Biomedical subjects

Michael Schatz

Publications and source records attributed to Michael Schatz.

48 records · Page 3Linked to original sources

PubMed2004

Variability of symptoms in mild persistent asthma: baseline data from the MIAMI study.

OBJECTIVE: To describe the variability of the asthma phenotype in patients with mild persistent asthma enrolled in the Mild Asthma Montelukast versus Inhaled Corticosteroid (MIAMI) study. METHODS: The variability of asthma rescue-free days, asthma symptoms, albuterol use, medical resource use, and exercise Limitations among patients with documented mild persistent asthma was compared between the month before study enrollment and the last 2 weeks of the run-in period. RESULTS: Patients eligible for randomization (n = 400), aged 15-85 years, exhibited symptoms (mean +/- SD) 3.6 +/- 1.3 days/week, beta-agonist use 3.5 +/- 1.3 days/week, and normal FEV1 (94.0 +/- 9.9% predicted) during the last 2 weeks of the run-in period. In the year before enrollment, medical intervention for asthma flares was common: 38.5% made office visits, 15.8% had oral corticosteroids, and 8.3% required emergency room or hospitalized care. In the month before enrollment, 11.8% experienced daily symptoms, and 28.3% had limitations of normal activity. Patients with daily symptoms in the month before study enrollment, compared with those having less-than-daily symptoms, experienced fewer rescue-free days (P = 0.024) and had more days per week with symptoms (P = 0.008) and requiring albuterol (P = 0.048) during the run-in; FEV1 was similar for both groups (93.1% vs. 94.2% predicted, respectively). CONCLUSION: Patients with mild persistent asthma reported a substantial disease burden in the year before enrollment. The asthma burden experienced by these patients both before and during the run-in period was of sufficient severity to support the recommendation that mild persistent asthma should be managed with daily controller therapy.

Acetates↗

PubMed2004

Effectiveness of budesonide administered via dry-powder inhaler versus triamcinolone acetonide administered via pressurized metered-dose inhaler for adults with persistent asthma in managed care settings.

BACKGROUND: Clinical studies have demonstrated the efficacy and relative safety of inhaled corticosteroids in the treatment of asthma. However, effectiveness and cost-effectiveness comparisons of available inhaled corticosteroids in real-life clinical settings are lacking. OBJECTIVE: This study compared the effectiveness and safety of budesonide administered via dry-powder inhaler versus that of triamcinolone acetonide administered via pressurized metered-dose inhaler in the treatment of adult patients with persistent asthma treated in a managed care setting. METHODS: This was a randomized, open-labe, 52-week study of adult patients (aged >or= 18 years) with persistent asthma enrolled in 25 US health plans. The primary study outcome was mean change from baseline to the end of treatment in symptom-free days. Secondary variables were changes from baseline in number of episode-free days, episode-free days at 52 weeks, forced expiratory volume in 1 second (FEV(1)), forced vital capacity, asthma symptom scores, breakthrough bronchdilator use, patient discontinuations, and health-related quality of life. Patients were issued diaries in which to record use of study medication and concomitant asthma medication use, as well as daytime and nighttime asthma symptom severity. Patients were assessed at weeks 4, 13, 26, 39, and 52. Safety was assessed based on adverse events and changes in laboratory tests, vital signs, and physical examinations. RESULTS: A total of 945 patients (344 men, 601 women; mean [SD] age, 46.8 [14] years) were enrolled; 631 received budesonide and 314 received triacinolane acetonide. Improvements in all effectiveness variables were observed with both treatments. The mean increase from baseline in the number of symptom-free days per month assessed at month 12 was 7.74 (95% CI, 6.81-8.66) for patients receiving budesonide and 3.78 (95% CI, 2.47-5.09) for patients receiving triamcinoline acetonide ( P<0.001). The estimated annual mean (SD) number symptom-free days for patients receiving budesonide was 141.1 (125.0) over the treatment phase, compared with 99.3 (112.1) for those receiving triamcinolone acetonide (P<0.001). Patients receiving budesonide demonstrated significant improvements (compared with those receiving triamcinolone acetonide) in overall quality of life, daytime and nighttime asthma symptom severity, breakthrough bronchodilator use, and FEV(1) (all P<0.001). Safety measures were similar between groups. CONCLUSION: In these managed care settings, budesonide inhalation powder administered via dry-powder inhaler was significantly more effective than triamcinolone acetonide administered via pressurized metered-dose inhaler in the treatment of adults with persistent asthma.

Administration, Inhalation↗

PubMed2004

Asthma during pregnancy.

OBJECTIVE: To determine neonatal and maternal outcomes stratified by asthma severity during pregnancy by using the 1993 National Asthma Education Program Working Group on Asthma and Pregnancy definitions of asthma severity. The primary hypothesis was that moderate or severe asthmatics would have an increased incidence of delivery at <32 weeks of gestation compared with nonasthmatic controls. METHODS: This was a multicenter, prospective, observational cohort study conducted over 4 years at 16 university hospital centers. Asthma severity was defined according to the National Asthma Education Program Working Group on Asthma and Pregnancy classification and modified to include medication requirements. This study had 80% power to detect a 2- to 3-fold increase in delivery less than 32 weeks of gestation among the cohort with the moderate or severe asthma compared with controls. Secondary outcome measures included obstetrical and neonatal outcomes. RESULTS: The final analysis included 881 nonasthmatic controls, 873 with mild asthma, 814 with moderate, and 52 with severe asthma. There were no significant differences in the rates of preterm delivery less than 32 weeks (moderate or severe 3.0%, mild 3.4%, controls 3.3%; P =.873) or less than 37 weeks of gestation. There were no significant differences for neonatal outcomes except discharge diagnosis of neonatal sepsis among the mild group compared with controls, adjusted odds ratio 2.9, 95% confidence interval 1.2, 6.8. There were no significant differences for maternal complications except for an increase in overall cesarean delivery rate among the moderate-or-severe group compared with controls (adjusted odds ratio 1.4, 95% confidence interval 1.1, 1.8). CONCLUSION: Asthma was not associated with a significant increase in preterm delivery or other adverse perinatal outcomes other than a discharge diagnosis of neonatal sepsis. Cesarean delivery rate was increased among the cohort with moderate or severe asthma. LEVEL OF EVIDENCE: II-2

Adult↗

PubMed2004

Update in the treatment of asthma during pregnancy.

Asthma is the most common potentially serious medical problem to complicate pregnancy. Recent reports suggest that 7 of every 100 pregnant women suffer from asthma during pregnancy. Asthmatic women have been shown to be at an increased risk of complications during pregnancy. This may be secondary to inadequately controlled asthma or perhaps the result of the effects of certain asthma medications taken during pregnancy. The choice to use a specific medication during pregnancy is based on available human and animal data. Much of the information currently available regarding the safety of various asthma medications during pregnancy comes from several large cohort studies. This article reviews the specific aspects of pharmacological therapy during pregnancy as provided in the recommendations of the joint ad hoc committee of the American College of Allergy Asthma and Immunology and the American College of Obstetricians and Gynecologists. This article presents practical strategies for the management of asthma in our pregnant patients.

Adrenergic beta-Agonists↗

PubMed2004

Asthma population management: development and validation of a practical 3-level risk stratification scheme.

OBJECTIVE: To define and validate a practical risk stratification scheme based on administrative data for use in identifying patients at high, medium, and low risk of requiring emergency hospital care for asthma. STUDY DESIGN: Retrospective cohort. PATIENTS AND METHODS: Predictors in 1999 were evaluated in relation to 2000 asthma emergency hospital care (any asthma hospitalization or emergency department visit) in a training set (n = 8789, 2000 emergency hospital care = 5.5%) and a testing set (n = 6104, 2000 emergency hospital care = 7.9%). Logistic regression was used to assign risk points in the training set, and positive and negative predictive values, sensitivities, and specificities were calculated in the training and testing sets. RESULTS: High risk was defined as asthma emergency hospital care in the previous year or use of >14 beta-agonist canisters and oral corticosteroid use; medium risk was defined as no emergency hospital care but use of either >14 beta-agonist canisters or oral corticosteroids; and low risk was defined as none of the above. For the high-risk groups in the training and testing sets, positive predictive values were 12.9% and 22.0%, sensitivities were 24.8% and 25.4%, specificities were 90.3% and 92.0%, and negative predictive values were 95.4% and 93.2%, respectively. The medium-risk groups identified another 32.6% of patients in the training set and 28.3% in the testing set requiring subsequent asthma emergency hospital care. CONCLUSION: This simple risk stratification scheme is useful for identifying patients from administrative data who are at increased risk of experiencing emergency hospital care for asthma.

Adolescent↗

PubMed2003

The relationship of sex to asthma prevalence, health care utilization, and medications in a large managed care organization.

BACKGROUND: Age-related sex differences in asthma hospitalizations and emergency department (ED) visits have been reported, but relationships of these differences to disease prevalence and outpatient management have not been defined. OBJECTIVE: To define the relationships of sex to asthma-related health care utilization and medications, accounting for age-related differences in asthma prevalence. METHODS: Computerized data from Southern California Kaiser-Permanente were used to identify asthmatic patients, aged 2 to 64 years, enrolled continuously during 1999 and 2000. Age-specific asthma prevalence in 1999 was calculated to identify ages of male or female predominance. Males and females were compared with regard to asthma-related health care utilization outcomes (outpatient clinic visits, ED visits, and hospitalizations) and medication use (beta-agonists, inhaled steroids, and oral steroids). Hospitalizations, ED visits, and oral steroid use were considered markers of disease severity. RESULTS: Of the 60,694 subjects, the female-male prevalence ratio was approximately 35:65 at each age between 2 and 13 years, it was inverse (65:35) between the ages of 23 and 64 years, and prevalences were relatively similar at the ages of 14 to 22 years. In patients aged 2 to 13 years, most utilization and medication variables were significantly greater in males (P < .01). Females aged 14 to 22 years had more outpatient and ED visits and used more oral steroids than males. In patients aged 23 to 64 years, all utilization variables were significantly greater in females, except beta-agonist use and mean inhaled steroid dispensings. CONCLUSIONS: Asthma utilization and severity appear greater in males aged 2 to 13 years, somewhat greater in females aged 14 to 22 years, and definitely greater in females aged 23 to 64 years. The mechanisms for these striking sex differences merit further investigation.

Adolescent↗

PubMed2003

Asthma morbidity during pregnancy can be predicted by severity classification.

BACKGROUND: The 1993 National Asthma Education Program Working Group on Asthma and Pregnancy defined asthma severity as mild, moderate, or severe on the basis of symptoms and spirometry, but no studies have evaluated the relationship between this classification system and subsequent asthma morbidity during pregnancy. OBJECTIVE: The objective of this study was to evaluate the relationship between asthma severity classification during pregnancy and gestational asthma exacerbations. METHODS: Asthma severity was defined according to the 1993 classification, adjusted to include medication requirements, in a volunteer sample of 1739 pregnant asthmatic patients who were less than 26 weeks' gestation. RESULTS: Initial asthma classification (mild, moderate, or severe) was significantly related to subsequent asthma morbidity during pregnancy (hospitalizations, unscheduled visits, corticosteroid requirements, and asthma symptoms during labor and delivery). Exacerbations during pregnancy occurred in 12.6% of patients initially classified as mild, 25.7% of patients classified as moderate, and 51.9% of patients classified as severe (P <.001). Asthma morbidity was similar, whether patients were classified as moderate or severe by symptoms and spirometry or by medication requirement. Thirty percent of initially mild patients were reclassified as moderate-severe during pregnancy, and 23% of the initially moderate-severe patients were reclassified as mild later in pregnancy; asthma morbidity in these patients changed accordingly. CONCLUSION: The National Asthma Education Program Working Group on Asthma and Pregnancy classification of asthma severity, adapted to include medication use, predicts subsequent asthma morbidity during pregnancy.

Adult↗

PubMed2003

Inhaled corticosteroids and allergy specialty care reduce emergency hospital use for asthma.

BACKGROUND: The interrelationships between optimal inhaled corticosteroid (IC) therapy, allergy specialist care, and reduced emergency hospital care for asthma have not been well defined. OBJECTIVE: We sought to evaluate the independent effectiveness of various levels of IC dispensing and allergy specialist care in reducing subsequent emergency asthma hospital use. METHODS: Asthmatic patients (n = 9608) aged 3 to 64 years were identified from an electronic database of a large health maintenance organization. The outcome was any year 2000 asthma hospitalization or emergency department visit. The main predictors were at least one allergy department visit and the number of IC canisters dispensed in 1999. Analyses were adjusted for age, sex, insurance type, and asthma severity (1999 emergency asthma hospital use, beta-agonist use, and oral corticosteroid use). RESULTS: Dispensing of 7 or more canisters of ICs (odds ratio [OR], 0.64; 95% CI, 0.43-0.94) and allergy care (OR, 0.73; 95% CI, 0.55-0.97) were associated with reduced subsequent emergency asthma hospital use. More patients with allergy specialist care than those without such care received 7 or more dispensations of ICs (24.7% vs 8.3%, P <.001). When 7 or more dispensations of ICs and allergy specialist care were simultaneously included in an adjusted model, both ICs (OR, 0.68; 95% CI, 0.46-1.00) and allergy care (OR, 0.77; 95% CI, 0.58-1.02) were independently associated with a lower risk of year 2000 emergency asthma hospital care, although significance was borderline. CONCLUSION: Allergy care reduces emergency hospital use for asthma by increasing use of ICs but probably also has an independent effect.

Administration, Inhalation↗

PubMed2003

The relationship of frequency of follow-up visits to asthma outcomes in patients with moderate persistent asthma.

BACKGROUND: Although regular follow-up is recommended for patients with asthma, the optimal frequency of such follow-up has not been defined. The purpose of this study was to evaluate the relationship of the interval between routine physician visits to asthma outcomes in patients with moderate persistent asthma. METHODS: The study population was a volunteer sample of subjects aged 18 years or older with moderate persistent asthma requiring at least moderate doses of inhaled corticosteroids who were followed for at least 6 months by one of two allergists in a large staff model HMO. Subjects were randomized to one of three groups: 1) monthly physician visits, 2) semi-annual physician visits, and 3) semiannual physician visits and monthly nurse phone calls. All subjects were advised to call their physician for questions or increased symptoms. The primary outcome variable was total asthma quality of life measured at baseline, 6 months and 12 months. Other outcome variables included specific asthma quality of life domains; spirometry, global asthma rating, satisfaction with treatment rating, and asthma resource and medication utilization during the one year of follow-up. RESULTS: The final cohort included 29 patients per group. There were no significant differences between groups in baseline demographics, smoking history, spirometry, asthma quality of life, global rating, or satisfaction with treatment rating. As per the protocol, patients in the monthly physician visit group made significantly more routine visits during the study than other patients (P<.0001), but there were no other significant differences between groups in any of the other outcome variables at 6 months, 12 months, or during the year of the study. CONCLUSION: Patients with the characteristics of those in this study do not need routine follow-up visits more often than every 6 months. Further studies will be necessary to determine optimal follow-up intervals for patients with other degrees of asthma severity and for those followed in other settings.

Adolescent↗

PubMed2003

Risk factors for asthma hospitalizations in a managed care organization: development of a clinical prediction rule.

OBJECTIVE: To use a computerized administrative database to develop and validate a clinical prediction rule for the occurrence of asthma hospitalizations. STUDY DESIGN: Retrospective cohort. METHODS: Subjects included asthmatic patients ages 3 to 64 who were continuously enrolled in the Southern California Kaiser Permanente managed care organization in both 1998 and 1999. Data were based on linkage of a hospital discharge database, diagnosis and procedures database, membership database, and prescription database. The outcome was any 1999 hospitalization with a primary diagnosis of asthma. The outcome was evaluated and modeled separately for children (ages 3-17) and adults (ages 18-64). RESULTS: Univariate analyses showed that hospitalized children were younger than nonhospitalized children. Adults and children hospitalized in 1999 had lower mean household incomes, were more likely to have required an emergency department visit or hospitalization in 1998, used more beta-agonists and oral corticosteroids in 1998, and had more 1998 prescribers than nonhospitalized patients. In multivariable analysis, independent predictors of 1999 hospitalization in children included age and 1998 hospitalizations, beta-agonist dispensings, total anti-inflammatory dispensings, and number of prescribers. Among adults, 1998 hospitalizations and oral steroid dispensings as well as income were independent predictors of hospitalization in 1999. The prediction rules developed in this study identified the 11% to 13% of adults or children with an approximately 6-fold higher likelihood for being hospitalized in the following year. CONCLUSION: These models can be used to identify high-risk asthmatic patients in whom targeted intervention might reduce asthma morbidity and cost of care.

Adolescent↗

PubMed2002

Variables affecting asthma course during pregnancy.

BACKGROUND: The course of asthma is frequently altered by pregnancy, but the mechanisms remain undefined. OBJECTIVE: The purpose of this study was to identify specific maternal or pregnancy characteristics that are related to the course of asthma during pregnancy. METHODS: A secondary analysis of a previous prospective study identified 568 pregnant women whose patient-reported asthma course during pregnancy was compared with the women's usual disease course. Potential explanatory variables were compared between groups defined by their pregnancy versus usual course (better, worse, same). RESULTS: Improvement of asthma during pregnancy was noted in 33.6%, worsening was reported in 36.3%, no change was reported in 26.4%, and the course was uncertain in 3.7%. There was a significant concordance between asthma course and course of rhinitis during pregnancy. Rhinitis improved in 51.1% of patients whose asthma improved during pregnancy and worsened in 19.8% of these women. Rhinitis worsened in 55.9% of patients whose asthma worsened during pregnancy and improved in 2.1% of these women. No significant relationships were found between gestational asthma course and maternal demographic factors, panic-fear score, smoking, maternal weight, infant birth weight, or infant sex. CONCLUSIONS: The relationship of gestational asthma course to rhinitis symptoms may have clinical and mechanistic significance. Further studies will be necessary to test this hypothesis.

Adult↗

PubMed2002

H1-antihistamines in pregnancy and lactation.

Antihistamines may be used for the treatment of allergic rhinitis, upper respiratory infections, urticaria/angioedema, atopic dermatitis, and, rarely, as adjunctive treatment for anaphylaxis, during pregnancy. Because these illnesses may affect maternal comfort and safety as well as threaten the fetus directly (anaphylaxis) or indirectly, they often require therapy during pregnancy. Based on the information available to date, in this chapter we have attempted to provide rational guidelines for the gestational use of H1-receptor antagonists in a manner that will lead to the optimal well-being of both the mother and her infant. As more information becomes available, the recommendations herein may require modification. Although this chapter has dealt specifically with gestational management, a case can be made for considering this information when making therapeutic decisions in all women of childbearing potential. First, most pregnancies are unplanned, and the peak period of fetal vulnerability to drug-induced teratogenesis begins the day a woman's period is due. Second, during gestation, substantial alterations in a previously successful but not optimal-for-pregnancy chronic therapeutic regimen may be psychologically threatening to the patient and may lead to either uncontrolled disease or unanticipated side effects. Thus, pregnancy-appropriate regimens should ideally be discussed with all women of childbearing age as part of the informed therapeutic decision-making process.

Animals↗