Abstract:
STUDY OBJECTIVE:A safe alternative to erythropoiesis-stimulating agents to treat anemia is warranted in patients with cancer and anemia; thus the objective of this trial was to compare the efficacy and safety of intravenous (IV) iron isomaltoside with oral iron in patients with cancer and anemia by testing the noninferiority of IV versus oral iron. DESIGN:Phase III, prospective, open-label, comparative, randomized, noninferiority, multicenter trial. SETTING:Forty-seven hospitals or private cancer clinics in Asia, the United States, and Europe. PATIENTS:A total of 350 patients with cancer and anemia. INTERVENTION:Patients were randomized in a 2:1 ratio to either intravenous iron isomaltoside or oral iron sulfate. Patients in the iron isomaltoside group were then randomized into an infusion subgroup (single intravenous infusions of a maximum dose of 1000 mg over 15 min) or a bolus injection subgroup (bolus injections of 500 mg over 2 min). MEASUREMENTS AND MAIN RESULTS:The primary efficacy outcome was change in hemoglobin concentration from baseline to week 4. Changes in other relevant hematology variables, effect on quality of life, and safety outcomes were also assessed. The primary efficacy outcome was tested for noninferiority, whereas the remaining outcomes were tested for superiority. Iron isomaltoside was noninferior to oral iron in change in hemoglobin concentration from baseline to week 4 (difference estimate 0.016, 95% confidence interval -0.26 to 0.29, p<0.001). A faster onset of the hemoglobin response was observed with infusion of iron isomaltoside (superiority test: p=0.03 at week 1), and a sustained effect on hemoglobin level was shown in both the iron isomaltoside and oral iron treatment groups until week 24. A significant mean decrease in fatigue score was observed from baseline to week 12 in the iron isomaltoside group (p<0.001) but not in the oral iron group (p=0.057). A higher proportion of patients treated with oral iron experienced adverse drug reactions (18.8% vs 6.6%, p<0.001) and discontinued the trial due to intolerance (8.0% vs 0.9%, p=0.001). Transient hypophosphatemia (phosphate level less than 2 mg/dl) was reported at similar low frequencies among the groups: 7.1% in the iron isomaltoside infusion subgroup versus 8.5% in the iron isomaltoside bolus injection subgroup versus 5.4% in the oral iron group. CONCLUSION:This trial demonstrated comparable sustained increases in hemoglobin concentration over time with both iron isomaltoside and oral iron. Iron isomaltoside was better tolerated than oral iron, and fatigue was significantly decreased with iron isomaltoside. Low rates of clinically insignificant hypophosphatemia were reported in patients receiving both treatments.
journal_name
Pharmacotherapyjournal_title
Pharmacotherapyauthors
Birgegård G,Henry D,Glaspy J,Chopra R,Thomsen LL,Auerbach Mdoi
10.1002/phar.1729subject
Has Abstractpub_date
2016-04-01 00:00:00pages
402-14issue
4eissn
0277-0008issn
1875-9114journal_volume
36pub_type
杂志文章,多中心研究,随机对照试验相关文献
PHARMACOTHERAPY文献大全abstract:STUDY OBJECTIVES:To compare the antiemetic effectiveness and safety of oral granisetron plus dexamethasone with those of oral ondansetron plus dexamethasone administered before emetogenic chemotherapy. DESIGN:Randomized, prospective, multicenter, open-label study. SETTINGS:University-teaching hospital and veterans he...
journal_title:Pharmacotherapy
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1592/phco.20.17.1318.34894
更新日期:2000-11-01 00:00:00
abstract:STUDY OBJECTIVE:To determine the frequency of medication errors, as well as the severity of harm resulting from these errors, related to the prescription, transcription, preparation, and administration of parenteral nutrition formulations. DESIGN:Prospective, observational study. SETTING:471-bed, academic teaching ho...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.29.8.966
更新日期:2009-08-01 00:00:00
abstract:STUDY OBJECTIVE:To evaluate the disposition of pentoxifylline and its metabolite, lisofylline, in New Zealand rabbits after two alternative routes of administration, intranasal and intratracheal. DESIGN:Pharmacokinetics study in an animal model. SETTING:University-affiliated animal care facility. SUBJECTS:Twenty New...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.27.2.200
更新日期:2007-02-01 00:00:00
abstract::This article on pharmacoepidemiology, the second of two parts, is a more focused discussion of the methodology of cohort studies and case-control studies, the basic methodologies of which were discussed in part I. The nested case-control study incorporates the strengths of both the cohort and case-control studies but ...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.24.13.1105.38083
更新日期:2004-09-01 00:00:00
abstract::We evaluated the efficacy and tolerability of amphotericin B triglyceride emulsion in 16 patients with acquired immunodeficiency syndrome-related candidal esophagitis and cryptococcosis, compared with standard amphotericin B in 24 patients. Compared with the conventional formulation, the fat emulsion was administered ...
journal_title:Pharmacotherapy
pub_type: 临床试验,杂志文章
doi:
更新日期:1998-09-01 00:00:00
abstract::Concerns about cross-allergenicity between sulfonamide antibiotics and nonantibiotic, sulfonamide-containing drugs persist and can complicate patients' drug therapy unnecessarily. No interaction between the human immune system and the sulfonamide functional group has been demonstrated. The immunologic determinant of t...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.24.9.856.36106
更新日期:2004-07-01 00:00:00
abstract::We conducted an extensive literature review to evaluate the appropriate use, route, and dose of vitamin K to reverse excessive anticoagulation. Issues such as sample size, study design, different patient populations, and various study end points confounded results. Of 18 studies published, 8 enrolled 229 patients to e...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.19.18.1415.30896
更新日期:1999-12-01 00:00:00
abstract::A hiccup is a myoclonic jerk of the diaphragm, and cases of hiccups may last for more than 48 hours (persistent hiccups) or even more than 2 months (intractable hiccups). Current pharmacologic treatment of persistent or intractable hiccups mainly includes antidopaminergic drugs. We describe the case of a 60-year-old m...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1002/phar.1523
更新日期:2014-12-01 00:00:00
abstract::We conducted a meta-analysis to determine what factors in treatment regimens for Helicobacter pylori are associated with increased discontinuation rates. Studies were selected from the 1990-1996 MEDLINE data base, and references in published articles and reviews were obtained. Each article was uniformally abstracted f...
journal_title:Pharmacotherapy
pub_type: 杂志文章,meta分析
doi:10.1592/phco.19.4.324.30939
更新日期:1999-03-01 00:00:00
abstract::Prostaglandins have been shown to relax the smooth muscle of the ductus arteriosus in the fetus in utero. This physiologic action has been applied to the management of newborn infants with certain types of congenital malformations. Infants with lesions producing right ventricular outflow obstruction have a compromised...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1002/j.1875-9114.1982.tb04522.x
更新日期:1982-05-01 00:00:00
abstract::Staphylococcus aureus (S. aureus) has proven to be a major pathogen with the emergence of methicillin-resistant S. aureus (MRSA) infections and recently with heteroresistant vancomycin-intermediate S. aureus (hVISA) and vancomycin-intermediate S. aureus (VISA) infections. Although vancomycin is traditionally a first-l...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1002/phar.1577
更新日期:2015-04-01 00:00:00
abstract::Information on amphotericin B use patterns and infusion-related adverse events were prospectively collected from 397 hospitalized adults. The methods of initiating amphotericin B varied greatly, with the majority of patients being gradually titrated to a full maintenance dose over 1-5 days. Overall, 71% of patients ex...
journal_title:Pharmacotherapy
pub_type: 临床试验,杂志文章,多中心研究,评审
doi:
更新日期:1990-01-01 00:00:00
abstract:STUDY OBJECTIVE:To categorize institutional review board (IRB) challenges and solutions encountered in a multicenter practice-based research network (PBRN) study and to assess the impact of IRB requirements on the willingness of individual principal investigators (PIs) to participate in future PBRN studies. DESIGN:Des...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1002/phar.1276
更新日期:2013-09-01 00:00:00
abstract:STUDY OBJECTIVE:To evaluate the clinical course and long-term impact of high-dose acyclovir (HD-A, 800 mg 4 times/day) cytomegalovirus (CMV) prophylaxis failure in a CMV-seropositive abdominal solid organ transplant population. DESIGN:Retrospective cohort study. SETTING:Tertiary academic medical center. PATIENTS:A t...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1002/phar.2126
更新日期:2018-07-01 00:00:00
abstract:STUDY OBJECTIVE:To determine the usage patterns of the lipid-based amphotericin B formulations at our institution and to compare the observed nephrotoxicity and efficacy of these formulations. DESIGN:Prospective and retrospective observational study SETTING:Urban 350-bed teaching hospital. PATIENTS:Sixty-seven nonhe...
journal_title:Pharmacotherapy
pub_type: 临床试验,杂志文章
doi:10.1592/phco.21.13.1107.34613
更新日期:2001-09-01 00:00:00
abstract::Erectile dysfunction, a problem estimated to affect up to 30 million American men, is associated with a number of systemic illnesses and drugs. Age is not thought to be an independent risk factor for the disorder, but accompanying illnesses and their treatments may contribute to its onset. Newer classes of antihyperte...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.19.8.573.31526
更新日期:1999-05-01 00:00:00
abstract::Antimicrobial resistance among gram-positive organisms such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) continues to limit therapeutic options. The oxazolidinones are a synthetic class of agents now commonly relied on for the treatment of serious MRSA and VRE infect...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1002/phar.1491
更新日期:2014-11-01 00:00:00
abstract::A man anticoagulated with warfarin 57.5 mg/week (international normalized ratio [INR] 1.94) was diagnosed with nonsmall cell lung cancer and prescribed weekly gemcitabine. With the first dose of the first cycle, his INR rose to 3.52, and his weekly warfarin dose was decreased to 52.5 mg. The lower warfarin dose was co...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.19.16.1331.30873
更新日期:1999-11-01 00:00:00
abstract::Aztreonam is the first monobactam available for use in this country. A parenteral antibiotic, its antibacterial spectrum is limited to gram-negative aerobic pathogens. The drug's pharmacologic, pharmacokinetic, and toxicologic properties are reviewed. Based on early experience in pediatric patients, certain recommenda...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:
更新日期:1991-01-01 00:00:00
abstract::Status epilepticus (SE) has a high mortality rate and is one of the most common neurologic emergencies. Fast progression of this neurologic emergency and lack of response to traditional antiepileptic drugs (AEDs) in most cases has challenged clinicians to use new agents. This article evaluates the efficacy and safety ...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1002/phar.2229
更新日期:2019-03-01 00:00:00
abstract::Rituximab has been approved by the United States Food and Drug Administration in combination with methotrexate for the treatment of rheumatoid arthritis in patients who failed to achieve adequate benefit from tumor necrosis factor-alpha inhibitors. Rituximab is a biologic agent that depletes peripheral B cells--an act...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.27.12.1702
更新日期:2007-12-01 00:00:00
abstract:BACKGROUND:Infections with adenoviruses (ADVs) can result in considerable mortality and morbidity in solid organ transplant (SOT) recipients. Standard therapy for ADV infections in transplant recipients is not established. At our institution, intravenous cidofovir and immunoglobulin have been used to treat disseminated...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1002/phar.2194
更新日期:2018-12-01 00:00:00
abstract::Although studies have shown that patients can distinguish probable adverse drug reactions (ADRs) from adverse clinical events (ACEs) caused by other factors, it is not known whether these attribution judgments add any independent validity to other accepted methods of identifying ADRs, such as physician assessments or ...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:
更新日期:1994-03-01 00:00:00
abstract::Hormonal emergency contraceptives have been used to prevent unwanted pregnancy for more than 3 decades. The mechanisms of action of the regimen containing a combination of estrogen and progestin, known as the Yuzpe regimen, and those of the levonorgestrel regimen continue to be controversial, especially over the possi...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.30.2.158
更新日期:2010-02-01 00:00:00
abstract::Pharmacists are uniquely qualified to play essential roles in the clinical implementation of pharmacogenomics. However, specific responsibilities and resources needed for these roles have not been defined. We describe roles for pharmacists that emerged in the clinical implementation of genotype-guided clopidogrel ther...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1002/phar.1481
更新日期:2014-10-01 00:00:00
abstract:STUDY OBJECTIVE:To determine clinical and microbiologic success in patients receiving adjunctive aerosolized antibiotics for the treatment of ventilator-associated pneumonia (VAP). DESIGN:Retrospective medical record review. SETTING:Level I trauma intensive care unit of a large academic medical center. PATIENTS:Fort...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.29.9.1054
更新日期:2009-09-01 00:00:00
abstract:STUDY OBJECTIVE:To compare the absorption profile of cyclosporine after preprandial administration with that after postprandial administration, and to determine which administration time resulted in a more stable absorption profile and the timing of the drug concentration that was the most reliable marker for monitorin...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.25.1.52.55617
更新日期:2005-01-01 00:00:00
abstract::Infantile spasms describe a pediatric epilepsy syndrome characterized by frequent clusters of brief symmetric muscle contractions; the condition is often associated with developmental delay. When infantile spasms are accompanied by hypsarrhythmia on electroencephalogram, the condition is labeled West syndrome. The mai...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.31.3.298
更新日期:2011-03-01 00:00:00
abstract:OBJECTIVE:Assess the effects of linezolid on hematologic outcomes in newly diagnosed patients with acute myeloid leukemia (AML) following induction chemotherapy. DESIGN:Single-center, retrospective, observational, cohort study. SETTING:Large, tertiary care academic medical center. PATIENTS:A total of 225 patients ≥ ...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1002/phar.1824
更新日期:2016-10-01 00:00:00
abstract:OBJECTIVES:To identify the impact of penicillin versus alternative β-lactams on clinical outcomes in patients with penicillin-susceptible Staphylococcus aureus (PSSA) bacteremia. DESIGN:Retrospective cohort study. SETTING:Academic medical center. PATIENTS:Adult patients with PSSA bacteremia treated with a β-lactam a...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1002/phar.2124
更新日期:2018-07-01 00:00:00