Ação da Substância - Creon

Eficácia do Creon

A eficácia da pancreatina foi avaliada em 30 estudos com pacientes com problemas pancreáticos, incluindo fibrose cística, pancreatite crônica e pós-cirurgia.

Em estudos comparados com placebo, o principal objetivo foi mostrar superioridade no coeficiente de absorção de gordura (CFA).

O CFA mede a porcentagem de gordura absorvida pelo corpo. Com pancreatina, o CFA aumentou para 83,0% contra 62,6% do placebo. Em todos os estudos, o CFA final com pancreatina foi consistente.

O tratamento melhorou sintomas como consistência das fezes, dores abdominais, gases e frequência de evacuações, independente da doença.

Eficácia em crianças

Eficácia comprovada em 288 crianças (recém-nascidos a adolescentes) com fibrose cística. O CFA excedeu 80% em todos os grupos pediátricos.

Referências Bibliográficas

1. Solvay Pharmaceuticals GmbH. A double-blind, randomized, multi-center, placebo-controlled, cross-over study to assess the efficacy and safety of pancrelipase delayed release 24,000 unit capsule in subjects with pancreatic exocrine insufficiency due to cystic fibrosis. Clinical Study Report 2008 (S245.3.126).
2. Solvay Pharmaceuticals Inc. USA. A comparison of the efficacy and safety of Creon 20, 000 MMS and placebo in the treatment of steatorrhea in pediatric and adolescent Cystic Fibrosis subjects with clinical exocrine pancreatic insufficiency. Internal lntegrated Medical and Statistical Report 1996 (S223.3.101).
3. BÜCHLER, M.; SANDER-STRUCKMEIER, S.; SCHMIDTMANN, B. Double-blind, multicenter, placebocontrolled, randomized, parallel group study to prove superior efficacy of Creon^© 20,000 Minimicrospheres™ in sachets in subjects with pancreatic exocrine insufficiency caused by total or partial gastrectomy. Solvay Pharmaceuticals Report 2000 (S245.3.102).
4. DUHAMEL, J. F.; HOSANSKY, F.; PATRIS, A. Open-label, multicenter, randomised cross-over study to investigate the patient's preference of Creon^© 10,000 Minimicrospheres™ over Creon^© 12,000 in subjects with pancreatic exocrine insufficiency caused by Cystic Fibrosis. Solvay Pharma (France) Report 1997 (K245.5.002).
5. MÖSSNER, K.; SAUERMANN, W.; SANDER, S. Double-blind, multicenter, randomized, cross-over study to prove the equivalent efficacy of Creon^© 10, 000 Minimicrospheres™ and Creon^© 10,000 Microspheres in subjects with pancreatic exocrine insufficiency caused by Chronic Pancreatitis. Solvay Pharmaceuticals Report 1998 (K245.5.003).
6. O'KEEFE, S. J.; SANDER, S.; GRÄVE, M. Double-blind, multicenter, randomized, parallel group comparative study to prove superior efficacy of Creon^© 10,000 Minimicrospheres™ versus placebo in patient with pancreatic exocrine insufficiency caused by Chronic Pancreatitis. Solvay Pharmaceuticals Report 1996 (K245.5.005).
7. SANDER-STRUCKMEIER, S.; BECKMANN, K. Double-blind, multicenter, placebo-controlled, randomized, parallel-group study to investigate the efficacy of Creon^© 10,000 MMS versus placebo in diabetes mellitus subjects (type 1 and 2) with pancreatic exocrine insufficiency. Solvay Pharmaceuticals Report 2001 (S245.3.112113).
8. SANDER-STRUCKMEIER, S.; SCHMIDTMANN, B. Double-blind, single-center, randomized, crossover study to prove the equivalent efficacy and tolerance of Creon^© 25,000 MMS versus Creon^© 25,000 MS in subjects with pancreatic exocrine insufficiency caused by partial or total pancreatectomy. Solvay Pharmaceuticals Report 1999 (S248.3.001).
9. SANDER-STRUCKMEIER, S.; SAUERMANN, W. Double-blind bicenter, randomized, cross-over study to prove equivalent efficacy and tolerance of Creon^© 25,000 MMS versus Creon^© 25,000 MMS (Pankreon Forte) in subjects with pancreatic exocrine insufficiency caused by Cystic Fibrosis. Solvay Pharmaceuticals Report 1998 (S248.3.002).
10. SANDER-STRUCKMEIER, S. Open-label, single-arm, multicenter study to evaluate the efficacy and tolerability of Creon for children in infants with pancreatic exocrine insufficiency caused by Cystic Fibrosis. Solvay Pharmaceuticals Report 2006 (S248.3.003).
11. SINAASAPPEL, M.; SAUERMANN, W.; SANDER, S. Double-blind, multicenter, randomized, cross-over study to prove the equivalent efficacy of Creon^© 10,000 Minimicrospheres™ and Creon 8,000 Microspheres in subjects with pancreatic exocrine insufficiency caused by Cystic Fibrosis. Solvay Pharmaceuticals Report 1998 (K245.5.004).
12. SMYTH, R.L.; COLLINS, S.; SAUERMANN, W. Open, randomized, cross-over, multicenter study to investigate relative patient preference for Creon^© 10,000 Minimicrospheres™ versus Creon^© 8,000 Microspheres in subjects with pancreatic exocrine insufficiency caused by Cystic Fibrosis. Solvay Pharmaceuticals Report 1999 (S245.3.105).
13. Solvay Pharmaceuticals Inc. USA. Double-blind, randomized, multicenter, placebo-controlled, parallel group study of the effects of oral pancreatic enzymes (Creon^© 10, 000 MMS) on steatorrhea in subjects with Chronic Pancreatitis. Internal Integrated Medical and Statistical Report 1996 (223.2.01).
14. Solvay Pharmaceuticals Inc. USA. A comparison of the efficacy and safety of Creon^© 25,000 MMS and placebo in the treatment of steatorrhea in adult Cystic Fibrosis subjects with clinical exocrine pancreatic insufficiency. Internal Integrated Medical and Statistical Report 1997 (S223.3.102).
15. Solvay Seiyaku K. K. Japan. The clinical Phase II study of Creon^© Minimicrospheres (SA-001). Internal Integrated Medical and Statistical Report I999 (K245.5.703).
16. Solvay Seiyaku K. K. Japan. A Clinical Phase III Long-Term Administration Study of SA-001. Internal Integrated Medical and Statistical Report 2003 (S245.3.103).
17. Solvay Seiyaku K. K. Japan. A Clinical Phase III Open-Label Study of SA-001. Internal Integrated Medical and Statistical Report 2003 (S245.3.104).
18. Solvay Seiyaku K. K. Japan. A Clinical Study of SA-001-Cystic Fibrosis. Internal Integrated Medical and Statistical Report 2003 (S245.2.002).
19. Solvay Seiyaku K. K. Japan S245.3.117. A Clinical Study of SA001 -Cystic Fibrosis. Interim Report. Internal Integrated Medical and Statistical Report 2004 (S245.3.117).
20. Solvay Seiyaku K. K. Japan. A double-blind, multicenter, randomized, parallel-group comparative study to prove superior efficacy of SA001 versus placebo in subjects with pancreatic exocrine insufficiency caused by Chronic Pancreatitis or pancreatectomy. Internal Integrated Medical and Statistical Report 2003 (S245.3.115).
21. Solvay Pharmaceuticals GmbH. Open-label, cross-over, randomized, reference-controlled multicenter study to investigate the parents' preference for Creon^© for children over Creon^© 12000 U in infants with pancreatic exocrine insufficiency due to cystic fibrosis. Clinical Study Report 2006 (S245.3.118).
22. Solvay Pharmaceuticals GmbH. Double-blind, placebo controlled, randomized, multicenter, parallel group study to investigate the efficacy of Creon^© 25, 000 Minimicrospheres versus placebo in subjects in a refeeding status after acute pancreatitis. Clinical Study Report 2005 (S248.4.001).
23. Solvay Pharmaceuticals GmbH. A double blind, placebo controlled, single center, pilot study to investigate the efficacy of Creon^© 25,000 Minimicrospheres in subjects recovered from acute pancreatitis with symptoms of mild pancreatic insufficiency. Clinical Study Report 2005 (S248.4.002).
24. Solvay Pharmaceuticals GmbH. A study to investigate the effect of pancrelipase delayed release capsules on mal digestion in subjects with exocrine pancreatic insufficiency due to chronic pancreatitis and pancreatectomy. Clinical Study Report 2009 (S245.3.124).
25. Solvay Pharmaceuticals GmbH. A double-blind, randomized, multi-center, placebo controlled, cross-over study to assess the efficacy and safety of Pancrelipase Delayed Release 12,000 unit capsules in subjects ages 7-11 with pancreatic exocrine insufficiency due to cystic fibrosis. Clinical Study Report 2009 (S245.3.127).
27. Solvay Pharmaceuticals Inc. A comparison of the efficacy and safety of Pancreatina 20,000 MMS and placebo in the treatment of steatorrhea in adult Cystic Fibrosis subjects with clinical exocrine pancreatic insufficiency. Internal Integrated Medical and Statistical Report 1997 (S223.3.102).
28. Abbott Products GmbH. One week double-blind, randomized, placebo-controlled, parallel group, multi-center study with Pancreatina 25000 Minimicrospheres™ in Subjects with pancreatic exocrine insufficiency after pancreatic surgery, followed by an open-label long term extension of 1 year. Clinical Study Report 2011 (S245.4.008).
29. Abbott Products GmbH. A one week double-blind, randomized, placebo controlled, parallel group, multi-center study with Creon 40000 MMS in subjects with pancreatic exocrine insufficiency due to chronic pancreatitis, followed by an open-label long-term extension. Clinical Study Report 2011 (S245.4.009).

Propriedades farmacológicas

Como age no organismo

Pancreatina de origem suína em microesferas com revestimento entérico, em cápsulas.

As cápsulas se dissolvem no estômago, liberando microesferas que se misturam ao alimento. Quando chegam ao intestino (pH > 5,5), o revestimento se quebra e libera enzimas que digerem gorduras, carboidratos e proteínas.

Como o corpo processa

Estudos em animais não mostraram absorção das enzimas intactas. Enzimas pancreáticas agem no trato gastrointestinal e são digeridas em peptídeos/aminoácidos antes da absorção.

O efeito começa quando as enzimas encontram o alimento no duodeno (pH > 5,5).

Testes em laboratório

Dados pré-clínicos não mostraram toxicidade relevante. Não foram feitos estudos de genotoxicidade, carcinogenicidade ou toxicidade reprodutiva.