Abstract:
:Objective: To evaluate the safety and efficacy of fulranumab as adjunct or monotherapy in patients with knee or hip pain related to moderate-to-severe osteoarthritis.Methods: Osteoarthritic patients (aged ≥18 years) from four phase 3 randomized, double-blind (DB), placebo-controlled studies were randomized to receive placebo, fulranumab 1 mg every 4 weeks (Q4wk), or 3 mg Q4wk in 16-week DB phase, followed by a 52-week post-treatment follow-up phase. Safety assessments included treatment-emergent adverse events (TEAEs), and neurological, sympathetic, and joint-related events of interest. Efficacy assessments included pain and physical function sub-scales of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores.Results: Of 245 patients from the ITT set (median age = 64 years; 62% women), 84 (34%) completed the DB phase; the majority of discontinuations (57%) were due to early study termination. In the DB phase, the incidence of TEAEs in fulranumab 3 mg (57.8%) and 1 mg (56.8%) was similar to placebo (56.8%). Two events adjudicated as joint-related events of interest include rapidly progressive osteoarthritis and fracture of unknown etiology. There were no new neurological TEAEs. Fulranumab showed evidence of efficacy in improving pain and physical function based on WOMAC sub-scale scores. Due to premature study termination, the number of patients enrolled were too small to make any definitive efficacy claims.Conclusions: Treatment with fulranumab was generally tolerated with no new safety signals. Within the limited sample analyzed, fulranumab showed evidence of improvement of pain and function in patients with moderate-to-severe osteoarthritis who had failed prior therapy and were candidates for joint replacement surgery.Clinical trial registration numbers: NCT02336685; NCT02336698; NCT02289716; NCT02301234KEY POINTSFulranumab as adjuvant or monotherapy was well tolerated with no new safety signalsFulranumab demonstrated evidence suggestive of efficacy in osteoarthritic pain of hip and kneeFulranumab demonstrated evidence suggestive of improvement of pain and physical function in osteoarthritis.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Kelly KM,Sanga P,Zaki N,Wang S,Haeussler J,Louie J,Thipphawong Jdoi
10.1080/03007995.2019.1653068subject
Has Abstractpub_date
2019-12-01 00:00:00pages
2117-2127issue
12eissn
0300-7995issn
1473-4877journal_volume
35pub_type
杂志文章,随机对照试验abstract:OBJECTIVE:To analyse the significance of 'onset of effect' on clinical outcome in the treatment of depression and the contribution of individual Montgomery-Asberg Depression Rating Scale (MADRS) items to improvements in the MADRS total score. RESEARCH DESIGN AND METHOD:All five published placebo-controlled clinical st...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1185/030079906X148319
更新日期:2006-11-01 00:00:00
abstract:BACKGROUND:Basal cell carcinoma (BCC) is the most common cancer. Most cases of BCCs are treated with only optimal surgical resection. However, unresectable, locally advanced or metastatic tumors might have potential to progress. In this patient group, there is no standardized treatment approach. Vismodegib is a new sel...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2015.1018988
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND:Insulin resistance alone does not result in the development of type 2 diabetes; progressive dysfunction of pancreatic islet alpha and beta cells, which results in inadequate control of hyperglycemia, must be present for the disease to develop. Because of these defects, meal-stimulated insulin secretion from ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079906x167336
更新日期:2007-04-01 00:00:00
abstract:OBJECTIVE:Modern immunology has been extremely successful in elucidating many features of the immune system, but not in stemming pandemics of non-infectious, immune-related disease associated with industrialized populations. These pandemics involve a broad range of allergic, autoimmune, and inflammatory diseases, poten...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2012.695731
更新日期:2012-07-01 00:00:00
abstract::During the past decades several epidemiological studies have provided a 'portrait' of the potential candidate for cardiovascular disease, introducing many emerging life-style risk factors such as obesity, unhealthy diet, exposure to passive smoking, lack of exercise, psychosocial stress, and depression, as well as ele...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079902125000525
更新日期:2002-01-01 00:00:00
abstract:OBJECTIVE:In this study, we explored the analgesic and antihyperalgesic properties of a synthetic cannabinoid (nabilone) on experimental heat pain in men and women, as well as its effects on descending pain inhibitory systems. RESEARCH DESIGN AND METHODS:A double-blind, placebo controlled, crossover study of nabilone ...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/030079908x280635
更新日期:2008-04-01 00:00:00
abstract:BACKGROUND:The literature on nonfulfillment of prescription medications spans over three decades of work. There is a wide variation in reported nonfulfillment rates, but no previous study has systematically reviewed this literature to explore the reasons behind this variation. OBJECTIVE:The objective of this study was...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990903550586
更新日期:2010-03-01 00:00:00
abstract::In a double-blind study of 102 patients with a mean age of 79 years, zopiclone was compared to flunitrazepam. The patients rated their sleep in a diary. There was no statistically significant difference between the relatively low dose of 5 mg zopiclone and 1 mg flunitrazepam for eleven out of the twelve variables meas...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/03007999509110492
更新日期:1995-01-01 00:00:00
abstract:UNLABELLED:Therapeutic interventions that block the renin-angiotensin-aldosterone system (RAAS) have an important role in slowing the progression of cardiovascular risk actors to established cardiovascular diseases. In recent years, angiotensin receptor blockers (ARBs) have emerged as effective and well-tolerated alter...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079907x210723
更新日期:2007-07-01 00:00:00
abstract:BACKGROUND:Undetected/uncontrolled diabetes is associated with substantial morbidity and mortality and consequent costs. Early detection through screening identifies patients at risk, allowing for earlier treatment initiation. OBJECTIVES:To determine the economic impact of screening for type 2 diabetes (T2DM). DATA S...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2016.1257977
更新日期:2017-02-01 00:00:00
abstract::In a double-blind trial in 26 patients with symptomatic gastro-oesophageal reflux, the alginate/effervescent/antacid compound 'Gaviscon' was compared with antacid containing placebo similarly formulated. Retrosternal pain after meals and at night was significantly reduced whilst patients were taking 'Gaviscon' and the...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997509114793
更新日期:1975-01-01 00:00:00
abstract::Objective: A prior study found that hyaluronic acid (HA) treatment may help reduce pain medication use (such as steroids, non-steroidal anti-inflammatory drugs [NSAIDs] and opioids) among knee osteoarthritis (OA) patients in the real-world setting. This study aims to update the prior study results to include only the ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2019.1596670
更新日期:2019-09-01 00:00:00
abstract::A national survey of psychotherapeutic drug use was carried out in the U.S.A. in 1979. Data were obtained from a probability sample (n = 3161) of adults in the general population, using a clinically-oriented interview lasting an average of 90 minutes. The data provide estimates of the prevalence of using anxiolytic an...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998409109542
更新日期:1984-01-01 00:00:00
abstract:OBJECTIVE:To compare the efficacy and safety of epoetin theta and epoetin beta in anaemic patients with chronic kidney disease, undergoing haemodialysis and previously on stable maintenance therapy with epoetin beta. METHODS:In this multicentre, randomised, controlled, double-blind study 270 haemodialysis patients wer...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007995.2010.511084
更新日期:2010-10-01 00:00:00
abstract:BACKGROUND:In order to reduce individual cardiovascular risk, many patients require life-long lipid-lowering therapy, often as a drug combination approach. We aimed to describe the usage pattern, effectiveness and tolerability of long-term treatment with lipid-lowering agents, with particular focus on an oral combinati...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1185/03007990802381406
更新日期:2008-10-01 00:00:00
abstract:BACKGROUND:In clinical practice, persistence with statin therapy is poor. While little is known about relative persistence to specific statins, previous studies have observed greater persistence in patients who achieve greater degrees of lipid lowering. Identification of statin therapies which improve patient persisten...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990802203279
更新日期:2008-07-01 00:00:00
abstract::A study was carried out in 80 mild to moderately depressed patients seen in general practice to assess the relative effectiveness and tolerance of a single night-time dose compared with the usual divided daily dosage regimen of a chlordiazepoxide (5 mg)/amitriptyline (12.5 mg) combination. Patients were assigned at ra...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998009109490
更新日期:1980-01-01 00:00:00
abstract:BACKGROUND:Tumor necrosis factor (TNF)-α plays a critical role in psoriasis pathogenesis, and several anti-TNF agents have been developed as therapeutic drugs in this indication. SCOPE:To present the preclinical rationale and clinical data for onercept, a novel anti-TNF agent developed for the treatment of moderate-to...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2010.507492
更新日期:2010-10-01 00:00:00
abstract:OBJECTIVES:Many insulin-treated patients with type 2 diabetes (T2D) do not reach hemoglobin A1c (HbA1c) < 7%, but have clinically relevant HbA1c reductions. Using an integrated database (IDB) of 53 insulin lispro clinical trials and a real-world evidence (RWE) database of T2D patients initiating insulin therapy, an exp...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1396968
更新日期:2018-02-01 00:00:00
abstract::Twenty-seven patients with tennis elbow were treated with triamcinolone acetonide (40 mg/ml) injected locally into the tender area without local anaesthetic. Reduction of pain or complete relief was achieved in 1 to 72 hours, although in 9 cases exacerbation of pain occurred before relief was given. The recurrence rat...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998009109477
更新日期:1980-01-01 00:00:00
abstract::An open, multi-centre trial was carried out to assess the efficacy and tolerance of acemetacin in the treatment of patients suffering from various rheumatic diseases. The patients were treated by general practitioners for a maximum period of 6 weeks with a daily dose of 60 mg acemetacin 3-times daily. Assessments were...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/03007998509109654
更新日期:1985-01-01 00:00:00
abstract:OBJECTIVE:Postpartum depression (PPD) is the most common medical complication of childbirth. PPD can be disabling, with potential negative effects on maternal health-related quality-of-life (HRQoL) as well as on children and partners. The objective of this study was to systematically review and summarize recently publi...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2018.1552039
更新日期:2019-03-01 00:00:00
abstract:OBJECTIVE:We sought to evaluate the relationship between different levels of medication possession ratio (MPR) attained and achievement of clinically meaningful reductions in lipid levels. RESEARCH DESIGN AND METHODS:This was a retrospective cohort study of 4691 new statin users from the Department of Veteran Affairs ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2013.766164
更新日期:2013-03-01 00:00:00
abstract:OBJECTIVE:Using a Delphi Consultation process, a group of medical writers established by the European Medical Writers Association (EMWA) set out to determine the current thinking on the problems of ghostwriting in medical publications and what should be done about them. In this context, ghostwriting is where a professi...
journal_title:Current medical research and opinion
pub_type: 指南,杂志文章
doi:10.1185/030079905x25569
更新日期:2005-02-01 00:00:00
abstract::Objectives: Atopic dermatitis (AD) is a chronic, relapsing skin condition, with signs and symptoms that impact patients' lives and are best measured from the patient perspective. Therefore, there is a need for AD-specific questionnaires that are consistent with Food and Drug Administration guidance and best measuremen...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2018.1560222
更新日期:2019-07-01 00:00:00
abstract:OBJECTIVE:Luseogliflozin is a novel sodium glucose cotransporter 2 inhibitor for type 2 diabetes mellitus (T2DM) treatment. An exploratory Phase II study was conducted to assess the efficacy and safety of several doses of luseogliflozin in Japanese T2DM patients. PATIENTS AND METHODS:Japanese T2DM patients aged 20-74 ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007995.2014.901943
更新日期:2014-07-01 00:00:00
abstract::Oxaprozin (4,5-diphenyl-2-oxazolepropionic acid) is a non-steroidal anti-inflammatory drug (NSAID) which is effective in models of inflammation, pain and pyrexia. It is effective and well tolerated in the clinical management of adult rheumatoid arthritis (RA), osteoarthritis (OA), ankylosing spondylitis, soft tissue d...
journal_title:Current medical research and opinion
pub_type: 评论,社论
doi:10.1185/030079904125004420
更新日期:2004-08-01 00:00:00
abstract:OBJECTIVE:To determine whether the efficacy and tolerability of adjunctive lamotrigine differ as a function of whether persons with mental retardation and refractory epilepsy resided in institutions or the community. RESEARCH DESIGN AND METHODS:The analysis was retrospective and employed data from a previously publish...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079906X96281
更新日期:2006-04-01 00:00:00
abstract:OBJECTIVE:The prevalence of non-steroidal anti-inflammatory drug (NSAID) and concurrent gastroprotective agent (GPA) use in the US is not known. As such, the prevalence of GPA use among arthritis patients taking NSAIDs was examined. METHODS:Men and women aged ≥ 40 with self-reported arthritis and members of a web-base...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/03007995.2013.781017
更新日期:2013-05-01 00:00:00
abstract::Adherence to allergen immunotherapy (AIT) is crucial for its efficacy. Subcutaneous AIT requires monthly visits (or more extended in the case of venom immunotherapy), while sublingual AIT is performed with a daily intake of allergen drops. Non-adherence to an AIT schedule and premature discontinuation are common probl...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2018.1552044
更新日期:2019-06-01 00:00:00