Citation Information :
Saxena GN, Mathur S. A Randomized Controlled Study of Efficacy and Safety Profile of Levosulpiride and Itopride in Functional Dyspepsia. J Mahatma Gandhi Univ Med Sci Tech 2020; 5 (2):50-56.
Introduction: Dyspepsia is a clinical problem of considerable magnitude for the healthcare system due to the high prevalence and chronic and recurrent nature of symptoms. Earlier dyspepsia was referred to as a heterogeneous group of symptoms in the upper abdomen and retrosternal which are related to ingestion of meals and include heartburn, regurgitation, epigastric pain, epigastric burning, postprandial fullness/distension, early satiety, bloating, belching, anorexia, nausea, and vomiting. This has prompted the search for newer agents with equal efficacy but lower side effect potential such as levosulpiride and itopride. Aim and objectives: To evaluate and compare the efficacy of the newer drugs like levosulpiride and itopride in functional dyspepsia. Observations and results: The most common presenting symptoms in the present study were epigastric fullness (81%), upper abdominal pain (55%), early satiety (52%), and epigastric burning (45%). Less common symptoms were bloating (27%), belching (11%), heartburn (10%), and nausea (8%). Conclusion: Drugs, itopride and levosulpiride, were equally effective in ameliorating different symptoms of functional dyspepsia at the end of 4 weeks of treatment. There was a significant reduction in mean global symptom score (GSS) and mean duration score and mean score of severity in follow-up visits at the 2nd and 4th week from the day of presentation (p value < 0.05).
A survey of dyspepsia in Great Britain. Aliment Pharmacol Ther 1996;10(1):83–89. DOI: 10.1111/j.1365-2036.1996.tb00180.x.
Dyspepsia and dyspepsia subgroups: a population-based study. Gastroenterology 1992;102(4):1259–1268. DOI: 10.1016/0016-5085(92)90764-P.
Functional bowel symptoms in a general Dutch population and associations with common stimulants. Neth J Med 2001;59(1):23–30. DOI: 10.1016/S0300-2977(01)00128-0.
Can the clinical history distinguish between organic and functional dyspepsia? JAMA 2006;295(13):1566–1576. DOI: 10.1001/jama.295.13.1566.
What is the prevalence of clinically significant endoscopic findings in subjects with dyspepsia? systematic review and meta-analysis. Clin Gastroenterol Hepatol 2010;8(10):830–837. DOI: 10.1016/j.cgh.2010.05.031.
Management of dyspepsia: report of a working party. Lancet 1998. 567–569.
Dyspepsia subgroups according to the ROME III criteria. Am J Gastroenterol 2007;112(1):132–140. DOI: 10.1038/ajg.2016.499.
Familial association in adults with functional gastrointestinal disorders. Mayo Clin Proc 2000;75(9)):907–912. DOI: 10.4065/75.9.907.
G-protein β3 submit 825 CC genotype is associated with unexplained (functional) dyspepsia. Gastroenterology 2004;126(4):971–979. DOI: 10.1053/j.gastro.2004.01.006.
38. Prokinetic agents, antiemetics, and agents used in irritable bowel syndrome. Goodman and Gilman's The pharmacological basis of therapeutics, Hardman JG, Limbird LE, Gilman AG.
Tachycardia during cisapride treatment. BMJ 1992;305(6856):748–749. DOI: 10.1136/bmj.305.6856.748-a.
Post marketing reports of QT prolongation and ventricular arrhythmia in association with cisapride and food and drug administration regulatory actions. The. American journal of gastroenterology 2001;96(6):1698–1703. DOI: 10.1111/j.1572-0241.2001.03927.x.
The effects of levosulpiride of gastric and gall-bladder emptying in functional dyspepsia. Aliment Pharmacol Ther 1994;8(6):631–638. DOI: 10.1111/j.1365-2036.1994.tb00341.x.
Comparative effects of levosulpiride and cisapride on gastric emptying and symptoms in patients with functional dyspepsia and gastroparesis. Aliment Pharmacol Ther 2000;14(5):561–569. DOI: 10.1046/j.1365-2036.2000.00742.x.
Characterization of acetylcholinesterase-inhibition by itopride. Japan J Pharmacol 1994;66(3):317–322. DOI: 10.1254/jjp.66.317.
Role of prokinetics in dyspepsia. Gastroenterol Today 2003;7(1):1–4.
A multicenter randomized trial comparing rabeprazole and itopride in patients with functional dyspepsia in Japan: the NOGOYA study. J Clin Biochem Nutr 2017;60(2):130–135. DOI: 10.3164/jcbn.16-106.
Effectiveness and safety of levosulpiride in the treatment of dysmotility like functional dyspepsia. Ther Clin Risk Manag 2007;3(1):149. DOI: 10.2147/tcrm.2007.3.1.149.
J Digest Endos 2010;1(4):171–175.
Levosulpiride for dyspepsia and emesis. Clin Drug Investig 2000;19(2):151–162. DOI: 10.2165/00044011-200019020-00008.
Levosulpiride and serum prolactin levels. Indian J Endocrinol Metab 2017;21(2):355. DOI: 10.4103/ijem.IJEM_555_16.
Drug-induced parkinsonism on the rise: beware of levosulpiride and its combinations with proton pump inhibitors. Neurol India 2017;65(1):173. DOI: 10.4103/0028-3886.198175.
Studio sull'efficaciadella levosulpiride nella dyspepsia e sulladinamicamotoriadellacolecisti. Provacontrollata verso Domperidone Minerva Dietol Gastroenterol 1987;33:1–5.
Gastrokinetic effects of levosulpiride in dyspeptic patients with diabetic gastroparesis. American Journal Of Gastroenterology 1995;90(11):1989–1993.
Levosulpiride versus domperidone in the treatment of functional dyspepsia. La clinicaterapeutica 1994;144(2):107–114.
Effect of acute and chronic levosulpiride administration on gastric tone and perception in functional dyspepsia. Aliment Pharmacol Ther 2002;16(3):613–622. DOI: 10.1046/j.1365-2036.2002.01180.x.
Randomized double blind placebo-controlled trial to assess the efficacy and tolerability of levosulpiride in dysmotility type of functional dyspepsia. J Evolut Med Dental Sciences 2016;5(30):1506–1510. DOI: 10.14260/jemds/2016/355.
Prokinetics for the treatment of functional dyspepsia: Bayesian network meta-analysis. BMC Gastroenterol 2017;17(1):83. DOI: 10.1186/s12876-017-0639-0.
Comparison of safety and efficacy of levosulpiride and itopride in treatment of gastroesophageal reflux disease. J Evid Med Healthcare 2017;4(6):292–297. DOI: 10.18410/jebmh/2017/55.
A placebo-controlled trial of itopride in functional dyspepsia. N Eng J Med 2006;354(8):832–840. DOI: 10.1056/NEJMoa052639.
Itopride therapy for functional dyspepsia: a meta-analysis. World J Gastroenterol 2012;18(48):7371. DOI: 10.3748/wjg.v18.i48.7371.
Itopride in functional dyspepsia: results of two phase III multicenter, randomized, double-blind, placebo-controlled trials. Gut 2008;57(6):740–746. DOI: 10.1136/gut.2007.132449.