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Cisapride, Omeprazole and H2 Blocker

CisaprideQuestion: I had a drug information question about the following combinations used in peptic ulcer disease: Cisapride and H2 Blocker, Omeprazole and H2 Blocker. I did a medline search and could not find any substantiation for the use in peptic ulcer disease. Are you aware of anything that may have been published recently dealing with these combinations in peptic ulcer disease?

Answer: There are not many studies on the use of combinations of drugs in the healing of peptic ulcer disease. There are several reasons for this. First, the use of combinations of drugs adds greatly to the cost of therapy and increases the risk of side effects. Second, the various drugs that are available for healing ulcers – H2 blockers (e.g., cimetidine or Tagamet), proton pump inhibitors (e.g., omeprazole or Prilosec) and prokinetics (e.g., cisapride or Propulsid) – are all quite good. The potential improvement in healing using combinations of drugs (as compared with single drugs), therefore, is relatively small. Third, to scientifically demonstrate the small benefit of combination therapy as compared to single drug therapy would require studies with many hundreds of patients, and such studies are very expensive to carry out. Finally, most drug companies do not manufacture more than one type of drug for healing ulcers, and they do not want to sponsor studies which use the products of other drug companies.

OmeprazolNevertheless, the use of combinations of drugs that act by different mechanisms makes sense. For example, the combination of omeprazole or an H2 blocker, which reduce acid production by the stomach, with cisapride, which prevents acid refluxing back into the esophagus, theoretically would attack the problem of esophageal ulcers in two different ways. On the other hand, the use of omeprazole and and H2 blocker together does not make sense because they have the same mechanism of action. With respect to ulcer disease in the stomach or duodenum, the use of omeprazole or an H2 blocker and misoprostil (which protects the lining of the stomach from ulcers) makes good sense.

Combination therapy for peptic ulcer disease also may have an additional meaning. Specifically, one drug may be used to heal the ulcers along with another drug to eradicate the bacterium, H. pylori, which contributes to most ulcers. This type of combination therapy is the rule rather than the exception, and the medical literature is replete with studies comparing these multiple drug regimens with single drug regimens. Although healing of the ulcers by the individual drugs may be similar, the eradication of the bacterium prevents ulcers from recurring.

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