Fixed-Dose Combination of Aspirin and Pantoprazole Effectively Prevents GI Damage, finds study

A recent phase III clinical trial provided strong results which supports a fixed-dose combination of aspirin and pantoprazole to be more effective and safer than aspirin alone in preventing gastroduodenal mucosal damage in patients using aspirin for the secondary prevention of cardiovascular and cerebrovascular diseases. The findings were published in the Indian Heart Journal.

This double-blind, double-dummy, randomized trial was conducted across multiple centers and it focused on patients who had been taking aspirin at doses of up to 150 mg daily for a period of 3 to 6 months and who were expected to continue this regimen for at least six months due to their need for secondary cardiovascular or cerebrovascular disease prevention. The trial compared the efficacy and safety of a combination therapy with aspirin (150 mg) along with pantoprazole (20 mg) against the use of aspirin alone (150 mg).

A total of 240 patients were included and randomized in a 2:1 ratio, with two-thirds receiving the combination therapy and one-third receiving aspirin alone. Over the course of the 24-week study, the primary endpoint measured was the occurrence of gastroduodenal mucosal damage being monitored at weeks 12 and 24.

The results of the study found that, only 9.7% of patients in the combination therapy group had experienced gastroduodenal events by the 12th week, when compared to 19.7% of the participants taking aspirin alone. This trend continued through the 24th week, where 11.0% of patients in the combination group reported such events against the 22.4% in the aspirin-only group. The statistical significance of these findings was reinforced by a p-value of less than 0.05 at both 12 and 24 weeks highlighting the reliability of the results.

This study highlighted a significant reduction in gastrointestinal injuries among patients in the combination therapy group. This finding is particularly important, given the risks of gastrointestinal complications associated with long-term aspirin use, especially at higher doses. The inclusion of pantoprazole appeared to reduce these risks effectively by providing a protective effect against the erosive action of aspirin on the stomach lining.

Also, both treatment regimens were well tolerated with no significant adverse effects reported in either group. This indicates that the addition of pantoprazole does not introduce any additional safety concerns by making the combination therapy a viable option for patients who require long-term aspirin therapy for secondary prevention but are at risk of gastrointestinal complications.

Reference:

Choudhary, R., Khan, M. A., Dosi, R., Choudhari, S., Pawar, D., Shahavi, V., & Sharma, A. (2024). Fixed dose combination of aspirin and pantoprazole: Results of a multicenter, comparative, randomized, double-blind, double dummy, phase III study in Indian patients. In Indian Heart Journal. Elsevier BV. https://doi.org/10.1016/j.ihj.2024.07.007