Abstract:
PURPOSE:The goal of this study was to evaluate clinical outcomes and patient-reported outcomes (PROs) over 12 months in patients with relapsing multiple sclerosis (RMS) who switched from glatiramer acetate (GA) to delayed-release dimethyl fumarate (DMF) 240 mg BID after suboptimal response to GA in real-world clinical practice. METHODS:The RESPOND (Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS) study was a Phase IV, prospective, multicenter, open-label, single-arm, 12-month observational trial. The study was conducted in the United States at 63 sites between August 2013 and February 2016. Patients diagnosed with RMS who experienced a suboptimal response to GA (defined as perceived suboptimal efficacy, intolerance, or poor adherence to GA) were eligible for enrollment. DMF treatment was initiated within 60 days of enrollment. The primary objective was to estimate the annualized relapse rate (ARR) at 12 months based on data collected from medical records and compare it with the 12 months before DMF initiation. Secondary objectives of the study included assessing the change in PRO scores from baseline to 12 months; PROs were recorded before and at 6 and 12 months after DMF initiation. FINDINGS:Of the 318 patients included in the analysis population, 247 (78%) completed treatment. Mean (SD) time on GA treatment before switching to DMF was 51.3 months (49.1 months). The ARR (95% CI) reported for the 12 months before DMF initiation was 0.49 (0.42-0.57) compared with 0.11 (0.07-0.17) at 12 months after DMF initiation, representing a 78% reduction in ARR (P < 0.0001). Statistically significant improvements from baseline were observed for multiple PROs, including the 36-item Short Form Health Survey physical and mental component summaries (P = 0.0201 and P = 0.0014, respectively), the 5-item Modified Fatigue Impact Scale (P = 0.0002), the 14-item Treatment Satisfaction Questionnaire for Medication (P < 0.0001), and the 7-item Beck Depression Inventory (P = 0.0117). IMPLICATIONS:DMF may be an effective treatment option in patients with RMS who experience a suboptimal response to GA. The results should be interpreted with caution due to the observational nature of the study and the lack of a control group. Other limitations of the study include a potential bias due to regression to the mean and lack of randomization. ClinicalTrials.gov identifier: NCT01903291.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Kresa-Reahl K,Repovic P,Robertson D,Okwuokenye M,Meltzer L,Mendoza JPdoi
10.1016/j.clinthera.2018.10.011subject
Has Abstractpub_date
2018-12-01 00:00:00pages
2077-2087issue
12eissn
0149-2918issn
1879-114Xpii
S0149-2918(18)30506-Xjournal_volume
40pub_type
杂志文章,多中心研究abstract:BACKGROUND:Inhaled dry powder insulin (IDPI) is the first inhaled insulin approved for the treatment of type 1 and type 2 diabetes mellitus (DM). OBJECTIVE:This article reviews available information on IDPI, focusing on its clinical pharmacokinetics, comparative efficacy, tolerability, adverse events, dosage and admin...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2007.05.015
更新日期:2007-05-01 00:00:00
abstract:BACKGROUND:High incidences of cardiovascular events coincide with a surge in blood pressure (BP) that occurs in the early morning hours at the time of arousal. Thus, control of BP at this time of day, using oral fixed-dose combinations (FDCs) as required, is important in reducing cardiovascular risk in hypertensive pat...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析
doi:10.1016/j.clinthera.2005.11.014
更新日期:2005-11-01 00:00:00
abstract:BACKGROUND:Short-term studies have demonstrated a modest weight-reducing to weight-neutral effect among patients receiving bupropion sustained-release (SR) for the treatment of depression. OBJECTIVE:This study was conducted to evaluate the long-term effects of bupropion SR on body weight in patients with depression. ...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(02)85141-4
更新日期:2002-04-01 00:00:00
abstract:BACKGROUND:Exenatide is an antidiabctic agent currently indicated as adjunctive therapy with oral agents for the treatment of type 2 diabetes mellitus (T2DM). Limited published data exist on the off-label use of exenatide in conjunction with insulin in the treatment of T2DM. OBJECTIVE:The aim of this retrospective stu...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2009.07.021
更新日期:2009-07-01 00:00:00
abstract::A comparison of single-agent antimicrobial therapy in the treatment of patients with perforated or gangrenous appendicitis and peritonitis was performed in a double-blind, randomized, prospective trial. Pathologic documentation of advanced appendicitis and positive intraoperative specimen cultures were required for in...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1990-01-01 00:00:00
abstract:BACKGROUND:Rosuvastatin is a new statin indicated to reduce elevated levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), and triglycerides and to increase levels of high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia, mixed dyslipidemia, and homozygous famili...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2004.09.005
更新日期:2004-09-01 00:00:00
abstract:BACKGROUND:The Lescol Intervention Prevention Study (LIPS) was a multinational randomized controlled trial that showed a 47% reduction in the relative risk of cardiac death and a 22% reduction in major adverse cardiac events (MACEs) from the routine use of fluvastatin, compared with controls, in patients undergoing per...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2005.09.012
更新日期:2005-09-01 00:00:00
abstract::Patient counseling is an important aspect of family planning. Patient choice, compliance, and satisfaction with a contraceptive method depend heavily on the counseling experience. This is especially true in the United Kingdom where contraceptives are provided to patients at no direct cost to them. Women are therefore ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(96)80187-1
更新日期:1996-01-01 00:00:00
abstract::Twenty-six women (aged 26 to 60) with stress incontinence underwent urodynamic investigation before and after oral administration of 5 mg of midodrine, a new adrenergic agent with alpha-stimulant activity. A significant increase in maximum urethral closing pressure combined with a nonsignificant increase in flow time ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1986-01-01 00:00:00
abstract:BACKGROUND:Meclofenoxate hydrochloride is a psychostimulant in the nootropic agent group available in capsule and tablet formulations approved for traumatic cataphora, alcoholic poisoning, anoxia neonatorum, and children's enuresis in China. Although these 2 generic formulations are marketed in China, information regar...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2008.09.013
更新日期:2008-09-01 00:00:00
abstract:BACKGROUND:Bisphosphonates are the class of medication used most widely to treat osteoporosis. Since an article reported that patients who used zoledronic acid, a bisphosphonate, had a higher proportion of atrial fibrillation (AF) in 2007, the issue of bisphosphonates and AF has become a growing concern. Due to the wid...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2011.07.012
更新日期:2011-09-01 00:00:00
abstract::Cefoperazone was evaluated as the therapeutic agent in 64 adults with serious infections. Included were pneumonias, urinary tract infections, septicemia, osteomyelitis, joint infections, and superficial infections. A total of 84 organisms, including many multiantibiotic-resistant strains, were designated as the etiolo...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1982-01-01 00:00:00
abstract::Hypoglycemia in people with insulin-treated type 2 diabetes can be a limiting factor for management and a barrier to optimizing glycemic control. Even mild episodes of hypoglycemia can affect an individual's quality of life, and fear of hypoglycemia can lead to underinsulinization. This article explores the prevalence...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2016.09.020
更新日期:2017-08-01 00:00:00
abstract:PURPOSE:Clopidogrel is a thienopyridine prodrug that inhibits platelet aggregation. It is prescribed to prevent atherothrombotic and thromboembolic events in patients receiving a stent implant in carotid, vertebral, or cranial arteries. The influence of cytochrome P-450 (CYP) 2C19 on the response to clopidogrel has bee...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2019.04.037
更新日期:2019-06-01 00:00:00
abstract::The comparative bioavailability of ceftibuten, a new third-generation cephalosporin antibiotic given orally once daily, in capsule and suspension dosage forms, was assessed in healthy male subjects. In three separate studies, subjects received either a 400-mg dose as a suspension or one laboratory-batch, 400-mg capsul...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(96)80068-3
更新日期:1996-11-01 00:00:00
abstract:PURPOSE:Each year in France, varicella and zoster affect large numbers of children and adults, resulting in medical visits, hospitalizations for varicella- and zoster-related complications, and societal costs. Disease prevention by varicella vaccination is feasible, wherein a plausible option involves replacing the com...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.01.006
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND:Nonadherence to treatment is an important determinant of long-term outcomes in women with osteoporosis. OBJECTIVES:This study was conducted to investigate the association between adherence and osteoporotic fracture risk and to identify optimal thresholds for good compliance and persistence. A secondary obje...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2008.12.019
更新日期:2008-12-01 00:00:00
abstract:BACKGROUND:Inhibitors of dipeptidyl peptidase (DPP) IV are a class of oral hypoglycemic agents that increase glucagon-like peptide-1 (GLP-1) levels by inhibiting its degradation. OBJECTIVE:This study evaluated the pharmacokinetics, pharmacodynamics, and tolerability of DA-1229, which is a newly developed DPP IV inhibi...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2012.08.006
更新日期:2012-09-01 00:00:00
abstract:BACKGROUND:Pitavastatin, a fully synthetic β-hydroxy-β-methylglutaryl-coenzyme A reductase inhibitor, is potent for the treatment of primary hyperlipidemia and mixed dyslipidemia. Recently, the original product and some generic products of pitavastatin calcium have become available in China. However, the intrasubject v...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.06.021
更新日期:2014-09-01 00:00:00
abstract:PURPOSE:Children with normal urinary tract anatomy and function and highly recurrent urinary tract infection (rUTI) may have a lack of alternatives when antibiotic prophylaxis and "watchful waiting" approaches fail. This retrospective review reports the outcomes in children who received a fluoroquinolone/probiotic comb...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.06.018
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Amlodipine is a third-generation dihydropyridine calcium antagonist for the treatment of angina and hypertension. The relative bioavailability of a newly developed dispersible tablet as compared with an established branded formulation has not been reported in a Chinese population. OBJECTIVE:The aim of this ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2009.04.013
更新日期:2009-04-01 00:00:00
abstract:OBJECTIVE:This post hoc analysis was aimed to summarize the efficacy and tolerability of duloxetine as represented by number needed to treat (NNT) and number needed to harm (NNH) to provide a clinically useful assessment of the position of duloxetine among current agents used to treat diabetic peripheral neuropathic pa...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2007.12.002
更新日期:2007-01-01 00:00:00
abstract:PURPOSE:In patients with type 2 diabetes mellitus (T2DM) not achieving glycemic targets using oral antidiabetes drugs (OADs), studies suggest that timely insulin initiation has clinical benefits. Insulin initiation at the early versus late stage of disease progression has not been explored in detail. This retrospective...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.11.011
更新日期:2016-01-01 00:00:00
abstract::Macrolide and beta-lactam antimicrobial agents are frequently used for the treatment of upper and lower respiratory tract infections and skin or skin structure infections. To evaluate the relative in vitro activity of these antimicrobial drugs against organisms commonly involved in these infections, we tested clarithr...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1993-01-01 00:00:00
abstract:BACKGROUND:Immune thrombocytopenic purpura (ITP) is characterized by platelet deficiency due to platelet destruction and/or inadequate production. Initial therapy consists of corticosteroids or intravenous immunoglobulin (IVIg). Patients with chronic refractory disease might undergo splenectomy. Although there is no tr...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2009.09.013
更新日期:2009-09-01 00:00:00
abstract:BACKGROUND:Impaired mineral homeostasis affecting calcium, phosphate, and magnesium is a result of parathyroid hormone (PTH) deficiency in hypoparathyroidism. The current standard of treatment with active vitamin D and oral calcium does not control levels of these major minerals. Recombinant full-length human PTH 1-84 ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.04.001
更新日期:2014-05-01 00:00:00
abstract:OBJECTIVE:This paper examines the rationale for using direct thrombin inhibitors in the management of acute coronary syndrome (ACS). BACKGROUND:With traditional management of ACS using aspirin and unfractionated heparin (UH), refractory angina and new myocardial infarction (MI) continue to develop. Growing understandi...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析
doi:10.1016/S0149-2918(00)80065-X
更新日期:2000-08-01 00:00:00
abstract::Biotechnology represents an opportunity for innovative products, new markets, or capital investments, depending on one's perspective. A primary consideration in regulating this industry is to ensure that innovation is not stifled yet the public is protected from potentially unsafe or ineffective products. We compared ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1993-03-01 00:00:00
abstract:OBJECTIVE:This study was conducted to evaluate data on chemotherapy-associated anemia and thrombocytopenia, and cycle delays in patients with cancer in a community oncology practice. METHODS:Data on adult patients (age > or =18 years) with cancer treated in outpatient oncology clinics throughout the United States betw...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1016/j.clinthera.2009.11.020
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Granisetron, a selective 5-hydroxytryptamine3 antagonist, is effective for the treatment of patients with postoperative nausea and vomiting. Dexamethasone decreases chemotherapy-induced emesis when added to an antiemetic regimen. OBJECTIVE:This study compared the efficacy of granisetron alone with granisetr...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验,收录出版
doi:10.1016/s0149-2918(03)80092-9
更新日期:2003-02-01 00:00:00