{"id":16325,"date":"2017-09-25T10:04:13","date_gmt":"2017-09-25T10:04:13","guid":{"rendered":"http:\/\/biomedpharmajournal.org\/?p=16325"},"modified":"2020-04-24T15:23:42","modified_gmt":"2020-04-24T15:23:42","slug":"effect-of-intermittent-therapy-with-rabeprazole-20mg-in-patients-with-symptomatic-gastroesophageal-reflux-disease-a-double-blind-omeprazole-controlled-study","status":"publish","type":"post","link":"https:\/\/biomedpharmajournal.org\/staging\/vol10no3\/effect-of-intermittent-therapy-with-rabeprazole-20mg-in-patients-with-symptomatic-gastroesophageal-reflux-disease-a-double-blind-omeprazole-controlled-study\/","title":{"rendered":"Effect of Intermittent Therapy With Rabeprazole 20mg in Patients With Symptomatic Gastroesophageal Reflux Disease-A Double Blind Omeprazole-Controlled Study"},"content":{"rendered":"<p><strong>Introduction<\/strong><\/p>\n<p>Proton pump inhibitors (PPI) are highly efficacious in providing symptomatic relief, healing erosions and improving quality of life in patients with symptomatic gastro esophageal reflux disease. (GERD)<sup>1<\/sup> Worldwide Proton pump inhibitors (PPI) are being used in the treatment of GERD.<sup>2<\/sup>\u00a0Anti secretary agents such as esomeprazole, pantoprazole, ilaprazole, rabeprazole causes decrease in acid production and have high healing rates and rates of resolution of reflux symptoms\u00a0 at 4 weeks but do not help in long term maintenance intermittent therapy.<sup>3<\/sup>\u00a0In our randomized control trail long term intermittent rabeprazole therapy has proved efficacious than omeprazole.<\/p>\n<p><strong>Materials\u00a0 and\u00a0 Methods<\/strong><\/p>\n<p><strong>Study Design<\/strong><\/p>\n<p>This prospective study\u00a0 concluded in 60 patients in department of Medicine Sree\u00a0 Balaji Medical College and Hospital, Chennai, India with GERD symptoms heat burn, regurgitation, epigastric pain, abdominal bloating, loss of appetite. This double blind rabeprazole, omeprazole study comprised of two phases. First phase symptomatic GERD patients either erosive or non-erosive esophagitis received\u00a0 4 weeks course of either rabeprazole or omeprazole\u00a0 20mg orally once a day and second\u00a0 phase received 4 days a week intermittently for 6 months of rabeprazole\u00a0 or omeprazole. If heart burn occurs during this period they were supplemented with on demand liquid antacid 20ml orally. Prior to entering the screening period written informed consent was obtained\u00a0 from each\u00a0 patients.<\/p>\n<p><strong>Patients<\/strong><\/p>\n<p>Male and Female\u00a0 patients aged 21-65 years of either sex with a minimum 3 months history of GERD symptoms. Patients were excluded if they had evidence of clinically significant cardiovascular, hepatic, renal, endocrinal, neurological, haematological abnormalities, known case of gastric or duodenal ulcer on long term PPI medication, patients who were on long term aspirin, non steroidal anti-inflammatory drugs, feeding or pregnant women, and those not willing for\u00a0 endoscopy. Efficacy and safety assessments patients were assessed at beginning of initial phase, during maintenance and after end of 6 months. Physical examination, vital signs and reflux clinical scoring system performed. Heart burn frequency was assessed as the number of days in a week in which symptoms occurred as 4 point scale 0=no symptoms\u00a0 1= mild occasional symptoms 2= moderate symptoms 3= severe disturbing symptoms.<\/p>\n<p><strong>Results<\/strong><\/p>\n<p>Results of the study revealed that symptomatic response to therapy was over all in non-erosive esophasitis compared to erosive esophasitis 83.5% vs 59%. Maintenance group rabeprazole was superior when compared to omeprazole non-erosive group (88.5% to 66%) and in erosive group (79.2% to 52.8%) Fig.1. On demand antacid therapy requirement is less in rabeprazole 19.8% compared to omeprazole 29.7%. Both drugs were well tolerated and no major adverse side effect observed except headache in 13.2% in rabeprazole versus 6.6% in omeprazole.<\/p>\n<p>&nbsp;<\/p>\n<table style=\"width: 70%;\" border=\"1\" cellpadding=\"5\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" class=\"alignnone size-thumbnail wp-image-16327\" src=\"https:\/\/biomedpharmajournal.org\/wp-content\/uploads\/2017\/08\/Vol10No3_Eff_Ved_fig1-150x150.jpg\" alt=\"Figure 1: Efficacy of Rabeprazole with Omeprazole\" width=\"150\" height=\"150\" srcset=\"https:\/\/biomedpharmajournal.org\/staging\/wp-content\/uploads\/2017\/08\/Vol10No3_Eff_Ved_fig1-150x150.jpg 150w, https:\/\/biomedpharmajournal.org\/staging\/wp-content\/uploads\/2017\/08\/Vol10No3_Eff_Ved_fig1-256x256.jpg 256w, https:\/\/biomedpharmajournal.org\/staging\/wp-content\/uploads\/2017\/08\/Vol10No3_Eff_Ved_fig1.jpg 641w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/><\/td>\n<td><strong>Figure 1: Efficacy of Rabeprazole with Omeprazole<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"http:\/\/biomedpharmajournal.org\/wp-content\/uploads\/2017\/08\/Vol10No3_Eff_Ved_fig1.jpg\" target=\"_blank\">Click here to View figure<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>Discussion<\/strong><\/p>\n<p>GERD is a common recurrent usually life long disorder resulting in disturbing health related quality of life in an individual<sup>4.<\/sup> Mono therapy for optimal management is insufficient. There are more studies indicate prokinetic with\u00a0 PPI\u00a0 combination\u00a0 is a better option. There are some studies indicate\u00a0 the demerits of\u00a0 prokinetics on long term.<sup>5,6\u00a0<\/sup>This study focus on \u00a0using mean percentage of heart burn free days as the primary\u00a0 outcome measure. We demonstrated that a 6 months intermittent regimen of rabeprazole 20mg\u00a0 in symptomatic\u00a0 GERD\u00a0 patients\u00a0 provide adequate efficacy in 82.5% compared to 66% in omeprazole group. The percentage of heart burn free day time and night time periods were significantly\u00a0 better for rabeprazole group. Further more\u00a0 daily use of risk antacid on demand therapy for relief of heart burn was lower in rabeprazole group than omeprazole.<sup>7<\/sup><\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p>Based\u00a0 on the symptomatic relief of intermittent rabeprazole for long term (6 months ) treatment with 20mg of rabeprazole was significantly more effective than 20mg of omeprazole. The\u00a0 overall efficacy and safety profile demonstrate in this study suggest that intermittent use of rabeprazole may be effective\u00a0 maintenance treatment strategy for patients with symptomatic GERD.<\/p>\n<p><strong>Reference<\/strong><\/p>\n<ol>\n<li>Moayyedi P., Tolley N. J.\u00a0 gastro\u2013esophageal reflux disease.\u00a0<em>Lancet.<\/em> 2006:367;2086-100.<br \/>\n<a href=\"https:\/\/doi.org\/10.1016\/S0140-6736(06)68932-0\" target=\"_blank\">CrossRef<\/a><\/li>\n<li>Bate C. M., Griffin S. M., Keeling P. W et al., Reflex Symptom relief with omeprozole in patients without unequivocal oesophatis aliment.<em> pharmacol Ther<\/em> . 1996;10:547-55.<\/li>\n<li>Carlson R., Dent J., Watts R. et al GERD in primary care\u00a0 an international study of different treatment strategies with omeprazole international GERD\u00a0 study group. <em>EUR J Gastro enterol Hepatol<\/em>. 1998;10;119-24.<br \/>\n<a href=\"https:\/\/doi.org\/10.1097\/00042737-199802000-00004\" target=\"_blank\">CrossRef<\/a><\/li>\n<li>KAJI M.,\u00a0 FUJIWARA Y., SUGUSHIBA M. et al., prevalence\u00a0 of GERD\u00a0 on health \u2013related\u00a0 quality of life. <em>Journal of gastro enterology and Hepatology.<\/em> 2010;25(6):1151-56.<br \/>\n<a href=\"https:\/\/doi.org\/10.1111\/j.1440-1746.2010.06249.x\" target=\"_blank\">CrossRef<\/a><\/li>\n<li>Stanely M., Rotrosen J. The Benzamides pharmacology neurobiology and clinical aspects in: Advances in biochemical, psychopharmacology, 35. Raven press, NEW York. 1982:7-15.<\/li>\n<li>Rossi F., Forgione A. Pharmaco toxicological aspects of levosulpiride. <em>Pharmacol Res.<\/em> 1995;31:81-94.<br \/>\n<a href=\"https:\/\/doi.org\/10.1016\/1043-6618(95)80052-2\" target=\"_blank\">CrossRef<\/a><\/li>\n<li>Hungin A. P., Rubin G. P., O\u2019Flanagon H. Long term\u00a0 prescribing of proton pump inhibitors on general practice.\u00a0\u00a0<em>Br. J. Gen. Pract<\/em>. 1999;49:451-453.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Introduction Proton pump inhibitors (PPI) are highly efficacious in providing  [&#8230;]<\/p>\n","protected":false},"author":9,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[51],"tags":[],"class_list":["post-16325","post","type-post","status-publish","format-standard","hentry","category-vol10no3"],"_links":{"self":[{"href":"https:\/\/biomedpharmajournal.org\/staging\/wp-json\/wp\/v2\/posts\/16325","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/biomedpharmajournal.org\/staging\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/biomedpharmajournal.org\/staging\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/biomedpharmajournal.org\/staging\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/biomedpharmajournal.org\/staging\/wp-json\/wp\/v2\/comments?post=16325"}],"version-history":[{"count":6,"href":"https:\/\/biomedpharmajournal.org\/staging\/wp-json\/wp\/v2\/posts\/16325\/revisions"}],"predecessor-version":[{"id":32777,"href":"https:\/\/biomedpharmajournal.org\/staging\/wp-json\/wp\/v2\/posts\/16325\/revisions\/32777"}],"wp:attachment":[{"href":"https:\/\/biomedpharmajournal.org\/staging\/wp-json\/wp\/v2\/media?parent=16325"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/biomedpharmajournal.org\/staging\/wp-json\/wp\/v2\/categories?post=16325"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/biomedpharmajournal.org\/staging\/wp-json\/wp\/v2\/tags?post=16325"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}