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Randomized Controlled Trial of Effectiveness of Lafutidine Versus Pantoprazole in Uninvestigated Dyspepsia

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Randomized Controlled Trial of Effectiveness of Lafutidine Versus Pantoprazole in Uninvestigated Dyspepsia Research Article Randomized controlled trial of effectiveness of lafutidine versus pantoprazole in uninvestigated dyspepsia Somnath Maity, Supriyo Choudhury1, Avijit Hazra, Amal Kanti Das ABSTRACT Objectives: 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 effi cacy 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]. Materials and Methods: A prospective, open label, randomized, controlled trial was conducted in a tertiary care hospital. Ambulatory adult patients with dyspepsia, not Departments of Pharmacology, Institute of Postgraduate Medical yet subjected to endoscopy, were recruited if they had at least moderately severe Education and Research, Kolkata, symptoms, defi ned as a score of ≥ 4 on a 7-point Global Overall Symptom (GOS) 1Pharmacology, College of Scale. Those with alarm features or signifi cant comorbidity were excluded. Subjects Medicine and Sagore Dutta received either once daily lafutidine 10 mg or pantoprazole 40 mg, orally, for 8 weeks. Hospital, Kolkata, West Bengal, Refl ux, dysmotility and pain scores were assessed by Modifi ed Frequency Scale for the India Symptoms of Gastroesophageal Refl ux Disease (mFSSGERD), and quality of life (QoL) by SF-8 scale. The latter had physical and mental components summarized by physical RReceived:eceived: 27-04-2014 component summary score (PCS) and a mental component summary score (MCS). RRevised:evised: 25-06-2014 Results: Of 122 patients enrolled, data of 57 on lafutidine and 60 on pantoprazole AAccepted:ccepted: 31-07-2014 were analyzed. At 4 weeks, proportion of subjects responding (GOS score ≤ 2) in the CCorrespondenceorrespondence tto:o: two arms (lafutidine 45.61% vs. pantoprazole 48.33%, P = 0.854) or showing symptom Dr. Avijit Hazra, resolution (GOS score ≤ 1) (lafutidine 12.28% vs. pantoprazole 5.00%; P = 0.197) were E-mail: [email protected] 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 signifi cant 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. KKEYEY WWORDS:ORDS: Dyspepsia, lafutidine, pantoprazole, randomized controlled trial Introduction represents a symptom cluster rather than a diagnosis. The first influential definition was the 1988 Working Party classification[1] Dyspepsia is a common problem. The term refers to symptoms arising from the upper gastrointestinal tract and that stated that dyspepsia includes any symptom referable to the upper gastrointestinal tract; symptoms need to be present for at AAccessccess thisthis articlearticle onlineonline least 4 weeks and include upper abdominal pain or discomfort, QQuickuick RResponseesponse Code:Code: heartburn, acid reflux, nausea and vomiting. It subdivided WWebsite:ebsite: www.ijp-online.com dyspepsia patients, on the basis of symptom patterns, into DDOI:OI: 10.4103/0253-7613.140580 ‘ulcer-like’ (epigastric pain), ‘reflux-like’ (heartburn and acid regurgitation), ‘dysmotility-like’ (bloating and nausea) and ‘unclassifiable’ categories. In India, dyspepsia is more prevalent in metropolitan cities where it is reported by almost one-third of the population.[2] Uninvestigated dyspepsia 498 Indian Journal of Pharmacology | October 2014 | Vol 46 | Issue 5 Maity, et al.: Lafutidine versus pantoprazole in uninvestigated dyspepsia describes patients matching the 1988 Working Party definition misoprostol, sucralfate or other ulcer healing agents within of dyspepsia who have not yet undergone endoscopic 15 days prior to enrollment (but not antacids), concomitant investigation.[3] Empirical therapy with antacids, antisecretory use of psychotropic drugs and history of alcohol or substance and prokinetic agents has long been the approach for most abuse were other exclusion criteria. primary care physicians in the initial management of patients Subjects were randomized (simple balanced randomization with uninvestigated dyspepsia.[4,5] by computer generated list) to two groups of 61 subjects Lafutidine is the newest H2 receptor antagonist to each. One group received tablet lafutidine 10 mg (brand used be introduced in India. It suppresses both daytime and LAFAXID-10, marketed by M/s Zuventus Pharmaceuticals, nighttime acid secretion through reversible H2 receptor Mumbai) while the other received tablet pantoprazole antagonism and can provide effective symptom relief in 40 mg (brand used PAN-40, marketed by M/s Alkem gastroesophageal reflux disease at single daily doses.[6] It has Laboratories, Mumbai). Both drugs were administered as a additional mucoprotective effect that is independent of its acid single daily morning dose before breakfast for 8 weeks. Each antisecretory activity. A recent study has reported that improved subject underwent one follow-up study visit at 4 weeks following mucosal host-defense via capsaicin-sensitive afferent nerves commencement of trial medication and the treatment concluded may contribute to the therapeutic action of lafutidine.[7] The at 8 weeks. protective effects may be the result of activation of capsaicin The primary efficacy variable was GOS Scale score which sensitive calcitonin gene related peptide (CGRP)[8,9] which is obtained by a validated 7-point Likert scale.[11] Subjects produces nitric oxide (NO) in endothelial cells. NO participates were asked to rate the overall severity of their dyspepsia in the regulation of gastric mucosal blood flow through symptoms during the previous one month on following 7 vasodilatation in the gastric microvasculature.[10] CGRP released points: (1) no problem, (2) minimal problem (can be easily from afferent neurons in the gastric mucosa stimulates D cells ignored without effort), (3) mild problem (can be ignored in the antral and fundic glands and increases somatostatin with effort), (4) moderate problem (cannot be ignored but secretion from D cells. Somatostatin inhibits gastric acid does not influence daily activities), (5) moderately severe secretion, acting directly on somatostatin receptors on parietal problem (cannot be ignored and occasionally limits daily cells and indirectly by decreasing gastrin from antral G cells. activities), (6) severe problem (cannot be ignored and often Pantoprazole is a proton pump inhibitor (PPI) widely used limits concentration on daily activities) and (7) very severe in India. There are few published reports on head-to-head problem (cannot be ignored, markedly limits daily activities comparison between pantoprazole and H2-receptor blockers and often requires rest). Subjects achieving overall severity in general and pantoprazole and lafutidine in particular. We score ≤ 2 in this scale were considered as responders and therefore sought to compare the effectiveness of lafutidine those achieving score of ≤ 1 were considered as having versus pantoprazole in uninvestigated dyspepsia. attained symptom resolution. Secondary efficacy measures used were the Modified Materials and Methods Frequency Scale for the Symptoms of Gastroesophageal The study was designed as a single center, prospective, Reflux Disease (mFSSGERD)[12] and Quality of Life (QOL) as parallel group, open label, randomized controlled trial. measured by short form-8 (SF-8) questionnaire scores.[13] The It has been registered with Clinical Trials Registry mFSSGERD scale provided total score (Q-T), reflux score (Q-R), India [CTRI/2013/12/004261]. dyspepsia score (Q-D) and pain score (Q-P). The SF-8 was After obtaining institutional ethics committee approval, divisible into a physical component summary score (PCS) patients of either sex, aged between 18–55 years, attending and a mental component summary score (MCS). Variation the outpatient clinic in General Medicine in a teaching Hospital between pre- and post-treatment scores were compared in in Kolkata with a complaint of dyspepsia were screened both the groups. between June 2011–May 2012. Patients symptomatic for at Safety was evaluated at each visit by thorough history least 1 month with moderate-to-severe symptoms (score ≥ 4 and clinical examination. Complaints of the patient as well on the 7-point Global Overall Symptoms [GOS] scale) were as adverse events noted by the investigators were recorded included after obtaining written informed consent. Pregnant or as treatment emergent adverse events. In addition, routine lactating women, patients with alarm features (unintentional blood counts and tests of hepatorenal function were done at weight loss, recurrent vomiting, dysphagia, hemetemesis, baseline and at study end. Compliance with study medication melena, fever, jaundice, or anemia), history of any serious was assessed by the traditional pill count method. gastrointestinal disease (including peptic ulcers, malignancy, The sample size was calculated to detect a difference of esophageal dysmotility, a previous endoscopic diagnosis
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