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  1. Article ; Online: Strategies for tailoring asthma treatment in adults.

    Colice, Gene L

    JAMA

    2013  Volume 309, Issue 2, Page(s) 136

    MeSH term(s) Adrenal Cortex Hormones/administration & dosage ; Asthma/drug therapy ; Asthma/physiopathology ; Biomarkers/analysis ; Female ; Humans ; Male
    Chemical Substances Adrenal Cortex Hormones ; Biomarkers
    Language English
    Publishing date 2013-01-09
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2012.73382
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  2. Article ; Online: Comparative effectiveness of intravenous and inhaled magnesium in acute asthma.

    Colice, Gene L

    Journal of comparative effectiveness research

    2013  Volume 2, Issue 5, Page(s) 437–441

    Abstract: Evaluation of: Goodacre S, Cohen J, Bradburn M et al. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomized controlled trial. Lancet Respir. Med. 1, 293-300 (2013). Acute ... ...

    Abstract Evaluation of: Goodacre S, Cohen J, Bradburn M et al. Intravenous or nebulised magnesium sulphate versus standard therapy for severe acute asthma (3Mg trial): a double-blind, randomized controlled trial. Lancet Respir. Med. 1, 293-300 (2013). Acute exacerbations of asthma are common. The current recommended treatment approach to managing an acute asthma exacerbation is to administer a short-acting inhaled β2-agonist (SABA). SABAs are rapidly effective but may not provide the bronchodilation needed to restore adequate lung function. Consequently, in severe acute asthma exacerbations, despite a standard approach to treatment including SABAs, hospitalization is common. Magnesium is a bronchodilator that may provide additional benefit to SABAs in managing acute asthma exacerbations. In this article, the comparative effectiveness of inhaled and intravenous magnesium in addition to standard therapy is evaluated in the management of severe acute asthma exacerbations. Although neither inhaled nor intravenous magnesium achieved the protocol-specified benefits, intravenous magnesium was associated with fewer hospitalizations and a trend for greater improvement in the symptom of breathlessness than inhaled magnesium.
    MeSH term(s) Asthma/therapy ; Female ; Humans ; Male
    Language English
    Publishing date 2013-09
    Publishing country England
    Document type Comment ; Journal Article
    ISSN 2042-6313
    ISSN (online) 2042-6313
    DOI 10.2217/cer.13.55
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  3. Article ; Online: The misuse of asthma drugs.

    Colice, Gene L

    Expert review of respiratory medicine

    2013  Volume 7, Issue 3, Page(s) 307–320

    Abstract: There are three major problems with asthma care in the USA and misuse of asthma drug therapy contributes to each. Asthma patients suffer from symptoms regularly partly because healthcare providers do not understand the Expert Panel Report III (EPR3) ... ...

    Abstract There are three major problems with asthma care in the USA and misuse of asthma drug therapy contributes to each. Asthma patients suffer from symptoms regularly partly because healthcare providers do not understand the Expert Panel Report III (EPR3) recommendations on assessing asthma symptoms to determine drug treatment and, consequently, undertreat the disease. Asthma patients experience exacerbations often in part because the EPR3 provides limited guidance on using exacerbation risk to guide asthma treatment, again leading to undertreatment. The EPR3 recommends inhaled corticosteroids as the preferred therapy for mild persistent asthma but American healthcare providers disregard this recommendation based on different perceptions about the risks and benefits of inhaled corticosteroids and choose drug treatments with higher healthcare costs.
    MeSH term(s) Anti-Asthmatic Agents/adverse effects ; Anti-Asthmatic Agents/economics ; Anti-Asthmatic Agents/therapeutic use ; Asthma/diagnosis ; Asthma/drug therapy ; Asthma/economics ; Asthma/physiopathology ; Attitude of Health Personnel ; Disease Progression ; Drug Costs ; Drug Utilization ; Guideline Adherence ; Health Knowledge, Attitudes, Practice ; Humans ; Inappropriate Prescribing/economics ; Lung/drug effects ; Lung/physiopathology ; Patient Selection ; Practice Guidelines as Topic ; Practice Patterns, Physicians' ; Predictive Value of Tests ; Risk Assessment ; Risk Factors ; Severity of Illness Index ; Treatment Outcome
    Chemical Substances Anti-Asthmatic Agents
    Language English
    Publishing date 2013-06
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2479146-5
    ISSN 1747-6356 ; 1747-6348
    ISSN (online) 1747-6356
    ISSN 1747-6348
    DOI 10.1586/ers.13.27
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  4. Article ; Online: Predicting death in massive hemoptysis.

    Colice, Gene L

    Respiration; international review of thoracic diseases

    2012  Volume 83, Issue 2, Page(s) 99–100

    MeSH term(s) Female ; Hemoptysis/mortality ; Hospital Mortality ; Humans ; Male ; Severity of Illness Index
    Language English
    Publishing date 2012
    Publishing country Switzerland
    Document type Comment ; Editorial
    ZDB-ID 206674-9
    ISSN 1423-0356 ; 0025-7931
    ISSN (online) 1423-0356
    ISSN 0025-7931
    DOI 10.1159/000334075
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  5. Article: Pragmatic research and outcomes in asthma and COPD.

    Colice, Gene L

    Pragmatic and observational research

    2012  Volume 3, Page(s) 11–25

    Abstract: Asthma and chronic obstructive pulmonary disease (COPD) are common diseases which cause patients and society considerable difficulties. These are costly diseases which cause substantial morbidity and death. Health care policy makers have made improving ... ...

    Abstract Asthma and chronic obstructive pulmonary disease (COPD) are common diseases which cause patients and society considerable difficulties. These are costly diseases which cause substantial morbidity and death. Health care policy makers have made improving outcomes in asthma and COPD a priority. Application of guideline recommended approaches to asthma and COPD care in the real-life setting has been emphasized but outcomes have not improved. Failure to improve outcomes may not be because of inconsistent applications of guideline recommendations, but rather because there are difficulties implementing the Expert Panel Report III (EPR 3) method for categorizing asthma severity and the Global Initiative for Obstructive Lung Disease (GOLD) method for diagnosing COPD. As these serve as the foundation for treatment recommendations for these diseases, alternative approaches should be considered for categorizing asthma severity and identifying COPD patients. Claims-based algorithms provide an intriguing option for identifying persistent asthma patients and symptomatic COPD patients in administrative databases. These methods could be used as the basis for pragmatic research, both retrospective and prospective, on assessing outcomes of guideline recommended treatment approaches in asthma and COPD. Important questions urgently need to be answered about how guideline recommended approaches regarding use of long-acting inhaled β-agonist/inhaled corticosteroid (LABA/ICS) in asthma and long-acting inhaled anti-muscarinic agent (LAMA) and LABA/ICS in COPD affect outcomes in real-life situations.
    Language English
    Publishing date 2012-04-17
    Publishing country New Zealand
    Document type Review ; Journal Article
    ZDB-ID 2586661-8
    ISSN 1179-7266
    ISSN 1179-7266
    DOI 10.2147/POR.S16671
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  6. Article ; Online: Population Pharmacokinetic Modeling and Exposure-Efficacy and Body Weight-Response Analyses for Tezepelumab in Patients With Severe, Uncontrolled Asthma.

    Zheng, Yanan / Abuqayyas, Lubna / Quartino, Angelica / Guan, Ye / Gao, Yuying / Liu, Lu / Hellqvist, Åsa / Colice, Gene / MacDonald, Alexander

    Journal of clinical pharmacology

    2024  

    Abstract: Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin. This analysis assessed the suitability of a fixed-dose regimen of tezepelumab 210 mg every 4 weeks (Q4W) in adults and adolescents with severe, ... ...

    Abstract Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin. This analysis assessed the suitability of a fixed-dose regimen of tezepelumab 210 mg every 4 weeks (Q4W) in adults and adolescents with severe, uncontrolled asthma. A population pharmacokinetic model was developed using data from 1368 patients with asthma or healthy participants enrolled in 8 clinical studies (phases 1-3). Tezepelumab exposure-efficacy relationships were analyzed in the phase 3 NAVIGATOR study (NCT03347279), using asthma exacerbation rates over 52 weeks and changes in pre-bronchodilator forced expiratory volume in 1 s at week 52. Tezepelumab pharmacokinetics were well characterized by a 2-compartment linear disposition model with first-order absorption and elimination following subcutaneous and intravenous administration at 2.1-420 and 210-700 mg, respectively. There were no clinically relevant effects on tezepelumab pharmacokinetics from age (≥12 years), sex, race/ethnicity, renal or hepatic function, disease severity (inhaled corticosteroid dose level), concomitant asthma medication use, smoking history, or anti-drug antibodies. Body weight was the most influential covariate on tezepelumab exposure, but no meaningful differences in efficacy or safety were observed across body weight quartiles in patients with asthma who received tezepelumab 210 mg subcutaneously Q4W. There was no apparent relationship between tezepelumab exposure and efficacy at this dose regimen, suggesting that it is on the plateau of the exposure-response curve of tezepelumab. In conclusion, a fixed-dose regimen of tezepelumab 210 mg subcutaneously Q4W is appropriate for eligible adults and adolescents with severe, uncontrolled asthma.
    Language English
    Publishing date 2024-04-17
    Publishing country England
    Document type Journal Article
    ZDB-ID 188980-1
    ISSN 1552-4604 ; 0091-2700 ; 0021-9754
    ISSN (online) 1552-4604
    ISSN 0091-2700 ; 0021-9754
    DOI 10.1002/jcph.2433
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  7. Article ; Online: Emerging therapeutic options for asthma.

    Colice, Gene L

    The American journal of managed care

    2011  Volume 17 Suppl 3, Page(s) S82–9

    Abstract: Asthma is characterized by eosinophilic airway inflammation and elevated serum immunoglobulin E (IgE) levels. Due to these pathologic features, the foundation of asthma treatment has historically been anti-inflammatory therapy with inhaled ... ...

    Abstract Asthma is characterized by eosinophilic airway inflammation and elevated serum immunoglobulin E (IgE) levels. Due to these pathologic features, the foundation of asthma treatment has historically been anti-inflammatory therapy with inhaled corticosteroids (ICSs). Numerous factors in addition to IgE and eosinophils, however, likely play important roles in mediating the airway inflammatory response characteristic of asthma. ICSs are effective therapy for some patients with persistent asthma, but clinical trials have shown that even increasing doses of ICSs under carefully controlled situations does not always result in acceptable asthma control. Consequently, other classes of medications, in addition to ICSs, are recommended in those patients with more severe asthma. The class of medication most commonly used in more severe asthma, along with ICSs, is long-acting inhaled beta2-agonists, but leukotriene modifying agents and anti-IgE monoclonal antibodies may also be used. Agents such as tiotropium, a long-acting inhaled anti-muscarinic agent, and those aimed at inhibiting cytokines, such as mepoluzimab, daclizumab, and etanercept, hold promise in the treatment of asthma. Other agents under investigation include phosphodiesterase type 4 inhibitors and oligonucleotides. Bronchial thermoplasty, a nonpharmacologic option, may also be beneficial in patients with poorly controlled asthma. As our understanding of the complex pathophysiology of asthma increases, it will enable the development of novel therapeutic approaches for patients who are not responding well to traditional treatments. Although more studies are necessary to ensure the efficacy and safety of both pharmacologic and nonpharmacologic approaches, there is future promise for therapeutic advances in severe, persistent asthma.
    MeSH term(s) Adrenal Cortex Hormones/therapeutic use ; Adrenergic beta-1 Receptor Agonists/therapeutic use ; Anti-Asthmatic Agents/therapeutic use ; Asthma/blood ; Asthma/drug therapy ; Asthma/pathology ; Cytokines/antagonists & inhibitors ; Drug Therapy, Combination ; Eosinophils ; Health Status Indicators ; Humans ; Immunoglobulin E/blood ; Leukotriene Antagonists/therapeutic use ; Phosphodiesterase 4 Inhibitors/therapeutic use ; Severity of Illness Index
    Chemical Substances Adrenal Cortex Hormones ; Adrenergic beta-1 Receptor Agonists ; Anti-Asthmatic Agents ; Cytokines ; Leukotriene Antagonists ; Phosphodiesterase 4 Inhibitors ; Immunoglobulin E (37341-29-0)
    Language English
    Publishing date 2011-04
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 2035781-3
    ISSN 1936-2692 ; 1088-0224 ; 1096-1860
    ISSN (online) 1936-2692
    ISSN 1088-0224 ; 1096-1860
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    Zs.A 5353: Show issues Location:
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  8. Article ; Online: Racial disparities in lung cancer resection.

    Colice, Gene L

    JAMA

    2010  Volume 303, Issue 23, Page(s) 2411–2412

    MeSH term(s) African Continental Ancestry Group ; Carcinoma, Non-Small-Cell Lung/diagnostic imaging ; Carcinoma, Non-Small-Cell Lung/ethnology ; Carcinoma, Non-Small-Cell Lung/surgery ; European Continental Ancestry Group ; Healthcare Disparities ; Humans ; Lung Neoplasms/diagnostic imaging ; Lung Neoplasms/ethnology ; Lung Neoplasms/surgery ; Mass Screening ; Physician-Patient Relations ; Prognosis ; Tomography, X-Ray Computed ; United States
    Language English
    Publishing date 2010-06-16
    Publishing country United States
    Document type Editorial ; Comment
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2010.839
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  9. Article ; Online: COPD and cardiac death: pressure (NT-proBNP), inflammation (CRP) or both?

    Colice, Gene L

    Respiration; international review of thoracic diseases

    2010  Volume 79, Issue 5, Page(s) 353–354

    MeSH term(s) Biomarkers/blood ; C-Reactive Protein/analysis ; Heart Diseases/blood ; Heart Diseases/complications ; Humans ; Hypertension, Pulmonary/blood ; Hypertension, Pulmonary/complications ; Inflammation/blood ; Inflammation/complications ; Natriuretic Peptide, Brain/blood ; Peptide Fragments/blood ; Pulmonary Disease, Chronic Obstructive/blood ; Pulmonary Disease, Chronic Obstructive/complications
    Chemical Substances Biomarkers ; Peptide Fragments ; pro-brain natriuretic peptide (1-76) ; Natriuretic Peptide, Brain (114471-18-0) ; C-Reactive Protein (9007-41-4)
    Language English
    Publishing date 2010
    Publishing country Switzerland
    Document type Comment ; Editorial
    ZDB-ID 206674-9
    ISSN 1423-0356 ; 0025-7931
    ISSN (online) 1423-0356
    ISSN 0025-7931
    DOI 10.1159/000279440
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  10. Article ; Online: Efficacy and safety of tezepelumab in patients with uncontrolled disease while receiving maintenance therapy for moderate or severe asthma.

    Corren, Jonathan / Wechsler, Michael E / Chupp, Geoffrey / Roseti, Stephanie L / Hellqvist, Åsa / Martin, Neil / Llanos, Jean-Pierre / Ambrose, Christopher S / Colice, Gene

    The journal of allergy and clinical immunology. In practice

    2022  Volume 11, Issue 3, Page(s) 943–945.e2

    MeSH term(s) Humans ; Asthma/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Anti-Asthmatic Agents/therapeutic use ; Double-Blind Method
    Chemical Substances tezepelumab (RJ1IW3B4QX) ; Antibodies, Monoclonal, Humanized ; Anti-Asthmatic Agents
    Language English
    Publishing date 2022-11-11
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2843237-X
    ISSN 2213-2201 ; 2213-2198
    ISSN (online) 2213-2201
    ISSN 2213-2198
    DOI 10.1016/j.jaip.2022.10.042
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