidiasis and aspergillosis in adult allogeneic stem cell transplant recipients by means of population pharmacokinetic (PK) modelling and simulation.

Methods: Allogeneic stem cell transplant recipients receiving voriconazole were included in this observational study. A population PK model was developed.

Stability of mycophenolate mofetil in polypropylene 5% dextrose infusion bags and chemical compatibility associated with the use of the Equashield closed-system transfer device.

Stability studies are necessary in healthcare settings as they facilitate fast, cost-effective and efficient work related to batch manufacturing and availability of supplies. We studied the stability of 1-10 mg/mL mycophenolate mofetil (MMF) in polypropylene 5% dextrose infusion bags prepared from Cellcept and with a generic brand name (Micofenolato de Mofetilo Accord) at different storage temperatures. To ensure chemical compatibility during preparation, we also tested MMF sorption to the Equashield closed-system drug transfer device used in this step.

Effect of Sirolimus Exposure on the Need for Preemptive Antiviral Therapy for Cytomeglovirus Infection after Allogeneic Hematopoietic Stem Cell Transplantation.

The current study evaluates the clinical effect of sirolimus exposure on the occurrence of cytomegalovirus (CMV) DNAemia necessitating preemptive antiviral therapy. A total of 167 consecutive recipients of reduced-intensity conditioning (RIC) allogeneic hematopoietic stem cell transplantation (allo-HSCT) who received sirolimus- and tacrolimus-based graft-versus-host disease (GVHD) prophylaxis and whose CMV serostatus was positive for donors and/or recipients were included in this multicenter retrospective study. A parametric model with consecutive sirolimus blood levels describing the time to CMV DNAemia-RAT was developed using NONMEM version 7.

Validated HPLC-UV detection method for the simultaneous determination of ceftolozane and tazobactam in human plasma.

Aim: A simple, rapid, economical and sensitive HPLC-UV method was developed for the simultaneous quantification of ceftolozane and tazobactam in plasma samples.

Methodology: After deproteinization followed by a liquid-liquid back-extraction, the compounds were separated on a C18 column (150 mm × 4.6 mm, 5 μm) with UV-visible detection at 220 nm.

Sirolimus exposure and the occurrence of cytomegalovirus DNAemia after allogeneic hematopoietic stem cell transplantation.

Sirolimus appears to protect against cytomegalovirus (CMV) in organ transplant recipients. The effect of this drug in allogeneic hematopoietic stem cell transplantation recipients remains unexplored. By means of multivariate continuous-time Markov model analyses, we identified 3 independent covariates that significantly impacted the risk of CMV DNAemia: recipient/donor CMV serostatus, tacrolimus exposure, and sirolimus exposure.

Effectiveness of Nivolumab versus Docetaxel as Second-Line Treatment in Non-Small Cell Lung Cancer Patients in Clinical Practice.

Aims: To evaluate the effectiveness of nivolumab as second-line treatment compared to standard therapy with docetaxel in adult patients with non-small cell lung cancer (NSCLC) in clinical practice.

Methods: This is an observational, retrospective cohort study of adult patients diagnosed with NSCLC, stage III-IV, treated with docetaxel or nivolumab as second-line treatment. The end points evaluated were overall survival (OS) and progression-free survival (PFS).

Dosing of caspofungin based on a pharmacokinetic/pharmacodynamic index for the treatment of invasive fungal infections in critically ill patients on continuous venovenous haemodiafiltration.

Introduction: The study objective was to evaluate the efficacy of different dosages of caspofungin in the treatment of invasive candidiasis and aspergillosis, in relation to the probability of pharmacokinetic/pharmacodynamic (PK/PD) target attainment, using modelling and Monte Carlo simulations in critically ill adult patients on continuous haemodiafiltration.

Methods: Critically ill adult patients on continuous venovenous haemodiafiltration treated with caspofungin were analysed. A population PK model was developed.

Stability of tacrolimus ophthalmic solution.

Purpose: The stability of 0.3-mg/mL tacrolimus ophthalmic solution at different storage temperatures was studied.

Methods: A sterile ophthalmic solution of 0.

A Time-to-Event Model for Acute Kidney Injury after Reduced-Intensity Conditioning Stem Cell Transplantation Using a Tacrolimus- and Sirolimus-based Graft-versus-Host Disease Prophylaxis.

There is a paucity of data evaluating acute kidney injury (AKI) incidence and its relationship with the tacrolimus-sirolimus (Tac-Sir) concentrations in the setting of reduced-intensity conditioning (RIC) after allogeneic stem cell transplantation (allo-HSCT). This multicenter retrospective study evaluated risk factors of AKI defined by 2 classification systems, Kidney Disease Improving Global Outcome (KDIGO) score and "Grade 0-3 staging," in 186 consecutive RIC allo-HSCT recipients with Tac-Sir as graft-versus-host disease prophylaxis. Conditioning regimens consisted of fludarabine and busulfan (n = 53); melphalan (n = 83); or a combination of thiotepa, fludarabine, and busulfan (n = 50).

A model-based meta-analysis of sofosbuvir-based treatments in chronic hepatitis C patients.

The objective of this study was to compare the efficacy of sofosbuvir-based treatments in patients with chronic hepatitis C virus (HCV) infection using a model-based meta-analysis (MBMA). A bibliographic search was performed to identify clinical trials involving sofosbuvir as a unique direct-acting antiviral (DAA) agent or together with daclatasvir, ledipasvir or simeprevir for the treatment of diagnosed HCV infection. The time course of the virological response (VR) was modelled to estimate the effect of treatment and the influence of population characteristics on the longitudinal efficacy profile.

A pharmacokinetic approach to model-guided design of infliximab schedules in ulcerative colitis patients.

Background: Infliximab, an anti-tumour necrosis factor approved for treatment of Crohn´s disease and ulcerative colitis, is administered at predefined interdose intervals. On insufficient response or loss of response, treatment can be intensified. The lack or loss of response is likely related to complex pharmacokinetics of infliximab.

Dose modifications of anti-TNF drugs in rheumatoid arthritis patients under real-world settings: a systematic review.

Anti-TNF dose modifications in rheumatoid arthritis have implications on healthcare resource utilization. The objective was to systematically review the dose modifications, both escalations and reductions, of currently available anti-TNF drugs (adalimumab, certolizumab, etanercept, golimumab and infliximab) in the real-world setting. We performed a systematic literature search of MEDLINE, ISI Web of Science, EMBASE, Indice Médico Español databases and American College of Rheumatology and European League Against Rheumatism annual congresses databases.

Adjusting the dose of tamoxifen in patients with early breast cancer and CYP2D6 poor metabolizer phenotype.

Background: CYP2D6 is a key enzyme in tamoxifen metabolism, transforming it into its main active metabolite, endoxifen. Poor CYP2D6 metabolizers (PM) have lower endoxifen plasma concentrations and possibly benefit less from treatment with tamoxifen. We evaluated tamoxifen dose adjustment in CYP2D6 PM patients in order to obtain plasma concentrations of endoxifen comparable to patients with extensive CYP2D6 metabolism (EM).

Comparing the digoxin test with the Architect® i1000sr system with respect to the AxSYM® system.

Objective: To assess the technique employed by the autoanalyser Architect® i1000sr to determine digoxin in serum samples, compared with the assay developed for AsSYM® using microparticle enzyme immunoassay (DigoxinII).

Method: A prospective analysis of the samples from 100 requests to monitor patients being treated with digoxin. The samples were processed in AxSYM® and Architect®.

[Effectiveness of palifermin in the prevention of oral mucositis in patients with haematological cancers].

Objective: To assess the effectiveness of palifermin for the prevention of oral mucositis in patients with haematological cancers.

Methods: Retrospective observational study of cohorts of patients with haematological cancer undergoing cytotoxic therapy causing hematopoietic ablation. The main variable assessed was the duration of the oral mucositis.

[Design and validation of a dosing algorithm for vancomycin in premature neonates].

Introduction: Inappropriate use of vancomycin contributes to the development of resistant bacteria and jeopardizes the safety and effectiveness of treatment. The aim of this article was to design and validate an empirical dosing algorithm for vancomycin in premature neonates according to their population-based pharmacokinetic characteristics.

Patients And Methods: We performed a retrospective analysis of 129 serum samples from a cohort of 53 neonates.

[Pharmacoeconomic assessment of two tocolysis protocols for the inhibition of premature delivery].

Objective: Pharmacoeconomic assessment of two tocolysis protocols alternatively using atosiban or ritodrine as first-choice tocolytic agent able to delay birth for 48 hours in the acute management of premature birth risk in gravid women.

Methods: The modeling technique used for the selection of the most efficient protocol was the decision analysis. A search for controlled clinical trials comparing the effectiveness and/or safety of atosiban versus ritodrine was performed in Medline and the Cochrane Library.

[Acute renal failure probably associated with topiramate].

A case of acute renal failure probably associated with topiramate is discussed. The patient showed a significant, progressive increase in creatinine and serum urea values 5 days after topiramate treatment onset, as well as diminished creatinine clearance and non-oliguric acute renal failure requiring haemodialysis initiation. Upon topiramate discontinuance altered parameters became normal.

Effectiveness and safety of bemiparin versus low-molecular weight heparins in orthopaedic surgery.

Objective: To evaluate the effectiveness and safety of bemiparin in the prophylaxis of thromboembolism in orthopaedic surgery with respect to other low-molecular-weight heparins.

Methods: A meta-analysis of effectiveness and safety of low-molecular weight heparins versus standard heparin in orthopaedic surgery was performed. A literature search was done of Medline and Excerpta Medica from 1988 to 1998.