Publication: Estudio descriptivo de utilización de ciproterona/etinilestradiol en la práctica clínica
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2018-02
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Abstract
Antecedentes: La combinación ciproterona/etinilestradiol (CPA/EE) está formada por un antiandrógeno y un progestágeno, cuya indicación se centra en problemas androgénicos. Su extenso uso como anticonceptivo, provocó una alarma que llevó a su retirada en Francia en 2013. Tras ello, la EMA estableció una serie de recomendaciones para el correcto uso del fármaco y la subsecuente actualización de las guías clínicas.
Objetivos: El objetivo principal de este estudio es conocer el manejo de CPA/EE, con el fin de evaluar el cumplimiento de las nuevas recomendaciones de las guías clínicas sobre la prescripción de CPA/EE en la práctica clínica.
Material y métodos: Se llevó a cabo un estudio observacional de tipo transversal, identificando anualmente una cohorte de mujeres que iniciaron el tratamiento de CPA/EE durante los años 2011-2016 (a excepción del año 2013), utilizando para ello la base de datos de Atención Primaria THIN (The Health Improvement Network) de Reino Unido. Restringiendo al año 2016, se recogieron las variables en torno al estilo de vida, calculó la incidencia acumulada anual de la proporción de nuevas usuarias de CPA/EE durante los años 2011-2016. Además, para la caracterización de las nuevas usuarias de CPA/EE se llevó a cabo un análisis descriptivo en el que se calcularon medias (ej. la edad) y proporciones.
Resultados: La incidencia acumulada de prescripción de CPA/EE en 2011 fue de 15,89/10.000 y 9,90/10.000 en 2016, mostrando una tendencia constante de disminución, especialmente pronunciada en el grupo etario entre 21-30 años. Durante el año 2016, se identificaron 1658 nuevas usuarias de CPA/EE. La prevalencia de obesidad y tabaquismo entre las usuarias fueron 10,4% y 10,9%, respectivamente. Las mujeres presentaron un bajo perfil de riesgo cardiovascular (<1%). Durante el año previo al estudio, más del 75% de las mujeres recibieron tratamiento para el acné y/o fueron diagnosticadas de alguna condición androgénica, siendo esta mayoritariamente acné (52,5%).
Conclusión: El presente estudio muestra una disminución continuada de la incidencia de prescripción de ciproterona. Sin embargo, los resultados obtenidos sugieren que se está realizando un correcto seguimiento de las recomendaciones de utilización de la combinación CPA/EE establecidas por la EMA en 2013 y de las Guías Clínicas de tratamiento de acné en la población de Reino Unido.
Background: Cyproterone acetate/ethinylestradiol (CPA/EE) is an antiandrogen and a progestagen which is indicated for androgenic problems. Its extensive use for contraceptive purposes solely ended up with the withdrawal of this drug in France in 2013. Following this, the EMA established new recommendations for the correct use of this combination, together with the update of clinical guidelines . Objective: The main objective of this study is to characterise new users of CPA/EE and investigate if prescribing patterns are in line with the approved indications and recommendations. Material and methods: We used medical records from the primary care database THIN (The Health Improvement Network) database from The United Kingdom. We conducted an observational crossectional study, identifying annually a cohort of women initiating the treatment with CPA/EE during the years 2011-2016 (except for the year 2013). The annually cumulative incidence of the new users of CPA/EE was calculated from 2011 to 2016. Restricting to year 2016, we collected information towards lifestyle, comorbilities, possible indication and treatment data of new users. A descriptive analysis was performed as well as evaluation of proportion of new users with any androgenic condition. Results: The cumulative incidence of the prescription of CPA/EE in 2011 was 15.89/10,000 and 9.90/10,000 in 2016, showing a constant decreasing trend. This decreased was notable among women aged 21-30 years. For year 2016, 1658 women were identified as new users of CPA/EE. Frequency of obesity (BMI >30) and current smoking was 10.4% and 10.9%, respectively; with a low cardiovascular risk profile was (<1%). More than 75% of the users received any acne treatment and/or had any androgenic diagnosis in the year prior, being acne the most common diagnosis (52.5%). Conclusion: This study shows a constant decrease trend in prescription of CPA/EE in the last years. However, drug utilization and tretament patterns of CPA/EE are in line with both EMA and Acne Clinical guidelines.
Background: Cyproterone acetate/ethinylestradiol (CPA/EE) is an antiandrogen and a progestagen which is indicated for androgenic problems. Its extensive use for contraceptive purposes solely ended up with the withdrawal of this drug in France in 2013. Following this, the EMA established new recommendations for the correct use of this combination, together with the update of clinical guidelines . Objective: The main objective of this study is to characterise new users of CPA/EE and investigate if prescribing patterns are in line with the approved indications and recommendations. Material and methods: We used medical records from the primary care database THIN (The Health Improvement Network) database from The United Kingdom. We conducted an observational crossectional study, identifying annually a cohort of women initiating the treatment with CPA/EE during the years 2011-2016 (except for the year 2013). The annually cumulative incidence of the new users of CPA/EE was calculated from 2011 to 2016. Restricting to year 2016, we collected information towards lifestyle, comorbilities, possible indication and treatment data of new users. A descriptive analysis was performed as well as evaluation of proportion of new users with any androgenic condition. Results: The cumulative incidence of the prescription of CPA/EE in 2011 was 15.89/10,000 and 9.90/10,000 in 2016, showing a constant decreasing trend. This decreased was notable among women aged 21-30 years. For year 2016, 1658 women were identified as new users of CPA/EE. Frequency of obesity (BMI >30) and current smoking was 10.4% and 10.9%, respectively; with a low cardiovascular risk profile was (<1%). More than 75% of the users received any acne treatment and/or had any androgenic diagnosis in the year prior, being acne the most common diagnosis (52.5%). Conclusion: This study shows a constant decrease trend in prescription of CPA/EE in the last years. However, drug utilization and tretament patterns of CPA/EE are in line with both EMA and Acne Clinical guidelines.