Economic Burden Associated with the Treatment with a Cardiovascular Polypill in Secondary Prevention in Spain: Cost-Effectiveness Results of the NEPTUNO Study.

Purpose: The aim of this study was to estimate health-care resources utilization, costs and cost-effectiveness associated with the treatment with CNIC-Polypill as secondary prevention of atherosclerotic cardiovascular disease (ASCVD) compared to other treatments, in clinical practice in Spain.

Patients And Methods: An observational, retrospective study was performed using medical records (economic results [healthcare perspective], NEPTUNO-study; BIG-PAC-database) of patients who initiated secondary prevention between 2015 and 2018. Patients were followed up to 2 years (maximum).

Uptake of Ozenoxacin and Other Quinolones in Gram-Positive Bacteria.

The big problem of antimicrobial resistance is that it requires great efforts in the design of improved drugs which can quickly reach their target of action. Studies of antibiotic uptake and interaction with their target it is a key factor in this important challenge. We investigated the accumulation of ozenoxacin (OZN), moxifloxacin (MOX), levofloxacin (LVX), and ciprofloxacin (CIP) into the bacterial cells of 5 species, including (SA4-149), (SEP7602), (SPY165), (SAG146), and (EF897) previously characterized.

Comparative activity of ozenoxacin and other quinolones in Staphylococcus aureus strains overexpressing the efflux pump-encoding genes mepA and norA.

Background: To evaluate the activity of ozenoxacin (OZN) in Staphylococcus aureus strains overexpressing the efflux pump-encoding genes mepA and norA.

Methods: S. aureus NCTC-8325-1, S.

Safety and efficacy profile of ozenoxacin 1% cream in pediatric patients with impetigo.

Background: Ozenoxacin is a topical antibiotic approved in the United States for treatment of impetigo in adults and children age ≥2 months. This analysis evaluated the efficacy and safety of ozenoxacin in specific pediatric age groups.

Methods: Data for children aged 2 months to <18 years recruited from eight countries who had participated in phase 1 and 3 trials of ozenoxacin were extracted and analyzed by age range.

Ozenoxacin, a New Effective and Safe Topical Treatment for Impetigo in Children and Adolescents.

Background: Ozenoxacin is a topical antibiotic approved in Europe to treat non-bullous impetigo in adults and children aged ≥6 months. This analysis evaluated the efficacy and safety of ozenoxacin in paediatric patients by age group.

Methods: Pooled data for patients aged 6 months to <18 years who had participated in a phase I or in two phase III clinical trials of ozenoxacin 1% cream were analysed by age group: 0.

Mutant prevention concentration of ozenoxacin for quinolone-susceptible or -resistant Staphylococcus aureus and Staphylococcus epidermidis.

Ozenoxacin (OZN) belongs to a new generation of non-fluorinated quinolones for the topical treatment of skin infections which has shown to be effective in the treatment of susceptible and resistant Gram-positive cocci. The mutant prevention concentration (MPC) of ozenoxacin, levofloxacin and ciprofloxacin was determined in quinolone-susceptible and -resistant strains including methicillin-susceptible S. aureus, methicillin-resistant S.

Microbiological profile of ozenoxacin.

To explore the antibacterial spectrum of ozenoxacin and compare its activity with that of other antibacterial agents. In 2010, 10,054 isolates were collected from 128 centers worldwide. Minimum inhibitory concentrations against Gram-positive and Gram-negative isolates were determined for 23 and 13 antibacterial agents, respectively.

Topical Antibacterial Agent for Treatment of Adult and Pediatric Patients With Impetigo: Pooled Analysis of Phase 3 Clinical Trials.

Ozenoxacin is a novel topical antibacterial agent with potent bactericidal activity against Gram-positive bacteria that has been developed as a 1% cream for treatment of impetigo. This article presents pooled results of pivotal clinical trials of ozenoxacin with the objective of evaluating the efficacy, safety, and tolerability of ozenoxacin 1% cream after twice-daily topical treatment for 5 days in patients with impetigo. A pooled analysis was performed of individual patient data from two multicenter, randomized, double-blind, vehicle-controlled phase 3 registration studies conducted in patients with impetigo.

Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Randomized Clinical Trial.

Importance: Ozenoxacin, a novel topical antibacterial agent with potent bactericidal activity against gram-positive bacteria, has been developed as a cream with 1% active drug for the treatment of impetigo, a highly contagious bacterial skin infection.

Objectives: To evaluate the efficacy, safety, and tolerability of ozenoxacin cream, 1%, after 5-day twice-daily topical treatment in patients with impetigo.

Design, Setting, And Participants: This randomized, double-blind, vehicle-controlled clinical trial included patients 2 months or older with impetigo who were enrolled at centers in 6 countries from June 2, 2014, through May 30, 2015.

Comparative in vitro antibacterial activity of ozenoxacin against Gram-positive clinical isolates.

Aim: To compare the in vitro activity of the anti-impetigo agent, ozenoxacin, and other antimicrobial agents against Gram-positive clinical isolates from skin and soft tissue infections.

Materials & Methods: Isolates were collected in two studies: 1097 isolates from 49 centers during 2009-2010 and 1031 isolates from ten centers during 2014. Minimum inhibitory concentrations were determined for 18 and 11 antimicrobials in these studies, respectively, using standard broth microdilution methods.

Therapeutic efficacy of ozenoxacin in animal models of dermal infection with Staphylococcus aureus.

Aim: To assess different concentrations and formulations of topical ozenoxacin using a mouse model of Staphylococcus aureus dermal infection for identification of the best formulation for treating patients with impetigo.

Materials & Methods: The efficacy of ozenoxacin formulations was compared with vehicle control, mupirocin and retapamulin ointments in a mouse model.

Results: The most effective concentrations of ozenoxacin for reducing S.

Studies on articular and general toxicity of orally administered ozenoxacin in juvenile rats and dogs.

Aim: Ozenoxacin is a nonfluorinated quinolone antibacterial approved for topical treatment of impetigo. Because quinolones have known chondrotoxic effects in juvenile animals, the potential toxicity of ozenoxacin was assessed in preclinical studies.

Materials & Methods: Ozenoxacin or ofloxacin (300 mg/kg/day for 5 days, for each compound) was orally administered to juvenile rats, and oral ozenoxacin (10-100 mg/kg/day for 14 days) was administered to juvenile dogs.

Usefulness of a Cardiovascular Polypill in the Treatment of Secondary Prevention Patients in Spain: A Cost-effectiveness Study.

Introduction And Objectives: To estimate the health benefits and cost-effectiveness of a polypill intervention (aspirin 100 mg, atorvastatin 20 mg, ramipril 10 mg) compared with multiple monotherapy for secondary prevention of cardiovascular events in adults with a history of myocardial infarction from the perspective of the Spanish National Health System.

Methods: An adapted version of a recently published Markov model developed and validated in Microsoft Excel was used to compare the cost-effectiveness of the polypill with that of its combined monocomponents over a 10-year time horizon. The population included in the model had a mean age of 64.

Validation of the Spanish Acne Severity Scale (Escala de Gravedad del Acné Española--EGAE).

Background: Several acne grading systems have been described, but consensus is lacking on which shows superiority. A standardized system would facilitate therapeutic decisions and the analysis of clinical trial data.

Objective: To assess the feasibility, reliability, validity and sensitivity to change of the Spanish Acne Severity Scale (EGAE).

Lack of irritative potential of nadifloxacin 1% when combined with other topical anti-acne agents.

Background: Diverse options are available for the treatment of acne. Topical therapy is standard, especially in cases of mild to moderate acne, while the current treatments for acne vulgaris are topical keratolytics and topical antibiotics. Tolerability is a critical factor in patient compliance with topical acne therapies.

[Feasibility and reliability of the Spanish version of the Leeds Revised Acne Grading Scale].

Background: Although there are more than 25 acne grading systems, there is no consensus on which is most appropriate. Unification of the classifications is recommended in order to facilitate therapeutic decisions.

Objective: To assess the feasibility and reliability of the Spanish version of the Leeds revised acne grading (LRAG) scale in patients with acne vulgaris in Spain.

Comparison of propofol and etomidate regarding impact on seizure threshold during electroconvulsive therapy in patients with schizophrenia.

Background: While propofol is known to shorten seizures during electroconvulsive therapy, in our previous study on patients with schizophrenia, there was no need for more frequent restimulations when using propofol compared with etomidate. We hypothesized that etomidate and propofol have similar effects on seizure activity in cases where seizure duration is shorter than 20 seconds. In this study, etomidate and propofol are compared regarding their impact on seizure threshold and seizure duration.

Dealing with time-dependent pharmacokinetics during the early clinical development of a new leukotriene B4 synthesis inhibitor.

Purpose: The aim of this study was to explore the possibility of achieving a practical dosing regimen for 2,4,6-triiodophenol (AM-24), a new leukotriene B4 (LTB4) synthesis inhibitor. First, a model capable of dealing with the nonlinearity in its pharmacokinetic profile was built, and then it was combined with a pharmacodynamic model previously established with data from earlier phase I trials.

Methods: One week after the first 240-, 350-, or 500-mg oral dose of AM-24, six additional doses were given to 24 healthy volunteers once daily.