157 results on '"Craig, Timothy J."'
Search Results
2. Artificial Intelligence–Generated Scientific Literature: A Critical Appraisal
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Zybaczynska, Justyna, Norris, Matthew, Modi, Sunjay, Brennan, Jennifer, Jhaveri, Pooja, Craig, Timothy J., and Al-Shaikhly, Taha
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Review articles play a critical role in informing medical decisions and identifying avenues for future research. With the introduction of artificial intelligence (AI), there has been a growing interest in the potential of this technology to transform the synthesis of medical literature. Open AI’s Generative Pre-trained Transformer (GPT-4) (Open AI Inc, San Francisco, CA) tool provides access to advanced AI that is able to quickly produce medical literature following only simple prompts. The accuracy of the generated articles requires review, especially in subspecialty fields like Allergy/Immunology.
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- 2024
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3. Impact of Sulfonamide Allergy Label on Clinical Outcomes in Patients with Pneumocystis jiroveciiPneumonia
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Stone, Shane, Henao, Maria P., Craig, Timothy J., and Al-Shaikhly, Taha
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Introduction: The presence of antibiotic allergy labels can have harmful impacts on clinical outcomes, particularly among immunosuppressed patients, in whom there have been associations with increased complications, readmission rates, and mortality. We explore the effects of a sulfonamide allergy label (SAL) on clinical outcomes in adult patients with Pneumocystis jiroveciipneumonia (PJP). Methods: In this retrospective matched cohort study, we utilized TriNetX, a multicenter national database, to match 535 adult patients with PJP and SAL to an equal number of controls. We identified cases indexed between 01/01/2010 and 01/01/2023 utilizing ICD-10 codes for PJP and allergy status to sulfonamides and through detection of P. jiroveciiantigen with immunofluorescence or PCR. Propensity score matching was performed in a 1:1 fashion for demographics and comorbidities, and our analysis included clinical outcomes that occurred within 30 days after the occurrence of the index event. Results: While hospitalization risk tended to be lower among patients with SAL as compared to controls (RR: 0.90; 95% CI 0.81–1.01), there were no major differences in the risk of respiratory failure (RR: 0.94; 95% CI 0.84–1.05), prednisone use (RR: 1; 95% CI 0.91–1.10), intensive level of care requirement (RR: 0.85; 95% CI 0.69–1.06), intubation (RR: 0.85; 95% CI 0.61–1.19), or mortality (RR: 0.98; 95% CI 0.68–1.42). The presence of SAL did however impact antibiotic prescription patterns, with an underutilization of trimethoprim (RR: 0.50; 95% CI 0.43–0.59) and sulfamethoxazole (RR, 0.47; 95% CI 0.40–0.56) and overuse of alternative agents by patients with SAL as compared to controls. Yet, there was no difference in the occurrence of adverse outcomes such as hepatotoxicity (RR: 1.09; 95% CI 0.49–2.45) or acute kidney injury (RR: 0.94; 95% CI 0.78–1.14) between patients with SAL and controls. Conclusions: The presence of SAL alters antibiotic prescription patterns among adults with Pneumocystisinfection but has no clinically significant impact on outcomes.
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- 2024
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4. Outcomes of acute pyelonephritis in patients with a penicillin allergy label in the United States.
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Al-Obaydi, Sarah, Ssentongo, Paddy, Cherneskie, John J., Craig, Timothy J., and Al-Shaikhly, Taha
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- 2024
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5. Improving Detection of Alpha-1 Antitrypsin Deficiency: Role of the Allergist
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Craig, Timothy J., Corbett, Mark L., and Meadows, J. Allen
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Alpha-1 antitrypsin deficiency (AATD) is a genetic disorder that manifests as lung and/or liver disease. Because symptoms of AATD overlap with those of common pulmonary and hepatic conditions, AATD is often misdiagnosed, which has resulted in substantial underdiagnosis of AATD worldwide. Although screening patients for AATD is recommended, the lack of procedures to facilitate testing remains a barrier to accurate diagnosis of AATD. Delays in AATD diagnosis can worsen outcomes for patients by postponing appropriate disease-modifying treatments. Patients with AATD-related lung disease experience symptoms similar to other obstructive lung disorders and are often misdiagnosed for years. In addition to existing screening guidelines, we recommend that screening for AATD become a standard part of allergists’ workups of patients with asthma and fixed obstructive disease, chronic obstructive pulmonary disease, bronchiectasis without known origin, and patients under consideration for treatment with biologics. This Rostrum article reviews screening and diagnostic tests available in the United States and emphasizes evidence-based strategies to increase testing frequency and improve AATD detection rates. We underscore the pivotal role of allergists in managing care for patients with AATD. Finally, we urge health care providers to be aware of potentially poor clinical outcomes among patients with AATD during the coronavirus disease 2019 pandemic.
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- 2023
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6. Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
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Craig, Timothy J, Reshef, Avner, Li, H Henry, Jacobs, Joshua S, Bernstein, Jonathan A, Farkas, Henriette, Yang, William H, Stroes, Erik S G, Ohsawa, Isao, Tachdjian, Raffi, Manning, Michael E, Lumry, William R, Saguer, Inmaculada Martinez, Aygören-Pürsün, Emel, Ritchie, Bruce, Sussman, Gordon L, Anderson, John, Kawahata, Kimito, Suzuki, Yusuke, Staubach, Petra, Treudler, Regina, Feuersenger, Henrike, Glassman, Fiona, Jacobs, Iris, and Magerl, Markus
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Hereditary angioedema is a rare and potentially life-threatening genetic disease that is associated with kallikrein–kinin system dysregulation. Garadacimab (CSL312), a novel, fully-human monoclonal antibody that inhibits activated factor XII (FXIIa), is being studied for the prevention of hereditary angioedema attacks. The aim of this study was to evaluate the efficacy and safety of once-monthly subcutaneous administrations of garadacimab as prophylaxis for hereditary angioedema.
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- 2023
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7. Small molecule drugs for atopic dermatitis, rheumatoid arthritis, and hereditary angioedema.
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Geng, Bob and Craig, Timothy J.
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- 2022
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8. Physician and patient perspectives on the management of hereditary angioedema: a survey on treatment burden and needs.
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Riedl, Marc A., Craig, Timothy J., Banerji, Aleena, Aggarwal, Kavita, Best, Jessica M., Rosselli, Jinky, Hahn, Rebecca, and Radojicic, Cristine
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PHYSICIANS' attitudes ,ANGIONEUROTIC edema ,MEDICAL personnel ,PATIENT participation ,PHYSICIANS - Abstract
The article focuses on the survey of treatment burden and needs of Physician and patient perspectives on the management of hereditary angioedema. Topics discussed include Hereditary angioedema (HAE) is a rare disorder caused by genetic mutations that lead to recurrent episodes Of swelling in various parts of the body; and Prophylactic treatment is common for patients with HAE, and the therapeutic options have expanded in recent years.
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- 2021
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9. Patient perspectives on the treatment burden of injectable medication for hereditary angioedema.
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Radojicic, Cristine, Riedl, Marc A., Craig, Timothy J., Best, Jessica M., Rosselli, Jinky, Hahn, Rebecca, and Banerji, Aleena
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ANGIONEUROTIC edema ,QUALITY of life ,PATIENTS' attitudes ,DRUGS ,INJECTIONS - Abstract
Hereditary angioedema (HAE) is a rare, chronic disease characterized by debilitating swelling episodes in various parts Of the body. Patients experience significant burdens related to the symptoms and management of HAE. which can affect their daily lives and reduce their overall quality of life. Prophylactic treatment options have expanded in the past decade to the benefit of patients; however, these therapies require scheduled injections, which can be painful, burdensome, and time consuming. We conducted an online survey of patients with HAE in the USA to better understand their experiences with available prophylactic medications and the associated treatment burdens. Our survey results suggest that most patients are satisfied with their current therapies but desire novel medications with a simpler route of administration and that, although most patients experience significant treatment-related burdens, they learn to cope with these challenges over time. [ABSTRACT FROM AUTHOR]
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- 2021
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10. Caregivers' role in managing hereditary angioedema and perceptions of treatment-related burden.
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Craig, Timothy J., Banerji, Aleena, Riedl, Marc A., Best, Jessica M., Rosselli, Jinky, Hahn, Rebecca, and Radojicic, Cristine
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ANGIONEUROTIC edema ,CAREGIVERS ,ADULTS ,GASTROINTESTINAL system ,PATIENTS' attitudes - Abstract
Hereditary angioedema (HAE) is a rare genetic disease that results in recurrent, debilitating, and potentially life-threatening swelling episodes in the extremities, genitals, gastrointestinal tract, and upper airway Patients can experience significant burdens related to their disease. Informal or familial caregivers often support patients with HAE and likely share in the diseaserelated burdens, although there are limited HAE caregiver-focused reports in the scientfic literature. In the United States, we conducted an online survey of adults caring for an individual with HAE to better understand their experiences with the disease and identify psychosocial impacts of providing care for a patient with HAE. Thirty caregivers provided responses to the survey. Most caregivers were family members of the care recipient and many had HAE themselves. Caregivers reported participating in a number of medical-related tasks and experiencing some burdens as a result of caringfor a person with HAE. [ABSTRACT FROM AUTHOR]
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- 2021
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11. Androgen use in hereditary angioedema: A critical appraisal and approaches to transitioning from androgens to other therapies.
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Johnston, Douglas T., Li, H. Henry, Craig, Timothy J., Bernstein, Jonathan A., Anderson, John, Joseph, Kusumam, and Riedl, Marc A.
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ANDROGENS ,ANGIONEUROTIC edema ,LITERATURE reviews - Abstract
Background: Hereditary angioedema (HAE) is a rare genetic disorder clinically characterized by recurrent attacks of subcutaneous and mucosal swelling. Attenuated androgens have been a prophylactic treatment option to reduce the frequency of HAE attacks for > 4 decades. However, the advent of effective on-demand treatments and highly effective, more tolerable, long-term prophylactic therapies has led to a decline in the use of attenuated androgens for the management of HAE in regions where newer therapies are available. A consensus about the best approach for discontinuing or tapering off attenuated androgen therapy does not exist. Objective: To develop a consensus on androgen tapering for patients with HAE. Methods: We sent an open-ended survey about androgen tapering to 21 physicians who treat HAE, 12 of whom responded. We reviewed the collective experience of the participating physicians in combination with results from a literature review on the topic. Results: The survey and literature review underscored potential concerns related to rapid androgen withdrawal in patients with HAE, including physician and patient concerns that the frequency and severity of attacks would abruptly worsen. In addition, discontinuation of attenuated androgens may have the potential for transient adverse effects, such as an increase in the rate of attacks or effects related to hormone withdrawal. Our survey showed that physicians often taper androgens to prevent increases in HAE attacks and possible withdrawal complications. Conclusion: Based on both experiences of the physicians who responded to our survey and reports in the endocrine literature, we provided recommendations for androgen tapering. However, we noted that the likelihood of adverse effects due to androgen withdrawal in patients with HAE is poorly understood and requires further study. [ABSTRACT FROM AUTHOR]
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- 2021
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12. Pulmonary Therapy Podcast—COVID-19: Research and Real-World Experiences from the Editorial Board
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Beeh, Kai Michael, Chaudhuri, Nazia, Craig, Timothy J., Kaplan, Alan, and Kennedy, Marcus Peter
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The Editorial Board have prepared a podcast describing their experiences over the past year of the COVID-19 pandemic. The Editorial Board describe how COVID-19 impacted their research and how the initial clinical response changed over the course of the year in terms of treatment, personal protective equipment (PPE), and policy changes. The podcast and transcript can be viewed below the abstract of the online version of the manuscript. Alternatively, the podcast and transcript can be downloaded here: https://doi.org/10.6084/m9.figshare.14402291
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- 2021
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13. Rhinitis 2020: A practice parameter update.
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Dykewicz, Mark S., Wallace, Dana V., Amrol, David J., Baroody, Fuad M., Bernstein, Jonathan A., Craig, Timothy J., Dinakar, Chitra, Ellis, Anne K., Finegold, Ira, Golden, David B.K., Greenhawt, Matthew J., Hagan, John B., Horner, Caroline C., Khan, David A., Lang, David M., Larenas-Linnemann, Desiree E.S., Lieberman, Jay A., Meltzer, Eli O., Oppenheimer, John J., and Rank, Matthew A.
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This comprehensive practice parameter for allergic rhinitis (AR) and nonallergic rhinitis (NAR) provides updated guidance on diagnosis, assessment, selection of monotherapy and combination pharmacologic options, and allergen immunotherapy for AR. Newer information about local AR is reviewed. Cough is emphasized as a common symptom in both AR and NAR. Food allergy testing is not recommended in the routine evaluation of rhinitis. Intranasal corticosteroids (INCS) remain the preferred monotherapy for persistent AR, but additional studies support the additive benefit of combination treatment with INCS and intranasal antihistamines in both AR and NAR. Either intranasal antihistamines or INCS may be offered as first-line monotherapy for NAR. Montelukast should only be used for AR if there has been an inadequate response or intolerance to alternative therapies. Depot parenteral corticosteroids are not recommended for treatment of AR due to potential risks. While intranasal decongestants generally should be limited to short-term use to prevent rebound congestion, in limited circumstances, patients receiving regimens that include an INCS may be offered, in addition, an intranasal decongestant for up to 4 weeks. Neither acupuncture nor herbal products have adequate studies to support their use for AR. Oral decongestants should be avoided during the first trimester of pregnancy. Recommendations for use of subcutaneous and sublingual tablet allergen immunotherapy in AR are provided. Algorithms based on a combination of evidence and expert opinion are provided to guide in the selection of pharmacologic options for intermittent and persistent AR and NAR. [ABSTRACT FROM AUTHOR]
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- 2020
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14. POPS case: A 30-year-old Filipino woman with fevers, lymphadenopathy, painful scalp lesions, and a neck mass.
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Daley, Aparna S., Naro, Gillian R., Craig, Timothy J., Hussein, Rezhan H. A., Banjade, Rashmi, Jacobs, Jennifer B., and Ross, Ian R.
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TRACHEAL fistula ,ESOPHAGEAL fistula ,SYMPTOMS ,FEVER ,SCALP ,ESOPHAGEAL atresia - Abstract
We described a case of a 30-year-old Filipino woman who presented with fevers, night sweats, left hip pain, painful scalp lesions, and a neck mass. Symptoms began 6 months earlier, with nasal drainage, fever, cough, and occasional hemoptysis, which did not resolve with outpatient antibiotics. A further workup revealed lymphadenopathy and several lytic bone lesions. Her hospital course was later further complicated by the development of a tracheoesophageal fistula secondary to an esophageal mass and, then later, aseptic meningitis. Extensive diagnostic workup and immunologic tests were performed and finally led to the diagnosis. Here, we discussed the diagnostic workup and pathophysiology of the underlying condition. This case illustrated the importance of appropriate immunologic workup to make the diagnosis of a rare condition that proves to be clinically significant and presents challenges in management. [ABSTRACT FROM AUTHOR]
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- 2020
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15. A Review: Does Complement or the Contact System Have a Role in Protection or Pathogenesis of COVID-19?
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Maglakelidze, Natella, Manto, Kristen M., and Craig, Timothy J.
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Introduction: COVID-19 presentation may include a profound increase in cytokines and associated pneumonia, rapidly progressing to acute respiratory distress syndrome (ARDS). This so-called cytokine storm often leads to refractory edema, respiratory arrest, and death. At present, anti-IL-6, antiviral therapy, convalescent plasma, hydroxychloroquine, and azithromycin among others are being investigated as potential treatments for COVID-19. As the disease etiology and precise therapeutic interventions are still not definitively defined, we wanted to review the roles that complement and the contact system may have in either the treatment or pathogenesis of the disease. Methods: We searched the recent literature (PubMed) on complement and coronavirus; contact system and coronavirus; bradykinin and coronavirus; and angiotensin receptor and coronavirus. The manuscript complies with ethics guidelines and was deemed exempt from institutional review board approval according to Human Subjects Protection Office guidelines. Results: Mouse models are available for the study of coronavirus and complement. Although complement is effective in protecting against many viruses, it does not seem to be protective against coronavirus. C3 knockout mice infected with SARS-CoV had less lung disease than wild-type mice, suggesting that complement may play a role in coronavirus pathogenesis. Some evidence suggests that the observed pulmonary edema may be bradykinin-induced and could be the reason that corticosteroids, antihistamines, and other traditional interventions for edema are not effective. Angiotensin-converting enzyme 2 (ACE2) is a co-receptor for SARS-CoV-2, and studies thus far have not concluded a benefit or risk associated with the use of either ACE-inhibitors or angiotensin receptor antagonists. Summary: Activation of complement and the contact system, through generation of bradykinin, may play a role in the SARS-CoV-2-induced pulmonary edema, and our search suggests that further work is necessary to confirm our suspicions.
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- 2020
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16. Insights into the treatment burden of hereditary angioedema in the evolving treatment landscape.
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Banerji, Aleena, Riedl, Marc A., Craig, Timothy J., and Radojicic, Cristine
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ANGIONEUROTIC edema ,PHYSICIANS - Abstract
The article discusses insights into the treatment burden of hereditary angioedema in evolving treatment landscape. Topics discussed include hereditary angioedema (HAE) is a rare genetic disease characterized by unpredictable, and potentially life-threatening episodes of cutaneous and submucosal swelling in various parts of the body; and HAE symptoms typically manifest during childhood with development of recurrent episodes of angioedema in the extremities, face, and gastrointestinal tract.
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- 2021
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17. Garadacimab for hereditary angioedema attack prevention: long-term efficacy, quality of life, and safety data from a phase 2, randomised, open-label extension study
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Craig, Timothy J, Levy, Donald S, Reshef, Avner, Lumry, William R, Martinez-Saguer, Inmaculada, Jacobs, Joshua S, Yang, William H, Ritchie, Bruce, Aygören-Pürsün, Emel, Keith, Paul K, Busse, Paula, Feuersenger, Henrike, Alexandru Bica, Mihai, Jacobs, Iris, Pragst, Ingo, and Magerl, Markus
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Garadacimab is a fully human immunoglobulin G4 monoclonal antibody targeting activated factor XII. This study evaluated long-term efficacy, health-related quality of life (HRQoL), and safety data for garadacimab in adults with hereditary angioedema.
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- 2024
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18. Garadacimab for the prevention of hereditary angioedema attacks: a plain language summary of the VANGUARD study
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Craig, Timothy J, Reshef, Avner, Li, H Henry, Jacobs, Joshua S, Bernstein, Jonathan A, Farkas, Henriette, Yang, William H, G Stroes, Erik S, Ohsawa, Isao, Tachdjian, Raffi, Manning, Michael E, Lumry, William R, Saguer, Inmaculada Martinez, Aygören-Pürsün, Emel, Ritchie, Bruce, Sussman, Gordon L, Anderson, John, Kawahata, Kimito, Suzuki, Yusuke, Staubach, Petra, Treudler, Regina, Feuersenger, Henrike, Wieman, Lolis, Jacobs, Iris, and Magerl, Markus
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What is this summary about?This summarizes an article about the clinical study ‘VANGUARD’ that was published in The Lancetjournal in February 2023. Hereditary angioedema (HAE) is a rare genetic disease that causes swellings throughout the body (called HAE attacks). HAE attacks in the upper airways (including the tongue and vocal cords) can be life threatening by making breathing difficult. HAE attacks may occur frequently and without warning, and people with HAE have a lower quality of life than other people.In the VANGUARD study, researchers tested the safety of a new medicine called garadacimab and whether it could prevent HAE attacks. Garadacimab was injected subcutaneously (just under the skin) with a needle once a month.What were the results?In the VANGUARD study, patients took garadacimab or placebo (an identical-looking dummy substance with no medical effect, used for comparison). The aim was to see if garadacimab could prevent HAE attacks better than placebo.Patients taking garadacimab had very few or no HAE attacks, but those taking placebo carried on having attacks. Garadacimab gave protection from HAE attacks shortly after it was first used, and this carried on for the 6 months of treatment. Most patients taking garadacimab (62%) had no HAE attacks throughout the 6 months of treatment (were attack free), but 100% of patients taking placebo had HAE attacks throughout the study. More patients taking garadacimab (82%) than placebo (33%) had a ‘good’ or ‘excellent’ experience living with HAE. Patients taking garadacimab and placebo had similar rates of side effects. Only 5% (2 out of 39) of patients taking garadacimab had discomfort or skin changes at the place of injection compared with 12% (3 out of 25) taking placebo.What do the results mean?Taking garadacimab once a month helps prevent HAE attacks from happening, with most patients being attack free throughout the 6 months of treatment. Garadacimab had very few and mostly mild or moderate side effects. Overall, garadacimab is a beneficial treatment for preventing HAE attacks.
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- 2024
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19. Racial and ethnic disparities in the treatment of patients with atopic dermatitis in the United States: A retrospective matched cohort study
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Al-Obaydi, Sarah, Craig, Timothy J., and Al-Shaikhly, Taha
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- 2023
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20. Understanding alpha-1 antitrypsin deficiency: A review with an allergist's outlook.
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Henao, Maria Paula and Craig, Timothy J.
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ALPHA 1-antitrypsin ,ALLERGISTS ,SERPINS ,LEUCOCYTE elastase ,ALLERGY treatment ,FOOD allergy - Abstract
Alpha-1 antitrypsin (AAT) is the prototypical protease inhibitor from the serine protease inhibitor (serpin) superfamily that protects lung tissue from proteolytic damage by inhibiting neutrophil elastase. Approximately 1 in 2750 to 1 in 4500 individuals have an autosomal codominant condition that leads to a deficiency of circulating AAT. In individuals with AAT deficiency (AATD), AAT is retained in liver cells, which predisposes them to liver disease, and does not reach lung tissues through circulation, where it normally acts as the primary natural regulator of proteolytic activity in the pulmonary tissues, which thus leads to lung disease. Despite being commonly labeled as a rare disease, AATD is one of the most common autosomal genetic disorders and is considered highly underrecognized, with ≤10% of individuals suspected with AATD identified. Screening guidelines have been established, and the diagnosis is easy to confirm when the condition is suspected. Early recognition is key to prevent morbidity and mortality associated with the disease. For this reason, all patients with chronic obstructive pulmonary disease and patients with asthma and fixed obstruction should be tested to exclude the diagnosis of AATD. Augmentation therapy of the deficient protein is available for those with significant lung disease and protein deficiency, and analysis of recent data supported preservation of lung tissue with this treatment. In this review, oriented toward specialists in allergy and immunology, we focused our discussion on the presentation, diagnosis, and treatment of pulmonary symptoms of AATD. [ABSTRACT FROM AUTHOR]
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- 2017
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21. Clinical characteristics and cytokine changes in children with pneumonia requiring mechanical ventilation
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Nguyen Thi Dieu, Thuy, Pham Nhat, An, Craig, Timothy J, and Duong-Quy, Sy
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Objective To assess clinical characteristics and cytokine levels in children with severe pneumonia who required ventilatory support.Methods In this prospective, descriptive, cross-sectional study, blood and endotracheal fluid samples were obtained from patients with severe pneumonia, aged <5 years, within 24 h following intubation. Blood samples were also obtained from age-matched healthy controls. Cytokine levels were investigated using flow cytometry-assisted immunoassay.Results Forty-five patients with severe pneumonia requiring mechanical ventilation (aged 10 ± 5 months) and 35 healthy age-matched controls were included. Patients with severe pneumonia had significantly increased serum interleukin (IL)-6, IL-8, and granulocyte/macrophage colony-stimulating factor concentrations compared with controls (80.84 pg/ml versus 2.06 pg/ml, 90.03 pg/ml versus 6.62 pg/ml, and 115.58 pg/ml versus 11.47 pg/ml, respectively). In the severe pneumonia group, serum IL-10 levels were significantly higher in patients aged <6 months versus those aged 6–12 months. Age-group differences in serum cytokine levels did not correspond to age-group differences in endotracheal-fluid cytokine levels. Serum IL-6 levels were significantly higher in patients who subsequently died versus those who survived (267.12 pg/ml versus 20.75 pg/ml, respectively).Conclusion High IL-6 concentrations were associated with mortality in patients <5 years of age with severe pneumonia requiring mechanical ventilation.
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- 2017
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22. Effects of genetic factors to inhaled corticosteroid response in children with asthma: a literature review
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Duong-Thi-Ly, Huong, Nguyen-Thi-Thu, Ha, Nguyen-Hoang, Long, Nguyen-Thi-Bich, Hanh, Craig, Timothy J., and Duong-Quy, Sy
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Numerous studies have examined the association between pharmacogenetic effects and the response to inhaled corticosteroids (ICS) in patients with asthma. In fact, several single nucleotide polymorphisms of a number of candidate genes have been identified that might influence the clinical response to ICS in children with asthma. Their direct or indirect effects depend on their role in the inflammatory process in asthma or the anti-inflammatory action of corticosteroids, respectively. Among the genes identified, variants in T-box 21 (TBX21) and Fc fragment of IgE receptor II (FCER2)contribute indirectly to the variability in the response to ICS by altering the inflammatory mechanisms in asthma, while other genes such as corticotropin releasing hormone receptor 1 (CRHR1), nuclear receptor subfamily 3 group C member 1 (NR3C1), stress induced phosphoprotein 1 (STIP1), dual specificity phosphatase 1 (DUSP1), glucocorticoid induced 1 (GLCCI1),histone deacetylase 1 (HDAC),ORMDL sphingolipid biosynthesis regulator 3 (ORMDL3), and vascular endothelial growth factors (VEGF)directly affect this variability through the anti-inflammatory mechanisms of ICS. The results to date indicate various potential genetic factors associated with the response to ICS, which could be utilized to predict the individual therapeutic response of children with asthma to ICS. Clinical trials are underway and their results are greatly anticipated. Further pharmacogenetic studies are needed to fully understand the effects of genetic variation on the response to ICS in children with asthma.
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- 2017
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23. Circulating microRNAs as biomarkers in patients with allergic rhinitis and asthma.
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Panganiban, Ronaldo P., Wang, Yanli, Howrylak, Judie, Chinchilli, Vernon M., Craig, Timothy J., August, Avery, and Ishmael, Faoud T.
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Background MicroRNAs (miRNAs) are emerging as important regulatory molecules that might be involved in the pathogenesis of various diseases. Circulating miRNAs might be noninvasive biomarkers to diagnose and characterize asthma and allergic rhinitis (AR). Objective We sought to determine whether miRNAs are differentially expressed in the blood of asthmatic patients compared with those in the blood of nonasthmatic patients with AR and nonallergic nonasthmatic subjects. Furthermore, we sought to establish whether miRNAs could be used to characterize or subtype asthmatic patients. Methods Expression of plasma miRNAs was measured by using real-time quantitative PCR in 35 asthmatic patients, 25 nonasthmatic patients with AR, and 19 nonallergic nonasthmatic subjects. Differentially expressed miRNAs were identified by using Kruskal-Wallis 1-way ANOVA with Bonferroni P value adjustment to correct for multiple comparisons. A random forest classification algorithm combined with a leave-one-out cross-validation approach was implemented to assess the predictive capacities of the profiled miRNAs. Results We identified 30 miRNAs that were differentially expressed among healthy, allergic, and asthmatic subjects. These miRNAs fit into 5 different expression pattern groups. Among asthmatic patients, miRNA expression profiles identified 2 subtypes that differed by high or low peripheral eosinophil levels. Circulating miR-125b, miR-16, miR-299-5p, miR-126, miR-206, and miR-133b levels were most predictive of allergic and asthmatic status. Conclusions Subsets of circulating miRNAs are uniquely expressed in patients with AR and asthmatic patients and have potential for use as noninvasive biomarkers to diagnose and characterize these diseases. [ABSTRACT FROM AUTHOR]
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- 2016
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24. Patients perception of self-administrated medication in the treatment of hereditary angioedema.
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Wang, Adrian, Fouche, Andrew, and Craig, Timothy J.
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- 2015
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25. Efficacy of C1 esterase inhibitor concentrate in treatment of cutaneous attacks of hereditary angioedema.
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Bork, Konrad, Craig, Timothy J., Bernstein, Jonathan A., Feuersenger, Henrike, Machnig, Thomas, and Staubach, Petra
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ESTERASES ,ANGIONEUROTIC edema ,SKIN diseases ,THERAPEUTICS research - Abstract
Background: Although treatment with C1 esterase inhibitor (C1-INH) concentrate is well established for hereditary angioedema (HAE) attacks in general, data that assess its efficacy for cutaneous attack treatment are sparse. Objective: To assess efficacy of plasma-derived, nanofiltered C1-INH concentrate for cutaneous attack treatment by comparing treated attacks from the uncontrolled I.M.P.A.C.T.2 study with historical data for untreated attacks. Methods: Cutaneous attack data from patients with HAE who were treated for cutaneous edema with 20 IU/kg body weight C1-INH concentrate in the uncontrolled I.M.P.A.C.T.2 study (38 patients) were compared with data from untreated patients from an historical data base (46 patients) and included subset analyses for facial edema (treated group, 21 patients; untreated group, 33 patients) and peripheral edema (30 patients in each group). Average attack duration (AAD) per patient was the efficacy end point used to compare treated and untreated patients. Differences were assessed with a Wilcoxon test (primary analysis) and a log-rank test; AAD per patient was analyzed descriptively and graphically with Kaplan-Meier curves. Results: The AAD per patient of all cutaneous attacks or facial and peripheral cutaneous attack subsets was significantly faster with C1-INH treatment than without treatment (Wilcoxon and log-rank tests, both p < 0.0001 for all comparisons). Mean AADs per patient for all, facial, and peripheral attacks were 2.04, 1.45, and 2.16 days, respectively, in the C1-INH-treated group, and were 3.74, 4.45, and 2.98 days, respectively, in the untreated group. Kaplan-Meier curves corroborated the observed group differences. Conclusion: Treatment of cutaneous HAE attacks (all attacks or facial and peripheral attack subsets) with 20 IU/kg C1-INH concentrate provided faster attack resolution compared with no treatment. [ABSTRACT FROM AUTHOR]
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- 2015
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26. Racial and Ethnic Disparities in Allergen Immunotherapy Prescription for Allergic Rhinitis
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Modi, Sunjay, Norris, Matthew R., Nguyen, Victoria, Bower, Robert, Craig, Timothy J., and Al-Shaikhly, Taha
- Abstract
Racial and ethnic differences exist in the severity of various atopic diseases including allergic rhinitis (AR). Patients of under-represented races and ethnicities may be subjected to disparate subcutaneous allergen immunotherapy (SCIT) prescription practices.
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- 2023
- Full Text
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27. Outcomes of acute pyelonephritis in patients with a penicillin allergy label in the United States
- Author
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Al-Obaydi, Sarah, Ssentongo, Paddy, Cherneskie, John J., Craig, Timothy J., and Al-Shaikhly, Taha
- Published
- 2023
- Full Text
- View/download PDF
28. Barriers to self-administered therapy for hereditary angioedema.
- Author
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Tuong, Linh-An C., Olivieri, Kirsten, and Craig, Timothy J.
- Subjects
ANGIONEUROTIC edema ,GENETIC disorders ,QUALITY of life ,SELF medication ,EDEMA - Abstract
Presently, the movement of care for hereditary angioedema (HAE) is out of the clinic, emergency department, and hospitals and into the home. Much of the transition relies on specialized nurses who teach patients self-administration skills. Our goal was to assess nurses to uncover barriers that they have encountered in an effort to improve self-therapy education and patient care. A survey of 21 questions was sent to 38 HAE home care nurses throughout the United States. Results were collected anonymously and data were analyzed. Nurses feel that there is an increased need for teaching patients self-therapy skills. The majority are very comfortable teaching self-administration and troubleshooting-associated problems. Perceived difficulties in providing adequate teaching include distance to patient's home and logistics of coordinating, scheduling, and obtaining supplies. Teaching is preferred when done at home by a visiting nurse with a care partner available and multiple training sessions are needed. Very few patients refused self-administration after initially being taught; reasons cited for refusal include fear of injection or infection, lack of skills, interference of daily activities, and financial restraints. As for nurses, they were most worried about safety, lack of skill retention, and inappropriate use of the drug. Self- administration of HAE treatment is increasingly more accessible and should be offered to patients as a safe and practical option. The barriers to self-administration revealed in this study include distance to the patient's home, coordinating care, obtaining medications/equipment, and scheduling training sessions. Moving to self- or home treatment through nursing instruction will improve patient's independence and quality of life, lead to earlier therapy, and reduce costs associated with care. [ABSTRACT FROM AUTHOR]
- Published
- 2014
- Full Text
- View/download PDF
29. The Allergies, Immunotherapy, and RhinoconjunctivitiS (AIRS) survey: Patients' experience with allergen immunotherapy.
- Author
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Skoner, David P., Blaiss, Michael S., Dykewicz, Mark S., Smith, Nancy, Leatherman, Bryan, Bielory, Leonard, Walstein, Nicole, Craig, Timothy J., and Allen-Ramey, Felicia
- Subjects
IMMUNOTHERAPY ,ALLERGENS ,ASTHMA ,IMMUNOLOGY - Abstract
Allergen immunotherapy (AIT) is used for the treatment of allergic rhinoconjunctivitis as a subcutaneous injection (subcutaneous immunotherapy [SCIT]). Extracts used for SCIT are also used off-label to formulate a liquid delivered as sublingual drops (sublingual immunotherapy [SLIT]). This study was designed to survey patients' experiences and beliefs regarding SCIT and SLIT. People who had ever been diagnosed with nasal and/or ocular allergies were identified in a 2012 telephone survey of U.S. households. Respondents were asked questions about their or their child's use of SCIT and SLIT and their beliefs about AIT. Of 2765 respondents, 46.5% had ever heard of AIT and 22.7% had ever initiated it: 20.9% with SCIT and 1.8% with SLIT (p < 0.0001). The most frequently cited reason for beginning AIT was that symptoms were unresolved with other medications (SCIT, 32.1%; SLIT, 14.0%). Some or full symptom relief was reported by 74.9% of respondents treated with SCIT and 66.0% of those treated with SLIT (p = 0.17 for SCIT versus SLIT). Approximately one-third of respondents who had ever heard of or had been treated with AIT said 'don't know' when asked if immunotherapy controls allergy symptoms for years (33.6%), is a very safe treatment (29.3%), or can cure allergy symptoms (27.5%). Effective relief of allergy symptoms was cited most often as the primary benefit of SCIT (37.8%) and convenience was the primary benefit of SLIT (14%). Only one-fifth of respondents had ever been treated with AIT, largely with SCIT. More than one-half of respondents had never heard of AIT and respondents' beliefs indicated a need for educational efforts. [ABSTRACT FROM AUTHOR]
- Published
- 2014
- Full Text
- View/download PDF
30. Ocular and nasal allergy symptom burden in America: The Allergies, Immunotherapy, and RhinoconjunctivitiS (AIRS) surveys.
- Author
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Bielory, Leonard, Skoner, David P., Blaiss, Michael S., Leatherman, Bryan, Dykewicz, Mark S., Smith, Nancy, Ortiz, Gabriel, Hadley, James A., Walstein, Nicole, Craig, Timothy J., and Allen-Ramey, Felicia
- Subjects
IMMUNOTHERAPY ,SYMPTOMS ,OCULAR manifestations of general diseases ,NASAL manifestations of general diseases - Abstract
Previous nationwide surveys of allergies in the United States have focused on nasal symptoms, but ocular symptoms are also relevant. This study determines the effects of ocular and nasal allergies on patients' lives. Telephone surveys of randomly selected U.S. households (the patient survey) and health care providers (provider survey) were conducted in the United States in 2012. Study participants were 2765 people ≥5 years of age who had ever been diagnosed with nasal or ocular allergies and 500 health care providers in seven specialties. Respondents to the patient survey reported a bimodal seasonal distribution of allergy symptoms, with peaks in March to May and September. Nasal congestion was the most common of the symptoms rated as 'extremely bothersome' (39% of respondents), followed by red, itchy eyes (34%; p = 0.84 for difference in extreme bothersomeness of nasal and ocular symptoms). Twenty-nine percent of respondents reported that their or their child's daily life was impacted 'a lot' when allergy symptoms were at their worst. Workers rated their mean productivity at 29% lower when allergy symptoms were at their worst (p < 0.001 compared with no symptoms). Providers reported that itchy eyes was the symptom causing most patients to seek medical treatment by pediatricians (73%), ophthalmologist/optometrists (72%), and nurse practitioners or physician assistants (62%), whereas nasal congestion was the symptom causing most patients to seek treatment from otolaryngologists (85%), allergist/immunologists (79%), and family medicine practitioners (64%). Ocular and nasal allergy symptoms substantially affected patients' lives and were comparable in their impact. [ABSTRACT FROM AUTHOR]
- Published
- 2014
- Full Text
- View/download PDF
31. Diagnosis and treatment of nasal and ocular allergies: the Allergies, Immunotherapy, and RhinoconjunctivitiS (AIRS) surveys.
- Author
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Blaiss, Michael S., Dykewicz, Mark S., Skoner, David P., Smith, Nancy, Leatherman, Bryan, Craig, Timothy J., Bielory, Leonard, Walstein, Nicole, and Allen-Ramey, Felicia
- Published
- 2014
- Full Text
- View/download PDF
32. High-grade fever and pancytopenia in an adult patient with common variable immune deficiency.
- Author
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Bajaj, Puneet, Clement, Jincy, Bayerl, Michael G., Kalra, Neelu, Craig, Timothy J., and Ishmael, Faoud T.
- Subjects
IMMUNODEFICIENCY ,FEVER ,POLYMERASE chain reaction ,MULTIPLE organ failure ,BACTEREMIA ,PATIENTS - Abstract
Fever of unknown origin in patients with common variable immune deficiency (CVID) can be caused by variety of infectious, autoimmune, or malignancy-related etiologies. We present a 52-year-old man with history of CVID, who presented with 3 weeks of persistent high-grade fevers. During admission, he developed severe pancytopenia with shock and multiorgan failure. An extensive workup was performed for typical and atypical infections, autoimmune pathologies, and malignancy. His peripheral blood smear showed marked anisocytosis and poikilocytosis with elevated atypical lymphocytes. Flow cytometry showed markedly elevated CD8 counts, with abnormal CD4/CD8 ratio. Monospot test was negative but real-time polymerase chain reaction showed high Epstein-Barr virus load. Initial clinical suspicion was high for bacterial infections including pneumonia and acute sinusitis complicated by bacteremia and sepsis. Hematologic malignancy was also high on the differentials because of presence of rapidly progressive pancytopenia. The final diagnosis in this case illustrates a rare but potentially fatal disease that can present in CVID patients with persistent fevers and pancytopenia and can be refractory to standard treatment regimen. Because allergy and immunology physicians commonly treat CVID patients, they should be aware of this disease condition including pathophysiology, clinical presentation, laboratory workup, and treatment options. [ABSTRACT FROM AUTHOR]
- Published
- 2014
- Full Text
- View/download PDF
33. Sleep impairment and daytime sleepiness in patients with allergic rhinitis: the role of congestion and inflammation.
- Author
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Thompson, Alison, Sardana, Niti, and Craig, Timothy J
- Published
- 2013
- Full Text
- View/download PDF
34. Nanofiltered C1 esterase inhibitor for treatment of laryngeal attacks in patients with hereditary angioedema.
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Riedl, Marc A., Lumry, William R., Li, H. Henry, Craig, Timothy J., Fitts, David, Kalfus, Ira, and Uknis, Marc E.
- Subjects
ESTERASES ,ENZYME inhibitors ,LARYNGEAL edema ,ANGIONEUROTIC edema ,ENZYME deficiency ,DRUG efficacy ,DRUG tolerance ,GENETICS - Abstract
Background: Laryngeal edema is a life-threatening manifestation of hereditary angioedema (HAE), an autosomal-dominant disorder caused by quantitative or functional C1 esterase inhibitor (C1 INH) deficiency. The preparation of nanofiltered C1 INH (C1 INH-nf) used in this study is indicated for routine prophylaxis against angioedema attacks in the United States and for treatment, preprocedure prevention, and routine prevention of HAE in Europe. The objective of this analysis was to evaluate the effectiveness and tolerability of C1 INH-nf when used for the treatment of laryngeal attacks. Methods: A post hoc analysis of an open-label treatment study evaluated the effectiveness of C1 INH-nf in the treatment of laryngeal attacks in patients with HAE. Outcomes included unequivocal or clinical relief rates and time from treatment to onset of relief. Data were compiled from this and three other studies for post hoc dosing and tolerability analyses. In all studies, C1 INH-nf at 1000 U was administered i.v., with a second 1000-U dose given after 60 minutes if indicated. Results: In the open-label treatment study, 60 (50/84) and 77% (65/84) of attacks achieved unequivocal relief within 1 and 4 hours, respectively, after treatment. Time to unequivocal relief was shorter with prompt treatment. When C1 INH-nf was administered within 4 hours of symptom onset, clinical relief was achieved in 94% (45/48) of attacks within 4 hours after treatment. Of 265 attacks from the four studies, 62% received two 1000-U doses of C1 INH-nf. No serious adverse events occurring within 7 days after treatment were attributed to study drug, and only one patient required intubation after receiving C1 INH-nf (14.5 hours after symptom onset). Conclusion: This analysis supports that C1 INH-nf is an effective and well-tolerated therapy for laryngeal angioedema attacks. [ABSTRACT FROM AUTHOR]
- Published
- 2013
- Full Text
- View/download PDF
35. Patients perception of self-administrated medication in the treatment of hereditary angioedema
- Author
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Wang, Adrian, Fouche, Andrew, and Craig, Timothy J.
- Abstract
Early therapy of hereditary angioedema (HAE) decreases morbidity, improves outcomes, decreases absenteeism, and possibly decreases mortality. This can be accomplished best with self-therapy. Previously, the authors examined barriers to self-therapy from the perspective of the nurse and the physician, but data are lacking on what patients perceive as major barriers to self-administered therapy for HAE.
- Published
- 2015
- Full Text
- View/download PDF
36. Suspecting and Testing for Alpha-1 Antitrypsin Deficiency—An Allergist's and/or Immunologist's Perspective
- Author
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Craig, Timothy J.
- Abstract
Alpha-1 antitrypsin deficiency (AATD) is a hereditary, monogenic disorder with no unique clinical features. AATD can be difficult to diagnose as patients commonly present with respiratory symptoms often mistaken for other respiratory syndromes such as asthma or smoking-related chronic obstructive pulmonary disease. In addition, symptoms related to AATD may also affect other organs, including the liver, vasculature, and skin. The severity of AATD varies between individuals, and in severe cases, the irreversible lung damage can develop into emphysema. Early diagnosis is critical to enable the implementation of lifestyle changes and therapeutic options that can slow further deterioration of pulmonary tissue. Once AATD is suspected, a range of tests are available (serum alpha-1 proteinase inhibitor [A1-PI] level measurement, phenotyping, genotyping, gene sequencing) for confirming AATD. Currently, intravenous infusion of A1-PI is the only therapy that directly addresses the underlying cause of AATD, and has demonstrated efficacy in a recent randomized, placebo-controlled trial. This review discusses the etiology, testing, and management of AATD from the allergist's and/or immunologist's perspective. It aims to raise awareness of the condition among physicians who care for people with obstructive lung disorders and are therefore likely to see patients with obstructive lung disease that may, in fact, prove to be AATD.
- Published
- 2015
- Full Text
- View/download PDF
37. Strain accumulation in the New Madrid and Wabash Valley seismic zones from 14 years of continuous GPS observation
- Author
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Craig, Timothy J. and Calais, Eric
- Abstract
The mechanical behavior—and hence earthquake potential—of faults in continental interiors is an issue of critical importance for the resultant seismic hazard, but no consensus has yet been reached on this controversial topic. The debate has focused on the central and eastern United States, in particular, the New Madrid Seismic Zone, struck by four magnitude 7 or greater earthquakes in 1811–1812, and to a lesser extent the Wabash Valley Seismic Zone just to the north. A key aspect of this issue is the rate at which strain is currently accruing on those plate interior faults, a quantity that remains debated. Here we address this issue with an analysis of up to 14.6 years of continuous GPS data from a network of 200 sites in the central United States centered on the New Madrid and Wabash Valley seismic zones. We find that the high‐quality sites in these regions show motions that are consistently within the 95% confidence limit of zero deformation. These results place an upper bound on strain accrual on faults of 0.2 mm/yr and 0.6 mm/yr in the New Madrid and Wabash Valley Seismic Zones, respectively. For the New Madrid region, where a paleoseismic record is available for the past ∼5000 years, we argue that strain accrual—if any—does not permit the 500–900 year repeat time of paleo‐earthquakes observed in the Upper Mississippi Embayment. These results, together with increasing evidence for temporal clustering and spatial migration of earthquake sequences in continental interiors, indicate that either tectonic loading rates or fault properties vary with time in the New Madrid Seismic Zone and possibly plate wide. Strain accumulation in the New Madrid region is within error of zeroStrain accumulation in the Wabash Valley region is within error of zeroCEUS behaves as a rigid plate, to within the level of noise
- Published
- 2014
- Full Text
- View/download PDF
38. Physician Implementation of Asthma Management Guidelines and Recommendations: 2 Case Studies
- Author
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Craig, Timothy J.
- Abstract
Despite the development and availability of new treatments and prescription medications, asthma remains a widespread chronic health problem in the United States. Achieving asthma control in patients is a resource-intensive enterprise that requires close assessment and personalized management. Asthma is simply not a disease that can be remedied with prescription medications alone. In 2007, the National Asthma Education and Prevention Program released their Guidelines for the Diagnosis and Management of Asthma. The guidelines provide assistance and direction to health care professionals in the assessment and treatment of patients with asthma. Two cases are presented to illustrate the treatment process in light of the Guidelines and the outcomes of these patients, who have varying degrees of support, education, and assessment of adherence to an asthma treatment plan. J Am Osteopath Assoc. 2014;114(11 suppl 3):eS4-eS15 doi:10.7556/jaoa.2014.165
- Published
- 2014
- Full Text
- View/download PDF
39. Effect of time to treatment on response to C1 esterase inhibitor concentrate for hereditary angioedema attacks.
- Author
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Craig, Timothy J, Rojavin, Mikhail A, Machnig, Thomas, Keinecke, Heinz-Otto, and Bernstein, Jonathan A
- Published
- 2013
- Full Text
- View/download PDF
40. Exercise-induced bronchospasm, asthma control, and obesity.
- Author
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Ostrom, Nancy K., Parsons, Jonathan P., Eid, Nemr S., Craig, Timothy J., Stoloff, Stuart, Hayden, Mary Lou, and Colice, Gene L.
- Subjects
EXERCISE ,BRONCHIAL spasm ,PHYSICAL fitness ,ASTHMA ,RESPIRATORY diseases - Abstract
Exercise-induced bronchospasm (EIB) commonly affects patients with asthma. However, the relationship between EIB and asthma control remains unclear. Exercise limitation due to asthma might lead to reduced physical activity, but little information is available regarding obesity and EIB in asthma. A recent survey evaluated the frequency of EIB and exercise-related respiratory symptoms in a large number of patients with asthma. The survey results were reanalyzed to address any relationship between EIB and asthma control and obesity. A nationwide random sample of children aged 4-12 years (n = 250), adolescents aged 13-17 years (n = 266), and adults aged ≥18 years (n = 1001) with asthma were interviewed by telephone. Questions in the survey addressed asthma symptoms in general, medication use, and height and weight. Asthma control was categorized using established methods in the Expert Panel Report 3. Body mass index (BMI) was calculated using standard nomograms and obesity was defined as a BMI ≥30 kg/m². Most children (77.6%), adolescents (71.1%), and adults (83.1%) had either "not well" or "very poorly" controlled asthma. Children with "not well" controlled asthma reported a history of EIB significantly more often than those with "well" controlled" asthma. Asthma patients of all ages who had "not well" and "very poorly" controlled asthma described multiple (four or more) exercise-related respiratory symptoms significantly more often than those with "well-controlled" asthma. Obesity was significantly more common in adolescents with "not well" and "very poorly" controlled asthma and adults with "very poorly" controlled asthma. Children, adolescents, and adults with asthma infrequently have well-controlled disease. A history of EIB and exercise-related respiratory symptoms occur more commonly in patients with not well and very poorly controlled asthma. Obesity was found more often in adolescents and adults, but not children, with asthma, which was not well and very poorly controlled. [ABSTRACT FROM AUTHOR]
- Published
- 2013
- Full Text
- View/download PDF
41. Signs and symptoms preceding acute attacks of hereditary angioedema: Results of three recent surveys.
- Author
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Reshef, Avner, Prematta, Michael J., and Craig, Timothy J.
- Subjects
ANGIONEUROTIC edema ,HEALTH surveys ,SYMPTOMS ,DRUG efficacy ,METABOLIC disorder treatment ,EDEMA ,THERAPEUTICS - Abstract
In patients with hereditary angioedema (HAE), premonitory symptoms ('prodromes') may appear hours to days before attack onset. It remains to be determined if prodromes could be useful indicators for early treatment initiation. Most published reports of prodromes have been limited to case reports or small case series. The common objective of several recent survey-based studies was to collect information relevant to prodromal patterns in patients with HAE. Three separate surveys solicited prodromal data from HAE patients. Although differences in survey methodologies permit only descriptive analysis of data, responses to the surveys provide the largest compilation of observational data on this topic to date. Prodromes were reported by 82.5-95.7% of patients surveyed. In one survey, about two-thirds of subjects reported experiencing prodromes before all or most acute HAE attacks, and only 6% of subjects noted the appearance of prodromes in <10% of all attacks. The most common types of prodromal symptoms were related to skin/soft tissue and gastrointestinal tract. Most prodromes were experienced hours to days before the onset of angioedema. A large percentage of surveyed subjects indicated being able to predict an impending HAE attack all or most of the time; <10% reported being rarely or never able to predict an attack. Although insufficient to establish the clinical role of prodromal symptoms, results of these surveys provide additional data on the scope of prodromes and could stimulate further research into the potential efficacy and cost-effectiveness of HAE attack prediction and prodrome-triggered interventions. [ABSTRACT FROM AUTHOR]
- Published
- 2013
- Full Text
- View/download PDF
42. Analysis of hereditary angioedema attacks requiring a second dose of ecallantide.
- Author
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Li, H Henry, Campion, Marilyn, Craig, Timothy J, Soteres, Daniel F, Riedl, Marc, Lumry, William R, Macginnitie, Andrew J, Shea, Elizabeth P, and Bernstein, Jonathan A
- Published
- 2013
- Full Text
- View/download PDF
43. Nanofiltered C1 esterase inhibitor (human) for hereditary angioedema attacks in pregnant women.
- Author
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Baker, James W., Craig, Timothy J., Riedl, Marc A., Banerji, Aleena, Fitts, David, Kalfus, Ira N., and Uknis, Marc E.
- Subjects
ANGIONEUROTIC edema ,ESTERASES ,PREGNANT women ,RANDOMIZED controlled trials ,DRUG efficacy ,PREGNANCY ,THERAPEUTICS - Abstract
Data are limited on hereditary angioedema (HAE) in pregnant women and the safety and efficacy of therapies for treatment and prevention of HAE attacks during pregnancy. Prospective studies are unlikely given the rarity of HAE and ethical considerations regarding enrollment of pregnant female subjects in clinical trials. A retrospective analysis of clinical trial and compassionate-use data was conducted to identify subjects who received nanofiltered C1 esterase inhibitor (C1 INH-nf; human) during pregnancy. This study evaluates the efficacy and safety of human C1 INH-nf for treatment and prevention of HAE attacks in pregnant women. Data from pregnant subjects enrolled in either open-label extensions of two randomized, double-blind, placebo-controlled trials of C1 INH-nf or in a compassionate-use program were retrospectively analyzed for efficacy (e.g., total attacks, attack frequency during prophylaxis, and monthly attack rates) and safety (e.g., pregnancy outcomes and adverse events). C1 INH-nf was administered as acute treatment, preprocedural prophylaxis, or routine prophylaxis. C1 INH-nf prophylaxis substantially reduced monthly attack rates. Of 16 subjects, 13 delivered 14 healthy neonates (1 set of twins). Two adverse fetal outcomes were reported; neither was considered by the principal investigator to be related to C1 INH-nf. One subject's pregnancy outcome was unknown. This analysis shows a favorable risk-benefit profile for C1 INH-nf for managing HAE during pregnancy. NCT Identifier: NCT00438815; NCT00462709. [ABSTRACT FROM AUTHOR]
- Published
- 2013
- Full Text
- View/download PDF
44. Efficacy and safety of ecallantide in treatment of recurrent attacks of hereditary angioedema: Open-label continuation study.
- Author
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Lumry, William R., Bernstein, Jonathan A., Li, H. Henry, MacGinnitie, Andrew J., Riedl, Marc, Soteres, Daniel F., Craig, Timothy J., Campion, Marilyn, Iarrobino, Ryan, Stolz, Leslie E., and Pullman, William E.
- Subjects
ANGIONEUROTIC edema ,STATISTICS ,DRUG efficacy ,THERAPEUTICS ,ANAPHYLAXIS ,DRUG allergy ,DRUG side effects - Abstract
Hereditary angioedema (HAE) is a rare disorder characterized by recurrent attacks of potentially life-threatening edema. The plasma kallikrein inhibitor ecallantide is approved for treatment of acute HAE attacks. This study evaluates the efficacy and safety of ecallantide for treatment of multiple HAE episodes in the DX-88/19 (continuation) study. Patients received 30 mg of subcutaneous ecallantide for acute HAE attack symptoms, with no limit on number of episodes treated. Primary end point was change in patient-reported mean symptom complex severity (MSCS) score at 4 hours. Additional end points included change in MSCS score at 24 hours, treatment outcome score (TOS) at 4 and 24 hours, and time to response. Safety parameters included adverse events. Statistical analyses were conducted on qualifying treatment episodes (those with ≥12 patients). One hundred forty-seven patients received treatment for 625 episodes; analyses were conducted through 13 treatment episodes. Across 13 episodes at 4 hours, mean change in MSCS score ranged from -1.04 to -1.36, and mean TOSs ranged from 56.2 to 79.8. Median time to onset of sustained improvement ranged from 59 to 113 minutes. There was no indication of reduced efficacy with repeated ecallantide use. No new safety signals were detected. Eight patients (5.4%) reported potential hypersensitivity reactions, six of whom met the definition of anaphylaxis based on National Institute of Allergy and Infectious Diseases criteria. Ecallantide is effective for acute recurrent HAE attacks and maintains its efficacy and safety during multiple treatment episodes in patients with HAE. Potential hypersensitivity reactions were consistent with prior reports. [ABSTRACT FROM AUTHOR]
- Published
- 2013
- Full Text
- View/download PDF
45. C1-inhibitor therapy for hereditary angioedema attacks: Prospective patient assessments of health-related quality of life.
- Author
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Bewtra, Againdra K., Levy, Robyn J., Jacobson, Kraig W., Wasserman, Richard L., Machnig, Thomas, and Craig, Timothy J.
- Subjects
ANGIONEUROTIC edema ,QUALITY of life ,MENTAL health ,LIFESTYLES ,THERAPEUTICS - Abstract
C1-inhibitor (INH) concentrate, which is recommended as first-line treatment for acute hereditary angioedema (HAE) attacks in many countries, was recently approved in the United States. We sought to solicit patients' feedback about their health-related quality of life (HRQoL) while being treated with CI-INH concentrate for acute HAE attacks under real-world conditions, as well as the personal impact of the availability of C1-INH on lifestyle and mental health domains. Subjects enrolled in an open-label study of C1-INH at 20 U/kg for acute HAE attacks were invited to participate in a prospectively designed survey to solicit "real-time" patient responses that were collected via an interactive voice response service or online with a personal computer. Eighteen subjects submitted 60 quarterly HRQoL and treatment impact survey responses over 29 months. Seventeen of 18 patients responding reported mean short form 12 HRQoL scores that were within a normal range. More than one-half indicated that C1-INH availability made them feel somewhat or much better, and >80% reported having a better outlook on the future and feeling more secure about the danger of life-threatening attacks. These data confirm a high level of HRQoL and a positive impact in lifestyle and emotional domains among patients who were treated for acute attacks of HAE with C1-INH concentrate. [ABSTRACT FROM AUTHOR]
- Published
- 2012
- Full Text
- View/download PDF
46. Treatment response after repeated administration of C1 esterase inhibitor for successive acute hereditary angioedema attacks.
- Author
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Craig, Timothy J., Bewtra, Againdra K., Hurewitz, David, Levy, Robyn, Janss, Gerti, Jacobson, Kraig W., Packer, Flint, Bernstein, Jonathan A., Rojavin, Mikhail A., Machnig, Thomas, Keinecke, Heinz-Otto, and Wasserman, Richard L.
- Subjects
PLACEBOS ,ESTERASES ,ANGIONEUROTIC edema ,SYMPTOMS ,REGRESSION analysis - Abstract
Placebo-controlled studies established the efficacy of replacement therapy with C1 esterase inhibitor (C1-INH) concentrate for treating single acute hereditary angioedema (HAE) attacks, but only limited data from prospective studies are available on repeated treatment of successive HAE attacks. This study evaluates the association between repeated treatments with 20 U/kg of C1-INH concentrate (Berinert; CSL Behring, Marburg, Germany) for HAE attacks at any body location and treatment response. In a post hoc analysis of an open-label extension study (International Multicenter Prospective Angioedema C1-INH Trial [I.M.P.A.C.T.2]), the association between repeated treatment with C1-INH and times to onset of symptom relief and complete resolution of HAE symptoms was assessed in patients who were treated for at least 15 attacks by linear regression on the ordinal attack number. Eighteen patients received C1-INH concentrate for at least 15 HAE attacks over a mean duration of 34 months. Demographic and baseline characteristics of these patients were similar to those of all patients in the study. The distribution of body locations and the intensity of HAE attacks were similar for each of the first 15 attacks and subsequent attacks. The extent of previous use of C1-INH concentrate had no effect on the time to onset of symptom relief, the time to complete resolution of HAE symptoms, or the time between attacks treated with C1-INH concentrate; the median of individual linear regression coefficients was not statistically significantly different from 0. Treatment with 20 U/kg of C1-INH concentrate provided consistent treatment response in patients treated for multiple successive HAE attacks at any body location. (Clinicaltrials.gov identifier: NCT00292981) [ABSTRACT FROM AUTHOR]
- Published
- 2012
- Full Text
- View/download PDF
47. Discrepancies between guidelines and international practice in treatment of hereditary angioedema.
- Author
-
Dispenza, Melanie C. and Craig, Timothy J.
- Subjects
ANGIONEUROTIC edema ,ESTERASES ,ANTIFIBRINOLYTIC agents ,MEDICAL societies ,PHYSICIANS ,ANDROGENS ,DIAGNOSIS ,THERAPEUTICS - Abstract
Hereditary angioedema (HAE) is an autosomal dominant disorder characterized by decreased expression or loss of function of C1 esterase inhibitor (C1-INH). In 2010, international guidelines were published regarding the management of both acute HAE attacks and prophylactic treatment. Additionally, several clinical trials for HAE therapies were published in 2010. The purpose of this study was to assess the adherence of internationally based physicians to the current evidence-based studies and the 2010 International Consensus Algorithm. Internationally based physician members of the World Allergy Organization were surveyed regarding their diagnosis and management of patients with HAE. Only physicians who treat HAE patients were included in the analyses. Of the 201 responding physicians, the most highly used therapies for acute HAE attacks were C1-INH (59%), fresh frozen plasma (FFP; 42%), and icatibant (32%). For their preferred long-term prophylactic therapy, 74% used attenuated androgens and 18% used antifibrinolytics. Physicians in Latin and South America, in particular, were less likely than their international counterparts to prescribe C1-INH and more likely to prescribe attenuated androgens and FFP, and European physicians were the most likely to prescribe icatibant. Over one-third of physicians described themselves as 'unfamiliar' with emerging HAE therapies. Many international physicians neither follow current evidence-based studies nor adhere to the 2010 International Consensus Algorithm for treating HAE. Further education of physicians, government authorities, and professional medical groups is necessary to enhance availability to therapies and appropriate use of them. [ABSTRACT FROM AUTHOR]
- Published
- 2012
- Full Text
- View/download PDF
48. Exercise-induced bronchospasm in children with asthma in the United States: Results from the Exercise-Induced Bronchospasm Landmark Survey.
- Author
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Ostrom, Nancy K., Eid, Nemr S., Craig, Timothy J., Colice, Gene L., Hayden, Mary Lou, Parsons, Jonathan P., and Stoloff, Stuart W.
- Subjects
BRONCHIAL diseases ,ASTHMA ,EXERCISE physiology ,RESPIRATORY diseases ,PHYSICAL activity - Abstract
Despite the availability of effective therapies, uncontrolled asthma remains a common problem. Previous large surveys suggest that exercise-related respiratory symptoms may be a significant element of uncontrolled asthma. The Exercise-Induced Bronchospasm (EIB) Landmark Survey is the first comprehensive, national survey evaluating EIB awareness and impact among the general public, asthma patients, and health care providers. This study was designed to evaluate the prevalence and impact of exercise-related respiratory symptoms in children (aged 4-17 years) with asthma. A national survey was conducted with parents of 516 children diagnosed with asthma or taking medications for asthma in the prior year. The majority of parents reported that their child experienced one or more exercise-related respiratory symptom and almost one-half (47.4%) experienced four or more symptoms. Most commonly reported symptoms were coughing, shortness of breath, and wheezing. Respondents reported that asthma limited their child's ability to participate either 'a lot' or 'some' in sports (30%), other outdoor activities (26.3%), and normal physical exertion (20.9%). Only 23.1% of children with exercise-related respiratory symptoms were reported to take short-acting beta-agonists such as albuterol 'always' or 'most of the time' before exercising. Exercise-related respiratory symptoms among pediatric asthma patients are common and substantially limit the ability of children to participate normally and perform optimally in physical activities. Such symptoms may reflect uncontrolled underlying asthma that should be evaluated and treated with appropriate controller medications. Despite the availability of preventative therapy, many children do not use short-acting bronchodilators before exercise as recommended in national guidelines. [ABSTRACT FROM AUTHOR]
- Published
- 2011
- Full Text
- View/download PDF
49. Impact of exercise-related respiratory symptoms in adults with asthma: Exercise-Induced Bronchospasm Landmark National Survey.
- Author
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Parsons, Jonathan P., Craig, Timothy J., Stoloff, Stuart W., Hayden, Mary Lou, Ostrom, Nancy K., Eid, Nemr S., and Colice, Gene L.
- Subjects
ASTHMA treatment ,EXERCISE physiology ,PHYSICAL activity ,BRONCHIOLE diseases ,RESPIRATORY diseases - Abstract
An estimated 5-20% of the general population and up to 90% of people with asthma experience exercise-induced bronchospasm (EIB). The EIB Landmark Survey is the first comprehensive study on exercise-related respiratory symptoms in the United States. Two surveys were conducted: the first surveyed adults (≥18 years) in the general public and the second surveyed adults with asthma or taking medications for asthma in the prior year. Parameters assessed included exercise-related respiratory symptoms, activity levels, and short-acting beta-antagonist (SABA) use. In the general public survey (n = 1085), 8% were currently diagnosed with asthma. However, 29% reported experiencing one or more of six respiratory-related symptoms during or immediately after exercising. In the EIB in adult asthma survey (n = 1001), although >80% of adults experienced one or more of six exercise-related respiratory symptoms, only 30.6% reported a diagnosis of EIB. Almost one-half (45.6%) of adults with asthma reported that they avoid physical activities because of symptoms. Despite symptoms, only 22.2% of respondents took SABAs before exercise 'always' or 'most of the time'; 36.3% took rescue medications after or during exercise. Exercise-related respiratory symptoms limit physical activities and negatively impact daily lives. However, adults in the United States lack awareness of EIB. Although many subjects stated that their asthma symptoms limit their physical activity, few adhered to treatment guidelines by using SABAs appropriately before exercising. Findings from this survey support the need for better communication about the proper evaluation and management of EIB in the community and in asthma patients. [ABSTRACT FROM AUTHOR]
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- 2011
- Full Text
- View/download PDF
50. A 64-year-old man with chronic obstructive pulmonary disease and an atypical rash.
- Author
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Craig, Ethan T., Banta, Erin, and Craig, Timothy J.
- Subjects
CASE studies ,OBSTRUCTIVE lung disease diagnosis ,PULMONARY function tests ,OLDER men ,RESPIRATORY obstructions ,DISEASES in older people - Abstract
A 64-year-old male patient with a 15-year history of chronic obstructive pulmonary disease presented with an atypical rash that was refractory to standard therapy. Pulmonary function tests confirmed an obstructive lung disease. Basic laboratory workup revealed conflicting information, leading to a diagnostic challenge discussed in this article. Ultimately, careful testing did reveal the diagnosis and the patient was treated accordingly. [ABSTRACT FROM AUTHOR]
- Published
- 2011
- Full Text
- View/download PDF
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