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author:("Saito, kuo")
1.  Effects of Olmesartan-Based Treatment on Masked, White-Coat, Poorly Controlled, and Well-Controlled Hypertension: HONEST Study 
The authors examined the effects of olmesartan-based treatment on clinic systolic blood pressure (CSBP) and morning home systolic blood pressure (HSBP) in 21,340 patients with masked hypertension (MH), white-coat hypertension (WCH), poorly controlled hypertension (PCH), and well-controlled hypertension (CH) using data from the Home Blood Pressure Measurement With Olmesartan Naive Patients to Establish Standard Target Blood Pressure (HONEST) study. MH, WCH, PCH, and CH were defined using CSBP 140 mm Hg and MHSBP 135 mm Hg as cutoff values at baseline. At 16 weeks, the MH, WCH, PCH, and CH groups had changes in CSBP by −1.0, −15.2, −23.1, and 1.8 mm Hg, and changes in morning HSBP by −12.5, 1.0, −20.3, and 2.0 mm Hg, respectively. In conclusion, in “real-world” clinical practice, olmesartan-based treatment decreased high morning HBP or CBP without excessive decreases in normal morning HBP or CBP according to patients' BP status.
doi:10.1111/jch.12323
PMCID: PMC4237560  PMID: 24766515
2.  Application of a navigation system for contouring anatomical plasty of the distal end of the humerus 
Computer Aided Surgery  2012;17(4):179-186.
The effectiveness of navigation systems in performing accurate orthopaedic surgery has been reported previously, but there have been no reports on the application of navigation in surgeries involving bone resection around the elbow joint. In this study, anatomical plasty or bone resection was performed to restore anatomical morphology in 10 cases of osteoarthritis of the elbow and deformity of the distal end of the humerus. Bone resection was performed on the distal end of the humerus using navigation and on the proximal end of the ulna via freehand surgery. Postoperatively, the elbow function was evaluated and pre- and postoperative CT images were used to measure the bone resection. There were no complications arising from the use of navigation, and elbow function was improved in all cases. By evaluating the CT images, it was found that navigated resection of the fossae of the distal humerus was more effective than freehand resection of the processes of the proximal ulna, thus confirming the usefulness of navigation. In future, to fully confirm this finding, it will be necessary to conduct prospective controlled studies of cases in which navigation is used to perform arthroplasty, including those that involve the proximal end of the ulna.
doi:10.3109/10929088.2012.692815
PMCID: PMC3409460  PMID: 22681497
Navigation-assisted surgery; elbow joint; osteoarthritis; arthroplasty; anatomical plasty; osteophyte; coronoid fossa; olecranon fossa
3.  A case of squamous cell carcinoma arising from a suprapubic cystostomy tract 
BMC Urology  2011;11:20.
Background
Patients with spinal cord injury and a chronic indwelling urinary catheter are known to have an increased risk of bladder malignancy. However, squamous cell carcinoma (SCC) of the epidermis around a suprapubic cystostomy is relatively rare. Here, we report a case of lower abdominal SCC arising from the suprapubic cystostomy tract.
Case presentation
A 58-year-old man with a complete spinal cord injury was referred to our hospital with a chief complaint of an abdominal mass. Abdominal enhanced computed tomography (CT) showed a 7-cm mass surrounding the suprapubic cystostomy and bilateral inguinal and para-aortic lymph nodes metastasis. Histopathological examination of percutaneous biopsy specimens was performed. The diagnosis was stage IV (cT4N1M1) epidermal SCC, which was treated with palliative external radiation therapy.
Conclusion
The SCC in this case was thought to arise from mechanical stimulus of the suprapubic cystostomy. Physicians and patients should pay careful attention to any signs of neoplasms with long-term indwelling catheters, such as skin changes around the suprapubic cystostomy site. This case presentation is only the fourth report of SCC arising from the suprapubic cystostomy tract in the literature. In cases of unresectable tumors and contraindications to chemotherapy, palliative radiotherapy may lead to disease remission and symptom relief.
doi:10.1186/1471-2490-11-20
PMCID: PMC3198751  PMID: 21967681
4.  Genome-Wide Association Study Identifies HLA-DP as a Susceptibility Gene for Pediatric Asthma in Asian Populations 
PLoS Genetics  2011;7(7):e1002170.
Asthma is a complex phenotype influenced by genetic and environmental factors. We conducted a genome-wide association study (GWAS) with 938 Japanese pediatric asthma patients and 2,376 controls. Single-nucleotide polymorphisms (SNPs) showing strong associations (P<1×10−8) in GWAS were further genotyped in an independent Japanese samples (818 cases and 1,032 controls) and in Korean samples (835 cases and 421 controls). SNP rs987870, located between HLA-DPA1 and HLA-DPB1, was consistently associated with pediatric asthma in 3 independent populations (Pcombined = 2.3×10−10, odds ratio [OR] = 1.40). HLA-DP allele analysis showed that DPA1*0201 and DPB1*0901, which were in strong linkage disequilibrium, were strongly associated with pediatric asthma (DPA1*0201: P = 5.5×10−10, OR = 1.52, and DPB1*0901: P = 2.0×10−7, OR = 1.49). Our findings show that genetic variants in the HLA-DP locus are associated with the risk of pediatric asthma in Asian populations.
Author Summary
Asthma is the most common chronic disorder in children, and asthma exacerbation is an important cause of childhood morbidity and hospitalization. Here, taking advantage of recent technological advances in human genetics, we performed a genome-wide association study and follow-up validation studies to identify genetic variants for asthma. By examining 6,428 Asians, we found rs987870 and HLA-DPA1*0201/DPB1*0901 were associated with pediatric asthma. The association signal was stretched in the region of HLA-DPB2, collagen, type XI, alpha 2 (COL11A2), and Retinoid X receptor beta (RXRB), but strong linkage disequilibrium in this region made it difficult to specifically identify causative variants. Interestingly, the SNP (or the HLA-DP allele) associated with pediatric asthma (Th-2 type immune diseases) in the present study confers protection against Th-1 type immune diseases, such as type 1 diabetes and rheumatoid arthritis. Therefore, the association results obtained in the present study could partially explain the inverse relationship between asthma and Th-1 type immune diseases and may lead to better understanding of Th-1/Th-2 immune diseases.
doi:10.1371/journal.pgen.1002170
PMCID: PMC3140987  PMID: 21814517
5.  Rationale, study design, baseline characteristics and blood pressure at 16 weeks in the HONEST Study 
Hypertension Research  2012;36(2):177-182.
On the basis of the studies that investigated the relationship between baseline clinic blood pressure (CBP) or home blood pressure (HBP) values and cardiovascular (CV) events, HBP has been reported to have a stronger prognostic ability. However, few studies have compared the prognostic ability of on-treatment CBP and HBP. The relationship between on-treatment HBP, measured twice in the morning and twice at bedtime, and CV events was investigated in over 20 000 patients in the HONEST (Home blood pressure measurement with Olmesartan Naive patients to Establish Standard Target blood pressure) Study, a prospective, 2-year observational study of treatment with an angiotensin receptor blocker, olmesartan (OLM), in OLM-naive hypertensive patients. This report summarizes the study protocol, the baseline characteristics of the patients and CBP and HBP at 16 weeks. A total of 22 373 patients were registered across Japan; baseline data from 22 162 patients were collected. Baseline HBP (mean±s.d.) in the morning (the first measurement) was 151.6±16.4/87.1±11.8 mm Hg and at bedtime was 144.3±16.8/82.8±11.9 mm Hg, whereas CBP was 153.6±19.0/87.1±13.4 mm Hg. At 16 weeks, morning HBP was 135.0±13.7/78.8±9.9 mm Hg and bedtime HBP was 129.7±13.8/74.7±10.1 mm Hg, whereas CBP was 135.6±15.4/77.6±10.9 mm Hg. The follow-up period for each patient ends on 30 September 2012. The HONEST Study is expected to provide evidence showing the relationship between baseline and on-treatment CBP and HBP levels (both first and second measurements) and CV events.
doi:10.1038/hr.2012.160
PMCID: PMC3565096  PMID: 23096234
cardiovascular event; clinic blood pressure; home blood pressure; olmesartan
6.  Enhanced Blood Pressure–Lowering Effect of Olmesartan in Hypertensive Patients With Chronic Kidney Disease–Associated Sympathetic Hyperactivity: HONEST Study 
To investigate the blood pressure (BP)–lowering effect of olmesartan in relation to chronic kidney disease (CKD)–associated sympathetic nerve activity, a subanalysis was performed using data from the first 16 weeks of the Home BP Measurement With Olmesartan-Naive Patients to Establish Standard Target Blood Pressure (HONEST) study, a prospective observational study of hypertensive patients. Essential hypertensive patients who took no antihypertensive agent at baseline were classified based on baseline morning home systolic BP (MHSBP) in quartiles. In each class, patients were further classified based on baseline morning home pulse rate (MHPR). A subgroup analysis in patients with/without chronic kidney disease (CKD) was performed. A total of 5458 patients (mean age, 63.0 years; 51.6% women) were included. In the 4th quartile of baseline MHSBP (≥165 mm Hg), patients with MHPR ≥70 beats per minute had a greater BP reduction (by 3.2 mm Hg) than those with MHPR <70 beats per minute after 16 weeks of olmesartan-based treatment (P=.0005). An even greater BP reduction (by 6.6 mm Hg) was observed in patients with CKD than in patients without CKD in this group (P=.0084). Olmesartan was more effective in hypertensive patients with high MHSBP and MHPR ≥70 beats per minute, especially in patients with CKD. Olmesartan may have enhanced BP-lowering effects by improving renal ischemia in hypertensive CKD patients with potential increased sympathetic nerve activity.
doi:10.1111/jch.12132
PMCID: PMC3884768  PMID: 23889717
7.  Combinations of olmesartan and a calcium channel blocker or a diuretic in elderly hypertensive patients: a randomized, controlled trial1 
Journal of Hypertension  2014;32(10):2054-2063.
Objective:
The aim of the present study was to compare the cardiovascular effects of olmesartan, an angiotensin II receptor blocker, combined with a calcium channel blocker (CCB) or a diuretic, in a prospective, randomized, open-label, blinded endpoint trial.
Methods:
Japanese hypertensive patients aged at least 65 to less than 85 years with SBP at least 140 mmHg and/or DBP at least 90 mmHg with antihypertensive treatment, or SBP at least 160 mmHg and/or DBP at least 100 mmHg without antihypertensive treatment were randomized to receive olmesartan with either a dihydropyridine CCB or a low-dose diuretic. If SBP and/or DBP remained at least 140 and/or at least 90 mmHg, the other antihypertensive drug was added. The primary endpoint was a composite of fatal and nonfatal cardiovascular events. The median follow-up time was 3.3 years.
Results:
Blood pressure decreased similarly in both groups. The primary endpoint occurred in 116/2568 patients (4.5%) in the olmesartan plus CCB group and in 135/2573 patients (5.3%) in the olmesartan plus diuretic group [hazard ratio 0.83, 95% confidence interval (CI) 0.65–1.07, P = 0.16]. Rates of all-cause death and cardiovascular deaths were similar. Among patients aged at least 75 years, the incidence of stroke tended to be lower in the olmesartan plus CCB group than in the olmesartan plus diuretic group (hazard ratio 0.63, 95% CI 0.38–1.02, P = 0.059, interaction P = 0.019). Fewer patients in the olmesartan plus CCB group (8.2%, 211/2568) than in the olmesartan plus diuretic group (9.8%, 253/2573; P = 0.046) experienced serious adverse events.
Conclusion:
Despite no significant difference in cardiovascular events, the different safety profiles suggest that the combination of olmesartan and CCB may be preferable to that of olmesartan and diuretic.
doi:10.1097/HJH.0000000000000281
PMCID: PMC4166009  PMID: 24999799
blood pressure; calcium channel blockers; diuretics; hypertension; olmesartan; randomized controlled trial
8.  Combination therapy of hypertension in the elderly: a subgroup analysis of the Combination of OLMesartan and a calcium channel blocker or diuretic in Japanese elderly hypertensive patients trial 
Hypertension Research  2014;38(1):89-96.
Combination of OLMesartan and a calcium channel blocker or a diuretic in Japanese elderly hypertensive patients (COLM) trial demonstrated that olmesartan combinations with a CCB or diuretic have similar effects on reducing cardiovascular risk in elderly hypertensive patients. However, the safety profiles suggest that olmesartan combined with CCB may be preferable to olmesartan combined with diuretic. In this subgroup analysis, we further evaluated the effects and safety of these combinations in elderly (65–74 years old (y.o.)) and very elderly (75–84 y.o.) hypertensive patients. In the COLM trial, 5141 patients (2918 elderly and 2223 very elderly) were randomly assigned to receive olmesartan-based therapy with either CCB or diuretic. The hazard ratios and 95% confidence intervals, respectively, in the elderly age group and in the very elderly group were: 1.04 (0.72–1.50; olmesartan plus CCB vs. olmesartan plus diuretic, P=0.85) and 0.71 (0.51–0.99, P=0.045) for the primary composite end point, and 1.07 (0.67–1.72, P=0.77) and 0.64 (0.42–0.98, P=0.036) for the composite of hard end points. The hazard ratios for stroke (fatal and non-fatal) were 1.48 (0.88–2.48; olmesartan plus CCB vs. olmesartan plus diuretic, P=0.13) and 0.63 (0.39–1.02, P=0.059) (interaction-P=0.019). Withdrawal rates from the trial, withdrawal due to serious adverse event and the incidence of any adverse event were higher in the olmesartan plus diuretic group than in the olmesartan plus CCB group in both age groups. In conclusion, angiotensin receptor blocker (ARB) and CCB combination may be preferable to an ARB and diuretic combination in the very elderly hypertensive patients for the reduction of cardiovascular risk, particularly for the reduction in stroke risk.
doi:10.1038/hr.2014.144
PMCID: PMC4287656  PMID: 25253583
calcium channel blocker; combination therapy; diuretic; elderly hypertension; olmesartan
9.  Comparison of olmesartan combined with a calcium channel blocker or a diuretic in elderly hypertensive patients (COLM Study): safety and tolerability 
Hypertension Research  2014;38(2):132-136.
The cardiovascular effects of combined therapy with the angiotensin receptor blocker (olmesartan) and a dihydropyridine calcium channel blocker (CCB) or a diuretic were compared in high-risk elderly Japanese hypertensive patients by performing a randomized, open label, blinded-endpoint study of morbidity and mortality (the COLM study). Here we report the results obtained with respect to safety and tolerability. High-risk hypertensive patients aged 65–84 years were enrolled and were randomized to receive olmesartan combined with either a CCB (amlodipine or azelnidipine) or a low-dose diuretic for at least 3 years. The primary endpoint was a composite of fatal and non fatal cardiovascular events, whereas adverse events (AEs) and the percentage of patients who discontinued the allocated treatment were evaluated as secondary endpoints. A total of 5141 patients were randomized. Both combination regimens achieved a similar reduction of cardiovascular morbidity and mortality. The incidences of AEs, serious AEs, drug-related serious AEs and discontinuation due to serious AEs were lower in the olmesartan plus CCB group than in the olmesartan plus diuretic group. Serum levels of uric acid and creatinine were significantly higher in the olmesartan plus diuretic group than in the olmesartan plus CCB group. Olmesartan combined with a CCB was significantly superior to olmesartan plus a diuretic with regard to the frequency of AEs and discontinuation of treatment.
doi:10.1038/hr.2014.141
PMCID: PMC4322201  PMID: 25253582
adverse event; combination therapy; discontinuation; elderly hypertensive patient; olmesartan

Results 1-9 (9)