Aprotinin treatment against SARS-CoV-2: A randomized phase III study to evaluate the safety and efficacy of a pan-protease inhibitor for moderate COVID-19.

BACKGROUND: SARS-CoV-2 virus requires host proteases to cleave its spike protein to bind to its ACE2 target through a two-step furin-mediated entry mechanism. Aprotinin is a broad-spectrum protease inhibitor that has been employed as antiviral drug for other human respiratory viruses. Also, it has important anti-inflammatory properties for inhibiting the innate immunity contact system. METHODS: This was a multicentre, double-blind, randomized trial performed in four Spanish hospitals comparing standard treatment versus standard treatment + aprotinin for patients with COVID-19 between 20 May 2020 and 20 October 2021. The primary efficacy outcomes were length of hospital stay and ICU admission. The secondary endpoints were each of the primary efficacy outcomes and a composite of oxygen therapy, analytical parameters and death. Safety outcomes included adverse reactions to treatment during a 30-day follow-up period. Treatment was given for 11 days or till discharge. RESULTS: With almost identical analytical profiles, significant differences were observed in treatment time, which was 2 days lower in the aprotinin group (p = .002), and length of hospital admission, which was 5 days shorter in the aprotinin group (p = .003). The incidence of discharge was 2.19 times higher (HR: 2.188 [1.182-4.047]) in the aprotinin group than in the placebo group (p = .013). In addition, the aprotinin-treated group required less oxygen therapy and had no adverse reactions or side effects. CONCLUSION: Inhaled aprotinin may improve standard treatment and clinical outcomes in hospitalized patients with COVID-19, resulting in a shorter treatment time and hospitalization compared with the placebo group. The administration of aprotinin was safe.

Inmunoglobulinas por vía intravenosa: una alternativa terapéutica a tener en cuenta en el paciente trasplantado renal con COVID-19 / Intravenous immunoglobulins: A therapeutic alternative to consider in kidney transplant patients with COVID-19

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Efficacy and safety of alendronic acid in the treatment of osteoporosis in children.

OBJECTIVES: to describe the efficacy and safety of the off-label use of alendronate in the treatment of osteoporosis in children and adolescents. METHOD: a retrospective study (2008-2014) of all patients under 18 years who were dispensed alendronate for this indication. The criteria for initiating treatment were: bone mineral density with a Z-score ≤ -2.5 SD, a past history of bone fractures without a previous traumatism, and persistent pain. The variables collected were: demographic, treatment-related, clinical. and safety data. The treatment was considered to be effective when there was an increase in bone mineral density up to a Z-score > -2.5 SD. RESULTS: a total of 12 patients, 8 of them male, with a mean age of 11 years (± 3 SD), were treated with alendronate. After a mean time of treatment of 2.15 years (± 1.2 SD), there was an increase in bone mineral density in all patients, 9 of which achieved a Z-score > -2.5 SD, so the drug was considered effective in 75% of cases. No patient had bone fractures or expressed adverse effects during treatment. CONCLUSIONS: alendronate increased bone mineral density and was well tolerated in all patients, therefore it could be considered as a therapeutic option in the treatment of osteoporosis in children.

Objetivos: describir la efectividad y seguridad del uso de acido alendronico en el tratamiento de la osteoporosis en ninos y adolescentes, en condiciones distintas a las autorizadas en la ficha tecnica. Métodos: estudio retrospectivo (2008-2014) de todos los pacientes menores de 18 anos a los que se dispenso acido alendronico para esta indicacion. Los criterios para iniciar tratamiento fueron: densidad mineral osea con puntuacion Z-score ≤ -2,5 DE, antecedentes de fracturas oseas sin traumatismo previo y dolor persistente. Las variables recogidas fueron: demograficas, de tratamiento, clinicas y de seguridad. Se considero efectividad del tratamiento al aumento de la densidad mineral osea hasta obtener Z-score > -2,5 DE. Resultados: un total de 12 pacientes, 8 varones, con una media de edad de 11 anos (} 3 DE), fueron tratados con acido alendronico. Tras un tiempo medio de tratamiento de 2,15 anos (} 1,2 DE), se produjo aumento de la densidad mineral osea en todos los pacientes, 9 de los cuales obtuvieron Z-score > -2,5 DE, por lo que el farmaco se considero efectivo en el 75% de los casos. Ningun paciente presento fracturas oseas ni manifesto efectos adversos durante el tratamiento. Conclusiones: el acido alendronico incremento la densidad mineral osea y se tolero bien en todos los pacientes, por lo que se podria considerar como opcion terapeutica en el tratamiento de la osteoporosis infantil.

Efficacy and safety of alendronic acid in the treatment of osteoporosis in children / Efectividad y seguridad del ácido alendrónico en el tratamiento de la osteoporosis infantil

Objectives: to describe the efficacy and safety of the off-label use of alendronate in the treatment of osteoporosis in children and adolescents. Method: a retrospective study (2008-2014) of all patients under 18 years who were dispensed alendronate for this indication. The criteria for initiating treatment were: bone mineral density with a Z-score ≤-2.5 SD, a past history of bone fractures without a previous traumatism, and persistent pain. The variables collected were: demographic, treatment-related, clinical. and safety data. The treatment was considered to be effective when there was an increase in bone mineral density up to a Z-score >-2.5 SD. Results: a total of 12 patients, 8 of them male, with a mean age of 11 years (± 3 SD), were treated with alendronate. After a mean time of treatment of 2.15 years (±1.2 SD), there was an increase in bone mineral density in all patients, 9 of which achieved a Z-score >-2.5 SD, so the drug was considered effective in 75% of cases. No patient had bone fractures or expressed adverse effects during treatment. Conclusions: alendronate increased bone mineral density and was well tolerated in all patients, therefore it could be considered as a therapeutic option in the treatment of osteoporosis in children (AU)

Objetivos: describir la efectividad y seguridad del uso de ácido alendrónico en el tratamiento de la osteoporosis en niños y adolescentes, en condiciones distintas a las autorizadas en la ficha técnica. Métodos: estudio retrospectivo (2008-2014) de todos los pacientes menores de 18 años a los que se dispensó ácido alendrónico para esta indicación. Los criterios para iniciar tratamiento fueron: densidad mineral ósea con puntuación Z-score ≤-2,5 DE, antecedentes de fracturas óseas sin traumatismo previo y dolor persistente. Las variables recogidas fueron: demográficas, de tratamiento, clínicas y de seguridad. Se consideró efectividad del tratamiento al aumento de la densidad mineral ósea hasta obtener Z-score >-2,5 DE. Resultados: un total de 12 pacientes, 8 varones, con una media de edad de 11 años (± 3 DE), fueron tratados con ácido alendrónico. Tras un tiempo medio de tratamiento de 2,15 años (± 1,2 DE), se produjo aumento de la densidad mineral ósea en todos los pacientes, 9 de los cuales obtuvieron Z-score >-2,5 DE, por lo que el fármaco se consideró efectivo en el 75% de los casos. Ningún paciente presentó fracturas óseas ni manifestó efectos adversos durante el tratamiento. Conclusiones: el ácido alendrónico incrementó la densidad mineral ósea y se toleró bien en todos los pacientes, por lo que se podría considerar como opción terapéutica en el tratamiento de la osteoporosis infantil (AU)