Search PubMed⌕ Search

Biomedical subjects

E D Bateman

Publications and source records attributed to E D Bateman.

At least 19 recordsLinked to original sources

The salmeterol/fluticasone combination is more effective than fluticasone plus oral montelukast in asthma.

The aim of this study was to compare the efficacy and safety of salmeterol/fluticasone propionate combination product (SFC) with fluticasone propionate (FP) plus oral montelukast (M) over 12 weeks in symptomatic asthma patients. The study was a multinational, randomised, double-blind, double-dummy, parallel-group design in patients aged > or = 15 years. After a 4-week run-in during which all patients received FP 100 microg twice daily, patients were randomised to inhaled SFC (50/100 microg) twice daily or inhaled FP 100 microg twice daily and oral M 10 mg once daily. Patients kept daily records of their peak expiratory flow (PEF) symptom scores and use of rescue medication. Over the 12-week treatment period, the adjusted increase in mean morning PEF was significantly greater in the SFC group (36 l/min) than the FP/M group (19 l/min; P < 0.001). The improvement in FEV1 was also significantly greater in the SFC group (mean treatment difference 0.11 l; P < 0.001). SFC provided significantly better control of daytime and night-time symptoms and there were fewer exacerbations. Patients in the SFC group were also significantly more likely to have a rescue-free day. Both treatments were equally well tolerated. Combination therapy with FP plus salmeterol (SFC) produced significantly greater improvements in lung function and asthma control than the addition of montelukastto FP.

Acetates↗

Socioeconomic deprivation and asthma prevalence and severity in young adolescents.

This study used the international study of asthma and allergies in childhood (ISAAC) to investigate the association between asthma and socioeconomic deprivation among young adolescents in Cape Town, South Africa. The completed ISAAC written and video questionnaires of 4,706 13-14-yr-old school pupils were used. The prevalence of asthma symptoms was analysed by a local index of socioeconomic deprivation, based on residential location and defined on a 10-category scale from least to most deprived. Linear trends were examined visually and the prevalence odds ratio was used to summarize overall trends. In general, the least socioeconomically deprived pupils reported higher prevalences of asthma symptoms "ever" and "in the last 12 months". In contrast, the most socioeconomically deprived pupils reported higher asthma-symptom occurrence monthly or more frequently in the previous 12 months. A subgroup of pupils from low-income areas commuting to better-off schools showed the highest symptom prevalences. The findings are consistent with a model in which an increase in the incidence of asthma is driven by factors associated with improved social circumstances, whereas severity is determined by factors associated with poverty. The impact of social mobility on asthma, including reporting of symptoms, deserves closer study.

Adolescent↗

Achieving guideline-based asthma control: does the patient benefit?

Asthma management guidelines define asthma control, but the outcome criteria used do not include the patient's own assessment of their health. The objective of the present study was to determine the association between the achievement of asthma control, as defined by the Global Initiative for Asthma (GINA) guidelines, and patient-assessed asthma-related quality of life (QOL), particularly whether maximal or near-maximal QOL scores were attainable. Clinical data from three studies that compared salmeterol/fluticasone propionate combination therapy (SFC) with other treatments in patients with persistent asthma were retrospectively analysed. Achievement of asthma control was determined over an 8-week period in each study according to six parameters derived from the GINA guideline treatment goals. Asthma Quality of Life Questionnaire (AQLQ) scores (a 7-point scale, where 1=severe impairment and 7=no impairment) were analysed by treatment group for well-controlled and not well-controlled patients. The analysis showed that, across a range of severities, well-controlled asthma patients had consistently higher AQLQ scores at endpoint and larger AQLQ improvements from baseline, than patients who were not well controlled. For many well-controlled patients, endpoint scores approached 7, indicating little or no impact of asthma on their QOL. However, AQLQ scores of not well-controlled patients also improved substantially in some treatment groups, particularly the SFC group. These results suggest a relationship between the achievement of guideline-based asthma control and improvements in quality of life to levels where there is little or no impact of asthma on quality of life. Guideline-based asthma control is therefore beneficial to the patient and should be tested in prospective studies.

Albuterol↗

Clinical equivalence of salmeterol/fluticasone propionate in combination (50/100 microg twice daily) when administered via a chlorofluorocarbon-free metered dose inhaler or dry powder inhaler to patients with mild-to-moderate asthma.

This multi-centre, randomized, double-blind, double-dummy, parallel-group study was designed to investigate the hypothesis of equivalent efficacy and comparable safety of two inhaled presentations of salmeterol/fluticasone propionate combination product (SALM/FP) 50/100 microg administered twice daily to patients with mild-to-moderate asthma for 12 weeks. The delivery systems were a 25/50 microg strength hydrofluoroalkane (HFA) metered-dose inhaler (MDI) and a Diskus inhaler (50/100 microg strength). A third group received FP 100 microg twice daily via a chlorofluorocarbon MDI (50 microg strength). A total of 497 patients aged 11-79 years with reversible airways obstruction who were symptomatic on inhaled corticosteroid (ICS) therapy and had room for improvement in lung function were randomized to treatment in a double-blind, parallel-group design (SALM/FP MDI: n=165; SALM/FP Diskus: n=167; FP MDI: n=165) for 12 weeks. A total of 383 patients completed the study according to the protocol. According to the primary efficacy variable, increase in mean morning PEF over weeks 1-12, the two inhaled presentations of SALM/FP were clinically equivalent (adjusted mean increases 43 and 46 l min(-1); treatment difference 3 l min(-1); 95% confidence interval: -6 to 11 l min(-1)). Equivalence was also demonstrated by all secondary efficacy measures. The SALM/FP MDI was significantly superior to the FP MDI for increase in mean morning PEF (treatment difference 19 l min(-1); P<0.001) and for all secondary measures except FEV1 and symptom-free nights. There was no significant difference between the groups with respect to adverse events and serum cortisol levels. These results demonstrate that the SALM/FP 25/50 microg HFA MDI (two inhalations twice daily) is clinically equivalent to the SALM/FP 50/100 microg Diskus (one inhalation twice daily). Patients switching to SALM/FP from other MDI-based asthma treatments may now do so without a change of delivery device.

Adolescent↗

Measuring asthma control.

Asthma control may be defined in several ways, but in clinical practice refers to the achievement of an acceptable clinical state, often based on goals of asthma management. It differs from the assessment of disease severity, which quantifies departure from 'normal'. Most references to asthma control in the current literature refer to one or more endpoints rather than a comprehensive composite assessment based on relevant clinical features of the disease. Recent developments have been the introduction of validated measurement tools such as the Asthma Control Questionnaire and Asthma Control Diary, which include symptoms, beta-agonist use and a measure of airway calibre, each scored on a 7-point scale and then aggregated. An alternative view is that a wholly patient-focused outcome (based entirely on patient recall of symptoms over the last week or month) is preferable. In general, however, care-givers appear to favour the inclusion of objective measures, and a range of indicators of disease activity are being investigated, including airway hyperresponsiveness and markers of airway inflammation. The potential value of the wider use of a composite measure of clinical control is being increasingly recognized, and further attempts to develop, validate and apply a simple tool suitable for use in primary care are underway.

Asthma↗

Changes in fatal and near-fatal asthma in an urban area of South Africa from 1980-1997.

Over the past two decades, changes in the health services designed to improve access to and quality of asthma care have occurred in South Africa. The aim of this study was to investigate the incidence of fatal and near-fatal asthma (NFA) from 1980-1997 in an urban part of South Africa. A retrospective analysis of fatal asthma and NFA in the Cape Town City Council area was performed. Mortality data were obtained from death notification records. Data on NFA were obtained from the records of patients admitted for asthma to intensive care units (ICUs) at major academic hospitals serving the area. There were 1,506 deaths (mean age 56 yrs) from asthma reported; 39 and 3% occurred in people under 55 and 15 yrs, respectively. Average annual asthma mortality rate (8.1 +/- 1.9 per 100,000 population) was highest amongst people of mixed race (10.1 +/- 2.0), followed by Blacks (6.8 +/- 3.1) and Whites (5.0 +/- 1.9, p<0.001). Asthma mortality declined by 0.28 deaths per 100,000 population per year; rates decreased in all ethnic groups. Most deaths (72.3%) were outside a health facility and a higher number of deaths occurred on weekends (223 deaths x day(-1)) than weekdays (207 deaths x day(-1), p=0.014). Paediatric asthma ICU admissions declined by 1.81 children yr(-1). The annual number of adults admitted to ICU for asthma, and the proportion requiring intermittent positive pressure ventilation did not change. These results indicate that the incidence of fatal and near-fatal asthma in this area has declined over the period and this may reflect improved asthma management. However, the relatively high asthma mortality rate in people of mixed race and the predominance of deaths outside health facilities and on weekends suggest problems with access to care.

Adolescent↗

Is overall asthma control being achieved? A hypothesis-generating study.

The efficacy of asthma therapy is traditionally measured using single end-points. In contrast, the aim of therapy is to achieve overall control, defined by management guidelines as achieving a number of treatment goals. These goals reflect expert opinion, rather than being evidence based. The objective of this study was to determine whether guideline-defined asthma control is achievable. Eight studies of salmeterol/fluticasone propionate combination therapy were analysed using three asthma control measures of varying stringency, derived from the guideline goals. For each measure, only patients meeting all goals were classified as controlled. The analysis demonstrated that asthma control, as defined by management guidelines, can be achieved. For a given therapy, similar proportions of patients achieved control irrespective of disease severity, suggesting that outcome expectations should not be reduced for patients with more severe disease. Substantially more patients achieved the target values for individual goals than achieved overall control, indicating that reliance on individual end-points is likely to result in significant overestimation of true control. The findings of this hypothesis-generating study should be prospectively tested. Future research will include a randomized controlled study designed to assess the proportion of patients able to achieve overall control of asthma when treatment is titrated appropriately.

Albuterol↗

Using clinical measures of disease control to reduce the burden of asthma.

Clinical treatment guidelines encourage physicians to select asthma treatment in order to achieve established clinical treatment goals. Treatment selected on this basis may have profound effects upon other outcomes, some of which, such as improvements in well-being and lifestyle, are of direct benefit to the patient, and others, such as utilisation of healthcare resources and productivity, are of benefit to society. There is, however, evidence that a large proportion of patients do not achieve the goals of asthma management, such as those appearing in the international guide produced by the Global Initiative on Asthma (GINA). Furthermore, evaluation of the individual guideline goals provides little indication of the level of overall control achieved in individual patients, in spite of the fact that overall or comprehensive control is likely to be of greater value to the patient than control of only limited aspects of the disease. To give an indication of overall asthma control, and assess whether it is possible to reach this target, the GINA goals of asthma management have been amalgamated into a composite measure of overall asthma control. This approach has been used to assess recent clinical trials with the fluticasone propionate plus salmeterol combination given through a single inhaler compared with alternative treatment approaches. The studies showed that overall asthma control can be achieved, but at the fixed treatment doses used in clinical trials by only about half of the patients. Once such measures of control are included in management guidelines, healthcare professionals may need help to ensure implementation, using methods such as educational programmes and computerised disease management programmes. Improving asthma control in this way is likely to be associated with significant economic benefits.

Anti-Asthmatic Agents↗

Aetiology and outcome of pneumonia in human immunodeficiency virus-infected children hospitalized in South Africa.

UNLABELLED: To determine the aetiology and outcome of pneumonia in human immunodeficiency virus (HIV)-infected children, we prospectively investigated 250 children hospitalized with pneumonia who were known or clinically suspected to be HIV-positive, or who required intensive care support in Cape Town, South Africa. Blood culture, induced sputum or bronchoalveolar lavage, nasopharyngeal aspirate and gastric lavage were performed. Of the total, 151 children (60.4%) were HIV-infected. Pneumocystis carinii pneumonia (PCP), occurring in 19 (7.6%) children (15 HIV-positive), was the AIDS-defining infection in 20.3%. The incidence and type of bacteraemia (14.3%) were similar in HIV-positive and HIV-negative patients; S. pneumoniae (5%) and S. aureus (2%) were the predominant isolates. Sputum or BAL cultures yielded bacteria in 145 of 243 (60%) specimens; viruses were cultured in 37 (15.2%). Bacterial prevalence (including M. tuberculosis in 8%) and anti-microbial resistance did not differ by HIV status except for S. aureus which was more common in HIV-infected children. Thirty-one (20%) HIV-positive and 8 (8%) HIV-negative children died [RR 1.16 (95% CI 1.05-1.28), p=0.008]; using multiple logistic regression, PCP was the only risk factor for mortality (p = 0.03). CONCLUSION: In South Africa, PCP is an important AIDS-defining infection in children; bacterial pathogens occur commonly and with a similar prevalence in HIV-positive and HIV-negative children hospitalized for pneumonia. HIV-infected children with pneumonia have a worse outcome than HIV-negative patients.

Female↗

Guideline for the management of chronic asthma in adults--2000 update. South African Pulmonology Society Adult Asthma Working Group.

OBJECTIVE: To make recommendations for the cost-effective management of asthma incorporating recent advances in the understanding and treatment of asthma since the last guideline statement in 1992. The guideline is applicable to adults and children over 12 years of age. OPTIONS: Asthma should be graded according to standard severity criteria. The principle of 'hit early, hit hard' with corticosteroids to achieve rapid control is encouraged; thereafter treatment should be tailed down to the lowest dose of corticosteroids that maintains the aims of asthma treatment. OUTCOMES: The aims of asthma management should be achieved; these include: (i) avoidance of causative and trigger factors; (ii) abolition of symptoms and ability to lead a normal lifestyle; (iii) restoration of normal (or best possible) lung function; (iv) reduction of the risk of severe attacks; and (v) optimisation of treatment with minimal side-effects. EVIDENCE: Based on a selective review of randomised, controlled studies to support an evidence-based approach to treatment. BENEFITS, HARMS AND COSTS: Appropriate management of asthma should lead to a reduction in morbidity and mortality of asthma and a consequent reduction in cost of asthma care. Side-effects of corticosteroids are placed in perspective together with a strategy to minimise these effects. RECOMMENDATIONS: Asthma should be managed with inhaled corticosteroids as the most important anti-inflammatory treatment, except in the case of mild intermittent asthma which may be treated with beta 2 agonists on a pro re nata (prn) basis. It is preferable to add long-acting beta 2 agonists to low-dose inhaled corticosteroids before increasing corticosteroids. Leukotriene receptor antagonists are currently recommended for use in combination with inhaled corticosteroids pending further data on their long-term benefits. Differentiation of asthma from chronic obstructive pulmonary disease (COPD) is important. Early referral to a pulmonologist in difficult cases is encouraged. VALIDATION: Endorsed by the South African Pulmonology Society, the Allergy Society of South Africa and the South African Medical Association. The guideline is compatible with those of other international societies.

Adrenal Cortex Hormones↗

Efficacy of azathioprine as second-line treatment in pulmonary sarcoidosis.

BACKGROUND AND AIM OF WORK: Immunosuppressives such as azathioprine are occasionally used in sarcoidosis where corticosteroids cannot be used because of poor response, contraindications or unacceptable side effects. The aim of this study was to assess the efficacy and safety of azathioprine in the treatment of pulmonary sarcoidosis. METHODS: A retrospective study was performed on patients in the Respiratory Clinic of the university teaching hospital on all biopsy-proven sarcoid treated with azathioprine between 1969 and 1993 (n = 10). All had previously shown only partial (n = 6) or no (n = 4) response to high dose oral corticosteroids. Azathioprine in a dose of 100-150 mg was administered daily, while continuing a small dose of oral corticosteroid. Patients underwent regular clinical evaluation, pulmonary function testing and chest radiography. RESULTS: In one patient the course was too brief to evaluate (26 days). Two patients had significant and sustained improvement in lung function (vital capacity increasing from 72% to 89% and from 49% to 79% of predicted respectively, and transfer factor from 78% to 114% and from 27% to 49% of predicted respectively), and chest radiograph cleared. Two patients had short-lived improvement and steroid-sparing effect. In the remainder (n = 5), no benefit was observed. No patient responded to azathioprine who had failed to respond to high dose corticosteroids. There was no significant toxicity. CONCLUSIONS: Azathioprine may provide a safe alternative to corticosteroids when a steroid-sparing effect is required, but it is unlikely to be effective in patients who fail to respond to high dose corticosteroids and/or have radiographic evidence of significant fibrosis.

Adrenal Cortex Hormones↗

Latent adenoviral infection in follicular bronchiectasis.

The follicular form of bronchiectasis originally described by Whitwell (1) has been associated with adenoviral infection. The present study compares resected lungs from 16 patients with follicular bronchiectasis (in 10 of whom a nonviral etiology was identified) with those from eight patients with a nonfollicular histologic pattern. DNA isolated from sections of 45 paraffin-embedded lung samples was subjected to the polymerase chain reaction (PCR) using primers for the E1A region of the adenovirus genome and the human HLA DQ alpha gene. In situ hybridization (ISH) was performed on separate sections cut from the same blocks using a probe for the entire adenovirus 5 genome. E1A was demonstrated in six of eight patients (75%) with non-follicular bronchiectasis (non-FB) and in four of 16 (25%) with follicular bronchiectasis (FB) (p < 0.03, Fisher's exact test). The optical density ratio for the E1A product of PCR (ratio of E1A product from specimen to that from 1 pg adenovirus DNA) was significantly lower in FB than in non-FB (0.057 +/- 0.054 versus 0.365 +/- 0.223 [mean +/- SEM], p < 0.05). Moreover, the duration of symptoms of bronchiectasis in patients without E1A in bronchial specimens was significantly shorter than that of patients with positive E1A PCR products (3.09 +/- 1.44 versus 14.41 +/- 3.33 yr; p < 0.05). By ISH, adenovirus was demonstrated in three patients with FB and in two with non-FB (17.2 and 18.8% of tissue blocks, respectively; NS).(ABSTRACT TRUNCATED AT 250 WORDS)

Adenovirus E1A Proteins↗

Serum angiotensin-converting enzyme activity, concentration, and specific activity in granulomatous interstitial lung disease, tuberculosis, and COPD.

Angiotensin-converting enzyme (ACE) activity in serum is used as an aid to the diagnosis and follow-up of patients with sarcoidosis. A theoretical limitation of measurements of activity is that these may be affected by the presence of pharmacologic or endogenous inhibitors of ACE. Immunoassays of ACE concentration avoid this problem and, when combined with tests of ACE activity, permit calculation of specific activity of ACE. In this study, we set out to develop a sensitive radioimmunoassay for ACE to compare results obtained with this method with results of ACE activity and calculated ACE specific activity in patients suffering from a variety of lung diseases. In a group of control subjects (n = 32), the ACE concentration was 453.7 +/- 159.8 (SD) ng/mL; 95% confidence interval (CI), 398.34 to 509.06, but levels were significantly elevated in sarcoidosis (979.3 +/- 558.6 ng/mL; 95% CI, 827.5 to 1,131.1; n = 51; p < 0.001 vs control subjects), silicosis (646.5 +/- 239.1 ng/mL; 95% CI, 544.2 to 748.8; n = 21; p < 0.01), and miliary tuberculosis (647.0 +/- 217.1 ng/mL; 95% CI, 551.9 to 742.1; n = 29; p < 0.01). The levels were normal in COPD, interstitial pulmonary fibrosis, and active cavitary pulmonary tuberculosis. The overall correlation between ACE activity and concentration measurements was strong (r = 0.93). No evidence of endogenous ACE inhibition was observed in any of the disease categories studied except in COPD where an elevation of ACE specific activity was observed, raising the possibility that in this condition different isozymes of ACE with higher specific activity might be released.

Adult↗

High dose fluticasone propionate, 1 mg daily, versus fluticasone propionate, 2 mg daily, or budesonide, 1.6 mg daily, in patients with chronic severe asthma. International Study Group.

Airway inflammation is now regarded as fundamental in the pathogenesis of asthma and treatment with inhaled corticosteroids has proved effective. There is a need for drugs in this category with higher topical potency but fewer side-effects than those presently available. A double-blind, parallel group study was conducted in 671 patients with severe asthma (already taking between 0.8-2.0 mg of inhaled corticosteroid daily) to compare the safety and efficacy of 6 weeks of treatment with inhaled fluticasone propionate (FP), 1 mg daily, to fluticasone propionate, 2 mg daily, and budesonide (BUD), 1.6 mg daily, delivered via a metered-dose inhaler. Peak expiratory flow (PEF), asthma symptoms, and usage of rescue medication were recorded daily by the patient. At each clinic visit (-2, 0, 3 and 6 weeks) morning serum cortisol levels, bone markers and spirometry were assessed. The changes in mean morning PEF from baseline (weeks 1-6) were: FP 2 mg daily +24 l.min-1; FP 1 mg daily +21 l.min-1; BUD 1.6 mg daily +13 l.min-1. A similar rank order for the three treatments was seen for evening PEF, clinic spirometry, reduction of diurnal PEF variation, symptom scores, and requirement for rescue bronchodilators. The mean serum cortisol levels remained well within the normal range in all three groups. Analysis of the geometric mean cortisol ratio (treatment/baseline ratio after 6 weeks treatment) showed a changed rank order, the values being: FP 1 mg daily 1.04; BUD 1.6 mg daily 0.97; FP 2 mg daily 0.88.(ABSTRACT TRUNCATED AT 250 WORDS)

Aerosols↗