Abstract:
OBJECTIVE:Report efficacy findings from three clinical trials (one phase 2 and two phase 3 [OPUS-1, OPUS-2]) of lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease (DED). RESEARCH DESIGN AND METHODS:Three 84-day, randomized, double-masked, placebo-controlled trials. Adults (≥18 years) with DED were randomized (1:1) to lifitegrast 5.0% or matching placebo. Changes from baseline to day 84 in signs and symptoms of DED were analyzed. MAIN OUTCOME MEASURES:Phase 2, pre-specified endpoint: inferior corneal staining score (ICSS; 0-4); OPUS-1, coprimary endpoints: ICSS and visual-related function subscale (0-4 scale); OPUS-2, coprimary endpoints: ICSS and eye dryness score (EDS, VAS; 0-100). RESULTS:Fifty-eight participants were randomized to lifitegrast 5.0% and 58 to placebo in the phase 2 trial; 293 to lifitegrast and 295 to placebo in OPUS-1; 358 to lifitegrast and 360 to placebo in OPUS-2. In participants with mild-to-moderate baseline DED symptomatology, lifitegrast improved ICSS versus placebo in the phase 2 study (treatment effect, 0.35; 95% CI, 0.05-0.65; p = 0.0209) and OPUS-1 (effect, 0.24; 95% CI, 0.10-0.38; p = 0.0007). Among more symptomatic participants (baseline EDS ≥40, recent artificial tear use), lifitegrast improved EDS versus placebo in a post hoc analysis of OPUS-1 (effect, 13.34; 95% CI, 2.35-24.33; nominal p = 0.0178) and in OPUS-2 (effect, 12.61; 95% CI, 8.51-16.70; p < 0.0001). LIMITATIONS:Trials were conducted over 12 weeks; efficacy beyond this period was not assessed. CONCLUSIONS:Across three trials, lifitegrast improved ICSS in participants with mild-to-moderate baseline symptomatology in two studies, and EDS in participants with moderate-to-severe baseline symptomatology in two studies. Based on the overall findings from these trials, lifitegrast shows promise as a new treatment option for signs and symptoms of DED.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Holland EJ,Whitley WO,Sall K,Lane SS,Raychaudhuri A,Zhang SY,Shojaei Adoi
10.1080/03007995.2016.1210107subject
Has Abstractpub_date
2016-10-01 00:00:00pages
1759-1765issue
10eissn
0300-7995issn
1473-4877journal_volume
32pub_type
杂志文章abstract:OBJECTIVE:To compare clinical characteristics, statin treatment patterns and adherence among patients at different risk for coronary heart disease (CHD) as defined by National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guidelines. METHODS:Patients ≥ 18 years old with ≥ 1 claim for dyslipidemi...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2014.971151
更新日期:2014-12-01 00:00:00
abstract::An open study was carried out in 37 patients, with chronic, moderate to severe gastric or bilious reflux associated with hiatus hernia or subsequent to gastro-oesophageal surgery, to assess the effectiveness of an alginate/antacid combination product ('Gastrocote'). The overall success rate of treatment was 81% after ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998009110074
更新日期:1980-01-01 00:00:00
abstract::Objective: Determine healthcare resource utilization (HCRU) and costs associated with fatigue and stiffness among patients with rheumatoid arthritis (RA).Methods: A retrospective claims analysis compared RA patients with fatigue or stiffness to matched RA control patients with neither. Claims from a large US commercia...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2019.1658974
更新日期:2020-01-01 00:00:00
abstract::A study was carried out in 21 patients with Type IIb or Type IV hyperlipoproteinaemia to evaluate the effect of treatment with 600 mg bezafibrate per day over a period of 3 months. The results of the lipid parameters studied showed that there were significant reductions after 1 and 3-months' treatment, respectively, o...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998309112398
更新日期:1983-01-01 00:00:00
abstract:OBJECTIVE:To review the evidence evaluating the efficacy of vardenafil in subgroups of hypertensive patients with erectile dysfunction (ED). METHODS:Meta-analysis of randomized, double-blinded, placebo-controlled, flexible-dose vardenafil clinical trials that were >or=12 weeks in duration evaluated men with a >or=6-mo...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1185/030079907X219616
更新日期:2007-10-01 00:00:00
abstract:MOTIVATION:The American Society of Parenteral and Enteral Nutrition (ASPEN) guidelines advise use of enteral nutrition (EN) for critically ill hospital patients requiring nutritional support, but no studies have comprehensively estimated economic benefits from adherence to this recommendation. METHODS:We systematicall...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析,评审
doi:10.1185/03007995.2010.545816
更新日期:2011-02-01 00:00:00
abstract::Impaired red cell deformability has been found in patients suffering from chronic peripheral vascular disorders, the implication being that microcirculatory blood flow is hindered and tissue hypoxaemia is aggravated. Measurement of erythrocyte deformability by a standard filtration technique for whole blood was carri...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997909109432
更新日期:1979-01-01 00:00:00
abstract::The most common side-effect of statins, mainly during dose titration, is liver toxicity, In these cases, sufficient control of low density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolaemia (HFH) becomes problematical. In patients with intolerance to resins as well, especially...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:
更新日期:2001-01-01 00:00:00
abstract:OBJECTIVE:To review the pharmacoeconomic literature evaluating use of antihistamines in treating allergic rhinitis (AR) in the US. METHODS:Three independent reviewers conducted a comprehensive search of the current literature with PubMed. They identified articles describing original research comprising US cost analyse...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990902875992
更新日期:2009-06-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to compare the efficacy and safety of doses of fentanyl buccal tablet (FBT) proportional to doses of opioids used for background analgesia versus dose titration starting with the minimal dose for the management of breakthrough cancer pain (BTcP). METHODS:A total of 82 cancer patien...
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:10.1185/03007995.2012.683112
更新日期:2012-06-01 00:00:00
abstract::A double-blind, placebo-controlled study was carried out in 231 adult patients suffering from acute diffuse pharyngitis or acute tonsillitis with fever and dysphagia to assess the effectiveness of niflumic acid combined with standard antibiotic therapy in relieving pain and inflammation. Patients were allocated at ran...
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:10.1185/03007999009112689
更新日期:1990-01-01 00:00:00
abstract:OBJECTIVE:To assess the safety, tolerability and pharmacokinetics of an interleukin (IL)-12/23 monoclonal antibody (mAb) in subjects with a relapsing form of multiple sclerosis (MS). METHODS:A phase I, double-blind, placebo-controlled, sequential dose escalation study was conducted in 20 subjects with MS. Subjects 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:10.1185/030079906X120931
更新日期:2006-09-01 00:00:00
abstract:BACKGROUND:Most studies investigating the benefits of statins have focused on North American and European populations. This study focuses on evaluating the lipid-lowering effects of rosuvastatin and atorvastatin in Asian patients. OBJECTIVES:The DIrect Statin COmparison of LDL-C Values: an Evaluation of Rosuvastatin t...
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:10.1185/030079907x242809
更新日期:2007-12-01 00:00:00
abstract:OBJECTIVE:To identify and compare health-economic models that were developed to evaluate the cost-effectiveness of treatments for type 2 diabetes mellitus (T2DM), and their use within Health Technology Assessments (HTAs). METHODS:In total, six commonly used databases were searched for articles published between Octobe...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2015.1102722
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVES:Compare migraine duration with frovatriptan (versus baseline) in migraineurs reporting long- (24-72 h) or short-duration (<24 h) migraines at baseline. METHODS:Post hoc analysis of two postmarketing surveillance studies of migraineurs in German primary care clinics using frovatriptan (2.5 mg) to treat a sin...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2010.503488
更新日期:2010-09-01 00:00:00
abstract::An open multicentre trial was carried out in 13 hypertensive patients, who had responded satisfactorily to and been stabilized on treatment with 400 mg acebutolol daily in divided doses, to assess the effectiveness and tolerance of the same daily dosage given as a single morning dose. On admission, patients were chang...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997709110191
更新日期:1977-01-01 00:00:00
abstract:BACKGROUND:Fibromyalgia (FM) is characterized by persistent and widespread pain and often associated with other symptoms and comorbidities. Thus, FM patients seek care from multiple physician specialties. This study compared prescribing patterns, patient-reported outcomes (PROs), healthcare resource use (HRU), and dire...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2011.553214
更新日期:2011-03-01 00:00:00
abstract:OBJECTIVE:Statin dose, adherence, and cardiovascular (CV) outcomes are important factors when considering switching statin therapies. The objective of the study was to compare CV event rates and risk in managed care patients receiving atorvastatin versus those switched to simvastatin from atorvastatin. METHODS:Patient...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2013.802229
更新日期:2013-07-01 00:00:00
abstract:BACKGROUND:Atrial fibrillation (AF) is the most common arrhythmia in clinical practice and is associated with increased cardiovascular morbidity and mortality. Epicardial adipose tissue (EAT) serves as a biologically active organ with important endocrine and inflammatory function. Review An accumulating body of evidenc...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2018.1462786
更新日期:2018-11-01 00:00:00
abstract:OBJECTIVE:We evaluated the clinical efficacy of sacubitril/valsartan in a group of ambulatory patients with heart failure (HF) with reduced ejection fraction (HFrEF) referred to our HF clinic. METHODS:Patients (n = 29; 72% males; mean age 76 years) with HFrEF in New York Heart Association (NYHA) classes II-III were in...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2019.1576481
更新日期:2019-03-01 00:00:00
abstract:OBJECTIVE:To assess the efficacy of fenofibrate and statin dual therapy versus a double or equivalent dose of statin monotherapy. METHODS:A systematic literature search and meta-analysis was performed for publications before 1 January 2014 in MEDLINE, Embase, and BIOSIS Previews, among others. RESULTS:The difference ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析,评审
doi:10.1185/03007995.2015.1098597
更新日期:2015-12-01 00:00:00
abstract::An open, multi-centre study was carried out in 117 pregnant women presenting with vaginal candidosis to assess the effectiveness of econazole in providing mycological control and symptom relief, and in preventing, as far as possible, the risk of contamination of the newborn: nearly 50% of the patients were in the last...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/03007998509109606
更新日期:1985-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the clinical efficacy and safety of mometasone furoate administered via a dry powder inhaler (MF-DPI) in Japanese patients with intermittent or mild persistent asthma who were not previously receiving inhaled corticosteroids. RESEARCH DESIGN AND METHODS:This was an 8-week open-label study conduct...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990903422380
更新日期:2010-01-01 00:00:00
abstract:OBJECTIVE:Research indicates that insomnia may contribute significantly to healthcare costs; however, information on the effects of treatments on costs has not been thoroughly published. This study presents predictive models that forecast, from the perspective of commercial managed care, the effects of insomnia medicat...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079907X199619
更新日期:2007-06-01 00:00:00
abstract:OBJECTIVE:Thiazide diuretics such as hydrochlorothiazide (HCT) are a widely used first-line treatment for hypertension, but most patients will not achieve blood pressure (BP) control with HCT alone and so will require combination therapy. In this study the efficacy, safety and tolerability of a single-pill combination ...
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:10.1185/03007990902804158
更新日期:2009-04-01 00:00:00
abstract:BACKGROUND:Natalizumab is a highly effective treatment for patients with relapsing-remitting multiple sclerosis (RRMS). Treatment with natalizumab has been associated with progressive multifocal leukoencephalopathy (PML), a rare yet serious disease of the brain. Published studies have quantified the PML risk by the pre...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2013.869492
更新日期:2014-04-01 00:00:00
abstract:OBJECTIVE:Transient ischemic attack (TIA) is a serious condition which should be considered on the same spectrum as other conditions involving brain ischemia. Efficient management of these patients is therefore critical. The aim of this research was to gain insights into 'real-world' global trends of the current manage...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2011.652257
更新日期:2012-03-01 00:00:00
abstract::The effect of spironolactone in the alleviation of the symptoms of the premenstrual syndrome was compared with placebo in a double-blind, parallel group controlled study. One tablet daily of 100 mg spironolactone or placebo was given to 63 women from Day 12 of the menstrual cycle until the first day of the next menstr...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998709112403
更新日期:1987-01-01 00:00:00
abstract:OBJECTIVE:To compare the analgesic efficacy and safety of oxymorphone extended release (ER) and oxycodone controlled release (CR) in patients with moderate to severe cancer pain. RESEARCH DESIGN AND METHODS:This randomized, multicenter, double-blind, 2-period crossover study included adult outpatients (>or= 18 years o...
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:10.1185/030079904125003854
更新日期:2004-06-01 00:00:00
abstract:OBJECTIVES:Due to the high cost of nonvalvular atrial fibrillation (NVAF), this condition may be a suitable candidate for condition-specific bundled payments. This paper evaluates the healthcare cost of NVAF and uses common bleeding and stroke risk scores (HAS-BLED and CHA2DS2-VASc) to explore the risk-based healthcare...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1409200
更新日期:2018-02-01 00:00:00