Evidence map›Paper›PMID 42730423›Full record

ArticleGastroenterology research2026

Safety and Efficacy of Fixed-Dose Pantoprazole and Sustained Release Levosulpiride for Short-Term Management of Gastroesophageal Reflux Disease.

Yogesh Garje, Vijay Kamat, Kalidas Biswas, M Murugesh, Manoj Kumar Agarwal, Pushparaj Karmarkar, Narendra D Kulkarni, Jitendra Anand, Sunil Kumar Mahavar, B Ramesh Kumar and 8 more

Abstract read
In one paragraph

Article in Gastroenterology research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Yogesh Garje(Ex employee) Medical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai 400063, Maharashtra, India.
Vijay KamatDepartment of Surgery, Karnataka Institute of Medical Sciences, Hubli 22, Dharwad, Karnataka, India.
Kalidas BiswasDepartment of Gastroenterology, Medical College & Hospital, Kolkata 700037, West Bengal, India.
M MurugeshClinical Research Room, Kovai Diabetes Speciality Centre and Hospital, Coimbatore 641009, Tamil Nadu, India.
Manoj Kumar AgarwalDepartment of Gastroenterology, Belle Vue Clinic, Kolkata 700017, West Bengal, India.
Pushparaj KarmarkarDepartment of General Surgery, Sanjeevan Hospital, Pune 411004, Maharashtra, India.
Narendra D KulkarniDr. Hedgewar Hospital, Aurangabad 431005, Maharashtra, India.
Jitendra AnandKanoria Hospital & Research Centre, Gandhinagar 382428, Gujarat, India.
Sunil Kumar MahavarDepartment of Medicine, S.M.S. Medical College & Attached Hospital, Jaipur 302004, Rajasthan, India.
B Ramesh KumarDepartment of Gastroenterology, Osmania General Hospital, Hyderabad, Telangana, India.
Mukesh MishraDepartment of Internal Medicine, Shat Ayu Multispeciality Hospital, Nagpur 440012, Maharashtra, India.
P Shravan KumarGastroenterology Department, Gandhi Hospital, Secunderabad, Telangana, India.
Ashwini SatpathyMedical Affairs and Clinical Research, Mankind Pharma, New Delhi, India.ORCID https://orcid.org/0000-0001-6425-6134
Shruti DharmadhikariMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai 400063, Maharashtra, India.ORCID https://orcid.org/0000-0002-2249-2662
Chintan KhandhediaMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai 400063, Maharashtra, India.ORCID https://orcid.org/0009-0004-5632-7181
Neeraj MarkandeywarMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai 400063, Maharashtra, India.ORCID https://orcid.org/0009-0009-6300-6665
Amey ManeMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai 400063, Maharashtra, India.ORCID https://orcid.org/0000-0002-2902-4693
Suyog MehtaMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai 400063, Maharashtra, India.ORCID https://orcid.org/0000-0001-7553-4128

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Gastroesophageal reflux disease (GERD) and dyspepsia are highly prevalent in India. Pantoprazole suppresses gastric acid secretion by inhibiting H Methods: This phase IV, open-label, single-arm study was conducted at 11 sites across India. Of 540 screened patients, 509 were enrolled and received FDC once daily for 4 weeks. Safety was evaluated through adverse events (AEs) and serious AEs (SAEs). Efficacy was assessed using the Frequency Scale for the Symptoms of GERD (FSSG), Likert Scale, Clinical Global Impression of Improvement (CGI-I), Clinical Global Impression of Severity (CGI-S), and Modified Simpson Angus Scale (MSAS). Results: Of 509 patients, 492 completed the study. Seventy-nine AEs were documented in 69 patients, all mild-to-moderate and no SAEs were reported. The FDC demonstrated significant reduction in GERD symptom severity, with a mean (standard deviation) change from baseline of -16.99 (8.76) (P < 0.0001) on FSSG Scale at visit 4. Additionally, reductions were observed in acid reflux symptoms with a mean (SD) change from baseline of -9.15 (5.25) and dyspeptic symptoms -7.8 (4.05); both changes were statistically significant (P < 0.0001). The Likert Scale also demonstrated a significant reduction in symptom severity indicated by a mean (standard deviation) change from baseline of -1.26 (1.00) (P < 0.0001). At visit 4, CGI-I scores classified 196 patients as "very much improved", while CGI-S indicated "normal" status in 173 patients. The absence of significant movement disorders, assessed by MSAS at visit 4, further supports the favorable safety profile of FDC in management of GERD. Conclusion: The FDC of pantoprazole and levosulpiride is well tolerated and effective for the short-term treatment of GERD in patients unresponsive to PPI therapy. Symptom reductions and favorable global assessments indicate therapeutic benefit of therapy in refractory GERD population.

Indexed as

CGI-ICGI-SFSSGGERDLevosulpirideLikert ScaleMSASPantoprazole

Identifiers

PMID42730423
PMCPMC13568749

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.