Safety and efficacy of Creon® Micro in children with exocrine pancreatic insufficiency due to cystic fibrosis

Abstract

Creon Micro was well tolerated. Growth development parameters increased over the 3-month treatment period. Treatment was considered easy to use and acceptance was good.

Contribution of pancreatic enzyme replacement therapy to survival and quality of life in patients with pancreatic exocrine insufficiency

“…In children < 2 years of age, significant increases in the weight-for-age z-score were observed after 8 wk of PERT, as well as increases in the length-for-age z-score (Figure 1A)[27]. Similar results were observed over 12 wk of PERT in children 1 mo to < 4 years of age, with marked increases particularly observed in children < 2 years of age (Figure 1B)[28]. In older children ≥ 7 years of age, 12 mo of PERT was shown to lead to and maintain age-appropriate growth and weight gain[29].…”

“…The positive effects of PERT in patients with CF are further supported by findings from open-label studies in different age groups, including an 8-wk study in children < 2 years of age[27], a 12-wk study in children 1 mo to < 4 years of age[28], a 12-mo study in children ≥ 7 years of age[29], and a 14-d study in children 6-36 mo of age[30] (). In addition to improvements in fat and protein absorption, PERT was associated with age-appropriate increases in growth parameters.…”

Impact of clinical and laboratory weight gain in a cohort of patients with cystic fibrosis diagnosed by newborn screening factors

“…A insuficiência pancreática exócrina afeta, aproximadamente, 80-90% dos pacientes com Fibrose Cística, sendo muitas vezes identificada já nos primeiros meses de vida. 10 Manifestações digestivas comprometem significativamente o estado nutricional devido à má digestão e absorção de nutrientes, incluindo as vitaminas lipossolúveis. 11 Como resultado, esteatorreia, dor abdominal, deterioração de órgãos,perda de peso, tornando menor a expectativa de vida.…”

The economic consequences of the introduction of Creon Micro into the basal therapy of exocrine pancreas deficiency due to cystic fibrosis in the children presenting with mucoviscidosis

“…Целью данного исследования был экономический анализ последствий широкого использования нового препарата для заместительной терапии -Креон Микро. Эта новая лекарственная форма микросферических заместительных ферментов специально разработана для заместительной терапии у детей, и в первую очередь у детей с муковисцидозом [9]. Препарат представляет собой кишечнорастворимые гранулы, которые дозируются с помощью прилагаемой мерной ложечки, вмещающей 100 мг гранул, которые в свою очередь содержат 60,12 мг свиного панкреатина (5000 единиц липазы, 3600 единиц амилазы и 200 еди ниц протеазы).…”

“…Каширская и соавт. [9] опубликовали результаты 3-месячного открытого многоцентрового клинического испытания препарата Креон Микро, проведенного в Российской Федерации. В него были включены дети в возрасте от 1 мес до 4 лет.…”