Abstract:
INTRODUCTION:The long-term safety of dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (RRMS) has been studied in mainly Caucasian patients. The present interim analysis aimed to evaluate the 72-week safety of DMF in Japanese patients with RRMS. METHODS:Safety data of Japanese subjects enrolled in the 24-week randomised, double-blind, placebo-controlled APEX study (Part I) and its following open-label extension (Part II) were analysed at 72 weeks from the beginning of Part I. In Part I, subjects were randomised to DMF treatment or matching placebo while all subjects received DMF treatment during Part II. Adverse events (AEs) reported throughout the study period were recorded. RESULTS:Overall, 109 Japanese subjects completed 72 weeks of treatment. The incidence of AEs and serious AEs was 95% and 19%, respectively, in the DMF group compared with 84% and 18%, respectively, in the placebo group at 24 weeks. Common AEs (at least 5%) reported with treatment included nasopharyngitis, flushing, hot flush, gastrointestinal events, pruritus, rash, headache, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST). AEs led to discontinuation of DMF in 5% of patients and included MS relapse, flushing, abdominal pain, liver disorder and increased ALT/AST. After an initial decrease from baseline of 17% in the DMF group at week 24, the mean lymphocyte counts stabilised and were maintained until week 72. No opportunistic/serious infections nor malignancies were reported with DMF treatment. The incidences of AEs, serious AEs, and discontinuation due to AEs were similar between the DMF and the placebo groups. CONCLUSION:The 72-week safety profile of DMF in Japanese patients with RRMS was consistent with previous studies that enrolled mostly Caucasian patients, with a lower incidence of flushing and related symptoms and a lower reduction in the lymphocyte count compared with previous reports. TRIAL REGISTRATION:ClinicalTrials.gov identifier NCT01838668. FUNDING:Biogen Japan Ltd.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Ochi H,Niino M,Onizuka Y,Hiramatsu K,Hase M,Yun J,Matta A,Torii Sdoi
10.1007/s12325-018-0788-8subject
Has Abstractpub_date
2018-10-01 00:00:00pages
1598-1611issue
10eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-018-0788-8journal_volume
35pub_type
杂志文章,随机对照试验abstract::Data from the Framingham Heart Study and risk-appraisal models were used to develop a Coronary Heart Disease (CHD) Risk Factor Calculator for early identification of high-risk individuals. The Calculator was tested at an employee health fair for a large northeastern US corporation. Of the 590 employees who registered ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850248
更新日期:2001-01-01 00:00:00
abstract::Treating hyperglycemia is a critical aspect of managing type 2 diabetes mellitus (T2DM), but can be especially challenging in patients from vulnerable groups such as those with chronic kidney disease, African Americans, and older people. The dipeptidyl peptidase (DPP)-4 inhibitors are relatively new oral antidiabetes ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-013-0071-y
更新日期:2013-12-01 00:00:00
abstract::The lipid triad is the association of small, dense (sd) low-density lipoprotein (LDL), low high-density lipoprotein (HDL), and hypertriglyceridemia, all of which play a role in coronary artery disease in patients with type 2 diabetes. Although statins have demonstrated clear positive effects on cardiovascular morbidit...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/BF02849947
更新日期:2005-11-01 00:00:00
abstract::Duodenal self-expandable metal stents (SEMS) are designed for palliation and prompt relief of malignant gastric outlet obstruction (GOO). This mini-invasive endoscopic treatment is preferable to surgery due to its lower morbidity and mortality, shorter hospitalization, and earlier symptoms relief; furthermore endoscop...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0061-2
更新日期:2010-10-01 00:00:00
abstract:INTRODUCTION:Adrenocortical carcinoma (ACC) is a rare malignancy with poor prognosis. It is vitally important to predict prognosis and restrict unnecessary adjuvant treatments for patients with ACC. This study aims to confirm the prognostic value of Ki-67 and provide a prognostic evaluation on ACC after primary surgery...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01050-0
更新日期:2019-10-01 00:00:00
abstract::This study compared technetium-99m-hexakis-2-methoxyisobutyl-isonitrile (Tc-99m MIBI) with technetium-99m methylene iphosphonate (Tc-99m MDP) to determine whether Tc-99m MIBI could distinguish vertebral metastases from traumatic vertebral fractures. Twenty patients with traumatic vertebral fracture (and no malignant d...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850344
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:It is hypothesized that diabetes mellitus (DM) and mood disorders share points of pathophysiological commonality in the central nervous system. METHODS:A PubMed search of all English-language articles published between 1966 and March 2009 was performed with the following search terms: depression, mood disor...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0011-z
更新日期:2010-02-01 00:00:00
abstract:INTRODUCTION:Respiratory tract infections are common, and these infections occur frequently in children, susceptible adults, and older persons. The risk for recurrences and complications relates not only to the presence of viruses but also to immune function. Therefore, modulation of the immune system and antiviral int...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-015-0194-4
更新日期:2015-03-01 00:00:00
abstract:INTRODUCTION:Diabetes-related healthcare costs are increasing in the United States, with inpatient hospitalization the largest component of medical expenditures. The aims of this study were to characterize hospitalized type 2 diabetes mellitus (T2DM) patients, understand the relationship between hospitalization and hea...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-015-0223-3
更新日期:2015-07-01 00:00:00
abstract::Recently, high levels of neurotrophic factors have been found in bronchial asthma; these factors include nerve growth factor, brain-derived neurotrophic factor, and leukemia inhibitory factor, among others. Neurotrophic factors are first synthesized in bronchial epithelial cells, immune cells, and other cells in the a...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/BF02848784
更新日期:2007-05-01 00:00:00
abstract::Convergent evidence indicates that abnormalities in the innate immune system may be pertinent to the pathogenesis, phenomenology, and possible treatment of several mental disorders. In keeping with this view, the targeting of interleukin-6 with the human monoclonal antibody sirukumab may represent a possible treatment...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-016-0455-x
更新日期:2017-01-01 00:00:00
abstract:INTRODUCTION:Diabetic peripheral neuropathy (DPN) is one of the most common complications of diabetes and has been associated with cardiovascular disease, the leading cause of mortality in diabetes. As asymptomatic myocardial ischemia (MI) is frequent in diabetes, we hypothesized that DPN may be associated with MI in p...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-016-0399-1
更新日期:2016-10-01 00:00:00
abstract:BACKGROUND:Studies assessing the effect of high dose tigecycline on severe infections are limited and remain controversial. OBJECTIVES:To assess systematically the effectiveness and safety of high dose tigecycline in the treatment of severe infections. METHODS:Pubmed, Web of Science, Embase, MEDLINE, Cochrane Library...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
doi:10.1007/s12325-020-01235-y
更新日期:2020-03-01 00:00:00
abstract:INTRODUCTION:Stimulant medications are the most effective drugs in the treatment of attention-deficit hyperactivity disorder (ADHD) in children and in adults. However, some patients do not respond to this treatment and other patients suffer from adverse effects. Very often there are also comorbid disorders that warrant...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析,评审
doi:10.1007/s12325-009-0008-7
更新日期:2009-02-01 00:00:00
abstract::Intensive postremission chemotherapy has produced disease-free survival comparable to that of bone marrow transplantation in patients with acute myelogenous leukemia (AML), but its efficacy was unknown in Taiwan. We assessed the efficacy of intensive postremission chemotherapy, consisting of high-dose arabinoside-C (H...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02852390
更新日期:2001-03-01 00:00:00
abstract:INTRODUCTION:One method of treatment for allergic diseases is allergen-specific immunotherapy (SIT). The clinical efficacy of SIT in pollen-induced allergic rhinitis has been demonstrated in several controlled clinical trials. There is no consensus about the protective effect of SIT. In this study, we evaluated the cor...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0004-3
更新日期:2008-01-01 00:00:00
abstract:INTRODUCTION:The Medicare Part D prescription plan has a coverage gap from $2250 to $5100 per year (2006 thresholds) in which patients pay full drug costs (the "donut hole"). We examined prescription costs in patients aged >or=65 years with atrial fibrillation (AF), and the proportions entering/exiting the donut hole i...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-009-0054-1
更新日期:2009-08-01 00:00:00
abstract:INTRODUCTION:The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. METHODS:The authors revi...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-017-0560-5
更新日期:2017-07-01 00:00:00
abstract:INTRODUCTION:Alcohol dependence represents a severe pathological disorder associated with a significant rate of morbidity and mortality. To date, limited pharmacological agents exist to treat this disorder, and there is a growing interest for new therapies. In this context, pregabalin represents a promising strategy. P...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-012-0061-5
更新日期:2012-11-01 00:00:00
abstract::The aim of this prospective, randomized, open-label, blinded endpoint (PROBE) study was to compare the antihypertensive efficacy of 2 angiotensin II (AII) receptor antagonists with different pharmacologic profiles, valsartan and olmesartan, in patients with mild-to-moderate essential hypertension. After an initial 2-w...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF02850182
更新日期:2005-01-01 00:00:00
abstract::A 54-y-old patient with rheumatoid arthritis (RA) and bilateral lower-limb lymphoedema is presented. Complete decongestive physical therapy (CDP) is the cornerstone of the management programme in all patients suffering from lymphoedema associated with RA, but it is not clear which therapy is the most effective in decr...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0006-1
更新日期:2008-01-01 00:00:00
abstract::The prevalence of chronic airways diseases such as chronic obstructive pulmonary disease and asthma is increasing. They lead to symptoms such as a cough and shortness of breath, partially through bronchoconstriction. Inhaled anticholinergics are one of a number of treatments designed to treat bronchoconstriction in ai...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-009-0074-x
更新日期:2009-10-01 00:00:00
abstract:INTRODUCTION:This retrospective study evaluates the efficacy of palliative chemotherapy with a modified docetaxel, cisplatin, 5-fluorouracil (5-FU; "TPF" regimen) regimen (mTPF; reduced doses of docetaxel, cisplatin, and 5-FU with reduction of intravenous 5-FU from 4 days to 2 days) in Asian patients with recurrent and...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-011-0085-2
更新日期:2012-01-01 00:00:00
abstract::Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice. While randomized clinical trials (RCTs) are the "gold standard" for evaluating the safety and efficacy of new therapeutic agents, necessarily strict inclusion and exclusion criteria mean that tr...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-018-0805-y
更新日期:2018-11-01 00:00:00
abstract:PURPOSE:To evaluate the impact on cost, time, resource use, and clinic workflow of converting the route of drug administration from a neurokinin-1 receptor antagonist (NK-1 RA) 30-min intravenous (IV) infusion to aprepitant IV, and more specifically to IV push, within a multicenter community oncology practice. METHODS...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01377-z
更新日期:2020-07-01 00:00:00
abstract::The present study, which was designed as a prospective, double-masked, randomized, controlled, single-site study, was conducted to compare the effects of 3 approved ophthalmic nonsteroidal anti-inflammatory drugs-nepafenac ophthalmic suspension 0.1% (Nevanac; Alcon Laboratories, Inc., Fort Worth, Tex), ketorolac trome...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/BF02877774
更新日期:2007-11-01 00:00:00
abstract:INTRODUCTION:Video-assisted thoracic surgery (VATS) lung resections are complex procedures with a critical role played by endoscopic staplers in the transection of vessels, bronchi, and lung tissue. This retrospective, observational study compared hospital resource use, costs, and complications of VATS lobectomy proced...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0679-z
更新日期:2018-05-01 00:00:00
abstract:OBJECTIVES:Because clinical guidelines do not offer clear recommendations for treatment options after discontinuing a tumor necrosis factor (TNF) blocker, this study evaluated treatment patterns within 360 days after discontinuation of TNF-blocker treatment. METHODS:The IMS LifeLink Health Plan Claims database was use...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-014-0110-3
更新日期:2014-04-01 00:00:00
abstract:INTRODUCTION:To date, no study has reported the prevalence of cannabis use in chronic pain patients. The aim of this study is to investigate the trends in cannabis use among chronic pain in-patients from 2011 to 2015 in the USA. METHODS:Patients were identified from the National Inpatient Sample (NIS) database using t...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01416-9
更新日期:2020-08-01 00:00:00
abstract::Patients with severe gastrointestinal motility disorders are often found to have intravenous access clots or deep venous thrombosis. It has previously been reported that many patients who have intravenous access thrombosis have concomitant thrombotic risk factors. In this study, the goal was to determine the underlyin...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850315
更新日期:2006-09-01 00:00:00