Self-measured home blood pressure highlights cardiovascular risk in women: the HOMED-BP study.

No studies examined sex differences in relation to the prognostic significance of self-measured home blood pressure (HBP). We compared the predictive power for the risk of cardiovascular events in 1547 women and 1516 men with hypertension using HBP captured at treatment-free baseline and during on-treatment follow-up, based on the Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) study. To express the change in risk for the composite cardiovascular endpoint associated with a 1-SD increase in HBP at baseline or on treatment, we derived multivariable-adjusted hazard ratios (HR) based on a Cox regression model. Over a median follow-up of 7.3 years, 100 composite events occurred, including 40 events in women. In women, systolic HBP both at baseline and on-treatment showed significant risk increment (at baseline: HR per 1-SD increment, 1.62; 95% confidence interval [CI], 1.17-2.24. on-treatment: HR, 1.74; 95% CI, 1.32-2.29). However, systolic HBP at baseline did not predict cardiovascular events in men (P = 0.25). On-treatment HBP was significantly associated with cardiovascular risk (P ≤ 0.012) irrespective of sex. Nevertheless, the point estimate of HR for systolic HBP in men (1.33) was less than that in women (1.74), and the interaction of sex with 1 SD-increase in systolic HBP in cardiovascular risk was significant irrespective of baseline (P = 0.039) or follow-up (P = 0.040) measurement when they were mutually adjusted. The increase in cardiovascular risk with the systolic HBP was steeper in women than in men for both baseline and on-treatment. The current findings unveil the importance of the control of systolic HBP, especially in women. Clinical Trial Registration: UMIN Clinical Trial Registry ( http://www.umin.ac.jp/ctr ), Unique identifier: C000000137.

A Multi-institutional Study to Diagnose the Risk of Lymph Node Metastasis Using a CRP Genetic Polymorphism Test Kit in pT1, cN0 Thoracic Esophageal Squamous Cell Carcinoma.

BACKGROUND/AIM: For patients with T1a muscularis mucosae (MM) esophageal squamous cell carcinoma (ESCC) with lymphovascular invasion (LVI) or T1b submucosal (SM) ESCC, endoscopic resection is non-curative, and adjuvant treatment entailing esophagectomy or definitive chemoradiotherapy is necessary. This is because about 30% of these cases have lymph node (LN) metastasis. The purpose of this study was to test the utility of a CRP genetic polymorphism test kit for determining the risk of LN metastasis with the aim of eliminating additional invasive adjuvant therapy. PATIENTS AND METHODS: This is a retrospective, multi-institutional, observational study. The CRP 1846C>T genetic polymorphisms were identified using a fully automated genotyping system. The primary end points were an 85% negative predictive value (NPV) for diagnosis of LN metastasis in pT1a (MM) and 80% NPV in pT1b (SM1) patients. RESULTS: A total of 742 ESCC (105 pMM, 166 pSM1 and 471 pSM2-3) patients who had received esophagectomy with 2- or 3-field LN dissection at 65 institutions were enrolled. According to this test, patients with the C/C and C/T genotypes were considered to be low risk. The NPVs using this test were 82.8% in pMM and 71.7% in pSM1 patients. CONCLUSION: CRP 1846C>T genetic polymorphism is not a useful diagnostic indicator for determining the risk of LN metastasis; however, the possibility that CRP gene polymorphisms are involved in the mechanism of lymph node metastasis in solid tumors still remains.

[A Case of Unilateral Interstitial Lung Disease in a Patient Treated with Oxaliplatin, 5-Fluorouracil, and Leucovorin].

Respiratory symptoms are rarely reported as side effects of oxaliplatin, 5-fluorouracil, and Leucovorin(FOLFOX)therapy. We report a case of a patient with FOLFOX-induced unilateral interstitial pneumonia. The patient was a 68-year-old man who underwent ileocecal resection of cecum cancer. FOLFOX regimen was started as an adjuvant chemotherapy. After the administration of 11 courses, he visited our hospital with fever, dyspnea, and anorexia. We diagnosed this as FOLFOX- induced unilateral interstitial pneumonia through a blood test, chest radiograph, computed tomography, and bronchoscopy. Treatment was started with 30 mg of prednisolone, and the dosage was gradually decreased. The patient responded well to the treatment and was discharged from the hospital without any complications on the 33th day after admission.

Postoperative diaphragmatic hernia with upside-down stomach: a case report.

A 31-year-old man presented to our hospital's Emergency Department with sudden epigastric pain and vomiting. He had undergone endoscopic resection via the retroperitoneal route for a retroperitoneal tumor located in the left diaphragmatic crus of the esophageal hiatus at another hospital 8 months previously. Radiography and computed tomography showed inversion of the stomach beyond the diaphragm into the thoracic cavity, with the gastroesophageal junction serving as the fulcrum point. This finding led to a diagnosis of postoperative diaphragmatic hernia accompanied by an upside-down stomach (UDS). The prolapsed stomach in the thoracic cavity was reduced to the abdominal cavity using laparoscopic surgery. The postoperative course was favorable, and the patient was discharged from the hospital on postoperative day 7. No recurrence has been observed in the past 5 years. The pathological condition of a UDS observed in esophageal hiatal hernias may be found in postoperative diaphragmatic hernias. Laparoscopic surgery for a postoperative diaphragmatic hernia with a UDS is considered a useful surgical procedure. Laparoscopic surgery can simultaneously confirm the viability of the herniated organs, reduce the organs to the abdominal cavity, and close and reinforce the diaphragm.

An inguinal hernia that arose after robot-assisted radical prostatectomy and the repair of an intraoperative external iliac vein injury: A case report.

This case involved a 63-year-old man. He underwent robot-assisted radical prostatectomy (RARP) for prostate cancer. One year after the operation, he consulted our hospital about left inguinal swelling. Under a diagnosis of a left external inguinal hernia, transabdominal preperitoneal repair (TAPP) was performed under general anesthesia. The inside of the hernia orifice had been damaged by the RARP, and the resultant fibrosis was so marked that it was difficult to dissect the preperitoneal space. Furthermore, an external iliac vein injury occurred during the operation. The bleeding was controlled, and we used laparoscopic continuous non-absorbable sutures to repair the external iliac vein injury. The number of TAPP procedures performed after radical prostatectomy has been increasing in recent years, but dissecting the preperitoneal space inside a hernia orifice is difficult. Although external iliac vein injuries are rare complications of TAPP procedures, they can be laparoscopically repaired.

Incisional hernia after extreme lateral interbody fusion on the lumbar spine: A case report.

INTRODUCTION: Extreme lateral interbody fusion is a minimally invasive lateral transpsoas approach for spine surgery. We herein report a case of an incisional hernia after an extreme lateral interbody fusion on the lumbar spine that was successfully treated by laparoscopic surgery with intraperitoneal onlay mesh repair. PRESENTATION OF CASE: A 78-year-old woman was referred to our hospital with a complaint of left abdominal bulge and pain. She had undergone an extreme lateral interbody fusion for a lumbar spinal canal stenosis from L1 to L4 a year prior. Abdominal computerized tomography showed a left lumbar incisional hernia, and laparoscopic surgery was performed. The hernia orifice was sutured closed and covered with mesh. The patient was discharged five days after the operation with no complications. DISCUSSION: When performing XLIF for a spinal disorder, the muscles should be separated bluntly along their fibers to prevent muscle atrophy, and the incised fascia should be securely sutured closed. Abdominal wall incisional hernias can occur after spinal surgeries such as extreme lateral interbody fusion. CONCLUSION: Laparoscopic repair for abdominal wall incisional hernia after spine surgery is safe and feasible.

Laparoscopic treatment for adult inguinal hernia with cryptorchidism: A case report.

INTRODUCTION: Cryptorchidism or undescended testis is the most common disorder of male children, which is often diagnosed and treated during childhood. Adult patients with cryptorchidism are uncommon. Herein we report the case of adult inguinal hernia with cryptorchidism successfully treated by laparoscopic surgery simultaneously. PRESENTATION OF CASE: We report a case of 68 year-old-man who was admitted to our hospital with a complaint of bulge and pain in the right groin area from 2 weeks before. CT or MRI revealed a right inguinal hernia and an undescended testis in the right inguinal canal. He was diagnosed with right inguinal hernia accompanied by cryptorchidism. Laparoscopic transabdominal preperitoneal repair (TAPP) and orchiectomy were performed simultaneously. Postoperative period was uneventful and he was discharged home on the 1st postoperative day. Pathological examination of the specimen was reported as atrophic testis with no malignancy. There has been no recurrence during a follow-up. DISCUSSION: To our Knowledge, the case report of adult inguinal hernia with cryptorchidism treated by laparoscopic surgery is rare. All cases recommended the feasibility of laparoscopic surgery. CONCLUSION: Adult inguinal hernia with cryptorchidism is a rare condition. TAPP and simultaneous laparoscopic orchiectomy for inguinal hernia with cryptorchidism were safe and feasible. It could be the first surgical option for the treatment of such adult patients.

Predictive power of home blood pressure indices at baseline and during follow-up in hypertensive patients: HOMED-BP study.

We compared the predictive power for a major adverse cardiovascular event (MACE) of four home blood pressure (BP) indices (systolic BP, diastolic BP, mean BP, and pulse pressure (PP)) obtained at baseline before treatment and during the on-treatment follow-up period in 3147 patients with essential hypertension (women: 50.1%, mean age: 59.5 years). Associations between MACE and each index were determined using Cox proportional hazard models and the likelihood ratio (LR) test. During a median follow-up of 5.4 years, 46 patients experienced MACE, which was a composite of cardiovascular death, non-fatal stroke, and non-fatal myocardial infarction. The LR test showed that systolic, diastolic, and mean BP during follow-up was more closely associated with cardiovascular risk than the corresponding indices at baseline (LR χ2 for baseline versus follow-up: systolic BP, (6.0, P = 0.014) versus (11.3, P = 0.0008); diastolic BP, (0.4, P = 0.53) versus (12.4, P = 0.0004); mean BP, (3.2, P = 0.074) versus (15.0, P = 0.0001)), whereas neither PP at baseline nor that during follow-up was significantly associated with MACE risk. Among home BP indices during follow-up, mean BP further improved prediction models in which systolic or diastolic BP was already included (P ≤ 0.042), but neither systolic nor diastolic BP improved models with mean BP (P = 0.80). In addition to home systolic and diastolic BP, mean BP during follow-up period provides essential information in predicting future cardiovascular diseases, whereas its utilization should be further assessed by an intervention trial targeting mean BP levels.

Effect of amlodipine, efonidipine, and trichlormethiazide on home blood pressure and upper-normal microalbuminuria assessed by casual spot urine test in essential hypertensive patients.

The aim of this study was to assess the effects of irbesartan alone and combined with amlodipine, efonidipine, or trichlormethiazide on blood pressure (BP) and urinary albumin (UA) excretion in hypertensive patients with microalbuminuria (30≤UA/creatinine (Cr) ratio [UACR] <300 mg/g Cr) and upper-normal microalbuminuria (10≤UACR<30 mg/g Cr). This randomized controlled trial enrolled 175 newly diagnosed and untreated hypertensive patients (home systolic blood pressure [SBP]≥135 mmHg; 10≤UACR<300 mg/g Cr of casual spot urine at the first visit to clinic). All patients were treated with irbesartan (week 0). Patients who failed to achieve home SBP ≤125 mmHg on 8-week irbesartan monotherapy (nonresponders, n = 115) were randomized into three additional drug treatment groups: trichlormethiazide (n = 42), efonidipine (n = 39), or amlodipine (n = 34). Irbesartan monotherapy decreased home SBP and first morning urine samples (morning UACR) for 8 weeks (p < 0.0001). At 8 weeks after randomization, all three additional drugs decreased home SBP (p < 0.0002) and trichlormethiazide significantly decreased morning UACR (p = 0.03). Amlodipine decreased morning UACR in patients with microalbuminuria based on casual spot urine samples (p = 0.048). However, multivariate analysis showed that only higher home SBP and UACR at week 8, but not any additional treatments, were significantly associated with UACR reduction between week 8 and week 16. In conclusion, crucial points of the effects of combination therapy on UACR were basal UACR and SBP levels. The effect of trichlormethiazide or amlodipine treatment in combination with irbesartan treatment on microalbuminuria needs to be reexamined based on a larger sample size after considering basal UACR and SBP levels.

The regulation mechanisms of AhR by molecular chaperone complex.

The AhR, so called the dioxin receptor, is a member of the nuclear receptor superfamily. The ligand-free AhR forms a cytosolic protein complex with the molecular chaperone HSP90, co-chaperone p23, and XAP2 in the cytoplasm. Following ligand binding like 2, 3, 7, 8-tetrachlorodibenzo-p-dioxin (TCDD), the AhR translocates into the nucleus. Although it has been reported that HSP90 regulates the translocation of the AhR to the nucleus, the precise activation mechanisms of the AhR have not yet been fully understood. AhR consists of the N-terminal bHLH domain containing NLS and NES, the middle PAS domain and the C-terminal transactivation domain. The PAS domain is familiar as a ligand and HSP90 binding domain. In this study, we focused on the bHLH domain that was thought to be a HSP90 binding domain. We investigated the binding properties of bHLH to HSP90. We analyzed the direct interaction of bHLH with HSP90, p23 and XAP2 using purified proteins. We found that not only the PAS domain but also the bHLH domain bound to HSP90. The bHLH domain forms complex with HSP90, p23 and XAP2. We also determined the bHLH binding domain was HSP90 N-domain. The bHLH domain makes a complex with HSP90, p23 and XAP2 via the HSP90 N-domain. Although the NLS is closed in the absence of a ligand, the structure of AhR will be changed in the presence of a ligand, which leads to NLS open, result in the nuclear translocation of AhR.

Home blood pressure predicts stroke incidence among older adults with impaired physical function: the Ohasama study.

OBJECTIVE: Several observational studies have found modifying effects of functional status on the association between conventional office blood pressure (BP) and adverse outcomes. We aimed to examine whether the association between higher BP and stroke was attenuated or inverted among older adults with impaired function using self-measured home BP measurements. METHODS: We followed 501 Japanese community-dwelling adults aged at least 60 years (mean age, 68.6 years) with no history of stroke. Multivariate-adjusted hazard ratios for 1-SD increase in home BP and office BP measurements were calculated by the Cox proportional hazards model. Functional status was assessed by self-reported physical function. RESULTS: During a median follow-up of 11.5 years, first strokes were observed in 47 participants. Higher home SBP, but not office SBP, was significantly associated with increased risk of stroke among both 349 participants with normal physical function and 152 participants with impaired physical function [hazard ratio (95% confidence interval) per 14.4-mmHg increase: 1.74 (1.12-2.69) and 1.77 (1.06-2.94), respectively], with no significant interaction for physical function (P = 0.56). Higher home DBP, but not office DBP, was also significantly associated with increased risk of stroke (P ≤ 0.029) irrespective of physical function (all P > 0.05 for interaction). Neither home BP nor office BP was significantly associated with all-cause mortality irrespective of physical function. CONCLUSION: Higher home BP was associated with increased risk of stroke even among those with impaired physical function. Measurements of home BP would be useful for stroke prevention, even after physical function decline.

Incorporation of serum carcinoembryonic antigen levels into the prognostic grouping system of colon cancer.

PURPOSE: This study aimed to clarify the significance of preoperative serum carcinoembryonic antigen (CEA) on disease-free survival (DFS) in colon cancer and propose a new prognostic grouping system. METHODS: A multiinstitutional retrospective cohort of 7296 colon cancer patients who underwent R0 surgery between 1997 and 2006 was analyzed. We stratified preoperative serum CEA values into three categories (C-stages): C0 (normal CEA), C1A (up to double the cutoff value), and C1B (more than double the cutoff value) and stratified each TNM stage by C-stage. Multivariate analyses using Cox regression models were used to analyze the significance of C-stage on 5-year DFS. RESULTS: CEA level was an independent factor affecting DFS; the 5-year DFS of patients with C0 and C1, as well as those with C1A and C1B, differed significantly (C0 84.6%, C1 69.8%, C1A 72.7%, and C1B 66.4%, P < 0.0001). Additionally, the DFS of pStages IIC and C1B was significantly lower than of pStages IIIA and C0 (65.8 vs. 87.7%, respectively; hazard ratio 3.44, 95% confidence interval 1.97-5.88, P < 0.0001). Moreover, the 5-year DFS of pStages IIIA and C0 or C1A did not differ significantly from pStages I and C1A (87.7 vs. 87.7%, P = 0.90 and 86.4 vs. 87.7%, P = 0.78, respectively). CONCLUSIONS: pStage IIC and C1B disease should be considered candidates for intensive adjuvant chemotherapy. Conversely, pStages IIIA and C0 or C1A could be exempted from adjuvant chemotherapy. Incorporating C-stage into the current TNM staging system may facilitate decision making regarding the use of adjuvant chemotherapy in colon cancer patients.

Seasonal variation in self-measured home blood pressure among patients on antihypertensive medications: HOMED-BP study.

Seasonal variation of blood pressure (BP) has been reported in small populations or by BP levels captured at only a few points in a year, for example, summer and winter. We aimed to investigate the multiyear seasonal variation in self-measured home BP among hypertensive patients receiving antihypertensive medications. We selected 1649 eligible patients receiving antihypertensive drug treatment, and weekly averaged home BPs were analyzed throughout the follow-up period. Systolic and diastolic home BPs were fitted with the cosine function: 'Variation+Other Effects+Intercept', in which the 'Variation' was expressed by a cosine curve with three parameters representing: (1) maximum-minimum difference of home BP in one cycle of the cosine curve; (2) time required for one cycle of the cosine curve for home BP variation; and (3) time at which home BP reached the maximum point. Maximum-minimum differences in home BP were 6.7/2.9 mm Hg, and the highest home BPs were observed in mid-to-late January. In the multivariable-adjusted model, a large maximum-minimum difference in home BP was associated with lower body mass index and older age, and larger differences were observed in men compared with women. Summer-winter difference in home BP was essentially similar every year, though it was marginally reduced by 0.14/0.04 mm Hg per year, under long-term antihypertensive treatment. Records of daily home BP measurements enable us to capture long-term factors such as seasonal variation. Home BP should therefore be carefully monitored, particularly in patients with increased BP in winter, to mitigate cardiovascular risk.

Risk Factors for Stroke among Young-Old and Old-Old Community-Dwelling Adults in Japan: The Ohasama Study.

AIM: Few studies have addressed stroke risk factors in older populations, particularly among the old-old. We examined differences in traditional risk factors for stroke among the old-old compared with the young-old in community-dwelling Japanese adults. METHODS: We followed 2,065 residents aged ≥ 60 years who had no history of stroke. Traditional risk factors for stroke were obtained from a self-administered questionnaire at baseline. We classified participants into two age categories, 60-74 years (n=1,502) and ≥ 75 years (n=563), and assessed whether traditional risk factors were differentially associated with stroke incidence according to age category. Hazard ratios were calculated by the Cox proportional hazards model, adjusting for confounding factors and competing risk of death. RESULTS: During a median follow-up of 12.8 and 7.9 years, 163 and 111 participants aged 60-74 and ≥ 75 years, respectively, developed a first stroke. Hypertension was consistently associated with increased risk of stroke, regardless of age category. Diabetes mellitus was associated with increased risk of stroke in those aged 60-74 years (hazard ratio, 1.50; 95% confidence interval, 1.00-2.25), but not in those aged ≥ 75 years (hazard ratio, 0.65; 95% confidence interval, 0.33-1.29), with significant interaction by age (P=0.035). No traditional risk factor other than hypertension was associated with stroke among those aged ≥ 75 years. CONCLUSION: Those with hypertension had significantly higher stroke risk among old people, while diabetes mellitus was differentially associated with stroke according to age category. Our findings indicate the importance of different prevention strategies for stroke incidence according to age category.

Lacunar Infarcts Rather than White Matter Hyperintensity as a Predictor of Future Higher Level Functional Decline: The Ohasama Study.

OBJECTIVE: We aimed to determine the associations between silent cerebrovascular lesions, characterized by lacunar infarcts and white matter hyperintensity, and future decline in higher level functional capacity in older community-dwelling adults. MATERIALS AND METHODS: For this observational study, we selected individuals from the general population of Ohasama, a rural Japanese community. Three hundred thirty-one participants who were free of functional decline at baseline and who were at least 60 years old underwent brain magnetic resonance imaging and answered a questionnaire on higher level functional capacity derived from the Tokyo Metropolitan Institute of Gerontology Index of Competence. Weassessed the relationship between silent cerebrovascular lesions with a decline in higher level functional capacity at 7 years using multiple logistic regression analysis adjusted for possible confounding factors. RESULTS: During the follow-up, 22.1% reported declines in higher level functional capacity. After adjustment for putative confounding factors, the presence of silent cerebrovascular lesions (odds ratio [95% confidence interval], 2.10 [1.05-4.21]) and both lacunar infarcts (2.04 [1.05-3.95]) and white matter hyperintensity (2.02 [1.02-3.95]) was significantly associated with the risk of functional decline at 7-year follow-up. In subscale analysis, specifically lacunar infarcts were strongly associated with the future risk of decline in intellectual activity (3.16 [1.27-7.84]). CONCLUSION: Silent cerebrovascular lesions are associated with future risk of decline in higher level functional capacity. Appropriate management of health risk factors to prevent silent cerebrovascular lesions may prevent higher level functional decline in the elderly population.

Menstrual Factors and Stroke Incidence in Japanese Postmenopausal Women: The Ohasama Study.

BACKGROUND: The association between stroke and menstrual factors, for example, age at the time of menarche and age at the time of menopause, has not been well studied so far and the findings are inconsistent. We sought to examine this association in Japanese postmenopausal women. METHODS: We followed 1,412 postmenopausal women aged ≥35 without a history of stroke in Ohasama, Japan. Baseline data were collected using a self-administered questionnaire. Adjusted hazard ratios (HRs) and 95% CIs of each menstrual factor for stroke incidence were calculated using the Cox proportional hazard model. RESULTS: During a median follow-up of 12.8 years, 143 participants developed a stroke for the first time. Women aged ≤13 at the time of menarche had a significantly higher probability of encountering a stroke incidence in their lives compared with women aged 15 at the time of menarche (HR 1.83; 95% CI 1.04-3.22). The same was also true for cerebral infarction (HR 2.34; 95% CI 1.18-4.66). While early menopause was not significantly associated with stroke incidence, women aged ≤45 at the time of menopause faced a higher risk for cerebral infarction compared with women aged 50 years at the time of menopause (HR 3.25; 95% CI 1.54-6.86). CONCLUSIONS: Early menarche and its associated features might be a useful tool for future intervention strategies targeting modifiable factors that trigger menstrual onset.

Reference values and associated factors for Japanese newborns' blood pressure and pulse rate: the babies' and their parents' longitudinal observation in Suzuki Memorial Hospital on intrauterine period (BOSHI) study.

OBJECTIVE: Currently, normative means and ranges of blood pressure (BP) and pulse rates in Japanese newborns are not available. The objective of the present study was to estimate BP, pulse rate, and their distribution among Japanese newborns. METHODS: Using oscillometric devices, arm or calf BP and pulse rate levels were obtained from 3148 infants born between 2007 and 2014, consecutively at Suzuki Memorial Hospital, Iwanuma, Japan. Of those, data from 2628 full-term, singleton newborns with BP measured on day 3 after birth were analyzed. RESULTS: Arm SBP/DBP and pulse rate in the reference group (n = 2628) were 70.5 ±â€Š7.4/44.3 ±â€Š6.7 mmHg and 117.3 ±â€Š16.6 bpm, respectively. The 5-95th percentiles were 58-83 mmHg for SBP, 35-57 mmHg for DBP, and 91-145 bpm for pulse rate. Similar values were obtained from calf measurements. In multiple regression analysis, birth weight and spontaneous cephalic delivery were positively and light/deep sleep was inversely associated with higher arm SBP/DBP (P ≤ 0.04), whereas sex, Apgar score, gestational age, and mother's age did not significantly affect BP levels (P ≥ 0.06). Male sex, gestational age, spontaneous cephalic delivery, and light/deep sleep were inversely associated with higher pulse rate (P ≤ 0.02). CONCLUSION: The present study is the first to show the distributions of Asian newborns' BP levels and pulse rate. The assessment of newborns' BP levels and pulse rate should consider birth weight, gestational age after birth, and actual condition at BP measurement.

The velocity of antihypertensive effects of seven angiotensin II receptor blockers determined by home blood pressure measurements.

BACKGROUND: We aimed to examine the blood pressure (BP)-lowering effect and the time to attain the maximal antihypertensive effect (stabilization time) of several angiotensin II receptor blockers (ARBs) based on home BP measurements. METHODS: We surveyed consecutive newly diagnosed, untreated patients with hypertension who started the treatment with a mid-level dose of one of seven ARBs (losartan 50 mg, telmisartan 40 mg, candesartan 8 mg, olmesartan 20 mg, valsartan 80 mg, irbesartan 100 mg, or azilsartan 20 mg). All study participants measured home BP in the morning for at least 1 week during an untreated period and 4 weeks during the treatment period. RESULTS: Age, the proportion of men, and baseline home BP levels did not differ significantly between groups (total n = 232; age, 62.2 years; 50.9% men; home SBP/DBP, 151.6/90.0 mmHg). Significant differences in the BP-lowering effect and the stabilization time between ARBs were observed (P ≤ 0.02). The extent of BP-lowering effects of azilsartan 20 mg was significantly greater than that of valsartan 80 mg or irbesartan 100 mg (15.3 vs. 7.9 or 8.2 mmHg, respectively P ≤ 0.03). The stabilization time of losartan for home SBP was significantly longer than that of valsartan, irbesartan, or azilsartan (22.8 vs. 7.1, 4.7, or 7.1 days, respectively, P ≤ 0.01). CONCLUSION: The maximum effect and the stabilization time differed among ARBs used at the mid-level dose in Japan. An ARB should be chosen based on its desired characteristics.

Does Antihypertensive Drug Class Affect Day-to-Day Variability of Self-Measured Home Blood Pressure? The HOMED-BP Study.

BACKGROUND: Recent literature suggests that blood pressure variability (BPV) predicts outcome beyond blood pressure level (BPL) and that antihypertensive drug classes differentially influence BPV. We compared calcium channel blockers, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockade for effects on changes in self-measured home BPL and BPV and for their prognostic significance in newly treated hypertensive patients. METHODS AND RESULTS: We enrolled 2484 patients randomly allocated to first-line treatment with a calcium channel blocker (n=833), an angiotensin-converting enzyme inhibitor (n=821), or angiotensin receptor blockade (n=830). Home blood pressures in the morning and evening were measured for 5 days off treatment before randomization and for 5 days after 2 to 4 weeks of randomized drug treatment. We assessed BPL and BPV changes as estimated by variability independent of the mean and compared cardiovascular outcomes. Home BPL response in each group was significant (P≤0.0001) but small in the angiotensin-converting enzyme inhibitor group (systolic/diastolic: 4.6/2.8 mm Hg) compared with the groups treated with a calcium channel blocker (systolic/diastolic: 8.3/3.9 mm Hg) and angiotensin receptor blockade (systolic/diastolic: 8.2/4.5 mm Hg). In multivariable adjusted analyses, changes in home variability independent of the mean did not differ among the 3 drug classes (P≥0.054). Evening variability independent of the mean before treatment significantly predicted hard cardiovascular events independent of the corresponding home BPL (P≤0.022), whereas BPV did not predict any cardiovascular outcome based on the morning measurement (P≥0.056). Home BPV captured after monotherapy had no predictive power for cardiovascular outcome (P≥0.22). CONCLUSIONS: Self-measured home evening BPV estimated by variability independent of the mean had prognostic significance, whereas antihypertensive drug classes had no significant impact on BPV changes. Home BPL should remain the primary focus for risk stratification and treatment. CLINICAL TRIAL REGISTRATION: URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: C000000137.

Impact of Lateral Pelvic Lymph Node Dissection on the Survival of Patients with T3 and T4 Low Rectal Cancer.

BACKGROUND: The aim of this study was to clarify the survival benefit of lateral pelvic lymph node dissection (LPLND) for patients with pathological T3 and T4 (pT3/T4) low rectal cancer. METHODS: We evaluated the impact of LPLND on survival for pT3/T4 low rectal cancer patients. The primary endpoint of the study was overall survival (OS). The large-scale database of the Japanese Society for Cancer of the Colon and Rectum registration system was accessed and the data were analyzed using a propensity score matching method based on the likelihood of receiving LPLND. Using seven covariates, the propensity scores were calculated with multivariate logistic regression. A total of 499 propensity score-matched pairs of patients were selected from the entire cohort of 1,840 patients who had received curative resection for pT3/T4 low rectal cancer between 1995 and 2004. RESULTS: In the matched cohort, the 5-year OS of the patients who had and had not undergone LPLND were 68.9 and 62.0 %, respectively (p = 0.013; hazard ratio [HR], 0.755; 95 % confidence interval [CI], 0.604-0.944). The 5-year OS of the patients with node-negative disease who had and had not received LPLND differed statistically significantly (5-year OS were 82.1 and 71.4 %, respectively. p = 0.006; HR, 0.579; 95 % CI 0.389-0.862). However, those with node-positive disease did not differ significantly (5-year OS were 55.5 and 53.8 %, respectively. p = 0.415; HR 0.893; 95 % CI 0.681-1.172). CONCLUSIONS: The impact of LPLND on OS for patients with node-negative pT3/T4 low rectal cancer was suggested in this retrospective cohort study. To determine true benefits and harms of LPLND, further prospective studies may be warranted.