Abstract Purpose The objective of this study was to evaluate the efficacy and safety of a fimasartan/amlodipine combination in patients with hypertension and to determine the optimal composition for ...a future single-pill combination formulation. Methods This Phase II study was conducted by using a randomized, multicenter, double-blind, placebo-controlled, 3 × 3 factorial design. After a 2-week placebo run-in period, eligible hypertensive patients (with a sitting diastolic blood pressure SiDBP between 90 and 114 mm Hg) were randomized to treatment. They received single or combined administration of fimasartan at 3 doses (0, 30, and 60 mg) and amlodipine at 3 doses (0, 5, and 10 mg) for 8 weeks. The primary efficacy end point was the change in SiDBP from baseline and at week 8; secondary end points included the change in SiDBP from baseline and at week 4 and the changes in sitting systolic blood pressure from baseline and at weeks 4 and 8. Treatment-emergent adverse events (AEs) were also assessed. Findings 420 Korean patients with mild to moderate hypertension were randomly allocated to the 9 groups. Mean (SD) SiDBP changes in each group after 8 weeks were as follows: placebo, –6.0 (8.5) mm Hg; amlodipine 5 mg, –10.6 (9.2) mm Hg; amlodipine 10 mg, –15.9 (7.2) mm Hg; fimasartan 30 mg, –10.1 (9.1) mm Hg; fimasartan 60 mg, –13.0 (10.0) mm Hg; fimasartan 30 mg/amlodipine 5 mg, –16.2 (8.5) mm Hg; fimasartan 30 mg/amlodipine 10 mg, –19.5 (7.5) mm Hg; fimasartan 60 mg/amlodipine 5 mg, –16.6 (6.9) mm Hg; and fimasartan 60 mg/amlodipine 10 mg, –21.5 (8.3) mm Hg. All treatment groups produced significantly greater reductions in blood pressure compared with the placebo group. In addition, all combination treatment groups had superior reductions in blood pressure compared with the monotherapy groups. In the combination treatment groups, doubling fimasartan dose in the given dose of amlodipine did not show further BP reduction, whereas doubling amlodipine dose showed significantly further BP reduction in the given dose of fimasartan. During the study period, 75 (17.9%) of 419 patients experienced 110 AEs. Ninety-five AEs were mild, 9 were moderate, and 6 were severe in intensity. Eight patients discontinued the study due to AEs. There was no significant difference in incidence of AEs among groups ( P = 0.0884). The most common AE was headache (12 patients 2.9%), followed by dizziness (11 patients 2.6%) and elevated blood creatine phosphokinase levels (6 patients 1.4%). Implications Fimasartan combined with amlodipine produced superior blood pressure reductions and low levels of AEs compared with either monotherapy. Therefore, a single-pill combination with fimasartan 60 mg/amlodipine 10 mg will be developed. ClinicalTrials.gov: NCT01518998.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background The effect of vitamin D on allergic conditions is unclear. In particular, large-scale, population-based studies examining this relationship in adult Asian populations are lacking. ...Objective To evaluate the association between serum vitamin D levels and allergic conditions in the general adult Korean population. Methods A cross-sectional study was performed by using data collected from 15,212 individuals 19 years or older who participated in the Korean National Health and Nutrition Examination Survey from 2008 to 2010. The confounder-adjusted mean serum 25-hydroxyvitamin D (25OHD) levels of participants with and without allergic conditions (including atopic dermatitis, asthma, allergic rhinitis, and increased total and allergen-specific serum IgE) were compared by using multiple linear regression analyses. Multiple logistic regression analyses with confounder adjustment estimated the odds ratios (ORs) for developing each condition according to adequate, inadequate, or deficient serum 25(OH)D levels. Results After adjusting for potential confounders, mean serum 25(OH)D levels were significantly lower in participants diagnosed with atopic dermatitis than in those without this diagnosis (mean ± SE, 18.58 ± 0.29 ng/mL vs 19.20 ± 0.15 ng/mL; P = .02). Compared with participants with adequate vitamin D levels (≥20 ng/mL), confounder-adjusted ORs of atopic dermatitis were significantly higher in those with inadequate (12-19.99 ng/mL) or deficient (<12 ng/mL) levels (OR 95% CI, 1.50 1.10-2.06 and 1.48 1.04-2.12, respectively; P = .02). This relationship was not observed in participants with the other allergic conditions. Conclusion Vitamin D–insufficient adult individuals within the general Korean population have an increased likelihood of atopic dermatitis, but not asthma, allergic rhinitis, or IgE sensitization.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
To investigate the effects of different sleeping positions of head and body on intraocular pressure (IOP) and ocular perfusion pressure (OPP) in healthy, young subjects.
Prospective, comparative case ...series.
Twenty healthy young Korean subjects.
We measured IOP and blood pressure (BP) with the subjects seated and recumbent, including supine, right lateral decubitus, left lateral decubitus, prone with right head turn, and prone with left head turn positions. We measured IOP using an Icare tonometer in both eyes 5 minutes after assuming each position in a randomized sequence. We calculated the OPP using the formulas based on the mean BP adjusted for the height of the eye over the heart. The eye on the lower side in the lateral decubitus or prone with head turn position was termed the dependent eye.
Difference in IOP and OPP of the dependent and nondependent eyes during changes of sleeping positions of body and head.
Mean IOP of right and left eyes while sitting was significantly lower than that measured in each recumbent position (all P<0.001). The OPPs in both eyes were significantly higher in all recumbent positions than in a sitting position (all P<0.001). Mean IOP of the dependent eyes was higher than that of the nondependent eyes in the lateral decubitus positions and in the prone positions with head turns (all P<0.001). No significant intereye difference in OPP was found for any position. Among IOPs measured in the recumbent positions, mean IOP of the dependent eye in the lateral decubitus position or in the prone position with head turn was significantly higher than that of the ipsilateral eye in the supine position (all P<0.0001).
All sleeping positions of head and body resulted in an elevation of IOP and an increase in the calculated OPP compared with the sitting position in healthy, young subjects. The postural change from supine to lateral decubitus or prone with head turn position increased the IOP of the dependent eyes without significant alteration in OPP in healthy awake subjects. Further research is needed under nocturnal conditions in a sleep laboratory.
The authors have no proprietary or commercial interest in any of the materials discussed in this article.
Background Laryngeal ultrasonography (LUS) is a new method of vocal cord (VC) evaluation in patients with risk of vocal cord palsy (VCP). The previously described anterior-approach LUS reportedly, ...however, has high failure rate of VC visualization in male patients. We devised a novel lateral-approach LUS to overcome this limitation. Methods A total of 382 (82 male, 300 female) consecutive LUS and direct laryngoscopy (DL) examinations were performed on perioperative thyroidectomy and parathyroidectomy patients. The anterior-approach LUS was used for female patients whereas the lateral-approach LUS was used for male patients. Findings were cross-validated independently with DL examinations. Results Both anterior and lateral LUS methods had 100% visualization rate (no failed visualization) with an overall sensitivity of 100% (23/23) and specificity of 99.2% (356/359) for VCP. Among the 300 female patients, 18 patients had VCP. Sensitivity and specificity of anterior-approach LUS were 100% (18/18) and 99.3% (280/282), respectively. Among the 80 male patients, 5 patients had VCP. Sensitivity and specificity of lateral-approach LU were 100% (5/5) and 98.7% (76/77), respectively. Conclusion The new LUS approach significantly enhances the visualization of vocal cords and, therefore, overall diagnostic efficacy of LUS in male patients.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Ethanol causes diverse neurologic conditions caused by acute and chronic brain damage. This review provides an overview of Wernicke encephalopathy and other ethanol-related brain changes, such as ...chronic brain atrophy, Marchiafava-Bignami disease, osmotic demyelination syndrome, chronic hepatic encephalopathy, and acute alcohol withdrawal. As clinical symptoms of this spectrum of diseases have nonspecific neurologic alterations, radiologists should have current radiologic information and understand the imaging findings pertaining to the pathophysiology to support diagnosis.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Summary Epithelial-mesenchymal transition (EMT) is known to play an important role in breast cancer invasion and metastatic progression. However, the pattern of expression of EMT markers in the ...progression from in situ to invasive breast carcinoma is not clear. To investigate this, we performed immunohistochemical analyses of EMT markers (expression of vimentin, smooth muscle actin, osteonectin, and N-cadherin; loss of E-cadherin; alteration of β -catenin), breast cancer stem cell (CSC) markers (CD44+ /CD24− , ALDH1), and CD146, an EMT inducer, in invasive carcinomas and ductal carcinoma in situ (DCIS) of the breast. Expression of EMT markers was closely associated with the basal-like subtype and CSC phenotype in invasive carcinoma but not in pure DCIS, except for vimentin. The expression of smooth muscle actin and N-cadherin, loss of E-cadherin, and alteration of β -catenin were significantly higher in invasive carcinomas than in pure DCIS ( P = .015, P = .029, P = .001, and P = .007, respectively). Subgroup analyses revealed greater loss of E-cadherin and alteration of β -catenin in invasive carcinoma than in pure DCIS in basal-like subtype ( P = .001) but not in non–basal-like subtypes. Moreover, expression of EMT markers and CD146 was higher in the invasive than in the DCIS component of basal-like cancers. Our study confirmed that EMT is an intrinsic characteristic of basal-like subtype and is associated with CSC phenotype. Furthermore, we showed higher expression of EMT markers in invasive carcinomas than in pure DCIS, especially in basal-like subtype, and in the invasive component of basal-like breast cancers, suggesting that EMT may be involved in the progression from in situ to invasive basal-like breast cancers.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Summary Fibronectin (FN), a large heterodimeric glycoprotein, can be found in soluble form in plasma or in insoluble form as an extracellular matrix protein. Cellular FN is produced by various types ...of benign and malignant epithelial and mesenchymal cells and is widely distributed in malignant tumors. We evaluated FN expression in cancer cells (epithelial FN; E-FN) and intratumor stroma (stromal FN, S-FN) of 1596 invasive breast cancer samples using immunohistochemistry on tissue microarrays. Correlations of FN expression with clinicopathologic factors and patient survival were investigated. Among 1512 informative cases, E-FN expression was observed in 355 (23.5%) cases, and S-FN expression showed no/weak staining in 362 (23.9%), moderate staining in 744 (49.2%), and strong staining in 406 (26.9%) cases. E-FN expression was correlated with advanced pT ( P < .001) and pN ( P < .001), histologic type ( P = .006), high histologic grade ( P < .001), lymphovascular invasion ( P < .001), hormone receptor negativity ( P < .001), and human epidermal growth factor receptor-2 (HER2) positivity ( P < .001). Strong S-FN expression showed an association with advanced pN ( P = .002), histologic type ( P < .001), high histologic grade ( P < .001), lymphovascular invasion ( P < .001), and HER2 positivity ( P < .001). Patients with E-FN expression showed worse overall survival ( P < .001) and disease-free survival ( P < .001) than did those with negative expression of FN. E-FN expression was an independent prognostic factor, especially in the hormone receptor–positive group. Expression of S-FN did not have a significant effect on patient survival. In conclusion, E-FN expression could be a promising prognostic marker in patients with invasive breast cancer.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Purpose The dizziness handicap inventory (DHI) is widely used to evaluate self-perceived handicap due to dizziness, and is known to correlate with vestibular function tests in chronic ...dizziness. However, whether DHI reflects subjective symptoms during the acute phase has not been studied. This study aims to investigate the correlations of subjective and objective measurements to highlight parameters that reflect the severity of dizziness during the first week of acute unilateral vestibulopathy. Materials and methods Thirty-seven patients with acute unilateral vestibulopathy were examined. Patients’ subjective perceptions of dizziness were measured using the DHI, Vertigo Visual Analog Scale (VVAS), Disability Scale (DS), and Activity-Specific Balance Scale (ABC). Additionally, the oculomotor tests, Romberg and sharpened Romberg tests, functional reach test, and dynamic visual acuity tests were performed. The correlation between the DHI and other tests was evaluated. Results DHI-total scores exhibited a moderately positive correlation with VVAS and DS, and a moderately negative correlation with ABC. However, DHI-total score did not correlate with results of the Romberg, sharpened Romberg, or functional reach tests. When compared among four groups divided according to DHI scores, VVAS and DS scores exhibited statistically significant differences, but no significant differences were detected for other test results. Conclusion Our findings revealed that the DHI correlated significantly with self-perceived symptoms measured by VVAS and DS, but not ABC. There was no significant correlation with other balance function tests during the first week of acute vestibulopathy. The results suggest that DHI, VVAS and DS may be more useful to measure the severity of acute dizziness symptoms.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background The aim of this prospective randomized study was to compare the efficacy of 3 injection methods, intra-articular injection, subacromial injection, and hydrodilatation (HD), in the ...treatment of primary frozen shoulder. Methods Patients with primary frozen shoulder were randomized to undergo intra-articular injection (n = 29), subacromial injection (n = 29), or HD (n = 28). Evaluations using a visual analog scale for pain, Simple Shoulder Test, Constant score, and passive range of shoulder motion were completed before treatment and 1 month, 3 months, and 6 months after treatment. Results Among the 3 injection methods for primary frozen shoulder, HD resulted in a greater range of motion in forward flexion and external rotation, a lower visual analog scale score for pain after 1 month, and better outcomes for all functional scores after 1 month and 3 months of follow-up. However, there were no significant differences in any clinical outcomes among the 3 groups in the final follow-up at 6 months. Conclusions Although HD yielded more rapid improvement, the 3 injection methods for primary frozen shoulder resulted in similar clinical improvement in the final follow-up at 6 months.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
