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The Relationship of Long Acting Beta Agonists to Asthma Mortality
S142 Abstracts
548
SUNDAY
Immunotherapy in Mixed Rhinitis: Is it Effective Compared to Use in Allergic Rhinitis? A. M. Smith, M. Rezvani, J. A. Bernstein; University of Cincinnati, Cincinnati, OH. RATIONALE: Immunotherapy (IT) is an effective therapeutic option for patients with allergic rhinitis (AR). However, approximately 50% of AR patients report significant non-allergic triggers, termed mixed rhinitis (MR). Mixed rhinitis is often more difficult to treat. The purpose of this study was to compare the efficacy of IT between AR and MR patients. METHODS: A historical prospective cohort study design was employed. Medical records were reviewed from an academic allergy practice to identify AR patients who started IT in 2001. One reviewer compiled data through chart review using a standardized form, including allergic and nonallergic triggers, symptoms, and medications at the onset and after completion of 3 years of IT. The relationship between rhinitis subtype and outcomes including changes in symptoms and medication use was analyzed. RESULTS: Among 98 patients enrolled, 65 (66%) were classified as MR based on having at least one non-allergic trigger. Patients were predominantly Caucasian (n 5 83, 85%) and male (n 5 55, 56%). No significant differences in symptom status were found. After a full course of IT, all patients had decreased use of antihistamines, decongestants, and nasal corticosteroids (p < 0.02); AR patients had a greater reduction in nasal corticosteroid use compared to MR patients (p 5 0.049, OR 0.25, 95% CI 0.065-0.99). Furthermore, 20.4% of MR patients required 3 or more medications after completing IT compared to 4% of AR patients (p 5 0.025). CONCLUSIONS: Immunotherapy is effective in decreasing medication use in both AR and MR patients. Despite this overall efficacy, MR patients require more medication after completing IT to maintain symptom control.
549
Nearly Half of Systemic Reactions (SRs) to Allergen Immunotherapy (AIT) Occurred More Than 30 Minutes After the Injection M. A. Rank, C. L. Oslie, J. L. Krogman, M. A. Park, J. T. Li; Mayo Clinic, Rochester, MN. RATIONALE: Previous studies reporting SRs to AIT have found that most occur within 30 minutes of the injection. We studied SR timing, epinephrine administration, and gender differences to provide a framework for improving AIT safety. METHODS: A retrospective chart review from 2004-2006 at a single institution included all patients receiving AIT. Fisher’s exact test was used to compare differences between groups. RESULTS: We found that 338 patients had 10,445 AIT injections and a total of 29 SRs in 25 different patients for a rate of 0.28% per injection and 7.4% per patient. There were no emergency department visits, hospitalizations, or fatalities. Nearly half (48%) of the SRs occurred > 30 minutes after the injection with an mean of 61 minutes (range of 30-190 minutes). Epinephrine was administered for 45% of the SRs (22% received repeated doses). Of the 14 reactions occurring > 30 minutes after the injection, 7 received epinephrine compared to 6 of the 15 patients with reactions occurring <30 minutes (p 5 0.72). Five patients had a decreased peak flow rate (PFR) or a documented physical exam (PE) abnormality; all 5 of these patients presented with their SRs > 30 minutes after the injection (p 5 0.02). Females represented the majority of the SRs (60%), though received epinephrine 27% of the time compared to 90% for males (p < 0.001). Eighty percent of females receiving epinephrine had abnormalities in PFR or PE compared to 12% of males (p 5 0.03). CONCLUSIONS: Providers of AIT should develop a detailed management plan for SRs occurring > 30 minutes after the injection.
J ALLERGY CLIN IMMUNOL FEBRUARY 2008
550
Cochrane Systematic Review: Safety Profile of Sublingual Immunotherapy (SLIT) for Allergic Rhinitis (AR) S. Radulovic1, M. A. Calderon1, D. R. Wilson2, S. R. Durham1; 1Imperial College, London, UNITED KINGDOM, 2Royal Centre for Defence Medicine & University Hospital, Birmingham, UNITED KINGDOM. RATIONALE: SLIT is widely used in Europe due to its efficacy, safety and convenience. This current systematic review up-date evaluated all adverse events (AE) occurring during SLIT for AR. METHODS: Cochrane ENT Disorders Group searched data bases for SLIT in AR (09-2002 to 07-2006). Only double-blind randomized placebocontrolled trials were included. AE were analysed as discontinuous data; therefore, only descriptive analysis is presented. RESULTS: AE were analysed in 48 trials (27 new and 21 trials from the previous review 3) and a total of 3413 participants (1773 SLIT and 1640 placebo). Local AE were reported in 21 studies. Most common was buccal pruritus (7 trials; SLIT 791 participants, 1342 events; placebo 766 participants, 474 events); followed by labial oedema, bucco-lingual oedema and throat irritation. Systemic AE were reported in 18 studies. Rhinitis was the most commonly reported (14 trials; SLIT 733 participants, 1395 events; placebo 702 participants, 1034 events); followed by conjunctivitis alone, rhino-conjunctivitis, cough, asthma/wheezing, gastro-intestinal symptoms. Fifteen studies reported AE which led to the discontinuation of SLIT, most reasons were discomfort due to local AE, though systemic reactions were also described. None of the studies reported anaphylaxis or use of adrenaline. Twenty one studies reported data in a manner not suitable for analysis. CONCLUSIONS: SLIT has proved to be a safe route. The majority of AE were local. Systemic AE were predominantly mild to moderate and their causality was unlikely to be related to SLIT. Adrenaline use was not required. Funding: Imperial College
551
The Relationship of Long Acting Beta Agonists to Asthma Mortality P. L. Gomez Dinger, M. S. Kaplan, B. J. Goldberg, A. M. Staveren, J. Y. Hsu; Kaiser Permanente, Los Angeles, CA. RATIONALE: The purpose of this study is to test the hypothesis that long acting beta agonist (LABA) use is associated with increased asthma mortality and to examine additional risk factors. METHODS: This is a retrospective study of 232,837 asthma patients defined using the Kaiser Permanente Southern California databases from January 1, 1997 to December 31, 2004. Patients are age > 12 years old who have a diagnosis of asthma and have 2 or more asthma related dispensing in a 12 month period of time. Exclusion criteria consist of diagnosis of COPD or cystic fibrosis. The primary outcome of death was evaluated and asthma medications were assessed for the use of long acting beta agonist with and without concomitant inhaled corticosteroid (ICS) use. A logistic regression analysis was done to adjust for the factors of age, gender and ethnicity. RESULTS: Asthma patients on LABA (10.64%) had a higher mortality (0.26%) than those who were not using LABA (0.13%) (p < 0.0001). There was no statistically significant difference in mortality in patients on LABA whether or not they were also on ICS (p 5 .5686). Patients on LABA with inhaled corticosteroid had a significant increase in mortality (0.26%) over those never prescribed LABA at all (0.13%) (p < .0001). The adjusted OR for patients on LABA is 2.68 (1.74-4.13) and OR for blacks is 2.82 (1.70-4.69). CONCLUSIONS: This asthma cohort demonstrated a statistically significant increase in asthma mortality associated with long acting beta agonist use and black ethnicity in which concomitant ICS was not adequately protective.
548
SUNDAY
Immunotherapy in Mixed Rhinitis: Is it Effective Compared to Use in Allergic Rhinitis? A. M. Smith, M. Rezvani, J. A. Bernstein; University of Cincinnati, Cincinnati, OH. RATIONALE: Immunotherapy (IT) is an effective therapeutic option for patients with allergic rhinitis (AR). However, approximately 50% of AR patients report significant non-allergic triggers, termed mixed rhinitis (MR). Mixed rhinitis is often more difficult to treat. The purpose of this study was to compare the efficacy of IT between AR and MR patients. METHODS: A historical prospective cohort study design was employed. Medical records were reviewed from an academic allergy practice to identify AR patients who started IT in 2001. One reviewer compiled data through chart review using a standardized form, including allergic and nonallergic triggers, symptoms, and medications at the onset and after completion of 3 years of IT. The relationship between rhinitis subtype and outcomes including changes in symptoms and medication use was analyzed. RESULTS: Among 98 patients enrolled, 65 (66%) were classified as MR based on having at least one non-allergic trigger. Patients were predominantly Caucasian (n 5 83, 85%) and male (n 5 55, 56%). No significant differences in symptom status were found. After a full course of IT, all patients had decreased use of antihistamines, decongestants, and nasal corticosteroids (p < 0.02); AR patients had a greater reduction in nasal corticosteroid use compared to MR patients (p 5 0.049, OR 0.25, 95% CI 0.065-0.99). Furthermore, 20.4% of MR patients required 3 or more medications after completing IT compared to 4% of AR patients (p 5 0.025). CONCLUSIONS: Immunotherapy is effective in decreasing medication use in both AR and MR patients. Despite this overall efficacy, MR patients require more medication after completing IT to maintain symptom control.
549
Nearly Half of Systemic Reactions (SRs) to Allergen Immunotherapy (AIT) Occurred More Than 30 Minutes After the Injection M. A. Rank, C. L. Oslie, J. L. Krogman, M. A. Park, J. T. Li; Mayo Clinic, Rochester, MN. RATIONALE: Previous studies reporting SRs to AIT have found that most occur within 30 minutes of the injection. We studied SR timing, epinephrine administration, and gender differences to provide a framework for improving AIT safety. METHODS: A retrospective chart review from 2004-2006 at a single institution included all patients receiving AIT. Fisher’s exact test was used to compare differences between groups. RESULTS: We found that 338 patients had 10,445 AIT injections and a total of 29 SRs in 25 different patients for a rate of 0.28% per injection and 7.4% per patient. There were no emergency department visits, hospitalizations, or fatalities. Nearly half (48%) of the SRs occurred > 30 minutes after the injection with an mean of 61 minutes (range of 30-190 minutes). Epinephrine was administered for 45% of the SRs (22% received repeated doses). Of the 14 reactions occurring > 30 minutes after the injection, 7 received epinephrine compared to 6 of the 15 patients with reactions occurring <30 minutes (p 5 0.72). Five patients had a decreased peak flow rate (PFR) or a documented physical exam (PE) abnormality; all 5 of these patients presented with their SRs > 30 minutes after the injection (p 5 0.02). Females represented the majority of the SRs (60%), though received epinephrine 27% of the time compared to 90% for males (p < 0.001). Eighty percent of females receiving epinephrine had abnormalities in PFR or PE compared to 12% of males (p 5 0.03). CONCLUSIONS: Providers of AIT should develop a detailed management plan for SRs occurring > 30 minutes after the injection.
J ALLERGY CLIN IMMUNOL FEBRUARY 2008
550
Cochrane Systematic Review: Safety Profile of Sublingual Immunotherapy (SLIT) for Allergic Rhinitis (AR) S. Radulovic1, M. A. Calderon1, D. R. Wilson2, S. R. Durham1; 1Imperial College, London, UNITED KINGDOM, 2Royal Centre for Defence Medicine & University Hospital, Birmingham, UNITED KINGDOM. RATIONALE: SLIT is widely used in Europe due to its efficacy, safety and convenience. This current systematic review up-date evaluated all adverse events (AE) occurring during SLIT for AR. METHODS: Cochrane ENT Disorders Group searched data bases for SLIT in AR (09-2002 to 07-2006). Only double-blind randomized placebocontrolled trials were included. AE were analysed as discontinuous data; therefore, only descriptive analysis is presented. RESULTS: AE were analysed in 48 trials (27 new and 21 trials from the previous review 3) and a total of 3413 participants (1773 SLIT and 1640 placebo). Local AE were reported in 21 studies. Most common was buccal pruritus (7 trials; SLIT 791 participants, 1342 events; placebo 766 participants, 474 events); followed by labial oedema, bucco-lingual oedema and throat irritation. Systemic AE were reported in 18 studies. Rhinitis was the most commonly reported (14 trials; SLIT 733 participants, 1395 events; placebo 702 participants, 1034 events); followed by conjunctivitis alone, rhino-conjunctivitis, cough, asthma/wheezing, gastro-intestinal symptoms. Fifteen studies reported AE which led to the discontinuation of SLIT, most reasons were discomfort due to local AE, though systemic reactions were also described. None of the studies reported anaphylaxis or use of adrenaline. Twenty one studies reported data in a manner not suitable for analysis. CONCLUSIONS: SLIT has proved to be a safe route. The majority of AE were local. Systemic AE were predominantly mild to moderate and their causality was unlikely to be related to SLIT. Adrenaline use was not required. Funding: Imperial College
551
The Relationship of Long Acting Beta Agonists to Asthma Mortality P. L. Gomez Dinger, M. S. Kaplan, B. J. Goldberg, A. M. Staveren, J. Y. Hsu; Kaiser Permanente, Los Angeles, CA. RATIONALE: The purpose of this study is to test the hypothesis that long acting beta agonist (LABA) use is associated with increased asthma mortality and to examine additional risk factors. METHODS: This is a retrospective study of 232,837 asthma patients defined using the Kaiser Permanente Southern California databases from January 1, 1997 to December 31, 2004. Patients are age > 12 years old who have a diagnosis of asthma and have 2 or more asthma related dispensing in a 12 month period of time. Exclusion criteria consist of diagnosis of COPD or cystic fibrosis. The primary outcome of death was evaluated and asthma medications were assessed for the use of long acting beta agonist with and without concomitant inhaled corticosteroid (ICS) use. A logistic regression analysis was done to adjust for the factors of age, gender and ethnicity. RESULTS: Asthma patients on LABA (10.64%) had a higher mortality (0.26%) than those who were not using LABA (0.13%) (p < 0.0001). There was no statistically significant difference in mortality in patients on LABA whether or not they were also on ICS (p 5 .5686). Patients on LABA with inhaled corticosteroid had a significant increase in mortality (0.26%) over those never prescribed LABA at all (0.13%) (p < .0001). The adjusted OR for patients on LABA is 2.68 (1.74-4.13) and OR for blacks is 2.82 (1.70-4.69). CONCLUSIONS: This asthma cohort demonstrated a statistically significant increase in asthma mortality associated with long acting beta agonist use and black ethnicity in which concomitant ICS was not adequately protective.