Xavier Carné

Upper gastrointestinal bleeding in relation to previous use of analgesics and non-steroidal anti-inflammatory drugs

Abstract To assess the risk of upper gastrointestinal bleeding associated with the use of individual non-narcotic analgesics and non-steroidal anti-inflammatory drugs (NSAI Ds), 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.

Role of a research ethics committee in follow-up and publication of results

Follow-up of clinical trials is a commitment rarely fulfilled by research ethics committees (RECs). We assessed the output of clinical trials submitted in 1997 to our REC, and talked to principal investigators, sponsors, contract research organisations, or a combination of these. During 1997, our REC reviewed 166 clinical trials, and approved 158. The recruitment rate was lower than expected in 45% (64/143) of all initiated clinical trials; 64% (92/143) were finished in accordance with protocol. 3 years after, the results of only 21% (26/123) of finished clinical trials were published in peer-reviewed journals, rising to 31% (38/123) if in-press articles were included. RECs should devote more effort and resources to assess public dissemination of results of clinical trials.

Adverse Drug Reactions Leading to Hospital Admission

SummaryThis article describes the implementation of a simple method of drug surveillance set up at a hospital emergency ward. From a total of 48678 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 indepth clinical and anamnesic study of specific diseases, as compared with voluntary reporting.

Spontaneous Adverse Drug Reaction Reporting in Rural Districts of Mozambique

AbstractBackground: The roll out of various public health programmes involving mass administration of medicines calls for the deployment of responsive pharmacovigilance systems to permit identification of signals of rare or even common adverse reactions. In developing countries in Africa, these systems are mostly absent and their performance under any circumstance is difficult to predict given the known shortage of human, financial and technical resources. Nevertheless, the importance of such systems in all countries is not in doubt, and research to identify problems, with the aim of offering pragmatic solutions, is urgently needed. Objective: To examine the impact of training and monitoring of healthcare workers, making supervisory visits and the availability of telecommunication and transport facilities on the implementation of a pharmacovigilance system in Mozambique. Methods: This was a descriptive study enumerating the lessons learnt and challenges faced in implementing a spontaneous reporting system in two rural districts of Mozambique — Namaacha and Matutuine — where remote location, poor telecommunication services and a low level of education of health professionals are ongoing challenges. A ’yellow card’ system for spontaneous reporting of adverse drug reactions (ADRs) was instituted following training of health workers in the selected districts. Thirty-five health professionals (3 medical doctors, 2 technicians, 24 nurses, 4 basic healthcare agents and 2 pharmacy agents) in these districts were trained to diagnose, treat and report ADRs to all medicines using a standardized yellow card system. There were routine site visits to identify and clarify any problems in filling in and sending the forms. One focal person was identified in each district to facilitate communication between the health professionals and the National Pharmacovigilance Unit (NPU). The report form was assessed for quality and causality. The availability of telecommunications and transport was assessed. Results: Fourteen months after the first training, 67 ADR reports involving 74 adverse events were received by the NPU involving 25 separate drugs, 16 of which were causally (certainly, probably or possibly) linked to the reaction. Most reported ADRs were dermatological reactions (83.1%). Antimalarial drugs (chloroquine, amodiaquine, quinine, artesunate and sulfadoxine/pyrimethamine) were mentioned in 33 (50.8%) of the reports. There were 14 reactions classified as serious and no fatal reactions were reported. There were differences in telecommunications and transport facilities between the districts that might have contributed to the different number of reports. Conclusion: Health professionals of all levels of education (including basic training) from rural areas could contribute to ADR spontaneous reporting systems. Training, quality-assurance visits and the ongoing presence of focal persons can promote reporting and improve the quality of reports submitted.

Non-steroidal anti-inflammatory drugs in elderly people. Gastrointestinal bleeding is common.

EDITOR,--In their editorial on non-steroidal anti-inflammatory drugs and elderly patients D N Bateman and J G Kennedy erroneously quote an incidence of upper gastrointestinal bleeding of 210 cases per million people over 60 compared with 35 per million under 60,1 from a study carried out in our department.2 In fact, the annual incidences in our study were 10 times these—that is, 2100 and …

The value of the case—control approach for the evaluation of the risk of upper gastrointestinal bleeding associated with the previous use of non-steroidal anti-inflammatory drugs

Several studies have reported an association between upper gastrointestinal bleeding (UGIB) and the previous use of acetylsalicylic acid (ASA) [1–11] or non-steroidal anti-inflammatory drugs (NSAIDs) as a whole [12–14]. However, specific estimates for individual drugs are not available because the lower prevalence of use of each individual NSAID — compared with that of ASA — limits the statistical power of any analytical study designed to quantify individual risks.

Asma por acido acetilsalicilico, otros antiinflamatorios no esteroides y tartrazina

Asma inducido por acido acetilsalicflico (AAS) y otros antiinflamatorios no esteroideos (AINE), ha sido descrito con una prevalencia entre el 16-19% de pacientes asmaticos. La induccion por tartrazina se ha hallado hasta en el 30% de pacientes con asma por AAS, aunque tambien puede encontrarse de forma aislada. El diagnostico de asma inducido por AINE o por tartrazina es dificil por historia clinica, debido a la aparicion tardia de los sintomas tras la ingesta del farmaco desencadenante, a la variabilidad en la intensidad de las crisis, y a la dificultad en conocer si una especialidad farmaceutica o producto alimentario contienen tartrazina como excipiente. Es por ello que debe recurrirse en ocasiones al test de provocacion oral. Como normal general, se evitara en pacientes asmaticos la administracion de AINE y farmacos que contengan tartrazina en su excipiente. Se adjunta una tabla con la lista de presentaciones farmaceuticas que contienen tartrazina.