Publication: Atención farmacéutica a pacientes con migraña: efectividad, seguridad e impacto en la calidad de vida de los anticuerpos monoclonales de administración subcutánea
Authors
Carvajal Sánchez, Miguel Ángel
item.page.secondaryauthor
Escuela Internacional de Doctorado
item.page.director
Nájera Pérez, María Dolores ; Manresa Ramón, Noemí ; León Villar, Josefa
Publisher
Universidad de Murcia
publication.page.editor
publication.page.department
DOI
item.page.type
info:eu-repo/semantics/doctoralThesis
Description
Abstract
INTRODUCCIÓN Y OBJETIVOS
La migraña es un trastorno incapacitante caracterizado por un fuerte dolor de cabeza que puede ocurrir junto con síntomas como náuseas, vómitos o sensibilidad a la luz o al sonido.
Se trata de una patología con un enorme impacto en la sociedad. A nivel mundial es la sexta enfermedad más prevalente y en España la sufren más de cinco millones de personas. En nuestro país tiene una prevalencia en torno al 13%, siendo una de las causas principales de solicitud de atención médica, tanto en atención primaria como hospitalaria, afectando a quienes la padecen a nivel personal, estudiantil y profesional.
El tratamiento se fundamenta en el tratamiento sintomático de las crisis y en la prevención de éstas. Erenumab, galcanezumab y fremanezumab son anticuerpos monoclonales de administración subcutánea indicados para la profilaxis de la migraña en adultos. Están dirigidos a bloquear el péptido relacionado con el gen de la calcitonina (CGRP) circulante (fremanezumab, galcanezumab) o directamente su receptor (erenumab). Son fármacos de reciente comercialización, por lo que resulta necesario conocer su efectividad y su perfil de seguridad en vida real.
El objetivo de este estudio es analizar los resultados del seguimiento farmacoterapéutico obtenidos a través del programa de Atención Farmacéutica (AF) para pacientes diagnosticados de migraña en tratamiento con estos fármacos e identificar intervenciones farmacéuticas que tengan un impacto clínico positivo en estos pacientes.
MATERIAL Y MÉTODOS
Estudio observacional retrospectivo, sobre los datos de la historia clínica electrónica y los documentos de AF, de todos los pacientes a cargo del Servicio de Neurología (SNRL) en tratamiento con erenumab, galcanezumab o fremanezumab desde el 1 de enero de 2020 hasta el 28 de febrero de 2023 en el Hospital Morales Meseguer (HMM) de Murcia.
RESULTADOS
El diseño y puesta en marcha de la consulta de AF del Servicio de Farmacia Hospitalaria (SFH) permitió dispensar los tratamientos realizando un seguimiento farmacoterapéutico adaptado a las particularidades de cada paciente. De forma global, estos tratamientos fueron efectivos, consiguiendo reducir los episodios de migraña a la mitad en un 55-65% de los tratamientos los dos primeros años y con reducciones estadísticamente significativas de 9-11 episodios mensuales de migraña totales y 3-5 episodios intensos durante el primer año de tratamiento (p<0,001). Su uso repercutió positivamente en la calidad de vida: el primer año los pacientes categorizados en los grados de menor discapacidad incrementaron un 19% y un 24% y los categorizados como mayor discapacidad disminuyeron un 24% y un 36% según las escalas Migraine Disability Assessment Scale (MIDAS) y Headache Impact Test-6 (HIT-6), respectivamente. En los dos primeros años, también incrementaron estadísticamente el valor del índice de utilidad (IU) (+0,34) y de la escala visual analógica (EVA) (+3,0) respecto al valor basal (p<0,01). En cuanto al perfil de seguridad, el 71% de los tratamientos experimentaron reacciones adversas (RA), siendo el estreñimiento la más frecuente. Sin embargo, solo en un 16% se hizo cambio a otro anticuerpo subcutáneo y un 17% suspendieron tratamiento. El programa de AF permitió identificar 14 intervenciones farmacéuticas aplicables a este perfil de pacientes, tanto de carácter general (64,3%), como relacionadas con la efectividad (7,1%), con la calidad de vida (7,1%) y con la seguridad (14,3%).
CONCLUSIONES
La consulta de AF del SFH permitió realizar un seguimiento cercano e individualizado de los pacientes tratados con anticuerpos subcutáneos anti-CGRP. Estos tratamientos son efectivos reduciendo el número de episodios de migraña mensuales y tienen un impacto positivo en la calidad de vida. Respecto a su perfil de seguridad, presentan un porcentaje reducido de suspensiones de tratamiento por RA.
Migraine is a disabling disorder characterised by a severe headache that may occur along with symptoms such as nausea, vomiting or sensitivity to light or sound. It is a condition with a huge impact on society. Worldwide it is the sixth most prevalent disease and in Spain more than four million people suffer from it. In our country it has a prevalence of around 13%, being one of the main causes of requests for medical attention, both in primary care and in hospital, affecting those who suffer from it on a personal, student and professional level. Treatment is based on symptomatic treatment of seizures and seizure prevention. Erenumab, galcanezumab and fremanezumab are subcutaneously administered monoclonal antibodies indicated for migraine prophylaxis in adults. They are aimed at blocking circulating calcitonin gene-related peptide (CGRP) (fremanezumab, galcanezumab) or directly its receptor (erenumumab). They are recently marketed drugs, so it is necessary to know their effectiveness and safety profile in real life. The aim of this study is to analyse the results of pharmacotherapeutic follow-up obtained through the pharmaceutical care programme for patients diagnosed with migraine who are being treated with these drugs to identify pharmaceutical interventions that have a positive clinical impact on these patients. MATERIAL AND METHODS Retrospective observational study, using data from the electronic medical records and pharmaceutical care documents, of all patients under the care of the Neurology Department being treated with erenumab, galcanezumab or fremanezumab from 1 January 2020 to 28 February 2023 at the Morales Meseguer Hospital in Murcia. RESULTS The design and implementation of the Pharmacy Service's Pharmaceutical Care consultation allowed treatments to be dispensed with pharmacotherapeutic monitoring adapted to each patient's specific needs. Overall, these treatments were effective, reducing migraine episodes by half in 55-65% of treatments in the first two years and with statistically significant reductions of 9-11 total monthly migraine episodes and 3-5 severe episodes during the first year of treatment (p<0.001). Their use had a positive impact on quality of life: in the first year, patients categorised as having lower levels of disability increased by 19% and 24%, and those categorised as having higher levels of disability decreased by 24% and 36% according to the Migraine Disability Assessment Scale (MIDAS) and Headache Impact Test-6 scales, respectively. In the first two years, there was also a statistically significant increase in the utility index (UI) (+0.34) and the visual analog scale (VAS) (+3.0) compared to baseline (p<0.01). In terms of safety profile, 71% of treatments experienced adverse reactions, with constipation being the most common. However, only 16% switched to another subcutaneous antibody and 17% discontinued treatment. The pharmaceutical care programme identified 14 pharmaceutical interventions applicable to this patient profile, both general (64.3%) and related to effectiveness (7.1%), quality of life (7.1%) and safety (14.3%). CONCLUSIONS The Pharmaceutical Care consultation of the Pharmacy Service allowed to have a close and individualised monitoring of patients treated with subcutaneous anti-CGRP antibodies. These treatments are effective in reducing the number of monthly migraine episodes and have a positive impact on quality of life. Regarding their safety profile, they have a low percentage of treatment discontinuations due to adverse reactions.
Migraine is a disabling disorder characterised by a severe headache that may occur along with symptoms such as nausea, vomiting or sensitivity to light or sound. It is a condition with a huge impact on society. Worldwide it is the sixth most prevalent disease and in Spain more than four million people suffer from it. In our country it has a prevalence of around 13%, being one of the main causes of requests for medical attention, both in primary care and in hospital, affecting those who suffer from it on a personal, student and professional level. Treatment is based on symptomatic treatment of seizures and seizure prevention. Erenumab, galcanezumab and fremanezumab are subcutaneously administered monoclonal antibodies indicated for migraine prophylaxis in adults. They are aimed at blocking circulating calcitonin gene-related peptide (CGRP) (fremanezumab, galcanezumab) or directly its receptor (erenumumab). They are recently marketed drugs, so it is necessary to know their effectiveness and safety profile in real life. The aim of this study is to analyse the results of pharmacotherapeutic follow-up obtained through the pharmaceutical care programme for patients diagnosed with migraine who are being treated with these drugs to identify pharmaceutical interventions that have a positive clinical impact on these patients. MATERIAL AND METHODS Retrospective observational study, using data from the electronic medical records and pharmaceutical care documents, of all patients under the care of the Neurology Department being treated with erenumab, galcanezumab or fremanezumab from 1 January 2020 to 28 February 2023 at the Morales Meseguer Hospital in Murcia. RESULTS The design and implementation of the Pharmacy Service's Pharmaceutical Care consultation allowed treatments to be dispensed with pharmacotherapeutic monitoring adapted to each patient's specific needs. Overall, these treatments were effective, reducing migraine episodes by half in 55-65% of treatments in the first two years and with statistically significant reductions of 9-11 total monthly migraine episodes and 3-5 severe episodes during the first year of treatment (p<0.001). Their use had a positive impact on quality of life: in the first year, patients categorised as having lower levels of disability increased by 19% and 24%, and those categorised as having higher levels of disability decreased by 24% and 36% according to the Migraine Disability Assessment Scale (MIDAS) and Headache Impact Test-6 scales, respectively. In the first two years, there was also a statistically significant increase in the utility index (UI) (+0.34) and the visual analog scale (VAS) (+3.0) compared to baseline (p<0.01). In terms of safety profile, 71% of treatments experienced adverse reactions, with constipation being the most common. However, only 16% switched to another subcutaneous antibody and 17% discontinued treatment. The pharmaceutical care programme identified 14 pharmaceutical interventions applicable to this patient profile, both general (64.3%) and related to effectiveness (7.1%), quality of life (7.1%) and safety (14.3%). CONCLUSIONS The Pharmaceutical Care consultation of the Pharmacy Service allowed to have a close and individualised monitoring of patients treated with subcutaneous anti-CGRP antibodies. These treatments are effective in reducing the number of monthly migraine episodes and have a positive impact on quality of life. Regarding their safety profile, they have a low percentage of treatment discontinuations due to adverse reactions.
publication.page.subject
Citation
item.page.embargo
Collections
Ir a Estadísticas
Este ítem está sujeto a una licencia Creative Commons. http://creativecommons.org/licenses/by-nc-nd/4.0/