Paliperidone extended-release: safety and tolerability from a metabolic profile perspective.

Pharmacologic management strategies for schizophrenia, a relatively common psychotic disorder, include the use of typical and atypical antipsychotic drugs. In general, typical (or conventional) antipsychotics have a proven track record in effectively managing the positive symptoms of schizophrenia but sometimes lack efficacy in treating negative symptoms. The conventional agents are also associated with adverse neurologic effects such as extrapyramidal symptoms (EPS). The development of atypical antipsychotics has partly ameliorated the issue of EPS induced by typical antipsychotics. However, several of these atypical antipsychotic agents have been associated with adverse metabolic effects, including weight gain, dyslipidemia, and increased serum glucose levels. Paliperidone (9-hydroxy-riperidone) extended-release (ER) is an atypical antipsychotic indicated for the treatment of schizophrenia which utilizes a patented oral osmotic system technology that provides constant drug delivery over the course of the day. The efficacy and safety of paliperidone ER in patients with schizophrenia have been established. This review focuses on the metabolic safety of paliperidone ER in patients with schizophrenia. Clinical trials have demonstrated a lack of significant change in lipid profiles with paliperidone ER; furthermore, reported incidences of glucose-related adverse events in clinical trials were very low and similar to those seen with placebo. While dose-related increases in bodyweight of 1-2 kg have been observed with paliperidone ER, there are few reports of clinically relevant increases in bodyweight during treatment. Placebo-controlled trials indicate that the risk of developing metabolic disorders with paliperidone ER is low and similar to that seen with placebo. Furthermore, the ER formulation of paliperidone may offer potential advantages over atypical antipsychotics such as risperidone, particularly with regard to side effects and compliance, but comparative studies are needed.

Variability in the diagnosis and management of patients with Alzheimer's disease and cerebrovascular disease: results from the GALATEA multicentre, observational study.

BACKGROUND AND OBJECTIVES: There is frequently a degree of variability among different types of dementia specialists in clinical practice in both the clinical diagnosis and the management of patients with Alzheimer's disease and cerebrovascular disease (CVD). This variability may have an adverse effect on the use of medical resources as well as on patients' well-being. The main objective of this study was to describe the current diagnosis and management of patients with Alzheimer's disease and CVD in Spain. Other objectives were to determine whether there were significant differences in the diagnosis and management of these patients depending on physician characteristics and/or patient profile. METHODS: This was an epidemiological, cross-sectional, multicentre study in which 107 physicians participated and recruited patients with Alzheimer's disease and CVD. During a 1-month period, physicians collected data on diagnosis, treatment, follow-up, adverse events and other characteristics of these patients. This study was performed under naturalistic conditions, and no restrictions were imposed on the physicians. RESULTS: Physicians were mainly neurologists (76%), geriatricians (14%) and psychiatrists (8%) with a median age of 42 years. A total of 720 patients with a diagnosis of Alzheimer's disease and CVD were recruited. The median age of the patients was 78 years. Almost all patients were diagnosed by neuroimaging (98%) together with medical history (87%). The existence of a previous stroke coincident with cognitive deterioration was used as a diagnostic method in only 27% of patients. Among non-pharmacological treatment measures, diet was the most frequently recommended (61%), followed by cognitive stimulation (50%) and physical exercise (44%). The most commonly used pharmacological treatments were galantamine (59%), donepezil (14%) and rivastigmine (11%). The incidence of adverse events was low (3%), and all were considered non-severe. There were no significant correlations between physician age or physician years of practice and the diagnostic method used. The diagnostic method most frequently used by psychiatrists (100%) and geriatricians (97%) was medical history whereas this method was not used as much by neurologists (85%) [p = 0.0150]. Neuroimaging methods were more frequently used by neurologists (99%) and geriatricians (96%) compared with psychiatrists (84%) [p < 0.0001]. Patients with attention disorders had a higher frequency of follow-up visits (p = 0.0145) and were treated less frequently with donepezil (p = 0.0118). CONCLUSIONS: Several possible areas of improvement in the management of patients with Alzheimer's disease and CVD were identified. These included better control of cardiovascular risk factors, such as hypertension and hyperlipidaemia, which have a high prevalence in this population, as has been shown in the present study. These potentially modifiable risk factors may assist in the prevention of Alzheimer's disease. Also identified was the need to emphasize the role of general practitioners in decreasing the time to diagnosis of Alzheimer's disease. Development of well designed clinical practice guidelines may help physicians decide on the most appropriate ways of diagnosing and managing patients with Alzheimer's disease and CVD and reduce practice variations between different medical specialities.