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  • According to the labeling of

    2019-05-10

    According to the labeling of dabigatran in Japan, patients to be considered for the prescription of the lower dose of 220mg/day are as follows: (1) aged ≥70 years, (2) with moderate renal impairment (ClCr 30–50mL/min), (3) concomitant use of a p-glycoprotein inhibitor, and (4) history of hemorrhage or hemorrhagic tendency. In the present study, 89.5% of the patients aged ≥70 years used the low dose (220mg/day), whereas only 53.9% of the patients aged <65 years and 47.7% of the patients aged <70 used the higher dose (300mg/day) of dabigatran. This suggests that leukotriene receptor agonist low-dose administration is preferably selected regardless of the dosage chosen criteria for age in the label (Table 1). Low dose of dabigatran was given to 91.9% of the patients with ClCr levels of 30–50mL/min, and also used in 84.9% of the patients diagnosed with renal impairment as comorbidity (Table 1). Of note, 38 patients with ClCr levels of <30mL/min were administered dabigatran despite contraindication. Among the patients with a history of hemorrhage, 84% were administered the low-dose, whereas 12% were administered the high-dose of dabigatran (Table 1). As described above, low-dose administration was selected for more patients (85–90% or more) than recommended in the labeling of dabigatran.
    Conclusions The selected dosage of dabigatran is chosen predominantly in accordance with the label recommendation. The main prescribed dosage strength is 220mg/day of dabigatran. The assessment of predefined serious safety outcomes for intensive survey revealed an incidence of myocardial infarction of 0.06 per 100 patient-years and 0.55 per 100 patient-years for serious hemorrhage, and 0.13 per 100 patient-years for gastrointestinal disorders. Among NVAF patients newly treated with dabigatran or those switching from warfarin to dabigatran, the favorable safety profile of dabigatran, as demonstrated previously in randomized clinical trials, is corroborated in the real world setting in Japan.
    Source of funding The PMS study was conducted under the sponsorship of Nippon Boehringer Ingelheim.
    Conflicts of interest
    Acknowledgment
    1. Introduction
    2. Case report An 85-year-old man was referred to our hospital with a persistent fever and swelling in the right chest. In August 2010, a permanent pacemaker was implanted for sick sinus syndrome via the right subclavian vein since the left subclavian vein was occluded. He had a history of thoracic aorta replacement and chronic renal failure on hemodialysis and was hospitalized for dementia and declining mobility. In August 2011, a catheter was inserted in the right internal jugular vein for dialysis shunt occlusion. However, at the start of September, he experienced fever as well as redness and swelling of the pacemaker pocket. Antibiotics were administered for 4 weeks; however, his condition did not improve, so he was referred to our hospital. Immediately after he arrived at our hospital, his pacemaker and pacing leads were removed and a temporary pacemaker was implanted via the right femoral vein. Methicillin-resistant Staphylococcus aureus was detected in his wound and blood samples for which vancomycin was administered for 4 weeks. Negative blood cultures were confirmed over 2 weeks after the completion of vancomycin therapy. Re-implantation of a permanent pacemaker was considered. However, the subclavian vein approach was impossible because of occlusion and an infection of the right pocket and jugular vein. Epicardial lead insertion from below the xiphoid process was considered difficult because of the high risk of general anesthesia and adhesions from past aortic replacement surgery. Therefore, PMI via the right external iliac vein was considered. Under local anesthesia, a skin incision was made two finger breadths above the right inguinal ligament. The subcutaneous tissue was peeled back to expose the external iliac vein (Fig. 1). The external iliac vein was punctured under direct vision and a 55-cm-long sheath was inserted. A 75-cm-long active fixation lead (CapSureFix NOVUS 5076®; Medtronic) was screwed to the right ventricular septum (Fig. 2). A subcutaneous pocket was created by hand for the device in the external oblique fascia from the incision site. The incision site was closed using absorbable suture (2-0 PDS™; Ethicon) and skin staplers (Appose™; Covidien). The procedure lasted for approximately 2h and a small amount of bleeding was noted. He was discharged from the hospital 3 days after the procedure without any complications.