Hepatotoxicity associated with the new antidepressants.

BACKGROUND: Safety profiles of classical and new antidepressants are well established. Hepatotoxicity is known to occur. Recently, several cases of severe hepatic injury associated with the new antidepressants have been reported, prompting us to quantify this risk. METHOD: To estimate the cumulative incidence of hepatic adverse reactions associated with antidepressants, we used cases of hepatic damage collected via spontaneous reporting and included in the Spanish Pharmacovigilance System database; for exposure, we have used data from drug sales to the Spanish National Health System. RESULTS: The estimated reported incidence did not show major differences for the antidepressants studied, ranging from 1.28 cases per 100,000 patient-years for sertraline to 4.00 for clomipramine, except for nefazodone, which was the agent that had the highest incidence with 28.96 cases per 100,000 patient-years. CONCLUSION: The reported incidence of hepatic adverse reactions to nefazodone seems to be higher than that estimated so far. Given the high prevalence of depression and the widespread use of antidepressants, physicians should be alert to the possibility that these medications cause hepatitis and consider early discontinuation of an antidepressant if the condition is suspected.

[Hormonal replacement therapy in Spain]. / Tratamiento hormonal sustitutivo en España. Un estudio de utilización.

BACKGROUND: The consumption of hormonal replacement therapy (HRT) in Spain is not known. Therefore, we have conducted a study to know the mean features of that consumption and to find out the prevalence of use among women older than 40. SUBJECTS AND METHOD: To know the consumption, we have used the information contained in ECOM database from the Ministry of Health regarding medicines sold to the Spanish Health System. Also, data gathered by the General Practitioner Sentinel Network of Castilla y León had been used. The data of consumption are presented in daily defined dose per 1000 women more than 40 years (DHD); prevalence of use per year and for ages was also estimated. RESULTS: The HRT consumption in Spain throughout the National Health System was 6,94 DHD in 1989 and 39.92 DHD in 1999. The percentage of women using this therapy was 0.7% in 1989 and 3,4 in 1999; the group 50-54 years had the highest prevalence of use, 10,84% (IC 95%, 10.66-11.01). CONCLUSIONS: The release into the market of those transdermal forms of HRT facilitated an increase in the consumption. Nonetheless, the proportion of postmenopausal women on HRT in Spain is lower than that of the other countries from the European Union. The proportion of women treated with estrogens and progestins is also small compared with current recommendations.

[The use of anxiolytic and hypnotic drugs in Spain (1995-2002)]. / Utilización de ansiolíticos e hipnóticos en España (1995-2002).

BACKGROUND: Recent studies have revealed a rise in the use of anxiolytic and hypnotic drugs as well as the improper use thereof in Western countries. This study is aimed at ascertaining the pattern of use of anxiolytic and hypnotic drugs in Spain within the 1995-2002 period. METHODS: The data related to the use of medications was taken from the Ministry of Health and Consumer Affairs' ECOM (Medicinal Products Consumption) database, which includes information on the use of medications delivered through the community pharmacies and reimbursed by the National Health System. The data are expressed in Defined Daily Doses per 1,000 inhabitants per day. RESULTS: The use of anxiolytic and hypnotic drugs rose from 39.71 Defined Daily Doses per 1,000 inhabitants per day in 1995 to 62.02 in 2002. Throughout the period under study, benzodiazepines having a medium-range half-life (8-24 h.) were those most used, especially lorazepam, alprazolam and lormetazepam. The active ingredient having shown the greatest drop in use was flunitrazepam. CONCLUSIONS: Although the use of anxiolytic and hypnotic drugs has undergone a considerable rise in recent years in Spain, the pattern of use has shown no major changes.

[Evolution of antipsychotic drug consumption in the autonomous community of Castile and Leon, Spain (1990-2001)]. / Evolución del consumo de fármacos antipsicóticos en Castilla y León (1990-2001).

BACKGROUND: Over the past ten years, new drugs and new approaches to treatment have been implemented making it possible to assume changes in the use of antipsychotic drugs in our environment. This study is aimed at characterizing the pattern of use of antipsychotic drugs in Castile and Leon throughout the 1990-2001 period as well as ascertaining the bearing which the marketing of new antipsychotic drugs may have had on the pattern of consumption of these drugs. METHODS: The drug consumption data was obtained from the Ministry of Health and Consumer Affairs' consumption database ECOM (Especialidades Consumo de Medicamentos). This database contains information on the consumption of medications dispensed charged to the Social Insurance system in community pharmacies nationwide. To estimate the consumption outside of the National Health System, data from the IMS (International Marketing Services) firm for the years 2000 and 2001 was used. The data was given in Defined Daily Doses/1000 inhabitants/day. RESULTS: The use of antipsychotic drugs rose by 146% within the 1990-2001 period. Throughout the period studied, haloperidol was the antipsychotic drug most used in Spain and in Castile and Leon. The atypical antipsychotic drugs totaled 49% of the total consumption for 2001 and 90% of the costs, a strong trend being found toward an increase in the consumption of these atypical antipsychotic drugs in detriment to the typical antipsychotic drugs. It has been estimated that 14% of the antipsychotic drugs used in Castile and Leon were used outside of the National Health System.. Appreciable differences exist among the different provinces. CONCLUSIONS: The consumption of antipsychotic drugs in Castile and Leon grew by 146% throughout the twelve months studied. The marketing of new atypical antipsychotic drugs and the legal measures related to the deinstitutionalization of mental patients may have played a major role in this increase. The marketing of the new antipsychotic drugs has led to a change in their pattern of use and has give rise to an rise in the direct costs. The consumption of these medications not charged to the National Health System is minor, but not negligible.

Ginecomastia asociada al uso concomitante de cisaprida y lansoprazol / Gynecomastia associated to simultaneous administration of cisapride and lansoprazole

No disponible

Tratamiento hormonal sustitutivo en España. Un estudio de utilización / Hormonal replacement therapy in Spain

FUNDAMENTO: El consumo del tratamiento hormonal sustitutivo (THS) en España no se conoce con exactitud. Por este motivo, nos hemos planteado un estudio que permita conocer el consumo cuantitativo del THS, sus características y la prevalencia de uso de esta terapia de sustitución. SUJETOS Y MÉTODO: Para conocer el consumo, se utilizó la información que ofrece la base de datos de medicamentos ECOM del Ministerio de Sanidad y Consumo. También se empleó la información proveniente de una encuesta a mujeres a las que fue prescrito THS por los médicos pertenecientes a la Red de Médicos Centinelas de Castilla y León. Los datos de consumo se presentan en dosis diarias definidas por 1.000 mujeres con más de 40 años por día (DHD); se estimó también la prevalencia de uso por año y por grupos de edad. RESULTADOS: El consumo de THS en España a través de Sistema Nacional de Salud pasó de 6,94 dosis diarias definidas (DDD) por 1.000 mujeres mayores de 40 años en 1989 a 39,92 en 1999. El porcentaje de mujeres mayores de 40 años que usaban THS pasó del 0,7 por ciento en 1989 al 3,4 por ciento en 1999; el grupo de edad 50-54 años, con el 10,8 por ciento (intervalo de confianza del 95 por ciento, 10,7-11,0), fue el de mayor consumo. Los síntomas de la menopausia fueron el motivo más frecuente de prescripción de esta medicación. En la mitad de los casos se prescribieron estrógenos solos. CONCLUSIONES: La introducción en el mercado de las formas transdérmicas de administración de THS propició un aumento del consumo; no obstante, la proporción de mujeres posmenopáusicas que reciben THS en España es baja si se compara con la de otros países. La proporción de terapia combinada de estrógenos y progestágenos es igualmente baja si tenemos en cuenta las recomendaciones para su empleo. (AU)

Evolución del consumo de antidiabéticos en España durante el período 1989-1998 / The evolution of the consumption of antidiabetics in Spain during the period 1989-1998

El objetivo del presente estudio ha sido conocer la evolución de las tendencias de utilización de insulina y fármacos antidiabéticos orales en España durante la década 1989-1998. Para ello se ha realizado un estudio de utilización de medicamentos longitudinal, descriptivo y retrospectivo que incluyese las especialidades farmacéuticas pertenecientes al grupo Anatómico Terapéutico A10 (antidiabéticos) dispensadas con cargo a la Seguridad Social. El consumo conjunto de insulina y de fármacos antidiabéticos orales ha experimentado un notable incremento durante el periodo estudiado, pasando de 16,02 dosis diarias definidas por 1.000 habitantes y día en 1989 a 32,74 en 1998. En 1998, los dos principios activos más consumidos del grupo fueron la glibenclamida y la acarbosa. La utilización de insulina también ha experimentado un importante incremento, sin embargo, en términos absolutos queda lejos del total de antidiabéticos orales. La aparición de los nuevos sistemas de inyección de insulina y de nuevos antidiabéticos orales como la acarbosa ha podido jugar un papel importante. Un incremento en la prevalencia de esta patología, junto con un mejor diagnóstico y tratamiento de la misma podría explicar una parte del incremento del consumo experimentado por este grupo farmacológico (AU)

The aim of the present study has been to known the trends in the use of insulins and oral antidiabetics in Spain along the period 1989-1998. For this purpose, a longitudinal, descriptive and retrospective study of the use of pharmaceutical products belonging to the anatomical therapeutic group A/0 (antidiabetics) and dispensed at the Social Security expense has been done. Overall insulin and oral antidiabetics consumption has experienced an important increase, from 16.02 defined daily doses per 1,000 inhabitants per day in 1989 to 32.74 in 1998. In 1998, the most utilized medication was glibenclamide and acarbose. Insulin utilization also increased, though, in absolute values, it remained below that of oral antidiabetics. The introduction in Spain of newer systems to deliver insulin and newer oral antidiabetics like acarbose may have played an important role. An increase in the prevalence, along with a better diagnosis and treatment, may explain a part of the increase in consumption experienced by this pharmacological group (AU)