Evaluation of Safety, Efficacy and Tolerability of Rabeprazole (Enteric Coated, EC) 20mg with Levosulpride (Sustained Release, SR) 75mg Fixed Dose Combination in Patients with Gastroesophageal Reflux Disease
Authors/Creators
- 1. Assistant Professor, PDU Government Medical College, Rajkot, Gujarat, India
- 2. Senior Resident, PDU Medical College, Rajkot, Gujarat, India
- 3. MD Pharmacology, Senior Resident, MP Shah Government Medical College, Jamnagar, Gujarat, India
Description
Background: Gastroesophageal reflux disease is a highly prevalent gastrointestinal disorder in 10-20% of population. Main treatment possibilities for GERD are lifestyle modifications and pharmacological therapy. New publications have raised questions upon long term safety and over prescription of current therapeutic agents. Methodology: The present study is prospective, single centre, open-label, comparative, observational study initiated to compare the safety, efficacy, and tolerability of rabeprazole (enteric coated, EC) 20mg with levosulpride (sustained release, SR) 75mg fixed dose combination in patients with gastroesophageal reflux disease. Results: Global assessment of efficacy at the end of therapy was rated as “excellent” (17% in group A and 10% in group B),”very good” (63% in group A and 50% in group B) “good” (17% in group A and 23% in group B), and “satisfactory” (3% in group A and 16% in group B). On global assessment of tolerability, the product rated to have “good” (84% in group A and 64% in group B) and “moderate” (16% in group A and 36% in group B) at the end of the study. Conclusion: The treatment with levosulpride to rabeprazole in GERD patients with high FSSG score provides better symptomatic relief compared to rabeprazole monotherapy with minimal mild side effects.
Abstract (English)
Background: Gastroesophageal reflux disease is a highly prevalent gastrointestinal disorder in 10-20% of population. Main treatment possibilities for GERD are lifestyle modifications and pharmacological therapy. New publications have raised questions upon long term safety and over prescription of current therapeutic agents. Methodology: The present study is prospective, single centre, open-label, comparative, observational study initiated to compare the safety, efficacy, and tolerability of rabeprazole (enteric coated, EC) 20mg with levosulpride (sustained release, SR) 75mg fixed dose combination in patients with gastroesophageal reflux disease. Results: Global assessment of efficacy at the end of therapy was rated as “excellent” (17% in group A and 10% in group B),”very good” (63% in group A and 50% in group B) “good” (17% in group A and 23% in group B), and “satisfactory” (3% in group A and 16% in group B). On global assessment of tolerability, the product rated to have “good” (84% in group A and 64% in group B) and “moderate” (16% in group A and 36% in group B) at the end of the study. Conclusion: The treatment with levosulpride to rabeprazole in GERD patients with high FSSG score provides better symptomatic relief compared to rabeprazole monotherapy with minimal mild side effects.
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IJPCR,Vol14,Issue6,Article71.pdf
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Additional details
Dates
- Accepted
-
2022-06-05
Software
- Repository URL
- https://impactfactor.org/PDF/IJPCR/14/IJPCR,Vol14,Issue6,Article71.pdf
- Development Status
- Active
References
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