Browsing by Subject "safety"

Now showing 1 - 3 of 3
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    Open Access
    Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma
    (BioMed Central Ltd, 2011) Woodcock, Ashley; Bleecker, Eugene R; Busse, William W; Lotvall, Jan; Snowise, Neil G; Frith, Lucy; Jacques, Loretta; Haumann, Brett; Bateman, Eric D
    BACKGROUND: Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD) evening and twice-daily (BD) regimens of the novel inhaled corticosteroid fluticasone furoate (FF) in asthma patients. METHODS: Patients with moderate asthma (age [greater than or equal to] 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibility of [greater than or equal to] 12% and [greater than or equal to] 200 ml) were randomized to FF or fluticasone propionate (FP) regimens in a double-blind, crossover study. Patients were not permitted to have used any ICS for [greater than or equal to] 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 mug OD, FF or FP 100 mug BD and matching placebo by inhalation for 28 days each. Primary endpoint was Day 28 evening pre-dose (trough) FEV1; non-inferiority of FF 200 mug OD and FF 100 mug BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs) and 24-hour urinary cortisol excretion were assessed. RESULTS: The intent-to-treat population comprised 147 (FF) and 43 (FP) patients. On Day 28, pre-dose FEV1 showed FF 200 mug OD to be non-inferior (pre-defined limit -110 ml) to FF 100 mug BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml); all FF and FP regimens were significantly superior to placebo (p [less than or equal to] 0.02). AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 mug OD, 0.75; 100 mug BD, 0.84; p [less than or equal to] 0.02). CONCLUSIONS: FF 200 mug OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose.TRIAL REGISTRATION:Clinicaltrials.gov; NCT00766090.
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    Statin therapy for the octogenarian?
    (2012) Blom, D J
    Cardiovascular risk increases progressively with age. Statins in octogenarians may therefore potentially bring about large reductions in absolute risk. Epidemiological studies, however, show that statin prescription declines with age and is lowest in the oldest patients with the highest cardiovascular risk. Reasons for low statin utilisation in the elderly include safety concerns, doubts about the utility of statin therapy in those of advanced age and a paucity of definite trial evidence supporting statin prescription in octogenarians. Some of the more recently completed statin outcome trials have randomised patients as old as 82 years. A meta-analysis of secondary prevention, with patients aged 65–82 years at randomisation, supported statin prescription in this age group, as statin therapy was associated with relative risk reduction similar to that observed in younger patients. A Swedish registry study showed improved survival in octogenarians prescribed a statin following hospitalisation with an acute myocardial infarction. Currently there is no definite evidence that statin therapy prevents or ameliorates cognitive impairment or dementia. Statin therapy should be considered in octogenarians at high cardiovascular risk, taking into account factors such as biological vs. chronological age, life expectancy, quality of life, risk of interaction with medications taken for co-morbidities and the ability of the patient to take the statin safely.
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    Understanding Railway Trespassing in a South African City: The Case Of Cape Town
    (2020) Williams, Faizel; Vanderschuren, Marianne
    Trespassing behaviour is a problem for railway operations and manifests itself through train-pedestrian collisions, incidents of theft and vandalism to rail infrastructure, as well as encroachment on railway property. The study has consisted of a quantitative and a qualitative part. The quantitative part analyses demographic, temporal and spatial data on train-pedestrian fatalities and injuries, as well as data on occurrences of theft and malicious damage to rail infrastructure in the Cape Town Functional Region between 2015 and 2018. The qualitative part presents the perspective from a diverse group of subject matter experts, having explored opinions on trespassing behaviours and preventative measures. Additionally, the trespassing behaviour at several sites was investigated and a case study evaluation of the efficacy of a pilot Rail Enforcement Unit was carried out. There were 456 railway-related deaths during the study period with 330 of this being train-pedestrian collisions. There were 4715 occurrences of theft and malicious damage to railway assets over the period. Several hot-spot areas were identified via the data and interviews with experts and several sites chosen for further verification. Site visits confirmed widespread trespassing behaviours with the two worst locations recording an average of over 300 persons in a 15-minute period. The case study reviewing the effectiveness of the security and enforcement countermeasure revealed that occurrences of train-pedestrian incidents, as well as security occurrences have increased by 1.4% and 7.5% respectively. Evidence of geographical displacement of crime is evident, suggesting that enforcement countermeasures are temporarily effective and need to be considered in combination with other measures to ensure its durability. In conclusion, this research presents a detailed analysis of railway trespassing and its main effects in order to understand the problem locally. Different approaches are required to combat the various guises of railway trespassing. Certain countermeasures may well be within the rail operator's remit, but essentially, the nature of problems experienced by the rail operator is beyond a rail problem, and requires a systems approach involving multiple authorities