Extended-pulsed fidaxomicin versus vancomycin in patients 60 years and older with Clostridium difficile infection: cost-effectiveness analysis in Spain.

The cost of treating Clostridium difficile infection (CDI) in Spain is substantial. Findings from the randomised, controlled, open-label, phase 3b/4 EXTEND study showed that an extended-pulsed fidaxomicin (EPFX) regimen was associated with improved sustained clinical cure and reduced recurrence of CDI versus vancomycin in patients aged 60 years and older. We assessed the cost-effectiveness of EPFX versus vancomycin for the treatment of CDI in patients aged 60 years and older from the perspective of the National Health System (NHS) in Spain. We used a Markov model with six health states and 1-year time horizon. Health resources, their unit costs and utilities were based on published sources. Key efficacy data and transition probabilities were obtained from the EXTEND study and published sources. A panel of Spanish clinical experts validated all model assumptions. In the analysis, 0.638 and 0.594 quality-adjusted life years (QALYs) per patient were obtained with EPFX and vancomycin, respectively, with a gain of 0.044 QALYs with EPFX. The cost per patient treated with EPFX and vancomycin was estimated to be €10,046 and €10,693, respectively, with a saving of €647 per patient treated with EPFX. For willingness-to-pay thresholds of €20,000, €25,000 and €30,000 per QALY gained, the probability that EPFX was the most cost-effective treatment was 99.3%, 99.5% and 99.9%, respectively. According to our economic model and the assumptions based on the Spanish NHS, EPFX is cost-effective compared with vancomycin for the first-line treatment of CDI in patients aged 60 years and older.

[Patient characteristics and health care burden during the influenza A (H1N1) 2009 pandemic in the university Hospital Vall d'Hebron of Barcelona]. / Características de los pacientes y carga asistencial durante la pandemia de gripe A (H1N1) 2009 en el Hospital Universitario Vall d'Hebron de Barcelona.

BACKGROUND AND OBJECTIVE: The influenza A (H1N1) 2009 pandemic initially had a mild impact in Catalonian hospitals, but in the autumn there was an important pandemic wave. We describe the main characteristics of patients seen in the Vall d'Hebron University Hospital in Barcelona (HUVH) during this pandemic, the risk factors associated with hospitalization and the health-care burden generated. MATERIAL AND METHOD: We included all cases of influenza A (H1N1) 2009 with laboratory confirmation seen in the HUVH from July 2, 2009 to January 22, 2010. We performed a descriptive analysis of the cases and a multivariate analysis to identify variables associated with the risk of hospitalization. RESULTS: The diagnosis was confirmed in 741 patients; 56.8% were under 16 years, while only 2.8% were 65 and over. Thirty three per cent of children had no risk factor for complications, whereas in adults it was 45%. One hundred and ninety cases were hospitalized, 26 of them in the intensive care unit (ICU) with 5 deaths. The factors associated with risk of hospitalization were, age less than one year, immunodeficiency, and neuromuscular disease in children; and chronic lung disease in adults. The diagnosis of pneumonia in the emergency department was an important predictor of hospitalization in both children and adults. The maximum caseload was recorded on November 19, with 43 hospital admissions, 6 of them in the ICU. CONCLUSIONS: Between July and September 2009 the pandemic had a low impact on hospital resources, but in autumn there was a marked increase in emergency department visits and hospitalizations. Children had higher rates of confirmed cases, while adults had higher rates of hospitalizations. The risk of hospitalization was higher in patients with certain conditions especially in those with pneumonia. The pandemic wave was a moderate work load for HUVH, since it did not involve any modification of the usual health care programs.

Internal and external validation of a model to predict adverse outcomes in patients with left-sided infective endocarditis.

INTRODUCTION: Early identification of prognostic factors is essential to improve the grim prognosis associated with left-sided infective endocarditis. This group identified three independent risk factors obtained within 72 h of admission, (Staphylococcus aureus, heart failure and periannular complications) for inhospital mortality or urgent surgery in a series of 317 patients diagnosed at five tertiary centres (derivation sample). A stratification score was constructed for the test cohort by a simple arithmetic sum of the number of variables present. The goal was to validate this model internally and externally in a prospective manner with two different cohorts of patients. METHODS: The appropriateness of the model was tested prospectively on predicting events in two cohorts of patients with left-sided endocarditis: internally with the 263 consecutive patients diagnosed at the same centres where the model was derived (internal validation sample), and externally with 264 patients admitted at another hospital (external validation sample). RESULTS: The discriminatory power of the model, expressed as the area under the receiver operating characteristic curve was similar between derivation and both validation samples (internal 0.67 vs 0.68, p=0.79; external 0.67 vs p=0.74, p=0.09). There was a progressive, significant pattern of increasing event rates as the risk stratification score increased in both validation cohorts (p<0.001 by χ² for trend). CONCLUSIONS: The early risk stratification model derived, based on variables obtained within 72 h of admission, is applicable to different populations with left-sided endocarditis. A simple bedside assessment tool is provided to clinicians that identifies patients at high risk of having an adverse event.

[Current infectious disease care in Spain]. / La asistencia infectológica actual en España.

Despite the specialist activity of Infectious Diseases not being officially recognised, the majority of the hospitals in the autonomous communities of Spain are equipped with structures, with significant heterogeneity among them, to be able to offer high quality care in these diseases. The main characteristics of and Infectious Diseases Department is its important healthcare activity, more than in other officially recognised medical specialities, and also its important interrelationship with other services in the hospital which is clearly horizontal healthcare. Furthermore, the aforementioned infectious disease care units have developed important activities in the arena of community and public health and, in collaboration with health authorities, contribute to the rational use of antimicrobials and the relationship with Primary Care. The future of specialists in infectious diseases, when they are officially recognised, will be the creation of clinical management units in every health institution with the objective of coordinating all the specialised health care, both in the hospital environment and in its health area of influence.

Correlation of the MIC and dose/MIC ratio of fluconazole to the therapeutic response of patients with mucosal candidiasis and candidemia.

We report on the correlation of the outcomes for two cohorts of patients who had been treated for candidemia (126 episodes) or oropharyngeal candidiasis (110 episodes) with various doses of fluconazole and the MIC of fluconazole obtained by using the EUCAST standard for fermentative yeasts. Of 145 episodes caused by an isolate with a fluconazole MIC < or =2 mg/liter, 93.7% (136 of 145) responded to fluconazole treatment. The response for those infected with a strain with a MIC of 4 mg/liter was 66% but reached 100% when the dose was greater than 100 mg/day, whereas the response for those infected with strains with MICs > or =8 mg/liter was only 12%. Hence, a MIC of 2 mg/liter or 4 mg/liter was able to predict successful treatment. A cure rate of 93.9% (140 of 149) was achieved when the dose/MIC ratio was > or =100 but fell to 14.6% (16 of 109) when the ratio was less. The dose/MIC required to achieve a response rate of 50% (the 50% effective concentration) was 43.7 for the cohort of patients with oropharyngeal candidiasis. Classification and regression analysis indicated that a dose/MIC of 35.5 was the threshold for the prediction of cure or failure. However, an increase in exposure above this threshold further increased the probability of cure, and all patients were cured when the dose/MIC exceeded 100. Monte Carlo simulations showed a probability of target attainment of 99% at MICs < or =2 mg/liter and a pharmacodynamic target of a dose/MIC ratio of 100, which was equivalent to an unbound fraction of the fluconazole area under the curve versus the MIC of 79.