title: Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia.
abstract: OBJECTIVE
  Lafutidine is a new H2-blocker in India claimed to be more potent and effective than existing H2-blockers. Proton pump inhibitors (PPIs), by virtue of their mechanism of action, have greater efficacy than H2-blockers in gastric acid suppression. However, clinical trials comparing H2-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].
  
  
  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.
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
authors.forename: Somnath
authors.initials: S
authors.lastname: Maity
authors.affiliation: Department of Pharmacology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.
authors.forename: Supriyo
authors.initials: S
authors.lastname: Choudhury
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
authors.forename: Avijit
authors.initials: A
authors.lastname: Hazra
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
authors.forename: Amal Kanti
authors.initials: AK
authors.lastname: Das
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D000081:Acetamides / Q000627:therapeutic use*; D000328:Adult; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000188:drug therapy; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D000077402:Pantoprazole; D010880:Piperidines / Q000627:therapeutic use*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011725:Pyridines / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000081:Acetamides; D006635:Histamine H2 Antagonists; D010880:Piperidines; D054328:Proton Pump Inhibitors; D011725:Pyridines; C076948:lafutidine; D000077402:Pantoprazole
keywords: Dyspepsia; lafutidine; pantoprazole; randomized controlled trial