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Citrato de fentanilo oral transmucosa en el tratamiento del dolor irruptivo en pacientes con cáncer en España: resultados del estudio EDIPAD
| Content Provider | Semantic Scholar |
|---|---|
| Author | Trelis, Jordi Pérez-Hernández, C. Sánchez-Domínguez, F. Martínez-Calderón, F. Gracia, Alfredo Zsolt, I. |
| Copyright Year | 2004 |
| Abstract | espanolIntroduccion: Se denomina dolor irruptivo o episodico a la crisis dolorosa de intensidad elevada y aparicion brusca que se instaura sobre un dolor cronico de base controlado con opioides. El citrato de fentanilo oral transmucosa (CFOT) es un farmaco recientemente introducido en nuestro pais, que ha sido especificamente desarrollado para el tratamiento de este tipo de dolor. Tras su comercializacion en el ano 2001, se planteo la realizacion de un estudio observacional post-autorizacion con el objetivo de evaluar la seguridad y tolerabilidad del mismo. Adicionalmente se planteo la obtencion de datos de efectividad del CFOT y la comparacion de los mismos con los obtenidos hasta la visita basal para otros tratamientos administrados, distintos a CFOT. Metodos: Para el estudio se reclutaron 312 pacientes oncologicos, con dolor de base controlado con opioides, que presentaban crisis de dolor irruptivo y fueron seguidos durante un mes, realizandose visitas de control semanales. Doscientos noventa y cinco pacientes fueron validos para el estudio de la seguridad y tolerabilidad de CFOT (poblacion de seguridad). Por otra parte, 138 pacientes fueron evaluados para efectividad, ya que cumplian los criterios de inclusion y exclusion del estudio y les habian sido administrados tratamientos distintos a CFOT antes de la visita basal. Se determinaron las siguientes variables: disminucion de la intensidad del dolor tras la administracion del tratamiento mediante una escala visual analogica (EVA) de 0 a 10 puntos, el tiempo transcurrido hasta que se producia el inicio del alivio del dolor y el alivio maximo tras el tratamiento administrado. Resultados: Seguridad: de los 295 pacientes evaluados, 59 (20%) presentaron alguna reaccion adversa. Todas ellas fueron de intensidad leve o moderada. No se notifico ninguna reaccion adversa grave durante el desarrollo del estudio. Las reacciones mas frecuentemente descritas fueron las de origen gastrointestinal, seguidas de alteraciones del SNC (somnolencia, alucinaciones, desorientacion y mareo), todas ellas propias del tratamiento con opioides. Efectividad: tras la administracion de CFOT en la visita final (± 30 dias), el tiempo transcurrido hasta el inicio del alivio del dolor fue significativamente menor que el transcurrido tras la administracion de otros tratamientos distintos a CFOT antes de la visita basal (12,1 ±12,9 minutos vs 29,4±18,1 minutos respectivamente; p EnglishIntroduction: Breakthrough pain refers to a sudden and severe painful outbreak that develops over a chronic pain controlled with opioids. OTFC is a drug that has been recently launched in our country, specifically developed for the management of this type of pain. After its launching in 2001, a post-authorization observational study was considered in order to assess its safety and tolerability. Collection of data regarding the effectiveness of OTFC was also considered, as well as their comparison with data obtained prior to the baseline visit for other therapies different to OTFC. Methods: Three hundred and twelve cancer patients with chronic pain controlled with opioids were recruited for the study. They presented breakthrough pain episodes and were followed-up for one month, with weekly control visits. Two hundred and ninety five patients were eligible for the safety and tolerability study of OTFC (safety population). On the other hand, 138 patients were assessed in terms of effectiveness, since they fulfilled the inclusion and exclusion criteria of the study and had received other therapies different to OTFC prior to the baseline visit. The following variables were determined: decrease of pain severity after the administration of therapy with an analogical visual scale scoring from 0 to 10, time elapsed until the beginning of pain relief and maximum relief after the administered treatment. Results: Safety: Of the 295 assessed patients, 59 (20%) had some adverse reaction. All of them were mild or moderate. No severe adverse reactions were notified during the study period. The most frequently reported adverse reactions were gastrointestinal effects, followed by CNS disorders (somnolence, hallucinations, confusion and dizziness) that are typical of treatment with opioids. Effectiveness: After the administration of OTFC in the last visit (+ 30 days), the time elapsed until the beginning of pain relief was significantly lower than the time elapsed after the administration of other treatments different to OTFC prior to the baseline visit (12.1 ± 12.9 minutes vs. 29.4 ± 18.1 minutes respectively; p |
| Starting Page | 22 |
| Ending Page | 34 |
| Page Count | 13 |
| File Format | PDF HTM / HTML |
| Volume Number | 11 |
| Alternate Webpage(s) | http://scielo.isciii.es/pdf/dolor/v11n4/original.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
