Objective: This randomized, double-blind, placebo-controlled, dose-ranging phase 2 study explored safety, efficacy, and biomarker effects of ELND005 (an oral amyloid anti-aggregation agent) in mild to moderate Alzheimer disease (AD). Methods:A total of 353 patients were randomized to ELND005 (250, 1,000, or 2,000 mg) or placebo twice daily for 78 weeks. Coprimary endpoints were the Neuropsychological Test Battery (NTB) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. The primary analysis compared 250 mg (n ϭ 84) to placebo (n ϭ 82) after an imbalance of infections and deaths led to early discontinuation of the 2 higher dose groups. Results:The 250 mg dose demonstrated acceptable safety. The primary efficacy analysis at 78 weeks revealed no significant differences between the treatment groups on the NTB or ADCS-ADL. Brain ventricular volume showed a small but significant increase in the overall 250 mg group (p ϭ 0.049). At the 250 mg dose, scyllo-inositol concentrations increased in CSF and brain and CSF Ax-42 was decreased significantly compared to placebo (p ϭ 0.009). Conclusions:Primary clinical efficacy outcomes were not significant. The safety and CSF biomarker results will guide selection of the optimal dose for future studies, which will target earlier stages of AD.
BACKGROUND Oxaliplatin is a third‐generation platinum analog that is used to treat a variety of solid tumors, particularly colorectal carcinoma. Patients may develop hypersensitivity reactions, although this complication occurs infrequently. METHODS Three patients developed hypersensitivity reactions to oxaliplatin while undergoing treatment on a Phase I trial of oxaliplatin and capecitabine. An Entrez PUBMED search was performed to identify other cases. RESULTS Two patients experienced the abrupt onset of erythema alone or with pruritis during the 9th and 11th infusions of oxaliplatin, whereas the other patient developed fever and mild dyspnea a few hours after the 9th oxaliplatin infusion. All 3 patients were rechallenged successfully for at least 1 additional oxaliplatin infusion by using oral dexamethasone, 20 mg orally, 6 and 12 hours before the administration of oxaliplatin and by administering intravenously 125 mg of solumedrol, 50 mg of diphenhydramine, and 50 mg of cimetidine 30 minutes before oxaliplatin. The literature review suggests two distinct patterns of reactions: classic hypersensitivity (as experienced by the first two patients) and idiosyncratic reactions (as experienced by the third patient). CONCLUSIONS Patients who develop mild to moderate hypersensitivity to oxaliplatin may be pretreated with steroids and antagonists of Type 1 and 2 histamine receptors, whereas patients who develop severe reactions are unlikely to tolerate further therapy. Cancer 2003;97:2301–7. Published 2003 American Cancer Society. DOI 10.1002/cncr.11379
Objective: To evaluate the effectiveness of professionally applied fluoride varnish on the incidence of dental caries amongst older adults resident in LTCFs in Northern Ireland. Background:The oral health status of older adults within Long-Term Care Facilities (LTCFs) is significantly worse than their community living peers. Whilst evidence suggests an important role for fluoride varnish in preventing caries in this population, very few studies have evaluated this intervention. Materials and Methods: A quality improvement project was undertaken with dentate residents (n = 190) in nine LTCFs who had fluoride varnish applied by Dental Care Professionals on two separate occasions during a 12-month period (intervention group). Nine LTCFs were chosen as matched controls (control group) with comparable numbers of residents of similar medical status (n = 217). For the intervention group, oral hygiene training was also provided for the care home staff. Results: A total of 407 patients (n = 271 female) were included in the analyses (mean age [SD]: 84.1 [6.6] years). After 12 months, the intervention group recorded a significant reduction in mean number of carious teeth (mean [95% CI]: −0.85 [−1.12, −0.58]; P < .001). Patients in the control group had significant increases in the mean number of carious teeth (mean [95%
THIS study examines health visitors' dental health knowledge, their attitudes and their personal dental health and working behaviours. Eighty-four per cent of health visitors employed in 1991 by the Western Health and Social Services Board in Northern Ireland participated in this study. The results suggested that their knowledge of dental health was high but there was confusion over some topics. Similarly, their atti tudes appeared positive, but many of them admitted only to giving dental health education if they felt the mother would be receptive. Personal health be haviours were not closely associated with working behaviour. The study demonstrates that while health visitors have the necessary qualities to act as dental health educators there is still a need to facili tate and improve their knowledge and attitudes to enable them to be effective dental health educators.
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