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| RESEARCH ARTICLE
|Year : 2014 | Volume
| 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
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.
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal
Source of Support: None, Conflict of Interest: None
Clinical trial registration CTRI/2013/12/004261
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