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Biomedical subjects

Michael Woodward

Publications and source records attributed to Michael Woodward.

6 recordsLinked to original sources
PubMed2006

A naturalistic study of galantamine for Alzheimer's disease.

OBJECTIVE: To collect descriptive data on the treatment of Alzheimer's disease with galantamine under naturalistic conditions. STUDY DESIGN: This was a prospective, open-label, observational study. PATIENTS: Subjects (n = 345) with mild to moderately severe dementia of the Alzheimer's type were recruited from 48 hospitals in Australia. METHODS: Subjects were enrolled and received treatment with galantamine for 6 months in a clinical practice setting. Subjects were assessed at baseline and 3 and 6 months after starting treatment using the Mini-Mental State Examination (MMSE), the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus) and the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) [the latter only if the baseline MMSE score was at least 25]. Subjects were also assessed using an abridged Instrumental Activities of Daily Living (IADL) questionnaire that included questions on using the telephone, ability to travel more than 1km outside the home, taking medications and managing money, and an 11-item behaviour assessment scale that measured aggression, sleep disturbance, disinhibition, personality changes, irritability, depression, agitation, apathy, inertia, hallucinations and aberrant motor behaviour. RESULTS: Of the 345 subjects who were enrolled in the study (intent-to-treat [ITT] population), 229 completed the baseline, 3- and 6-month visits (per-protocol [PP] population). The mean age of the PP population was 78.0 +/- 6.8 years. At 6 months, most PP subjects (70%) showed an increase in MMSE score compared with baseline, with a mean increase in score of 2.0 +/- 3.1 points from a baseline of 20.8 +/- 4.2 points. In the ITT population, 44% of subjects (151/345) showed an increase in MMSE after 6 months. If data were unavailable the patient was classified as a nonresponder. Of the 21 PP patients who were assessed using ADAS-cog, 18 (86%) demonstrated a decrease in the ADAS-cog score, reflecting an improvement in cognition. Of the ITT population, 33% (19/57) had a decreased ADAS-cog score after 6 months. Most PP subjects (86%) were considered responders according to the CIBIC-plus score, with 65% showing some improvement over 6 months of treatment. Of the ITT population, 54% (187/345) showed no deterioration in CIBIC-plus score after 6 months.No deterioration in IADL or behaviour assessments occurred in the majority of PP subjects over 6 months. CONCLUSIONS: In a clinical practice setting, the majority of subjects receiving galantamine who completed the study maintained their ratings of cognition, function, behaviour or global assessment over the 6-month period.

Activities of Daily Living↗
PubMed2005

Risperidone for psychosis of Alzheimer's disease and mixed dementia: results of a double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of low-dose risperidone in treating psychosis of Alzheimer's disease (AD) and mixed dementia (MD) in a subset of nursing-home residents who had dementia and aggression and who were participating in a randomized placebo-controlled trial of risperidone for aggression. METHOD: This post-hoc analysis included only patients diagnosed with AD or MD with psychosis, defined by a score of >or= 2 on any item of the Behavioral Pathology of Alzheimer's Disease (BEHAVE-AD) psychosis subscale at both screening and baseline. Co-primary efficacy endpoints were changes in scores on BEHAVE-AD psychosis subscale and Clinical Global Impression of Change (CGI-C). RESULTS: Overall, 93 patients (46 risperidone and 47 placebo) fulfilled the psychosis of AD criteria. Mean change at endpoint in BEHAVE-AD psychosis subscale with risperidone was superior to placebo (-5.2 vs -3.3; p = 0.039). Distribution of CGI-C at endpoint also favoured risperidone (p < 0.001). The superior improvement with risperidone compared with placebo occurred as early as the first two weeks and persisted to the end of the treatment period. At endpoint, 59% of risperidone-treated patients were responders (i.e. were 'very much' or 'much' improved) compared with 26% of patients receiving placebo. The mean risperidone dose was 1.03 +/- 0.61 mg/day. Twelve weeks of treatment were completed by 37 patients treated with risperidone (80%) and 35 with placebo (74%). A total of 46 (98%) placebo- and 44 (96%) risperidone-treated patients experienced at least one adverse event, with only somnolence occurring more frequently in the risperidone group. CONCLUSION: Risperidone effectively reduces psychosis and improves global functioning in elderly patients with moderate-to-severe psychosis of AD and MD.

Aged↗
PubMed2005

Medication management at home: medication-related risk factors associated with poor health outcomes.

BACKGROUND: Some patients may have medication-related risk factors only identified by home visits, but the extent to which those risk factors are associated with poor health outcomes remains unclear. OBJECTIVE: To determine the association between medication-related risk factors and poor patient health outcomes from observations in the patients' homes. DESIGN: Cross-sectional study. SETTING: Patients' homes. SUBJECTS: 204 general practice patients living in their own homes and at risk of medication-related poor health outcomes. METHODS: Medications and medication-related risk factors were identified in the patients' homes by community pharmacists and general practitioners (GPs). The medication-related risk factors were examined as determinants of patients' self-reported health related quality of life (SF-36) and their medication use, as well as physicians' impression of patient adverse drug events and health status. RESULTS: Key medication-related risk factors associated with poor health outcomes included: Lack of any medication administration routine, therapeutic duplication, hoarding, confusion between generic and trade names, multiple prescribers, discontinued medication repeats retained and multiple storage locations. Older age and female gender were associated with some poorer health outcomes. In addition, expired medication and poor adherence were also associated with poor health outcomes, however, not independently. CONCLUSION: The findings support the theory that polypharmacy and medication-related risk factors as a result of polypharmacy are correlated to poor health outcomes.

Adult↗
PubMed2004

Medication reviews in the community: results of a randomized, controlled effectiveness trial.

AIMS: To examine the effectiveness of a multidisciplinary service model delivering medication review to patients at risk of medication misadventure in the community. METHODS: The study was carried out in three Australian states; Queensland, New South Wales and Western Australia, and conducted as a randomized, controlled effectiveness trial with the general practitioner (GP) as the unit of randomization. In total, 92 GPs, 53 pharmacists and 400 patients enrolled in the study. The multidisciplinary service model consisted of GP education, patient home visits, pharmacist medication reviews, primary healthcare team conferences, GP implementation of action plans in consultation with patients, and follow-up surgery visits for monitoring. Effectiveness was assessed using the four clinical value compass domains of (i) functional status, (ii) clinical outcomes, (iii) satisfaction and (iv) costs. The domains of functional status (assessed by the health-related quality of life measure SF-36 subscales) and clinical outcomes (as assessed by adverse drug events (ADEs), number of GP visits, hospital services and severity of illness) were measured at baseline and endpoint. Satisfaction was measured by success in implementation and by participant satisfaction at endpoint, and costs (as assessed using medication and healthcare service costs, less intervention costs) were measured preintervention and during the trial. In addition, process evaluation was conducted for intervention patients, in which problems and recommendations from the medication reviews were described. RESULTS: The model was successfully implemented with 92% of intervention GPs suggesting that the model had improved the care of participating patients, a view shared by 94% of pharmacists. In addition, positive trends in clinical outcomes (ADEs and severity of illness) and costs (an ongoing trend towards reduction in healthcare service costs) were evident, although the trial was limited to a 6-month intervention time. No differences between intervention and control groups were identified for the health-related quality of life domain. The cost-effectiveness ratio for the intervention based on cost savings, reduced adverse events and improved health outcomes was small. The most common problems identified in the medication reviews were potential adverse drug reactions, suboptimal monitoring and adherence/lack of concordance issues. In total, 54.4% of recommendations were enacted, and 23.9% were implemented precisely as recommended in the medication review. Follow-up evaluation showed that 70.9% of actions had a positive outcome, 15.7% no effect and 3.7% had a negative outcome. CONCLUSIONS: Most studies emphasize efficacy and the best achievable clinical outcomes rather than whether an intervention will be effective in practice. The current trial showed that three of the four domains in the clinical value compass showed trends of improvement or were indeed improved in the relatively short follow-up period of the trial, suggesting that a service based on this model could achieve similar benefits in practice. A domiciliary medication review programme similar to this model has now been implemented into national Australian practice, where GPs and pharmacists are reimbursed by the Australian government for the provision of these services.

Adult↗
PubMed2003

A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia.

BACKGROUND: This randomized, double-blind, placebo-controlled trial examined the efficacy and safety of risperidone in the treatment of aggression, agitation, and psychosis in elderly nursing-home patients with dementia. METHOD: Elderly patients with a DSM-IV diagnosis of dementia of the Alzheimer's type, vascular dementia, or a combination of the 2 (i.e., mixed dementia) and significant aggressive behaviors were randomized to receive, for a period of 12 weeks, a flexible dose of either placebo or risperidone solution up to a maximum of 2 mg/day. Outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI), the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) rating scale, and the Clinical Global Impression of Severity (CGI-S) and of Change (CGI-C) scales. RESULTS: A total of 345 patients were randomized to treatment with risperidone or placebo, and 337 patients received at least one dose of study drug. The trial was completed by 67% of patients in the placebo group and 73% of patients in the risperidone group. The mean +/- SE dose of risperidone was 0.95 +/- 0.03 mg/day. The primary endpoint of the study, the difference from baseline to endpoint in CMAI total aggression score, showed a significant reduction in aggressive behavior for risperidone versus placebo (p <.001). A similar improvement was also seen for the CMAI total non-aggression subscale (p <.002) and for the BEHAVE-AD total (p <.001) and psychotic symptoms subscale (p =.004). At endpoint, the CGI-S and the CGI-C scores indicated a significantly greater improvement with risperidone compared with placebo (p <.001). Overall, 94% and 92% of the risperidone and placebo groups, respectively, reported at least 1 adverse event. Somnolence and urinary tract infection were more common with risperidone treatment, whereas agitation was more common with placebo. There was no significant difference in the number of patients who reported extrapyramidal symptoms between the risperidone (23%) and placebo (16%) groups. CONCLUSION: Treatment with low-dose (mean = 0.95 mg/day) risperidone resulted in significant improvement in aggression, agitation, and psychosis associated with dementia.

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