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Background@#To evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus. @*Methods@#This was a post-marketing surveillance study of empagliflozin 10 and 25 mg. Information on adverse events and adverse drug reactions (ADRs) was collected as safety data sets. Available effectiveness outcomes, including glycosylated hemoglobin (HbA1c) level, fasting plasma glucose, body weight, and blood pressure, were assessed. @*Results@#The incidence rate of ADRs was 5.14% in the safety dataset (n=3,231). Pollakiuria, pruritis genital, and weight loss were the most common ADRs. ADRs of special interest accounted for only 1.18%, and there were no serious events that led to mortality or hospitalization. In the effectiveness data set (n=2,567), empagliflozin significantly reduced the mean HbA1c level and body weight during the study period by –0.68%±1.39% and –1.91±3.37 kg (both P<0.0001), respectively. In addition, shorter disease duration, absence of dyslipidemia, and higher baseline HbA1c levels were identified as the clinical features characteristic of a “responder” to empagliflozin therapy. @*Conclusion@#Empagliflozin is a safe and potent glucose-lowering drug in routine use among Korean patients with type 2 diabetes mellitus. It is expected to have better glycemic efficacy in Korean patients with poorly controlled type 2 diabetes mellitus.
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Background and Objectives@#Pulmonary arterial hypertension (PAH) is a rare but fatal disease. Recent advances in PAH-specific drugs have improved its outcomes, although the healthcare burden of novel therapeutics may lead to a discrepancy in outcomes between developing and developed countries. We analyzed how the epidemiology and clinical features of PAH has changed through the rapidly advancing healthcare infrastructure in South Korea. @*Methods@#PAH was defined according to a newly devised 3-component algorithm. Using a nationwide health insurance claims database, we delineated annual trends in the prevalence, incidence, medication prescription pattern, and 5-year survival of PAH in Korea. Cumulative survival and potential predictors of mortality were also assessed among 2,151 incident PAH cases. @*Results@#Between 2002 or 2004 and 2018, the prevalence and incidence of PAH increased 75-fold (0.4 to 29.9 per million people) and 12-fold (0.5 to 6.3 per million person-years), respectively. The proportion of patients on combination PAH-specific drug therapy has also steadily increased up to 29.0% in 2018. Among 2,151 incident PAH cases (median [interquartile range] age, 50 [37–62] years; 67.2% female), the 5-year survival rate and median survival duration were 71.8% and 13.1 years, respectively. Independent predictors of mortality were age, sex, etiology of PAH, diabetes, dyslipidemia, and chronic kidney disease. @*Conclusions@#This nationwide study delineated that the prevalence and incidence of PAH have grown rapidly in Korea since the early 2000s. The use of combination therapy has also increased, and the 5-year survival rate of PAH in Korea was similar to those in western countries.
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The Korean Society of Heart Failure guidelines aim to provide physicians with evidence-based recommendations for diagnosing and managing patients with heart failure (HF). In Korea, the prevalence of HF has been rapidly increasing in the last 10 years. HF has recently been classified into HF with reduced ejection fraction (EF), HF with mildly reduced EF, and HF with preserved EF (HFpEF). Moreover, the availability of newer therapeutic agents has led to an increased emphasis on the appropriate diagnosis of HFpEF. Accordingly, this part of the guidelines will mainly cover the definition, epidemiology, and diagnosis of HF.
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The Korean Society of Heart Failure (KSHF) guidelines aim to provide physicians with evidencebased recommendations for the management of patients with heart failure (HF). After the first introduction of the KSHF guidelines in 2016, newer therapies for HF with reduced ejection fraction, HF with mildly reduced ejection fraction, and HF with preserved ejection fraction have since emerged. The current version has been updated based on international guidelines and research data on Korean patients with HF. Herein, we present Part II of these guidelines, which comprises treatment strategies to improve the outcomes of patients with HF.
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Objective@#This study evaluated the clinical usefulness of mean platelet volume (MPV) for predicting functional outcomes in subarachnoid hemorrhage (SAH) patients. @*Methods@#This is a retrospective analysis of patients who were diagnosed with SAH in the emergency room. Based on their modified Rankin Scale (mRS) score, patients were divided into two groups: 0-2 (good outcome) and 3-6 (poor outcome). Univariable and multivariable analyses were performed to investigate whether MPV, along with other multiple factors, was associated with poor prognosis. Receiver operating characteristic (ROC) curve analysis was performed to determine the value of MPV as a predicting factor of neurological prognosis. Compared to other factors, Hunt Hess grade (HHG) and modified Fisher grade (mFG) considerably influenced the outcomes in both groups (Model 1; model including all factors). Hence, a new model (Model 2) was constructed, comprising multiple factors excluding these two factors. @*Results@#A total of 143 patients were included in this study. Although MPV was different between the two groups, it was not a significant factor in Model 1 in the multivariable analysis. In Model 2, MPV (odds ration [OR], 1.71; 95% confidence interval [CI], 1.05-2.8), age (OR, 1.06; 95% CI, 1.03-1.1), and surgical treatment (OR, 0.37; 95% CI, 0.15-0.87) were significant factors related to poor outcomes. Area under the curve (AUC) of Model 1 was 0.93, 0.85 in HHG; 0.78 in Model 2, 0.65 in mFG, and 0.62 in MPV. @*Conclusion@#Although MPV differed significantly between the good and poor outcome groups, it is insufficient to predict poor outcomes in SAH patients as an independent biomarker.
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Elbow pain is a common symptom encountered in clinical practice. Pathology can arise from any component of the joint, including the bone, tendons, ligament, bursa, or nerves. This paper discusses how elbow pain can be differentiated according to its anatomic location and presents the corresponding causes, diagnosis, and treatment options.
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BACKGROUND/OBJECTIVES@#This study aimed to identify preschool children’s eating behaviors associated with early childhood obesity and its multi-level, socio-ecological determinants. @*SUBJECTS/METHODS@#In a cross-sectional study of 364 mothers of preschool children aged 3–5 years, these children’s healthy eating behaviors were assessed using a validated preschool nutrition quotient (NQ-P) questionnaire. The children’s overweight or obesity statuses were determined based on body mass index percentiles from the 2017 Korean National Growth Chart. The associations between the NQ-P score and risk of overweight or obesity were examined using multivariable logistic regression. The associations of individual, maternal, physical, and media environmental factors with the NQ-P score were also examined using multivariable linear regression. @*RESULTS@#Preschool children with greater NQ-P scores were at a significantly lower risk of overweight or obesity (P < 0.01). The NQ-P score had a significantly positive association with maternal body mass index and an inverse association with household income (all P < 0.05). Maternal parenting and feeding practices exhibited associations with the NQ-P score.Positive associations were observed with “warm,” “structured,” and “autonomy-supportive” parenting as well as monitoring feeding practices (all P < 0.05). In addition, the NQ-P score had a significantly positive association with the childcare center’s anti-obesogenic environment, such as the provision of nutritional and physical-activity support and vicinity of the built food environment to the home, including access to good-quality food, fruits and vegetables, and low-fat foods (all P < 0.05). Regarding media environments, the NQ-P score demonstrated more significant associations with viewing and eating and/or cooking content displayed on online video platforms (all P < 0.05) than with that on television. @*CONCLUSIONS@#Our findings confirm the significance of healthy eating behaviors in earlychildhood-obesity prevention and underscore the importance of multilevel maternal, physical, and media environmental interventions that effectively guide eating behaviors in preschool children.
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The Korean Society of Heart Failure (KSHF) Guidelines provide evidence-based recommendations based on Korean and international data to guide adequate diagnosis and management of heart failure (HF). Since introduction of 2017 edition of the guidelines, management of advanced HF has considerably improved, especially with advances in mechanical circulatory support and devices. The current guidelines addressed these improvements. In addition, we have included recently updated evidence-based recommendations regarding acute HF in these guidelines. In summary, Part IV of the KSHF Guidelines covers the appropriate diagnosis and optimized management of advanced and acute HF.
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Most patients with heart failure (HF) have multiple comorbidities, which impact their quality of life, aggravate HF, and increase mortality. Cardiovascular comorbidities include systemic and pulmonary hypertension, ischemic and valvular heart diseases, and atrial fibrillation. Non-cardiovascular comorbidities include diabetes mellitus (DM), chronic kidney and pulmonary diseases, iron deficiency and anemia, and sleep apnea. In patients with HF with hypertension and left ventricular hypertrophy, renin-angiotensin system inhibitors combined with calcium channel blockers and/or diuretics is an effective treatment regimen. Measurement of pulmonary vascular resistance via right heart catheterization is recommended for patients with HF considered suitable for implantation of mechanical circulatory support devices or as heart transplantation candidates. Coronary angiography remains the gold standard for the diagnosis and reperfusion in patients with HF and angina pectoris refractory to antianginal medications. In patients with HF and atrial fibrillation, longterm anticoagulants are recommended according to the CHA 2 DS 2 -VASc scores. Valvular heart diseases should be treated medically and/or surgically. In patients with HF and DM, metformin is relatively safer; thiazolidinediones cause fluid retention and should be avoided in patients with HF and dyspnea. In renal insufficiency, both volume status and cardiac performance are important for therapy guidance. In patients with HF and pulmonary disease, beta-blockers are underused, which may be related to increased mortality. In patients with HF and anemia, iron supplementation can help improve symptoms. In obstructive sleep apnea, continuous positive airway pressure therapy helps avoid severe nocturnal hypoxia. Appropriate management of comorbidities is important for improving clinical outcomes in patients with HF.
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Purpose@#We evaluated whether there is an association between sequential changes in kinetic profiles by computer-aided detection (CAD) during neoadjuvant chemotherapy (NAC) and pathologic complete response (pCR) and residual cancer burden (RCB) in dynamic contrast-enhanced MRI (DCE-MRI) of patients with invasive breast cancer. @*Materials and Methods@#This retrospective study involved 51 patients (median age, 48 years; range, 33–60 years) who underwent pre-, interim-, and post-NAC DCE-MRIs at 3 T. The tumor size and CAD-generated kinetic profiles (peak enhancement and delayed enhancement [persistent, plateau, and washout] components) were measured. Percentage changes in pre- and interim-NAC (ΔMRI value1) and pre- and post-NAC (ΔMRI value2) were compared between pCR and non-pCR cases, and according to RCB. Receiver operating characteristic curve analysis was performed to evaluate the association between pCR and MRI parameters (including CAD-generated kinetic profiles). @*Results@#The pCR rate was 19.6% (10/51). There were statistically significant differences in Δtumor size2 (p < 0.01), Δpeak enhancement2 (p = 0.01), Δpersistent2 (p = 0.01), Δplateau2 (p = 0.02), and Δwashout2 (p = 0.03) between pCR and non-pCR. ΔTumor size2 provided very good diagnostic accuracy for pCR (cut-off, -90%; area under the curve, 0.88). There were differences in Δtumor size2, Δpeak enhancement2, Δplateau2, and Δwashout2 between RCB classes (p < 0.01). @*Conclusion@#DCE-MRI using CAD has the potential for predicting pCR and RCB classes.
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Purpose@#Foley catheter (FC) insertion is very basic yet one of the most widely performed procedures all across the fields of medicine. Since FC was first introduced in 19020’s, no significant improvement has been made in view of methodology, despite the inconvenience associated with cumbersome preparation, procedure, and the patients’ discomfort with having to have their genitalia exposed. We developed a new, easy-to-use FC insertion device, Quick Foley, that provides an innovative approach to introducing FC while simplifying and minimizing time spent without compromising the sterility. @*Methods@#We developed an all-in-one disposable FC introducer contains all the necessary components in a single-device-kit. Minimal plastic components are necessary to keep accuracy and consistency, but the rest are made of the paper to minimize plastic waste. The preparation is done by connecting to the drainage bag, spurring the lubricant gel through gel insert, separating the tract, and connecting with the ballooning syringe. For the insertion, after sterilizing the urethral orifice, rotate the control knob to feed FC to the end of the urethra. After ballooning, dissembling of the device is done only by opening and removing the module, then only the FC remains. @*Results@#As the device is all-in-one, there is no need to prearrange the FC tray, simplifies the FC preparation and catheterization procedure. This device not only makes it convenient for the practitioner, but ultimately, it will reduce the psychological discomfort experienced by patient by truncating perineal exposure time. @*Conclusions@#We have successfully developed a novel device that reduces the cost and burden of using FC for practitioners while maintaining an aseptic technique. Furthermore, this all-in-one device allows the entire procedure to be completed much more quickly compared to the current method, so this minimizes perineal exposure time. Both practitioners and patients can benefit by this new device.
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Purpose@#Prior research has indicated that stroke can influence the symptoms and presentation of neurogenic bladder, with various patterns emerging, including abnormal facial and linguistic characteristics. Language patterns, in particular, can be easily recognized. In this paper, we propose a platform that accurately analyzes the voices of stroke patients with neurogenic bladder, enabling early detection and prevention of the condition. @*Methods@#In this study, we developed an artificial intelligence-based speech analysis diagnostic system to assess the risk of stroke associated with neurogenic bladder disease in elderly individuals. The proposed method involves recording the voice of a stroke patient while they speak a specific sentence, analyzing it to extract unique feature data, and then offering a voice alarm service through a mobile application. The system processes and classifies abnormalities, and issues alarm events based on analyzed voice data. @*Results@#In order to assess the performance of the software, we first obtained the validation accuracy and training accuracy from the training data. Subsequently, we applied the analysis model by inputting both abnormal and normal data and tested the outcomes. The analysis model was evaluated by processing 30 abnormal data points and 30 normal data points in real time. The results demonstrated a high test accuracy of 98.7% for normal data and 99.6% for abnormal data. @*Conclusions@#Patients with neurogenic bladder due to stroke experience long-term consequences, such as physical and cognitive impairments, even when they receive prompt medical attention and treatment. As chronic diseases become increasingly prevalent in our aging society, it is essential to investigate digital treatments for conditions like stroke that lead to significant sequelae. This artificial intelligence-based healthcare convergence medical device aims to provide patients with timely and safe medical care through mobile services, ultimately reducing national social costs.
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Purpose@#Vibegron, a novel, potent β3 agonist, has been approved for clinical use in overactive bladder (OAB) treatment in Japan and the Unites States. We performed a bridging study to investigate the efficacy and safety of a daily 50-mg vibegron (code name JLP-2002) dose in Korean patients with OAB. @*Methods@#A multicenter, randomized, double-blind, placebo-controlled study was conducted from September 2020 to August 2021. Adult patients with OAB with a symptom duration of more than 6 months entered a 2-week placebo run-in phase. Eligibility was assessed at the end of this phase and selected patients entered a double-blind treatment phase after 1:1 randomization to either the placebo or vibegron (50 mg) group. The study drug was administered once daily for 12 weeks and follow-up visits were scheduled at weeks 4, 8, and 12. The primary endpoint was the change in mean daily micturition at the end of treatment. The secondary endpoints included changes in OAB symptoms (daily micturition, nocturia, urgency, urgency incontinence, and incontinence episodes, and mean voided volume per micturition) and safety. A constrained longitudinal data model was used for statistical analysis. @*Results@#Patients who took daily vibegron had significant improvements over the placebo group in both primary and secondary endpoints, except for daily nocturia episodes. The proportions of patients with normalized micturition and resolution of urgency incontinence and incontinence episodes were significantly higher in vibegron group than in the placebo. Vibegron also improved the patients’ quality of life with higher satisfaction rates. The incidence of adverse events in the vibegron and placebo groups was similar with no serious, unexpected adverse drug reactions. No abnormality in electrocardiographs was observed as well as no significant increase in postvoid residual volume. @*Conclusions@#Once daily vibegron (50 mg) for 12 weeks was effective, safe, and well-tolerated in Korean patients with OAB.
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Background/Aims@#We used next-generation sequencing (NGS) to analyze resistance-associated substitutions (RASs) and retreatment outcomes in patients with chronic hepatitis C virus (HCV) infection who failed direct-acting antiviral agent (DAA) treatment in South Korea. @*Methods@#Using prospectively collected data from the Korean HCV cohort study, we recruited 36 patients who failed DAA treatment in 10 centers between 2007 and 2020; 29 blood samples were available from 24 patients. RASs were analyzed using NGS. @*Results@#RASs were analyzed for 13 patients with genotype 1b, 10 with genotype 2, and one with genotype 3a. The unsuccessful DAA regimens were daclatasvir+asunaprevir (n=11), sofosbuvir+ribavirin (n=9), ledipasvir/sofosbuvir (n=3), and glecaprevir/pibrentasvir (n=1). In the patients with genotype 1b, NS3, NS5A, and NS5B RASs were detected in eight, seven, and seven of 10 patients at baseline and in four, six, and two of six patients after DAA failure, respectively. Among the 10 patients with genotype 2, the only baseline RAS was NS3 Y56F, which was detected in one patient. NS5A F28C was detected after DAA failure in a patient with genotype 2 infection who was erroneously treated with daclatasvir+asunaprevir. After retreatment, 16 patients had a 100% sustained virological response rate. @*Conclusions@#NS3 and NS5A RASs were commonly present at baseline, and there was an increasing trend of NS5A RASs after failed DAA treatment in genotype 1b. However, RASs were rarely present in patients with genotype 2 who were treated with sofosbuvir+ribavirin. Despite baseline or treatment-emergent RASs, retreatment with pan-genotypic DAA was highly successful in Korea, so we encourage active retreatment after unsuccessful DAA treatment.
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Purpose@#We evaluated the change in patient quality of life after the use of a hydrophilic-coated catheter (SpeediCath) in adults requiring intermittent catheterization (IC). @*Methods@#This was a multicenter, open-label, observational study using the Patient Perception of Intermittent Catheterization (PPIC) questionnaire and the Intermittent Self-Catheterization questionnaire (ISC-Q) and safety at 12 and 24 weeks in adult patients who had already used other type of catheters prior to switching to SpeediCath or in patients undergoing self-IC for the first time for any reason. @*Results@#Among a total of 360 subjects, 215 (59.7%) were women, and the mean age was 62.0±13.2 years. At 24 weeks, the satisfaction rate after using SpeediCath was 84.1%, and 80% of patients responded that they could easily perform IC. In total, 81.6% of patients were willing to continue using SpeediCath. The mean ISC-Q score was 54.90±18.65 at 24 weeks. Men found less interference in their daily life by performing IC than women and found it easier to handle the catheter before it was inserted into the urethra. At week 12, the mean change in ISC-Q was significantly greater in patients <65 years (20.24±23.55) than in those ≥65 years (7.57±27.70, P=0.049), but there was no difference at 24 weeks. The most common adverse events were urinary tract infection in 9.72%, gross hematuria in 2.78%, and urethral pain in 1.39%. @*Conclusions@#The use of a SpeediCath provided good quality of life for patients who needed self-IC regardless of age or sex.
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Pulmonary hypertension is a rare and progressive illness with a devastating prognosis. Promising research efforts have advanced the understanding and recognition of the pathobiology of pulmonary hypertension. Despite remarkable achievements in terms of improving the survival rate, reducing disease progression, and enhancing quality of life, pulmonary arterial hypertension (PAH) is not completely curable. Therefore, an effective treatment strategy is still needed. Recently, many studies of the underlying molecular mechanisms and technological developments have led to new approaches and paradigms for PAH treatment. Management based on stem cells and related paracrine effects, epigenetic drugs and gene therapies has yielded prospective results for PAH treatment in preclinical research. Further trials are ongoing to optimize these important insights into clinical circumstances.
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Li-Fraumeni syndrome (LFS) is an inherited autosomal-dominant tumor-predisposition disorder caused by germline mutations in the TP53 tumor suppressor gene. Since patients with LFS are likely to develop therapy-related cancers, radiation therapy should be avoided if breast cancer is found in these individuals. Herein, we present a case of secondary breast cancer in an LFS patient after radiation and chemotherapy for the first diagnosed breast sarcoma.
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Inflammation is a protective mechanism against pathogens, but if maintained continuously, it destroys tissue structures. Aggregatibacter actinomycetemcomitans is a gram-negative, facultative anaerobic bacterium often found in severe periodontitis. A. actinomycetemcomitans invades epithelial cells and triggers inflammatory response in the immune cells. In this study, we investigated the effect of water-soluble rosehip extract on A. actinomycetemcomitans-induced inflammatory responses. A human monocytic cell line (THP-1) was differentiated to macrophages by phorbol 12-mystristate 13-acetate treatment. The cytotoxic effect of extract was determined using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay. The effects of extract on bacterial growth were examined by measuring the optical densities using a spectrophotometer. THP-1-derived macrophages were infected A. actinomycetemcomitans after extract treatment, and culture supernatants were analyzed for cytokine production using enzyme-linked immunosorbent assay. Protein expression was measured by western blotting. Extract was not toxic to THP-1-derived macrophages. A. actinomycetemcomitans growth was inhibited by 1% extract. The extract suppressed A. actinomycetemcomitans-induced tumor necrosis factor-α, interleukin (IL)-1β, and IL-8 production. It also decreased mitogen-activated protein kinase (MAP kinase) and nuclear factor-κB (NF-κB) phosphorylation. Moreover, the extract inhibited the expression of inflammasome components, including nucleotide-binding oligomerization domain-like receptor pyrin domain-containing protein 3, Absent in Melanoma 2, and apoptosis associated speck-like protein containing a CARD. And cysteine-aspartic proteases-1 and IL-1β expression were decreased by the extract. In summary, extract suppressed A. actinomycetemcomitans growth and decreased inflammatory cytokine production by inhibiting activation of MAP kinase, NF-κB, and inflammasome signaling. Rosehip extract could be effective in the treatment of periodontal inflammation induced by A. actinomycetemcomitans infection.
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Background and Objectives@#This study aimed to investigate the association between cardiovascular events and 2 different levels of elevated on-treatment diastolic blood pressures (DBP) in the presence of achieved systolic blood pressure targets (SBP). @*Methods@#A nation-wide population-based cohort study comprised 237,592 patients with hypertension treated. The primary endpoint was a composite of cardiovascular death, myocardial infarction, and stroke. Elevated DBP was defined according to the Seventh Report of Joint National Committee (JNC7; SBP <140 mmHg, DBP ≥90 mmHg) or to the 2017 American College of Cardiology/American Heart Association (ACC/AHA) definitions (SBP <130 mmHg, DBP ≥80 mmHg). @*Results@#During a median follow-up of 9 years, elevated on-treatment DBP by the JNC7 definition was associated with an increased risk of the occurrence of primary endpoint compared with achieved both SBP and DBP (adjusted hazard ratio [aHR], 1.14; 95% confidence interval [CI], 1.05–1.24) but not in those by the 2017 ACC/AHA definition. Elevated ontreatment DBP by the JNC7 definition was associated with a higher risk of cardiovascular mortality (aHR, 1.42; 95% CI, 1.18–1.70) and stroke (aHR, 1.19; 95% CI, 1.08–1.30). Elevated on-treatment DBP by the 2017 ACC/AHA definition was only associated with stroke (aHR, 1.10;95% CI, 1.04–1.16). Similar results were seen in the propensity-score-matched cohort. @*Conclusion@#Elevated on-treatment DBP by the JNC7 definition was associated a high risk of major cardiovascular events, while elevated DBP by the 2017 ACC/AHA definition was only associated with a higher risk of stroke. The result of study can provide evidence of DBP targets in subjects who achieved SBP targets.
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Male breast cancer is rare, accounting for approximately 1% of breast cancers. Metastasis from extra-mammary malignancy to the breast in men is extremely rare. The most common primary tumors that metastasize to the breast in male are prostate, lung, stomach, colorectal cancer, melanoma, and sarcoma. To our knowledge, only a few cases of bladder cancer presenting with metastasis to the male breast have been reported, and metastasis with infiltration rather than mass is extremely rare. We report imaging findings on mammography and ultrasonography in a 59-year-old male with bladder cancer metastatic to the breast.