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Silvio Garattini

Publications and source records attributed to Silvio Garattini.

At least 19 recordsLinked to original sources
PubMed2006

Fish oil and mental health: the role of n-3 long-chain polyunsaturated fatty acids in cognitive development and neurological disorders.

Epidemiological and experimental studies have indicated that consumption of more n-3 long-chain polyunsaturated fatty acids may reduce the risk for a variety of diseases, including cardiovascular, neurological and immunological disorders, diabetes and cancer. This article focuses on the role of marine n-3 long-chain polyunsaturated fatty acids in brain functions, including the development of the central nervous system and neurological disorders. An overview of the major animal studies and clinical trials is provided here, focusing on fatty acid supplementation during pregnancy and infancy, and prevention and management of Alzheimer's disease, schizophrenia, depression and attention deficit hyperactive disorder. Although an optimal balance in n-3/n-6 long-chain polyunsaturated fatty acid ratio is important for proper neurodevelopment and cognitive functions, results from randomized controlled trials are controversial and do not confirm any useful effect of supplementation on development of preterm and term infants. The relationship between fatty acid status and mental disorders is confirmed by reduced levels of n-3 long-chain polyunsaturated fatty acids in erythrocyte membranes of patients with central nervous system disorders. Nevertheless, there are very little data supporting the use of fish oil in those patients. The only way to verify whether n-3 long-chain polyunsaturated fatty acids are a potential therapeutic option in the management and prevention of mental disorders is to conduct a large definitive randomized controlled trials similar to those required for the licensing of any new pharmacological treatment.

Adult↗
PubMed2006

Orphan drug development is progressing too slowly.

AIMS: To assess the methodological quality of OMP dossiers and to discuss possible reasons for the small number of products licensed. METHODS: Information about orphan drug designation and approval was obtained from the website of the European Commission-Enterprise and Industry DG and from the European Public Assessment Reports. RESULTS: Out of 255 OMP designations, only 18 were approved (7.1%). Their dossiers often showed methodological limitations such as inappropriate clinical design, lack of active comparator where available and use of surrogate end-points. CONCLUSIONS: The paucity of European incentives for manufacturers and the poor documentation underpinning the applications may have limited the number of new OMP. The over 5000 rare diseases awaiting therapy are an important public health issue.

Animals↗
PubMed2005

The impact of European regulatory policies on psychotropic drug prescribing patterns.

Thanks to their alleged better tolerability atypical or second-generation antipsychotic drugs (SGA) have gained a considerable fraction of the market at the expense of the classical antipsychotics. The massive advertising of SGA focussed the doubtful reduction of extra-pyramidal side effects (EPS) overlooking the information about the cardiovascular risk induced by SGA. This also led to extensive off-label use as the control of behavioural symptoms associated with dementia in elderly patients. Although the European Medicine Agency (EMEA) eventually warned physicians and patients of the risk associated with SGA use in this area, the regulatory system has some responsibility in this situation. No added therapeutic value is required for new drugs to be approved for the market. They are only evaluated for their own quality, efficacy and safety with no comparison with available alternative treatments. This implies that new drugs may, in fact, be potentially less effective or less safe than other drugs currently in use.

Drug Prescriptions↗
PubMed2004

Role of presynaptic alpha2-adrenoceptors in antidepressant action: recent findings from microdialysis studies.

The therapeutic effect of an antidepressant drug takes at least 2 to 3 weeks to develop and a significant proportion of patients have no or only partial benefit regardless of the class of antidepressant used. Research into the neurobiological basis of antidepressant action has suggested new strategies to improve the antidepressant effect. Recent microdialysis studies show that hypofunction of the presynaptic autoreceptors enhances the increase of extracellular serotonin (5-HT) induced by selective serotonin reuptake inhibitors (SSRIs) so it has been suggested that the antidepressant effect may be speeded up by blockade of the autoreceptors. The similarity between the synaptic mechanisms controlling serotonergic and noradrenergic transmission has stimulated preclinical research into the role of presynaptic alpha(2)-adrenoceptors in the effect of noradrenaline (NA) reuptake inhibitors (NRIs) on NA availability at central synapses. The microdialysis studies reviewed here indicate that NRIs including desipramine, reboxetine and atomoxetine, the mixed 5-HT/NA reuptake inhibitors sibutramine, duloxetine, venlafaxine or the NA/DA reuptake inhibitor amineptine, increased extracellular NA in various regions of the rat brain. The effect was enhanced by chronic treatment and even more by the co-administration of alpha(2)-adrenoceptor antagonists. The results support the theory that desensitization of the alpha(2)-adrenoceptor contributes to enhancing the effect of NRIs seen after chronic administration and may account for the slow onset of the antidepressant effect. Finally, they suggest that co-administration of an alpha(2)-adrenoceptor antagonist may improve the therapeutic effect of NRI.

Adrenergic Uptake Inhibitors↗
PubMed2004

Risk:benefit assessment of old medicines.

Any meaningful discussion about the present value of old drugs requires appropriate comparisons with new drugs. While there is noisy propaganda claiming the superiority of new drugs, the evidence supporting these claims is often scanty and poor. Therefore, the database utilizable to evaluate old and new drugs is incomplete and fragile. There are several reasons, including the poor dossiers presented for the approval of new drugs, the lack of comparisons aimed at showing superiority of new drugs, the bias frequently involved in clinical trials and the conflict of interests. This brief discussion reviews these questions and gives some examples by comparing diuretics and new antihypertensive agents, ticlopidine and clopidogrel, and atypical and classical antipsychotic agents.

Antihypertensive Agents↗
PubMed2004

[A model for integrating biomedical research information].

Any new knowledge obtained from clinical research cannot easily be transferred to clinical practice for several reasons, including publication bias, lack of medical knowledge databases (or lack of their completeness), and lack of integration among these databases. Several initiatives have been launched to organize and combine scientific information and clinical knowledge in order to make them accessible to everyone. The most important of these initiatives was proposed by the National Library of Medicine, in collaboration with the National Institutes of Health, which has so far developed and integrated several databases that are currently freely available on the internet for use by researchers, physicians, and consumers. The more well-known of these databases are PubMed (the free version of Medline), ClinicalTrials.gov, National Guideline Clearinghouse, Drug Information and MedlinePlus. These have been designed using a uniform language and structure, in order to be able to organize and link the knowledge coming from the medical literature, clinical research, medical guidelines, and experience in the use of drugs. The model is restricted to the US, but could easily be applied in Europe and, in particular, in Italy.

Biomedical Research↗