Objectives To evaluate the impact of discontinuation adalimumab (ADA) for 1 year in Japanese patients with early rheumatoid arthritis (RA). Methods This 52-week postmarketing study, HOPEFUL-2, enrolled who had completed HOPEFUL-1 RA, which received either ADA + methotrexate (MTX) or MTX alone a 26-week randomised phase, followed by ADA+MTX open-label phase. Results A total 220 (ADA discontinuation: 114 vs continuation: 106 patients) were this study. The proportion sustained low disease...

On the basis of studies that investigated relationship between baseline clinic blood pressure (CBP) or home (HBP) values and cardiovascular (CV) events, HBP has been reported to have a stronger prognostic ability. However, few compared ability on-treatment CBP HBP. The HBP, measured twice in morning at bedtime, CV events was over 20 000 patients HONEST (Home measurement with Olmesartan Naive Establish Standard Target pressure) Study, prospective, 2-year observational study treatment an...

The long-term safety of dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (RRMS) has been studied mainly Caucasian patients. present interim analysis aimed to evaluate the 72-week DMF Japanese RRMS. Safety data subjects enrolled 24-week randomised, double-blind, placebo-controlled APEX study (Part I) and its following open-label extension II) were analysed at 72 weeks from beginning Part I. In I, randomised treatment or matching placebo while all received during...

Morning home blood pressure (BP) levels are more closely associated with cardiovascular risk than clinic BP levels. However, control of morning has been worse that in clinical practice. We examined the effects olmesartan-based treatment using data (n=21 341) from first 16 weeks Home measurement Olmesartan Naive patients to Establish Standard Target (HONEST) study, a prospective observational study for olmesartan-naive essential hypertension. After 16-week treatment, and systolic (SBP)...

Morning hypertension is a risk factor for cardiovascular and cerebrovascular events. Furthermore, it useful measure definitive diagnosis of hypertension, patients who self-assess their own blood pressure (BP) in the morning tend to exhibit better compliance with antihypertensive medication than those do not. The objective this analysis was determine BP- pulse rate-lowering effects azelnidipine, long-acting dihydropyridine calcium antagonist administered once daily morning. We conducted...

We investigated the relationship between cardiovascular disease (CVD) and achieved blood pressure, dietary habits presence/absence of metabolic syndrome (MetS) in hypertensive patients treated with olmesartan medoxomil. A prospective cohort study a 3-year follow-up was conducted 14 721 olmesartan-naive outpatients (mean age: 64.9 years, 49.6% women) essential hypertension. The association CVD MetS by Cox proportional hazards analysis. There were 3059 (31.8%) (Japanese criteria) among 9625...

The efficacy and safety of the angiotensin receptor blocker olmesartan medoxomil (OLM) was assessed in 550 elderly Japanese hypertensive patients who were followed for 24 weeks daily clinical practice. Patients given OLM alone or combination with other antihypertensive drugs at discretion investigators. After treatment, systolic diastolic blood pressure (BP) significantly decreased from baseline ( P <.0001). When classified as either young‐old (65–74 years) older‐old (75 years older),...

The effect of beta-blockers in treating Japanese heart failure (HF) patients with preserved left ventricular (LV) ejection fraction (EF) is unclear. This prospective observational study enrolled 1,682 HF who received carvedilol for the first time. Patients were followed a mean 1.6 years. 1,492 baseline LVEF measurements allocated to following groups: reduced EF (LVEF < 40%; n = 724), borderline 4050%; 355), and ≥ 50%; 413). Baseline characteristics, New York Heart Association (NYHA) class,...

To identify risk factors for cardiovascular disease (CVD) in hypertensive patients with no history of CVD being treated antihypertensive drugs, we examined subgroup data (n = 13 052) from the prospective, observational Olmesartan Mega Study to Determine Relationship between Cardiovascular Endpoints and Blood Pressure Goal Achievement (OMEGA) study. Risk CVD, stroke coronary heart (CHD) were using a Cox proportional hazards model. In addition, effect statin therapy at baseline on CHD...

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 first 16 weeks Home BP Measurement With Olmesartan‐Naive Patients Establish Standard Target Blood Pressure ( HONEST) study, prospective observational study hypertensive patients. Essential patients who took no antihypertensive agent at baseline were classified based on morning home systolic MHSBP )...

The authors assessed the early antihypertensive efficacy of olmesartan medoxomil (OM) in a 12‐week prospective observational study. Of 2221 patients with untreated hypertension who received OM (mainly 10 or 20 mg), 331 whose blood pressure (BP) was measured at 1 week after initiation treatment were defined as ``early BP determination group,'' whereas remaining 1890 ``standard group.'' Baseline characteristics, doses OM, concomitant drugs used, and during did not differ between 2 groups....

Background: In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct post-marketing survey evaluate the safety and efficacy of drug in accordance with Good Post-Marketing Surveillance Practice under Article 14.4 (re-examination) Pharmaceutical Affairs Law at contracted medical institutions. We report results use survey, which we conducted as survey. Objective: This prospective was assess β-adrenergic receptor antagonist (β-blocker) Artist® Tablets (carvedilol)...

Abstract The evaluation of the antihypertensive effect multiple drugs using data from an observational study requires adjustment for time‐dependent confounders. Marginal structural models (MSMs) have been proposed to address this type confounding through inverse probability weighting. Generally, probabilities are estimated logistic regression that assume linearity between link and predictors, but might be inaccurate. In article, we MSMs assess blood pressure‐lowering effects combination...

Combination therapy with multiple anti-hypertensives is required to achieve target blood pressure (BP) control and recommended as the first-line in hypertension. Although angiotensin receptor blockers (ARBs) may be combined other anti-hypertensives, it unclear how effects of ARBs are influenced by co-administered anti-hypertensives. We investigated effect olmesartan medoxomil (OLM) when given alone (monotherapy) or concomitantly 6507 OLM-naïve Japanese “real world” clinical practice. After a...

Morning hypertension is a risk factor for cardiovascular and cerebrovascular events, consequently diagnosis control of morning are considered very important. We previously reported the results Azelnidipine Treatment Hypertension Open-label Monitoring in Early (At-HOME) Study, which indicated that azelnidipine effectively controlled hypertension.The objective this At-HOME subgroup analysis was to evaluate sustained blood pressure (BP)-lowering effect azelnidipine, using mean evening systolic...

Current data for the use of dimethyl fumarate (DMF) in Japanese patients with relapsing-remitting multiple sclerosis (RRMS) is limited.To assess efficacy DMF RRMS.The phase 3, multinational APEX study (ClinicalTrials.gov identifier: NCT01838668) consisted two parts: a 24-week double-blind part where subjects were randomized to receive 240 mg or placebo twice daily East Asian and Eastern European countries, an open-label extension all received DMF. The primary endpoint was total number new...

Background . Familial hypercholesterolemia (FH) is a genetic disorder characterized by high levels of low-density lipoprotein cholesterol (LDL-C). Because underdiagnosis, acute coronary syndrome (ACS) often the first clinical manifestation FH. In Japan, there are few reports on prevalence and diagnostic ratios FH proportion ACS among patients in settings. Methods. This retrospective, observational study used anonymized data from electronic healthcare databases between April 2001 March 2015...

There is insufficient evidence regarding the appropriate dose of methotrexate (MTX) required to achieve specific treatment goals in patients with rheumatoid arthritis (RA) receiving biologic drugs Japan. The present study aimed assess dose-response effect MTX combination adalimumab (ADA) low disease activity (LDA) and/or remission at 24 weeks RA patients.This analysis used data ADA all-case survey Japan (n = 7740), and 5494 who received were classified into five groups by weighted average...

The use of dimethyl fumarate has not been reported in treatment-naïve Japanese patients with relapsing-remitting multiple sclerosis.The purpose this study was to evaluate the efficacy and safety sclerosis.APEX a phase 3, multinational trial, which consisted 24-week, randomized (1:1), double-blind where received 240 mg or placebo twice daily, followed by an open-label extension all mg. primary endpoints were total number new gadolinium-enhancing (Gd+) lesions Weeks 12-24 (Part I) long-term...

We studied the agreement rate between achievement of blood pressure (BP) target according to 2002 Japanese Guidelines for Treatment Hypertension in Elderly (EG 2002) and Society 2004 (JSH 2004) versus a physicians' assessment BP-lowering efficacy olmesartan medoxomil elderly patients. The more closely agreed with BP EG than that JSH 2004. This study was started July 2004, shortly after published. Our data suggest guidelines at time strongly influence their treatment strategy individual...

<h3>Background</h3> Treatment with adalimumab (ADA) has been reported to improve work productivity and reduce indirect cost due impairment in patients rheumatoid arthritis (RA). The impact of disease duration at the time treatment initiation on is less well understood. <h3>Objectives</h3> To assess before starting ADA economic benefit Japanese RA. <h3>Methods</h3> Data were taken from first 24 weeks a 48-week, multicenter, prospective, single-cohort study self-reported activity 897 RA...

In Japan, when pharmaceutical companies launch a new drug, they are obligated to conduct post-marketing survey evaluate the safety and efficacy of drug in accordance with Good Post-Marketing Surveillance Practice under Article 14-4 (re-examination) Pharmaceutical Affairs Law at contracted medical institutions. We report results long-term special that we conducted as survey.The prospective was assess β-adrenergic receptor antagonist (β-blocker) Artist® tablets 10 mg, 20 mg (carvedilol)...