Publications by authors named "Dutkowski R"

Aims: The effectiveness of oseltamivir to improve seasonal influenza symptoms in clinical practice was analyzed using pooled data from patients who were also taking analgesics and other over-the-counter (OTC) medications.

Methods: Data were pooled from 1,709 patients aged 13 - 64 years with confirmed seasonal influenza who enrolled in six randomized, placebo-controlled trials of oseltamivir (75 mg b.i.

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A 2008 review by our group concluded that the risk of neuropsychiatric adverse events (NPAEs) in influenza patients was not increased by oseltamivir exposure, and did not identify any mechanism by which oseltamivir or its metabolites could cause or worsen such events. The current article reviews new information on this topic. Between September 16, 2007 and May 15, 2010, 1,805 spontaneously-reported NPAEs were identified in 1,330 patients receiving oseltamivir: 767 (42.

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Background: Haematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients are at high risk for severe influenza and its complications, and may not be adequately protected by vaccination.

Methods: Liver, kidney, or liver-kidney transplant or allogeneic HSCT recipients aged ≥1 year were randomized to oseltamivir (75 mg once daily for those ≥13 years or weight-based dosing for children 1-12 years) or placebo for 12 weeks during periods of local influenza circulation. Patients were assessed for influenza infection via daily diary, every-other-week culture and PCR, and baseline and end-of-treatment serology.

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Article Synopsis
  • A study was conducted with 49 children aged 1-12 years who took oseltamivir for 6 weeks to prevent influenza.
  • Out of these, 17 children reported a total of 22 adverse events, with three likely linked to the medication (nausea or vomiting).
  • No serious adverse events occurred, and the medication's tolerability was similar to data from shorter treatment studies.
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Article Synopsis
  • Few studies have explored the effectiveness of self-collected nose and throat swabs for confirming influenza cases in community environments.
  • The research involved 176 outpatients with confirmed influenza, analyzing their virus detection and viral load trends over time.
  • Results showed that self-swabs provided consistent and reliable data, indicating they can be a valid method for confirming influenza A or B infections outside of clinical settings.
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Oseltamivir (Tamiflu®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) is an orally administered antiviral for the treatment and prevention of influenza A and B infections that is registered in more than 100 countries worldwide. More than 83 million patients have been exposed to the product since its introduction.

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Objective: Acute otitis media (AOM) is the most common complication of pediatric influenza, and imposes a substantial health care burden. We examined the influence of oseltamivir treatment on the incidence and course of AOM in children with influenza.

Methods: In the original study, 695 children 1-12 years who presented within 48h of the onset of influenza-like symptoms were randomized to oseltamivir (2mg/kg) or placebo given twice daily for 5 days.

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Seasonal influenza viruses cause annual disease epidemics that affect individuals at low and high risk for secondary illnesses. Influenza vaccines are widely used in high-risk patients to prevent infection, but the protection afforded varies by population; uptake is also limited in some groups. Antiviral drugs for influenza are now readily available.

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Although clinical evidence is currently lacking, opinion in the literature on avian influenza A/H5N1 suggests that increased doses of the oral neuraminidase inhibitor oseltamivir may offer clinical benefits against highly pathogenic influenza where high levels of viral replication and disseminated infection cause severe disease. We assessed the pharmacokinetics and safety/tolerability of oseltamivir at dosages up to 450 mg twice daily. Healthy adult volunteers were randomised to receive placebo or oseltamivir 75, 225 or 450 mg every 12h for 5 days.

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After reports from Japan of neuropsychiatric adverse events (NPAEs) in children taking oseltamivir phosphate (hereafter referred to as oseltamivir [Tamiflu; F. Hoffmann-La Roche Ltd, Basel, Switzerland]) during and after the 2004--5 influenza season, Roche explored possible reasons for the increase in reporting rate and presented regular updates to the US FDA and other regulatory authorities. This review summarizes the results of a comprehensive assessment of the company's own preclinical and clinical studies, post-marketing spontaneous adverse event reporting, epidemiological investigations utilizing health claims and medical records databases and an extensive review of the literature, with the aim of answering the following questions: (i) what the types and rates of neuropsychiatric abnormalities reported in patients with influenza are, and whether these differ in patients who have received oseltamivir compared with those who have not; (ii) what levels of oseltamivir and its active metabolite, oseltamivir carboxylate are achieved in the CNS; (iii) whether oseltamivir and oseltamivir carboxylate have pharmacological activity in the CNS; and (iv) whether there are genetic differences between Japanese and Caucasian patients that result in different levels of oseltamivir and/or oseltamivir carboxylate in the CNS, differences in their metabolism or differences in their pharmacological activity in the CNS.

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The bioavailability of oseltamivir phosphate and oseltamivir carboxylate were assessed in healthy volunteers when delivered as a solution of the active pharmaceutical ingredient (API) compared with the commercial capsule formulation. The 90% confidence intervals (CIs) for the ratios of the two treatments (capsule versus solution) were within the reference region [0.80-1.

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Background: Among asthmatic children, influenza is associated with increased hospitalizations. Although vaccination is safe and effective among asthmatic children, its protective efficacy varies and uptake rates can be low. In comparison, oseltamivir (Tamiflu) is effective against all influenza strains and can reduce the severity and duration of influenza among adults and children.

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Recent cross species transmission of avian influenza has highlighted the threat of pandemic influenza. Oseltamivir (Tamiflu) has been shown to be effective in the treatment and prevention of epidemic influenza infection in adults, adolescents and children (> or = 1 year). Although oseltamivir has not been approved for prophylactic use in children, it has been shown to be effective.

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Article Synopsis
  • - A study involving 277 households assessed the effectiveness of postexposure prophylaxis (PEP) and treatment for influenza using oseltamivir, focusing on reducing influenza transmission among close contacts.
  • - PEP showed a protective efficacy of 58.5% for households and 68.0% for individual contacts against lab-confirmed influenza compared to only treating index cases.
  • - Importantly, no resistant strains of the virus were found in either treated individuals or their contacts, indicating that PEP is effective in further minimizing influenza spread in households after initial treatment.
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Oseltamivir is a novel agent approved for the treatment and prevention of influenza infection and illnesses in adults and children. Assessment of data from the clinical trial programme, a US health insurance database study and postmarketing surveillance allowed a comprehensive review of the safety of oseltamivir in clinical use in subjects >1 year of age. Oseltamivir has been studied over the course of a 5-year development programme in >11000 subjects from North America, Europe and the Southern Hemisphere, including otherwise healthy adults, approximately 500 elderly/high-risk subjects, and children (>1000) aged 1-12 years.

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Objective: To evaluate the effect of uncomplicated viral respiratory infections (colds) on middle ear pressure in healthy school-aged children.

Methods: Children (ages 2-12) with normal tympanograms before onset of illness had bilateral tympanometry daily except weekends for 2 weeks after the onset of a cold. Nasopharyngeal secretion obtained at onset of illness was cultured for bacterial pathogens of otitis media using selective agars and tested for rhinovirus, coronavirus, respiratory syncytial virus, influenza A and B, and parainfluenza 1-3 by reverse transcriptase polymerase chain reaction technology.

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Objective: Oseltamivir (Ro 64-0796) is an ester prodrug of the active metabolite Ro 64-0802 (oseltamivir carboxylate), a potent and selective inhibitor of the neuraminidase enzyme of influenza virus. In this study we report the pharmacokinetics of oseltamivir in healthy children volunteers (study 1) and in children with influenza (study 2).

Study Participants And Methods: In study 1, an open-label, single dose study, serial plasma samples were obtained from a total of 18 healthy children (5 to 18 years) who were grouped by age (n = 6 per group) and received single oral doses of oseltamivir 2 mg/kg.

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Background: Oral oseltamivir administration is effective treatment for influenza in adults. This study was conducted to determine the efficacy, safety and tolerability of oseltamivir in children with influenza.

Methods: In this randomized, double blind, placebo-controlled study, children 1 through 12 years with fever [> or =100 degrees F (> or =38 degrees C)] and a history of cough or coryza <48 h duration received oseltamivir 2 mg/kg/dose or placebo twice daily for 5 days.

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Although acute respiratory infection (ARI) is the most frequent clinical syndrome in childhood, there is no validated measure of its severity. Therefore a parental questionnaire was developed: the Canadian Acute Respiratory Illness Flu Scale (CARIFS). A process of item generation, item reduction, and scale construction resulted in a scale composed of 18 items covering three domains; symptoms (e.

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Localized treatment with recombinant human interleukin-2 (rIL-2) +/- recombinant murine interferon-gamma (rIFN-gamma) results in regression of early B16 melanomas in normal C57BL/6 (B6) mice, but not in syngeneic beige mice, which have defective natural killer (NK) cells. Injection of antibodies to asialo GM1 (a-AGM1) or Thy1 abolishes the tymoricidal effects of rIL-1 +/- rIFN-gamma. Thus, cells activated by these cytokines must be either NK-like cells that are AGM1+ Thy1+, or NK-like cells (AGM1+) cooperating with T lymphocytes (Thy1+), since either antibody (a-AGM1 or a-Thy1) independently abrogates the in vivo antitumor effect.

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A mouse hybrid cell line (WA17d) was derived which contained multiple copies of human chromosome 21 and no other human chromosome. Cell extracts of this line were prepared and subjected to two-dimensional gel electrophoresis. Several proteins were identified whose synthesis was altered by the presence of chromosome 21 and 6 proteins were identified as being specific to this human chromosome.

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Although regions of DNA reacting with anti-Z-DNA antibodies have been identified in the polytene chromosomes of Drosophila spp. and the metaphase chromosomes from a number of different mammalian species, the biological role of this DNA is unknown. Flow cytometry was used in the present studies to quantitate the binding of anti-Z-DNA antibodies in quiescent and activated human peripheral blood lymphocytes; the antibody binding was then correlated with cell cycle phase.

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