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Biomedical subjects

K Campion

Publications and source records attributed to K Campion.

13 recordsLinked to original sources

Zanamivir for the treatment of influenza A and B infection in high-risk patients: a pooled analysis of randomized controlled trials.

BACKGROUND: Influenza can cause significant morbidity and mortality, particularly in patients considered to be at high risk (such as the elderly and those with chronic disease) of developing influenza-related complications. Data on the efficacy of zanamivir in high-risk patients are lacking because individual studies recruited a limited number of these patients. METHODS: A retrospective pooled analysis of data from high-risk patients in studies completed before or during the 1998-1999 winter season was performed to investigate the efficacy and safety of inhaled zanamivir (10 mg twice daily for 5 days) for the treatment of confirmed influenza. All studies were randomized, double-blind, and placebo-controlled with 21- to 28-day follow-up. A total of 2751 patients was recruited. Of these, 321 (12%) were considered high risk and 154 were randomized to zanamivir. The median time to alleviation of influenza symptoms and time to return to normal activities were the main outcome measures. RESULTS: Zanamivir-treated high-risk patients had a treatment benefit of 2.5 days compared with those given placebo (P = .015). Patients treated with zanamivir returned to normal activities 3.0 days earlier (P = .022) and had an 11% reduction (P = .039) in the median total symptom score over 1 to 5 days relative to those taking placebo. In addition, zanamivir reduced the incidence of complications requiring antibiotic use by 43% relative to placebo users (P = .045). Adverse events reported were of a similar nature and frequency between the two groups. CONCLUSION: This pooled analysis shows that zanamivir is an effective and well-tolerated treatment for influenza in patients considered at high-risk of developing influenza-related complications.

Administration, Inhalation↗

Effectiveness and role of zanamivir in the treatment of influenza infection.

Influenza is a worldwide public health issue. The virus circulates annually in winter and can cause significant morbidity in the general population and increased mortality rates in those who are more susceptible to complications if infected by the virus, especially the elderly. Although antivirals to treat and prevent influenza have been available in several countries for up to 30 years, annual influenza vaccination strategies remain the primary focus in reducing the burden of illness caused by this viral infection. Zanamivir is the first of a new class of compounds to offer significant advantages over existing influenza treatments. It is a potent and specific competitive inhibitor of both influenza A and B virus neuraminidase. The drug is administered topically by inhalation directly to the site of virus replication in a dose of 10 mg twice daily for 5 days. In both experimental and naturally acquired treatment studies, zanamivir has been shown to have efficacy against both influenza A and B virus and to be well tolerated. Significant treatment benefits resulting in reductions in illness of up to 2.5 days have been demonstrated in both the general population and in patients considered at high risk. In addition, patients receiving zanamivir have been able to return to normal activities significantly faster.

Adult↗

Multiple sclerosis.

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Disease Progression↗

The PACE pilot study: 12-month results and implications for future primary prevention trials in the elderly. (Prevention with low-dose Aspirin of Cardiovascular disease in the Elderly)

OBJECTIVE: To document compliance with medication, drop-out and drop-in rates, and baseline cardiovascular event rates during the pilot phase of the PACE (Prevention with low-dose Aspirin of Cardiovascular disease in the Elderly) study. DESIGN: Randomized, double-blind, placebo-controlled trial of low-dose aspirin therapy. SETTING: Community-based, in general practices and residential retirement villages, in Victoria, Australia. SUBJECTS: Four hundred persons aged 70 years and older (53% females), ambulatory and living independently, who volunteered to participate. None had significant vascular disease, peptic ulceration, hemorrhagic symptoms, or were currently taking non-steroidal anti-inflammatory drugs. MAIN OUTCOME MEASURES: Compliance with medication (assessed by pill count and platelet function tests), self-reported drop-out and drop-in rates, and incidence of cardiovascular events reported by participants and their general practitioners during a 12-month period. RESULTS: Two fatal cardiovascular events, three non-fatal coronary events, and eight non-fatal cerebrovascular events were observed during the 12-month period. These incidence figures were approximately 15%, 15%, and 40%, respectively, of those in the general population of the same age and sex, based on morbidity data available from the Australian Bureau of Statistics. Compliance to medication was excellent (87%), and premature withdrawal (other than for a study end point) was limited to 14.5%. Secondary 'softer' endpoints, such as transient ischaemic attack and unstable angina, necessitated patient withdrawal from randomized therapy and possibly contributed to the small number of primary 'hard' end points observed. The projected power of the main study to detect a 20% treatment effect on overall cardiovascular mortality in 15,000 subjects over a 4-year period may, therefore, be substantially reduced. CONCLUSIONS: These results suggest that any future primary prevention study of cardiovascular disease in the elderly examining the effect of low-dose aspirin on overall cardiovascular mortality will likely need to use much larger numbers of patients or use a combined end point of fatal and non-fatal ischemic events.

Aged↗

Adverse effects of low-dose aspirin in a healthy elderly population.

The adverse effects of low-dose aspirin (100 mg daily) in the elderly were studied over a 12-month period in a double-blind, randomized, placebo-controlled trial of 400 subjects who were 70 years of age or older and had no preexisting major vascular diseases at the time of entry. Subjects were randomized so that 200 subjects received low-dose enteric-coated aspirin (100 mg daily) and 200 subjects received placebo. Compliance with medication, assessed by pill count, was 86%. Gastrointestinal symptoms were reported by 18% (n = 36) of participants receiving aspirin and 13% (n = 26) of those receiving placebo. Clinically evident gastrointestinal bleeding occurred in 3% (n = 6) of subjects receiving aspirin and none receiving placebo. Aspirin-treated subjects had a significant decrease in mean hemoglobin levels of 0.33 gm/dl during the 12-month study period, which was significantly greater than the decrease in the placebo-treated group (0.11 gm/dl; p < 0.05). These rates of unwanted symptoms are comparable with previous studies that used higher doses of aspirin. Until the risk-benefit trade-off from the use of low-dose aspirin in the elderly is established with an appropriate clinical trial, caution should be exercised when this compound is used for primary prevention of cardiovascular disease in this age group.

Aged↗

Haematological profile of healthy elderly Australians.

OBJECTIVE: To determine normal values for haematological parameters in healthy elderly persons, and document any changes in these over a 12 month period. DESIGN: The study was conducted as part of a randomised controlled trial of low-dose aspirin for primary prevention of cardiovascular disease in the elderly. All participants (380) had a full blood examination performed at entry, which was repeated after 12 months. The baseline results for all patients and the 12 month findings in a cohort of 162 persons allocated placebo were used in the present study. SETTING: Community-based (general practices and residential retirement villages). SUBJECTS: Persons aged 70 years and over (53% females) who were ambulatory, living independently, and volunteered to participate. None had significant vascular disease, peptic ulceration, haemorrhagic symptoms or were currently taking non-steroidal anti-inflammatory drugs. MAIN OUTCOME MEASURES: Full blood examination (excluding white cell differential counts) performed with a Technicon H1 analyser. RESULTS: The mean haemoglobin level +/- standard deviation (SD) was 14.69 +/- 1.10 g/dL (for men) and 13.72 +/- 1.05 g/dL (for women). Significant differences (P less than 0.001) in packed cell volume, red cell and platelet counts were observed between the two sexes. No clinically significant change was observed in any of the parameters over a 12 month period. CONCLUSIONS: Haematological reference values for healthy elderly Australians are consistent with normal values reported in younger populations for both sexes. As a result recommendations are provided for normal reference values among this group in an Australian setting.

Aged↗

Questionnaire development: an examination of the Nordic Musculoskeletal questionnaire.

This paper describes the outcome of user trials of the Nordic Musculoskeletal Questionnaire which encompassed the views of the following groups: data entry clerks, technical staff, administrative clerks and 481 subjects employed in 10 supermarkets. A significant number of improvements was identified, especially concerning its wording, layout and administration. This has led to a standardized version being produced for use in studying the prevalence of reported symptoms in many types of occupational groups.

Journal Article↗

Comparison of recruitment strategies for a large-scale clinical trial in the elderly.

Formal evaluation of recruitment strategies for clinical trials conducted in the community setting, rather than in hospitals, is limited despite recruitment rates and costs having significant implications for the planning of large trials. As part of the development of a large-scale primary prevention trial of low-dose aspirin in 15,000 elderly persons (aged 70 years and above) to be undertaken in a community setting, a pilot study involving 400 participants was carried out to evaluate different recruitment strategies. Three techniques were compared: recruiting from the electoral roll (by individual invitation using direct mail), local community approach (through retirement villages, local media, elderly community groups), and using general/family practice (identifying persons over 70 within a practice and direct mail invitation to participate). Screening of potential participants was carried out by a trained trial nurse with limited involvement only of medical practitioners. The target recruitment figure was achieved in 4 months using the equivalent of 1.5 full-time nurses. General practice was the most effective method utilized, with a yield of one participant recruited per six approached at an estimated cost of A$48.36 per recruited participant. This compares with yield rates of 1 per 29 (for the local community approach) and 1 per 17 for the electoral roll, and costs per participant of A$42.54 and A$59.37 respectively. Other less tangible benefits of general practice include the greater cooperation of primary care practitioners in patient follow-up and end-point ascertainment.

Aged↗