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Omalizumab: an update on efficacy and safety in moderate-to-severe allergic asthma.

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Omalizumab: an update on efficacy and safety in moderate-to-severe allergic asthma.

Allergy Asthma Proc. 2012 Sep-Oct;33(5):377-85

Authors: Chipps BE, Figliomeni M, Spector S

Abstract
Omalizumab is an anti-immunoglobulin E (anti-IgE) monoclonal antibody approved in the United States since 2003 for treatment of moderate-to-severe allergic asthma in adults and adolescents (aged ≥12 years) inadequately controlled with inhaled corticosteroids (ICSs). Current treatment guidelines recommend considering the addition of omalizumab if allergic asthma symptoms are not adequately controlled with high-dose ICS + long-acting beta-agonist (LABA) therapy. This study was designed to review the clinical efficacy and safety of omalizumab as established in previously published pivotal clinical trials used to support registration in the United States, i.e., primarily including patients receiving only concomitant ICS therapy, as well as results from the recently completed additional study, which specifically enrolled patients who were poorly controlled despite high-dose ICS + LABA therapy ± additional controllers (including oral corticosteroids [OCSs]). Summary of published omalizumab pivotal trials and associated extension trials, plus key results from the additional study, were used. Pediatric data (i.e., <12 years) were outside the scope of this article. Treatment with omalizumab significantly reduced asthma exacerbations versus placebo when added to ICS therapy during both steroid-stable and steroid-reduction phases of two pivotal trials. In the additional study, omalizumab significantly reduced asthma exacerbation rates versus placebo when added to high-dose ICS + LABA therapy with or without other controller medications. Results from the additional clinical study further support current asthma guideline recommendations to consider omalizumab in steps 5 or 6 for persistent allergic asthma patients whose symptoms are not adequately controlled despite high-dose ICS + LABA therapy ± additional controllers (including OCS).

PMID: 23026179 [PubMed - in process]

The prevalence of undiagnosed and undertreated Chronic Obstructive Pulmonary Disease in lung cancer population.

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The prevalence of undiagnosed and undertreated Chronic Obstructive Pulmonary Disease in lung cancer population.

Respirology. 2012 Oct 10;

Authors: Zhang J, Zhou JB, Lin XF, Wang Q, Bai CX, Hong QY

Abstract
SUMMARY AT A GLANCE: This study showed that underdiagnosis and undertreatment of COPD remains substantial in lung cancer patients. Documentation of smoking history or respiratory symptoms promotes disease diagnosis. Education of COPD knowledge among patients and doctors and improvement of disease management are urgently required in this special population. ABSTRACT: Background and Objective:  Chronic obstructive disease (COPD) is a risk factor and important co-existing disease for lung cancer, however, the current status of diagnosis and treatment of COPD in lung cancer patients is not fully described. This study addressed this issue in a general teaching hospital in China. Methods:  Medical records of hospitalized lung cancer patients in Zhongshan Hospital, Fudan University between January 2006 and December 2010 were reviewed. The definition of COPD was according to the spirometric criteria of Global Initiative for Chronic Obstructive Lung Disease (GOLD) document. The diagnostic rate (COPD recorded as a discharge diagnosis/spirometry-defined percentage) and conformity to GOLD treatment guidelines were investigated. The factors influencing diagnosis were analyzed. Results:   During the study period, the prevalence of spirometry-defined COPD in hospitalized lung cancer patients was 21.6% (705/3263). The overall diagnostic rate of COPD was 7.1%, and the treatment conformity for stable and acute exacerbation of COPD was 27.1% and 46.8%, respectively. Respiratory physicians had a higher diagnostic rate than non-respiratory doctors (34.8% vs. 2.9%, p<0.001), and a better treatment conformity for acute exacerbation of COPD (63.6% vs. 37.5%, p=0.048). Patients with COPD as a discharge diagnosis had more chance to receive guideline-consistent treatment. The diagnostic rate of COPD was higher among patients with a history of smoking, respiratory diseases or symptoms. Conclusions:  COPD is substantially underdiagnosed and undertreated in a hospitalized lung cancer population. History of smoking, respiratory diseases and symptoms promotes disease diagnosis. Education of COPD knowledge among patients and doctors are urgently required in this special population. © 2012 The Authors. Respirology © 2012 Asian Pacific Society of Respirology.

PMID: 23051099 [PubMed - as supplied by publisher]

Practice parameters for the non-respiratory indications for polysomnography and multiple sleep latency testing for children.

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Practice parameters for the non-respiratory indications for polysomnography and multiple sleep latency testing for children.

Sleep. 2012 Nov;35(11):1467-73

Authors: Aurora RN, Lamm CI, Zak RS, Kristo DA, Bista SR, Rowley JA, Casey KR

Abstract
BACKGROUND: Although a level 1 nocturnal polysomnogram (PSG) is often used to evaluate children with non-respiratory sleep disorders, there are no published evidence-based practice parameters focused on the pediatric age group. In this report, we present practice parameters for the indications of polysomnography and the multiple sleep latency test (MSLT) in the assessment of non-respiratory sleep disorders in children. These practice parameters were reviewed and approved by the Board of Directors of the American Academy of Sleep Medicine (AASM). METHODS: A task force of content experts was appointed by the AASM to review the literature and grade the evidence according to the American Academy of Neurology grading system. RECOMMENDATIONS FOR PSG AND MSLT USE: PSG is indicated for children suspected of having periodic limb movement disorder (PLMD) for diagnosing PLMD. (STANDARD)The MSLT, preceded by nocturnal PSG, is indicated in children as part of the evaluation for suspected narcolepsy. (STANDARD)Children with frequent NREM parasomnias, epilepsy, or nocturnal enuresis should be clinically screened for the presence of comorbid sleep disorders and polysomnography should be performed if there is a suspicion for sleep-disordered breathing or periodic limb movement disorder. (GUIDELINE)The MSLT, preceded by nocturnal PSG, is indicated in children suspected of having hypersomnia from causes other than narcolepsy to assess excessive sleepiness and to aid in differentiation from narcolepsy. (OPTION)The polysomnogram using an expanded EEG montage is indicated in children to confirm the diagnosis of an atypical or potentially injurious parasomnia or differentiate a parasomnia from sleep-related epilepsy (OPTION)Polysomnography is indicated in children suspected of having restless legs syndrome (RLS) who require supportive data for diagnosing RLS. (OPTION) RECOMMENDATIONS AGAINST PSG USE: Polysomnography is not routinely indicated for evaluation of children with sleep-related bruxism. (STANDARD) CONCLUSIONS: The nocturnal polysomnogram and MSLT are useful clinical tools for evaluating pediatric non-respiratory sleep disorders when integrated with the clinical evaluation.

PMID: 23115395 [PubMed - in process]

Adverse drug reactions and outcome of short course anti-tuberculosis drugs between single daily dose and split drug dose (BID) in pulmonary tuberculosis.

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Adverse drug reactions and outcome of short course anti-tuberculosis drugs between single daily dose and split drug dose (BID) in pulmonary tuberculosis.

J Med Assoc Thai. 2012 Aug;95 Suppl 8:S1-5

Authors: Chuchottaworn C, Saipan B, Kittisup C, Cheewakul K

Abstract
BACKGROUND: Standard six months short course regimen for treatment of pulmonary tuberculosis is very effective and is recommended as standard treatment. But this regimen composes of many drugs and causes high adverse drug reactions especially gastrointestinal irritation. Spitted administration of drugs to two times a day may reduce adverse drug reactions.
OBJECTIVE: To study adverse drug reactions and outcome of single daily versus split drug (two times a day) administration of standard six month short course regimen in newly diagnosed pulmonary tuberculosis.
MATERIAL AND METHOD: Newly diagnosed pulmonary tuberculosis patients of the Central Chest Institute of Thailand were randomized to receive standard six months regimen once daily or two times a day (split drug). Patients were followed-up every two weeks and a questionnaire was used to detect adverse drug reactions. Outcome of treatment was evaluated according to national tuberculosis treatment guideline.
RESULTS: 122 pulmonary tuberculosis were eligible for the present study and 61 patients were enrolled to each group of once daily or split drug regimen. Pulmonary tuberculosis patients who received split drug regimen had a higher cure rate but not statistical significance because of lower transfer out rate. Adverse drug reactions were similar in both groups of patients who received once daily and split drug regimen. Although split drug group had lower gastrointestinal adverse drug reactions.
CONCLUSION: Split drug regimen has the same cure rate of treatment as single daily regimen and same adverse drug reactions.

PMID: 23130467 [PubMed - indexed for MEDLINE]

Clinical use of approved influenza antivirals: therapy and prophylaxis.

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Clinical use of approved influenza antivirals: therapy and prophylaxis.

Influenza Other Respi Viruses. 2013 Jan;7 Suppl 1:7-13

Authors: Ison MG

Abstract
Please cite this paper as: Ison. (2012) Clinical use of approved influenza antivirals: therapy and prophylaxis. Influenza and Other Respiratory Viruses 7(Suppl. 1), 7-13. Currently, there are two commonly used classes of antiviral agents approved for the prevention of and treatment for influenza: the M2 Inhibitors (amantadine and rimantadine) and the neuraminidase inhibitors (oseltamivir, laninamivir, peramivir and zanamivir). These agents have been proven to be safe and effective alone or in combination for the treatment of uncomplicated influenza in otherwise healthy individuals. Although there are few prospective, randomized studies of these antivirals for the treatment of pregnant women, hospitalized patients, and immunocompromised patients infected with seasonal, pandemic, or avian H5N1 influenza, these agents are widely used for these indications. This article reviews the pharmacokinetics and clinical data available relative to the use of commercially available antiviral agents for the prevention of and treatment for influenza.

PMID: 23279892 [PubMed - in process]

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