Intermittent PPI Therapy Safe After Endoscopic Hemostasis

Caroline Helwick

May 07, 2014

CHICAGO — For patients receiving proton pump inhibitors (PPIs) after endoscopic treatment for bleeding ulcers, intermittent therapy appears to be as effective as continuous therapy, a systematic review of the 2 approaches has shown.

"These are robust data from randomized controlled trials," said lead investigator Hamita Sachar, MD, senior fellow in the digestive disease section at the Yale School of Medicine in New Haven, Connecticut.

"Intermittent PPI therapy should be the regimen of choice in this population," she told Medscape Medical News.

The current standard of care for patients with bleeding ulcers is endoscopic hemostasis followed by a bolus of PPI and then 72 hours of continuous infusion.

With the intermittent regimen, patients are given a dose of PPI, either orally or intravenously, at set intervals.

"Intermittent PPI therapy requires fewer resources and costs less than continuous infusion. It could also improve the patient experience by not requiring infusion equipment, which restricts patients," Dr. Sachar said during a press briefing held in advance of Digestive Disease Week (DDW) 2014, where she presented the data.

Results of 13 Randomized Trials

To evaluate intermittent therapy, Dr. Sachar and her colleagues conducted a systematic review and meta-analysis of 13 randomized trials involving 1619 patients.

The primary outcome for the meta-analysis was rebleeding within 7 days, which 10 of the trials reported.

 
Intermittent PPI therapy is safe, less costly, and more comfortable for patients.
 

All study participants were patients with high-risk bleeding ulcers (active bleeding, visible vessel, adherent clot) who underwent successful endoscopic therapy. Patients who received intermittent PPI therapy were compared with those who received the current standard of continuous intravenous PPI therapy for 72 hours.

"We have recognized the benefits of intermittent therapy, but we wanted to be sure it is as effective," said Dr. Sachar.

For all outcomes, intermittent PPI therapy was at least as effective as the continuous therapy.

In the intermittent group, 47 of 691 patients experienced rebleeding within 7 days — the primary outcome — as did 64 of 682 patients in the continuous group (relative risk, 0.72).

"We found that using intermittent PPI therapy resulted in a similar likelihood of rebleeding, death, and other clinically meaningful outcomes," Dr. Sachar reported. "None of the outcomes were poorer with intermittent PPIs."

Table. Meta-Analysis of Randomized Trials: Intermittent vs Continuous PPI Therapy

Outcome Studies Patients Relative Risk Absolute Risk Difference, %
Mortality 11 1453 0.64 –0.74
Intervention        
   Surgery or radiology 12 1491 0.87 –0.30
   Urgent 9 1283 0.95 –0.45
Rebleeding        
   7 days 10 1346 0.72 –2.64
   3 days 8 1146 0.73 –2.36
   30 days 13 1619 0.89 –0.97

 

The predefined margin of noninferiority for the primary outcome was a 3% absolute difference in risk. "The upper boundary of the 95% confidence interval for the absolute risk difference was well below the 3% for the primary and secondary outcomes," said Dr. Sachar.

"The results point to the need to revise the current standard of care," she said.

In intermittent PPI, patients are not connected to infusion equipment, which markedly reduces the need for pharmacy and nursing oversight, she explained. "Intermittent PPI therapy is safe, less costly, and more comfortable for patients."

This finding "has the potential for significant system-wide savings," said Amit Bhatt, MD, from the Cleveland Clinic.

"Rebleeding after initial hemostasis can result in increased morbidity and expense, and is an independent risk factor for death," Dr. Bhatt told Medscape Medical News. In addition, "upper gastrointestinal bleeding from peptic ulcer disease is a common and costly reason for hospitalization."

During the press briefing, DDW council chair Lawrence Friedman, MD, who is chair of the Department of Medicine at Newton-Wellesley Hospital in Massachusetts, reported that he has always believed that these approaches are comparable. He said that on the basis of individual studies, he considers intermittent PPI a reasonable alternative.

He emphasized, however, that gastroenterologists should always follow the guidelines. Before formal recommendations are made, these data will have to be published.

"I do think this approach will work its way into the guidelines," Dr. Friedman said.

Dr. Sachar, Dr. Bhatt, and Dr. Friedman have disclosed no relevant financial relationships.

Digestive Disease Week (DDW) 2014. Abstract 331. Presented May 4, 2014.

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