Safety of Low-Dose Oral Minoxidil in Patients With Hypertension and Arrhythmia: A Multicenter Study of 264 Patients / Seguridad de minoxidil oral a dosis bajas en pacientes con hipertensión o arritmias: estudio multicéntrico de 264 pacientes

Background and objective Systemic adverse effects (AE) are a major concern of low-dose oral minoxidil (LDOM) treatment, especially in patients with arterial hypertension or arrhythmia. The objective of this study was to evaluate the safety of LDOM in patients with hypertension or arrhythmia. Patients and methods Retrospective multicenter study of patients with hypertension or arrhythmia treated with LDOM for any type of alopecia. Results A total of 254 patients with hypertension [176 women (69.3%) and 78 men (30.7%)] with a mean age of 56.9 years (range 19–82) were included. From them, the dose of LDOM was titrated in 128 patients, allowing the analysis of 382 doses. Patients were receiving a mean of 1.45 (range 0–5) antihypertensive drugs. Systemic AE were detected in 26 cases (6.8%) and included lightheadedness (3.1%), fluid retention (2.6%), general malaise (0.8%), tachycardia (0.8%) and headache (0.5%), leading to LDOM discontinuation in 6 cases (1.5%). Prior treatment with doxazosin (P<0.001), or with three or more antihypertensive drugs (P=0.012) was associated with a higher risk of discontinuation of LDOM. Conclusions LDOM treatment showed a favorable safety profile in patients with hypertension or arrhythmia, similar to general population (AU)

Antecedentes y objetivo Los efectos adversos sistémicos son una de las principales limitaciones del uso de minoxidil oral a dosis bajas (MODB), especialmente en pacientes con hipertensión arterial o arritmias. El objetivo de este estudio fue evaluar la seguridad de MODB en estos pacientes. Material y método Estudio retrospectivo multicéntrico con pacientes con antecedentes de hipertensión o arritmias tratados con MODB para cualquier tipo de alopecia. Resultados Se incluyó un total de 254 pacientes con hipertensión (176 mujeres [69,3%] y 78 hombres [30,7%]) con una edad media de 56,9 años (rango 19 – 82). La dosis de MODB se incrementó gradualmente en 128 pacientes, obteniendo un total de 382 dosis analizadas. Los sujetos estaban tomando de media 1,45 fármacos antihipertensivos (rango 0 – 5). Se detectaron EA sistémicos en 26 casos (6,8%), incluyendo mareo (3,1%), retención de líquidos (2,6%), malestar general (0,8%), taquicardia (0,8%) y cefalea (0,5%), requiriendo suspensión del MODB en seis casos (1,5%). Los pacientes en tratamiento con doxazosina (p < 0,001) o con tres o más antihipertensivos (p = 0,012) presentaron mayor riesgo de suspensión de MODB. Conclusión El tratamiento con MODB mostró un perfil de seguridad favorable en pacientes con hipertensión o arritmias, similar al de la población general (AU)

[Artíulo traducido] Seguridad de minoxidil oral a dosis bajas en pacientes con hipertensión o arritmias: estudio multicéntrico de 264 pacientes / Safety of Low-Dose Oral Minoxidil in Patients With Hypertension and Arrhythmia: A Multicenter Study of 264 Patients

Antecedentes y objetivo Los efectos adversos sistémicos son una de las principales limitaciones del uso de minoxidil oral a dosis bajas (MODB), especialmente en pacientes con hipertensión arterial o arritmias. El objetivo de este estudio fue evaluar la seguridad de MODB en estos pacientes. Material y método Estudio retrospectivo multicéntrico con pacientes con antecedentes de hipertensión o arritmias tratados con MODB para cualquier tipo de alopecia. Resultados Se incluyó un total de 254 pacientes con hipertensión (176 mujeres [69,3%] y 78 hombres [30,7%]) con una edad media de 56,9 años (rango 19 – 82). La dosis de MODB se incrementó gradualmente en 128 pacientes, obteniendo un total de 382 dosis analizadas. Los sujetos estaban tomando de media 1,45 fármacos antihipertensivos (rango 0 – 5). Se detectaron EA sistémicos en 26 casos (6,8%), incluyendo mareo (3,1%), retención de líquidos (2,6%), malestar general (0,8%), taquicardia (0,8%) y cefalea (0,5%), requiriendo suspensión del MODB en seis casos (1,5%). Los pacientes en tratamiento con doxazosina (p < 0,001) o con tres o más antihipertensivos (p = 0,012) presentaron mayor riesgo de suspensión de MODB. Conclusión El tratamiento con MODB mostró un perfil de seguridad favorable en pacientes con hipertensión o arritmias, similar al de la población general (AU)

Background and objective Systemic adverse effects (AE) are a major concern of low-dose oral minoxidil (LDOM) treatment, especially in patients with arterial hypertension or arrhythmia. The objective of this study was to evaluate the safety of LDOM in patients with hypertension or arrhythmia. Patients and methods Retrospective multicenter study of patients with hypertension or arrhythmia treated with LDOM for any type of alopecia. Results A total of 254 patients with hypertension [176 women (69.3%) and 78 men (30.7%)] with a mean age of 56.9 years (range 19–82) were included. From them, the dose of LDOM was titrated in 128 patients, allowing the analysis of 382 doses. Patients were receiving a mean of 1.45 (range 0–5) antihypertensive drugs. Systemic AE were detected in 26 cases (6.8%) and included lightheadedness (3.1%), fluid retention (2.6%), general malaise (0.8%), tachycardia (0.8%) and headache (0.5%), leading to LDOM discontinuation in 6 cases (1.5%). Prior treatment with doxazosin (P<0.001), or with three or more antihypertensive drugs (P=0.012) was associated with a higher risk of discontinuation of LDOM. Conclusions LDOM treatment showed a favorable safety profile in patients with hypertension or arrhythmia, similar to general population (AU)

Safety of Low-Dose Oral Minoxidil in Patients With Hypertension and Arrhythmia: A Multicenter Study of 264 Patients. / [Artíulo traducido] Seguridad de minoxidil oral a dosis bajas en pacientes con hipertensión o arritmias: estudio multicéntrico de 264 pacientes.

BACKGROUND AND OBJECTIVE: Systemic adverse effects (AE) are a major concern of low-dose oral minoxidil (LDOM) treatment, especially in patients with arterial hypertension or arrhythmia. The objective of this study was to evaluate the safety of LDOM in patients with hypertension or arrhythmia. PATIENTS AND METHODS: Retrospective multicenter study of patients with hypertension or arrhythmia treated with LDOM for any type of alopecia. RESULTS: A total of 254 patients with hypertension [176 women (69.3%) and 78 men (30.7%)] with a mean age of 56.9 years (range 19-82) were included. From them, the dose of LDOM was titrated in 128 patients, allowing the analysis of 382 doses. Patients were receiving a mean of 1.45 (range 0-5) antihypertensive drugs. Systemic AE were detected in 26 cases (6.8%) and included lightheadedness (3.1%), fluid retention (2.6%), general malaise (0.8%), tachycardia (0.8%) and headache (0.5%), leading to LDOM discontinuation in 6 cases (1.5%). Prior treatment with doxazosin (P<0.001), or with three or more antihypertensive drugs (P=0.012) was associated with a higher risk of discontinuation of LDOM. CONCLUSIONS: LDOM treatment showed a favorable safety profile in patients with hypertension or arrhythmia, similar to general population.

Safety of Low-Dose Oral Minoxidil in Patients With Hypertension and Arrhythmia: A Multicenter Study of 264 Patients.

BACKGROUND AND OBJECTIVE: Systemic adverse effects (AE) are a major concern of low-dose oral minoxidil (LDOM) treatment, especially in patients with arterial hypertension or arrhythmia. The objective of this study was to evaluate the safety of LDOM in patients with hypertension or arrhythmia. PATIENTS AND METHODS: Retrospective multicenter study of patients with hypertension or arrhythmia treated with LDOM for any type of alopecia. RESULTS: A total of 254 patients with hypertension [176 women (69.3%) and 78 men (30.7%)] with a mean age of 56.9 years (range 19-82) were included. From them, the dose of LDOM was titrated in 128 patients, allowing the analysis of 382 doses. Patients were receiving a mean of 1.45 (range 0-5) antihypertensive drugs. Systemic AE were detected in 26 cases (6.8%) and included lightheadedness (3.1%), fluid retention (2.6%), general malaise (0.8%), tachycardia (0.8%) and headache (0.5%), leading to LDOM discontinuation in 6 cases (1.5%). Prior treatment with doxazosin (P<0.001), or with three or more antihypertensive drugs (P=0.012) was associated with a higher risk of discontinuation of LDOM. CONCLUSIONS: LDOM treatment showed a favorable safety profile in patients with hypertension or arrhythmia, similar to general population.

Low-Dose Rituximab for Bullous Pemphigoid. Protocol and Single-Center Experience / Baja dosis de rituximab para penfigoide ampolloso. Protocolo y experiencia de un único centro

Background Low-dose rituximab is a protocol used in several autoimmune diseases, that has also shown to be effective and safe in pemphigus vulgaris. Objectives To study whether low-dose rituximab is also effective for bullous pemphigoid. Methods Patients with BP were treated with a single cycle of two infusions of rituximab 500 mg at an interval of 2 weeks. Early and late end points were monitored. Results Six patients, five males and a female, with a mean age of 78.6 years (range 65–89) and a mean history of BP of 6.7 months (range 2–16) were included. A rapid and marked response was observed after a single cycle of treatment, with a mean time to disease control and to end of consolidation phase of 1.9 (range 1–3), and 4 weeks (range 3–5), respectively. Four patients achieved a late end point at a mean of 15.75 weeks (range 13–20). Three of them achieved partial remission with no therapy (two patients) or with minimal therapy (one patient), and one of them achieved complete remission with no therapy. One patient has 6 weeks of clinical follow-up after rituximab administration. The remaining patient relapsed 4 weeks after the rituximab treatment, and remains in complete remission with more than minimal therapy. One patient had a herpetic gingivostomatitis related to rituximab. Conclusions Low-dose rituximab for BP achieved acceptable remission rates and steroid-sparing activity, with a better safety profile and a lower cost, compared to standard doses. This pilot study suggests that low-dose rituximab could be a therapeutic option for BP (AU)

Antecedentes La administración de dosis bajas de rituximab es un protocolo utilizado en diversas enfermedades autoinmunes, que ha demostrado también su eficacia y seguridad para el pénfigo vulgar. Objetivos Determinar si rituximab a dosis bajas es efectivo para el penfigoide ampolloso (PA). Métodos Se trató a los pacientes con PA con un ciclo único de 2 infusiones de rituximab 500 mg con un intervalo de 2 semanas. Se monitorizaron los puntos temprano y final tardío. Resultados Se incluyeron en el estudio 6 pacientes, 5 varones y una mujer, con una edad media de 78,6 años (rango: 65.89) e historia media de PA de 6,7 meses (rango: 2-16). Se observó una respuesta rápida y acusada tras un ciclo único de tratamiento, con un tiempo medio hasta el control de la enfermedad y el final de la fase de consolidación de 1,9 (rango: 1-3) y 4 semanas (rango: 3-5), respectivamente. Cuatro pacientes lograron un punto final tardío a una media de 15,75 semanas (rango: 13-20). Tres de ellos lograron una remisión parcial sin terapia (2 pacientes) o con terapia mínima (un paciente), logrando uno de ellos la remisión completa sin terapia. A un paciente se le realizó un seguimiento de 6 semanas tras la administración de rituximab. El paciente restante sufrió una recaída transcurridas 4 semanas del tratamiento de rituximab, permaneciendo en remisión completa con terapia mínima. Un paciente manifestó gingivoestomatitis herpética relacionada con rituximab. Conclusiones La administración de dosis bajas de rituximab para PA logró tasas de remisión aceptables y reducción de esteroides, con un mejor perfil de seguridad y un menor coste, en comparación con las dosis estándar. Este estudio piloto sugiere que la administración de bajas dosis de rituximab podría ser una opción terapéutica para el PA (AU)

[Artículo traducido] Baja dosis de rituximab para penfigoide ampolloso. Protocolo y experiencia de un único centro / Low-Dose Rituximab for Bullous Pemphigoid. Protocol and Single-Center Experience

Antecedentes La administración de dosis bajas de rituximab es un protocolo utilizado en diversas enfermedades autoinmunes, que ha demostrado también su eficacia y seguridad para el pénfigo vulgar. Objetivos Determinar si rituximab a dosis bajas es efectivo para el penfigoide ampolloso (PA). Métodos Se trató a los pacientes con PA con un ciclo único de 2 infusiones de rituximab 500 mg con un intervalo de 2 semanas. Se monitorizaron los puntos temprano y final tardío. Resultados Se incluyeron en el estudio 6 pacientes, 5 varones y una mujer, con una edad media de 78,6 años (rango: 65.89) e historia media de PA de 6,7 meses (rango: 2-16). Se observó una respuesta rápida y acusada tras un ciclo único de tratamiento, con un tiempo medio hasta el control de la enfermedad y el final de la fase de consolidación de 1,9 (rango: 1-3) y 4 semanas (rango: 3-5), respectivamente. Cuatro pacientes lograron un punto final tardío a una media de 15,75 semanas (rango: 13-20). Tres de ellos lograron una remisión parcial sin terapia (2 pacientes) o con terapia mínima (un paciente), logrando uno de ellos la remisión completa sin terapia. A un paciente se le realizó un seguimiento de 6 semanas tras la administración de rituximab. El paciente restante sufrió una recaída transcurridas 4 semanas del tratamiento de rituximab, permaneciendo en remisión completa con terapia mínima. Un paciente manifestó gingivoestomatitis herpética relacionada con rituximab. Conclusiones La administración de dosis bajas de rituximab para PA logró tasas de remisión aceptables y reducción de esteroides, con un mejor perfil de seguridad y un menor coste, en comparación con las dosis estándar. Este estudio piloto sugiere que la administración de bajas dosis de rituximab podría ser una opción terapéutica para el PA (AU)

Background Low-dose rituximab is a protocol used in several autoimmune diseases, that has also shown to be effective and safe in pemphigus vulgaris. Objectives To study whether low-dose rituximab is also effective for bullous pemphigoid. Methods Patients with BP were treated with a single cycle of two infusions of rituximab 500 mg at an interval of 2 weeks. Early and late end points were monitored. Results Six patients, five males and a female, with a mean age of 78.6 years (range 65–89) and a mean history of BP of 6.7 months (range 2–16) were included. A rapid and marked response was observed after a single cycle of treatment, with a mean time to disease control and to end of consolidation phase of 1.9 (range 1–3), and 4 weeks (range 3–5), respectively. Four patients achieved a late end point at a mean of 15.75 weeks (range 13–20). Three of them achieved partial remission with no therapy (two patients) or with minimal therapy (one patient), and one of them achieved complete remission with no therapy. One patient has 6 weeks of clinical follow-up after rituximab administration. The remaining patient relapsed 4 weeks after the rituximab treatment, and remains in complete remission with more than minimal therapy. One patient had a herpetic gingivostomatitis related to rituximab. Conclusions Low-dose rituximab for BP achieved acceptable remission rates and steroid-sparing activity, with a better safety profile and a lower cost, compared to standard doses. This pilot study suggests that low-dose rituximab could be a therapeutic option for BP (AU)

Low-Dose Rituximab for Bullous Pemphigoid. Protocol and Single-Center Experience.

BACKGROUND: Low-dose rituximab is a protocol used in several autoimmune diseases, that has also shown to be effective and safe in pemphigus vulgaris. OBJECTIVES: To study whether low-dose rituximab is also effective for bullous pemphigoid. METHODS: Patients with BP were treated with a single cycle of two infusions of rituximab 500mg at an interval of 2 weeks. Early and late end points were monitored. RESULTS: Six patients, five males and a female, with a mean age of 78.6 years (range 65-89) and a mean history of BP of 6.7 months (range 2-16) were included. A rapid and marked response was observed after a single cycle of treatment, with a mean time to disease control and to end of consolidation phase of 1.9 (range 1-3), and 4 weeks (range 3-5), respectively. Four patients achieved a late end point at a mean of 15.75 weeks (range 13-20). Three of them achieved partial remission with no therapy (two patients) or with minimal therapy (one patient), and one of them achieved complete remission with no therapy. One patient has 6 weeks of clinical follow-up after rituximab administration. The remaining patient relapsed 4 weeks after the rituximab treatment, and remains in complete remission with more than minimal therapy. One patient had a herpetic gingivostomatitis related to rituximab. CONCLUSIONS: Low-dose rituximab for BP achieved acceptable remission rates and steroid-sparing activity, with a better safety profile and a lower cost, compared to standard doses. This pilot study suggests that low-dose rituximab could be a therapeutic option for BP.

Low-Dose Rituximab for Bullous Pemphigoid. Protocol and Single-Center Experience. / [Artículo traducido] Baja dosis de rituximab para penfigoide ampolloso. Protocolo y experiencia de un único centro.

BACKGROUND: Low-dose rituximab is a protocol used in several autoimmune diseases, that has also shown to be effective and safe in pemphigus vulgaris. OBJECTIVES: To study whether low-dose rituximab is also effective for bullous pemphigoid. METHODS: Patients with BP were treated with a single cycle of two infusions of rituximab 500 mg at an interval of 2 weeks. Early and late end points were monitored. RESULTS: Six patients, five males and a female, with a mean age of 78.6 years (range 65-89) and a mean history of BP of 6.7 months (range 2-16) were included. A rapid and marked response was observed after a single cycle of treatment, with a mean time to disease control and to end of consolidation phase of 1.9 (range 1-3), and 4 weeks (range 3-5), respectively. Four patients achieved a late end point at a mean of 15.75 weeks (range 13-20). Three of them achieved partial remission with no therapy (two patients) or with minimal therapy (one patient), and one of them achieved complete remission with no therapy. One patient has 6 weeks of clinical follow-up after rituximab administration. The remaining patient relapsed 4 weeks after the rituximab treatment, and remains in complete remission with more than minimal therapy. One patient had a herpetic gingivostomatitis related to rituximab. CONCLUSIONS: Low-dose rituximab for BP achieved acceptable remission rates and steroid-sparing activity, with a better safety profile and a lower cost, compared to standard doses. This pilot study suggests that low-dose rituximab could be a therapeutic option for BP.

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