Vedamanickam R, Prasad B. H, Vinothkumar R, Dinakaran N. Effect of Intermittent Therapy With Rabeprazole 20mg in Patients With Symptomatic Gastroesophageal Reflux Disease-A Double Blind Omeprazole-Controlled Study. Biomed Pharmacol J 2017;10(3).

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Manuscript accepted on :August 03, 2017
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R. Vedamanickam¹, B. Harri Prasad², R. Vinothkumar³ and Nagendram Dinakaran⁴

¹Department of Medicine. Sree Balaji Medical College and Hospital, Chrompet, Chennai.

²Department of Medical Gastroenterology and Hepalology, Sree Balaji Medical College and Hospital, Chrompet, Chennai.

³Sree Balaji Medical College and Hospital, Chrompet, Chennai.

⁴Senior Gastroenterologist, Chennai.

DOI : https://dx.doi.org/10.13005/bpj/1259

Abstract

Long term intermittent management of symptomatic erosive and non - erosive  gastro esophageal reflux (GERD) disease  needs elucidation  and   evaluation. To evaluate the clinical value of maintenance  intermittent with oral rabeprazole  20mg  once a day  versus omeprazole  20mg once a day in patients with symptomatic. This prospective  study  included  60 adults patients  of either  sex aged  21-65  years  with mean  age of   31.4 + 1.2 years  with  symptomatic  history  of  GERD more than  3 months duration consist of both  erosive  and  non - erosive esophagitis. They were divided into  two groups  one  group   enrolled  with oral  rabepazole  20mg once a day initial 4 weeks  followed by intermittent  maintenance  therapy of same dose 4 days  a week  for 6 months, another group  enrolled  with oral omeprazole 20mg  once a day for initial 4 weeks followed by intermittent maintenance therapy 4 days a week  for 6 months. When symptoms  recurs, on demand  liquid  antacid 15 ml given when heart burn occurs   either day time or night time. The outcome was elicited  on clinical score severity of symptoms. Patients rated symptoms severity on a 5 point scale. 0= no symptoms  and 4= very severe symptoms that interfere considerable  with daytime or sleep. The primary  efficacy end point mean  percentage of  heart burn free days was significantly greater  with  rabeprazole when compared to omeprazole. Rabeprazole experienced  a significantly  higher percentage of symptoms free daytime 75.9% versus  62.7% in omeprazole group and night time 82.6% in rabeprazole  compared  to  61.4% in omeprazole group. Intermittent  use of rabeprazole  may be  an effective  maintenance  treatment  strategy in patients  with GERD.

Keywords

GERD; erosive and non-erosive; gastritis; rabeprazole omeprazole

Introduction

Proton pump inhibitors (PPI) are highly efficacious in providing symptomatic relief, healing erosions and improving quality of life in patients with symptomatic gastro esophageal reflux disease. (GERD)¹ Worldwide Proton pump inhibitors (PPI) are being used in the treatment of GERD.² Anti secretary agents such as esomeprazole, pantoprazole, ilaprazole, rabeprazole causes decrease in acid production and have high healing rates and rates of resolution of reflux symptoms  at 4 weeks but do not help in long term maintenance intermittent therapy.³ In our randomized control trail long term intermittent rabeprazole therapy has proved efficacious than omeprazole.

Materials  and  Methods

Study Design

This prospective study  concluded in 60 patients in department of Medicine Sree  Balaji Medical College and Hospital, Chennai, India with GERD symptoms heat burn, regurgitation, epigastric pain, abdominal bloating, loss of appetite. This double blind rabeprazole, omeprazole study comprised of two phases. First phase symptomatic GERD patients either erosive or non-erosive esophagitis received  4 weeks course of either rabeprazole or omeprazole  20mg orally once a day and second  phase received 4 days a week intermittently for 6 months of rabeprazole  or omeprazole. If heart burn occurs during this period they were supplemented with on demand liquid antacid 20ml orally. Prior to entering the screening period written informed consent was obtained  from each  patients.

Patients

Male and Female  patients aged 21-65 years of either sex with a minimum 3 months history of GERD symptoms. Patients were excluded if they had evidence of clinically significant cardiovascular, hepatic, renal, endocrinal, neurological, haematological abnormalities, known case of gastric or duodenal ulcer on long term PPI medication, patients who were on long term aspirin, non steroidal anti-inflammatory drugs, feeding or pregnant women, and those not willing for  endoscopy. Efficacy and safety assessments patients were assessed at beginning of initial phase, during maintenance and after end of 6 months. Physical examination, vital signs and reflux clinical scoring system performed. Heart burn frequency was assessed as the number of days in a week in which symptoms occurred as 4 point scale 0=no symptoms  1= mild occasional symptoms 2= moderate symptoms 3= severe disturbing symptoms.

Results

Results of the study revealed that symptomatic response to therapy was over all in non-erosive esophasitis compared to erosive esophasitis 83.5% vs 59%. Maintenance group rabeprazole was superior when compared to omeprazole non-erosive group (88.5% to 66%) and in erosive group (79.2% to 52.8%) Fig.1. On demand antacid therapy requirement is less in rabeprazole 19.8% compared to omeprazole 29.7%. Both drugs were well tolerated and no major adverse side effect observed except headache in 13.2% in rabeprazole versus 6.6% in omeprazole.

Figure 1: Efficacy of Rabeprazole with Omeprazole   Click here to View figure

Discussion

GERD is a common recurrent usually life long disorder resulting in disturbing health related quality of life in an individual^4. Mono therapy for optimal management is insufficient. There are more studies indicate prokinetic with  PPI  combination  is a better option. There are some studies indicate  the demerits of  prokinetics on long term.^5,6 This study focus on  using mean percentage of heart burn free days as the primary  outcome measure. We demonstrated that a 6 months intermittent regimen of rabeprazole 20mg  in symptomatic  GERD  patients  provide adequate efficacy in 82.5% compared to 66% in omeprazole group. The percentage of heart burn free day time and night time periods were significantly  better for rabeprazole group. Further more  daily use of risk antacid on demand therapy for relief of heart burn was lower in rabeprazole group than omeprazole.⁷

Conclusion

Based  on the symptomatic relief of intermittent rabeprazole for long term (6 months ) treatment with 20mg of rabeprazole was significantly more effective than 20mg of omeprazole. The  overall efficacy and safety profile demonstrate in this study suggest that intermittent use of rabeprazole may be effective  maintenance treatment strategy for patients with symptomatic GERD.

Reference

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