Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Int J Cardiol. 2021 Jan 15;323:77-82. doi: 10.1016/j.ijcard.2020.08.032. Epub 2020 Aug 14.
Dabigatran-induced gastrointestinal discomfort (DGID) is an important factor influencing the adherence to dabigatran. We investigated the incidence and risk factors of DGID and its impact on the adherence and persistence to dabigatran.
We prospectively enrolled the patients prescribed with dabigatran in 10 tertiary hospitals of the South Korea. The adherence was assessed using the percentage of the prescribed doses of the medication presumably taken by the patient (PDT by pill count). We evaluated the relationship between DGID and the baseline GI symptoms or the previous GI disease history using a questionnaire.
A total of 474 patients (mean age 67.8 ± 9.3 years, male 68.6%, and mean CHADS-VASc score 2.2 ± 1.2) were enrolled. The adherence assessed by the PDT was 93.5 ± 5.5% at 1-month and 96.4 ± 8.4% at 6-months among the persistent patients. During the 6-month follow-up, 82 (18.1%) patients discontinued dabigatran, and the most common reason for dabigatran discontinuation was DGID (49, 59.8%). Sixty-eight (14.3%) patients experienced DGID, and there was no difference in the clinical factors between those with or without DGID. Among the patients who experienced DGID, 42 discontinued dabigatran (61.8%). In a multivariate analysis, DGID was the only predictor of dabigatran discontinuation and a low adherence.
Overall adherence of dabigatran was excellent, but those with DGID showed low adherence and persistence. Furthermore, it was challenging to predict DGID by clinical parameters. Therefore, it is recommended to follow the patients closely to check for DGID when prescribing dabigatran.
达比加群引起的胃肠道不适（DGID）是影响达比加群依从性的重要因素。我们调查了 DGID 的发生率和危险因素及其对达比加群依从性和持久性的影响。
我们前瞻性地招募了韩国 10 家三级医院处方达比加群的患者。通过患者可能服用的药物剂量的百分比（通过药丸计数评估的 PDT）来评估依从性。我们使用问卷评估 DGID 与基线胃肠道症状或既往胃肠道疾病史之间的关系。
共纳入 474 例患者（平均年龄 67.8±9.3 岁，男性 68.6%，平均 CHADS-VASc 评分 2.2±1.2）。在持续用药的患者中，1 个月时 PDT 评估的依从性为 93.5±5.5%，6 个月时为 96.4±8.4%。在 6 个月的随访期间，82 例（18.1%）患者停用了达比加群，停用达比加群的最常见原因是 DGID（49 例，占 59.8%）。68 例（14.3%）患者出现 DGID，DGID 患者与无 DGID 患者的临床因素无差异。在出现 DGID 的患者中，有 42 例停用了达比加群（61.8%）。多变量分析显示，DGID 是达比加群停药和低依从性的唯一预测因素。
达比加群的总体依从性非常好，但 DGID 患者的依从性和持久性较低。此外，通过临床参数预测 DGID 具有挑战性。因此，建议在开具达比加群时密切关注患者，以检查 DGID。
