Management of dyspepsia symptoms on dabigatran during RELY-ABLE: long-term follow up study after RE-LY

Purpose: Data from the RE-LY trial showed that dabigatran etexilate (DE) was associated with more dyspepsia-like symptoms (DE 110 mg twice daily [bid] 11.8% total rate; 150 mg bid 11.3% total rate; dose independent) compared to well controlled warfarin (5.8% total rate). Almost 50% of the patients originally randomized to DE in the RE-LY trial were enrolled in the long-term follow-up study RELY-ABLE, where they continued to receive the blinded DE dose assigned in the RE-LY trial. Investigators completed specific case report forms (CRFs) during the RELY-ABLE trial to assess dyspepsia symptoms occurring at any time on DE treatment and whether specific measures provided symptom relief. Methods: A questionnaire in the CRFs collected descriptive information on the occurrence of dyspepsia and related events, the duration of episodes, therapies and responses to treatment. A total of 5851 patients were enrolled into the RELY-ABLE study (2914 on DE 110 mg bid and 2937 on 150 mg bid) and data were available from 5081 patients (86.8%). Patients were asked to describe the presence of new or worsening dyspepsia during their participation in the RE-LY and RELY-ABLE trials. If dyspepsia or a related event was reported, additional information regarding symptom alleviation and duration of symptoms was to be collected. Results: During the course of DE treatment 9.6% of patients (DE 110 mg and 150 mg bid) reported a period with dyspeptic symptoms; 2% reported prevalent dyspepsia; 6.8% reported previous and current dyspeptic symptoms. Occurrence of dyspepsia or abdominal discomfort was similar between the two DE dosages. The mean duration of dyspepsia symptoms was 44.7 days with DE 110 mg bid and 57.4 days with DE 150 mg bid. Overall, 1071 patients used 1123 treatments. The only treatments that appeared to reduce symptoms were concomitant food intake, proton pump inhibitors or H2-blocking agents (success rates 88%, 90% and 87%, respectively). Conclusion: Dyspepsia and related symptoms associated with the use of DE can be transient. If symptoms persist, some patients appear to benefit from measures that reduce stomach acidity. In RELY-ABLE, symptom improvement was reported with concomitant food intake, H2-blockers or proton pump inhibitors.