Off-label use of intravascular iodinated organic and MR contrast media.

UNLABELLED: This paper analyses off-label prescribing of the iodinated organic and magnetic resonance (MR) contrast media used in diagnostic imaging and evaluates the liability profiles and medicolegal issues associated with such use. The term off-label generally indicates the use of known drugs for which new scientific evidence suggests use in a manner and in clinical scenarios not explicitly addressed by the drug data sheet and is outside the indications for which the medication was approved. In addition, the term also indicates the use of drugs with a different route of administration and dosage from those indicated in the information leaflet. Intravascular contrast media used in diagnostic imaging are drugs in the complete sense of the term, even though they have unique characteristics which in many ways distinguish them from other pharmacological agents. The off-label use of contrast media in diagnostic imaging is a little-investigated field and most commonly, but not exclusively, applies to gadolinium-based contrast media used in MR angiography as well as cardiac and paediatric applications. In particular, the off-label use of contrast media mostly concerns deviations from the recommended dose. As contrast media are to all effects pharmaceutical agents, their off-label use can be considered admissible within the limitations laid down by the Italian law in force (Article 3 of Law 94/98) and its interpretation, i.e. the following criteria must be present: the lack of a valid diagnostic alternative; written informed consent by the patient; the presence of scientific publications validated at the international level; assumption of responsibility by the radiologist. CONCLUSIONS: The use of contrast media in modern image-guided medicine is essential. In cases in which the information contained in the information leaflet is modified and updated in any way whatsoever (indications, dosage, at others), specifically if restrictions are introduced in accordance with the law in force, the pharmaceutical industry must provide formal and timely notification to radiologists. On their part as prescribers and users of contrast media, radiologists must remain up to date regarding any changes in indications, dosage and route of administration. Lastly, we propose that the radiology report includes not only the type but also the dose of contrast medium used.

[Isolated systolic hypertension in the elderly]. / L'ipertensione sistolica isolata dell'anziano.

Isolated systolic hypertension is the most common type of hypertension in the elderly. A number of trials have widely shown that it is an independent risk factor for cardiovascular morbidity and mortality. This review focuses the prevalence of isolated systolic hypertension, its pathophysiology, diagnosis and treatment. The optimal treatment strategy is to maximize reduction in systolic blood pressure and to minimize reduction in diastolic blood pressure. All classes of antihypertensive agents can be used, but calcium antagonists, ACE-inhibitors and, more recently, the angiotensin II antagonists appear to be more successful in improving large artery stiffness and therefore are especially useful in treating isolated systolic hypertension in the elderly. A careful evaluation and treatment has to be made in particular in those patients with more risk factors, in order to choose the most appropriate drug and to avoid dangerous drug-drug interactions where polypharmacy occurs.

[The longevity of centenarians]. / Longevità familiare degli ultracentenari.

BACKGROUND: The increase of mean lifetime has also given rise to an increase in the number of centenarians; such a circumstance finds its explanation in an improvement in hygienic conditions in addition to the progress in the medical field. The aim of this retrospective study is the attempt to identify the probable factors encouraging the achievement of an extreme longevity. METHODS: The study was carried out, on a house to house basis, on a sample of 46 calabrian centenarians. In order to demonstrate the hereditary component, the frequency of the centenarians among the closest relatives was considered, through birth and death certificates. The case history questionnaire used most geriatric and gerontological centres associated to the national project Italian Multicentric Study on Centena-rians was used. RESULTS: The profile of our long-lived subject has allowed us to underline the importance of the environmental factor as well as the hereditary component. In most cases these subjects live with their family and have excellent relationships, receiving a great deal of attention from the persons with which they live. CONCLUSIONS: The authors have therefore reached the conclusion by stressing the importance of both factors (hereditary and genetic); however a type of intervention in order to lengthen the mean lifetime is hypothesized exclusively in the environment field through the elimination of certain risk factors.

[Possibly ranitidine-induced autoimmune hepatitis]. / Verosimile epatite autoimmune da ranitidina.

Approved for clinical use in peptic ulcer in 1983, ranitidine competitively inhibits the interaction of histamine with H2 receptors. The incidence of adverse reactions has been low and generally minor. After reviewing the literature on hepatitis associated with ranitidine use, we report the case of a young woman, affected by multiple sclerosis, who developed severe liver injury associated with the intake of this drug. This case meets the principal criteria necessary to establish a causal relationship between the administration of a drug and the verification of an adverse reaction. The singularity of our case with respect to others reported in the literature arises from the demonstration of an anatomo-pathological picture suggestive of toxic or idiosyncratic hepatitis after the initial administration that, at rechallenge, evolved into a histologic picture of autoimmune hepatitis. We believe that physicians should be aware of the potential hepatotoxicity of ranitidine.

[Stenosis of the internal carotid arteries and cardiovascular risk factors in a group of patients aged 65 years and over]. / Stenosi delle arterie carotidi interne e fattori di rischio cardiovascolari in un gruppo di pazienti ultrasessantacinquenni.

BACKGROUND: In the present study, the degree of stenosis of internal carotid arteries and the presence of cardiovascular risk factors are examined. METHODS: Two hundred patients underwent high resolution B-mode echotomography of the carotid arteries; furthermore, the presence of associated cardiovascular risk factors was considered. RESULTS: Small stenosis (< 16%) were reported in 113 (56.5%) patients; moderate stenosis (16-49%) were reported in 58 (29%) patients; severe stenosis (50-79%) were reported in 19 (9.5%) patients; subocclusive stenosis (80-99%) were reported in 2 (1%) patients; occlusions were reported in 8 (4%) patients. One hundred and fifty patients (75%) presented one or more associated cardiovascular risk factors. Hypertension was present in 122 (61%) patients; hypercholesterolemia in 43 (21.5%) patients; diabetes mellitus in 41 (20.5%) patients; 26 (13%) patients were smokers. CONCLUSIONS: According to other studies, stenosis < 50% were the most frequent (85.5%) in the subjects examined. Stenosis > or = 50% were more frequent in males than females. Hypertension was the most frequent associated cardiovascular risk factor; therefore the degree of stenosis increased with the increasing number of cardiovascular risk factors.

Comparable seropositivity for ascariasis and toxocariasis in tropical slum children.

The seropositivities for infection by Ascaris lumbricoides and Toxocara canis were determined in children (1-15 years old) of a slum area of Caracas, Venezuela, and the levels that indicate the presence of active infection were defined. In children aged from 1 to 3 years, approximately 10% were positive for either parasite, and this figure increased to about 30% in 4- to 6-year-olds. For toxocariasis, the percentage of positivity remained at this level up to the age of 15 years. Whilst the positivity in children 10-15 years of age was comparable for Ascaris and Toxocara, a peak of positivity (50%) was found for Ascaris at 7-9 years of age. These results indicate that for these urban slum children, infection by Toxocara is essentially as common as that by Ascaris and, thus, that toxocariasis represents a potential public health problem in the tropical environment that is largely overlooked.

Progressive encephalopathy in children with chronic renal insufficiency in infancy.

A retrospective analysis of children with renal failure during the first year of life revealed that 20 of 23 patients developed profound neurologic abnormalities. The encephalopathy was characterized by developmental delay, microcephaly, hypotonia, seizures, dyskinesia, and EEG abnormalities. No patient had been dialyzed, and four had not received aluminum salts prior to the development of neurologic symptoms. Inadequate statural growth and poor nutrition were present in all patients. It is probable that infants with chronic renal insufficiency are more susceptible to the development of this syndrome than are older children or adults because of the significant growth and maturation of the brain that occurs during the first years of life.