Corrigendum to "Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications".

[This corrects the article DOI: 10.1155/2021/9996193.].

Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications.

Background: Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs.

Assessing the Accuracy of Sales Forecasts Submitted by Pharmaceutical Companies Applying for Reimbursement in Austria.

Reimbursement decisions on new medicines require an assessment of their value. In Austria, when applying for reimbursement of new medicines, pharmaceutical companies are also obliged to submit forecasts of future sales. We systematically examined the accuracy of these pharmaceutical sales forecasts and hence the usefulness of these forecasts for reimbursement evaluations.

In vitro activity of voriconazole and amphotericin B against Candida albicans, Candida krusei, and Cryptococcus neoformans in human cerebrospinal fluid.

Purpose: Fungal central nervous system (CNS) infections show a high mortality rate and only a few antifungal agents are available to treat these infections. We hypothesize that the different biochemical properties of human cerebrospinal fluid (CSF) compared to the standard growth medium lead to the altered activity of antifungal agents in CSF. We investigated the in vitro activity of two of these agents, i.

Proposal for a regulation on health technology assessment in Europe - opinions of policy makers, payers and academics from the field of HTA.

In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): 'Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU'. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States.

Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets.

There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases, and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growth in both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated to finance new medicines as well as strategies to improve prescribing efficiency.

A survey of medicine use in children and adolescents in Austria.

Unlabelled: Aims of this survey were to evaluate prescription patterns for children and adolescents in primary and hospital care settings in Austria and to identify the medicines used most frequently in this population. Prescription data were assessed for the year 2014: for primary care, reimbursement data were obtained from Austrian health insurances; for hospital care, information on medicines dispensed to pediatric wards from hospital pharmacies. Frequencies of medicine use were analyzed by Anatomical Therapeutic Chemical classification system, age groups, and care setting.

Pharmacokinetics of doripenem in plasma and epithelial lining fluid (ELF): comparison of two dosage regimens.

Purpose: In 2014, FDA released a warning for prescription of doripenem for ventilator-associated bacterial pneumonia due to unsatisfactory clinical cure rates. The present study explores if the observed lack of efficacy might be explained by insufficient target site pharmacokinetics in intensive care patients after two different infusion schemes.

Methods: Plasma and bronchoalveolar lavage sampling was performed in 16 intubated patients with pneumonia receiving doripenem either as 1-h or as 4-h infusion.

Pharmacokinetics of Bevacizumab in Three Patients Under the Age of 3 Years with CNS Malignancies.

Background: Bevacizumab is a recombinant antibody that is increasingly used in pediatric malignancies. The pharmacokinetics of bevacizumab in pediatric patients have been shown to be influenced by tumor localization and body weight. In this report, we present data on the pharmacokinetics and safety of bevacizumab in children under the age of 3 years with central nervous system (CNS) malignancies.

Payers' Views of the Changes Arising through the Possible Adoption of Adaptive Pathways.

Payers are a major stakeholder in any considerations and initiatives concerning adaptive licensing of new medicinal products, also referred to as Medicines Adaptive Pathways to patients (MAPPs). Firstly, the scope and necessity of MAPPs need further scrutiny, especially with regard to the definition of unmet need. Conditional approval pathways already exist for new medicines for seriously debilitating or life-threatening diseases and only a limited number of new medicines are innovative.

Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease: A Randomized, Double-Blind, Placebo-Controlled Trial.

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in the world. Current treatment options provide relief from symptoms rather than stop disease progress. Results from various preclinical experiments suggest a causal benefit of acetylic salicylic acid (ASA) in the treatment of COPD.

Understanding the Activity of Antibiotics in Cerebrospinal Fluid in vitro.

Background: In vitro studies suggest that antimicrobial activity of antibiotics meant to treat central nervous system infections such as meningitis or ventriculitis may be altered by cerebrospinal fluid (CSF). This could explain the reason behind the often observed discrepancies between the activity of antibiotics determined in artificial growth media in vitro, and their sometimes reduced clinical efficacy in CSF in vivo. If conducted in CSF, in vitro microbiological investigations might predict the ability of antibiotic drugs to treat CSF infections better than experiments in artificial growth media.

[Polypharmacy--activities of the social insurance in Austria].

In Austria, about a quarter of the population older than 60 years receives more than five medicines per quarter at the expense of the statutory health insurance. Especially for older and multimorbid people the risk of adverse drug reactions increases by taking multiple drugs. The social insurance has initiated activities to direct the focus on the issue of polypharmacy and the associated problems.

Safety and immunogenicity of a vero cell culture-derived whole-virus H5N1 influenza vaccine in chronically ill and immunocompromised patients.

The development of vaccines against H5N1 influenza A viruses is a cornerstone of pandemic preparedness. Clinical trials of H5N1 vaccines have been undertaken in healthy subjects, but studies in risk groups have been lacking. In this study, the immunogenicity and safety of a nonadjuvanted cell culture-derived whole-virus H5N1 vaccine were assessed in chronically ill and immunocompromised adults.

Target site pharmacokinetics of linezolid after single and multiple doses in diabetic patients with soft tissue infection.

The underlying pathology of diabetic wounds, i.e. impairment of macro- and microcirculation, might also impact target site penetration of antibacterial drugs.

Pharmacokinetics and toxicity of intrathecal liposomal cytarabine in children and adolescents following age-adapted dosing.

Background And Objective: Assessment of the optimal drug dose for intrathecal therapy in children is challenging because of the non-linear increase in cerebrospinal fluid (CSF) volume throughout childhood and potential differences in the elimination rate in children versus adults. The present study was designed to prospectively collect pharmacokinetic and safety data on age-adapted intrathecal liposomal cytarabine in children aged >3 years.

Patients And Methods: Sixteen patients with malignant brain tumours were included in the study.

Tissue pharmacokinetics of ertapenem at steady-state in diabetic patients with leg infections.

Objectives: Ertapenem pharmacokinetics were determined in the interstitium of healthy tissue and of infected tissue of patients suffering from diabetic foot infections, to evaluate if antibiotic concentrations at the target site are sufficient to achieve bacterial killing.

Patients And Methods: Nine patients with diabetic foot infections received 1 g of ertapenem per day intravenously. At steady-state, ertapenem concentrations were measured over 8 h in plasma and in the interstitium of healthy subcutaneous adipose tissue and of soft tissue adjacent to the foot infection using microdialysis.

Good penetration of moxifloxacin into human abscesses.

Abscesses are often treated with antibiotics in addition to incision or when incision is unfeasible, but accurate information about antibiotic abscess penetration in humans is missing. This study aimed at evaluating the penetration of moxifloxacin into human abscesses. After administration of a single dose of 400 mg moxifloxacin, drug concentrations were measured in 10 differently located abscesses at incision, and in plasma over 8 h.

Abscess penetration of cefpirome: concentrations and simulated pharmacokinetic profiles in pus.

Purpose: Abscess patients frequently receive antibiotic therapy when incision cannot be performed or in addition to incision. However, antibiotic concentrations in human abscesses are widely unknown.

Methods: Pharmacokinetics of cefpirome in 12 human abscesses located in different body regions was studied.

Enhanced activity of linezolid against Staphylococcus aureus in cerebrospinal fluid.

Linezolid is considered for treatment of central nervous system (CNS) infections caused by multidrug-resistant Gram-positive bacteria. Therefore, the influence of cerebrospinal fluid (CSF) on the antimicrobial activity of linezolid was evaluated in vitro. Time-kill curves were conducted in CSF and Mueller-Hinton broth (MHB) using Staphylococcus aureus (ATCC 29213) and Staphylococcus epidermidis (ATCC 12228) strains.

Penetration of doripenem into skeletal muscle and subcutaneous adipose tissue in healthy volunteers.

Sufficient antibiotic concentrations at the infection site are a prerequisite for good bacterial killing. This study was performed to determine pharmacokinetics of doripenem in soft tissues and saliva. Six healthy male volunteers received a single intravenous infusion of 500 mg doripenem over 1 h.

Ramipril modulates circadian gene expression in skeletal muscle.

Objectives: Treatment with angiotensin converting enzyme (ACE)-inhibitors favorably affects glucose metabolism and the development of diabetes mellitus by largely elusive mechanisms. To identify these mechanisms, we studied the effect of ACE-inhibition on gene expression in skeletal muscle, a primary target tissue for insulin in glucose homeostasis.

Methods: A subject-blinded and analyst-blinded, placebo-controlled study was conducted in nine healthy men.

Cerebrospinal fluid impairs antimicrobial activity of fosfomycin in vitro.

Objectives: Fosfomycin penetrates well into cerebrospinal fluid (CSF) and is considered for treatment of infections of the central nervous system (CNS). This study evaluated the influence of human CSF on the antimicrobial activity of fosfomycin.

Methods: Time-kill curves were performed in Mueller-Hinton broth (MHB) and in pooled human CSF using fosfomycin concentrations ranging from 0.

Pharmacokinetics and safety of intrathecal liposomal cytarabine in children aged <3 years.

Background And Objective: Liposomal cytarabine (DepoCyte) is a slow-release formulation for intrathecal application, ensuring prolonged drug exposure. Although there is an urgent need for new treatment options for infants with leptomeningeal dissemination of a malignant brain tumour, there are no clinical and pharmacokinetic data available on this drug for children aged <3 years. The objective of this pilot study was to determine the feasibility, safety and pharmacokinetics of cytarabine after intrathecal administration of liposomal cytarabine 25 mg in patients aged <3 years.