Lansoprazole

證據等級: L5

預測適應症: 2 個

Lansoprazole: From Peptic Ulcer Disease to Duodenogastric Reflux

One-Sentence Summary

Lansoprazole is a proton pump inhibitor (PPI) widely used for treating acid-related gastrointestinal disorders, including peptic ulcer disease, gastroesophageal reflux disease (GERD), Helicobacter pylori eradication, and Zollinger-Ellison syndrome. The TxGNN model predicts it may be effective for Duodenogastric Reflux, with 0 clinical trials and 2 publications currently supporting this direction. However, one of these publications is an animal study raising a concerning safety signal — Lansoprazole may actually promote gastric carcinogenesis in the context of duodenogastric reflux, which significantly tempers the initial prediction.

Quick Overview

Item	Content
Original Indication	Peptic ulcer disease, GERD, H. pylori eradication, Zollinger-Ellison syndrome
Predicted New Indication	Duodenogastric Reflux
TxGNN Prediction Score	99.69%
Evidence Level	L4
India Market Status	✗ Not Marketed
Number of Registrations	0
Recommended Decision	Hold

Why Is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available from the regulatory database. Based on known pharmacological information, Lansoprazole is a proton pump inhibitor (PPI) that irreversibly blocks the H⁺/K⁺-ATPase enzyme on the gastric parietal cell — the final step in gastric acid secretion. This mechanism is well-established, making it effective for any condition driven by excessive or harmful gastric acid.

Duodenogastric reflux (DGR) involves the retrograde movement of duodenal contents — including bile acids, pancreatic enzymes, and intestinal fluid — back into the stomach. While DGR does expose the gastric mucosa to a mixed, partially acidic refluxate, the primary pathogenic drivers are bile acids and pancreatic fluid, not gastric acid itself. Theoretically, Lansoprazole could reduce the acidic component of the refluxate and offer some mucosal protection; however, it cannot address the mechanical or bile-driven pathology that characterises DGR. This makes the mechanistic link indirect and incomplete.

More importantly, the available preclinical evidence raises a red flag. A rat model study (PMID 15052437) found that Lansoprazole may promote gastric carcinogenesis in the presence of DGR, potentially through hypergastrinaemia and mucosal hyperproliferation. This reverses the expected benefit and makes this TxGNN prediction particularly difficult to advance without substantial further investigation.

Clinical Trial Evidence

Currently no related clinical trials registered for Lansoprazole in duodenogastric reflux.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
18679668	2008	Narrative Review	European Journal of Clinical Pharmacology	Comprehensive update on PPI clinical use and pharmacokinetics; confirms Lansoprazole and other PPIs as first-line therapy for peptic ulcer, GERD, H. pylori, NSAID-induced GI lesions, and Zollinger-Ellison syndrome — contextualises the drug’s established mechanism
15052437	2004	Animal Study (Rat Model)	Gastric Cancer	Lansoprazole promoted gastric carcinogenesis in rats with surgically induced duodenogastric reflux; suggests that acid suppression in a DGR environment may paradoxically increase cancer risk, possibly via elevated gastrin and mucosal hyperproliferation — a critical safety signal

India Market Information

Lansoprazole is currently not registered in India. No licensed products are available in the regulatory database.

Authorization Number	Product Name	Dosage Form	Approved Indication
—	—	—	No registrations on record

Safety Considerations

Drug Interactions: Lansoprazole has 618 documented drug interactions in the DDInter database. The most clinically significant are listed below:

Interacting Drug	Severity	Clinical Relevance
Acalabrutinib	Major	Lansoprazole raises gastric pH, substantially reducing Acalabrutinib oral absorption and efficacy
Atazanavir	Major	PPI-mediated pH elevation markedly reduces Atazanavir bioavailability; co-administration is generally contraindicated
Apalutamide	Moderate	May alter Lansoprazole exposure via CYP induction
Aprepitant	Moderate	Possible CYP3A4-mediated interaction
Bosutinib	Moderate	Reduced Bosutinib absorption at higher gastric pH
Brigatinib	Moderate	Possible pH-dependent absorption reduction
Bromocriptine	Moderate	Possible interaction
Amphotericin B	Moderate	Possible interaction
Hydrochlorothiazide	Moderate	Possible interaction
Atorvastatin	Moderate	Possible CYP-mediated interaction

Please refer to the full package insert for complete warnings and contraindications, which could not be retrieved in this data collection cycle.

Conclusion and Next Steps

Decision: Hold

Rationale: Evidence for Lansoprazole in duodenogastric reflux is limited to one animal study and a general PPI review — with zero registered clinical trials. More critically, the only directly relevant preclinical study found a harmful signal: Lansoprazole may increase gastric carcinogenesis risk in the DGR environment rather than providing benefit. Until this safety concern is resolved with human-level evidence, proceeding with development is not justified.

To proceed, the following is needed:

Safety data: Obtain the full package insert (CDSCO/TFDA) to extract approved warnings and contraindications (currently a blocking data gap)
MOA clarification: Retrieve Lansoprazole mechanism of action from DrugBank to better assess mechanistic overlap with DGR pathophysiology
Human-level evidence: Search for any observational studies, systematic reviews, or clinical trial sub-analyses examining Lansoprazole specifically in DGR patients
Carcinogenesis risk resolution: Commission or identify studies that specifically address whether the rat-model carcinogenesis signal (PMID 15052437) translates to humans — this is the primary decision gate
Indication scope clarification: Determine whether the target is DGR as a primary indication or as an adjunct condition managed alongside another pathology (e.g., peptic ulcer, post-surgical reflux)
India regulatory pathway: If evidence becomes favourable, assess the India registration pathway given zero current market presence
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.