Abstract:
BACKGROUND:In TRITON-TIMI 38, patients with acute coronary syndromes were treated with prasugrel or clopidogrel, with aspirin, for a median of 14.5 (maximum of 15) months. Based on this trial, the EU label for prasugrel recommends treatment for up to 12 months and excludes patients with prior stroke/transient ischemic attack (TIA). Furthermore, the EU label recommends the 10 mg maintenance dose (MD) for patients with body weight ≥60 kg and age <75 years. A lower MD of 5 mg is recommended for those with body weight <60 kg; although generally not recommended, 5 mg can be prescribed to patients ≥75 years after individual risk-benefit evaluation. This paper presents the one-year outcome data for this '10 mg indicated cohort'. METHODS AND RESULTS:From the overall cohort of 13,608 patients in TRITON-TIMI 38, 10,804 fulfilled inclusion criteria for the 10 mg indicated cohort, of whom 22% had a history of diabetes, 73% an index diagnosis of unstable angina/non-ST-segment-elevation myocardial infarction (UA/NSTEMI), and 27% an index diagnosis of ST-segment-elevation myocardial infarction (STEMI). In this cohort at 12 months, those given prasugrel experienced significantly fewer ischemic events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, 7.8% vs 10.5%, hazard ratio (HR) = 0.73, p < 0.001, than those given clopidogrel, with a non-significant increase in non-coronary artery bypass graft (CABG) TIMI major bleeding, 1.7% vs 1.5%, HR = 1.15, p = 0.40; similarly, in the overall cohort these frequencies were 9.4% vs 11.4%, HR = 0.81, p < 0.001, for cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, and 2.2% vs 1.8%, HR = 1.24, p = 0.10, for non-CABG TIMI major bleeding. There was a significant reduction in stent thrombosis in the prasugrel group, with similar mortality rates and no excess of strokes. CONCLUSIONS:Treatment with prasugrel according to EU label recommendations results in a significant 27% and 57% relative risk reduction (absolute risk reductions of 2.7% and 1.2%) in ischemic events and stent thromboses respectively compared with clopidogrel, with a 15% relative risk increase (absolute risk increase of 0.2%) for major bleeds (p = 0.40), and no excess of strokes. LIMITATIONS:Although restricted to 365 days of follow-up, this analysis encapsulates 1366 of 1424 (95.9%) of all primary endpoint events and 244 of 257 (94.9%) of all first non-CABG TIMI major bleeds reported in the pivotal manuscript. Furthermore, the 10 mg indicated cohort was not a pre-specified subgroup in the study protocol, but due to European labeling restrictions, results for all outcomes in this cohort are presented through 12 months.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Wilcox R,Iqbal K,Costigan T,Lopez-Sendon J,Ramos Y,Widimsky Pdoi
10.1185/03007995.2014.944638subject
Has Abstractpub_date
2014-11-01 00:00:00pages
2193-205issue
11eissn
0300-7995issn
1473-4877journal_volume
30pub_type
杂志文章,随机对照试验abstract:OBJECTIVE:The relationship between patient characteristics and posaconazole exposures was evaluated in a population pharmacokinetic (PK) model using trial data from neutropenic patients administered oral posaconazole suspension as antifungal prophylaxis. METHODS:Data were analyzed using nonlinear mixed-effects modelin...
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:10.1185/03007990903485056
更新日期:2010-02-01 00:00:00
abstract:BACKGROUND:Omega-3 fatty acids from fish and fish oils can protect against coronary heart disease (CHD), which is still the most common cause of death in the Western economies. Evidence from epidemiological and case cohort studies indicate that consumpton of fatty fish and omega-3 fatty acids reduces the risk of cardio...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079904x17956
更新日期:2005-01-01 00:00:00
abstract:OBJECTIVE:Generic drugs are identical or bioequivalent versions of the brand name drugs. They are the economic alternative of the costlier brand name drugs. This article presents a general overview of the procedure and regulatory aspects relating to generic drug approval in the US. METHODS:A computerized search was co...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2010.548374
更新日期:2011-03-01 00:00:00
abstract::A long-term follow-up study was carried out in 44 Type II diabetic patients to confirm the lack of effect of gliclazide on body weight as well as its hypoglycaemic efficacy and tolerance. Patients were assessed for up to 51 months. The results showed no overall significant change in body weight, 21 patients gaining we...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998409109552
更新日期:1984-01-01 00:00:00
abstract::A total of 247 patients suffering from rheumatoid arthritis and allied conditions were referred for routine ophthalmological examination with particular reference to ocular rheumatoid involvement. Of these, 197 were already receiving ibuprofen before their first assessment while 50 had a baseline assessment before com...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997609109292
更新日期:1976-01-01 00:00:00
abstract:BACKGROUND:Atrial fibrillation (AF) represents a significant health concern, due to the increased prevalence, morbidity, and mortality. METHODS AND RESULTS:There is a growing body of evidence correlating serum uric acid (SUA) with cardiovascular diseases such as arterial hypertension and AF. CONCLUSION:Thus, a questi...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1378521
更新日期:2017-11-01 00:00:00
abstract:OBJECTIVES:To describe multiple myeloma (MM) treatment patterns and comorbidities over time in the US. RESEARCH DESIGN AND METHODS:Study patients were newly diagnosed with MM (ICD-9-CM 203.0x) between 1 July 2006 and 31 March 2014 and had ≥6 months of data prior to the initial MM diagnosis in MarketScan Research Datab...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2015.1105202
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVE:To investigate whether once daily biphasic insulin aspart 30 (BIAsp 30) is noninferior to once daily insulin glargine (IGlar) among Chinese and Japanese insulin-naïve subjects with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS:This was a 24 week treat-to-target trial (NCT01123980) that include...
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:10.1185/03007995.2013.838155
更新日期:2013-12-01 00:00:00
abstract::A study was carried out in 15 male volunteers to evaluate qualitatively the secretion of growth factors following stimulation by oral amino acids. The results showed that oral administration of a combination of two amino acids (1200 mg 1-lysine plus 1200 mg 1-arginine) provoked a release of pituitary somatotropin and ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998109114287
更新日期:1981-01-01 00:00:00
abstract::A trial was carried out in 30 patients to assess the effectiveness of indanyl carbenicillin in acute or chronic urinary tract infections, many of which were complicated by a pathological urological or medical condition. In all patients, infection was due to a single species of pathogen: E. coli (19), Proteus (6), and ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997609109298
更新日期:1976-01-01 00:00:00
abstract::This commentary critically evaluates the limitations of genetic risk predictions in multifactorial disease, with specific reference to age-related macular degeneration (AMD). AMD is a common blinding disease with 33 million people worldwide experiencing vision impairment. Although gene polymorphism combinations infer ...
journal_title:Current medical research and opinion
pub_type: 社论
doi:10.1185/03007995.2011.603301
更新日期:2011-09-01 00:00:00
abstract::The therapeutic efficacy and tolerability of a new controlled-release 1000 mg tablet of naproxen (naproxen CR) were compared with 200 mg isoxicam in 100 out-patients with osteoarthritis. Medications were administered once daily for 4 weeks in a controlled, randomized, double-blind, parallel trial. Patients were assess...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998809111127
更新日期:1988-01-01 00:00:00
abstract:INTRODUCTION:This subanalysis compared the efficacy of betahistine plus piracetam dual therapy versus betahistine monotherapy using data from OSVaLD, a 3 month, open-label, observational study conducted in 2272 patients with peripheral vestibular vertigo. Of the 1898 patients included in the original efficacy populatio...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2015.1067193
更新日期:2015-11-01 00:00:00
abstract::Elevated serum cholesterol level is a key risk factor for cardiovascular morbidity and mortality. Cerivastatin is a highly effective lipid-lowering agent currently licensed at doses of 0.1, 0.2, 0.3 and 0.4 mg. This was a multicentre, randomised, double-blind, parallel-group study comparing the efficacy and safety of ...
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:10.1185/03007999909114095
更新日期:1999-01-01 00:00:00
abstract::Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia seen in clinical practice and has attracted much attention due to its association with a substantial mortality and morbidity, particularly from stroke, thromboembolism and heart failure. This Editorial Commentary provides a brief overview of the ...
journal_title:Current medical research and opinion
pub_type: 评论,社论
doi:10.1185/03007990902910443
更新日期:2009-05-01 00:00:00
abstract:OBJECTIVE:Painful physical symptoms are common in patients with major depressive disorder (MDD) and can negatively affect patient outcomes. Duloxetine has demonstrated efficacy in treating MDD and other certain painful conditions; this study specifically evaluated patients with both MDD and MDD-associated pain. METHOD...
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:10.1185/03007995.2011.609540
更新日期:2011-10-01 00:00:00
abstract::Filgrastim prophylaxis, both primary and secondary, was rapidly incorporated into clinical practice in the 1990s. When pegfilgrastim became available in 2002, it quickly replaced filgrastim as the colony-stimulating factor (CSF) of choice for prophylaxis. Use of prophylaxis increased markedly in the first decade of th...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2019.1703665
更新日期:2020-03-01 00:00:00
abstract:BACKGROUND:Inadequate treatment by non-specialty primary care physicians (PCPs) has been a concern in improving osteoporosis care. An increase in outpatient visits by older patients seeking osteoporosis care has been reported. But what percentages of these visits are made to PCPs are unknown. We investigated recent tre...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2013.809335
更新日期:2013-08-01 00:00:00
abstract::The efficacy of parenteral mecillinam was evaluated in 105 elderly patients with lower respiratory tract infections or urinary tract infections. Another antibiotic, usually amoxycillin, was given concurrently in cases of respiratory infection. An adequate response was note in 86% of chest infections and in all of the ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998109114254
更新日期:1981-01-01 00:00:00
abstract::Effective management of influenza depends on early recognition of influenza in the community and on rapid diagnosis. Early recognition is achieved by integrated clinical and laboratory based surveillance programmes in representative populations. The recent introduction of 'near patient tests' for influenza provide inc...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079902125000921
更新日期:2002-01-01 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:BACKGROUND:The presence of midline shift on neuroradiologic studies in brain tumor patients represents mass effect from the tumor and surrounding edema. We hypothesized that baseline cerebral edema as measured by midline shift would increase postoperative nausea (PON). We studied the incidence of PON in brain tumor pat...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/03007995.2013.811071
更新日期:2013-09-01 00:00:00
abstract:OBJECTIVE:Most registration studies for new osteoporosis drugs have used a combination of quantitative morphometry (QM) and visual semiquantitative reading (SQ) to define vertebral fractures. However, in the pivotal teriparatide Fracture Prevention Trial (ClinicalTrials.gov Identifier: NCT00670501), vertebral fractures...
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:10.1185/03007990902790993
更新日期:2009-04-01 00:00:00
abstract::An open, parallel-group study was carried out to compare the efficacy and tolerance of a sustained-release capsule formulation of tiaprofenic acid at a dosage of 600 mg once daily with standard 300 mg tiaprofenic acid tablets given twice daily. Four hundred and eighty-five general practice patients with rheumatic dise...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998709112408
更新日期:1987-01-01 00:00:00
abstract:OBJECTIVE:To investigate the effect of selective laser trabeculoplasty (SLT) on the intraocular pressure (IOP) of untreated fellow eyes in patients with open-angle glaucoma. STUDY DESIGN:Retrospective chart review. PATIENTS AND METHODS:Charts of all patients who underwent SLT at the University of Texas Southwestern M...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990902728316
更新日期:2009-03-01 00:00:00
abstract:BACKGROUND:The rising prevalence of nosocomial methicillin-resistant Staphylococcus aureus (MRSA) and the recent emergence of community-associated MRSA are major clinical, public health, and economic challenges. MRSA is a leading cause of nosocomial pneumonia and complicated skin and soft-tissue infections (cSSTI). Van...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990903512057
更新日期:2010-03-01 00:00:00
abstract::Abstract A growing body of evidence suggests that targeting low-density lipoprotein cholesterol is not enough and that a substantial residual risk remains despite aggressive statin treatment, particularly in patients with mixed dyslipidemia. Statin plus fibrate combination results in a more effective control of severa...
journal_title:Current medical research and opinion
pub_type: 评论,社论
doi:10.1185/03007995.2010.505463
更新日期:2010-09-01 00:00:00
abstract:OBJECTIVES:To derive current real-world data on the rates and costs of severe hypoglycemia (SH) for people with type 2 diabetes mellitus (T2D) who have initiated basal insulin therapy and to examine differences in SH rates and costs stratified by history of prior SH events. METHODS:We used a nation-wide electronic hea...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2014.936930
更新日期:2014-10-01 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::Faecal blood loss arising from tenoxicam at a dose of 20 mg/day was compared to that arising from piroxicam at a dose of 20 mg/day in a double-blind, parallel comparative study in 12 healthy male volunteers. Faecal blood loss was measured for a 1-week run-in on placebo, during 4 weeks of treatment and for a 2-week pos...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998509109629
更新日期:1985-01-01 00:00:00