SAN DIEGO – However, these patients face a considerable risk of overall mortality, despite a low incidence of recurrent GI bleeding.
“Peptic ulcer disease is a commonly encountered condition in our daily clinical practice,” one of the study authors, Louis Lau, MD, said at the annual Digestive Disease Week. “Most of the ulcers are due to H. pylori and NSAIDs or aspirin. However, idiopathic peptic ulcers remain an area to be investigated.”
According to Dr. Lau of the division of gastroenterology and hepatology at Prince of Wales Hospital, Hong Kong, H. pylori–negative idiopathic ulcers have increased in prevalence in the Asian Pacific region, from 1%-4% in 2000 to up to 20% in recent data. These ulcers have been shown to have a bleeding rate of up to 13% within 1 year () and have been associated with a mortality rate of up to 88% in 7 years of follow-up ( ).
“There is no consensus for the optimal management of this particular ulcer,” he continued. “One proposed management was maintenance PPI [proton pump inhibitors]. However, we would like to look for the best optimal prevention strategy.”
Dr. Lau and associates conducted a double-blind, randomized trial at Prince of Wales Hospital to determine if there were any differences between the PPI lansoprazole and the histamine2 receptor antagonist famotidine for the prevention of recurrent bleeding in patients with H. pylori–negative idiopathic peptic ulcers. It involved a 2-year follow-up period and included a screening and end-of-study esophagogastroduodenoscopy. The drugs were repackaged into identical green capsules.
The researchers limited the analysis to 228 patients over the age 18 with H. pylori–negative idiopathic ulcers, defined as having endoscopic biopsies negative for both rapid urease test and histology for H. pylori; no exposure to aspirin, NSAIDs, or drugs of unknown nature including traditional Chinese medicine within 4 weeks; and no other causes of ulceration identified. Exclusion criteria included patients with a strong indication for maintenance therapy with PPIs, those with prior gastric surgery, pregnant patients, and those with advanced malignancy or comorbidity.
The primary endpoint was clinical GI bleeding or reduction in hemoglobin level of 2 g/dL or more and confirmation of peptic ulcers by endoscopy. The secondary endpoint was recurrent ulcer detected by end-of-study endoscopy, with or without clinical symptoms.
Of the 228 patients, 114 received lansoprazole 30 mg daily and 114 received famotidine 40 mg daily. Recurrent upper GI bleeding was suspected in 10 patients in each of the treatment groups. Ulcer confirmation via endoscopy detected one ulcer in the lansoprazole group and three in the famotidine group (0.9% vs. 2.6%, respectively; P = .62). For the secondary endpoint, there were five recurrent ulcers in the lansoprazole group and nine in the famotidine group, (4.4% vs. 7.9%, respectively; P = .27).
Dr. Lau and colleagues observed eight deaths in the lansoprazole group (7%), compared with five (4.4%) in the famotidine group (P = .39), mainly caused by pneumonia, renal failure, and other chronic medical conditions. Intention-to-treat analysis at 2 years found that both groups were comparable in terms of time to analysis of recurrent upper GI bleeding, adjusted for death as a competing risk (Gray’s test, P = .313).
“In this randomized, controlled trial, we found that both a PPI and an H2 blocker are comparable in the prevention of idiopathic ulcer recurrent bleeding,” Dr. Lau concluded. “The rebleeding rate was five times lower than a previous cohort reported with no or irregular acid suppression therapy . With all this, there is still a considerable risk of recurrent ulcers and death. We postulate that there is an underlying mechanism for this type of idiopathic ulcer.”
The study was funded in part by the. Dr. Lau reported having no financial disclosures. Many of his coauthors reported having numerous financial ties to the pharmaceutical industry.
SOURCE: Lau L et al. DDW 2019, .