Abstract:
OBJECTIVE:To perform an open, non-controlled, multiple-dose, international, multicentre, phase III study to evaluate epoetin zeta, a biosimilar epoetin referenced to epoetin alfa, for the treatment of chemotherapy-induced anaemia in patients with cancer. METHODS:Safety, tolerability and efficacy of subcutaneously administered epoetin zeta were assessed in 216 patients with solid tumours or non-myeloid haematological malignancies receiving chemotherapy and at risk of transfusion. RESULTS:A significant (p < 0.0001) increase in mean haemoglobin (Hb) level (1.8 g/dL) was observed between baseline and week 12 (intent-to-treat population); 176/216 (81.5%) patients achieved a response (increase in Hb > or = 1 g/dL or reticulocyte count > or = 40,000 cells/microL) by week 8. Over the treatment period, 231 treatment-emergent adverse events were experienced by 91 patients; 9/216 (4.2%) experienced a clinically significant thrombotic event within the first 12 weeks of epoetin zeta treatment, significantly lower than the assumed 18% baseline incidence (p < 0.0001) based on historical data from epoetin trials. No transfusion was necessary for 175/216 patients (81.0%) and quality of life improved over the study. No patients developed anti-erythropoietin antibodies. Sponsor trial no: CT-830-05-0009. CONCLUSION:This study demonstrates that subcutaneously administered epoetin zeta is well-tolerated and has efficacy in the treatment of anaemia in patients with cancer receiving chemotherapy and at risk of transfusion.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Tzekova V,Mihaylov G,Elezovic I,Koytchev R,Epoetin Zeta Oncology Study Group.doi
10.1185/03007990903050876subject
Has Abstractpub_date
2009-07-01 00:00:00pages
1689-97issue
7eissn
0300-7995issn
1473-4877journal_volume
25pub_type
杂志文章,多中心研究abstract:OBJECTIVE:Several different durable or disposable insulin pen delivery devices are currently available, and newer, improved devices are being introduced. One prefilled insulin device, FlexPen (FP), has recently been improved (known as the Next Generation FlexPen (NGFP) in Europe or the improved FlexPen in the United St...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2010.512447
更新日期:2010-10-01 00:00:00
abstract::Forty-nine patients participated in a randomized double-blind, parallel group comparison of beclomethasone dipropionate aqueous nasal spray with terfenadine tablets in the treatment of hay fever. Symptom scores for nasal and ocular symptoms as well as grass pollen counts were registered daily for at least 1 month. Eva...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998509109635
更新日期:1985-01-01 00:00:00
abstract::A clinical study was carried out to evaluate the usefulness of intravenous lorazepam, given for sedation instead of opiate narcotics or diazepam, in 25 seriously-ill patients being treated in a respiratory and intensive care unit. All but 3 patients were on assisted ventilation. Standard doses of 4 mg lorazepam were g...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997609109320
更新日期:1976-01-01 00:00:00
abstract:OBJECTIVE:A trial was conducted to examine the effects of a timed sequence of hormone supplementation (HS) with oral estradiol (E(2)) and vaginal progesterone (P) following clomiphene citrate (CC) therapy to determine if this regimen can increase pregnancy rates in CC cycles. METHODS:This study was a randomized, open-...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/030079905X48429
更新日期:2005-07-01 00:00:00
abstract:OBJECTIVE:To compare real-world adherence to and persistence with deferasirox film-coated tablets (DFX-FCT) and deferasirox dispersible tablets (DFX-DT) among patients who switched from DFX-DT to DFX-FCT, overall and by disease type (sickle cell disease [SCD], thalassemia, and myelodysplastic syndrome [MDS]). METHODS:...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2018.1470500
更新日期:2018-11-01 00:00:00
abstract:OBJECTIVE:This study was undertaken to assess the long-term outcome of transcatheter arterial chemoembolization (TACE) after radiofrequency ablation (RFA) combined with a combined therapy for Chinese patients with intermediate (stage B) hepatocellular carcinoma (HCC) of single block type, and evaluate the survival rate...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2015.1058249
更新日期:2015-08-01 00:00:00
abstract::Objective To assess the efficacy of a mixed intervention, educational, and reminder calendar of the intake, as a strategy to improve therapeutic adherence with dabigatran in patients with non-valvular atrial fibrillation (NVAF). Methods This was a prospective, longitudinal, multi-center study, carried out in 110 speci...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究
doi:10.1080/03007995.2018.1435519
更新日期:2018-07-01 00:00:00
abstract::Two new benzodiazepines, potassium clorazepate (15 mg. at night), and lorazepam (1 mg. t.d.s.) were compared in 50 patients presenting with anxiety in general practice. The response to treatment was assessed clinically and for patient acceptance. The single-dose regime of potassium clorazepate was significantly better...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997409111880
更新日期:1974-01-01 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:OBJECTIVES:In ST-segment elevation myocardial infarction (STEMI), current guidelines discourage treatment of the non-culprit lesions at the time of the primary intervention. Latest trials have challenged this strategy suggesting benefit of early complete revascularization. We performed a Bayesian multiple treatment net...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2016.1260534
更新日期:2017-03-01 00:00:00
abstract::Anaemia is an important factor in the fatigue experienced by many patients receiving chemotherapy. A recent large-scale, randomised, placebo-controlled trial has shown that treatment with epoetin alfa raises haemoglobin levels, reduces fatigue and improves overall quality of life (QoL). In order to examine the relatio...
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:10.1185/174234305X13798
更新日期:2005-01-01 00:00:00
abstract::Sodium meclofenamate (200 to 400 mg daily) was compared with aspirin (2.4 to 4.8 g daily) for the treatment of rheumatoid arthritis in a 6-month, double-blind, multicentre study. Two groups of patients participated, one receiving stabilized doses of concomitant gold or steroid therapy and one not receiving such therap...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1981-01-01 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:OBJECTIVES:High-sensitivity C-reactive protein (hs-CRP) has been explored for use in predicting cardiovascular risk. The recent Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study found that statin therapy reduced cardiovascular events in those with ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2010.516994
更新日期:2010-10-01 00:00:00
abstract::A randomized study was performed on 24 patients with ankylosing spondylitis to compare the efficacy and tolerability of 20 mg tenoxicam daily with 50 mg diclofenac twice daily. There were 6 withdrawals from the group taking tenoxicam and 4 from the diclofenac group. Depression in 1 patient taking tenoxicam was the onl...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007999009112691
更新日期:1990-01-01 00:00:00
abstract::Using an equilibrium dialysis method, the competition was investigated between tritated-progesterone and a range of synthetic steroids for binding to 20,000 g. supernatants of human uterine endometrium and myometrium. Both types of uterine tissue showed similar patterns of progestogen binding and probably contain sim...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997509113654
更新日期:1975-01-01 00:00:00
abstract:OBJECTIVE:Perioperative pain management is an important aspect of recovery from total knee arthroplasty (TKA) because severe pain can delay ambulation and hospital discharge. The objective of this retrospective sequential cohort study was to determine the impact of local infiltration analgesia using liposome bupivacain...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2016.1205007
更新日期:2016-10-01 00:00:00
abstract::A double-blind crossover study was carried out in 24 patients with rheumatoid arthritis to investigate the relative efficacy of tolmetin (1600 mg/day) and phenylbutazone (400 mg/day). Each drug was given for 4 weeks, preceded by a 2-week wash-out period during which patients received paracetamol alone for pain relief....
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997609112003
更新日期:1976-01-01 00:00:00
abstract:BACKGROUND AND SCOPE:Whether generic drug products are truly therapeutically identical and interchangeable with their innovator counterparts is still a matter of debate. This review discusses the controversies related to the criteria for bioequivalence and therapeutic equivalence. These concerns are illustrated by usin...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990903116867
更新日期:2009-09-01 00:00:00
abstract:OBJECTIVE:Pharmaceutical preparations of human menopausal gonadotrophin (hMG), urine-derived follicle-stimulating hormone (u-FSH) and highly purified u-FSH (u-FSH-HP) have been available since the early 1960s and the mid 1980s and 1990s, respectively. Another commercial preparation of u-FSH-HP, Folyrmon P, was launched...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079905X48410
更新日期:2005-06-01 00:00:00
abstract:OBJECTIVE:To better understand depression's impact on family functioning from the perspectives of patients with major depressive disorder (MDD) and their partners; to develop and test patient and partner versions of a new self-reported measure, the Depression and Family Functioning Scale (DFFS), for use in clinical tri...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2012.658910
更新日期:2012-03-01 00:00:00
abstract:OBJECTIVES:Eltrombopag, an oral, nonpeptide thrombopoietin receptor agonist, has been shown to increase platelet counts in adults with chronic immune thrombocytopenia and chronic hepatitis C. This multicenter phase 2 study assessed the efficacy and safety of eltrombopag in patients receiving first-line carboplatin/pacl...
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:10.1185/03007995.2010.510051
更新日期:2010-10-01 00:00:00
abstract::A 4-weeks' double-blind, crossover study in 30 patients with definite or classical rheumatoid arthritis is reported using 300 mg ketoprofen per day and 150 mg indomethacin per day. Both drugs had similar effects upon the patients' subjective improvement of pain. Objectively, the results also suggest that ketoprofen ma...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997609111999
更新日期:1976-01-01 00:00:00
abstract::In a double-blind investigation in 21 patients undergoing minor plastic surgery the effects of 4 mg lorazepam or a mixture of 20 mg papaveretum/400 mug hyoscine given intramuscularly as premedicants were studied. Lorazepam produced superior preoperative and post-operative anterograde amnesia, with respect to both inci...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997609111993
更新日期:1976-01-01 00:00:00
abstract::A study was carried out to determine the efficacy and long-term safety of dantrolene in treating stroke patients with spasticity limiting rehabilitation. Fifteen of the 18 patients studied experienced reduction in spasticity and clinical improvement after treatment with dantrolene sodium for 6 weeks. Fourteen of these...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998409109576
更新日期:1984-01-01 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::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::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::The potential advantages of eletriptan lie firstly in its lipophilicity reflected as an increased rate of absorption and Tmax compared to sumatriptan. This is manifested in a modest advantage over sumatriptan in terms of speed of onset, 2 h headache response and 2 h pain free. However, eletriptan has not yet been show...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/0300799039117004
更新日期:2001-01-01 00:00:00
abstract:AIM:Non-peer-reviewed manuscripts posted as preprints can be cited in peer-reviewed articles, which has both merits and demerits. International Committee of Medical Journal Editors guidelines mandate authors to declare preprints at the time of manuscript submission. We evaluated the trends in pharma-authored research p...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1853083
更新日期:2020-12-09 00:00:00