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Biomedical subjects

C Hallett

Publications and source records attributed to C Hallett.

17 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

Palliative care: community nurses' perceptions of quality.

OBJECTIVES: To identify community nurses' perceptions of quality care provision for patients requiring palliative care. DESIGN: Semi-structured interviews were conducted with community nurses working within the district nursing service. An adaptation of Flanagan's critical incident technique was employed to elicit factors associated with high or poor quality palliative care. Interviews were tape recorded and transcribed. Data were analysed using thematic content analysis, recurrent themes being agreed by the research team. SETTING: One community healthcare trust. SUBJECTS: 62 members of the district nursing team (grades B-H). RESULTS: Respondents recounted the context in which high quality palliative care could be provided, the actions required, and the indicators that suggested the desired level of care had been achieved. Key factors identified were: the early referral of patients to the district nursing service, family circumstances, the availability of time, the accessibility of services and equipment, and the relationship with other healthcare professionals and informal carers. There was a general view that a positive outcome had been achieved when patients retained control over their circumstances and died a peaceful death, in the place of their choice, supported by their family. CONCLUSIONS: Community nurses were able to articulate clearly the essential components of high quality care. Whilst these factors do not represent a comprehensive list, they are put forward as a useful starting point for standard setting and subsequent audit.

Attitude of Health Personnel↗
PubMed1998

Clinical experience with fluticasone propionate in asthma: a meta-analysis of efficacy and systemic activity compared with budesonide and beclomethasone dipropionate at half the microgram dose or less.

The relative clinical efficacy and systemic effects of different inhaled corticosteroids is controversial. To obtain further information on this matter, the authors have performed meta-analysis of seven trials comparing fluticasone propionate (FP) with budesonide (Bud), and seven trials comparing FP with beclomethasone dipropionate (BDP) for the treatment of asthma of all severities in adult and paediatric patients. In all cases, the drugs were compared at clinically equivalent doses, i.e. FP was given at half (or less) the microgram dose. The total number of patients was 1980 (1000 treated with FP 200-800 micrograms day-1 and 980 with Bud 400-1600 micrograms day-1), and 1584 patients in the second analysis (780 treated with FP 200-1000 micrograms day-1 and 804 with BDP 400-2000 micrograms day-1). FP significantly improved mean morning peak expiratory flow rate (PEFR) compared with Bud, with an overall difference of +11 l min-1. Analysis of serum cortisols showed no differences between FP and Bud treatment at low doses, but at higher dosages, and overall, significant differences in favour of FP were observed. In the second meta-analysis, no significant differences in PEFR were observed between FP and BDP in any of the seven individual studies or in the pooled analysis. Analysis of serum cortisols showed a similar trend to the previous analysis, however, no overall difference in serum cortisol results were seen between FP and BDP. In conclusion, the pooled analysis shows that FP at half the dose (or less) is more effective than Bud and as effective as BDP in improving PEFR; in addition, these improvements were achieved with a reduction in cortisol suppression compared with BUD and with no greater degree of cortisol suppression compared with BDP. This demonstrates, in patients with asthma, that FP has an improved efficacy to safety ratio compared with older inhaled corticosteroids.

Adult↗
PubMed1995

Assessing equivalence of inhaled drugs.

The move to disease management has led to an increase in the practice of drug or formulation substitution on the basis of equivalence. Well established guidelines are available for judging equivalence between oral, but not inhaled, formulations. This article describes the criteria by which equivalence can be assessed and concludes that although traditional issues such as adequate sample size are important, studies also need to be designed in such a way as to avoid the possibility of falsely concluding clinical equivalence.

Administration, Inhalation↗
PubMed1987

The effect of midazolam (Hypnovel) administration on antipyrine pharmacokinetics in humans.

1. Twelve healthy volunteers were given a standard regimen of oral midazolam (Hypnovel) (15 mg nightly) for 10 consecutive nights. 2. Antipyrine pharmacokinetics were studied immediately before midazolam administration was started, after the dosage schedule had been completed and one week after dosing had been discontinued. 3. No statistically significant changes were seen in the disposition of antipyrine as assessed by the plasma half-lives, areas under the curve and plasma clearances. Therefore, although previous studies have demonstrated that high doses of midazolam induced the drug-metabolising enzymes in laboratory animals, such effects are unlikely to occur in humans being treated with therapeutic doses.

Adult↗
PubMed1985

A multi-centre, double-blind parallel trial of bromazepam ('Lexotan') and lorazepam to compare the acute benefit-risk ratio in the treatment of patients with anxiety.

A double-blind, multi-centre study was carried out in general practice to compare the efficacy and tolerance of treatment with bromazepam and lorazepam in 671 patients with anxiety. Patients were treated at random with either bromazepam (3 to 9 mg per day) or lorazepam (1 to 3 mg per day) for periods up to 2 weeks. In the doctors' global assessment of response, significantly more patients improved on bromazepam (84%) compared with lorazepam (77%). Thirty-three percent of the bromazepam patients reported at least one unwanted event compared with 37% in the lorazepam group. The results are discussed in the context of improving the benefit-risk ratio.

Adult↗
PubMed1984

Bromazepam: acute benefit-risk assessment in general practice.

A study was carried out in general practice to assess the benefit-risk ratio of a single new drug, bromazepam, prior to marketing. Analysis of data supplied by 393 participating doctors on 3101 patients showed that bromazepam, in a dose range of 3 mg to 9 mg daily in divided doses, was effective as an anxiolytic in 79% of the patients and that the acute risk of treatment was predictable and low. It is concluded that the acute benefit-risk ratio is acceptable with respect to the class of drug and indication for which bromazepam is prescribed.

Adolescent↗
PubMed1983

A clinical pharmacological comparison of diclofensine (Ro 8-4650) with nomifensine and amitriptyline in normal human volunteers.

1 Ten healthy male volunteers participated in a double-blind placebo-controlled crossover comparison of the pharmacodynamic profiles of single oral doses of diclofensine 25 mg and 50 mg, nomifensine 75 mg and amitriptyline 50 mg. 2 Diclofensine did not influence salivary flow or consistently affect pupil diameter and had no significant effect on subjective measurements of sedation and mood. It had no effect on reaction time, or on critical flicker frequency. 3 By contrast, amitriptyline significantly reduced salivary flow, produced significant sedation and impairment of mood, prolonged reaction time, and appeared to decrease (but not significantly) critical flicker frequency. 4 Nomifensine significantly reduced (i.e. improved) reaction time, and inhibited salivary flow. 5 Diclofensine did not significantly influence heart rate, blood pressure, systolic time intervals or high speed electrocardiogram. 6 No significant treatment-related differences were observed in serum prolactin, cortisol or growth hormone levels.

Adolescent↗
PubMed1983

Flunitrazepam: acute benefit-risk assessment in general practice.

A methodology is described which is practical in assessing the benefit-risk ratio of a single new drug prior to marketing. Flunitrazepam at doses of 0.5 mg, 1.0 mg (and 2 mg) nocte in 2,435 patients is shown to be effective in 78% of patients and the acute risk, predictable and low, irrespective of age or dose. One may conclude that the acute benefit-risk ratio is acceptable with respect to the class of drug and indication for which flunitrazepam is prescribed.

Adult↗
PubMed1981

Plasma viscosity--a new appraisal of its use as an index of disease activity in rheumatoid arthritis.

The suitability of the plasma viscosity (PV) test has been examined in relation to the more commonly used erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) estimations as a diagnostic aid in 120 outpatients with rheumatoid arthritis (RA) and as an index of improvement during subsequent specific antirheumatic drug treatment (60 outpatients). Correlation data based on 7 clinical variables suggest that PV estimations are at least as reliable as ESR and CRP in terms of diagnosis and as indices of improvement. The methodological advantages offered by the PV test lend support to its application in RA.

Arthritis, Rheumatoid↗
PubMed1980

Discriminatory indices of response of patients with rheumatoid arthritis treated with D-penicillamine.

A long-term study is being undertaken to classify drugs used as specific agents in the treatment of rheumatoid arthritis in terms of their effects on biochemical and clinical characteristics of the disease. In particular is hoped to establish those indices which are most relevant to the response of RA to treatment. Fifteen patients were treated with D-penicillamine after an initial period of 2 weeks on aspirin alone, when the baseline investigations were made. The dose of penicillamine was increased gradually to a maximum of 500 mg a day over the period of 6 months, and changes in 8 clinical and 25 laboratory indices were measured on 8 separate occasions in the 6-month period. Marked clinical improvement took place, and this was mirrored by changes in a wide range of biochemical parametaers. ESR and C-reactive protein were shown to be the most suitable indices of disease improvement with penicillamine treatment.

Adult↗
PubMed1977

Increased sensitivity to nitrazepam in old age.

The effects of a single 10 mg oral dose of nitrazepam were compared with those of a placebo in healthy young and old people. Both the young and the elderly slept better on three successive nights after nitrazepam but they felt less awake at 12 and 36 hours (P less than 0-01). Elderly people made significantly more mistakes in a psychomotor test than did the young, despite similar plasma concentrations of nitrazepam and half lives in the two groups. This difference in response to psychomotor testing is probably explained by an increased sensitivity of the ageing brain to the action of nitrazepam.

Adult↗