THERAPEUTIC EFFECTS AND SIDE EFFECTS OF OMEPRAZOLE CAPSULES MANUFACTURED IN IRAN IN COMPARISON WITH PRILOSEC IN PATIENTS WITH GERD

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AZIMI K.; MALEKZADEH R.; NASERI MOGHADAM S.; MINAPOOR M.

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Journal: Journal of Medical Council of Iran Year:2003 | Volume:21 | Issue:2 Page(s): 114-120

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Title

THERAPEUTIC EFFECTS AND SIDE EFFECTS OF OMEPRAZOLE CAPSULES MANUFACTURED IN IRAN IN COMPARISON WITH PRILOSEC IN PATIENTS WITH GERD

Author(s)

AZIMI K. | MALEKZADEH R. | NASERI MOGHADAM S. | MINAPOOR M. | Issue Writer Certificate

Keywords

GASTROESOPHAGEAL REFLUX DISEASE (GERD)Q3

TREATMENTQ3

PROTON PUMP INHIBITOR (PPI)Q3

Abstract

Gastroesophageal reflux disease (GERD) is a very common disease caused by a dysfunction of the lower esophageal sphincter and esophageal dysmotility . The main signs of GERD include heartburn, regurgitation and dysphagia. Endoscopic findings of reflux include mucosal breaking in the lower esophagus (reflux induced esophagitis). Proton pump inhibitors are the drugs of choice in this disease. This study aims to assess the efficacy and side effects of omeprazole capsules manufactured in Iran compared with that manufactured abroad.A total of 64 patients (37 male, 27 female, age range, 15- 72 years) who were endoscopically diagnosed as grade A or B esophagitis (according to the Los Angeles Classification) were enrolled. The patients were randomly divided into 2 groups; patients in the first group received omeprazole and those in the second group received Prilosec 20 mg twice a day orally for 8 weeks. The patients were assessed for signs of disease and probable side effects in the initial visit and subsequently after 2,4,6 and 8 weeks and according to intensity, a score was given to the cardinal signs of disease. prior to TREATMENT and at the end of the 8th week, Upper GI endoscopy was performed for all patients.Both drugs had similar effects in improving the signs of disease; mean total symptom score decreased from 6.8+1.7 to 0.4+0.9 in group which had been treated with drug manufactured abroad and from 6.5+ 1.9 to 0.3+ 0.8 in group which had been treated with drug manufactured in Iran (p>0.05). Endoscopic signs and adverse effects did not vary in two groups.It seems that Omeprazole manufactured in Iran with its low cost, has the same clinical utilization and side effects as that of its foreign counterpart. Therefore it is rationale to treat patients with the much cheaper drug manufactured in Iran without fear of severe side effects and in case of teatment failure it is necessary to revise the initial diagnosis and emphasize on life style modification.

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