Hepatotoxicidad por tamsulosina / dutasterida: reporte de un caso probable

La tamsulosina y dutasterida son medicamentos ampliamente usados como tratamiento de la hipertrofia benigna de próstata. teniendo un buen perfil de seguridad. Existen escasos reportes de injuria hepática asociado al uso de tamsulosina; sin embargo, no hay reportes de toxicidad hepática por el uso de dutasterida y del uso combinado de tamsulosina/dutasterida. Se presenta el caso de un varón de 64 años quien desarrolla injuria hepática tras el uso combinado de tamsulosina/dutasterida, desarrollando un patrón de daño hepatocelular y clínica de hepatitis aguda. Se realizo descarte de patología hepática viral, autoinmune y enfermedades metabólicas de depósito, así como de patología biliar mediante ecografía abdominal y colangioresonancia. En la evaluación de causalidad, presentó CIOMS-RUCAM: 6 puntos (probable) y Naranjo: 4 puntos (posible). El paciente presentó respuesta clínica y laboratorial luego de suspender el medicamento.

Tamsulosin and dutasteride are drugs widely used to treat benign prostatic hypertrophy. having a good safety profile. There are few reports of liver injury associated with the use of tamsulosin; however, there are no reports of hepatic toxicity from the use of dutasteride and the combined use of tamsulosin/dutasteride. We present the case of a 64-year-old man who developed liver injury after the combined use of tamsulosin/dutasteride, developing a pattern of hepatocellular damage and acute hepatitis symptoms. Viral, autoimmune, and metabolic storage diseases of the liver were ruled out, as well as biliary pathology by means of abdominal ultrasound and resonance cholangiography. In the causality evaluation, CIOMS-RUCAM presented: 6 points (probable) and Naranjo: 4 points (possible). The patient presented a clinical and laboratory response after discontinuing the drug.

Impacto del síndrome de iris flácido intraoperatorio (IFIS) en cirugía de cataratas mediante facoemulsificación: análisis de 622 casos / Impact of intraoperative floppy IRIS syndrome in cataract surger by phacoemulsification: Analysis of 622 cases

Introducción Los síndromes de pupila estrecha, incluido el síndrome de iris flácido intraoperatorio (IFIS), aumentan el riesgo de complicaciones durante la cirugía de cataratas si no se realiza una correcta planificación quirúrgica. La tamsulosina se asocia a un incremento muy significativo del riesgo de IFIS, debido a la inactivación prolongada de los receptores alfa-1 adrenérgicos en la fibra muscular lisa del iris. Material y métodos Estudio prospectivo observacional unicéntrico, llevado a cabo en el Hospital de l’Esperança - Parc de Salut Mar.ResultadosSe incluyeron 622 ojos de 502 pacientes, de los cuales 337 (62%) eran mujeres. La media de edad de la muestra era de 74,8 años. Se observaron 61 casos de IFIS (11%), de los cuales 13 recibían tratamiento con tamsulosina y uno con doxazosina. Se observaron 23 casos de IFIS en pacientes mujeres. La ratio mujer:hombre fue de aproximadamente 1:3. Se observaron 19 casos (3%) de IFIS severo, de los cuales 6 recibían tratamiento con alfa-antagonistas, sin correlación estadísticamente significativa.La media del tiempo quirúrgico fue de 13,80min (desviación estándar [DE]: 4,01min) en pacientes sin IFIS y de 16,93min (DE: 4,32min) en pacientes con IFIS. La relación entre la duración del procedimiento quirúrgico en minutos y la presencia de IFIS fue estadísticamente significativa, aplicando un test t-Student «a dos colas» o bilateral con un p valor de 0,01. Conclusión Independientemente del grado de severidad, el diagnóstico de IFIS alarga el tiempo quirúrgico en cirugía de cataratas. Esto supone otra evidencia más que apoya la utilización de tratamientos antagonistas adrenérgicos menos alfa-1 selectivos que la tamsulosina o la realización de la cirugía de cataratas antes de iniciar dichos tratamientos. (AU)

Background Small pupil syndromes, including intraoperative-floppy iris syndrome (IFIS), increase the risk of complications during cataract surgery if proper surgical planning is not performed. Tamsulosin is associated with a very significant increase in the risk of IFIS, due to the prolonged inactivation of alpha-1 adrenergic receptors in the smooth muscle fiber of the iris. Material and methods Single-center prospective observational study, carried out at the Hospital de l’Esperança – Parc de Salut Mar.ResultsSix hundred and twenty-two eyes of 502 patients were included, of which 337 (62%) were women. The mean age of the sample is 74.8 years. Sixty-one cases of IFIS (11%) were observed, of which 13 received treatment with Tamsulosin and 1 with Doxazosin. Twenty-three cases of IFIS were observed in female patients. The female:male ratio was approximately 1:3. Nineteen cases (3%) of severe IFIS were observed, of which 6 received treatment with alpha-antagonists, with no statistically significant correlation.The mean surgical time was 13.80min (standard deviation – SD: 4.01min) in patients without IFIS and 16.93min (SD: 4.32min) in patients with IFIS. The relationship between the duration of the surgical procedure in minutes and the presence of IFIS was statistically significant, applying a ‘two-tailed’ or bilateral t-Student test with a p value of 0.01. Conclusion Regardless of the degree of severity, the diagnosis of IFIS lengthens the surgical time in cataract surgery. This represents yet another piece of evidence that supports the use of less selective alpha-1 adrenergic antagonist treatments than tamsulosin or the performance of cataract surgery before starting these treatments. (AU)

Impact of intraoperative floppy IRIS syndrome in cataract surgery by phacoemulsification: Analysis of 622 cases.

BACKGROUND: Small pupil syndromes, including IFIS, increase the risk of complications during cataract surgery if proper surgical planning is not performed. Tamsulosin is associated with a very significant increase in the risk of IFIS, due to the prolonged inactivation of alpha-1 adrenergic receptors in the smooth muscle fiber of the iris. MATERIAL AND METHODS: Single-center prospective observational study, carried out at the Hospital de l'Esperança - Parc de Salut Mar. RESULTS: 622 eyes of 502 patients were included, of which 337 (62%) were women. The mean age of the sample is 74.8 years. 61 cases of IFIS (11%) were observed, of which 13 received treatment with Tamsulosin and 1 with Doxazosin. 23 cases of IFIS were observed in female patients. The female:male ratio was approximately 1:3. 19 cases (3%) of severe IFIS were observed, of which 6 received treatment with alpha-antagonists, with no statistically significant correlation. The mean surgical time was 13.80 min (Standard Deviation - SD: 4.01 min) in patients without IFIS and 16.93 min (SD: 4.32 min) in patients with IFIS. The relationship between the duration of the surgical procedure in minutes and the presence of IFIS was statistically significant, applying a 'two-tailed' or bilateral t-Student test with a p value of 0.01. CONCLUSION: Regardless of the degree of severity, the diagnosis of IFIS lengthens the surgical time in cataract surgery. This represents yet another piece of evidence that supports the use of less selective alpha-1 adrenergic antagonist treatments than Tamsulosin or the performance of cataract surgery before starting these treatments.

Physiopathology of the Priapism Secondary to Tamsulosin: Clinical Cases of Our Hospital and Literature Review

Objective: To describe two cases of man with the diagnosis of ischemic priapism after the intake of tamsulosin and to revise the scientific literature. Methods: We present two cases of men that developed an ischemic priapism after the intake of tamsulosin prescribed for STUI and were treated in our hospital. We described the two cases, from the diagnosis until the surgery that was performed. Also, we review the scientific literature about this topic. Results: In one hand, a 67 years old man with the previous diagnosis of diabetes mellitus, hypertension and dyslipidemia that take a one single dosis of tamsulosin and developed a priapism of 9 hours of duration. He was diagnosticated of low-flow priapism that was reverted after the use of intracavernosal phenylephrine. On the other hand, a 61 years old man without any medical condition. He developed a priapism after the intake of also one single dosis of tamsulosin and came to the hospital after 48 hours of the beginning of the erection. In this case, the use of intracavernosal phenylephrine wasn´t effective so we decided to performed a distal shunt between cavernosal and spongy body according to the techniques of Winter, Ebbehoj and Al-Ghorab. All of them without results. At the end, we tried a proximal shunt according Quackles technique, also ineffective. The patient declined another surgery for implantation of a pennis prothesis and went home after four days of hospitalization with the disappearance of the pain. Conclusions: The tamsulosin is a drug well known by urologist that have a safety profile probed with the years. Nevertheless, it's association with a disease like the priapism forced us to explain to our patients this rare adverse effect (AU)

Objetivo: Describir la fisiopatología del priapismoasociado a tamsulosina a través de dos casos clínicos tratados en nuestro centro.Método: Se presentan dos casos de varones que desarrollan un priapismo isquémico tras la toma de tamsulosina yque fueron tratados en nuestro hospital. Describimos amboscasos, desde el diagnóstico hasta el tratamiento. Además,revisamos la literatura científica sobre dicho tema.Resultado: Introducimos el caso de un hombre de 67años con comorbilidad cardiovascular que desarrolla un priapismo isquémico de 9 horas de duración que revirtió confenilefrina intracavernosa. Por otro lado, se presenta el casode un varón de 61 años sin patología de base con un priapismo de 48 horas que no mejoró tras tratamiento conservador ni tras cirugía de derivación cavernoso-esponjosa.Conclusiones: La tamsulosina es un fármaco seguroque en, raras ocasiones, puede asociarse a un priapismo isquémico. (AU)

Valor predictivo de proteína C reactiva y albúmina en la expulsión de litos ureterales de 6-10 mm del tercio inferior / Predictive Value of C-reactive Protein and Albumin in the Expulsion of Ureteral Stones (6-10 mm) from the Lower Third

Introducción La litiasis ureteral es responsable del 20% de casos de urolitiasis, el cólico renal afecta negativamente la calidad de vida, el mayor dilema es el elegir entre medidas conservadoras y cirugía. La mayoría de los litos ureterales de tercio distal menor de 6mm, pueden pasar espontáneamente con terapia conservadora. Sin embargo, ella se asocia a incomodidad, infecciones y ausencia laboral. La proteína C Reactiva (PCR) se ha utilizado como predictor en la expulsión de esos litos, además se introduce el uso de la albúmina como nuevo marcador de predicción. Objetivo El objetivo es analizar el valor predictivo de PCR y albúmina para la expulsión de litos ureterales de tercio inferior de 6­10 mm. Métodos Se realizó un estudio prospectivo en pacientes que presentaron cólico renal secundario a litiasis ureteral distal 6­10 Mm, los cuales recibieron tratamiento médico expulsivo durante 4 semanas, hasta la expulsión del lito o la necesidad de tratamiento quirúrgico en que se determinó punto de corte de PCR y albúmina por medio de una curva COR. Resultados 78 pacientes se enrolaron en el estudio, el paso espontáneo fue de 55,1% y el restante requirió de intervención quirúrgica, el punto de corte para PCR fue 5,95 mg/L y de 2,75 g/dl para albúmina. Conclusión El PCR es un parámetro predictivo en la expulsión de litos ureterales de tercio inferior en pacientes muy seleccionados. Se obtiene el siguiente punto de corte para predecir la eliminación del lito (5,95 mg/L) y se propone la albúmina como un nuevo parámetro bioquímico.

Introduction Ureteral stones is responsible for 20% of cases of urolithiasis, renal colic negatively affects quality of life, the main dilemma is choosing between conservative measures and surgery. Most ureteral stones of the distal third smaller than 6 mm can pass spontaneously with conservative therapy. However, this is associated with discomfort, infections. C Reactive protein (CRP) has been used as a predictor in the expulsion of these stones, and the use of albumin as a new marker of prediction is also introduced. Objective The objective is to analyze the predictive value of CRP and albumin for the expulsion of ureteral stones of the lower third of 6­10 mm Methods A prospective study was performed in patients who presented renal colic secondary to distal ureteral lithiasis 6­10 mm and who received medical expulsive treatment for 4 weeks, until the expulsion of the stone or the need for surgical treatment, PCR cut off point was determined and albumin by means of a ROC curve. Results 78 patients enrolled in the study, spontaneous passage was 55.1% and the remaining required surgical intervention, the cut-off point for PCR was 5.95 mg/L and 2.75 g/dl for albumin. Conclusion CRP is a predictive parameter in the expulsion of lower third ureteral stones in highly selected patients. The following cut off point is obtained to predict the elimination of lithium (5.95 mg/L) and albumin is proposed as a new biochemical parameter.

Effectiveness of medical expulsive therapy with the ɲ-adrenergic blocker tamsulosin for distal ureterolithiasis in adults attended in an emergency department in Chile. / Efectividad del tratamiento médico expulsivo con el bloqueador alfa tamsulosina en pacientes adultos que consultan por cálculo ureteral distal en un servicio de urgencias chileno.

OBJECTIVES: To assess the effectiveness of medical expulsive therapy with tamsulosin. MATERIAL AND METHODS: Randomized double-blind controlled trial in an emergency department. We enrolled adults with uncomplicated distal ureterolithiasis and no other complaint. Patients were randomized to take either tamsulosin (0.4 mg/d) plus a nonsteroidal anti-inflammatory drug (NSAID) or placebo plus the NSAID for 21 days. RESULTS: The stone expulsion rate did not differ statistically between the 2 groups (P=.29). Time until expulsion was also similar (P=.91). CONCLUSION: Medical expulsive therapy with tamsulosin does not improve the rate of distal ureteral stone expulsion.

OBJETIVO: Evaluar la efectividad del tratamiento médico expulsivo con tamsulosina. METODO: Ensayo clínico prospectivo aleatorizado doble ciego realizado en un servicio de urgencias. Se incluyen adultos con ureterolitiasis distal única no complicada, que fueron asignados aleatoriamente a tamsulosina 0,4 mg/día más antiinflamatorio no esteroideo (AINE) (grupo A), o con placebo más AINE (grupo B), durante 21 días. RESULTADOS: No se observaron diferencias estadísticamente significativas en la tasa de expulsión de litiasis entre ambos grupos (p = 0,29) ni en el tiempo de expulsión de esta (p = 0,91). CONCLUSIONES: La terapia expulsiva con tamsulosina no se asocia a una mayor tasa de expulsión de litiasis ureteral.

Efecto de la tamsulosina en la calidad de vida de pacientes con hiperplasia prostática benigna / The effect of tamsulosin in the quality of life of patients with benign prostatic hyperplasia

Resumen Introducción La hiperplasia prostática benigna es el padecimiento urológico más frecuente en hombres mayores de 50 años; sus síntomas afectan la calidad de vida. Los bloqueadores alfa-adrenérgicos son una opción para mejorarla. Objetivo Determinar la calidad de vida de pacientes con hiperplasia prostática benigna antes y después del tratamiento con un bloqueador alfa-adrenérgico. Material y métodos Estudio pretest-retest en hombres de 45 a 75 años con hiperplasia prostática benigna. Se administró tamsulosina (0.4 mg/día) por tres meses y se evaluó la severidad de los síntomas y la calidad de vida con el International Prostate Symptom Score (IPSS) y EuroQol 5-D. Se usaron X2 y prueba de rangos y signos de Wilcoxon. Resultados Se incluyeron 50 pacientes de 63.3 ± 10.3 años, 34 (68.0%) tenían síntomas severos antes del tratamiento y 19 (38.0%) después de tres meses (p < 0.05). Con el IPSS, 33 (66.0%) pacientes estaban en categorías de «tan insatisfecho como insatisfecho¼ a «muy insatisfecho¼ antes de la intervención y seis (12.0%) después de ella. La escala visual análoga (EVA) del EuroQol 5-D mostró puntuación basal de 72.9 ± 11.2 versus 83.4 ± 7.6 después (p < 0.05). Conclusión La tamsulosina reduce la severidad de los síntomas y mejora la calidad en de vida en la hiperplasia prostática benigna después de administrarla tres meses.

Abstract Introduction Benign prostatic hyperplasia is an urological disorder most common in men over 50 years old; the symptoms affect the quality of life. Alpha-adrenergic blockers are an option to improve it. Objective To determine the quality of life of patients with benign prostatic hyperplasia before and after treatment with an alphaadrenergic blocker. Material and methods Pretest-retest study in men of 45 to 75 years with benign prostatic hyperplasia. Tamsulosin was administered (0.4 mg/day) for three months; the severity of symptoms and quality of life were assessed with IPSS and EuroQol 5-D. Ranges and sign of Wilcoxon test and X2 were used. Results Fifty patients were included of 63.3 ± 10.3 years of age, 34 (68.0%) had severe symptoms before the treatment and 19 (38.0%) after three months (p < 0.05). With IPSS, 33 (66.0%) patients were in the categories of «as dissatisfied as unsatisfied¼ and «very dissatisfied¼ before the intervention and six (12.0%) after. The VAS of the EuroQol 5-D showed a baseline score of 72.9 ± 11.2 versus 83.4 ± 7.6 after (p < 0.05). Conclusion Tamsulosin reduces severity of symptoms and improves quality of life in benign prostatic hyperplasia after giving it three months.

Postural hypotension associated with inappropriate choice of drug treatment of benign prostatic hyperplasia / Hipotensión postural asociada con una escogencia inadecuada del tratamiento medicamentoso de la hiperplasia prostática benigna

A case of a 76 year old Colombian patient who developed an episode of postural hypotension, after using 4mg of doxazosin for treatment of benign prostatic hypertrophy (BPH) is presented. Because of his age and severity of symptoms (asthenia, weakness, adynamia), the patient was hospitalized. Changing doxazosin by tamsulosin allowed control of symptoms of BPH with no further episodes of orthostatic hypotension.

Se presenta el caso de un paciente colombiano de 76 años quien sufrió un episodio de hipotensión postural, después de tomar doxazosina de 4 mg para el manejo de la hiperplasia prostática benigna (HPB). Debido a la severidad de los síntomas (astenia, debilidad y adinamia), el paciente fue hospitalizado. El cambio de doxazosina por tamsulosina permitió el control de los síntomas de la HPB sin episodios ulteriores de hipotensión ortostática.

[Tamsulosin efficacy and safety for conservative management of renal colic: systematic review and meta-analysis of randomized controlled trials]. / Eficacia y seguridad de tamsulosina para el tratamiento conservador del cólico nefrítico: revisión sistemática con metaanálisis de ensayos clínicos aleatorizados.

BACKGROUND AND OBJECTIVE: The aim is to evaluate tamsulosin efficacy and safety on the expulsion of distal ureteral stones compared to a standard therapy. MATERIAL AND METHODS: Systematic searches were conducted on PubMed, SCOPUS and The Cochrane Library so as to identify randomized and controlled clinical trials in patients treated with tamsulosin with ureteral stone expulsion and adverse events published until 2014 December, without language restriction. Treatment effect was calculated along with the 95% confidence interval (95% CI), using the variance inverse method for random effects. Heterogeneity was determined by I(2). Publication bias was assessed by Egger test. RESULTS: The search identified 480 articles. Thirty-eight met the selection criteria, a total of 3,107 patients. The relative risk (RR) of expulsion was 1.53 (95% CI 1.38-1.69; I(2)=71%.), while the RR of adverse effects was 1.79 (95% CI 1.19-2,71; I(2)=0). CONCLUSIONS: Tamsulosin treatment seems to bring on the expulsion of distal ureteral stones, although at the expense of an appreciable risk of side effects.

[Intraoperative floppy iris syndrome after treatment with duloxetine: coincidence, association, or causality?]. / Síndrome de iris flácido intraoperatorio tras tratamiento con duloxetina: ¿casualidad, asociación o causalidad?

CASE REPORT: The case is presented of a severe Intraoperative Floppy Iris Syndrome (IFIS) in a patient that had been treated with duloxetine. DISCUSSION: Tamsulosin is the main etiological agent involved in IFIS. However several cases of IFIS, supposedly secondary to drugs of different groups have recently been reported in the literature. The authors use this case report as a means to discuss why most of these cases should be considered anecdotal evidence.