[People with intellectual disabilities (ID) in outpatient medical care: barriers to access and treatment process]. / Menschen mit geistiger Behinderung (MmgB) in der ambulanten medizinischen Versorgung: Barrieren beim Zugang und im Untersuchungsablauf.

BACKGROUND AND AIM: People with intellectual disabilities (ID) show an increased morbidity. Their access to healthcare could be a contributing factor, but there is little data on this in Germany. This paper addresses the question of what barriers and facilitators exist in the use of medical outpatient healthcare for people with ID, considering their own perspective and the perspectives of their accompanying relatives and their general practitioners (GPs). METHODS: In this cross-sectional study, people with ID in three sheltered workshops, their relatives and their GPs were interviewed by means of questionnaires. The data were evaluated descriptively, and a statistical comparison of the perspectives of the people with ID and their relatives was performed. The content structure follows Cantrell's pathway model (identifying need, accessing services and interaction during a consultation). RESULTS: People with ID communicate complaints to their relatives, who usually accompany them to medical appointments. There are more organisational than spatial barriers. The treatment is sometimes impeded by fears, restlessness or not allowing examinations. It is difficult to find experienced health professionals, which is why a list of such practices and, structurally, medical centres for people with ID would be beneficial. The views of people with ID and their relatives show hardly any differences. GPs cite increased treatment effort, desire for further training and appropriate remuneration. CONCLUSIONS: Relatives play an important role in the medical care of people with ID. Difficulties in care can arise from the specific, more complex requirements in treating people with ID, which present as organisational difficulties but also require an active readiness for inclusion.

[Health Care Use by Intellectually Disabled People: A Cross-Sectional Study in three Sheltered Workshops]. / Inanspruchnahme der gesundheitlichen Versorgung von Menschen mit geistiger Behinderung, eine Querschnittstudie in 3 Werkstätten.

STUDY OBJECTIVE: People with intellectual disabilities have a lower life expectancy and more frequent comorbidities than the general population and have unmet health needs. Insufficient medical care is suspected to be one reason, for which little data is available in Germany. The study therefore focuses on the question of how people with intellectual disabilities make use of medical care, including screening and preventive measures. METHOD: In a cross-sectional study in 3 workshops for people with intellectual disabilities, the use of health care was surveyed by means of questionnaires from their relatives. The evaluation was carried out descriptively and by means of inferential statistics comparing participants with the general population as well as within the group of participants for socio-demographic differences. RESULTS: Almost all 181 participants (participation rate 19.3%) had a family doctor. In comparison to the general population, the participants made more frequent use of the services of general practitioners and the care provided by numerous other specialist areas. They made less frequent use of screening for colon, breast, cervix and prostate and more frequent use for skin cancer and general check-up. Dental check-ups and preventive measures showed no difference. Participants living in institutional settings made more use of the regular services than those living with relatives or alone. Participants with a migration background were less aware of care services. CONCLUSIONS: The results do not show any indications of a general undersupply of health care. Participation in cancer screening with more complex examinations should be encouraged, especially for people with mental disabilities living alone or with relatives. Those with a migration background and their families should be specifically informed.

Factors predicting the probability of relapse after discontinuation of migraine preventive treatment with topiramate.

INTRODUCTION: Demographic and clinical variables were examined in a post hoc analysis of the PROlonged Migraine Prevention with Topiramate (PROMPT) study to determine potential contribution to relapse. METHODS: After a six-month open-label (OL) topiramate phase, patients were randomised to continue topiramate or switch to placebo in a six-month double-blind (DB) phase. 'Relapse' was investigated in terms of change in monthly migraine days after randomisation compared with the month before randomisation, and was analysed during the first ('initial relapse') and last month ('sustained relapse') of the DB phase. More than 40 potential predicting factors were entered into analyses of variance and covariance. RESULTS: For initial relapse, variable-by-treatment interactions were significant for the Headache Impact Test (HIT-6) at DB baseline, and decline in acute medication intake or reporting of 'anxiety' in the OL phase. For sustained relapse, no statistically significant interactions were observed. CONCLUSION: Relapse after topiramate discontinuation in migraine prophylaxis appears to be unaffected by patient characteristics or baseline migraine frequency.

Safety and efficacy of galantamine (Reminyl) in severe Alzheimer's disease (the SERAD study): a randomised, placebo-controlled, double-blind trial.

BACKGROUND: The efficacy of galantamine has been shown in patients with mild, moderate, and advanced moderate Alzheimer's disease (AD). Here we report its efficacy in patients with severe AD. METHODS: Between December, 2003, and March, 2007, patients aged 84 (SD 6) years with severe AD (mini-mental state examination [MMSE] score 5-12 points), in a nursing home setting were randomly assigned to receive galantamine (n=207), titrated initially to 24 mg/day, or placebo (n=200). Co-primary efficacy measures for cognitive function and ability to undertake normal daily activities were the severe impairment battery (SIB) and the seven-item minimum data set-activities of daily living (MDS-ADL), respectively. Adverse events, vital signs, laboratory parameters, and electrocardiograms were monitored. This trial is registered with ClinicalTrials.gov, number NCT00216593. FINDINGS: 168 of 207 (81%) patients in the galantamine group and 161 of 200 (81%) in the placebo group completed the study. Mean SIB scores increased (improved) by 1.9 (95% CI -0.1 to 3.9) points with galantamine and decreased (worsened) by 3.0 (-5.6 to -0.5) points with placebo (between-group least squares mean difference 4.36, 1.3 to 7.5; p=0.006). Mean MDS-ADL self-performance score worsened by 1.2 (0.6 to 1.8) points and 1.6 (0.8 to 2.3) points, respectively (between-group least squares mean difference -0.41, -1.3 to 0.5; p=0.383). Nominally significant between-group differences in favour of galantamine occurred for the SIB domains of memory (p=0.006), praxis (p=0.010), and visuospatial ability (p=0.002), and for the MDS-ADL subitem locomotion on unit (p=0.021). 183 of 207 patients (88%) who received galantamine and 177 of 200 (89%) who received placebo had adverse events, which were mostly mild to moderate. Eight patients (4%) in the galantamine group and 21 patients (11%) in the placebo group died. ECG abnormalities were similar between the two groups. INTERPRETATION: Galantamine can be started and used safely in elderly patients with severe AD. Galantamine improved cognitive function but failed to significantly improve the co-primary parameter of overall activities of daily living.

Optimal dosing of galantamine in patients with mild or moderate Alzheimer's disease: post Hoc analysis of a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Galantamine (hydrobromide), a reversible acetylcholinesterase inhibitor and allosteric nicotinic receptor modulator, slows cognitive and functional decline in mild to moderate dementia of the Alzheimer's type. Although several drugs are indicated for mild to moderate Alzheimer's disease (AD), no published study has separately analysed mild and moderate AD subgroups to assess the effect of dosage. OBJECTIVE: To compare the efficacy and safety of galantamine 16 and 24 mg/day in patient subgroups with mild or moderate AD. METHODS: This post hoc analysis (n = 838) of a 5-month, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of galantamine 16 and 24 mg/day in a subgroup of patients with mild AD (Mini-Mental State Examination [MMSE] >18) and a subgroup with moderate AD (MMSE 10-18). Efficacy outcomes included the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) score and treatment response (ADAS-cog maintenance [>or=0-point improvement], improvement >or=4 points and improvement >or=7 points). RESULTS: Mean ADAS-cog scores of patients with mild AD demonstrated significant improvement from baseline with galantamine 16 and 24 mg/day (p < 0.001 for both), whereas cognitive function did not change significantly for placebo recipients (p = 0.559). Patients with moderate AD improved with galantamine 24 mg/day (p = 0.009) but not with 16 mg/day (p = 0.768); a decline occurred with placebo (p < 0.001). A greater proportion of patients treated with galantamine 16 mg/day (76% and 52% for mild and moderate AD, respectively) or 24 mg/day (69% and 61%, respectively) demonstrated a treatment response (i.e. ADAS-cog was maintained or improved) relative to placebo (55% and 28%, respectively; p < 0.05). Patients with moderate AD trended toward greater response with the 24 mg/day dosage than with the 16 mg/day dosage. Galantamine was well tolerated. Adverse events were comparable for all study groups with mild or moderate AD. CONCLUSION: This post hoc analysis suggests that galantamine 16 mg/day is the optimal dosage for patients with mild AD, as similar efficacy is observed with the 24 mg/day dose. However, patients with moderate AD appear to gain additional benefit from galantamine 24 mg/day.

Treatment with galantamine and time to nursing home placement in Alzheimer's disease patients with and without cerebrovascular disease.

OBJECTIVE: This study evaluated patient and treatment (galantamine and other acetylcholinesterase inhibitors (AChEIs)) factors associated with the time until nursing home placement (NHP) in patients with Alzheimer's disease (AD) with and without cerebrovascular disease (CVD). METHODS: Re-contact follow-up study conducted in 2004 of 548 patients who had previously participated in RCTs with galantamine. Time to NHP was analyzed using Kaplan-Meier estimates and Cox regression analysed factors associated with NHP. RESULTS: There were 57% of female subjects and the mean age (SE) was 73.6 (+/-0.33) years. Within this cohort 78% of patients had AD, and 22% had AD with CVD. Overall, 59% of subjects had a NHP (median 42.4 months 95%CI: 38.0-48.0). The Cox regression model identified higher baseline Disability Assessment in Dementia (DAD) and Mini Mental State Examination (MMSE) scores, diagnosis (AD with CVD vs AD), living with caregiver, country, and treatment duration with galantamine or other AChEIs as factors associated with a reduced risk of institutionalization (p < 0.05). For each year of treatment with galantamine or other AChEI, the risk of being admitted to a nursing home within a given period was reduced by 31% (galantamine) and 29% (other AChEI). CONCLUSIONS: Long-term treatment with galantamine or other AChEIs appears to be associated with a significant delay in the time to NHP in patients with AD and AD with CVD. Further prospective studies are needed to confirm these findings.

Topiramate monotherapy in the treatment of newly or recently diagnosed epilepsy.

BACKGROUND: The efficacy of topiramate (TPM) as an adjunctive treatment for epilepsy has been established in placebo-controlled clinical trials. Clinical trials of antiepileptic monotherapy usually evaluate low and high doses of study drug or compare study drug with another active agent. OBJECTIVE: This article reviews available evidence for the use of TPM as monotherapy in patients with newly or recently diagnosed epilepsy. METHODS: A search of MEDLINE, EMBASE, BIOSIS, SCISEARCH, and the Cochrane Database of Systematic Reviews (all years) for reports of controlled trials of TPM monotherapy in patients with recently diagnosed (within the previous 3 years) epilepsy was conducted in January 2008 using the terms topiramate, epilepsy, newly diagnosed, recently diagnosed, and monotherapy. Identified trials were included in the review if they were published in peer-reviewed journals and enrolled > or = 20 patients. RESULTS: Three randomized, double-blind, controlled trials met the criteria for inclusion in the review. In a comparison of TPM 50 and 500 mg/d, the higher dose was associated with significantly greater freedom from seizures at 6 months compared with the lower dose (54% vs 39%, respectively; P = 0.02). The time to first seizure was significantly associated with mean plasma TPM concentrations (P = 0.015). In a comparison of TPM 50 and 400 mg/d, the time to first seizure was significantly longer with the higher dose compared with the lower dose (P<0.001, Kaplan-Meier analysis), and the probability of 12-month seizure freedom was significantly higher (76% vs 59%, respectively; P = 0.001). Again, the time to first seizure was significantly associated with mean plasma TPM concentrations (P = 0.029). In a comparative study of TPM 100 and 200 mg/d, carbamazepine 600 mg/d, and valproate 1250 mg/d, there was no significant difference in rates of 6-month seizure freedom with TPM 100 and 200 mg/d (49% and 44%, respectively), carbamazepine (44%), and valproate (44%). Adverse events in the 3 studies were similar between TPM dose groups, although the incidence generally increased with increasing doses, occurred early in treatment, and decreased with prolonged therapy. In a pooled analysis of the 3 trials, the most commonly occurring adverse events during dose titration were paresthesia (25%), fatigue (16%), dizziness (13%), somnolence (13%), and nausea (10%); the most frequent adverse events during maintenance therapy were headache (20%), decreased appetite (11%), and weight loss (11%). CONCLUSION: In the 3 studies reviewed, TPM monotherapy was effective and generally well tolerated in patients with newly diagnosed epilepsy.

[Alzheimer's disease: knowledge and attitudes in a representative survey]. / Sechs Fragen zur Alzheimer Demenz: Wissen und Einstellung in einer repräsentativen Bevölkerungsstichprobe.

Dementia is a prevalent syndrome in ageing societies and therefore of significant medical and social importance for the general population. We have studied knowledge and attitudes towards Alzheimer's dementia (AD) of 1245 epidemiologically representative individuals between 14 and 99 years. Only 13% mentioned memory disturbances, e.g. forgetfulness, as hallmarks of AD; 54% knew that age was a major risk factor; 47% felt that "brain-jogging" was therapeutically useful. In case of developing AD, more than 70% wished to be informed together with a close relative or friend; 7% felt that nobody else should know about their problem; and many more than 50% expected information on treatment, course, symptoms and causes. These results demonstrate, that there is a remarkable lack of relevant information on AD in the general population, and that most individuals wished to be informed about a potential diagnosis of AD together with their family and friends.

Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Use of preventive therapy for migraine is often recommended for only 6-9 months, but no randomised, placebo-controlled trials have investigated migraine frequency after the end of prophylaxis. We assessed the effects of discontinuation of topiramate after a treatment period of 6 months. METHODS: 818 patients who have migraines were enrolled from 88 clinics in 21 countries. After a 4-8-week lead-in period, patients received topiramate in a 26-week open-label phase. Daily dose was increased from 25 mg to 100 mg in steps of 25 mg every week; the dose could be adjusted further in the range 50-200 mg/day, but was stable for the final 4 weeks. Patients were randomly assigned to continue this dose or switch to placebo for a 26-week double-blind phase. The primary endpoint was the difference in number of days with migraine during the last 4 weeks of the double-blind phase compared with the last 4 weeks of the open-label phase. Analysis was by intention to treat. This trial is registered with EudraCT, number 2005-000321-29. FINDINGS: 559 patients (68.3%) completed the open-label phase; 514 entered the double-blind phase and were assigned to topiramate (n=255) or placebo (n=259). The mean increase in number of migraine days was greater in the placebo group (1.19 days in 4 weeks, 95% CI 0.71 to 1.66; p<0.0001) than in the topiramate group (0.10, -0.36 to 0.56; p=0.5756; mean difference between groups -1.09, -1.75 to -0.43; p=0.0011) [corrected] Patients in the placebo group had a greater number of days on acute medication than did those in the topiramate group (mean difference between groups -0.95, -1.49 to -0.41; p=0.0007). Quality of life, as assessed by the MIDAS questionnaire, fell in the placebo group but remained stable in the topiramate group. Patients were more satisfied with the efficacy of topiramate than with that of placebo, whereas satisfaction with tolerability was similar in both treatment groups. INTERPRETATION: Sustained benefit was reported after discontinuation of topiramate, although number of migraine days did increase. These findings suggest that patients should be treated for 6 months, with the option to continue to 12 months in some patients.

Early onset effects of galantamine treatment on attention in patients with Alzheimer's disease.

INTRODUCTION: Exploratory pilot studies and knowledge of its mode of action suggested that galantamine, a cholinesterase inhibitor and modulator of nicotinic receptors, can improve attention. This study was designed to test the effects of galantamine on attention in patients with mild-to-moderate Alzheimer's disease (AD) and to see how changes in attention affected their caregivers. METHODS: This was an open-label, multicentre study. Patients received galantamine (up to 24 mg/day) for 12 weeks. Attention was assessed after 1, 4, 8 and 12 weeks using computerized tests including Choice Reaction Time (CRT), and caregiver, physician and patient ratings. RESULTS: Data were available from 373 patients (mean age 75 years, mean baseline MMSE score 21). Attention as measured by CRT improved significantly from baseline to study endpoint (p < 0.001), improvements were observed after 1 week and statistical significance was maintained from 8 weeks. Physicians rated 67% of patients as globally improved and 5% as worsened. Caregivers reported improved attention in 57% of patients and worsening in 6%; 62% of patients considered they had improved and 3% considered themselves to be worse. Caregiver stress, time spent caring for patients and patients' interactions with others all improved from baseline to endpoint. Galantamine was generally well tolerated; the most common adverse events were gastrointestinal. CONCLUSION: Previous controlled trials have demonstrated that galantamine has a positive effect on cognition, activities of daily living, behaviour and global condition, but this is the first study to suggest that galantamine may specifically improve attention (according to both objective and subjective measures) in patients with AD. These effects may be a consequence of galantamine's potentiating action at nicotinic receptors.

Topiramate monotherapy as broad-spectrum antiepileptic drug in a naturalistic clinical setting.

Topiramate was assessed in an open-label trial as broad-spectrum antiepileptic monotherapy, independently from the epilepsy type or syndrome. Adults and children aged 2 years and older, who were diagnosed with epilepsy within the last 5 years, treatment-naive or failing prior treatment with one antiepileptic drug (AED), received individually adjusted doses of topiramate, after escalation to 100mg/day over 4 weeks (maximum 400mg/day) or 3mg/kg/day over 6 weeks (maximum 9 mg/kg/day), respectively. Patients were followed for >or=7 months and optionally up to a maximum of 13 months. Data were analysed for all patients (n=692), as well as for focal (n=421) and generalized epilepsies (n=148). The median topiramate dose used was 125 mg/day in adults and 3.3mg/kg/day in children (or=50% reduction in mean monthly seizure frequency. Patients with focal and generalized epilepsies alike responded to treatment (73.9 and 83.8% with at least 50% seizure reduction): 39.4% of patients with focal epilepsy and 61.5% of those with generalized epilepsy were seizure-free. The mean monthly seizure frequency was significantly reduced versus baseline at all visits (p<0.001). Similar response rates were obtained from the 237 patients completing the 1-year observation period. During the mandatory 7-month period of study, 8.8% of patients reported insufficient tolerability as a reason for dropout. The most frequent adverse event was paraesthesia. Our results support findings that emerge from controlled studies that topiramate is effective and well tolerated when used as initial or second monotherapy. They also suggest that in a naturalistic setting, overall good retention on treatment and seizure freedom are observed at low doses in a broad spectrum of epilepsies.

Driving ability under long-term treatment with transdermal fentanyl.

Clinical experience shows that neuropsychological side effects due to opioid therapy usually decrease during the first weeks of therapy. However, the effect of long-term treatment with transdermal fentanyl on complex activities, such as driving, is not yet clear. In a prospective trial, patients with continuous noncancer pain, who had received stable doses of transdermal fentanyl for at least 2 weeks, completed a series of computerized tests to measure attention, reaction, visual orientation, motor coordination and vigilance. Data from 90 healthy volunteers were matched to 30 patients; 9 patients were excluded from the per-protocol analysis because they took additional drugs in violation of the protocol. None of the performance measures for the 21 remaining fentanyl patients was significantly inferior to the controls. We conclude that stable doses of transdermal fentanyl for the treatment of chronic non-cancer pain are not associated with significant impairments in psychomotor and cognitive performance. The threshold for fitness to drive as defined by German law did not differ significantly between the groups.

Long-term treatment of patients with Alzheimer's disease in primary and secondary care: results from an international survey.

OBJECTIVE: The International Outcomes Survey in Dementia (IOSID) was initiated to observe the effects of current standard of care for Alzheimer's disease (AD) on patient outcomes and caregiver burden in a real-life setting. RESEARCH DESIGN AND METHODS: This 2-year, international, prospective, longitudinal and observational cohort survey involved patients with mild-to-moderate AD (Mini-Mental State Examination [MMSE] scores of 10-26 points) living in an ordinary household at baseline. There was no intervention with regard to patient management. Primary informal caregivers were also included in the survey. MAIN OUTCOME MEASURES: Patient parameters assessed included the MMSE, Disability Assessment for Dementia (DAD), Neuropsychiatric Inventory (NPI), and Clinical Global Impression (CGI). Caregiver burden was evaluated with the Zarit Burden Interview and caregiver distress was assessed as part of the NPI. Adverse events (AEs) were monitored. RESULTS: Of 2288 patients recruited, 1382 (60.4%) completed the survey. At baseline, the majority (79.3%) of patients were receiving treatment with acetylcholinesterase inhibitors (AChEIs) or/and memantine. MMSE, DAD, NPI and CGI scores all showed that patients experienced deterioration of AD symptoms during the survey. MMSE scores declined less steeply than might have been expected based on historical data. Scores on the four outcome scales were significantly correlated at all time points. Mean caregivers' feeling of strain and caregiver distress increased during the survey. AEs occurring in more than 2% of patients were nausea (3.0%), injury (2.6%), fall (2.4%), depression (2.2%) and urinary tract infection (2.2%). CONCLUSIONS: Community patients with AD experience progressive and interconnected decline in cognition, behaviour and functioning over time, placing increased burden on caregivers. However, improved care in recent years, including AChEI use, might be reflected in slower rates of patient decline than were evident in the past. Overall, relatively low rates of AEs were apparent during the survey. Limitations of this survey included a smaller than anticipated number of recruited patients confounding the possibility of performing comprehensive subgroup analyses, and the lack of randomisation inherent in the survey methodology.

Topiramate in patients with episodic migraine: reducing the risk for chronic forms of headache.

OBJECTIVE: The aim was to evaluate whether preventive treatment with topiramate in patients with episodic migraine reduces the risk of developing chronic forms of headache. BACKGROUND: Chronic forms of headache, including chronic migraine or medication overuse headache (MOH), are characterized by 15 or more headache days per month. Acute medication overuse has been shown to be a risk factor for developing chronic headache, but it is not known whether preventive treatment can reduce the risk of developing chronic forms of headache or the development of MOH. METHODS: Pooled data from 3 trials in patients with episodic migraine randomized either to treatment with 100 mg topiramate per day (n = 384) or with placebo (n = 372) were analyzed with regard to the number of headache days during a prospective 4-week baseline period and the individual final 4 weeks of each patient's treatment during the planned 26-week double-blind treatment period. RESULTS: The number of headache days per month in the topiramate versus the placebo-treated groups was 7.3 +/- 3.0 versus 7.3 +/- 3.1 during baseline and 4.1 +/- 4.2 versus 5.6 +/- 4.9 during the final 4 weeks, respectively (P < .001). At the end of the study, 8 versus 16 patients fulfilled International Headache Society criteria of chronic headache (odds ratio: 2.11, P= .082). Moreover, a significantly lower number of patients receiving topiramate treatment reported an increase in headache days per month by the end of the study when compared to placebo (66 vs 88 patients, respectively; odds ratio: 1.49, P < .05). Finally, the number of days with usage of acute medication was significantly lower in the topiramate arm compared with placebo (3.3 +/- 3.7 vs 4.3 +/- 3.6, respectively; P < .001). CONCLUSION: Preventive treatment with topiramate in patients with episodic migraine may reduce the risk of developing chronic forms of headache.

Long-term migraine prevention with topiramate: open-label extension of pivotal trials.

OBJECTIVE: To demonstrate that topiramate is an effective and generally well-tolerated migraine preventive therapy when used for up to 14 months. BACKGROUND: Topiramate 100 and 200 mg/d significantly reduced mean monthly migraine frequency during 2 large, 26-week, randomized, placebo-controlled trials. Only a small number of clinical trials have examined the long-term (> or =1 year) effectiveness and safety of migraine preventive therapies. METHODS: Five hundred sixty-seven patients with an established history of migraine with or without aura were enrolled in this 8-month, open-label extension of 2 large (49 US and 52 US and Canadian medical centers), randomized, double-blind, placebo-controlled, parallel group, 26-week trials of identical design. To be eligible for the open-label extension, patients were required to have either completed the double-blind phase of the 2 pivotal migraine prevention trials or withdrew after 4 weeks due to lack of efficacy. All eligible patients, regardless of type or dose of study medication (topiramate or placebo) received in the double-blind phase, were titrated to a clinically effective dose of open-label topiramate based on physician judgment of patient response. Efficacy of topiramate was measured as the change in mean monthly migraine frequency. RESULTS: The mean topiramate dose during the open-label extension phase was 124.7 mg/d and 150.3 mg/d for patients on placebo (n = 159) or topiramate (n = 408), respectively, during the double-blind phase (N = 567, 91% female, mean age 39.4 years). Patients on topiramate for up to 14 months had 2.2 +/- 2.4 (mean +/- SD) migraines per month after completion of the open-label extension phase (3.4 +/- 2.6 at double-blind endpoint). Patients on topiramate during the open-label extension phase only (placebo during the double-blind phase) had 3.0 +/- 2.9 migraines per month at open-label extension endpoint (4.9 +/- 3.0 migraines per month at double-blind endpoint). Discontinuation rates due to adverse events during the double-blind phase were 22.2% for patients on topiramate and 11.0% for patients on placebo. Discontinuation rates due to adverse events during the open-label extension phase were 8.6% for those patients who had already received topiramate during the double-blind phase and 20.9% for those patients who had previously received placebo. CONCLUSIONS: Patients receiving topiramate experienced a sustained reduction in migraine frequency for up to 14 months. The effectiveness and safety of topiramate was consistent with that observed during 2 26-week pivotal trials.

The Rapid Dementia Screening Test (RDST): a new economical tool for detecting possible patients with dementia.

The Rapid Dementia Screening Test (RDST) is a new psychometric screening tool to support the diagnosis of dementia. It includes two parts--a word generation task and a number transcoding task; it is short (taking approximately 3 min) and easy to administer, and it is well accepted by patients. After transformation of the raw scores in two age groups (under and over 60 years), the assessed cognitive abilities can be interpreted as age-appropriate or below average with good sensitivity and specificity, and subsequent diagnostic measures can be determined accordingly. The RDST is thus an economical tool for detecting demented patients by general practitioners.

Galantamine demonstrates efficacy and safety in elderly patients with Alzheimer disease.

Alzheimer disease (AD) treatment guidelines state that cholinergic agents are not cost-effective in patients with more severe disease. Because many physicians may deem an older patient unlikely to respond to treatment, older AD patients may remain untreated. Galantamine (Reminyl), a novel cholinergic agent, is effective in mild to moderate AD. This post hoc analysis of pooled phase III galantamine clinical trials was designed to assess whether older (> or =80 years) and younger (< or =79 years) AD patients experience similar benefits with galantamine based on changes in the ADAS-cog and CIBIC-plus. Mean ADAS-cog scores for older patients treated with galantamine 24 mg/day significantly improved versus baseline and versus placebo at month 3. Cognitive improvement was maintained versus placebo at month 6; the ADAS-cog score for placebo patients dropped below baseline at month 6. Change in CIBIC-plus for galantamine was significantly different from placebo at months 5 to 6. Mean ADAS-cog score in older patients taking galantamine for 12 months remained above baseline. The score for patients taking placebo for 6 months before switching to galantamine did not differ significantly from baseline at 12 months but was lower than in patients receiving galantamine for 12 months. Incidence of adverse events in patients > 80 years was similar to that in the overall study population. Galantamine maintained cognitive and global function in patients > 80 years with mild to moderate AD for at least 5 to 6 months and cognitive efficacy for 12 months. Prescribing approved therapies such as galantamine for older patients with AD is recommended.

Galantamine provides sustained benefits in patients with 'advanced moderate' Alzheimer's disease for at least 12 months.

Galantamine (Reminyl), a novel agent with a dual mode of action, modulates nicotinic acetylcholine receptors and inhibits acetylcholinesterase. Galantamine has consistently demonstrated a broad range of beneficial effects and has shown sustained benefits in cognitive and functional abilities for at least 12 months in patients with mild-to-moderate Alzheimer's disease (AD). As pivotal studies demonstrating the efficacy of cholinergic drugs were designed to exclude patients with severer AD, many patients with the advanced stage of this condition are currently not treated due to the lack of demonstrated efficacy in clinical trials. We aimed to investigate whether there was any evidence for the benefits of galantamine in patients with severer disease, by performing a post hoc analysis using data extracted from the population of the two long-term galantamine studies. We evaluated the efficacy of galantamine in patients with 'advanced moderate' AD. 'Advanced moderate' patients were those with baseline Mini Mental State Examination (MMSE) scores 30. These patients were compared with matched controls who received placebo in a different historical study. Cognitive abilities (assessed using the ADAS-cog scale) of 'advanced moderate' AD patients receiving galantamine for 12 months were maintained at baseline levels after 12 months, and significantly improved over those of placebo patients (p < 0.001). Of the 'advanced moderate' patients receiving galantamine, 51% with baseline ADAS-cog of >30 maintained or improved their ADAS-cog scores over baseline values, compared with 13% receiving placebo (p < 0.001). In the subgroup of 'advanced moderate' patients with baseline MMSE