ACG: Intravenous Pantoprazole As Effective As Cimetidine For Immediate Acid Relief In The Intensive Care Setting
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ACG: Intravenous Pantoprazole As Effective As Cimetidine For Immediate Acid Relief In The Intensive Care Setting

By Cameron Johnston
Special to DG News

LAS VEGAS, NV -- October 23, 2001 -- A relatively new intravenous formulation of pantoprazole sodium (Protonix I.V. American Home) seems to be as efficacious as cimetidine for treating hospitalized patients who are in urgent need of acid suppression.

Cimetidine has been the standard of treatment in these cases for years now, but has always carried with it the risk of the patient becoming tolerant to the drug, so its efficacy was limited to a very short course of treatment.

The formulation has been available in some countries for two years now, and was recently approved in the United States for the treatment of Zollinger-Ellis Syndrome, a hyper-secretory condition that can be fatal in some cases.

In a study presented today at the annual meeting of the American College of Gastroenterology, by Dr. Robert Aris and colleagues from the University of North Carolina, it was reported that pantoprazole IV, when tested in four different dosing schedules against cimetidine was as effective in all cases, but was able to maintain gastric pH higher, for a longer period of time.

The IV formulation of the drug is used only in hospital intensive care units, among patients who are at the highest risk of gastric bleeding, or who are bleeding already and require immediate relief from acid secretion and production.

The number of people being admitted to ICUs who need this kind of therapy is estimated to be increasing in the US at the rate of 12 percent per year. The IV drug might also find some use among patients who require proton pump inhibitors but are unable to take oral medications.

In Dr. Aris' study, 86 patients were randomized to receive either pantoprazole 40 mg every 24 hours, or every 12 hours; pantoprazole 80 mg every 12 or every eight hours; or 300 mg of cimetidine given as an initial bolus followed by a 50 mg per hour continuous infusion.

Pantoprazole 80 mg delivered every 8 hours was most efficacious, maintaining gastric pH at >4 for 81 percent at day one, and 73 percent at day two of the study.

By comparison, cimetidine provided adequate acid relief on day one, but was unable to maintain this relief across day two.

The other doses of pantoprazole IV maintained gastric pH >4 for anywhere from 55 percent to 83 percent at day two.

Adverse events in Dr. Aris' study were a problem, although how much of this was due to the drug and how much was due to the patient's pre-existing co-morbidities is debatable. Such adverse events included developing pneumonia (5/68), hyperthermia, phlebitis, and cholestatic jaundice.

"People would like to think that we can control those bleeds in the hospital by controlling the gastric pH," said Dr. Philip Katz, in a press conference at the ACG meeting. "The presumption is that intravenous proton pump inhibitors can do that better than oral agents, or better than IV H2 receptor antagonists."

Dr. Katz is chairman of medicine and chief of gastroenterology at the Graduate Hospital in Philadelphia, USA.

"If we can prove that intravenous PPIs get to a high pH faster, and stay there, then that will afford people an advantage," he said. "H2 blockers seem not to have been able to have the staying power, and IV PPIs seem to get their faster than oral."

Dr. Katz said price will definitely be an issue with IV PPIs since the drug has to be delivered in solution and with a special filter. "It's likely to be successful, but we have to ask is the price worth the benefit."

He added too that it's unclear whether there will be much use outside the ICU setting, and furthermore, that he doubts that these drugs will find a use among people who are in hospital but are unable to take medications orally.

"I find that less of a need," he said.

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