Efficacy of Cisapride in Patients with Functional Dyspepsia Resistant to Dopamine Antagonists

Lee, Sang In; Seo, Won Tae; Park, In Suh; Lee, Yong Chan; Lee, Dong Gi; Lee, Kwang Jae; Kim, Do Young; Shin, Yong Woon; Kim, Young Soo; Kim, Pum Soo; Kim, Dong Kee

Abstract

BACKGROUND/AIMS: Prokinetics are commonly used for the treatment of functional dyspesia, but their methods of action are different. First, we compared the efficacy and safety of the dopamine receptor antagonists, which were domperidone maleate and levosulpiride, in a 2 week treatment in functional dyspepsia, then investigated the efficacy and safety of cisapride tartrate in a 2 week treatment in those who were resistant to domperidone maleate or levosulpiride.
METHODS
One hundred Forty-nine patients, who were diagnosed with functional dyspepsia, were selected. The subjects were randomly divided into two groups, domperidone maleate (75) and levosupiride (74). Daily they took 30mg of domperidone maleate (DOM) or 75mg of levosulpiride (LEV) for 2 weeks. Then the subjects who didn't respond to these treatments took 30mg of cisapride tartrate for the following 2 weeks.
RESULTS
At week 0, the total symptom scores of the DOM group and LEV group were 8.01+/-2.57 and 8.14+/-2.65 respectively, which were not statistically different. At week 2, the total symptom scores of the DOM and LEV groups were significantly reduced to 4.28+/-3.30 and 4.85+/-3.53(p=0.0001). The efficacy rates of the DOM and LEV groups at week 2 were 50.8% vs. 44.1%. The rate of adverse events in the LEV groups was much higher than in the DOM group(17.7% vs. 8.0%). In addition the rate of change from normal to abnomal in prolactin level was markedly higher in the LEV than that of the DOM group(80.0% vs. 8.3%). After 2 weeks of treatment with cisapride tartrate, the total symptom score was significantly reduced to 3.77+/-2.49(p=0.0001), and the efficacy rate was 75.0%. The satisfaction of the resistant subjects in efficacy of cisapride compared with the previous treatment was 73.3%. The rate of adverse events of cisapride tartrate was 5.0%.
CONCLUSIONS
Considering efficacy and safety of domperidone maleate and levosulpiride, domperidone maleate was the safer drug for the treatment of functional dyspepsia, and cisapride tartrate can be a useful drug in those patients who are resistant to dopamine antagonists like domperidone maleate and levosulpiride.