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Falci D.R.,Hospital Nossa Senhora da Conceicao | Falci D.R.,Federal University of Health Sciences, Porto Alegre | Pasqualotto A.C.,Federal University of Health Sciences, Porto Alegre
Infection and Drug Resistance | Year: 2013

The triazole class of antifungal drugs comprises first-line agents for the treatment of several invasive fungal diseases. Isavuconazole is a novel broad-spectrum triazole agent. Here we summarize its characteristics and compare it with the currently available antifungal agents. Isavuconazole is administered as a prodrug, and it is water soluble. Oral and intravenous formulations are available. Its intravenous formulation does not contain cyclodextrin, which is an advantage over voriconazole, considering the potential for nephrotoxicity of cyclodextrin. As with other azoles, isavuconazole requires a loading dose. Due to its prolonged half-life, a once-a-day regimen is possible. Considering that isavuconazole shares the same mechanism of action with the other triazoles, cross-resistance is an important concern in the class. Tolerability and safety profiles are favorable, and no serious adverse events have been consistently reported. Significant interactions with drugs metabolized by cytochrome P450 are expected to occur, especially with substrates and inducers of the CYP3A4 enzyme. Isavuconazole has in vitro activity against most medically important fungi, including species of Candida, Aspergillus, and Cryptococcus. It has some activity against the agents of mucormycosis. Clinical data regarding isavuconazole remain limited because ongoing trials have not yet been completed or published. Isavuconazole has the potential to become first-line therapy for invasive aspergillosis. It also has the potential for use in the context of antifungal prophylaxis, salvage therapy, or in combination regimens. Results of clinical trials are ultimately expected in order to adequately position isavuconazole in the current antifungal armamentarium. © 2013 Falci and Pasqualotto. Source

Leo A.D.,Dell | Jerusalem G.,University of Liege | Petruzelka L.,Charles University | Torres R.,Instituto Nacional Del Cancer | And 11 more authors.
Journal of the National Cancer Institute | Year: 2014

BackgroundAt the time of the initial analysis of overall survival (OS) for the Comparison of Faslodex in Recurrent or Metastatic Breast Cancer (CONFIRM) randomized, double-blind, phase III trial, approximately 50% of patients had died. A final analysis of OS was subsequently planned for when 75% of patients had died.MethodsPatients were randomly assigned 1:1 to fulvestrant 500 mg administered as two 5-mL intramuscular injections on days 0, 14, and 28 and every 28 (±3) days thereafter or fulvestrant 250 mg administered as two 5-mL intramuscular injections (one fulvestrant and one placebo [identical in appearance to study drug]) on days 0, 14 (two placebo injections only), and 28 and every 28 (±3) days thereafter. OS was analyzed using an unadjusted log-rank test. No adjustments were made for multiplicity. Serious adverse events (SAEs) and best response to subsequent therapy were also reported. All statistical tests were two-sided.ResultsIn total, 736 women (median age = 61.0 years) were randomly assigned to fulvestrant 500mg (n = 362) or 250mg (n = 374). At the final survival analysis, 554 of 736 (75.3%) patients had died. Median OS was 26.4 months for fulvestrant 500mg and 22.3 months for 250mg (hazard ratio = 0.81; 95% confidence interval = 0.69-0.96; nominal P =. 02). There were no clinically important differences in SAE profiles between the treatment groups; no clustering of SAEs could be detected in either treatment group. Type of first subsequent therapy and objective responses to first subsequent therapy were well balanced between the two treatment groups.ConclusionsIn patients with locally advanced or metastatic estrogen receptor-positive breast cancer, fulvestrant 500mg is associated with a 19% reduction in risk of death and a 4.1-month difference in median OS compared with fulvestrant 250mg. Fulvestrant 500mg was well tolerated, and no new safety concerns were identified. © 2013 © The Author 2013. Published by Oxford University Press. Source

Tovo C.V.,Federal University of Health Sciences, Porto Alegre | de Mattos A.A.,Federal University of Health Sciences, Porto Alegre | de Almeida P.R.L.,Hospital Nossa Senhora da Conceicao
World Journal of Gastroenterology | Year: 2014

Elucidation of the natural history of chronic hepatitis C (CHC) and the identification of risk factors for its progression to advanced liver disease have allowed many physicians to recommend deferral treatment (triple therapy) in favour of waiting for new drug availability for patients who are at low risk of progression to significant liver disease. Newer generation drugs are currently under development, and are expected to feature improved efficacy and safety profiles, as well as less complex and shorter duration delivery regimens, compared to the current standards of care. In addition, patients with cirrhosis and prior null responders have a low rate (around 15%) of achieving sustained virological response (SVR) with triple therapy, and physicians must also consider the decision to wait for new treatments in the future for these patients as well. Naïve patients are the most likely to achieve a close to 100% SVR rate; therefore, it may be advisable to recommend that patients with mild to moderate CHC should wait for the newer therapy options. In contrast, patients with advanced fibrosis and cirrhosis will be those with the greatest need for expedited therapeutic intervention. There remains a need, however, for establishing definitive clinical management guidelines to maximize the benefit of waiting for new drugs and minimize risk of side effects and non-response to the current triple therapy. © 2014 Baishideng Publishing Group Co., Limited. All rights reserved. Source

Boniatti M.M.,Hospital Nossa Senhora da Conceicao | Azzolini N.,Santa Casa de Misericordia | Viana M.V.,Santa Casa de Misericordia | Ribeiro B.S.P.,Santa Casa de Misericordia | And 6 more authors.
Critical Care Medicine | Year: 2014

OBJECTIVE:: To determine whether there was an association between delayed medical emergency team calls and mortality after a medical emergency team review. DESIGN:: This was a prospective observational study. SETTING:: A university-affiliated tertiary referral hospital in Porto Alegre, Brazil. PATIENTS:: All patients were reviewed by the medical emergency team from July 2008 to December 2009. INTERVENTIONS:: None. MEASUREMENTS AND MAIN RESULTS:: There were 1,481 calls for 1,148 patients. Delayed medical emergency team calls occurred for 246 patients (21.4%). The criterion associated with delay was typically the same criterion for the subsequent medical emergency team call. Physicians had a greater prevalence of delayed medical emergency team calls (110 of 246 [44.7%]) than timely medical emergency team calls (267 of 902 [29.6%]; p < 0.001). The mortality at 30 days after medical emergency team review was higher among patients with delayed medical emergency team activation (152 [61.8%]) than patients receiving timely medical emergency team activation (378 [41.9%]; p < 0.001). In a multivariate analysis, delayed medical emergency team calls remained significantly associated with higher mortality. CONCLUSIONS:: Delayed medical emergency team calls are common and are independently associated with higher mortality. This result reaffirms the concept and need for a rapid response system. © 2013 by the Society of Critical Care Medicine. Source

Ferreira D.,Hospital Nossa Senhora da Conceicao
Einstein (São Paulo, Brazil) | Year: 2013

To verify acceptance of hospital diets as to the nutritional status among patients admitted to the Oncology/Hematology Unit of a tertiary care hospital. A cross-sectional study conducted among 100 patients, aged ≥ 18 years, of both genders. Body mass index and subjective global nutritional evaluation by patients were used to detect the nutritional status. The rest-ingestion index was used to evaluate diet acceptance, and the reasons for non-acceptance were identified by means of a questionnaire. Data were expressed in means and standard deviation, or medians and percentages. Comparisons were made using the Student's t test, Wilcoxon Mann-Whitney test, and Pearson's χ2 test. A total of 59% of patients were males, and mean age was 51.6±13.5 years. According to the global subjective nutritional evaluation done by the patients themselves, 33% of the participants were considered malnourished and the body mass index detected 6.3% of malnutrition. The main symptoms reported were lack of appetite, xerostomia (dry mouth), constipation, dysgeusia, odor-related nausea, and early satiety. The rest-ingestion index was approximately 37% and significantly greater among the malnourished relative to the well-nourished (58.8 versus 46.4%; p=0.04). The primary reasons reported for non-acceptance of the diet offered were lack of flavor, monotonous preparations, large quantities offered, lack of appetite, and inappropriate temperature of the meal. A high the rest-ingestion index was seen among the patients with cancer, especially those who were malnourished according to the global nutritional evaluation produced by the patient. Source

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