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Biomedical subjects

T Ekström

Publications and source records attributed to T Ekström.

At least 19 recordsLinked to original sources

Once-daily budesonide/formoterol in a single inhaler in adults with moderate persistent asthma.

Patients with moderate persistent asthma (n = 523; mean FEV1 77.4%) not fully controlled with inhaled corticosteroids (ICS; 400-1000 microg/day) were randomized to receive either once-daily budesonide/formoterol (160/4.5 microg, two inhalations); or twice-daily budesonide/formoterol (160/4.5 microg, one inhalation); or budesonide (400 microg) once-daily for 12 weeks. Once-daily dosing was administered in the evening and twice-daily dosing was administered in the morning and evening. All patients received twice-daily budesonide (200 microg) during a 2-week run-in. Compared with budesonide alone, change in mean morning and evening peak expiratory flow was greater in the once-daily budesonide/formoterol group (27 and 171 min(-1), respectively; P < 0.001) and twice-daily budesonide/formoterol group (23 and 24 l min(-1), respectively; P < 0.001). Night awakenings, symptom-free days, reliever-use-free days and asthma-control days were all improved during once-daily budesonide/formoterol therapy vs. budesonide (P < or = 0.05). Similar improvements were also seen with twice-daily budesonide/formoterol (P < or = 0.05). The risk of a mild exacerbation was reduced after once- and twice-daily budesonide/formoterol vs. budesonide (38% and 35%, respectively; P < 0.002). All treatments were well tolerated. Budesonide/formoterol, once- or twice-daily, in a single inhaler improved asthma symptoms and exacerbations compared with budesonide. In the majority of patients with moderate persistent asthma requiring ICS and long-acting beta-agonists, once-daily formoterol/budesonide provided sustained efficacy over 24 h, similar to twice-daily dosing.

Administration, Inhalation↗

The EDICT study.

Explore the source record for details and available documents.

Anti-Asthmatic Agents↗

Comparison of formoterol and terbutaline for as-needed treatment of asthma: a randomised trial.

BACKGROUND: Asthma guidelines recommend that long-acting inhaled beta-agonists should be used as maintenance therapy for patients with asthma inadequately controlled on an inhaled corticosteroid. We studied the safety and efficacy of the long-acting beta-agonist formoterol compared with terbutaline, each taken as needed, in patients with moderate to severe asthma. METHODS: Patients were taking an inhaled corticosteroid (mean dose 870 microg daily) and had a forced expiratory volume in 1 s (FEV1) of at least 50% predicted (mean 74%). Those requiring an inhaled beta-agonist three to eight times a day during the study run-in period (362 of 621 who started) were randomly assigned formoterol 4.5 microg or terbutaline 0.5 mg as needed by Turbuhaler in daily doses up to 54 microg and 6 mg, respectively, for 12 weeks in a double-blind, parallel-group study. Analyses were by intention to treat. FINDINGS: The 362 randomised patients (157 men, 205 women) had a mean age of 47 years. Patients taking formoterol had a longer time to their first severe asthma exacerbation (relative-risk ratio 0.55 [95% CI 0.34-0.89]), took fewer inhalations of study drug, and had larger increases in FEV1 (5%) and morning and evening peak expiratory flow (mean difference in increase 11 L/min and 8 L/min) than those taking terbutaline. No safety issues were identified. INTERPRETATION: When taken as needed, formoterol 4.5 microg provided better asthma control than terbutaline 0.5 mg in patients requiring moderate doses of relief medication despite inhaled corticosteroid treatment. Safety studies should be extended to a wider population of patients with asthma.

Administration, Inhalation↗

A cost-effectiveness study comparing the as-needed use of formoterol (Oxis) and terbutaline (Bricanyl) in patients with moderate to severe asthma.

This study evaluated the economic and health-related consequences of the as-needed use of a long-acting beta2-agonist with fast onset (formoterol, Oxis Turbuhaler 4.5 microg) versus a short-acting beta2-agonist (terbutaline, Bricanyl Turbuhaler 0.5 mg) in patients with moderate to severe asthma. A multi-national (Sweden, Norway, The Netherlands and Greece), multi-centre (35 centres), randomized, double-blind clinical trial was conducted using 362 patients on inhaled steroids during a 12-week period. The effectiveness results were pooled and the total costs included estimates for beta2-agonists, inhaled steroids, oral steroids, physician visits and sick-leave. The 182 patients in the formoterol group had 14,404 days of exposure and 29 severe exacerbations, and the 180 patients in the terbutaline group had 13,655 days of exposure and 48 severe exacerbations. The terbutaline group had 62% more severe exacerbations than the formoterol group (P=0.039), based on exposure time. Per patient, the calculated total costs were SEK 3386 for the formoterol group and SEK 3709 for the terbutaline group over the 12-week period. The conclusion is that the use of Oxis Turbuhaler instead of Bricanyl Turbuhaler for as-needed treatment is a more effective treatment generating cost savings from a societal perspective.

Acute Disease↗

Asthma care and factors affecting medication compliance: the patient's point of view.

OBJECTIVE: To identify important factors that can influence patient compliance with prescribed medication and to elucidate aspects of asthma care from the patient's point of view. DESIGN: Field investigation; the interviewer used a semi-structured questionnaire. SETTING: Patients with asthma in primary health care settings in Sweden. STUDY PARTICIPANTS: A sample of 77 patients was randomly selected from 11 primary health care centres in southern Sweden; 63 of these patients participated in the study. CONCLUSION: The factors of importance for self-reported compliance with prescribed medication were age, gender, duration of the disease, the attitude of the staff and information/education about asthma. The patients expressed important aspects of care, and these are in accordance with how an asthma nurse practice functions in Sweden.

Adult↗

Improved asthma control with budesonide/formoterol in a single inhaler, compared with budesonide alone.

Budesonide/formoterol in a single inhaler was compared with budesonide alone, and with concurrent administration of budesonide and formoterol from separate inhalers, in patients with asthma, not controlled with inhaled glucocorticosteroids alone. In this 12-week, double-blind, randomized, double-dummy study, 362 adult asthmatics (forced expiratory volume in one second 73.8% of predicted, inhaled glucocorticosteroid dose 960 microg x day(-1)) received single inhaler budesonide/formoterol (Symbicort Turbuhaler) 160/4.5 microg, two inhalations b.i.d., or corresponding treatment with budesonide, or budesonide plus formoterol via separate inhalers. There was a greater increase in morning peak expiratory flow (PEF) with single-inhaler (35.7 L x min(-1)) and separate-inhaler (32.0 L x min(-1)) budesonide and formoterol, compared with budesonide alone (0.2 L x min(-1); p<0.001, both comparisons); the effect was apparent after 1 day (p<0.001 versus budesonide, both comparisons). Similarly, evening PEF, use of rescue medication, total asthma symptom scores and percentage of symptom-free days improved more with both single inhaler and separate inhaler therapy than with budesonide alone, as did asthma control days (approximately 15% more, p<0.001 versus budesonide, both comparisons, with a marked increase in the first week). All treatments were well tolerated and the adverse event profile was similar in all three treatment groups. It is concluded that single inhaler therapy with budesonide and formoterol is a clinically effective and well-tolerated treatment for patients with asthma that is not fully controlled by inhaled glucocorticosteroids alone.

Administration, Inhalation↗

Effects of anti-reflux surgery on chronic cough and asthma in patients with gastro-oesophageal reflux disease.

This two-group prospective study evaluated the effect of anti-reflux surgery (fundoplication) on 24 patients with severe gastro-oesophageal reflux disease (GORD) and concomitant asthma (n=13) or chronic cough (n=11). Twenty-four hour oesophageal pH monitoring and lung function tests (FEV1, FVC) were done before and within 1 year after anti-reflux surgery. A diary was kept by the patient during the 4-week period prior to surgery and during 4-week periods 6 and 12 months postoperatively, with daily monitoring of peak expiratory flow rate, respiratory and reflux symptoms and medication. In non-asthmatic patients, coughing was reduced by 47% and 80% during the day and night, respectively, 12 months after surgery (P < 0.01). Concomitant hoarseness and expectoration were also significantly reduced (P<0.05). No effect on lung function was seen. In patients with asthma, small, non-significant reductions in asthma symptom scores and consumption of rescue medication were seen. Twenty-two patients were completely free from their GORD symptoms after surgery. In conclusion, anti-reflux surgery in patients with GORD had a more favourable effect on concomitant cough than concomitant asthma.

Adult↗

Patient questionnaires in primary health care. Validation of items used in asthma care.

OBJECTIVE: To evaluate each item in a patient questionnaire for the purpose of investigating whether the validity of each item is acceptable. DESIGN: The questionnaire was completed by the patients at an ordinary follow-up visit for their asthma, and within 1 week a nurse interviewed them by telephone with the aim of analysing the validity of each item through the use of predetermined criteria. SETTINGS: Patients with asthma in primary health care settings in Sweden. STUDY PARTICIPANTS: Fifty-one patients were consecutively included from three different primary health care units. RESULTS: Nine of 13 items had an acceptable validity. The four items that were not found to have acceptable validity were developed further. CONCLUSION: Evaluating each item in a questionnaire by means of interviews with the specific patient population is a useful method of assuring that the intention of the patient questionnaire has been met.

Asthma↗

Asthma nurse practice--a resource-effective approach in asthma management.

The objective of this study was to evaluate the efficacy of an Asthma Nurse Practice (ANP) in primary health care. A 12-month (September 1994-August 1995) open, prospective intervention study with pre- and post-test comparisons was performed on patients with asthma treated at a primary care centre in Sweden. Sixty-three patients with mild or moderate asthma participated and medication, structured follow-up and education in self-management at an ANP were assessed over a 12-month period. The main outcome measures assessed were pulmonary function, eosinophil cationic protein (ECP) in serum, respiratory symptoms, patient knowledge of asthma and emergency visits. ANP in primary health care increased patient knowledge of asthma and medication. The number of patients with nocturnal symptoms decreased significantly. Pulmonary function was improved: vital capacity (VC) 98-106, forced expiratory volume in 1 sec (FEV1) 93-100 and peak expiratory flow (PEF) 98-115% of predicted (P < 0.001). Variation in PEF fell from 21 to 12% (P < 0.001). ECP was significantly reduced. Visits to the emergency room were 60% fewer during the year of intervention (P < 0.01). In conclusion, patients attending an Asthma Nurse Practice, comprising a structured programme for asthma management, improve their knowledge and asthma control.

Adult↗

Mammary tumours in Sprague-Dawley rats after initiation with DMBA followed by exposure to 50 Hz electromagnetic fields in a promotional scheme.

In order to test whether a transient-producing intermittent magnetic field (MF) acts as a promoter in rat mammary tumour development, a study of a 50 Hz sinusoidal MF with flux densities of 0.25 and 0.5 mT was performed on female Sprague-Dawley rats. A single administration of 7 mg of 7,12-dimethyl-benz[a]anthracene (DMBA) was given by gavage to 52-day-old animals. After 1 week, exposure to an intermittent (15 s on/15 s off) transient-associated magnetic field was started. MF exposure was performed for 19 or 21 h per day up to 25 weeks, when the study was terminated. Twice a week a careful examination with palpation for tumours was done. Tumour incidence, the number of tumours per animal, tumour volume and tumour weight were recorded. A total of 70% of MF-exposed animals developed tumours. For animals exposed to DMBA alone the correspondent figure was 71.7%. No statistical differences were seen either for tumour-bearing animals or for the total number of tumours. A slightly larger total tumour weight and tumour volume was seen for animals exposed to 0.25 mT MF. These differences were not statistically significant.

9,10-Dimethyl-1,2-benzanthracene↗

Low-dose formoterol Turbuhaler (Oxis) b.i.d., a 3-month placebo-controlled comparison with terbutaline (q.i.d.).

This study compared the efficacy of a low dose of formoterol Turbuhaler 6 micrograms b.i.d. (F) with that of terbutaline 0.5 mg q.i.d. (T), and placebo (P) from Turbuhaler. After a 2-week run-in, 397 adults with mild to moderate asthma were randomly allocated to one of the treatments for 12 weeks. During run-in, the mean morning peak expiratory flow (PEF) was 360 (F), 368 (T) and 367 1 min-1 (P). F was better than T (P = 0.014) and P (P = 0.0001) in improving morning PEF [mean changes from run-in: 20 (F), 9 (T), and 21 min-1 (P)]. F was statistically significantly more effective than either T or P in reducing asthma symptoms. F gave also statistically significantly higher evening PEF and less use of rescue medication than P. Bronchodilator response to study drugs and additional 1.25 mg terbutaline was similar before and after the 12-week treatment period. There were no adverse effects of clinical relevance. In conclusion, formoterol Turbuhaler, 6 micrograms b.i.d. was more effective in improving PEF and offered better asthma control than either terbutaline Turbuhaler, 0.5 mg q.i.d. or placebo. Regular use of formoterol did not reduce the bronchodilator response to additional terbutaline. There were no clinically relevant adverse effects.

Adolescent↗

A 6-month comparison between formoterol and salmeterol in patients with reversible obstructive airways disease.

The aim of this randomized, open, parallel group study was to compare the clinical efficacy of formoterol dry powder capsule 12 micrograms b.i.d. and salmeterol dry powder 50 micrograms b.i.d. in the treatment of patients with reversible obstructive airways disease. The 6-month treatment was preceded by a 2 week run-in period. Morning pre-dose peak expiratory flow (PEF) during the last 7 days of treatment was the primary variable. Throughout the study, patients recorded morning and evening pre-dose PEF, use of rescue medication, respiratory symptoms and adverse events. Clinic visits were scheduled at monthly intervals. Of the 482 patients randomized (equal numbers in the two treatment groups), 428 completed the study. Four hundred and twenty-five patients were included in the efficacy analysis for the primary variable. For mean morning pre-dose PEF during the last 7 days of treatment, the 95% confidence interval (CI) for the treatment contrast formoterol minus salmeterol was included entirely in the pre-defined range of equivalence (CI limits = -8.69, +9.841 min-1). This was also the case for the morning PEF during the last week before each clinic visit. For mean evening pre-dose PEF, the estimated treatment contrasts showed a trend towards superiority of formoterol over salmeterol, which became statistically significant at 2, 3 and 4 months (P < 0.05; estimated contrasts 7.27, 10.45 and 10.511 min-1, respectively). No treatment group differences were found in use of rescue medication and respiratory symptom scores. The incidence of adverse events was similar in the two groups. These findings demonstrate that formoterol 12 micrograms b.i.d. and salmeterol 50 micrograms b.i.d., both formulated as dry powders, have similar long-term efficacy and safety profiles in patients with reversible obstructive airways disease.

Administration, Inhalation↗

A 3-month comparison of formoterol with terbutaline via turbuhaler. A placebo-controlled study.

BACKGROUND AND AIM: Oxis Turbuhaler is a new dry powder formulation of long-acting beta2-agonist formoterol. This study compared the efficacy and safety of regular use of the long-acting beta2-agonist formoterol and the short-acting terbutaline for 3 months in patients with asthma. METHOD: After 1-week run-in, 343 patients received either formoterol 12 microg bid (F) (delivered dose of 9 microg), terbutaline 500 microg qid (T) or placebo qid, in a parallel-group, double-blind, randomized manner. They had a mean of 61% of predicted forced expiratory volume in 1 second (FEV1) and a mean reversibility of 26%. Eighty-nine percent used inhaled corticosteroids. RESULTS: During run-in mean morning peak expiratory flow (PEF L/min) for F was 366 and 348 for T, and 344 for placebo (P). The F group improved morning PEF significantly compared with P (P = .0022) and T (P = .0001). Changes from run-in were + 18, -1.5, and +5 L/min after F, T, and P, respectively. The F group was statistically significantly better than P and T in increasing evening PEF and in reducing night-time asthma. The F and T statistically significantly reduced the use of rescue medication compared with P. The bronchodilating response to the study drug and to an additional 1.25 mg terbutaline was of the same magnitude before and throughout the study. No statistically significant treatment-by-time interaction was observed (P > .20). There were no adverse effects of clinical relevance. CONCLUSION: Formoterol Turbuhaler, 12 microg bid, was more effective than terbutaline Turbuhaler, 0.5 mg qid, and placebo. Regular use of formoterol or terbutaline did not significantly influence the response to additional inhalation of terbutaline.

Administration, Inhalation↗

Do low molecular weight heparin and dextran increase the blood loss in transurethral resection of the prostate?

OBJECTIVE: To evaluate whether the use of dextran or the combination of low molecular weight heparin and dextran increases the blood loss in elective transurethral resection for benign prostatic hyperplasia. PATIENTS AND METHODS: This open randomized controlled study included 198 patients operated under spinal anaesthesia who were allocated to four groups differing in the combination of prophylactic treatment used for thrombosis and for the substitution of blood loss. The prophylactic treatment was either dalteparin sodium, continued each day until mobilization, or 3% Ringer dextran-60 just before operation and continued with 6% dextran-70 for 2 days post-operatively, and the volume substitute was Ringer dextran or Ringer's acetate. Thus, the four treatments (by prophylaxis and volume substitute, respectively) were dalteparin and Ringer's acetate, dalteparin and dextran, dextran and Ringer's acetate, and dextran and dextran. The haemoglobin lost to the irrigation fluid was measured and used to calculate blood loss. RESULTS: Patients receiving dextran had a larger post-operative and total blood loss than those who did not. The need for transfusion did not differ between the treatment groups. CONCLUSION: The combination of dalteparin and dextran was not associated with an increased blood loss above that with dextran alone.

Aged↗

Two dimensional protein patterns of bronchoalveolar lavage fluid from non-smokers, smokers, and subjects exposed to asbestos.

BACKGROUND: Bronchoalveolar lavage (BAL) fluid contains a large number of proteins which comprise a potential resource for studying respiratory effects due to occupational and environmental exposures. A study was undertaken to compare protein patterns of BAL fluid from non-smokers, smokers, and subjects exposed to asbestos. METHODS: BAL fluid samples were analysed with two dimensional gel electrophoresis (2-DE). The separated proteins were detected, quantified, and pattern-matched between different individuals with a computerised imaging system designed for evaluations of 2-DE patterns. RESULTS: About 200 different protein spots were detected in each sample of BAL fluid. As is the case with blood plasma, the BAL fluid samples contained large amounts of albumin, transferrin, and immunoglobulins. Higher levels of basic proteins were found in smokers than in non-smokers, while subjects exposed to asbestos had increased amounts of several high molecular weight proteins as well as basic proteins. Lower levels of albumin and higher levels of immunoglobulins were found in smokers than in non-smokers, while higher levels of transferrin were found in asbestos exposed subjects than in unexposed subjects. Moreover, in the group exposed to asbestos differences were found between patients with pleuritis and patients with pleural plaque, and one protein spot was found only in two patients with progressive pleural disease. CONCLUSION: These results suggest that both smokers and asbestos exposed subjects have significant changes in their airway protein expression compared with non-smokers and unexposed subjects. It is inferred that analysis of protein patterns in the BAL fluid with 2-DE may be used to detect and characterise, at a molecular level, respiratory effects due to occupational and environmental exposures.

Adult↗