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Randomized Controlled Trial
. 2007 Dec;21(12):820-6.
doi: 10.1155/2007/203201.

Maintenance treatment of gastroesophageal reflux disease: an evaluation of continuous and on-demand therapy with rabeprazole 20 mg

D G Morgan  1 , M F J O'Mahony, W F O'Mahony, J Roy, F Camacho, J Dinniwell, G L A Horbay, F A Husein-Bhabha; RAB-GRD-3002 Study Group
Affiliations
Randomized Controlled Trial

Maintenance treatment of gastroesophageal reflux disease: an evaluation of continuous and on-demand therapy with rabeprazole 20 mg

D G Morgan et al. Can J Gastroenterol. 2007 Dec.

Abstract
in English, French

Objective: To evaluate continuous therapy (COT) and on-demand therapy (ODT) with rabeprazole 20 mg for maintenance in uninvestigated gastroesophageal reflux disease (GERD).

Methods: This randomized, open-label study enrolled 331 GERD (heartburn-predominant) patients with a pre-existing proton pump inhibitor history of one month or longer, to an acute four-week trial with 20 mg rabeprazole daily for heartburn management. Patients who achieved satisfactory heartburn control during the acute phase (three days or less of heartburn, with no more than one episode rated as moderate, and heartburn rated satisfactorily or completely controlled with minimal rescue antacid use in the seven days preceding randomization) were randomly assigned to six months of rabeprazole 20 mg given as either daily COT or daily ODT, which was initiated upon symptom recurrence and stopped upon symptom resolution. Rescue antacid usage was permitted and tracked. Primary efficacy was measured as the proportion of heartburn-free days over six months.

Results: For the 268 patients, the mean percentage of heartburn-free days for the COT group and for the ODT group were 90.3%+/-14.8% and 64.8%+/-22.3%, respectively (P<0.0001). COT was associated with an increased number of medication intake days (154+/-40.2) versus ODT (68+/-46.1), with less heartburn episodes observed with COT versus ODT, respectively (n=7, n=26, P<0.0001). Ninety-two per cent of COT patients and 79% of ODT patients were either 'satisfied' or 'very satisfied' with treatment. The mean usage of antacids was low and similar in both groups. COT and ODT regimens were safe and well-tolerated, with a similar incidence of adverse events.

Conclusion: Results based on symptom assessments favour COT with rabeprazole 20 mg for maintenance therapy in patients with uninvestigated GERD; however, both therapy types are safe and acceptable treatment options for selected patients.

OBJECTIF :: Évaluer le traitement ininterrompu (TI) et le traitement sur demande (TSD) à l’aide de 20 mg de rabéprazole pour le traitement d’entretien d’un reflux gastroœsophagien pathologique (RGOP) non exploré.

MÉTHODOLOGIE :: Cette étude aléatoire ouverte a porté sur 331 patients atteints de RGOP (surtout des brûlures d’estomac) ayant déjà pris des inhibiteurs de la pompe à proton pendant au moins un mois, participant à un essai aigu de quatre semaines au cours desquelles ils prenaient 20 mg de rabéprazole par jour pour traiter leurs brûlures d’estomac. Les patients qui contrôlaient leurs brûlures d’estomac de manière satisfaisante pendant la phase aiguë (trois jours ou moins de brûlures d’estomac, pas plus d’un épisode classé moyen et brûlures d’estomac classées comme satisfaisantes ou complètement contrôlée avec un usage minime d’anti-acides de sauvetage dans les sept jours précédant la randomisation) ont été divisés au hasard entre la prise de 20 mg de rabéprazole pendant six mois, administrée sous forme de TI quotidien ou de TSD quotidien, entrepris à la récurrence des symptômes et interrompu à leur disparition. L’utilisation d’anti-acides de sauvetage était autorisée et suivie. L’efficacité primaire était mesurée selon la proportion de journées sans brûlures d’estomac pendant six mois.

RÉSULTATS :: Pour les 268 patients, le pourcentage moyen de journées sans brûlures d’estomac pour le groupe ayant le TI et le groupe ayant le TSD était de 90,3 %±14,8 % et de 64,8 %±22,3 %, respectivement (P<0,0001). Le TI s’associait à un plus grand nombre de jours de prise de médicament (154±40,2) que le TSD (68±46,1) et à moins d’épisodes de brûlures d’estomac (n=7, n=26, P<0,0001). Quatre-vingt-douze pour cent des patients ayant le TI et 79 % de ceux ayant le TSD étaient soit « satisfaits », soit « très satisfaits » du traitement. Le recours moyen aux anti-acides était faible et similaire dans les deux groupes. Le TI et le TSD étaient sécuritaires et bien tolérés. Leur incidence et leurs effets néfastes étaient similaires.

CONCLUSION :: Les résultats fondés sur l’évaluation des symptômes favorisent le TI avec 20 mg de rabéprazole pour le traitement d’entretien des patients atteints d’une RGOP non explorée. Cependant, les deux types de traitement sont sécuritaires et acceptables pour certains patients.

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Figures

Figure 1)
Figure 1)
Percentage of heartburn (HB)-free days, and the percentage of HB-free or mild days. *P<0.0001. COT Continuous therapy; ODT On-demand therapy
Figure 2)
Figure 2)
Summary of heartburn (HB) control and HB control satisfaction. *P<0.001. COT Continuous therapy; ODT On-demand therapy
Figure 3)
Figure 3)
Change in gastroesophageal reflux disease symptoms assessment scale (14) score between the baseline and final week of the maintenance phase. *P<0.05 for the difference between the final visit and randomization; †P<0.05 for the difference between continuous therapy (COT) and on-demand therapy (ODT) groups
Figure 4)
Figure 4)
Change in patient assessment of upper gastrointestinal disorder – quality of life questionnaire (15) scores between the baseline (randomization) and last week of the maintenance phase. *P<0.05 for the difference between the final visit and randomization; †P<0.05 for difference between continuous therapy (COT) and on-demand therapy (ODT) groups
See this image and copyright information in PMC

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