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X Carné

Publications and source records attributed to X Carné.

32 records · Page 2Linked to original sources

Upper gastrointestinal bleeding in relation to previous use of analgesics and non-steroidal anti-inflammatory drugs. Catalan Countries Study on Upper Gastrointestinal Bleeding.

To assess the risk of upper gastrointestinal bleeding associated with the use of individual non-narcotic analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), a multicentre study of 875 cases of upper gastrointestinal bleeding and 2682 hospital controls was done. With control for confounding factors, the overall odds ratio estimate for aspirin taken at least once during the week before the first symptom was 7.2 (95% confidence interval 5.4-9.6). Non-aspirin NSAIDs associated with upper gastrointestinal bleeding were diclofenac (7.9 [4.3-14.6]), indomethacin (4.9 [2.0-12.2]), naproxen (6.5 [2.2-19.6]), and piroxicam (19.1 [8.2-44.3]). Paracetamol, propyphenazone, and dipyrone did not increase the risk. A previous history of gastrointestinal bleeding or peptic ulcer did not greatly affect odds ratio estimates, which differed according to sex and were higher for younger than for older patients. However, the incidence of upper gastrointestinal bleeding was higher among the elderly.

Adult↗

Agranulocytosis associated with aprindine and other antiarrhythmic drugs: an epidemiological approach.

The risk of agranulocytosis associated with anti-arrhythmic drugs has been assessed by studying previous drug exposure of all cases collected through a multicentre surveillance network in a defined geographical area during the period 1980-1988. One hundred and eighty-one patients with agranulocytosis (less than 500 granulocytes mm-3 at least in two different blood counts) were interviewed with a structured questionnaire. Eight cases attributable to anti-arrhythmic drugs were identified, all of them related to aprindine. Data on the consumption of several anti-arrhythmic drugs were identified, all of them related to aprindine. Data on the consumption of several anti-arrhythmic drugs (amiodarone, aprindine, quinidine, propafenone) were obtained in order to estimate the risk of agranulocytosis related with the previous use of these drugs. A relevant risk was identified only for aprindine, of the order of two cases per 1000 patient-years. Our data suggest that the risk of agranulocytosis associated with aprindine is lower than previously found.

Aged↗

[A matter of power].

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Clinical Trials as Topic↗

Methodological and political issues in clinical pharmacology research by the year 2000.

Parallel groups in a large, multicenter, phase III "pivotal" randomized clinical trial (RCT) with clinically relevant end-points are seen by the medical community as the "gold standard" of clinical research. However, there are limitations, some methodological and others political. The main one is the external validity of the method because a treatment, as studied in RCTs, does not necessarily reflect how it is used in clinical practice. Also, the method, as it stands, is not really predictive of the success in a particular patient of a certain intervention studied in a trial. To overcome these methodological drawbacks, different options have been implemented. The most important ones are: (1) the performance of pragmatic RCTs intended to address effectiveness rather than efficacy; (2) meta-analysis; and (3) the use of observational studies, with or without a comparison group. Recent experience has shown that type-A adverse drug reactions (ADRs) related to a specific class of drugs have been successfully characterized throughout cohort- or population-based case-control studies, whereas the evidence linking a specific drug entity to a type-B ADR, apparently severe enough to withdraw the drug from the market, has come mainly from case reports or case series. Other limitations of the RCT are more of a political nature. These large "pivotal" trials are mostly sponsored by the pharmaceutical industry, and to guarantee the scientific and ethical integrity of data produced, they are performed following standard operating procedures (SOPs) and good clinical practice (GCP) guidelines. Sometimes industry is not interested in sponsoring trials; thus, RCTs performed are in practice highly biased because of their potential economical profits. Furthermore, applying SOPs and GCPs is expensive and difficult to implement, and it is hard to find funding in public institutions. As a result, there is an urgent need to create a network of independent, skilled groups interested in sponsoring and performing institutional RCTs following "user friendly" GCP when the profits are low, but scientific interest high.

Forecasting↗

Adverse drug reactions leading to hospital admission.

This article describes the implementation of a simple method of drug surveillance set up at a hospital emergency ward. From a total of 48,678 patients admitted, the medical records of those presenting with one or more of a pre-established list of admission diagnoses (n = 7728; 15.8%) were checked. Of these 554 (1.1%) were diagnosed as experiencing an adverse drug reaction. When the medical record suggested an adverse drug reaction, drugs taken before admission were ascertained by interviewing the patients with a structured questionnaire. After excluding upper gastrointestinal bleeding (226 cases) and certain bone marrow blood dyscrasias (42 cases), 286 patients with drug-induced events leading to hospital admission were identified in 2 years. Fatal adverse drug reactions, previously undescribed reactions, and some specific examples, such as digoxin-amiodarone interaction, drug-induced pancreatitis, nicardipine-induced AV block, severe skin reactions, and NSAID-induced bronchospasm, are described. Basically, this method consists of assembling series of cases systematically, and is therefore devoid of selective bias. In addition, it allows a more in-depth clinical and anamnesic study of specific diseases, as compared with voluntary reporting.

Adult↗