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Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia
OBJECTIVES: Lafutidine is a new H(2)-blocker in India claimed to be more potent and effective than existing H(2)-blockers. Proton pump inhibitors (PPIs), by virtue of their mechanism of action, have greater efficacy than H(2)-blockers in gastric acid suppression. However, clinical trials comparing H...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Medknow Publications & Media Pvt Ltd
2014
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4175885/ https://www.ncbi.nlm.nih.gov/pubmed/25298578 http://dx.doi.org/10.4103/0253-7613.140580 |
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author | Maity, Somnath Choudhury, Supriyo Hazra, Avijit Das, Amal Kanti |
author_facet | Maity, Somnath Choudhury, Supriyo Hazra, Avijit Das, Amal Kanti |
author_sort | Maity, Somnath |
collection | PubMed |
description | OBJECTIVES: Lafutidine is a new H(2)-blocker in India claimed to be more potent and effective than existing H(2)-blockers. Proton pump inhibitors (PPIs), by virtue of their mechanism of action, have greater efficacy than H(2)-blockers in gastric acid suppression. However, clinical trials comparing H(2)-blockers directly with PPIs are limited. We carried out a head-to-head comparison of the effectiveness of lafutidine versus the PPI pantoprazole in uninvestigated dyspepsia [CTRI/2013/12/004261]. MATERIALS AND METHODS: A prospective, open label, randomized, controlled trial was conducted in a tertiary care hospital. Ambulatory adult patients with dyspepsia, not yet subjected to endoscopy, were recruited if they had at least moderately severe symptoms, defined as a score of ≥ 4 on a 7-point Global Overall Symptom (GOS) Scale. Those with alarm features or significant comorbidity were excluded. Subjects received either once daily lafutidine 10 mg or pantoprazole 40 mg, orally, for 8 weeks. Reflux, dysmotility and pain scores were assessed by Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (mFSSGERD), and quality of life (QoL) by SF-8 scale. The latter had physical and mental components summarized by physical component summary score (PCS) and a mental component summary score (MCS). RESULTS: Of 122 patients enrolled, data of 57 on lafutidine and 60 on pantoprazole were analyzed. At 4 weeks, proportion of subjects responding (GOS score ≤ 2) in the two arms (lafutidine 45.61% vs. pantoprazole 48.33%, P = 0.854) or showing symptom resolution (GOS score ≤ 1) (lafutidine 12.28% vs. pantoprazole 5.00%; P = 0.197) were comparable. Similarly at 8 weeks, both responder (lafutidine 52.63% vs. pantoprazole 56.67%; P = 0.712) and symptom resolution proportions (lafutidine 33.33% vs. pantoprazole 30%; P = 0.843) were comparable. Total score on mFSSGERD scale, as well as all its three component scores, and PCS and MCS scores on QoL SF-8 scale showed improvement but no statistically significant difference between the two arms. Tolerability of both drugs was excellent. CONCLUSIONS: Lafutidine is well-tolerated and there is no clinically worthwhile difference between the two drugs in the empirical treatment of uninvestigated dyspepsia. |
format | Online Article Text |
id | pubmed-4175885 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-41758852014-10-08 Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia Maity, Somnath Choudhury, Supriyo Hazra, Avijit Das, Amal Kanti Indian J Pharmacol Research Article OBJECTIVES: Lafutidine is a new H(2)-blocker in India claimed to be more potent and effective than existing H(2)-blockers. Proton pump inhibitors (PPIs), by virtue of their mechanism of action, have greater efficacy than H(2)-blockers in gastric acid suppression. However, clinical trials comparing H(2)-blockers directly with PPIs are limited. We carried out a head-to-head comparison of the effectiveness of lafutidine versus the PPI pantoprazole in uninvestigated dyspepsia [CTRI/2013/12/004261]. MATERIALS AND METHODS: A prospective, open label, randomized, controlled trial was conducted in a tertiary care hospital. Ambulatory adult patients with dyspepsia, not yet subjected to endoscopy, were recruited if they had at least moderately severe symptoms, defined as a score of ≥ 4 on a 7-point Global Overall Symptom (GOS) Scale. Those with alarm features or significant comorbidity were excluded. Subjects received either once daily lafutidine 10 mg or pantoprazole 40 mg, orally, for 8 weeks. Reflux, dysmotility and pain scores were assessed by Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (mFSSGERD), and quality of life (QoL) by SF-8 scale. The latter had physical and mental components summarized by physical component summary score (PCS) and a mental component summary score (MCS). RESULTS: Of 122 patients enrolled, data of 57 on lafutidine and 60 on pantoprazole were analyzed. At 4 weeks, proportion of subjects responding (GOS score ≤ 2) in the two arms (lafutidine 45.61% vs. pantoprazole 48.33%, P = 0.854) or showing symptom resolution (GOS score ≤ 1) (lafutidine 12.28% vs. pantoprazole 5.00%; P = 0.197) were comparable. Similarly at 8 weeks, both responder (lafutidine 52.63% vs. pantoprazole 56.67%; P = 0.712) and symptom resolution proportions (lafutidine 33.33% vs. pantoprazole 30%; P = 0.843) were comparable. Total score on mFSSGERD scale, as well as all its three component scores, and PCS and MCS scores on QoL SF-8 scale showed improvement but no statistically significant difference between the two arms. Tolerability of both drugs was excellent. CONCLUSIONS: Lafutidine is well-tolerated and there is no clinically worthwhile difference between the two drugs in the empirical treatment of uninvestigated dyspepsia. Medknow Publications & Media Pvt Ltd 2014 /pmc/articles/PMC4175885/ /pubmed/25298578 http://dx.doi.org/10.4103/0253-7613.140580 Text en Copyright: © Indian Journal of Pharmacology http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Maity, Somnath Choudhury, Supriyo Hazra, Avijit Das, Amal Kanti Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia |
title | Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia |
title_full | Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia |
title_fullStr | Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia |
title_full_unstemmed | Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia |
title_short | Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia |
title_sort | randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4175885/ https://www.ncbi.nlm.nih.gov/pubmed/25298578 http://dx.doi.org/10.4103/0253-7613.140580 |
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