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Biomedical subjects

S Shrewsbury

Publications and source records attributed to S Shrewsbury.

5 recordsLinked to original sources
PubMed2001

Salmeterol 100 microg: an analysis of its tolerability in single- and chronic-dose studies.

BACKGROUND: A combination product containing fluticasone propionate 100 or 250 microg and salmeterol 50 microg has recently been made available in the United States. Some patients, if previously instructed to double their inhaled corticosteroids, may double this product, inadvertently receiving higher doses of salmeterol, potentially causing systemic beta2-agonist-related effects. OBJECTIVES: To examine the systemic effects of single and chronic doses of salmeterol 100 microg. METHODS: Forty-four studies including a salmeterol 100 microg treatment arm were identified. Data on predictable systemic effects were available in 10 single-dose and 9 chronic-dose studies lasting more than 7 days, in patients with asthma (6 adult, 2 pediatric) or chronic obstructive pulmonary disease (1 study), which were included in a weighted, pooled analysis. RESULTS: Single 100-microg dose studies: mean change from baseline in heart rate was +2.3 beats per minute and systolic blood pressure +0.4 mm Hg. Tremor and palpitations were reported in 5.7% and 2.8%. Other systemic effects included a decrease in serum potassium for 3 subjects (2.1%); an increase in serum glucose, 1 subject (0.7%); and electrocardiographic (ECG) events, 24 cases (17.0%). Twenty-three of these were from one crossover study which reported 27 ECG events after placebo. Chronic dose studies (salmeterol 100 microg): mean change in heart rate and systolic blood pressure were +1.8 beats per minute and -0.2 mm Hg. Tremor and palpitations were reported in 5.6% and 1.7% of 1,504 patients. Thirteen recorded a decrease in serum potassium (0.9%) and 5 an increase in serum glucose (0.3%). Nine patients had ECG events (0.6%). Eight of these were "arrhythmia" from one study, which also reported 12 events before treatment. CONCLUSIONS: The mean systemic effects of salmeterol 100 microg are small and of doubtful clinical relevance. Patients (and their caregivers) can be reassured that inadvertently taking double doses of the new combination product are unlikely to affect them adversely.

Adolescent↗
PubMed2000

Meta-analysis of increased dose of inhaled steroid or addition of salmeterol in symptomatic asthma (MIASMA).

OBJECTIVE: To examine the benefits of adding salmeterol compared with increasing dose of inhaled corticosteroids. DESIGN: Systematic review of randomised, double blind clinical trials. Independent data extraction and validation with summary data from study reports and manuscripts. Fixed and random effects analyses. SETTING: EMBASE, Medline, and GlaxoWellcome internal clinical study registers. MAIN OUTCOME MEASURES: Efficacy and exacerbations. RESULTS: Among 2055 trials of treatment with salmeterol, there were nine parallel group trials of >/=12 weeks with 3685 symptomatic patients aged >/=12 years taking inhaled steroid in primary or secondary care. Compared with response to increased steroids, in patients receiving salmeterol morning peak expiratory flow was greater at three months (difference 22.4 (95% confidence interval 15.0 to 30.0) litre/min, P<0.001) and six months (27.7 (19.0 to 36.4) litre/min, P<0.001). Forced expiratory volume in one second (FEV(1)) was also increased at three months (0.10 (0.04 to 0.16) litres, P<0.001) and six months (0.08 (0.02 to 0.14) litres, P<0.01), as were mean percentage of days and nights without symptoms (three months: days-12% (9% to 15%), nights-5% (3% to 7%); six months: days-15% (12% to 18%), nights-5% (3% to 7%); all P<0.001) and mean percentage of days and nights without need for rescue treatment (three months: days-17% (14% to 20%), nights-9% (7% to 11%); six months: days-20% (17 to 23%), nights-8% (6% to 11%); all P<0.001). Fewer patients experienced any exacerbation with salmeterol (difference 2.73% (0.43% to 5.04%), P=0. 02), and the proportion of patients with moderate or severe exacerbations was also lower (2.42% (0.24% to 4.60%), P=0.03). CONCLUSIONS: Addition of salmeterol in symptomatic patients aged 12 and over on low to moderate doses of inhaled steroid gives improved lung function and increased number of days and nights without symptoms or need for rescue treatment with no increase in exacerbations of any severity.

Adrenergic beta-Agonists↗
PubMed2000

Salmeterol in paediatric asthma.

BACKGROUND: The addition of long acting inhaled beta(2) agonists is recommended at step 3 of the British guidelines on asthma management but a recent study suggested no additional benefit in children with asthma. METHODS: The aim of this study was to compare, in a double blind, three way, crossover study, the effects of the addition of salmeterol 50 microg bd, salmeterol 100 microg bd, and salbutamol 200 microg qds in asthmatic children who were symptomatic despite treatment with inhaled corticosteroids in a dose of at least 400 microg/day over a one month period. Symptom scores, morning and evening peak expiratory flow (PEF) rates, use of rescue medication, spirometric indices, and histamine challenge were measured. RESULTS: Forty five children aged 5-14 years were enrolled. All three treatments improved asthma control, morning and evening PEF rates, and spirometric indices with no change in bronchial hyperreactivity. Mean morning PEF was significantly better during the salmeterol treatment periods than with salbutamol treatment (p<0.05). The analysis of mean morning PEF gave an estimated treatment difference of 9.6 l/min for salmeterol 50 microg bd versus salbutamol 200 microg qds (95% confidence interval (CI) 2.1 to 17.1), and an estimated treatment difference of 13.8 l/min for salmeterol 100 microg bd versus salbutamol 200 microg qds (95% CI 6.0 to 21.5). There were no significant differences between the two doses of salmeterol and all treatments were well tolerated. CONCLUSIONS: In this population of moderate to severe asthmatic children on inhaled corticosteroids, salmeterol in a dose of either 50 microg bd or 100 microg bd is significantly more effective at increasing the morning PEF rate over a one month period than salbutamol 200 microg qds. The data provided no significant evidence of a difference in efficacy between the two doses of salmeterol, 50 microg and 100 microg. A trial of salmeterol 100 microg bd may be worth considering in those still symptomatic on the lower dose.

Adolescent↗