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, 2011, 640685

Lafutidine 10 Mg Versus Rabeprazole 20 Mg in the Treatment of Patients With Heartburn-Dominant Uninvestigated Dyspepsia: A Randomized, Multicentric Trial

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Lafutidine 10 Mg Versus Rabeprazole 20 Mg in the Treatment of Patients With Heartburn-Dominant Uninvestigated Dyspepsia: A Randomized, Multicentric Trial

Bhupesh Dewan et al. Gastroenterol Res Pract.

Abstract

Background. Empirical therapy with antisecretory agents like PPIs and H2RAs has long been the traditional approach in the initial management of uninvestigated dyspepsia. Aim. The objective of the study was to examine relief of dyspepsia with lafutidine, a second-generation H(2)-RA, and rabeprazole and to compare their efficacy. Methods. This was a randomized, open, comparative trial in adult uninvestigated dyspeptic patients, who had at least moderate severity of symptoms, defined as a score of ≥4 on a 7-point global overall symptom (GOS) scale, and were randomized to receive once daily either lafutidine 10 mg or rabeprazole 20 mg for 4 weeks. Results. A total of 236 patients were enrolled, out of which 194 patients were included in the analysis. At the end of week 4, a significant difference was observed for symptom relief (lafutidine 89.90% versus rabeprazole 65.26%, P < .01) and symptom resolution (lafutidine 70.71% versus rabeprazole 25.26%, P < .01). Both the drugs were well tolerated. Conclusion. Both lafutidine and rabeprazole provide symptom relief in patients with heartburn-dominant uninvestigated dyspepsia. The present study confirms the appropriateness of lafutidine as an empiric treatment and superior efficacy for primary care practice patients with dyspepsia.

Figures

Figure 1
Figure 1
CONSORT flow diagram showing the number of patients enrolled in the study randomized to each treatment group and reasons for discontinuation.
Figure 2
Figure 2
Proportion of patients who reported symptom relief for each individual symptom from baseline. The number of patients listed for each symptom is the number of patients that reported that symptom with a GOS score ≥4 at baseline.*P < .01 between the two treatment groups at week 4.
Figure 3
Figure 3
Proportion of patients who reported symptom resolution for each individual symptom from baseline. The number of patients listed for each symptom is the number of patients that reported that symptom with a GOS score ≥4 at baseline.*P < .01 between the two treatment groups at week 4.
Figure 4
Figure 4
Frequency distribution of satisfaction survey responses at the end of the treatment phase.

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