Effectiveness of Delayed-release Dimethyl Fumarate on Clinical and Patient-reported Outcomes in Patients With Relapsing Multiple Sclerosis Switching From Glatiramer Acetate: RESPOND, a Prospective Observational Study.


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.


Clin Ther


Clinical therapeutics


Kresa-Reahl K,Repovic P,Robertson D,Okwuokenye M,Meltzer L,Mendoza JP




Has Abstract


2018-12-01 00:00:00














  • Results of a randomized, double-blind, placebo-controlled study administering glimepiride to patients with type 2 diabetes mellitus inadequately controlled with rosiglitazone monotherapy.

    abstract:OBJECTIVE:This study was designed to assess the efficacy and safety of glimepiride plus rosiglitazone for type 2 diabetes mellitus (DM) inadequately controlled with rosiglitazone monotherapy. METHODS:This was a randomized, double-blind, placebo-controlled, multicenter study Patients were assigned to a 6-week forced ti...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: McCluskey D,Touger MS,Melis R,Schleusener DS,McCluskey D

    更新日期:2004-11-01 00:00:00

  • Potential Etiologic Factors of Microbiome Disruption in Autism.

    abstract:PURPOSE:The primary purpose of this article was to consider the candidate disruptors of the development of a healthy microbiome in patients with autism. The reported abnormalities in the microbiome of individuals with autism are discussed. METHODS:This selected review used data from published articles related to the a...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Buie T

    更新日期:2015-05-01 00:00:00

  • Use of the the combination labetalol plus chlorthalidone in essential arterial hypertension therapy.

    abstract::Eleven patients suffering from WHO stage II essential arterial hypertension were treated with the combination of labetalol plus chlorthalidone in the reciprocal ratio of 10:1 in the form of once-a-day administration in the morning. The dosage was individualized on the basis of hypotensive response and side effects unt...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Rossi AG

    更新日期:1981-01-01 00:00:00

  • A clinical and mycological assessment of tioconazole solution in the treatment of superficial dermatomycoses.

    abstract::The efficacy, acceptability, and tolerability of tioconazole solution (1%) in a pump spray were evaluated in an open-label trial in 26 patients with dermatophytosis, superficial candidiasis, and tinea versicolor. Medication was applied twice daily for 30 consecutive days. Eighteen patients had dermatophyte lesions: fo...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章


    authors: del Palacio Hernanz A,Lopez Gomez S,Iglesias Diez L

    更新日期:1987-01-01 00:00:00

  • Comparison of the effects of once-monthly versus once-daily risedronate in postmenopausal osteoporosis: a phase II, 6-month, multicenter, randomized, double-blind, active-controlled, dose-ranging study.

    abstract:BACKGROUND:Risedronate 5 mg/d is approved by the US Food and Drug Administration for the treatment and prevention of postmenopausal osteoporosis. Once-monthly dosing options might increase treatment compliance and persistence. OBJECTIVE:The aim of this study was to compare the tolerability and efficacy of 3 once-month...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Ste-Marie LG,Brown JP,Beary JF,Matzkin E,Darbie LM,Burgio DE,Racewicz AJ

    更新日期:2009-02-01 00:00:00

  • Treatment satisfaction in type 2 diabetes: a comparison between an inhaled insulin regimen and a subcutaneous insulin regimen.

    abstract:BACKGROUND:In patients with type 2 diabetes, published data suggest that glycemic control can be achieved as effectively with an inhaled insulin regimen (preprandial inhaled intrapulmonary insulin plus a single bedtime Ultralente injection) as with a conventional subcutaneous insulin regimen involving 2 to 3 injections...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Cappelleri JC,Cefalu WT,Rosenstock J,Kourides IA,Gerber RA

    更新日期:2002-04-01 00:00:00

  • Rofecoxib 50 mg and valdecoxib 20 or 40 mg in adults and adolescents with postoperative pain after third molar extraction: results of two randomized, double-blind, placebo-controlled, single-dose studies.

    abstract:OBJECTIVE:These studies assessed the comparative efficacy of rofecoxib and valdecoxib in the treatment of acute postoperative dental pain. METHODS:Two randomized, double-blind, placebo-controlled, single-dose studies were conducted in patients undergoing extraction of > or =2 third molars, with > or =1 mandibular impa...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Daniels SE,Desjardins PJ,Bird SR,Smugar SS,Tershakovec AM

    更新日期:2006-07-01 00:00:00

  • Effect of combined systemic and local morpholino treatment on the spinal muscular atrophy Δ7 mouse model phenotype.

    abstract:BACKGROUND:Spinal muscular atrophy (SMA) is a fatal motor neuron disease of childhood that is caused by mutations in the SMN1 gene. Currently, no effective treatment is available. One possible therapeutic approach is the use of antisense oligos (ASOs) to redirect the splicing of the paralogous gene SMN2, thus increasin...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Nizzardo M,Simone C,Salani S,Ruepp MD,Rizzo F,Ruggieri M,Zanetta C,Brajkovic S,Moulton HM,Müehlemann O,Bresolin N,Comi GP,Corti S

    更新日期:2014-03-01 00:00:00

  • Comparison of the Pharmacokinetics of the Phase II and Phase III Capsule Formulations of Selumetinib and the Effects of Food on Exposure: Results From Two Randomized Crossover Trials in Healthy Male Subjects.

    abstract:PURPOSE:Selumetinib (AZD6244, ARRY-142886), an oral, potent, and highly selective mitogen-activated protein kinase 1/2 inhibitor with a short half-life, has shown activity across various tumor types. Before initiation of Phase III trials, the site, scale, and color (hypromellose shell from white [Phase II] to blue [Pha...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Tomkinson H,McBride E,Martin P,Lisbon E,Dymond AW,Cantarini M,So K,Holt D

    更新日期:2017-11-01 00:00:00

  • Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.

    abstract::A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs an...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Carey JL,Nader N,Chai PR,Carreiro S,Griswold MK,Boyle KL

    更新日期:2017-01-01 00:00:00

  • Impact of palivizumab on expected costs of respiratory syncytial virus infection in preterm infants: potential for savings.

    abstract::In its clinical assessment of the respiratory syncytial virus (RSV)-specific monoclonal antibody palivizumab, the IMpact-RSV Study Group demonstrated a reduction in hospitalizations for RSV-related lower respiratory tract infection in infants who received prophylaxis compared with infants who did not receive prophylax...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Marchetti A,Lau H,Magar R,Wang L,Devercelli G

    更新日期:1999-04-01 00:00:00

  • Type 2 Diabetes, Hypoglycemia, and Basal Insulins: Ongoing Challenges.

    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


    authors: Blumer I,Clement M

    更新日期:2017-08-01 00:00:00

  • Antiemetic treatment with oral granisetron in patients receiving moderately emetogenic chemotherapy: a dose-ranging study.

    abstract::The antiemetic efficacy and tolerability of four different oral doses of granisetron (0.25, 0.5, 1, and 2 mg twice daily [BID]) were compared in a randomized, double-blind, parallel-group, multicenter study involving 930 patients with malignant disease receiving moderately emetogenic chemotherapy over a 7- or 14-day p...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: Bleiberg HH,Spielmann M,Falkson G,Romain D

    更新日期:1995-01-01 00:00:00

  • Pharmacokinetic Interaction Between Rosuvastatin, Telmisartan, and Amlodipine in Healthy Male Korean Subjects: A Randomized, Open-label, Multiple-dose, 2-period Crossover Study.

    abstract:PURPOSE:Rosuvastatin, a hydroxy methylglutaryl coenzyme A reductase inhibitor; telmisartan, an angiotensin receptor blocker; and amlodipine, a calcium channel inhibitor, are commonly prescribed together for the treatment of hypertension nonresponsive to monotherapy and accompanied by dyslipidemia. However, the pharmaco...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Son M,Guk J,Kim Y,Woo Chae D,Heo YA,Soh D,Park K

    更新日期:2016-08-01 00:00:00

  • Tapentadol hydrochloride: a centrally acting oral analgesic.

    abstract:BACKGROUND:Tapentadol hydrochloride is a centrally acting oral analgesic approved by the US Food and Drug Administration in November 2008 for the treatment of moderate to severe acute pain. It is available as immediate-release 50-, 75-, and 100-mg tablets. OBJECTIVE:The purpose of this article is to review animal stud...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Wade WE,Spruill WJ

    更新日期:2009-12-01 00:00:00

  • Outcomes research in oncology: improving patients' experiences with cancer treatment.

    abstract::Outcomes research in oncology is a relatively young field, but its potential for expanding our understanding of patients' experiences with cancer gives it increasing relevance to clinical oncology research. We provide a brief overview of the growing prevalence of oncology outcomes research, and we discuss some of the ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Schulman KA,Seils DM

    更新日期:2003-02-01 00:00:00

  • An examination of the effect of cytochrome P450 drug interactions of hydroxymethylglutaryl-coenzyme A reductase inhibitors on health care utilization: a Canadian population-based study.

    abstract:BACKGROUND:Cytochrome P450-related drug interactions can lead to adverse effects that may affect health care resource utilization. OBJECTIVE:The purpose of this study was to quantify the impact of drug interactions involving hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) on health care resource utiliz...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Einarson TR,Metge CJ,Iskedjian M,Mukherjee J

    更新日期:2002-12-01 00:00:00

  • A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit/Hyperactivity Disorder in School-age Children.

    abstract:PURPOSE:The limitations of current US Food and Drug Administration (FDA)-approved medications for the treatment of attention-deficit/hyperactivity disorder (ADHD) set the need for the development of novel, effective, and tolerable medications to treat this disorder. The purpose of this study was to evaluate whether tre...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Nasser A,Liranso T,Adewole T,Fry N,Hull JT,Chowdhry F,Busse GD,Cutler AJ,Jones NJ,Findling RL,Schwabe S

    更新日期:2020-08-01 00:00:00

  • Clinical Outcome and Antimicrobial Therapeutic Drug Monitoring for the Treatment of Infections in Acute Burn Patients.

    abstract:PURPOSE:In critical burn patients, the pharmacokinetic parameters (absorption, distribution, metabolism, and excretion) of many classes of drugs, including antibiotics, are altered. The aim of this study was to compare 2 groups of burn patients undergoing treatment for health care-associated infections with and without...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Machado AS,Oliveira MS,Sanches C,Silva Junior CVD,Gomez DS,Gemperli R,Santos SRCJ,Levin AS

    更新日期:2017-08-01 00:00:00

  • A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia.

    abstract:PURPOSE:The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia. METHODS:A randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertens...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Lee HY,Kim SY,Choi KJ,Yoo BS,Cha DH,Jung HO,Ryu DR,Choi JH,Lee KJ,Park TH,Oh JH,Kim SM,Choi JY,Kim KH,Shim J,Kim WS,Choi SW,Park DG,Song PS,Hong TJ,Rhee MY,Rha SW,Park SW

    更新日期:2017-12-01 00:00:00

  • Relative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol in a 1-year, population-based, matched cohort study of patients with chronic obstructive pulmonary disease (COPD): Effect on COPD-related exacerbations, emergency depart

    abstract:BACKGROUND:According to evidence-based guidelines, the combination of inhaled corticosteroids and inhaled long-acting beta(2)-agonists in a single inhaler is recommended for patients with chronic obstructive pulmonary disease (COPD) who are experiencing exacerbations. The relative effectiveness of combination products ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Blais L,Forget A,Ramachandran S

    更新日期:2010-07-01 00:00:00

  • A Phase I Study to Show the Relative Bioavailability and Bioequivalence of Fixed-Dose Combinations of Ambrisentan and Tadalafil in Healthy Subjects.

    abstract:PURPOSE:Pulmonary arterial hypertension (PAH) is a life-threatening disease that typically causes shortness of breath and exercise intolerance. Combination therapy with ambrisentan and tadalafil has proven to be more effective at preventing clinical failure events in patients with PAH than either drug alone. The aim of...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Okour M,Puri A,Chen G,Port K,Berni A,Khindri S,Schneider I,Tenero D

    更新日期:2019-06-01 00:00:00

  • Treatment of vaginal candidiasis in pregnant women.

    abstract::Pregnancy creates a climate favorable to the growth of Candida albicans, and this yeast often is difficult to eradicate in pregnant women. Miconazole nitrate administered intravaginally has been found to achieve comparable therapeutic and mycological cure rates in both pregnant and nonpregnant women. A number of clini...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Weisberg M

    更新日期:1986-01-01 00:00:00

  • Fluoxetine tenth anniversary update: the progress continues.

    abstract::This tenth anniversary review/update of fluoxetine concentrates on the past 5 years of its clinical application. The mechanism of action of fluoxetine; its metabolism; its efficacy in patients with various diagnostic subgroups of depression, patients with coincident medical disease, children and adolescents with depre...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Stokes PE,Holtz A

    更新日期:1997-09-01 00:00:00

  • The role of losartan in the management of patients with heart failure.

    abstract:BACKGROUND:Heart failure places a burden on patients and health care systems worldwide. Although the advent of angiotensin-converting enzyme (ACE) inhibitors markedly improved management of this chronic disorder, treatment is still not optimal, and morbidity and mortality remain high. OBJECTIVE:This review summarizes ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析,评审


    authors: Dickstein K

    更新日期:2001-09-01 00:00:00

  • Efficacy of long-term treatment with nipradilol, a nitroester-containing beta-blocker, in patients with mild-to-moderate essential hypertension.

    abstract::The effects of long-term treatment with nipradilol, a nitroester-containing beta-blocker, on casual and 24-hour blood pressures were studied in 70 patients with mild-to-moderate essential hypertension. Antihypertensive effects of nipradilol on casual blood pressure were observed in 68% of patients. Nipradilol reduced ...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章


    authors: Haneda T,Ogawa Y,Akaishi T,Takeda H,Tanazawa S,Inoue H,Ohki Y,Kato J,Morimoto H,Kanaya K

    更新日期:1995-07-01 00:00:00

  • Development of Novel Pharmaceutical Agents for Alzheimer's Disease: The Impact of Regulatory Initiatives in Japan and the United States.

    abstract:PURPOSE:The incidence of Alzheimer's disease (AD) has been steadily increasing worldwide. AD is a serious disease that has both societal and economic impacts. The greatest risk factor for AD is aging. Thus, because of the rapidly aging population in Japan, the development of new, effective drugs for AD is urgently need...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Tsukamoto K

    更新日期:2015-08-01 00:00:00

  • Intrinsic and extrinsic factors affecting patient engagement in diabetes self-management: perspectives of a certified diabetes educator.

    abstract::Patients with diabetes are responsible for the vast majority of management requirements of their condition. However, their ability and motivation to engage in required self-management behaviors may be mitigated by multiple intrinsic and extrinsic factors. Intrinsic barriers include attitudes and health beliefs, limite...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Rodriguez KM

    更新日期:2013-02-01 00:00:00

  • Real-time Assessment of the Development and Function of the Placenta Across Gestation to Support Therapeutics in Pregnancy.

    abstract::The placenta is vital to the health and development of the fetus, serving to deliver oxygen and nutrients, facilitate the removal of waste products, and provide a barrier to pathogens and other harmful substances present in the maternal circulation. When these processes fail to operate normally, they can lead to compl...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Weinberg DH

    更新日期:2020-11-24 00:00:00

  • Nisoldipine versus isosorbide dinitrate in coronary heart disease: results of a double-masked study.

    abstract::The efficacy and tolerability of a twice-daily dose of 5 mg of nisoldipine versus 40 mg of sustained-release isosorbide dinitrate (ISDN) were compared in a randomized, double-masked study in 91 patients. During the 21-day treatment period, the mean time taken during bicycle ergometry to the appearance of an ST segment...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Heublein B,Amende I,Blanke PM,Baunack-Frost AR,Breuer HW

    更新日期:1996-05-01 00:00:00