| 1. |
- López-Fauqued, M., et al.
(författare)
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Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials
- 2019
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Ingår i: Vaccine. - : Elsevier Ltd. - 0264-410X .- 1873-2518. ; 37:18, s. 2482-2493
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Tidskriftsartikel (refereegranskat)abstract
- Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV. © 2019 GlaxoSmithKline Biologicals SA
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| 2. |
- Halling, A, et al.
(författare)
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Comparison between the Klemetti index and heel DXA BMD measurements in the diagnosis of reduced skeletal bone mineral density in the elderly
- 2005
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Ingår i: Osteoporosis International. - : Springer Science and Business Media LLC. - 1433-2965 .- 0937-941X. ; 16:8, s. 999-1003
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Tidskriftsartikel (refereegranskat)abstract
- Osteopenia/osteoporosis affect many elderly people and might not be detected until symptoms of fractures occur. Early detection of osteopenia/osteoporosis is important and would allow preventive measures and treatment. Access to screening for osteopenia/osteoporosis is often limited, whereas panoramic radiography is commonly used in dentistry. The aim of this study was to determine the validity of the Klemetti index (KI), measured on panoramic radiographs, in the diagnosis of osteopenia/osteoporosis as defined by a bone mineral density (BMD) measurement below) 1.5 standard deviations (SDs) of a community based sample. In total, 211 consecutive participants ( 102 men and 109 women) 60 - 96 years in the SNAC-Blekinge study ( Swedish National Study on Ageing and Care) underwent bone densitometry [ by dual-energy X-ray absorptiometry (DXA)] of both heels. A panoramic radiograph was taken of each participant, and mandibular cortex on a panoramic radiograph was classified as '0' or normal ( even and sharp endosteal margin), '1', moderately eroded ( evidence of lacunar resorption or endosteal cortical residues), or '2', severely eroded ( unequivocal porosity). From logistic regression, the odds ratio of having a BMD measurement below -1.5 SD was 8.04 (95% CI 2.39 to 27.12, P< 0.001) in the 'osteopenic' (KI category 2), compared with the 'normal' group ( KI categories 0 and 1). Receiver operating characteristic (ROC) curve analysis was used to measure the validity of the KI indicating osteopenia ( KI category 2) in predicting reduced BMD. This point provided a sensitivity of 50% and a specificity of 89%. Positive and negative predictive values were 21% and 97%, respectively. There were 87% correctly classified subjects. The area under the ROC curve was 0.64. The present study demonstrated that a negative finding ( KI category < 2) is highly predictive of the absence of osteopenia/osteoporosis as defined by the DXA measurements.
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| 3. |
- Lagergren, M., et al.
(författare)
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A longitudinal study integrating population, care and social services data : The Swedish National study on Aging and Care (SNAC)
- 2004
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Ingår i: Aging Clinical and Experimental Research. - Milano : Kurtis. - 1594-0667 .- 1720-8319. ; 16:2, s. 158-168
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Tidskriftsartikel (refereegranskat)abstract
- Background and aims: A large, national, long-term, longitudinal, multi-purpose study has been launched in Sweden - the Swedish National study on Aging and Care (SNAC). The study involves four research centers collecting data in four different areas of Sweden.Methods: The study consists of two parts: the population part and the care and services part. In the population part, a large, representative panel of elders in different age cohorts is followed over time to record and describe the aging process from different aspects. In the care and services part, a systematic, longitudinal, individually-based collection of data is performed concerning provision of care and services together with functional ability, specific health care problems, and living conditions of the recipients living in the area.Resuits: The data collection in the population part of the SNAC is not yet completed. In the present article, some preliminary results are reported from the care and services part. These pertain to comparisons between the participating areas with respect to the prevalence of disability among those receiving care and social services in their ordinary homes and those receiving care in special accommodation. A comparison is also presented with regard to the amount of home help provided to subjects with a given disability.Conclusions: This project has several advantages. It is expected to generate a rich data base relevant for future research on aging and care and to have a direct impact on the future Swedish system of care and services for the elderly.
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| 4. |
- Wimo, Anders, et al.
(författare)
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Formal and informal care of community-living older people : A population-based study from the swedish national study on aging and care
- 2017
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Ingår i: The Journal of Nutrition, Health & Aging. - : SPRINGER FRANCE. - 1279-7707 .- 1760-4788. ; 21:1, s. 17-24
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Study formal and informal care of community-living older people in the Swedish National study of Aging and Care (SNAC). Design: Cross-sectional, population based cohort. Setting: Three areas in Sweden: Municipality of Nordanstig, Stockholm and Skane County. Participants: 3,338 persons >= 72 years. Measurements: Patterns and amounts of informal and formal care by cognition and area of residence. Results: 73% received no care; 14% formal care; and 17% informal care (7% received both). In the whole study population, including those who used no care, individuals in small municipalities received 9.6 hours of informal care/month; in mid-size municipalities, 6.6; and in urban areas, 5.6. Users of informal care received 33.1 hours of informal care/month in small municipalities, 54.6 in mid-size municipalities and 36.1 in urban areas. Individuals with cognitive impairment received 14.1 hours of informal care/month, 2.7 times more than people with no/slight impairment. In the whole study population, individuals in small municipalities received an average of 3.2 hours of formal care/month; in mid-size municipalities 1.4; and in urban areas, 2.6. Corresponding figures for formal care users were 29.4 hours in small municipalities, 13.6 in mid-size municipalities and 16.7 in urban areas. Formal care users received 7.1 hours, and informal care users, 5.9 hours for each hour/month received by people in the study population as a whole. Conclusions: More informal than formal care was provided. Informal care is more frequent in small municipalities than urban areas and for those with than without cognitive impairment. The relationship between data on the whole population and the data on users or care indicates that population-based data are needed to avoid overestimates of care.
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