Efficacy and tolerability of 20 mg pantoprazole versus 300 mg ranitidine in patients with mild reflux-oesophagitis: a randomized, double-blind, parallel, and multicentre study
BACKGROUND AND AIM METHODSPatients with endoscopically established mild GORD (stage I, modified Savary-Miller classification) were enrolled into a multicentre, randomized, double-blind, parallel-group comparison study (intention-to-treat population, n = 201; age range, 18-82 years). Patients took ei...
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| container_title | European journal of gastroenterology & hepatology |
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| creator | van Zyl, Jan H Grundling, Hendrik de K van Rensburg, Christoffel J Retief, Francois J OʼKeefe, Stephen J. D Theron, Ilse Fischer, Renate Bethke, Thomas |
| description | BACKGROUND AND AIM
METHODSPatients with endoscopically established mild GORD (stage I, modified Savary-Miller classification) were enrolled into a multicentre, randomized, double-blind, parallel-group comparison study (intention-to-treat population, n = 201; age range, 18-82 years). Patients took either oral pantoprazole 20 mg in the morning (n = 101) or ranitidine 300 mg in the evening (n = 100) once daily for 4 weeks or, if the healing was not complete, 8 weeks. Relief from key symptoms (heartburn, acid regurgitation, pain on swallowing) was assessed after 2, 4, and if applicable, 8 weeks. Healing of lesions was confirmed endoscopically after 4 and, if applicable, 8 weeks.
RESULTSComplete relief from key symptoms was noted after 2 weeks in 70/88 (80%) patients treated with pantoprazole vs 45/89 (51%) patients treated with ranitidine (‘per-protocol and key-point available’ populations, P < 0.001); the corresponding results after 4 weeks were 77/88 (88%) vs 51/88 (58%) (P < 0.001). Complete healing of lesions after 4 weeks of treatment was seen in 74/88 (84%) vs 49/89 (55%) in the pantoprazole and ranitidine group, respectively (P < 0.001, per-protocol); by week 8 the cumulative healing rates were 84/88 (95%) vs 69/89 (78%) in the pantoprazole and ranitidine group, respectively (P < 0.001). For the intention-to-treat populations, the corresponding values for healing after 4 and 8 weeks were 73% vs 49% (P < 0.001) and 83% vs 69% (P < 0.05), respectively. Both study medications were well tolerated.
CONCLUSIONCompared to ranitidine 300 mg, the regimen with pantoprazole 20 mg provides faster relief from symptoms and is significantly more effective in healing of oesophageal lesions in patients with mild reflux-oesophagitis. Thus, the low dose of pantoprazole offers a treatment approach which minimizes drug exposure and costs while retaining high efficacy. Eur J Gastroenterol Hepatol 12:197-202 © 2000 Lippincott Williams & WilkinsEuropean Journal of Gastroenterology & Hepatology 2000, 12:197-202 |
| doi_str_mv | 10.1097/00042737-200012020-00011 |
| format | Article |
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METHODSPatients with endoscopically established mild GORD (stage I, modified Savary-Miller classification) were enrolled into a multicentre, randomized, double-blind, parallel-group comparison study (intention-to-treat population, n = 201; age range, 18-82 years). Patients took either oral pantoprazole 20 mg in the morning (n = 101) or ranitidine 300 mg in the evening (n = 100) once daily for 4 weeks or, if the healing was not complete, 8 weeks. Relief from key symptoms (heartburn, acid regurgitation, pain on swallowing) was assessed after 2, 4, and if applicable, 8 weeks. Healing of lesions was confirmed endoscopically after 4 and, if applicable, 8 weeks.
RESULTSComplete relief from key symptoms was noted after 2 weeks in 70/88 (80%) patients treated with pantoprazole vs 45/89 (51%) patients treated with ranitidine (‘per-protocol and key-point available’ populations, P < 0.001); the corresponding results after 4 weeks were 77/88 (88%) vs 51/88 (58%) (P < 0.001). Complete healing of lesions after 4 weeks of treatment was seen in 74/88 (84%) vs 49/89 (55%) in the pantoprazole and ranitidine group, respectively (P < 0.001, per-protocol); by week 8 the cumulative healing rates were 84/88 (95%) vs 69/89 (78%) in the pantoprazole and ranitidine group, respectively (P < 0.001). For the intention-to-treat populations, the corresponding values for healing after 4 and 8 weeks were 73% vs 49% (P < 0.001) and 83% vs 69% (P < 0.05), respectively. Both study medications were well tolerated.
CONCLUSIONCompared to ranitidine 300 mg, the regimen with pantoprazole 20 mg provides faster relief from symptoms and is significantly more effective in healing of oesophageal lesions in patients with mild reflux-oesophagitis. Thus, the low dose of pantoprazole offers a treatment approach which minimizes drug exposure and costs while retaining high efficacy. Eur J Gastroenterol Hepatol 12:197-202 © 2000 Lippincott Williams & WilkinsEuropean Journal of Gastroenterology & Hepatology 2000, 12:197-202]]></description><identifier>ISSN: 0954-691X</identifier><identifier>EISSN: 1473-5687</identifier><identifier>DOI: 10.1097/00042737-200012020-00011</identifier><identifier>PMID: 10741935</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins, Inc</publisher><subject>2-Pyridinylmethylsulfinylbenzimidazoles ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Benzimidazoles - therapeutic use ; Biological and medical sciences ; Digestive system ; Double-Blind Method ; Enzyme Inhibitors - therapeutic use ; Esophagitis, Peptic - drug therapy ; Esophagitis, Peptic - etiology ; Female ; Gastroesophageal Reflux - complications ; Gastroesophageal Reflux - drug therapy ; Histamine H2 Antagonists - therapeutic use ; Humans ; Male ; Medical sciences ; Middle Aged ; Omeprazole - analogs & derivatives ; Pantoprazole ; Pharmacology. Drug treatments ; Ranitidine - therapeutic use ; Severity of Illness Index ; South Africa ; Sulfoxides - therapeutic use ; Treatment Outcome</subject><ispartof>European journal of gastroenterology & hepatology, 2000-02, Vol.12 (2), p.197-202</ispartof><rights>2000 Lippincott Williams & Wilkins, Inc.</rights><rights>2000 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1297102$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10741935$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van Zyl, Jan H</creatorcontrib><creatorcontrib>Grundling, Hendrik de K</creatorcontrib><creatorcontrib>van Rensburg, Christoffel J</creatorcontrib><creatorcontrib>Retief, Francois J</creatorcontrib><creatorcontrib>OʼKeefe, Stephen J. D</creatorcontrib><creatorcontrib>Theron, Ilse</creatorcontrib><creatorcontrib>Fischer, Renate</creatorcontrib><creatorcontrib>Bethke, Thomas</creatorcontrib><title>Efficacy and tolerability of 20 mg pantoprazole versus 300 mg ranitidine in patients with mild reflux-oesophagitis: a randomized, double-blind, parallel, and multicentre study</title><title>European journal of gastroenterology & hepatology</title><addtitle>Eur J Gastroenterol Hepatol</addtitle><description><![CDATA[BACKGROUND AND AIM
METHODSPatients with endoscopically established mild GORD (stage I, modified Savary-Miller classification) were enrolled into a multicentre, randomized, double-blind, parallel-group comparison study (intention-to-treat population, n = 201; age range, 18-82 years). Patients took either oral pantoprazole 20 mg in the morning (n = 101) or ranitidine 300 mg in the evening (n = 100) once daily for 4 weeks or, if the healing was not complete, 8 weeks. Relief from key symptoms (heartburn, acid regurgitation, pain on swallowing) was assessed after 2, 4, and if applicable, 8 weeks. Healing of lesions was confirmed endoscopically after 4 and, if applicable, 8 weeks.
RESULTSComplete relief from key symptoms was noted after 2 weeks in 70/88 (80%) patients treated with pantoprazole vs 45/89 (51%) patients treated with ranitidine (‘per-protocol and key-point available’ populations, P < 0.001); the corresponding results after 4 weeks were 77/88 (88%) vs 51/88 (58%) (P < 0.001). Complete healing of lesions after 4 weeks of treatment was seen in 74/88 (84%) vs 49/89 (55%) in the pantoprazole and ranitidine group, respectively (P < 0.001, per-protocol); by week 8 the cumulative healing rates were 84/88 (95%) vs 69/89 (78%) in the pantoprazole and ranitidine group, respectively (P < 0.001). For the intention-to-treat populations, the corresponding values for healing after 4 and 8 weeks were 73% vs 49% (P < 0.001) and 83% vs 69% (P < 0.05), respectively. Both study medications were well tolerated.
CONCLUSIONCompared to ranitidine 300 mg, the regimen with pantoprazole 20 mg provides faster relief from symptoms and is significantly more effective in healing of oesophageal lesions in patients with mild reflux-oesophagitis. Thus, the low dose of pantoprazole offers a treatment approach which minimizes drug exposure and costs while retaining high efficacy. Eur J Gastroenterol Hepatol 12:197-202 © 2000 Lippincott Williams & WilkinsEuropean Journal of Gastroenterology & Hepatology 2000, 12:197-202]]></description><subject>2-Pyridinylmethylsulfinylbenzimidazoles</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Benzimidazoles - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Digestive system</subject><subject>Double-Blind Method</subject><subject>Enzyme Inhibitors - therapeutic use</subject><subject>Esophagitis, Peptic - drug therapy</subject><subject>Esophagitis, Peptic - etiology</subject><subject>Female</subject><subject>Gastroesophageal Reflux - complications</subject><subject>Gastroesophageal Reflux - drug therapy</subject><subject>Histamine H2 Antagonists - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Omeprazole - analogs & derivatives</subject><subject>Pantoprazole</subject><subject>Pharmacology. Drug treatments</subject><subject>Ranitidine - therapeutic use</subject><subject>Severity of Illness Index</subject><subject>South Africa</subject><subject>Sulfoxides - therapeutic use</subject><subject>Treatment Outcome</subject><issn>0954-691X</issn><issn>1473-5687</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2000</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kstu1TAQhi0EoqeFV0BeIFYN9SWxE3aoKgWpUjcgsbMmttNjcOJgOxxOX6qviM8FyoaVx5rvH4_nH4QwJW8p6eQFIaRmksuKlYgywki1C-gTtKK15FUjWvkUrUjX1JXo6NcTdJrSt0JITuVzdEKJrGnHmxV6uBoGp0FvMUwG5-BthN55l7c4DJgRPN7hGaYc5gj3JYt_2piWhDnZpyJMLjvjJovdVMDs7JQT3ri8xqPzBkc7-OVXFWwK8xruCpzeYdjpTBjdvTXn2ISl97bqvZvKbYYI3lt_vm9oXHx2utSMFqe8mO0L9GwAn-zL43mGvny4-nz5sbq5vf50-f6m0pwTWvFWggYqgLaD7IWumSFM1oS3g6AN57ZnlNDWSM206KUcRNP0reGSd31LqOBn6M2h7hzDj8WmrEaXtPUeJhuWpGSRi67jBWwPoI4hpfJdNUc3QtwqStTOLPXHLPXXLLU3q0hfHd9Y-tGaf4QHdwrw-ghA0uCHMjXt0iPHutIGK1h9wDbB52LPd79sbFRrCz6v1f92hf8GbaGtZg</recordid><startdate>200002</startdate><enddate>200002</enddate><creator>van Zyl, Jan H</creator><creator>Grundling, Hendrik de K</creator><creator>van Rensburg, Christoffel J</creator><creator>Retief, Francois J</creator><creator>OʼKeefe, Stephen J. D</creator><creator>Theron, Ilse</creator><creator>Fischer, Renate</creator><creator>Bethke, Thomas</creator><general>Lippincott Williams & Wilkins, Inc</general><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200002</creationdate><title>Efficacy and tolerability of 20 mg pantoprazole versus 300 mg ranitidine in patients with mild reflux-oesophagitis: a randomized, double-blind, parallel, and multicentre study</title><author>van Zyl, Jan H ; Grundling, Hendrik de K ; van Rensburg, Christoffel J ; Retief, Francois J ; OʼKeefe, Stephen J. D ; Theron, Ilse ; Fischer, Renate ; Bethke, Thomas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3301-387aca16a18f7b6c42d0274038f61533eb21018d7c2c6b77f655b8d3739b80163</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2000</creationdate><topic>2-Pyridinylmethylsulfinylbenzimidazoles</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Benzimidazoles - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Digestive system</topic><topic>Double-Blind Method</topic><topic>Enzyme Inhibitors - therapeutic use</topic><topic>Esophagitis, Peptic - drug therapy</topic><topic>Esophagitis, Peptic - etiology</topic><topic>Female</topic><topic>Gastroesophageal Reflux - complications</topic><topic>Gastroesophageal Reflux - drug therapy</topic><topic>Histamine H2 Antagonists - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Omeprazole - analogs & derivatives</topic><topic>Pantoprazole</topic><topic>Pharmacology. Drug treatments</topic><topic>Ranitidine - therapeutic use</topic><topic>Severity of Illness Index</topic><topic>South Africa</topic><topic>Sulfoxides - therapeutic use</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>van Zyl, Jan H</creatorcontrib><creatorcontrib>Grundling, Hendrik de K</creatorcontrib><creatorcontrib>van Rensburg, Christoffel J</creatorcontrib><creatorcontrib>Retief, Francois J</creatorcontrib><creatorcontrib>OʼKeefe, Stephen J. D</creatorcontrib><creatorcontrib>Theron, Ilse</creatorcontrib><creatorcontrib>Fischer, Renate</creatorcontrib><creatorcontrib>Bethke, Thomas</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of gastroenterology & hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>van Zyl, Jan H</au><au>Grundling, Hendrik de K</au><au>van Rensburg, Christoffel J</au><au>Retief, Francois J</au><au>OʼKeefe, Stephen J. D</au><au>Theron, Ilse</au><au>Fischer, Renate</au><au>Bethke, Thomas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and tolerability of 20 mg pantoprazole versus 300 mg ranitidine in patients with mild reflux-oesophagitis: a randomized, double-blind, parallel, and multicentre study</atitle><jtitle>European journal of gastroenterology & hepatology</jtitle><addtitle>Eur J Gastroenterol Hepatol</addtitle><date>2000-02</date><risdate>2000</risdate><volume>12</volume><issue>2</issue><spage>197</spage><epage>202</epage><pages>197-202</pages><issn>0954-691X</issn><eissn>1473-5687</eissn><abstract><![CDATA[BACKGROUND AND AIM
METHODSPatients with endoscopically established mild GORD (stage I, modified Savary-Miller classification) were enrolled into a multicentre, randomized, double-blind, parallel-group comparison study (intention-to-treat population, n = 201; age range, 18-82 years). Patients took either oral pantoprazole 20 mg in the morning (n = 101) or ranitidine 300 mg in the evening (n = 100) once daily for 4 weeks or, if the healing was not complete, 8 weeks. Relief from key symptoms (heartburn, acid regurgitation, pain on swallowing) was assessed after 2, 4, and if applicable, 8 weeks. Healing of lesions was confirmed endoscopically after 4 and, if applicable, 8 weeks.
RESULTSComplete relief from key symptoms was noted after 2 weeks in 70/88 (80%) patients treated with pantoprazole vs 45/89 (51%) patients treated with ranitidine (‘per-protocol and key-point available’ populations, P < 0.001); the corresponding results after 4 weeks were 77/88 (88%) vs 51/88 (58%) (P < 0.001). Complete healing of lesions after 4 weeks of treatment was seen in 74/88 (84%) vs 49/89 (55%) in the pantoprazole and ranitidine group, respectively (P < 0.001, per-protocol); by week 8 the cumulative healing rates were 84/88 (95%) vs 69/89 (78%) in the pantoprazole and ranitidine group, respectively (P < 0.001). For the intention-to-treat populations, the corresponding values for healing after 4 and 8 weeks were 73% vs 49% (P < 0.001) and 83% vs 69% (P < 0.05), respectively. Both study medications were well tolerated.
CONCLUSIONCompared to ranitidine 300 mg, the regimen with pantoprazole 20 mg provides faster relief from symptoms and is significantly more effective in healing of oesophageal lesions in patients with mild reflux-oesophagitis. Thus, the low dose of pantoprazole offers a treatment approach which minimizes drug exposure and costs while retaining high efficacy. Eur J Gastroenterol Hepatol 12:197-202 © 2000 Lippincott Williams & WilkinsEuropean Journal of Gastroenterology & Hepatology 2000, 12:197-202]]></abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>10741935</pmid><doi>10.1097/00042737-200012020-00011</doi><tpages>6</tpages></addata></record> |
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| subjects | 2-Pyridinylmethylsulfinylbenzimidazoles Adolescent Adult Aged Aged, 80 and over Benzimidazoles - therapeutic use Biological and medical sciences Digestive system Double-Blind Method Enzyme Inhibitors - therapeutic use Esophagitis, Peptic - drug therapy Esophagitis, Peptic - etiology Female Gastroesophageal Reflux - complications Gastroesophageal Reflux - drug therapy Histamine H2 Antagonists - therapeutic use Humans Male Medical sciences Middle Aged Omeprazole - analogs & derivatives Pantoprazole Pharmacology. Drug treatments Ranitidine - therapeutic use Severity of Illness Index South Africa Sulfoxides - therapeutic use Treatment Outcome |
| title | Efficacy and tolerability of 20 mg pantoprazole versus 300 mg ranitidine in patients with mild reflux-oesophagitis: a randomized, double-blind, parallel, and multicentre study |
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