Paciente fumador con enfermedad cardiovascular: efectividad de vareniclina en la práctica clínica / A patient who smokes with cardiovascular disease: effectiveness of varenicline the clinical practice

Objetivos. El objetivo principal de este estudio es evaluar la efectividad y seguridad de vareniclina como tratamiento para dejar de fumar en un grupo de fumadores con enfermedad cardiovascular (EVC), en la práctica clínica. Material y métodos. Se ha revisado nuestra base de datos y se han incluido las historias clínicas que consignan ECV estable (>2 meses). Se trata de un estudio descriptivo, longitudinal con recogida retrospectiva de los datos. Se han incorporado a 180 pacientes todos tratados con vareniclina, a dosis estándar de 1 mg cada 12 h, durante 12 semanas, más apoyo psicológico y material de autoayuda. En total se llevaron a cabo 7 visitas (Basal, 2ª y 4ª semanas; 2º, 3º y 6º mes, y, finalmente, a la 52ª semana). Tambien se realizaron llamadas telefónicas, la manifestación verbal de abstinencia se confirmó con la medición del CO en aire espirado (<10 ppm). Resultados. La edad media de los participantes fue de 58 años, con predominio de varones (78%). Edad media de inicio 15,5 años, consumo medio de cigarrillos 25/día. Media en el test de Richmond 8,1; y en el test Fagerström 7,5 puntos. El 83% encendía el 1er cigarrillo en menos de media hora. Las tasas de abstinencia a las 12 s (52%); a las 24 s (44%) y a las 52 s (37%). La tasa de abandonos debido a la presencia de efectos adversos fue del 7,6%. Los efectos indeseados más frecuentes fueron, respectivamente: náuseas, cefalea, insomnio, vómitos y sueños anormales. Conclusiones. Los participantes presentan un consumo elevado de cigarrillos/día y una severa dependencia. Alta motivación, con elevada puntuación en el test de Richmond. Vareniclina se ha mostrado como un tratamiento farmacológico efectivo para conseguir el cese en fumadores con EVC estable, y el fármaco es, generalmente, bien tolerado, presentando un aceptable perfil de seguridad en el paciente con ECV estable (AU)

Objectives. The principal objective of this study is to evaluate effectiveness and safety of Varenicline as a smoking cessation treatment in a group of smokers with cardiovascular disease (CVD) in the clinical practice. Material and methods. A review was made of our database and the clinical records that achieved stable CVD (>2 months) were included. This is a descriptive, longitudinal study with retrospective collection of the data. A total of 180 patients, all treated with varenicline, at standard dose of 1 mg every 12 h, for 12 weeks, plus psychological support and self-help material were incorporated. In all, 7 visits (baseline, 2nd and 4th weeks; 2nd, 3rd and 6th month and finally at 52 weeks) were carried out. Telephone calls were also made; the oral manifestation of abstinence was confirmed with measurement of CO in expired air (<10 ppm). Results. Mean age of the participants was 58 years, with predominance of males (78%). Mean age at onset was 15.5 years, mean consumption of cigarettes 25/day. Mean on the Richmond test 8.1 and on the Fagerstrom test 7.5 points. A total of 83% smoked the 1st cigarette in less than half an hour. Abstinence rates at 12 w (52%); at 24 w (44%) and at 52 w (37%). Drop-out rate due to presence of adverse effects was 7.6%. The most frequent undesired effects were, respectively: nauseas, headache, insomnia, vomits and unusual dreams. Conclusions. The participants had an elevated use of cigarettes/day and severe dependence. High motivation, with high score on the Richmond test. Varenicline has proven to be an effective drug treatment to achieve smoking cessation in smokers with stable CVD, and the drug is generally well tolerated, with an acceptable safety profile in patients with stable CVD (AU)

Tratamiento del tabaquismo en la enfermedad pulmonar obstructiva crónica / Treatment of smoking habit in chronic obstructive pulmonary disease

Objetivo: El abandono del tabaquismo es el modo más efectivo y más coste‑eficiente para reducir el riesgo de provocar la enfermedad pulmonar obstructiva crónica (EPOC). Además, el abandono del tabaco es el único tratamiento que ha demostrado frenar el desarrollo de la enfermedad al prevenir el deterioro progresivo de la función pulmonar. El propósito fue evaluar la eficacia y seguridad del tratamiento farmacológico asociado con asesoramiento psicológico para el abandono del tabaco en pacientes con EPOC, y determinar qué fármaco obtiene mejores resultados. Material y métodos: Estudio analítico, longitudinal y retrospectivo. Se incluyeron 378 fumadores con EPOC que acudieron en demanda de ayuda para dejar de fumar. A todos se les realizó la historia clínica de tabaquismo, en total se llevaron a cabo 7 visitas (basal, 2ª y 4ª semana; 2º, 3º y 6º mes, y finalmente a la semana 52). También se efectuaron llamadas telefónicas intercaladas. Todos recibieron apoyo psicológico, terapia farmacológica y entrega de material escrito de autoayuda. Las intervenciones farmacológicas incluían el tratamiento con vareniclina (VNC), bupropion (BP) y parches de nicotina (TSN), con una duración de entre 8 y 12 semanas. La manifestación verbal de abstinencia se confirmó mediante la validación fisiológica de CO (monóxido de carbono) en aire espirado (< 10 ppm). Resultados: La edad media fue de 56,7 (± 9,3) años, por género, el 67,6% eran varones. Le media de edad de inicio al consumo fue de 15,5 (± 4,7) años. El consumo medio de cigarrillos al día fue de 27,9 (± 12,5). El análisis de la dependencia física por la nicotina mediante el test de Fagerström, mostró una media de 7,2 (± 2,8) y la motivación mediante el test de Richmond, una media de 8,6 (± 1,4). El 90% de los participantes encendía el primer cigarrillo en menos de 30 minutos. Las tasas de abstinencia con los distintos fármacos fueron a la 12ª semana (VNC: 51%; BP: 46%; TSN: 41%), a la semana 24 de seguimiento (VNC: 47%; BP: 38%; TSN: 34%) y a la finalización del estudio en la semana 52 (VNC: 36%; BP: 29%; TSN: 27%). Los tres fármacos utilizados en nuestro estudio fueron bien tolerados y seguros. La TSN fue la que menos y más levesefectos adversos ocasionó. Náuseas y cefalea fueron los más frecuentes en los sujetos que utilizaron vareniclina; insomnio y sequedad de boca fueron los más frecuentes entre los que usaron bupropion. En la mayoría de los casos, los efectos adversos fueron leves, y tan solo en un 6% de los participantes hubo que retirar la medicación. Conclusiones: Los participantes presentaban un consumo elevado de cigarrillos diarios y una severa dependencia. El 90% encendía el primer cigarrillo en menos de media hora. Presentaban una alta motivación y el 71% había realizado más de una tentativa de abandono. La terapia farmacológica de primera línea ha demostrado ser eficaz, segura y bien tolerada en este subgrupo de pacientes. Con vareniclina se obtienen tasas superiores de abstinencia en comparación con bupropion y los parches de nicotina (AU)

Background: To quit smoking is the most effective and most cost‑efficient way to reduce risk of causing chronic obstructive pulmonary disease (COPD). Furthermore, to quit smoking is the only treatment that has been demonstrated to stop the development of the disease as it prevents the progressive deterioration of pulmonary function. Our study has aimed to evaluate the efficacy and safety of the pharmacological treatment associated with psychological counseling to quit smoking in patients with COPD and to determine which drug obtains the best results. Methods: An analytic, longitudinal and prospective study was conducted. A total of 378 smokers with COPD who came seeking help to quit smoking were included. A clinical history of smoking habit was obtained in every case. In all, 7 visits were conducted (Baseline, 2nd and 4th weeks; 2nd, 3rd and 6th month, and finally at week 52). There were also telephone calls in between. All subjects received psychological support, drug therapy and were given written self‑help material. Pharmacological interventions included treatment with Varenicline (VNC), Bupropion (BP) and nicotine patches (TSN), with a duration of 8 to 12 weeks. Verbal statement of abstinence was confirmed by expired air (<10 ppm) CO (carbon monoxide) physiological validation. Results: Mean age was 56.7 (±9.3) years, and 67.6% were males. Mean age of onset of smoking was 15.5 (±4.7) years. Mean cigarettes consumed per day were 27.9 (±12.5). Analysis of physical dependence on nicotine using the Fagerström test showed a mean of 7.2 (±2.8) and motivation by the Richmond test a mean of 8.6 (±1.4). The first cigarette was lit up in less than 30 minutes by 90% of the participants. Abstinence rates with different drugs were the following at the 12th week (VNC 51%; BP 46%; TSN 41%), at week 24 of follow‑up (VNC 47%; BP 38%; TSN 34%) and at the end of the study at week 52 (VNC 36%; BP 29%; TSN 27%). The three drugs used in our study were well‑tolerated and safe. TSN was the drug causing the least and mildest adverse effects. Nausea and headache were the most frequent in subjects using Varenicline. Insomnia and mouth dryness were the most frequent among Bupropion users. In most of the cases, the adverse effects were mild. Withdrawal of the medications was only necessary in 6% of the participants. Conclusions: Participants had elevated daily cigarette consumption and severe dependence. The 1st cigarette was lit up in less than half an hour. They had high motivation and 71% had made more than one attempt to quit smoking. First line pharmacological therapy has been demonstrated to be effective, safe and well tolerated in this subgroup of patients. Higher rates of abstinence were obtained with Varenicline compared to Bupropion and nicotine patches (AU)

Abandono del tabaco y diabetes mellitus / Smoking cessation and diabetes mellitus

Objetivos. El objetivo principal del estudio fue analizar la tasa de abstinencia en fumadores diabéticos procedentes de la Unidad de Diabetes, tratados con terapia farmacológica y breve asesoramiento psicológico, a los que además se les entregó material informativo de autoayuda. Metodología. Estudio analítico, longitudinal y prospectivo. Los participantes eran diabéticos fumadores, se les informó que la acción sinérgica de la diabetes y el tabaco incrementa tanto la morbilidad como la mortalidad, y a todos se les ofreció ayuda para dejar de fumar. Se establecieron los siguientes criterios de inclusión: ser diabético, mayor de edad, consumo de cigarrillos o cualquier otro producto derivado del tabaco a diario, y encontrarse en la fase de preparación en el proceso de abandono. El programa de intervención incluía la realización de la Historia clínica de Tabaquismo, y también se investigó la comorbilidad asociada. Se utilizaron los fármacos de 1ª línea autorizados por la FDA (TSN, bupropion y vareniclina), más breve soporte psicológico durante un periodo de 8-12 semanas. El programa consistía en 7 visitas (visita basal; semanas 2ª y 4ª; 2º, 3º y 4º mes; y finalmente a la 52ª semana). Resultados. Participaron 96 pacientes, 68 (71%) eran varones. La media de edad era de 53,1 años. El consumo medio de cigarrillos fue de 29,7 cig./día. La edad media de inicio se situaba en torno a los 16 años. La cooximetría era de 27,8 ppm. El 19,8% consumía el 1er cigarrillo en menos de 5 minutos, el 45,8% en menos de 30 minutos, y el 34,4%, en más de 30 minutos. La abstinencia después de dos semanas del comienzo del tratamiento (vareniclina 58%, TSN 52% y bupropion 49%), confirmado con la cooximetría (<10 ppm). La abstinencia al final del seguimiento en la 52ª semana: los que fueron tratados con vareniclina (32%); con parches de nicotina 38%; con bupropion 33%. Conclusiones. El consumo de cigarrillos era elevado. Presentaban una dependencia severa, más del 65% encendía el 1º cigarrillo en menos de 30 minutos. La tasa global de abstinencia a la 52ª semana fue del 32,2%. A pesar del aumento del factor de riesgo que supone fumar en la diabetes, existen estudios muy limitados sobre el manejo del tabaquismo en este subgrupo de pacientes. El abandono del tabaquismo debe ser un componente esencial en el tratamiento integral del paciente diabético fumador (AU)

Objectives. The principal objective of the study was to analyze the abstinence rate in diabetic smokers from the Diabetes Unit, treated with pharmacological therapy and brief psychological counseling, who were also given self-help information material. Methodology. An analytic, longitudinal and prospective study was conducted. The participants were diabetics who smoked. They were informed that the synergic action of diabetes and smoking increased both morbidity and mortality and all were offered help to quit smoking. The following inclusion criteria were established: being diabetic, of legal age, smoker of cigarettes or any other tobacco-derived product daily, and being in the preparation phase in the abandonment process. The intervention program included obtaining a Clinical History of the Smoking habit and the associated comorbidity was also investigated. First line drugs authorized by the FDA (TSN, bupropion and varenicline) were used plus brief psychological support for a period of 8-12 weeks. The program consisted in 7 visits (baseline visit, weeks 2 and 4, 2nd, 3rd and 4th months, and finally at 52 weeks. Results. A total of 96 patients, 68 (71%) of whom were male, participated. Mean age was 53.1 years. Mean cigarette consumption was 29.7 cig/day. Mean age of onset was at about 16 years. Cooximetry was 27.8 ppm. The first cigarette was consumed in less than 5 minute by 19.8%, in less than 30 minutes by 45.8% and more than 30 minutes by 34.4%. Abstinence after two weeks of initiation of treatment was varenicline 58%; TSN 52% and bupropion 49%, confirmed with the cooximetry (<10 ppm). Abstinence at the end of follow-up at week 52 was: those treated with varenicline (32%); with nicotine patches 38%; with bupropion 33%. Conclusions. Cigarette smoking was high. Severe dependence was present in more than 65%, with lightening up of the first cigarette in less than 30 minutes. Global abstinence rate at 52 weeks was 32.2%. In spite of the risk factors supposed from smoking in diabetes, there are very limited studies on the management of smoking habit in this subgroup of patients. Smoking cessation should be an essential component in the comprehensive treatment of the diabetic patient who smokes (AU)

Malignant colonic adenomas. Therapeutic criteria. Long-term results of therapy in a series of 42 patients in our healthcare area

Objective: a) to evaluate the appropriateness of histological criteria as proposed by Morson as indicators for surgery; and b) to compare the adequacy of Morson’s criteria with Haggitt’s levels as indicators for surgery in the case of malignant sessile lesions. Material and methods: we carried out a prospective, protocolized study of 42 patients with polyps with invasive carcinoma (IC) who underwent colonoscopic polypectomy from 1979 through 2008. We applied the histological criteria proposed by Morson to all the patients included in the series. Results: we treated 24 polyps with IC and favorable histological criteria (FC) and 18 polyps showing unfavorable histological criteria (UC). All polyps with FC were treated by means of colonoscopic polypectomy. None of the patients showed signs of disease after a mean follow-up period o f 9.67 yrs. Patients with polyps with UC were recommended to undergo surgery. The presence of unfavorable histological criteria in the polypectomy sample was clearly associated with an unfavorable patient outcome and showed a 100% sensitivity level, a negative prognostic value (NPV) of 100%, and a false negative (FN) percentage of 0% for the prognosis of the disease. We found 12 sessile polyps (Haggitt’s level 4). Colonoscopic polypectomy was the treatment employed in 9 out of 12 cases. All patients are free from disease (mean follow- up 7.3 yrs). If Haggitt’s level criteria had been applied, all 12 patients would have undergone surgery. This means 58% more patients than following Morson’s criteria. Conclusions: Morson’s criteria are considered an adequate diagnostic tool for the indication of surgery in patients with malignant adenomas. Haggitt’s invasion levels do not accurately discriminate the necessity for surgery in case of malignant sessile lesions(AU)

Malignant colonic adenomas. Therapeutic criteria. Long-term results of therapy in a series of 42 patients in our healthcare area.

OBJECTIVE: a) to evaluate the appropriateness of histological criteria as proposed by Morson as indicators for surgery; and b) to compare the adequacy of Morson s criteria with Haggitt s levels as indicators for surgery in the case of malignant sessile lesions. MATERIAL AND METHODS: we carried out a prospective, protocolized study of 42 patients with polyps with invasive carcinoma (IC) who underwent colonoscopic polypectomy from 1979 through 2008. We applied the histological criteria proposed by Morson to all the patients included in the series. RESULTS: we treated 24 polyps with IC and favorable histological criteria (FC) and 18 polyps showing unfavorable histological criteria (UC). All polyps with FC were treated by means of colonoscopic polypectomy. None of the patients showed signs of disease after a mean follow-up period o f 9.67 yrs. Patients with polyps with UC were recommended to undergo surgery. The presence of unfavorable histological criteria in the polypectomy sample was clearly associated with an unfavorable patient outcome and showed a 100% sensitivity level, a negative prognostic value (NPV) of 100%, and a false negative (FN) percentage of 0% for the prognosis of the disease. We found 12 sessile polyps (Haggitt s level 4). Colonoscopic polypectomy was the treatment employed in 9 out of 12 cases. All patients are free from disease (mean follow-up 7.3 yrs). If Haggitt s level criteria had been applied, all 12 patients would have undergone surgery. This means 58% more patients than following Morson s criteria. CONCLUSIONS: Morson s criteria are considered an adequate diagnostic tool for the indication of surgery in patients with malignant adenomas. Haggitt s invasion levels do not accurately discriminate the necessity for surgery in case of malignant sessile lesions.

[Profile of the over-user of a health center]. / Perfil del hiperfrecuentador de un centro de salud.

OBJECTIVE: To find the sociodemographic and family characteristics of our Health Centre's over-user, along with the connection between psychological malaise, family dysfunction and greater or lesser attendance. DESIGN: We carried out a descriptive crossover study, after a prior simple random sampling. SETTING: La Felguera Health Centre (Asturias) in 1993. PATIENTS: We studied 276 over-users, defining as such someone who consulted 6 or more times during the year of the study (percentage > 75), with bureaucratic and scheduled visits being excluded. INTERVENTIONS: We used personal interviews with questionnaires to find: Family function (applying the family Apgar Test); psychological malaise (using the Goldberg General Health questionnaire in its reduced 28-item version); and sociodemographic characteristics (with a test composed by ourselves). MEASUREMENTS AND MAIN RESULTS: Average age of the over-user was 54 +/- 19. They were mainly women (72.1%). 51.1% were house-wives and only 25.75% had more than a primary education. 67.8% belonged to nuclear families and 8.3% to dysfunctional families. We found psychological malaise in 40.7%, with a statistically significant relationship between this and women (p < 0.05). CONCLUSIONS: The profile of the over-user of our health centre is a middle-aged housewife with a low level of education, who is part of a nuclear family. A high proportion suffer psychological malaise, but family dysfunction is not determinant.