Evaluation of LL-37 in healing of hard-to-heal venous leg ulcers: A multicentric prospective randomized placebo-controlled clinical trial.

Many patients with venous leg ulcers do not reach complete healing with compression treatment alone, which is current standard care. This clinical trial HEAL LL-37 was a phase IIb double-blind, randomized, placebo-controlled study, with the aim to evaluate the efficacy and safety of a new drug LL-37 for topical administration, in combination with compression therapy, in 148 patients suffering from hard-to-heal venous leg ulcers. The study had three arms, consisting of two groups treated with LL-37 at concentrations of 0.5 or 1.6 mg/mL, and a placebo cohort. Patients had a mean age of 67.6 years, a median ulcer duration of 20.3 months, and a mean wound size at the time of randomization of 11.6 cm2 . Efficacy analysis performed on the full study population did not identify any significant improvement in healing in patients treated with LL-37 as compared with the placebo. In contrast, a post hoc analysis revealed statistically significant improvement with LL-37 treatment in several interrelated healing parameters in the subgroup of patients with large target wounds (a wound area of at least 10 cm2 at randomization), which is a known negative prognostic factor for healing. The study drug was well tolerated and safe in both dose strengths. In summary, this clinical trial did not detect any significant differences in healing of venous lower leg ulcers in the entire study cohort comparing patients treated with LL-37 versus placebo. A subgroup analysis provided an interesting observation that LL-37 could offer a treatment benefit in patients with large ulcers, exigently warranting a further study adequately powered to statistically assess the treatment outcome in this patient group.

THE EVOLUTION OF HOME ENTERAL NUTRITION (HEN) IN POLAND DURING FIVE YEARS AFTER IMPLEMENTATION: A MULTICENTRE STUDY.

BACKGROUND: home enteral nutrition (HEN) is the best option for chronic. patients without the ability to swallow, but with intact digestive tract. Despite the increasing use of home enteral tube feeding (HETF), there is little published information about the types of patients receiving home enteral nutrition. The purpose of this paper to present the evolution of HETF. MATERIAL AND METHODS: the retrospective multicenter observational study was performed using questionnaires, which were distributed among the biggest Polish HEN centres. The study covered all patients treated between January, 2007 and January, 2014. RESULTS: in total 196 adult patients in 2008 (M:104. F: 92, mean age 58.1 [41-75]) and 2842 in 2013 (M: 1541, F: 1301, mean age 61.4 range: 1-91) were assessed. The number of patients grew significantly between 2008 and 2013 (p < 0.05), rising from 196 up to 2 842 (and 1 716 at the moment of study). The predominant primary disease was neurology in both time periods, but the profile switched from neurovascular to neurodegenerative (p > 0.05). Percutaneous endoscopic gastrostomy was the most common GI access ( > 60%), its use and the use of gastrostomies increased significantly since 2008 (p < 0.05). Although the reimbursement for HETF started in 2007, HEN centres expressed doubts about unclear rules for the qualification to HEN and its use. CONCLUSIONS: HETF is a safe, well-tolerated and cost-effective procedure. The profile of patients and techniques may vary at the beginning, but becomes similar to other HETF countries relatively soon. The number of patients grows quickly, and that fact suggests that the prevalence of HETF is similar in all countries.

Antecedentes: el inicio con nutrición enteral (HEN) es la mejor opción para los pacientes crónicos sin capacidad de tragar, pero con el tracto digestivo intacto. A pesar del aumento en el uso de la alimentación por sonda enteral domiciliaria (HETF), hay poca información publicada sobre los tipos de pacientes que reciben nutrición enteral domiciliaria. El propósito de este trabajo es presentar la evolución de HETF. Material y métodos: el estudio observacional multicéntrico retrospectivo se realizó mediante cuestionarios que se distribuyeron entre los mayores centros HEN polacos. El estudio abarcó a todos los pacientes tratados entre enero de 2007 y enero de 2014. Resultados: en total fueron evaluados 196 pacientes adultos en 2008 (M: 104 F: 92, edad media 58,1 [41-75]) y 2.842 en 2013 (M: 1541, F: 1.301, con una edad media de 61,4 rango: 1-91). El número de pacientes aumentó significativamente entre 2008 y 2013 (p < 0,05), al pasar de 196 hasta 2.842 (y 1.716 en el momento del estudio). La enfermedad primaria predominante fue la neurología en ambos períodos de tiempo, pero el perfil cambia de neurovascular a neurodegenerativa (p > 0,05). La gastrostomía endoscópica percutánea fue el acceso GI más frecuentes (> 60%), su uso y el uso de gastrostomías aumentó significativamente desde 2008 (p < 0,05). Aunque el reembolso de HETF comenzó en 2007, los centros de HEN expresaron dudas sobre las reglas poco claras para la calificación para HEN y su uso. Conclusiones: HETF es un procedimiento seguro, bien tolerado y rentable. El perfil de los pacientes y las técnicas puede variar al principio, pero se vuelve similar a otros países HETF relativamente pronto. El número de pacientes crece rápidamente, y ese hecho sugiere que la prevalencia de HETF es similar en todos los países.

The evolution of home enteral nutrition (HEN) in Poland during five years after implementation: a multicentre study / Evolución de la nutrición enteral domiciliaria (HEN) en Polonia durante cinco años después de su implantación: un estudio multicéntrico

Background: home enteral nutrition (HEN) is the best option for chronic. patients without the ability to swallow, but with intact digestive tract. Despite the increasing use of home enteral tube feeding (HETF), there is little published information about the types of patients receiving home enteral nutrition. The purpose of this paper to present the evolution of HETF. Material and methods: the retrospective multicenter observational study was performed using questionnaires, which were distributed among the biggest Polish HEN centres. The study covered all patients treated between January, 2007 and January, 2014. Results: in total 196 adult patients in 2008 (M:104. F: 92, mean age 58.1 [41-75]) and 2842 in 2013 (M: 1541, F: 1301, mean age 61.4 range: 1-91) were assessed. The number of patients grew significantly between 2008 and 2013 (p0.05). Percutaneous endoscopic gastrostomy was the most common GI access (>60%), its use and the use of gastrostomies increased significantly since 2008 (p <0.05). Although the reimbursement for HETF started in 2007, HEN centres expressed doubts about unclear rules for the qualification to HEN and its use. Conclusions: HETF is a safe, well-tolerated and cost-effective procedure. The profile of patients and techniques may vary at the beginning, but becomes similar to other HETF countries relatively soon. The number of patients grows quickly, and that fact suggests that the prevalence of HETF is similar in all countries (AU)

Antecedentes: el inicio con nutrición enteral (HEN) es la mejor opción para los pacientes crónicos sin capacidad de tragar, pero con el tracto digestivo intacto. A pesar del aumento en el uso de la alimentación por sonda enteral domiciliaria (HETF), hay poca información publicada sobre los tipos de pacientes que reciben nutrición enteral domiciliaria. El propósito de este trabajo es presentar la evolución de HETF. Material y métodos: el estudio observacional multicéntrico retrospectivo se realizó mediante cuestionarios que se distribuyeron entre los mayores centros HEN polacos. El estudio abarcó a todos los pacientes tratados entre enero de 2007 y enero de 2014. Resultados: en total fueron evaluados 196 pacientes adultos en 2008 (M: 104 F: 92, edad media 58,1 [41-75]) y 2.842 en 2013 (M: 1541, F: 1.301, con una edad media de 61,4 rango: 1-91). El número de pacientes aumentó significativamente entre 2008 y 2013 (p0,05). La gastrostomía endoscópica percutánea fue el acceso GI más frecuentes (>60%), su uso y el uso de gastrostomías aumentó significativamente desde 2008 (p< 0,05). Aunque el reembolso de HETF comenzó en 2007, los centros de HEN expresaron dudas sobre las reglas poco claras para la calificación para HEN y su uso. Conclusiones: HETF es un procedimiento seguro, bien tolerado y rentable. El perfil de los pacientes y las técnicas puede variar al principio, pero se vuelve similar a otros países HETF relativamente pronto. El número de pacientes crece rápidamente, y ese hecho sugiere que la prevalencia de HETF es similar en todos los países (AU)

Home enteral nutrition reduces complications, length of stay, and health care costs: results from a multicenter study.

BACKGROUND: Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently. OBJECTIVE: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness. DESIGN: The observational multicenter study in the group of 456 HEN patients [142 children: 55 girls and 87 boys, mean (±SD) age 8.7 ± 5.9 y; 314 adults: 151 women and 163 men, mean age 59.3 ± 19.8 y] was performed between January 2007 and July 2013. Two 12-mo periods were compared. During the first period, patients were tube fed a homemade diet and were not monitored; during the other period, patients received HEN. HEN included tube feeding and complex monitoring by a nutrition support team. The number of complications, hospital admissions, length of hospital stay, biochemical and anthropometric variables, and costs of hospitalization were compared. RESULTS: Implementation of HEN enabled weight gain and stabilized liver function in both age groups, but it hardly influenced the other tests. HEN implementation reduced the incidence of infectious complications (37.4% compared with 14.9%; P < 0.001, McNemar test), the number of hospital admissions [1.98 ± 2.42 (mean ± SD) before and 1.26 ± 2.18 after EN; P < 0.001, Wilcoxon's signed-rank test], and length of hospital stay (39.7 ± 71.9 compared with 11.9 ± 28.5 d; P < 0.001, Wilcoxon's signed-rank test). The mean annual costs ($) of hospitalization were reduced from 6500.20 ± 10,402.69 to 2072.58 ± 5497.00. CONCLUSIONS: The study showed that HEN improves clinical outcomes and decreases health care costs. It was impossible, however, to determine precisely which factor mattered more: the artificial diet itself or the introduction of complex care.