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Background: The long-term efficacy of corticosteroids to prevent atopic dermatitis (AD) relapses has partially been addressed in children. This study compared an intermittent dosing regimen of fluticasone propionate (FP) cream 0.05% with its vehicle base in reducing the risk of relapse in children with stabilized AD. Methods A randomized controlled, multicentric, double-blind trial was conducted. Children (2-10 years) with mild/moderate AD (exclusion criteria: > 30% affected body surface area and/or head) were enrolled into an Open-label Stabilization Phase (OSP) of up to 2 weeks on twice daily FP. Those who achieved treatment success entered the Double-blind Maintenance Phase (DMP). They were randomly allocated to receive FP or vehicle twice-weekly on consecutive days for 16 weeks. The primary study endpoint was relapse rate; time to relapse and severity of disease were also studied. Kaplan-Meier estimates were calculated. Results: Fifty-four patients (29 girls) entered the OSP (23 mild AD) and 49 (26 girls) continued into the DMP. Mean age was 5.5 (SD: 2.8) and 5.1 (SD: 2.3) yrs for FP and vehicle groups, respectively. Four patients withdrew from the DMP (two in every group). Patients treated with FP twice weekly had a 2.7 fold lower risk of experiencing a relapse than patients treated with vehicle (relative risk 2.72, SD: 1.28; p = 0.034). FP was also superior to vehicle for delaying time to relapse. Both treatment therapies were well tolerated. Conclusion: This long-term study shows that twice weekly FP provides an effective maintenance treatment to control the risk of relapse in children with AD. (c) 2018 SEICAP. Published by Elsevier Espana, S.L.U. All rights reserved.

ObjetivoConocer la calidad y la relevancia de las reacciones adversas a medicamentos (RAM) publicadas como Cartas al Director en las revistas médicas españolas.DiseñoEstudio descriptivo.ParticipantesCartas al director sobre RAM aparecidas durante 5 años (1994-98).EmplazamientoCuatro revistas españolas (Medicina Clínica, Revista Clínica Española, ATENCIÓN PRIMARIA y Anales de Medicina Interna).Mediciones principalesLas características de los pacientes, de los medicamentos, de las reacciones adversas, el algoritmo de causalidad, los criterios mínimos y la relevancia de la publicación.ResultadosDe 2.244 cartas, 204 (9,1%) se referían a RAM e incluían 235 casos. Los subgrupos terapéuticos más implicados fueron: anticoagulantes y antiplaquetarios, antibióticos y antineoplásicos. El 20,4% de los medicamentos era reciente. Las RAM más frecuentes afectaron al sistema nervioso (13,6%), el hígado (10,2%), la piel y anejos (9,8%), reacciones generales (9,8%) y aparato digestivo (8,1%). El 50,2% fueron moderadas y el 34%, graves/mortales. El valor medio (5,9±2,2) del algoritmo de causalidad fue similar entre revistas; las RAM fueron: 28 (11,9%) definidas, 182 (77%) posibles o probables y 26 (11,1%) improbables o condicionales; el 10,2% eran desconocidas. No se detectaron diferencias en la media (9,5±1,2) de criterios mínimos de publicación. La relevancia de la publicación fue de 3,2±1,6 puntos, superior en Medicina Clínica.ConclusionesLa publicación de RAM supone una parte importante de la sección de Cartas al Director en las revistas estudiadas. La relación de causalidad es aceptable y la calidad documental elevada, con pocas reacciones desconocidas y a medicamentos recientes. La relevancia ha sido escasa, aunque superior en Medicina Clínica.ObjectiveTo assess the quality and relevance of adverse drug reactions (ADRs) published as Letters to the Editor (LE) in Spanish medical journals.DesignObservational study.ParticipantsLE on adverse drug reactions published over 5 years (1994-98).SettingFour Spanish medical journals (Medicina Clínica, Revista Clínica Española, ATENCIÓN PRIMARIA, and Anales de Medicina Interna).Main measurementsPatient characteristics, drugs, ADR, causality algorithm, minimum criteria, and publication relevance.ResultsOut of 2,244 LE, 204 (9.1%) reported ADRs, which included 235 cases. The therapeutic subgroups most commonly implicated were anticoagulants and antiplatelet drugs, antibiotics, and antineoplastic agents; 20.4% of the drugs were recently marketed. ADRs most commonly involved the nervous system (13.6%), liver (10.2%), skin and appendages (9.8%), general reactions (9.8%), and the digestive system (8.1%). The reactions were moderate in 50.2% of cases and severe/fatal in 34%. The mean causality algorithm value (5.9±2.2) was similar among journals. Of the ADRs, 28 (11.9%) were definitive, 182 (77%) possible or probable, and 26 (11.1%) improbable or conditional; 10.2% were unknown. There were no differences in the mean minimum publication criteria (9.5±1.2). Publication relevance was 3.2±1.6 points, and higher in Medicina Clínica.ConclusionsADRs constitute an important part of LE in the journals studied. The causal relationship is acceptable, the documentation quality is high, with few unknown reactions and ADRs to recently marketed drugs. Relevance is generally low, although greater in Medicina Clínica.

ObjetivoDada la posibilidad de efectos adversos, interacciones con medicamentos e intoxicaciones por contaminantes entre consumidores de hierbas medicinales (HM), nuestro objetivo es describir el consumo de HM en usuarios de los centros de salud en tratamiento con medicamentos.DiseñoEstudio observacional, transversal.EmplazamientoTrece centros de salud de la Comunidad Valenciana.Pacientes u otros participantesUsuarios, de sexo indistinto, mayores de 14 años, seleccionados para un estudio de utilización de medicamentos para encontrar diferencias entre sexos. Mediciones y resultados principales. Las variables de estudio, edad, sexo, nivel educativo, consumo de medicamentos y uso de HM se recogieron desde la historia clínica, tarjeta de largo tratamiento y encuesta estructurada ad hoc. De los 812 usuarios, 801 consumen medicamentos. Toman HM, 159 (19,6%; IC del 95%, 16,9–22,3); edad media, 55,8 años (DE, 16,5); mujeres, 58,5% (IC del 95%, 50,8–66,1). Consumen HM, 226 (media, 1,42; IC del 95%, 1,32–1,52); los varones consumen más HM (p < 0,05). No existen diferencias de consumo de HM por edad, nivel educativo o número de medicamentos consumidos. Un 42,8% (IC del 95%, 35,1–50,2) de los que consumen HM acudieron a la consulta más de 10 veces en el último año. El 96,9% (IC del 95%, 93,7–98,4) de las HM se consumen por automedicación. Se consumen: «por gusto», 36,7% (IC del 95%, 30,4–43,0); problemas de estómago, 19,5% (IC del 95%, 14,3–24,6); nervios/depresión, 12,8% (IC del 95%, 8,5–17,2); trastornos intestinales, 10,6% (IC del 95%, 6,6–14,6); insomnio, 5,8% (IC del 95%, 3,1–9,6). Un 49,1% (IC del 95%, 42,6–52,6) es HM manufacturadas.ConclusionesUno de cada 5 pacientes en tratamiento con medicamentos consume HM por automedicación. La administración sanitaria y los médicos deberían informar de los riesgos para la salud y las contraindicaciones de estos productos.ObjectiveGiven the possibility of adverse side-effects, interactions with medicines and poisoning by contaminants among herbal medicine consumers (HM), we aimed to describe the consumption of HM by health centre users being treated with medicines.DesignCross-sectional, observational study.SettingThirteen health centres in the Community of Valencia.Patients and others participantsUsers of either sex, over 14, chosen for a study of use of medicines to find differences between the sexes.Measurements and main resultsThe study variables, age, gender, education, consumption of medicines and use of HM, were gathered from the clinical records, the long-treatment card and an ad hoc structured survey. 801 out of 812 users took medicines. 159 took HM (19.6%; 95% CI, 16.9–22.3); average age 55.8 (SD, 16.5); women 58.5% (95% CI, 50.8–66.1). They took 226 HM (mean of 1.42; 95% CI, 1.32–1.52). Men consumed more HM (p < 0.05). There were no differences in consumption of HM for age, educational background or number of medicines taken. 42.8% (95% CI, 35.1–50.2) of those who took HM attended for consultation over 10 times in the previous year. 96.9% (95% CI, 93.7–98.4) of HM were taken by self-medication. They were consumed: «because I like them» by 36.7% (95% CI, 30.4–43.0); stomach problems, 19.5% (95% CI, 14.3–24.6); nerves/depression, 12.8% (95% CI, 8.5–17.2); intestinal disorders, 10.6% (95% CI, 6.6–14.6); insomnia 5.8% (95% CI, 3.1–9.6). 49.1% (95% CI, 42.6–52.6) were manufactured HM.ConclusionsOne of every five patients being treated with medicines is also taking HM by self-medication. The health authorities and doctors should advise of the risks to health and of the counter-indications of these products.

UNLABELLED In an attempt to assess the relative toxicity of amoxycillin and amoxycillin-clavulanic acid, we compared the adverse drug reactions reports collected using the spontaneous reporting system of a Regional Drug Surveillance Centre of Spain for both drugs between November 1986 and December 1992. During the 7-year period 1986-92, the 247 reports of amoxycillin-clavulanic acid represent twice the number of reports of amoxycillin alone, and the number of reports related with sales received concerning the association were higher than those concerning amoxycillin alone. The adverse effects classified as severe were quantitatively and qualitatively similar for both drugs and gastrointestinal and skin are the most common system-organ affected by both drugs. With amoxycillin-clavulanic acid there is a higher proportion of stomatological reactions reported and a later onset of adverse drug reactions related with oropharyngeal lesions, and the reaction of the resistance mechanism when compared with the other organs and systems affected. The duration of the adverse drug reactions to amoxycillin-clavulanic acid is longer than for amoxycillin alone. IN CONCLUSION (i) the adverse drug reactions profile of both drugs is different; (ii) the higher reporting rate for amoxycillin-clavulanic acid may be due to more recent marketing; and (iii) amoxycillin-clavulanic acid produces proportionately more gastrointestinal and fewer skin adverse reactions than amoxycillin alone.

Objective: To analyze the case reports concerning children (14 years or younger) in the Spanish Pharmacovigilance System over a 10-year period (1982–1991). Findings: The study of 1419 reports of adverse drug reaction (9.8% of all those received) showed the most commonly involved organs and systems to be the skin, digestive tract, and nervous system (62.8%). The most commonly involved pharmacological groups were antibiotics, respiratory medications, and vaccines (69%). The absolute number of reports is higher in children between 1 and 4 years of age (37.9%). There were more reports among males than in females. Less than 5% of the reports notified directly life-threatening or fatal reactions. Conclusions: Adverse drug reaction are not common in pediatric patients, and most are mild. However, due to limitations of clinical trials in children, pharmacoepidemiological studies may be the only source of information on the benefit-risk profile of drugs received by these patients, and as such require special attention.

Background Case reports of suspected adverse drug reactions (ADRs) are common in the medical literature, but there is a high variation in their characteristics, quality and relevance. Purpose The aim of the study is characterise the publications of adverse drug reactions (ADRs) published as letters to the editor (LE) in four Spanish medical journals. Materials and methods Systematic literature survey was realised. The authors evaluated all case reports of adverse drug reactions published as LE during 2 years (since April 2006 to March 2008) in four Spanish medical journals (Medicina Clinica, Revista Clinica Espanola, Atencion Primaria and Anales de Medicina Interna). Reports were excluded if the event was due to medicinal plants or drug abuse, or if the publication was a cases serie. The evaluation of the cases selected for the study was realised by a group of experts made up of three physicians, a pharmacologist and a pharmacist. Main outcome measures are number of suspected adverse reactions and the following characteristics: therapeutic group of the implied drug, seriousness of the reaction, notification to the pharmacovigilance system, year of commercialisation, and previous knowledge of the reaction. Results A total of 771 LE were reviewed and 93 corresponded to suspected ADRs, 20 cases were excluded and finally The authors evaluated 73 publications corresponding to 79 patients and 97 active principles. About active principles implied:39, 2% were nervous system drugs; 22, 8 were antineoplastic and immunomodulating drugs (18, 6%); and 11, 4% were alimentary tract and metabolism drugs. About the seriousness of the ADRs: 44% were serious; 37% were moderate; 16% were mild; and only two cases (3%) were mortal reactions. Nine LE had been notified to the Spanish pharmacovigilance system, and nine active principles corresponded to a drug of recent commercialisation (less than 5 years from its approval). These new active principles were: telithromycin, erlotinib, ezetimibe (two cases), dutasteride, pioglitazone, tenofovir, inhaled iloprost and pregabalin. Analysing previous knowledge of the reaction: 54, 4% were well-known reactions, 31, 6% were anecdotal events, and 13, 9% were unknown reactions. Conclusions The drugs which are used for treat nervous system pathologies and antineoplastic and immunomodulating drugs are highly associated with ADRs. However it does not represent the real percentage of adverse effects of these groups as the main percentage remains underreported. It is necessary more information about new drugs, and a better collaboration between health professionals and the Spanish pharmacovigilance system.

To the Editor. The voluntary communication of isolated adverse drug reactions (ADRs) is the most effective means for the postmarketing identification of rare, serious adverse reactions. These communications can be made to Drug Surveillance Services or to medical and scientific journals. The publication of case reports is an important primary source of information on ADRs and contributes to the improvement of drug safety.1 We present 3 cases of dental discoloration in children related to the administration of amoxicillin-clavulanic acid. No similar cases have been published in either clinical trials or as isolated cases. Case 1 was a 6-year-old girl with a history of allergic rhinitis and asthma subjected to chronic treatment with budesonide …

ObjetivoAnalizar la relación entre el sexo del paciente y la calidad del medicamento controlando por las variables predictoras más relevantes.DiseñoEstudio observacional transversal.EmplazamientoTrece centros de salud de la Comunidad Valenciana.ParticipantesUsuarios adultos, seleccionados por muestreo consecutivo.Mediciones principalesEncuesta semiestructurada que recoge variables sociodemográficas, de utilización de medicamentos por problemas de salud, frecuentación de los servicios y origen de la prescripción. La calidad del medicamento se midió con el valor intrínseco (VI).ResultadosDe los 812 pacientes, 412 son mujeres. Los varones consumen más medicamentos con VI elevado (VIE) y las mujeres más de VI inaceptable. Las mujeres mayores de 45 años consumen más medicamentos de VI no elevado (VINE). El análisis multivariante pone de manifiesto: a) la prevalencia en las mujeres de uso de medicamentos de VINE es una vez y media mayor que en los varones, diferencias no significativas, y b) en el grupo de edad de 45-64 años el sexo femenino se comporta como modificador de efecto aumentando la prevalencia en el consumo de medicamentos de VINE en dos veces y media respecto a los varones ajustado por frecuentación, problemas de salud y origen de la prescripciónConclusionesSe contribuye a clarificar la influencia del sexo en la calidad del medicamento al señalar la mayor probabilidad de consumir medicamentos de peor calidad por el hecho de ser mujer y tener entre 45 y 64 años. Además, se demuestra el papel del origen de la prescripción y los problemas de salud en la explicación de este consumo diferencial.ObjectiveTo analyse the relationship between patient’s sex and quality of medicine taken by monitoring the most pertinent predictive variables.DesignObservational cross-sectional studySettingThirteen Health Centres in the Community of Valencia.ParticipantsAdult users, selected by consecutive sampling.Main measurementsA semi-structured questionnaire collected the following variables: social and personal details, use of medicines for health problems, frequency of use of services, and place where prescription was issued. The quality of the medication was measured by its intrinsic value (IV).Results412 of the 812 patients were women. Men took more medication with a high IV, and women more with an unacceptable IV. Women over 45 took more medication with a not-high IV. Multivariate analysis showed: a) women took one and a half times more medicines with a not-high IV than men, with differences not significant, and b) in the 45-64 age-group, being a woman operated as a modifier of effect, increasing prevalence of consumption of not-high IV to two and a half times more than men. This was adjusted for frequency of attendance, health problems and where the prescription was issued.ConclusionsThe study helped clarify the influence of gender on the quality of medicine, by pointing to the greater likelihood of women between 45 and 64 taking lower-quality medication. In addition, it showed the effect of where the prescription was issued and of health problems on explaining this difference in consumption.