Real-World Insurance Claims Analysis of Venous Thromboembolism in Japanese Patients with Inflammatory Bowel Disease.

BACKGROUND: Inflammatory bowel disease (IBD), which encompasses both ulcerative colitis (UC) and Crohn's disease (CD), is a risk factor for venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). AIM: To investigate the incidence of, and risk factors for, VTE in patients with IBD in Japan. METHODS: This was a retrospective, non-interventional study in patients with IBD from the Japan Medical Data Center claims database. Incidence rates (IRs; unique patients with events per 100 patient-years) were calculated for VTE, DVT, and PE among the IBD, UC, and CD cohorts. Odds ratios of potential risk factors were calculated by univariate and multivariate analyses in a nested case-control design. RESULTS: Overall, 16 273 patients with IBD were included: 13 585 with UC and 3443 with CD. VTE events occurred in 1.3%, 1.2%, and 1.9% of patients with IBD, UC, and CD, respectively. In patients with IBD, UC, and CD, IRs of VTE were 0.45, 0.40, and 0.64, respectively, IRs of DVT were 0.42, 0.38, and 0.61, respectively, and IRs of PE were 0.07, 0.07, and 0.11, respectively. In patients with IBD, treatment history (immunomodulators), cardiovascular risk (hypertension, high-density lipoprotein or diabetes mellitus, and history of coronary artery disease or heart failure), malignancy, and undergoing major surgery were identified as potential risk factors for VTE in the multivariate analysis, with similar risk factors reported for patients with UC and CD. CONCLUSIONS: This large study provides insight into the incidence and risk factors for VTE in patients with IBD from Japan.

Incidence, Characteristics and Management of Venous Thromboembolism in Japan During 2011.

BACKGROUND: This study aimed to determine the incidence, characteristics and management of venous thromboembolism (VTE) in Japan during 2011.Methods and Results:A retrospective study assessed responses to a questionnaire regarding treating newly diagnosed VTE at all admitting hospitals throughout Japan during 2011. More individuals were diagnosed with VTE than ever before, with 16,096 cases of diagnosed pulmonary embolism (PE) and 24,538 cases of diagnosed deep vein thrombosis (DVT). Almost half (47.2%) of the PE patients had a relatively mild condition with no right ventricular overload. Similarly, almost half (43.8%) of the DVT patients had a relatively mild condition with isolated calf thrombus. Most of PE patients were treated by anticoagulation, and fewer were treated using thrombolytic agent or inferior vena cava (IVC) filter. CONCLUSIONS: The present study showed a remarkable increase in the incidence of VTE in Japan during 2011. Relatively mild conditions such as non-massive PE and isolated calf DVT were frequently diagnosed. Among PE patients, thrombolytic therapy or IVC filter implantation decreased compared with previous surveys. The appropriate management of isolated calf DVT requires further investigation.

Current management of venous thromboembolism in Japan: Current epidemiology and advances in anticoagulant therapy.

Venous thromboembolism (VTE), manifesting as either deep vein thrombosis or pulmonary embolism, is common worldwide including in Japan. The number of patients clinically diagnosed with VTE is increasing with the majority of cases occurring out-of-hospital and of milder severity. Cancer is the largest risk factor for VTE and VTE in cancer patients confers an increased 1-year mortality rate. However, the majority of VTE cases are considered "idiopathic" or "unprovoked." The limited efficacies of unfractionated heparin and warfarin have stimulated the development of new anticoagulant therapies. Recently, parenteral and oral administration of the Xa inhibitors fondaparinux and edoxaban, respectively, was approved in Japan. These agents have the potential to provide safer and more efficacious treatment options for VTE. Although further randomized studies are required to validate the utility of these agents, they are expected to substantially improve quality of life in VTE patients. This review summarizes the current status of VTE management in Japan focusing on current epidemiology and recent advances in anticoagulant therapy.

Improving drug adherence using fixed combinations caused beneficial treatment outcomes and decreased health-care costs in patients with hypertension.

We enrolled 196 patients with hypertension who were already being treated with free-drug combinations of angiotensin-II receptor blocker (ARB) and amlodipine. The free-drug combinations of ARB and amlodipine were replaced with the same dose of the fixed-dose combinations. The average home blood pressure (BP) in all patients receiving fixed-dose combinations was significantly lower than those receiving free-drug combinations (131 ± 10/75 ± 8 vs. 136 ± 11/77 ± 9 mm Hg, P < .01) accompanied with increasing drug adherence. After lowering BP by fixed-dose combinations, the costs for medications decreased by 31% over the 3 months.

Multidetector-row computed tomography-based clinical assessment of fondaparinux for treatment of acute pulmonary embolism and acute deep vein thrombosis in Japanese patients.

BACKGROUND: Unfractionated heparin (UFH) is the standard drug for the initial treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) in Japan, whereas fondaparinux is the standard drug in Europe and the United States. Here, we examine the efficacy and safety of fondaparinux in Japanese patients. METHODS AND RESULTS: In 2 randomized, open-label, multicenter studies, 80 Japanese patients with acute PE or DVT received either subcutaneous fondaparinux or intravenous UFH as a non-comparative reference, in a 3:1 ratio, for 5-10 days. Concomitant warfarin therapy was continued until Day 90. Multidetector-row computed tomography-based assessment showed that 57.9% and 45.9% of the patients with acute PE and acute proximal DVT had proximal DVT and PE as a complication, respectively. There was no recurrence of symptomatic venous thromboembolism. In the fondaparinux group, the respective improvement rates at the end of the initial treatment and follow-up periods were 71.4% and 86.8% for 42 patients with PE, and 57.8% and 83.3% for 46 patients with DVT; similar results were noted in the UFH group. One patient in the fondaparinux group experienced major bleeding during the initial treatment, but no such episode in the UFH group. CONCLUSIONS: Once-daily, subcutaneous fondaparinux is as effective and safe without monitoring as adjusted-dose intravenous UFH for the initial treatment of acute PE and DVT in Japanese patients.

[Incidence and clinical characteristics of perioperative pulmonary thromboembolism in Japan in 2008--results from the annual study of Japanese Society of Anesthesiologists, Committee on Patient Safety and Risk Management, Perioperative Pulmonary Thromboembolism Working Group].

BACKGROUND: The Japanese Society of Anesthesiologists (JSA) has maintained records of the annual incidence and characteristics of perioperative pulmonary thromboembolism (perioperative PTE) since 2002. The aim of this paper was to provide recent results of the JSA annual study conducted in 2008, and to determine the current factors that tend to prevent perioperative venous thromboembolism (VTE) in Japan. METHODS: A comprehensive questionnaire designed by the JSA PTE working group was mailed to all institutions certified as teaching hospitals by JSA. The data tics of patients with perioperative PTE, such as types of diseases and surgeries, age, sex, methods used for the prevention of VTE (in some cases), and prognosis of perioperative PTE. RESULTS: The rate of effective responses was 56.1% (634/1116), and 1,177,626 surgeries were registered during the study period. There were 324 patients who were reported to have had PTE, and the incidence was 2.75 per 10,000 surgeries. The incidence of perioperative PTE in 2008 did not change significantly from that in 2005-07. The surgeries that most commonly resulted in perioperative PTE were limb and/or hip joint surgery (5.71 per 10,000 surgeries), craniotomy (4.64 per 10,000), and thoracotomy with laparotomy (3.46 per 10,000 surgeries). The mortality rate of perioperative PTE in 2008 was found to have significantly decreased from that in 2005-07 (15.6% vs. 22.4%; P = 0.01). Further, the rate of patients who received anticoagulant drugs in 2008 was significantly higher than that in 2005-07 (17.6% vs. 10.8%; P = 0.0018). Individual guidelines for the prevention of perioperative VTE were adopted in 55.4% of the training institutions. CONCLUSIONS: The increase in the percentage of patients who received anticoagulant drugs around the time of the operation, and the decreased mortality of patients with perioperative PTE suggested that the prophylaxis for perioperative VTE with anticoagulant drugs reduces perioperative mortality.

[Incidence and characteristics of perioperative pulmonary thromboembolism in Japan from 2005 through 2007--results of research by Japanese Society of Anesthesiologists, Committee on Patient Safety and Risk Management, Perioperative Pulmonary Thromboembolism Working Group].

BACKGROUND: This study aimed to investigate the annual incidence and characteristics of perioperative pulmonary thromboembolism (PTE) in Japan from 2005 through 2007, and to compare the current trend with that observed in our previous studies conducted since 2002. METHODS: In the 3-year study period, a questionnaire was annually mailed to every institution certified as a training hospital for anesthesiologists by the Japanese Society of Anesthesiologists (JSA). The survey included the parameters of age, sex, type of surgery, and the risk factors in patients who were operated upon. RESULTS: The average rate of effective responses was 55.1%, and a total of 825 cases of perioperative PTE were registered in the 3-year study period. The incidence of perioperative PTE was 2.79 per 10,000 cases in 2005, 2.25 per 10,000 cases in 2006, and 2.57 per 10,000 cases in 2007. The incidence of PTE in all the 3 years was significantly lower than that observed in 2002-03 (P < 0.01). In addition, the incidence of fetal PTE in 2006 and 2007 was also significantly lower than that in 2002-03. The incidence of PTE in older persons (66-85 years) was approximately twice (4.70 per 10,000 cases) and that in the oldest persons (> 86 years) was approximately thrice (6.28 per 10,000 cases) the incidence in middle-aged individuals (2.17 per 10,000 cases). PTE was found to be more frequent in females than in males (males, 1.89 per 10,000 cases; females, 3.75 per 10,000 cases). The types of surgery that most commonly resulted in perioperative PTE were limb and/or hip joint surgery (5.57 per 10,000 cases), thoracotomy with laparotomy (5.19 per 10,000 cases), and spinal surgery (4.49 per 10,000 cases). Perioperative PTE was fatal in 185 patients (22.4%), and the mortality rate of patients who had not received prophylaxis was significantly higher (37.8%) than that of patients who received anticoagulant drugs (20.8%). Guidelines for prevention of perioperative PTE were accepted by 58% of all training institutions. CONCLUSIONS: The incidence of perioperative PTE and fetal PTE has currently decreased; however, prophylaxis with anticoagulant drugs may have reduced the mortality in some cases.

Assessment by radionuclide ventriculography of postischemic regional left ventricular dysfunction in patients with healed myocardial infarction or angina pectoris.

Postischemic left ventricular (LV) dysfunction has been observed in experimental animal models after brief, complete coronary artery occlusion followed by reperfusion, but less relevant information is available for humans. The incidence and duration of postischemic LV dysfunction was examined by exercise radionuclide ventriculography in 50 patients with coronary artery disease. Cardiac imaging was performed at rest and was repeated during exercise and then immediately after and 5, 10, and 20 minutes after exercise. LV regional wall motion abnormalities were noted in 50 segments during exercise; they persisted in 30 of 50 segments after exercise, and remained apparent for 20 minutes in 11 segments. In contrast, in 33 segments, wall motion abnormalities were noted only after exercise and continued for 20 minutes in 13 of 33 segments. Exercise-related wall motion abnormalities were observed in 63 segments (76%) after exercise, and in 24 of 63 segments abnormalities continued for 20 minutes after exercise, although parameters of LV hemodynamic functions approached normal values after exercise. The mechanism of postexercise dysfunction is considered to involve acute myocardial stunning after a brief episode of myocardial ischemia, whereas regional wall motion abnormalities observed only after exercise seem to be related to increased levels of catecholamines or sympathetic overdrive, which mask less significant myocardial ischemia during exercise.