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Rabeprazole prevented recurrent peptic ulcer in patients on low-dose aspirin
Rabeprazole prevented peptic ulcer recurrence associated with long-term, low-dose aspirin therapy and was well tolerated in a phase 2/3 clinical trial.
In the PLANETARIUM study conducted at 63 centers in Japan from July 2011 to March 2013, researchers performed a double blind, parallel-group trial of rabeprazole for prevention of peptic ulcer recurrence in patients on long-term, low-dose aspirin therapy for cardiovascular or cerebrovascular protection. To assess its efficacy, dose-response and safety profile, patients with a history of gastric and duodenal ulcers were randomly assigned 10 mg rabeprazole once daily (n=151), 5 mg rabeprazole once daily (n=150) or 50 mg teprenone (geranylgeranylacetone) three times daily (n=151) as an active control.
Of the 452 patients in the final analysis, cumulative peptic ulcer recurrence rates over 24 weeks were 1.4% in the 10-mg rabeprazole group and 2.8% in the 5-mg rabeprazole group vs. 21.7% in the teprenone group (P<.001). Compared with controls, rabeprazole at 10 mg and 5 mg had HRs of 0.05 and 0.11, respectively, for ulcer recurrence. The cumulative bleeding ulcer occurrence rate for the same period was 4.6% in the teprenone group compared with 0% for rabeprazole-treated patients (P=.001). Drug-related adverse events occurred in 8.9% and 4.5% of patients assigned rabeprazole 10 mg and 5 mg, respectively, vs. 10.1% in the teprenone group.
“Rabeprazole 5 mg and 10 mg are efficacious in preventing ulcer recurrence in subjects with a history of ulcers currently taking [low-dose aspirin] for cardiovascular protection,” the researchers wrote, adding that the drug was well tolerated at both doses.
Disclosure: See the study for a full list of relevant financial disclosures.