Un registro europeo de ensayos clínicos en niños / A European registry of clinical trials in children

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[Drug utilization and recommended conditions for use in children]. / Utilización de medicamentos y condiciones de uso recomendadas en pediatría.

BACKGROUND: Studies carried out in other countries show that drugs are used in children outside the approved conditions, in a context in which investigation, information and authorization of medications in the pediatric population are scarce. OBJECTIVES: To evaluate the conditions of drug use recommended in children and variability in sources of drug information. METHODS: We performed a descriptive, retrospective study. Data on medication consumption in 1997 were obtained from a pediatric university hospital. Information on conditions of drug use in children was analyzed using a Spanish catalog of medications. This information was compared with that of a North American catalog for international reference. RESULTS: Most of the drugs used were of unrestricted (43; 47 %) or restricted (26; 28 %) pediatric use, but drugs that are not recommended (8; 9 %) or those with unspecified conditions of use in children were also used (15; 16 %). Approximately 12 % of the drugs were not identified in the North American catalog; of the remaining drugs, 60 % were of unrestricted pediatric use, 35 % of restricted use and 5 % were not recommended. CONCLUSIONS: A substantial proportion of drugs administered to hospitalized children are not recommended or their possible use in this population is not specified. It is worth encouraging research, having sources of information that help to make decisions, especially in conditions that have not been approved, and adapting regulatory attitudes, as far as possible, to the evidence and therapeutic needs.

Utilización de medicamentos y condiciones de uso recomendadas en pediatría / Drug utilization and recommended conditions for use in children

Antecedentes: Estudios realizados en otros países indican que en niños se utilizan fármacos en condiciones distintas a las aprobadas, en un contexto en que son escasas la investigación, información y autorización de medicamentos en población pediátrica. Objetivos: Evaluar las condiciones de uso recomendadas en pediatría para los fármacos utilizados en niños y la variabilidad de las fuentes de información sobre éstos. Métodos: Estudio descriptivo y retrospectivo. Se seleccionaron los datos de consumo de medicamentos en un hospital universitario pediátrico durante el año 1997. Se analizó la información sobre las condiciones de uso en pediatría de los fármacos utilizados a partir de un catálogo de medicamentos español. Esta información se comparó con la de un catálogo norteamericano de referencia internacional. Resultados: La mayor parte de los fármacos utilizados fueron de uso pediátrico no restringido (43 [47%]) o restringido (26 [28%]), pero también se utilizaron fármacos no recomendados (8 [9%]) o para los que no se especificaban condiciones de uso en niños (15 [16 %]). Alrededor del 12% de los fármacos no se identificaron en el catálogo norteamericano; de los restantes, el 60% de los fármacos fueron de uso pediátrico no restringido, el 35% de uso restringido y el 5% no recomendados. Conclusiones: En niños hospitalizados, una proporción relevante de los fármacos que se utilizan no se recomiendan o no se especifica su posible uso en población pediátrica. Sería conveniente incentivar la investigación, disponer de fuentes de información sobre terapéutica que ayuden a tomar decisiones, sobre todo en las condiciones no aprobadas, y que la actitud reguladora se ajuste en la medida de lo posible a las evidencias y necesidades terapéuticas (AU)

[Hemorrhages among patients treated with low-molecular-weight heparins]. / Hemorragias en pacientes tratados con heparinas de bajo peso molecular.

OBJECTIVE: Several cases have been reported of patients with severe hemorrhages caused by low-molecular-weight heparins (LMWH). The objective of the present report was to analyse risk factors for hemorrhage among patients diagnosed of hemorrhage due to LMWH. METHODS: Retrospective study (1989-1999) of patients diagnosed of LMWH hemorrhages in a third-level teaching hospital. A review was made of: a) clinical records from hospital files; b) reports of adverse drug reactions from a program on intensive surveillance of hospital adverse reactions. Information was collected of clinical perameters of patients, treatment, site, and severity of hemorrhage. RESULTS: A total of 36 patients diagnosed of LMWH hemorrhages were identified. The median age of patients was 76 years (range: 39 to 94 years). In 11 (31%) patients, hemorrhage originated during an ambulatory treatment, which prompted hospital admission. All patients had one or more risk factors for hemorrhage: age > or = 65 years (34; 94%); co-morbidities with hemorrhagic risk (28; 78%); use of platelet anti-aggregants or NSAIDs (17; 47%); length of treatment > 7 days (17; 47%) and use of anticoagulant doses (16; 44%). Hemorrhages occurred most commonly in the gastrointestinal tract and muscles (24; 67%). Most patients had major hemorrhages (26; 72%); and in 5 cases hemorrhages were fatal. In no patient was the dose adjusted by anti-Xa activity monitoring. CONCLUSIONS: Most patients with LMWH hemorrhages have different risk factors for hemorrhage. A careful assessment of hemorrhagic risk factors on patients is needed when LMWH are used, particularly in the ambulatory setting. LMWH doses should be adjusted in patients with hemorrhagic risk factors.

[Evidence based medical treatment of heart failure]. / Tratamiento médico de la insuficiencia cardíaca basado en la evidencia.

INTRODUCTION AND OBJECTIVES: Recommendations for the treatment of heart failure were carried out by a systematic review of the available evidence of the different pharmacologic treatments. MATERIAL AND METHODS: The review focused on the treatment of chronic and systolic heart failure. All the studies published in english about the pharmacologic treatment of heart failure where identified. The evidence of every pharmacologic treatment was classified according to: a) efficacy variables (reduction of mortality and hospitalizations, improvement of functional class, ejection fraction and exercise tolerance), and b) the level of quality of the evidence according to an evaluation scale. The evidence was also reviewed for the comparisons and the combinations of the pharmacologic treatments, as well as for the toxicity and costs of treatments. RESULTS: The recommendations were defined according to the NYHA functional class and were classified in the A, B and C categories according to the level of quality of the available evidence. The evidence on mortality was considered the most important. First line drugs, the alternatives and other possible treatments were take into account. CONCLUSIONS: There is enough evidence based on information about some variables such as reduction of mortality or hospitalizations to carry out treatment recommendations in all stages of heart failure. This point out the interest ant the priority of used them in the evaluation and improvement of the results of heart failure.

[Variability of prescriptions in prevailing indications in primary care: a multicenter study. Study of Prescriptions in Primary Care (GEPAP)]. / Variabilidad de la prescripción en indicaciones prevalentes en atención primaria: un estudio multicéntrico. Estudio de la Prescripción en Atención Primaria (GEPAP).

OBJECTIVES: It seems convenient to have information on how drugs are used in everyday's practice in order to be able to make drug selection proposals. The aim of this study was to describe the prescription profile in a number of prevalent indications and its variability among the participating centres. DESIGN: Cross-sectional descriptive study. SETTING: Four Primary care centres. PARTICIPANTS: Each of the 32 participating physicians collected information on 200 consecutive patients who received a prescription between October 1994 and January 1995. MEASUREMENTS AND MAIN RESULTS: 5932 patients, with a mean age of 56 years (SD = 18 years) were included. We analysed the prescriptions they received for hypertension (988 patients), hyperlipidaemia (254), peptic ulcer (PU) (136), nonulcer dyspepsia (271), chronic obstructive lung disease (COLD) (293), asthma (134) and depression (261). We describe the number of different drugs used (range: 14 for PU-63 for hypertension), the number of drugs that accounted for 90% of the prescriptions (range: 5 for PU-20 for depression), the number of recently marketed drugs (range: 0 for PU-9 for hypertension) and the proportion of prescribed drugs they accounted for (range: 0% for PU-12.4% for depression). We found an important variability among the participating centres in all the considered indications; for instance, statins for hyperlipidaemia. CONCLUSION: A rather high variability in prescription habits among participating centres was found. Prescription was highly concentrated in a few number of drugs, and the use of recently marketed drugs accounted for less than 10% of all prescriptions, although data show variability according to the considered indications.