Tadalafil 5mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: Analyses of data pooled from three randomized, double-blind, placebo-controlled studies
Nishizawa O.,Azumi General Hospital |
Yoshida M.,National Center for Geriatrics and Gerontology |
Takeda M.,Yamanashi University |
Yokoyama O.,University of Fukui |
And 3 more authors.
International Journal of Urology | Year: 2015
Objectives: Assess the efficacy and safety of tadalafil 5mg once-daily in Asian men with lower urinary tract symptoms by pooling data from three clinical studies. Methods: Data on 1199 Japanese, Korean, and Taiwanese men given tadalafil 5mg (n=601) or placebo (n=598) were pooled from three double-blind, placebo-controlled, 12-week studies. Efficacy measures included International Prostate Symptom Score, and Patient and Clinician Global Impressions of Improvement. These measures were also assessed for patient subgroups (age categories, baseline disease severity and/or prostate volume, prior alpha-blocker treatment). Safety measures included adverse events, including those in selected body systems. Efficacy measure changes throughout treatment were assessed by mixed-effect model repeated-measures analysis; baseline to end-point changes for the total population and subgroups were evaluated by analysis of covariance. Results: Tadalafil 5mg led to significant improvement (vs placebo) in all International Prostate Symptom Scores at all time-points (week4 P≤0.013 for all measures; week8 P≤0.005, week12 P<0.001). End-point results for both global impressions scales also favored tadalafil (both P<0.001 vs placebo). Tadalafil efficacy was similar between patient subgroups of varied disease severity (interaction P=0.097), prior alpha-blocker use (P=0.580), and prostate volume (P=0.921). The drug was slightly less effective in older men (interaction P=0.042). No unexpected adverse events were reported, and no meaningful adverse effects were observed in visual, auditory, or cardiovascular systems. Conclusions: Tadalafil 5mg once-daily for 12weeks is efficacious and safe in Asian men with lower urinary tract symptoms. Tadalafil is also effective in men of different ages, disease severity, prior alpha-blocker exposure, and prostate volumes. © 2015 The Japanese Urological Association.
Altorki N.K.,New York Medical College |
Yip R.,Mount Sinai School of Medicine |
Hanaoka T.,Azumi General Hospital |
Bauer T.,Helen aham Cancer Center |
And 13 more authors.
Journal of Thoracic and Cardiovascular Surgery | Year: 2014
Objectives A single randomized trial established lobectomy as the standard of care for the surgical treatment of early-stage non-small cell lung cancer. Recent advances in imaging/staging modalities and detection of smaller tumors have once again rekindled interest in sublobar resection for early-stage disease. The objective of this study was to compare lung cancer survival in patients with non-small cell lung cancer with a diameter of 30 mm or less with clinical stage 1 disease who underwent lobectomy or sublobar resection. Methods We identified 347 patients diagnosed with lung cancer who underwent lobectomy (n = 294) or sublobar resection (n = 53) for non-small cell lung cancer manifesting as a solid nodule in the International Early Lung Cancer Action Program from 1993 to 2011. Differences in the distribution of the presurgical covariates between sublobar resection and lobectomy were assessed using unadjusted P values determined by logistic regression analysis. Propensity scoring was performed using the same covariates. Differences in the distribution of the same covariates between sublobar resection and lobectomy were assessed using adjusted P values determined by logistic regression analysis with adjustment for the propensity scores. Lung cancer-specific survival was determined by the Kaplan-Meier method. Cox survival regression analysis was used to compare sublobar resection with lobectomy, adjusted for the propensity scores, surgical, and pathology findings, when adjusted and stratified by propensity quintiles. Results Among 347 patients, 10-year Kaplan-Meier for 53 patients treated by sublobar resection compared with 294 patients treated by lobectomy was 85% (95% confidence interval, 80-91) versus 86% (confidence interval, 75-96) (P =.86). Cox survival analysis showed no significant difference between sublobar resection and lobectomy when adjusted for propensity scores or when using propensity quintiles (P =.62 and P =.79, respectively). For those with cancers 20 mm or less in diameter, the 10-year rates were 88% (95% confidence interval, 82-93) versus 84% (95% confidence interval, 73-96) (P =.45), and Cox survival analysis showed no significant difference between sublobar resection and lobectomy using either approach (P =.42 and P =.52, respectively). Conclusions Sublobar resection and lobectomy have equivalent survival for patients with clinical stage IA non-small cell lung cancer in the context of computed tomography screening for lung cancer. Copyright © 2014 by The American Association for Thoracic Surgery.
Henschke C.I.,Mount Sinai School of Medicine |
Yip R.,Mount Sinai School of Medicine |
Boffetta P.,Mount Sinai School of Medicine |
Markowitz S.,Queens College, City University of New York |
And 5 more authors.
Lung Cancer | Year: 2015
Purpose: To address the prevalence of lung cancer in high and low-risk people according to their smoking history, age, and CT findings of emphysema. Methods: We reviewed the baseline low-dose CT scans of 62,124 current, former and never smokers, aged 40-90 to determine the prevalence of lung cancer. We performed logistic regression analysis of the prevalence of lung cancer to determine the odds ratio (OR) for emphysema, conditionally on age, female gender, and ethnicity. Results: The prevalence of lung cancer was 1.4% (95% CI: 1.3-1.6) for current smokers, 1.1% (95% CI: 1.0-1.2) for former smokers, and 0.4% (95% CI: 0.3-0.6) for never smokers. Emphysema was identified in 28.5% (6,684), 20.6% (5,422), and 1.6% (194) of current, former, and never smokers, respectively. The prevalence of lung cancer among current smokers was 1.1% for those without emphysema vs. 2.3% for those with emphysema (odds ratio [OR] 1.8; 95% confidence interval [CI]: 1.4-2.2) and the corresponding difference for former smokers was 0.9% vs. 1.8% (OR: 1.7; 95% CI: 1.3-2.2), and for never smokers, it was 0.4% vs. 2.6% (OR: 6.3; 95% CI: 2.4-16.9). Conclusions: Identification of emphysema in low-dose CT scans increases the risk of lung cancer and is important in determining follow-up of current, former, and never smokers. © 2015 Elsevier Ireland Ltd.
PubMed | Shinshu University, Azumi General Hospital, Aizawa Hospital and Chiba University
Type: Journal Article | Journal: Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association | Year: 2016
Although extensor tendon rupture associated with distal radioulnar joint disorder is often encountered, its treatment has not yet been established. We report the postoperative results for reconstruction of finger extensor tendon rupture due to distal radioulnar lesion and analyse the factors affecting postoperative extension lag.We examined 74 index, middle, ring, or little fingers with extensor tendon rupture of 34 hands. Primary diseases were rheumatoid arthritis in 24 hands and osteoarthritis in 10. Reconstruction methods included tendon graft in 45 fingers, extensor indicis proprius tendon transfer in 15, and end-to-side adjacent tendon suture in 14. At final postoperative follow-up ranging from 12 to 40 (mean: 18) months, we measured metacarpophalangeal (MCP) joint range of motion and extension lag and statistically evaluated the relationship between postoperative extension lag and several clinical factors.We encountered no cases of re-rupture or worsening of finger flexion range after reconstruction. Mean postoperative active flexion of the MCP joint was 78.1 (range: 45-95) degrees. Mean postoperative extension lag was 10.3 (range: 0-50) degrees. We observed that postoperative extension lag was significantly larger in fingers associated with extensor tendon rupture in two or three additional fingers in the affected hand or in fingers of patients aged 80 years or over. The interval from rupture to reconstruction, reconstruction method, or arthritis type did not remarkably affect outcome.This study uncovered that surgical intervention for extensor tendon rupture should be performed before three fingers become affected.
Uchiyama S.,Shinshu University |
Ikegami S.,Shinshu University |
Kamimura M.,Kamimura Clinic |
Mukaiyama K.,Azumi General Hospital |
And 3 more authors.
Bone | Year: 2015
Bisphosphonates are effective in increasing bone mineral density (BMD), but fragility fractures can still occur despite bisphosphonate treatment. The purpose of this study was to determine if long-term bisphosphonate users have characteristic findings in the musculoskeletal system, which could put them at risk of developing typical or atypical femoral fractures. We recruited 40 female patients who had taken bisphosphonates for more than 3. years. The control group included 60 volunteers who were matched by age, body mass index, and dual-energy X-ray absorptiometry-derived BMDs. We measured the skeletal muscle cross sectional area around the proximal thigh and buckling ratio of the femoral neck using quantitative computed tomography (qCT) and several biochemical markers of bone metabolism. Those parameters were compared between the groups. While no significant differences of buckling ratio derived from qCT were detected, the skeletal muscle cross sectional area was significantly smaller in the long-term bisphosphonate users than in the controls. Furthermore, the serum pentosidine level was significantly higher in the bisphosphonate users than in the controls. To determine if those differences were attributable to bisphosphonate treatment, we further compared those parameters between before and after 3. years of bisphosphonate treatment in 32 patients. After 3. years of bisphosphonate treatment, the BMD of the femoral neck and serum pentosidine level increased but not the skeletal muscle cross sectional area. In the present study, the skeletal muscle mass did not match the bone mass in long-term bisphosphonate users, thus suggesting that increases in BMD by bisphosphonates are unlikely to have secondary positive effects on the surrounding skeletal muscles. Also, serum pentosidine levels were greater in the long-term bisphosphonate users. Further study is necessary to test if such patients are prone to develop typical or atypical femoral fractures. © 2015 Elsevier Inc.
Tokuda Y.,National Hospital Organization |
Tokuda Y.,Shinshu University |
Arakura F.,National Hospital Organization |
Murata H.,Shinshu University |
And 3 more authors.
American Journal of Dermatopathology | Year: 2012
Acral pseudolymphomatous angiokeratoma of children (APACHE) is characterized by multiple angiomatous papules on the hands and feet in children. Here, we report a case of APACHE in a female patient followed up from 13 to 19 years of age with a dark red lesion on the center of the dorsum of the right thigh. Histologically, vacuolar alteration and exocytosis of lymphocytes, and specific dense cellular infiltration beneath the epidermis to the reticular dermis were found. On immunolabeling study, the lesion vessels were found to be positive for both the lymphatic endothelium-specific marker podoplanin and blood vessel-specific marker CD34. These findings suggested that APACHE is a type of vascular malformation. Copyright © 2012 by Lippincott Williams & Wilkins.
Tsushima K.,Azumi General Hospital |
Tsushima K.,Shinshu University |
Sone S.,Azumi General Hospital |
Yoshikawa S.,Shinshu University |
And 3 more authors.
Respiratory Medicine | Year: 2010
Objectives: The identification of early phase interstitial changes may influence the understanding of idiopathic interstitial pneumonitis. This study aimed to clarify its radiological patterns and the association with smoking. Methods: The subjects underwent low-dose computed tomography to screen lung cancer. The selected subjects with interstitial changes were monitored for the precise morphology of interstitial changes using a high-resolution computed tomography (HRCT) scan. The subjects were classified into normal and abnormal HRCT subjects. The radiological findings on the HRCT scan, serum Klebs von der Lungen-6 (KL-6), surfactant protein (SP)-A, SP-D, pulmonary function, and computed tomography (CT) scores were analyzed. Abnormal HRCT subjects were classified based on the radiological patterns, and were followed-up over a 4-year period. Results: HRCT abnormalities suggesting interstitial changes were identified in 80 of 3079 subjects. Seven subjects with honeycombing and 14 with combined pulmonary fibrosis and emphysema (CPFE) were identified. The frequencies of sex (male) and smoking in the subjects with honeycombing was higher than that of other patterns. The smoking history and the levels of serum KL-6, SP-A, and SP-D in abnormal HRCT subjects were significantly higher than those in normal HRCT subjects. Thirty-two of 73 abnormal HRCT subjects showed a progression of the CT scores in a chest HRCT over a 4-year period. Eighteen abnormal HRCT current smokers were included in the progression of CT scores. Conclusions: HRCT patterns, excluding interlobular septal thickening, show the progression of CT scores. Smokers with CT abnormalities may have a tendency to demonstrate worsening interstitial changes. © 2010 Elsevier Ltd. All rights reserved.
Uhara H.,Shinshu University |
Saiki M.,Nagano Municipal Hospital |
Kawachi S.,Azumi General Hospital |
Ashida A.,Shinshu University |
And 2 more authors.
Journal of the European Academy of Dermatology and Venereology | Year: 2013
Background/aim Drug-induced hypersensitivity syndrome (DIHS) is a severe reaction to drugs which characteristically occurs after a long latency period. In addition, human herpes virus 6 (HHV-6) reactivation is a characteristic finding in DIHS, which has been known to be related to disease severity. Because DIHS has generally been treated by systemic corticosteroids, the natural clinical course is not clear. Methods Data for patients with both DIHS and HHV-6 reactivation were retrospectively collected from four hospitals. Results Data were collected on 12 patients ranging in age from 21 to 76 years (median, 65.5). All cases had been suspected of DIHS at their initial visit, and the elevation of serum anti-HHV-6 antibody had been confirmed (4-256 times: median; 32). The culprit drugs were carbamazepine (6), salazosulfapyridine (4), mexiletine (1) and zonisamide (1). The period of latency from the first administration of the drug ranged from 15 to 50 days (median, 30). All patients were treated conservatively for DIHS without systemic corticosteroids. The peaks of the patients' symptoms and laboratory findings were as follows (days from the onset of skin lesions): fever, 4-16 (median, 10.5); liver abnormality, 3-22 (median, 7.5); leukocytosis, 7-20 (median, 9). All patients recovered without pneumonia, myocarditis, nephritis or other systemic disease, from 7 to 37 days (median, 18) after withdrawal of the drug and from 11 to 44 days (median, 21) after the onset of skin lesions. Conclusion It might be unnecessary to give systemic corticosteroids immediately to all patients suspected of having DIHS. © 2012 The Authors. Journal of the European Academy of Dermatology and Venereology © 2012 European Academy of Dermatology and Venereology.
Tsushima K.,Azumi General Hospital |
Sone S.,Azumi General Hospital |
Fujimoto K.,Shinshu University |
Kubo K.,Shinshu University |
And 3 more authors.
COPD: Journal of Chronic Obstructive Pulmonary Disease | Year: 2010
Rationale: Chronic obstructive pulmonary disease (COPD) is a major public health problem. This study was performed to determine whether the low attenuation area (LAA) and visual score provided by low-dose computed tomography (CT) can be used to detect occult parenchymal disease, such as insidious COPD. Methods: Each participant underwent low-dose CT scan and pulmonary function tests. The LAA of the corresponding lung area was calculated. The cut-off level between the normal lung density area and LAA was defined as 960 HU, and the severity of emphysematous change (visual score) and LAA were evaluated on three same chest CT slices obtained at full inspiration. Results: Forty-eight of 2,247 individuals including 1058 non-smokers and 1189 smokers were diagnosed with COPD. Chest CT findings in individuals diagnosed with COPD showed centrilobular emphysema (50), however, 17 of the subjects diagnosed with COPD had normal screening CT findings. Thirty-one subjects diagnosed with COPD showed a positive visual score, and 27 individuals with COPD showed LAA of more than 30. Nine of 17 subjects with a negative visual score showed LAA of more than 30. The visual score in smokers was significantly higher than that of non-smokers. The lung function in smokers was lower than that of non-smokers. Smokers also showed higher frequencies of chest CT abnormalities. Conclusion: Low-dose CT scans detected LAA and a positive visual score before COPD associated with an impaired lung function develops. Smokers with normal spirometry had a potential to develop an airflow obstruction accompanied with abnormal CT findings. © Copyright © 2010 Informa Healthcare USA, Inc.
PubMed | Shinshu University and Azumi General Hospital
Type: Case Reports | Journal: Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society | Year: 2016
We report on two elderly patients with cognitive impairments, for whom chronic carbon monoxide (CO) exposure was suspected based on elevated carboxyhaemoglobin levels in their serum. On their initial visits, cognitive impairment and brain magnetic resonance imaging findings in both patients were compatible with the diagnosis of Alzheimers-type dementia. However, after discontinuation of the use of a kotatsu, a charcoal-based heater, their serum carboxyhaemoglobin levels normalized and their physical symptoms resolved. Their cognitive function also slightly improved. The causal relationship between physical symptoms and cognitive impairment after chronic CO poisoning is uncertain; however, it is possible that chronic exposure to low CO levels exacerbated the clinical manifestation in our patients.