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| RESEARCH ARTICLE |
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| Year : 2014 | Volume
: 46
| Issue : 5 | Page : 498-502 |
Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia
Somnath Maity1, Supriyo Choudhury2, Avijit Hazra1, Amal Kanti Das1
1 Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
2 Department of Pharmacology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India
Correspondence Address:
Avijit Hazra
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0253-7613.140580
Clinical trial registration CTRI/2013/12/004261
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.
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