Efecto sinérgico del uso de estatinas con alfabloqueantes sobre la hiperplasia benigna de próstata y sintomatología urinaria asociada
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Date
2023-03-14
Authors
Rojas Ramírez, Frank Lenin
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Journal ISSN
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Publisher
Universidad Nacional de Trujillo
Abstract
La hiperplasia benigna de próstata (HBP) histológicamente hace referencia a la proliferación celular prostática con el subsecuente aumento de tamaño, frecuentemente se asocia a síntomas del tracto urinario bajo. El tratamiento de HBP incluye dos enfoques: conservador y activo con cirugía o fármacos. Los medicamentos más comúnmente usados son los bloqueadores α-adrenérgicos, inhibidores de la fosfodiesterasa tipo 5, inhibidores de la 5-alfa–reductasa, fármacos antimuscarínicos, agonistas β3 y fitoterapia. La tamsulosina, fármaco alfabloqueante, es uno de los fármacos más usados en el tratamiento médico, ejerciendo su acción relajante sobre el músculo liso urinario, actuando sobre el componente dinámico de la obstrucción urinaria. Las estatinas son inhibidores potentes de la biosíntesis de colesterol, se postula que pueden intervenir en la regulación de la apoptosis; mediante un efecto antioxidante podrían reducir la fibrosis a nivel vesical y prostática, ayudando de forma sinérgica junto con los alfabloqueantes en el manejo de HBP y su sintomatología asociada. Objetivo: Evaluar el efecto sinérgico de las estatinas con alfabloqueantes sobre la hiperplasia benigna de próstata y su sintomatología urinaria asociada. Materiales y métodos: Se realizará un estudio analítico, experimental, controlado, aleatorizado, teniendo como población a varones mayores de 50 años atendidos en el Servicio de Urología del Hospital Regional Docente de Trujillo, que consulten por sospecha de HBP desde el 1 de mayo del 2022 al 31 julio del 2023, con un seguimiento a cada paciente de 12 semanas.
A la muestra mínima de 241 pacientes, se adicionará 10 participantes en caso haya algunos que abandonen o se excluyan del estudio. Se formará dos grupos, el primero recibirá tamsulosina 0.4 mg VO más placebo de forma diaria y el segundo, tamsulosina 0.4 mg más atorvastatina 40mg VO de forma diaria. Se evaluará al inicio, a la mitad y al término del estudio con ecográfica prostática, tacto rectal, evaluación de sintomatología urinaria usando el IPSS, análisis de PSA total y examen físico general. Resultados esperados: Se espera encontrar que existe un efecto sinérgico en el uso de estatinas con alfabloqueantes sobre la HBP y su sintomatología urinaria asociada.
Abstract Benign prostatic hyperplasia (BPH) histologically refers to prostate cell proliferation with subsequent increase in size, frequently associated with lower urinary tract symptoms. BPH treatment includes two approaches: conservative and active with surgery or drugs. The most used medications are α-adrenergic blockers, phosphodiesterase type 5 inhibitors, 5-alpha-reductase inhibitors, antimuscarinic drugs, β3 agonists and phytotherapy. Tamsulosin, an alpha-blocking drug, is one of the most used drugs in medical treatment, exerting its relaxing action on urinary smooth muscle, acting on the dynamic component of urinary obstruction. Statins are powerful inhibitors of cholesterol biosynthesis, it is postulated that they may intervene in the regulation of apoptosis; Through an antioxidant effect they could reduce fibrosis at the bladder and prostate level, helping synergistically together with alpha blockers in the management of BPH and its associated symptoms. Objective: To evaluate the synergistic effect of statins with alpha blockers on benign prostatic hyperplasia and its associated urinary symptoms. Materials and methods: An analytical, experimental, controlled, randomized study will be carried out, with the population being men over 50 years of age treated at the Urology Service of the Hospital Regional Docente de Trujillo, who consult for suspected BPH since May 1, 2022 to July 31, 2023, with a follow-up of each patient for 12 weeks. To the minimum sample of 241 patients, 10 participants will be added in case there are some who drop out or are excluded from the study. Two groups will be formed, the first will receive tamsulosin 0.4 mg PO plus placebo daily and the second, tamsulosin 0.4 mg plus atorvastatin 40 mg PO daily. It will be evaluated at the beginning, in the middle and at the end of the study with prostate ultrasound, digital rectal examination, evaluation of urinary symptoms using the IPSS, total PSA analysis and general physical examination. Expected results: It is expected to find that there is a synergistic effect in the use of statins with alpha blockers on BPH and its associated urinary symptoms.
Abstract Benign prostatic hyperplasia (BPH) histologically refers to prostate cell proliferation with subsequent increase in size, frequently associated with lower urinary tract symptoms. BPH treatment includes two approaches: conservative and active with surgery or drugs. The most used medications are α-adrenergic blockers, phosphodiesterase type 5 inhibitors, 5-alpha-reductase inhibitors, antimuscarinic drugs, β3 agonists and phytotherapy. Tamsulosin, an alpha-blocking drug, is one of the most used drugs in medical treatment, exerting its relaxing action on urinary smooth muscle, acting on the dynamic component of urinary obstruction. Statins are powerful inhibitors of cholesterol biosynthesis, it is postulated that they may intervene in the regulation of apoptosis; Through an antioxidant effect they could reduce fibrosis at the bladder and prostate level, helping synergistically together with alpha blockers in the management of BPH and its associated symptoms. Objective: To evaluate the synergistic effect of statins with alpha blockers on benign prostatic hyperplasia and its associated urinary symptoms. Materials and methods: An analytical, experimental, controlled, randomized study will be carried out, with the population being men over 50 years of age treated at the Urology Service of the Hospital Regional Docente de Trujillo, who consult for suspected BPH since May 1, 2022 to July 31, 2023, with a follow-up of each patient for 12 weeks. To the minimum sample of 241 patients, 10 participants will be added in case there are some who drop out or are excluded from the study. Two groups will be formed, the first will receive tamsulosin 0.4 mg PO plus placebo daily and the second, tamsulosin 0.4 mg plus atorvastatin 40 mg PO daily. It will be evaluated at the beginning, in the middle and at the end of the study with prostate ultrasound, digital rectal examination, evaluation of urinary symptoms using the IPSS, total PSA analysis and general physical examination. Expected results: It is expected to find that there is a synergistic effect in the use of statins with alpha blockers on BPH and its associated urinary symptoms.
Description
Keywords
Estatinas, Hiperplasia Prostática, Atorvastatina, Tamsulosina, Próstata