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Background: Dyspepsia (including upper abdominal pain, abdominal pain, abdominal discomfort, epigastric discomfort, and dyspepsia) is a symptom that is carefully monitored during dabigatran treatment. However, detailed information on dyspepsia, including onset, duration, severity, and use of drug treatment, has not yet been established in Japanese patients. Methods: We conducted a multi-center, prospective, open-label, randomized, and parallel-group-comparison observational study of 309 patients with non-valvular atrial fibrillation who had been newly prescribed dabigatran at 19 institutes in Japan. Gastrointestinal adverse events were evaluated using the Global Overall Severity (GOS) scale self-reports to describe symptoms and to assess frequency and severity of symptoms (Part 1). Thereafter, patients with a GOS score ≥3 were randomized to receive a 4-week course of a proton pump inhibitor, an H2-receptor antagonist or a gastric mucosal protective drug (Part 2). Results: The incidence of dyspepsia symptoms due to dabigatran was 17.2% (53/309, 95% confidence interval 13.1–21.8%), with 77% of events occurring within 10 days of initiation. Five patients discontinued the study because of dyspepsia. At the end of the observation period, the mean GOS score of those reporting dyspepsia was 3.5±1.7, with 11.3% (35/309) reporting a score ≥3. Substantial differences in the incidence of dyspepsia were observed between the study institutes (0–41%). In the multivariate regression analysis, no significant factor was found to affect incidence or severity of dyspepsia. The majority (83–100%) reported that symptoms improved with treatment (GOS score ≤2), and there was no significant difference between the three different treatment groups. Conclusions: The reported symptoms of dyspepsia were generally mild, but were moderate in approximately 10% of patients. Proton pump inhibitors, H2-receptor antagonists, and rebamipide seemed to be equally effective in relieving dabigatran-related dyspepsia (umin-CTR UMIN000007579).

Frailty is a characteristic of older patients with heart failure, who undergo functional decline during hospitalization. At present, continuous intravenous infusion of diuretics is widely used for the treatment of hospitalized patients with heart failure. In this prospective, randomized, open-label controlled trial, we tested whether an early switch from continuous intravenous infusion therapy to oral treatment with diuretics prevents functional decline in patients hospitalized for heart failure.A total of 59 patients hospitalized for heart failure were randomized to either continuous intravenous infusion (n = 30) or oral medication (n = 29) within 48 h of admission. The primary outcome was the Barthel index, a universally utilized scale to assess the functional status of patients in their activities of daily living, assessed at 10 days. Secondary outcomes included the number of daily steps counted using pedometers and average hospital costs.Barthel index scores were significantly higher in the oral medication group than in the intravenous group (78.1 ± 20.8 vs. 59.6 ± 34.2, P = 0.029). The number of daily steps was significantly higher in the oral treatment group relative to the intravenous group (P < 0.001), and the average hospital costs were similar between the randomized groups. Multivariate analysis revealed that oral medication was a significant independent predictor of Barthel index score at day 10, and the number of daily steps was significantly associated with the patient's functional outcome.This trial showed that, in patients hospitalized for heart failure, oral medication increased functional independence during hospitalization compared with sustained continuous intravenous infusion, most likely because the release from the infusion line enabled the patients to be more mobile. Notably, these beneficial effects were achieved without increasing hospital costs.

Background: Fulminant type 1 diabetes is a non-autoimmune disorder characterized by sudden onset. This complication is rarely associated with myocarditis, suggesting an involvement of viral infection. We report a patient with myocarditis who was admitted for fulminant type 1 diabetes and diagnosed using a combination of noninvasive techniques. Case presentation: We describe the case of a 25-year-old Japanese man with fulminant type 1 diabetes complicated by myocarditis. The patient was admitted with flu-like symptoms and diabetic ketoacidosis, followed by chest pain the next day. Myocardial damage was suspected based on ST-segment elevation on electrocardiogram and elevation of cardiac enzymes. However, coronary angiography revealed no abnormality in the coronary arteries. We diagnosed myocarditis by a combination of echocardiography, cardiovascular magnetic resonance imaging (CMR), as well as Thallium-201 and Iodine-123 beta-methyl iodophenyl pentadecanoic acid (Tl-201 BMIPP and I-123 BMIPP) and myocardial imaging. More importantly, CMR revealed diffuse enhancement in the subepicardium of the left ventricle with late gadolinium enhancement, consistent with myocardial edema. The patient was successfully treated, received a two-week education program on diabetes and discharged without complication. Conclusions: The rapid onset and flu-like symptoms strongly suggest the involvement of viral infection in the pathogenesis of fulminant type 1 diabetes and myocarditis. While cardiac muscle biopsy is routinely performed, this case demonstrates that a combination of non-invasive techniques, especially CMR, may successfully diagnose myocarditis in patients with fulminant type 1 diabetes [ABSTRACT FROM AUTHOR]