摘要:

In the US and New Zealand, the past decade has seen tremendous growth in the marketing of prescription drugs directly to patients. The pharmaceutical industry has applied pressure in other countries to relax regulations governing such marketing although this has not yet been successful. While we still have much to learn about the potential impact on the public’s health of direct-to-consumer (DTC) marketing, some data are available.This article summarises the current literature on the benefits and risks of DTC marketing. This marketing strategy has grown substantially in the US, but only select drugs are advertised. Whether there is net benefit or harm to the public’s health as a result of DTC marketing depends critically on which drugs are advertised and the quality of the information provided in promotional material. Critical reviews of this promotional material suggest the information is of poor quality. Notably, 18% of the 50 drugs advertised most intensively in the US were medications used to treat psychiatric and neurological disorders. The impairments in decisional capacity often seen in psychiatric and neurological illness leave patients vunerable to the controlling influence of DTC marketing and, thus, undermine the patient autonomy that is said to be promoted by this marketing strategy. If there is any benefit from DTC marketing it is for significantly undertreated conditions. International restrictions on DTC marketing should remain in place until further evidence of net benefit or harm emerges from the DTC marketing experiment that is taking place in the US and New Zealand.

ISSN:1172-7047    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

Two of the four licensed cholinesterase inhibitors, galantamine and donepezil, have recently featured in published work showing how they act in dementia associated with cerebrovascular disease (CVD). It is timely to review this new evidence and place it within the current consensus understanding of what makes up a clearly heterogeneous dementia population. To do this, the current review explores the relationship between Alzheimer’s disease, for which this group of compounds originally received licensing approval, and vascular pathology within the brain, highlighting the significant overlap in risk factors and the frequent coexistence of the two conditions in the patients that are studied. Whether they are inter-related or separate entities is discussed, followed by a description of the current classifications of Alzheimer’s disease with CVD, and the three subtypes of ‘pure’ vascular dementia – subcortical, cortical and strategic infarct. Understanding these entities allows more accurate diagnostic and prognostic information to be given to patients, and leads towards matching the published clinical evidence discussed with more predictable clinical syndromes. This distinction is particularly relevant in terms of the studies conducted thus far.Galantamine has been studied in a placebo-controlled study of patients with Alzheimer’s disease and CVD as well as patients with vascular dementia, whereas donepezil was studied exclusively in patients with vascular dementia. Differences in the way the placebo groups acted in these studies confirmed the fact that these actually are two distinct groups. Galantamine showed efficacy across the combined groups studied, with placebo deterioration similar to previous Alzheimer’s disease studies, while donepezil produced a positive effect in vascular dementia – with this placebo group relatively unchanged. The symptomatic improvements seen were not really surprising, as cholinergic deficits are a common factor across all of these syndromes. Wherever this is the predominant biological finding, it would be expected that cholinesterase inhibitors would have a similar effect, whatever the condition causing it.

ISSN:1172-7047    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

Myoclonus is a sudden, abrupt, brief, ‘shock-like’ involuntary movement caused by muscular contractions (‘positive myoclonus’) or a sudden brief lapse of muscle contraction in active postural muscles (‘negative myoclonus’ or ‘asterixis’). Various disorders can cause myoclonus including neurodegenerative and systemic metabolic disorders and CNS infections. In addition, myoclonus has been described as an adverse effect of some drugs. Level II evidence is available to indicate that levodopa, cyclic antidepressants and bismuth salts can cause myoclonus, while there is less robust evidence to associate numerous other drugs with the induction of myoclonus.The pharmacological mechanisms responsible for this adverse effect are not well established, although increased serotonergic transmission may be involved in the induction of myoclonus by several drugs. Drug-induced myoclonus usually resolves after withdrawal of the offending drug, but in some cases specific treatments are needed.

ISSN:1172-7047    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

ObjectiveIn some countries, such as Germany, there has been a move towards the treatment of patients with Parkinson’s disease in specialised inpatient units. However, data on patient outcome and the daily costs of antiparkinsonian drugs in these settings are rare. This study was conducted to determine the effect of an inpatient setting (a specialised Parkinson’s disease clinic) on drug therapy costs and patient symptoms.Patients and MethodsThis study involved 63 consecutively referred inpatients of a Parkinson’s disease clinic. On entry to the clinic, the patients’ antiparkinsonian drug regimen was titrated in order to improve their motor function. The daily costs of drug therapy per patient (in 2002 values) were calculated, and the severity of Parkinson’s disease symptoms scored via scores on the Unified Parkinson’s Disease Rating Scale (UPDRS) and standardised instrumental procedures (peg insertion and tapping), both initially and at the end of the patients’ stay in the clinic. The variables between the two evaluation timepoints were compared.ResultsThe titration of antiparkinsonian drugs was associated with a significant decrease in the symptoms of Parkinson’s disease at discharge from the clinic compared with admission (as measured by UPDRS total and subscale scores [all p < 0.001], and, to a lesser extent, by peg insertion and tapping [both p < 0.05]). A significant increase in daily drug costs (an increase of euro14.11 per patient for all drugs and euro12.36 per patient for antiparkinsonian drugs [both p <0.001]) was also observed.ConclusionThe results demonstrate that the symptoms experienced by patients with Parkinson’s disease improve after performance of antiparkinsonian drug titration within the setting of a specialised Parkinson’s disease clinic. The effect on symptoms was seen most clearly with the UPDRS, although both peg insertion and tapping reflected this improvement to a certain extent. Drug titration resulted in, on average, a doubling of daily drug costs. Future trials are needed to investigate the long-term effects of such a hospital stay on indirect costs associated with treating Parkinson’s disease, and on caregiver burden, and also to compare the efficacy of a Parkinson’s disease clinic with an outpatient setting.

ISSN:1172-7047    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

Long-acting risperidone (Risperdal Consta™) is a novel, intramuscular formulation of the atypical antipsychotic risperidone, which has shown efficacy in the treatment of patients with schizophrenia.Long-acting risperidone is pharmacokinetically equivalent to and causes less plasma drug concentration fluctuation than the oral formulation. This novel formulation is an aqueous suspension of microspheres comprising risperidone and a biodegradable copolymer. Significant release of risperidone from the microspheres begins 3 weeks after the first injection: thus, administration of another antipsychotic is necessary during this period only. Steady-state plasma concentrations are reached after the fourth injection. Elimination is complete 7–8 weeks after the last injection.Long-acting risperidone 25 or 50mg every 2 weeks demonstrated significantly greater antipsychotic efficacy than placebo and equivalent efficacy to oral risperidone 2–6 mg/day in two randomised, double-blind, double-dummy, 12-week trials of patients with schizophrenia. Additionally, in one of these trials, improvements in health-related quality of life (HRQOL) were superior with long-acting risperidone than placebo.Compared with baseline, improvements in the symptoms of schizophrenia in stable patients were significant with long-acting risperidone 25 or 50mg (12-month trial) and 25, 37.5 or 50mg (12-week trial) every 2 weeks, in two noncomparative, multicentre trials. Patient satisfaction with their medication and patient HRQOL mental health scores improved significantly in the 12-month trial.Long-acting risperidone is generally well tolerated, with a low incidence of injection site pain and an otherwise similar profile of adverse effects to the oral formulation. The overall incidence of extrapyramidal disorders in clinical trials was low (≤ 10%) with similar, yet minimal, changes in extrapyramidal symptom severity between patients treated with long-acting risperidone, oral risperidone or placebo. Tardive dyskinesia was reported in the 12-month trial, in 0.7% of patients.ConclusionsLong-acting risperidone is effective and generally well tolerated in patients with schizophrenia, including those patients with stable symptoms. Long-acting risperidone is the first atypical antipsychotic available in a formulation which offers a sustained, steady release of drug and is thus an attractive, new option in the treatment of patients with schizophrenia.

ISSN:1172-7047    

出版商:ADIS    

年代:2004

数据来源: ADIS