Evidence of impaired dabigatran absorption following laparoscopic Roux‐en‐Y gastric bypass surgery: the Auckland regional experience (2011–2018)

Grainger, Brian; Holloway, Rossi; Merriman, Eileen; Booth, Michael; Royle, Gordon; Babor, Richard; Beban, Grant; Young, Laura

doi:10.1111/bjh.17004

Cited by 12 publications

(6 citation statements)

References 14 publications

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“…The authors did not measure dabigatran plasma concentrations, but inferred from a normal APTT that the absorption of dabigatran might have been insufficient. In a retrospective case series of nine patients who underwent gastric bypass surgery, dabigatran peak concentrations were consistently lower than those reported in clinical trials [ 28 ]. Five of these nine patients were switched to rivaroxaban, and peak serum concentrations were comparable to the range reported in the literature.…”

Section: Discussionmentioning

confidence: 99%

Absorption of Direct Oral Anticoagulants in Cancer Patients after Gastrectomy

et al. 2022

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Direct oral anticoagulants (DOACs) are safe and effective in cancer patients treated for venous thromboembolism (VTE) or atrial fibrillation (AF). Gastrectomy is the treatment of choice in patients with localized upper gastrointestinal cancer. DOACs are absorbed in the upper gastrointestinal tract, but to what extent is unclear. In a retrospective analysis, hospital data were searched for adult patients who underwent gastrectomy for gastroesophageal or pancreatic cancer, and DOAC therapy for VTE or AF after gastrectomy. DOAC blood levels were determined by chromogenic assays before and after administration, and thromboembolic and bleeding complications were recorded. Eleven patients (median age 76 years) received a factor Xa inhibitor (FXaI; apixaban (3), edoxaban (3), rivaroxaban (4)) or the factor IIa inhibitor dabigatran (1) for VTE (7) or AF (4) after gastrectomy. Eight patients on FXaI had anti-Xa (aXa) trough levels within the expected range (ER). In all of them, aXa levels increased upon DOAC administration. Two patients on 30 mg edoxaban had low aXa trough levels. Administration of 20 mg of rivaroxaban resulted in trough levels in the ER in one of them. None of the FXaI patients had thromboembolism, while two experienced bleeding (arterial puncture site, gastrointestinal). One dabigatran AF patient with trough and peak concentrations below the ER had strokes during 110 mg and 150 mg dabigatran administration. While on apixaban, aXa levels were in the ER, and no clinical complications occurred. DOACs, particularly FXaI, were adequately absorbed in cancer patients after gastrectomy. Our observation of recurrent thromboembolic events in a patient treated with dabigatran warrants cautious use in this specific patient population.

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Section: Discussionmentioning

confidence: 99%

Absorption of Direct Oral Anticoagulants in Cancer Patients after Gastrectomy

et al. 2022

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“…Sixteen studies reported clinical outcomes only (n = 3145 patients), [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31] three reported pharmacokinetic outcomes only (n = 3 patients), [32][33][34] and nine reported both clinical and pharmacokinetic outcomes (n = 81 patients). 15,[35][36][37][38][39][40][41][42] Only one study 17 compared DOACs with warfarin in patients with non-valvular atrial fibrillation after bariatric surgery and did not show a statistically significant difference in the rate of stroke or systemic embolism, or major bleeding between the two interventions (Table S2).…”

Section: Ta B L Ementioning

confidence: 99%

“…We identified 2519 records through database searches, http://clinicaltrials.gov, and reference lists (Figure 1). Twenty‐eight studies were included: 7 cohort studies, 6 case series, and 15 case reports 15–42 . Study characteristics can be found in Table 2.…”

Section: What Is the Efficacy And Safety Of Doacs After Bariatric Sur...mentioning

confidence: 99%

Direct oral anticoagulants after bariatric surgery—What is the evidence?

Leong

Chu

Crowther

et al. 2022

Journal of Thrombosis and Haemostasis

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Background Obesity is a global epidemic and bariatric surgery is used with increasing frequency to treat its complications. The extent to which bariatric surgery alters the efficacy, safety, and pharmacokinetics of direct oral anticoagulants (DOACs) is unknown. Aims In this review, we summarize the evidence supporting the use of DOACs after bariatric surgery and apply our findings to resolve several clinical cases. Materials & Methods We systematically searched MEDLINE, EMBASE, Cochrane Library, CINAHL and http://clinicaltrials.gov from January 1, 2000, to June 15, 2021 for randomized and non‐randomized studies evaluating the use of DOACs for any indication after bariatric surgery. Two reviewers independently screened titles, abstracts, and full‐text articles. Clinical and pharmacokinetic outcomes were pooled by random‐effects meta‐analysis with inverse variance weighting. We used the Newcastle‐Ottawa scale to assess risk of bias in non‐randomized studies and assessed the certainty of evidence with GRADE. Results From 2519 records, we included 28 studies (n = 3229 patients): no randomized trials, 7 cohort studies, 6 case series, and 15 case reports. Incidence rates for arterial thromboembolism, venous thromboembolism and major bleeding were: 0.73 (95% confidence interval [CI]: 0.01–5.10), 2.45 (95% CI: 0.40–7.94), and 3.40 (95% CI: 0.80‐9.36) events per 100 patient‐years, respectively. The pooled proportion of peak direct oral anticoagulant drug levels within the expected range was 58% (95% CI: 39%–74%). Conclusion There appears be substantial risk of DOAC malabsorption after bariatric surgery that could affect clinical outcomes, however the certainty of evidence was very low. PROSPERO: CRD42020202636.

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“…The drug concentration decreased significantly. According to the researchers, this may indicate impaired or delayed absorption [52]. Rottenstreich et al, observed that the C max of dabigatran in BS patients regularly using this drug was within the expected range [53].…”

Section: Anticoagulant Drugsmentioning

confidence: 99%

The Effects of Bariatric Surgery and Gastrectomy on the Absorption of Drugs, Vitamins, and Mineral Elements

2021

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Bariatric surgery, which is an effective treatment for obesity, and gastrectomy, which is the primary treatment method for gastric cancer, alter the anatomy and physiology of the digestive system. Weight loss and changes in the gastrointestinal tract may affect the pharmacokinetic parameters of oral medications. Both bariatric and cancer patients use drugs chronically or temporarily. It is important to know how surgery affects their pharmacokinetics to ensure an effective and safe therapy. The Cochrane, PubMed, and Scopus databases were searched independently by two authors. The search strategy included controlled vocabulary and keywords. Studies show that bariatric surgery and gastrectomy most often reduce the time to maximum plasma concentration (tmax) and decrease the maximum plasma concentration (Cmax) in comparison with the values of these parameters measured in healthy volunteers. Vitamin and mineral deficiencies are also observed. The effect depends on the type of surgery and the properties of the drug. It is recommended to use the drugs that have been tested on these groups of patients as it is possible to monitor them.

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Evidence of impaired dabigatran absorption following laparoscopic Roux‐en‐Y gastric bypass surgery: the Auckland regional experience (2011–2018)

Cited by 12 publications

References 14 publications

Absorption of Direct Oral Anticoagulants in Cancer Patients after Gastrectomy

Absorption of Direct Oral Anticoagulants in Cancer Patients after Gastrectomy

Direct oral anticoagulants after bariatric surgery—What is the evidence?

The Effects of Bariatric Surgery and Gastrectomy on the Absorption of Drugs, Vitamins, and Mineral Elements

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