No clinical benefit of adding cisapride to pantoprazole for treatment of gastro-oesophageal reflux disease.
OBJECTIVE
Although a proton pump inhibitor (PPI) and a prokinetic drug are often combined for the medical treatment of gastro-oesophageal reflux disease (GORD), there are few well-conducted clinical studies on the efficacy and tolerability of this therapy. This study investigates whether pantoprazole plus cisapride leads to an additional benefit in comparison to pantoprazole alone.


METHODS
Randomized double-blind prospective multicentre study conducted in patients of 33 hospitals in Ireland, South Africa and the UK.


METHODS
A total of 350 intention-to-treat (ITT) patients aged 18 years or older with GORD of grade II and III were included in the study. The per-protocol (PP) population comprised 152 patients in the pantoprazole group and 136 in the pantoprazole plus cisapride group.


METHODS
Patients received either pantoprazole 40 mg once daily or pantoprazole 40 mg once daily plus cisapride 20 mg twice daily. Treatment outcome was assessed after 4 and 8 weeks. The primary criterion was endoscopically confirmed healing after 4 weeks. Additionally, relief of leading symptoms was studied.


METHODS
The prior null hypothesis was no difference in healing rates between both treatment groups.


RESULTS
After 4 weeks of treatment 81% and 82%, and after 8 weeks 89% and 90%, of PP patients treated with pantoprazole or pantoprazole plus cisapride were healed, respectively. Thus, equivalence of the two treatment strategies could be proven. Additionally, improvement of symptom relief showed no significant difference between the two regimens. In contrast to disease grade at baseline, Helicobacter pylori status did not influence the healing rates in our study. Both study medications were tolerated well.


CONCLUSIONS
Addition of cisapride to pantoprazole provides no further benefit in the treatment of GORD.
van Rensburg
C J
CJ
Gastroenterology Unit, Tygerberg Hospital, Tygerberg, South Africa. sam871@mweb.co.za
Bardhan
K D
KD
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D020117:Cisapride / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004945:Esophagoscopy; D005260:Female; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy*; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017506:H(+)-K(+)-Exchanging ATPase / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives; D000077402:Pantoprazole; D054328:Proton Pump Inhibitors; D013454:Sulfoxides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles; D004791:Enzyme Inhibitors; D005765:Gastrointestinal Agents; D054328:Proton Pump Inhibitors; D013454:Sulfoxides; D000077402:Pantoprazole; D017506:H(+)-K(+)-Exchanging ATPase; D009853:Omeprazole; D020117:Cisapride