CONTROL OF ESOPHAGEAL AND INTRAGASTRIC P H WITH COMPOUNDED AND MANUFACTURED OMEPRAZOLE IN PATIENTS WITH REFLUX ESOPHAGITIS: A PILOT STUDY
Main Article Content
Keywords
Omeprazole/therapeutic use, gastroesophageal reflux/drug therapy, esophageal pH monitoring, gastric acidity determination
Abstract
Background
Proton pump inhibitors (PPI) are the drugs of choice for treatment of gastroesophageal reflux disease (GERD). Omeprazole, the first PPI commercialized, is now available in different formulations.
Objectives
To compare the efficacy of different omeprazole formulations on gastric acid secretion measured by intragastric and esophageal pH monitoring in patients with reflux esophagitis.
Methods
Prospective, open, randomized clinical trial involving H. pylori negative patients with typical symptoms of GERD. Patients were submitted to 24-h intragastric and esophageal pH studies during use of six different formulations of compounded and manufactured omeprazole.
Results
Thirty patients, 19 female, median age 55 years were studied. The intragastric pH was maintained below 4.0 for a median of 36.7% of total time in compounded group and 47.7% in manufactured group (p>0.05). There was also no statistical difference between the median percentage of time of pH below 4.0 in orthostatic and supine position in compounded and manufactured groups (30.1% and 49.6% and 28.8% and 55.2%, respectively). The esophageal pH was maintained below 4.0 for a median of 0.1% of total time in compounded group and 0.4% in manufactured group (p>0.05). In orthostatic position the median percentage of time of esophageal pH below 4.0 was 0.0% in both groups (p>0.05). In supine position, the median percentage of time of esophageal pH below 4.0 was 0.1% and 0.3% in compounded and manufactured groups, respectively (p>0.05).
Conclusion
The omeprazole formulations studied (compounded and manufactured) showed similar control of gastric acid secretion and esophageal acid exposure in patients with reflux esophagitis.
References
2. Mee AS, Rowley JL. Rapid symptom relief in reflux oesophagitis: a comparison of lansoprazole and omeprazole. Aliment Pharmacol Ther 1996;10:757-63.
3. Hatlebakk JG, Katz PO, Kuo B, Castell DO. Nocturnal gastric acidity and acid breakthrough on different regimens of omeprazole 40 mg daily. Aliment Pharmacol Ther 1998;12:1235-40.
4. Bell NJ, Burget D, Howden CW, Wilkinson J, Hunt RH. Appropriate acid suppression for the management of gastro-oesophageal reflux disease. Digestion 1992;51 Suppl 1:59-67.
5. Vaezi MF, Richter JE. Role of acid and duodenogastroesophageal reflux in gastroesophageal reflux disease. Gastroenterology 1996;111:1192-9.
6. Katz PO, Anderson C, Khoury R, Castell DO. Gastro-oesophageal reflux associated with nocturnal gastric acid breakthrough on proton pump inhibitors. Aliment Pharmacol Ther 1998;12:1231-4.
7. Fein M, Ritter MP, DeMeester TR, et al. Role of the lower esophageal sphincter and hiatal hernia in the pathogenesis of gastroesophageal reflux disease. J Gastrointest Surg 1999;3:405-10.
8. Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut 1999;45:17280.
9. Dixon MF, Genta RM, Yardley JH, Correa P. Classification and grading of gastritis. The updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994. Am J Surg Pathol 1996;20:1161-81.
10. Coelho LG, Reber M, Passos MC, et al. Application of isotope-selective non-dispersive infrared spectrometry for the evaluation of the 13C-urea breath test: comparison with three concordant methods. Braz J Med Bi ol Res 1999;32:1493-7.
11. Dicionário de especialidades farmacêuticas-DEF. http://www.epuc.com.br/DEF/Home.htm (Accessed : May 8, 2007).
12. Telelistas. http://www.telelistas.net/ (Accessed: May 8, 2007).
13. Chirac P. Médicamnts génériques:ni anges ni démons. Rev Prescr 1992;12:249-53.
14. Santos A, R. Análise conjuntural da indústria de medicamentos genéricos no Brasil no período de setembro de 2001 a agosto de 2002. Publ UEPG Ci Biol Saúde 2004;10:49-62.
15. Paumgartten FR. Papel das farmácias magistrais deve ser complementar (entrevista).Boletin Informativo ANVISA 2005;56: 4-5.
16. ANVISA. Resolução RDC número 354 de 18 de dezembro de 2003. Ementa não oficial: Permite a manipulação de produtos farmacêuticos em todas as formas farmacêuticas de uso interno, que contenham substâncias de baixo índice terapêutico, aos estabelecimentos farmacêuticos que cumprirem as condições especificadas. Diário Oficial da União; Poder Executivo. 22 de dezembro de 2003.
17. Bertges LC, Marques MRB, Pimentel CFM, Silva DC, Neves PO, Bertges KR. Utilização de fármacos manipulados no tratamento do Helicobacter pylori, em portadores de úlcera duodenal. VI Congresso Mineiro de Gastroenterologia 2003 oct23-25; Juiz de ForaMG. Congress; 2003:25.
18. Carvalho SD. Evolução clínica e tratamento da esofagite de refluxo complicada em crianças e adolescentes. [Mastre's thesis]. Belo HorizonteMG: Faculdade de Medicina da UFMG; 2004.
19. Katz PO, Ginsberg GG, Hoyle PE, Sostek MB, Monyak JT, Silberg DG. Relationship between intragastric acid control and healing status in the treatment of moderate to severe erosive oesophagitis. Aliment Pharmacol Ther 2007;1(25):617-28.
20. Katzka DA, Paoletti V, Leite L, Castell DO. Prolonged ambulatory pH monitoring in patients with persistent gastroesophageal reflux disease symptoms: testing while on therapy identifies the need for more aggressive anti-reflux therapy. Am J Gastroenterol 1996;91:2110-3.
21. Martinek J, Pantoflickova D, Hucl T, et al. Absence of nocturnal acid breakthrough in Helicobacter pylori-positive subjects treated with twice-daily omeprazole. Eur J Gastroenterol Hepatol 2004;16:445-50.
22. Sachs G, Athamann C, Weeks D, Scott D. Gastric consequences of proton pump inhibitor therapy and Helicobacter pylori eradication. In: Hunt RH, Tytgat, G.N.J., ed. Helicobacter pylori Basic mechanisms to clinical cure 2000. Boston: Kluwer Academic Publishers and Axcam Pharma; 2000:397-408.
23. Suerbaum S, Michetti P. Helicobacter pylori infection. N Engl J Med 2002;347:1175-86.
24. El-Omar EM. The importance of interleukin 1beta in Helicobacter pylori associated disease. Gut 2001;48:743-7.
25. Giral A, Celikel CA, Ozdogan O, Tozun N, Ulusoy NB, Kalayci C. Impact of Helicobacter pylori eradication on the anti-secretory efficacy of lansoprazole in gastroesophageal reflux disease patients. J Gastroenterol Hepatol 2005;20:1886-91.
26. Frazzoni M, Manno M, De Micheli E, Savarino V. Intra-oesophageal acid suppression in complicated gastro-oesophageal reflux disease: esomeprazole versus lansoprazole. Dig Liver Dis 2006;38:85-90.
27. Banki F, Demeester SR, Mason RJ, et al. Barrett's esophagus in females: a comparative analysis of risk factors in females and males. Am J Gastroenterol 2005;100:560-7.
28. Sloan S, Rademaker AW, Kahrilas PJ. Determinants of gastroesophageal junction incompetence: hiatal hernia, lower esophageal sphincter, or both? Ann Intern Med 1992;117:977-82.
29. Sontag SJ, Schnell TG, Miller TQ, et al. The importance of hiatal hernia in reflux esophagitis compared with lower esophageal sphincter pressure or smoking. J Clin Gastroenterol 1991;13:628-43.
30. Chen TS, Chang FY. The prevalence and risk factors of reflux esophagitis among adult Chinese population in Taiwan. J Clin Gastroenterol 2007;41:819-22.
31. Frazzoni M, Manno M, De Micheli E, Savarino V. Pathophysiological characteristics of the various forms of gastro-oesophageal reflux disease. Spectrum disease or distinct phenotypic presentations? Dig Liver Dis 2006;38:643-8.
32. Dickman R, Parthasarathy S, Malagon IB, et al. Comparisons of the distribution of oesophageal acid exposure throughout the sleep period among the different gastro-oesophageal reflux disease groups. Aliment Pharmacol Ther 2007;26:41-8.
33. DeVault KR. Review article: the role of acid suppression in patients with non-erosive reflux disease or functional heartburn. Aliment Pharmacol Ther 2006;23 Suppl 1:33-9.
34. Robertson D, Aldersley M, Shepherd H, Smith CL. Patterns of acid reflux in complicated oesophagitis. Gut 1987;28:1484-8.
35. Carlsson R, Dent J, Watts R, et al. Gastro- oesophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole. International GORD Study Group. Eur J Gastroenterol Hepatol 1998;10:11924.
36. Lind T, Havelund T, Carlsson R, et al. Heartburn without oesophagitis: efficacy of omeprazole therapy and features determining therapeutic response. Scand J Gastroenterol 1997;32:974-9.
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