Abstract:
BACKGROUND:Despite favorable evidence from clinical trials for single-dose palonosetron versus other commercially available 5-HT(3)-receptor antagonists for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV), clinical comparative data are scarce from hospital outpatient settings, where these antiemetic agents are used in patients diagnosed with cancer who are receiving chemotherapy (CTH). OBJECTIVE:The purpose of our retrospective study was to assess the hospital claims to evaluate the rate of uncontrolled CINV with antiemetic prophylaxis using palonosetron versus other 5-HT(3)-receptor antagonists in patients diagnosed with cancer who are receiving CTH (highly emetogenic CTH, moderately emetogenic CTH, low-emetogenic CTH, or minimally emetogenic CTH) treatment in a hospital outpatient setting. METHODS:Patients aged ≥18 years who had cancer and were being treated with CTH and antiemetic prophylaxis with palonosetron (Group 1) and other 5-HT(3) receptor antagonists (Group 2) for the first time between April 1, 2007, and March 31, 2009, were identified using a hospital-service database. Within each CTH cycle, CINV events were identified through International Classification of Diseases (ICD)-9 codes for nausea, vomiting, and/or volume depletion (from Day 1 of each CTH administration until the end of the CTH cycle) or for use of rescue medications (Day 2 until the end of the CTH cycle). A multivariate regression model was developed to predict uncontrolled CINV event rates per CTH cycle between Groups 1 and 2 matched on CTH emetogenicity distribution in the study follow-up period (first of 8 cycles or 6 months). A subgroup analysis of patients on CTH with the highest risk of nausea and vomiting (highly emetogenic CTH or moderately emetogenic CTH) was also conducted. RESULTS:Of 9144 identified patients, 1775 were prescribed palonosetron (Group 1). Group 1 patients were statistically younger (61.2 vs 62.8 years; P < 0.001), composed of more females (57.1% vs 51.9%; P < 0.001) and more whites (72.8% vs 71.4%; all races P < 0.001), received more highly emetogenic CTH treatments (43.3% vs 28.5%; all CTH P < 0.001), and had more lung (26.1% vs 22.4%) and breast cancer patients (19.3% vs 15.3%; all cancer P < 0.001). The regression model predicted a 13.7% decrease in CINV event rate per CTH cycle for Group 1 versus Group 2. For Subgroup 1, the model predicted a 12.5% decrease in the CINV event rate per cycle in Group 1 patients versus those in Group 2. CONCLUSIONS:In this study, patients with cancer who were treated with CTH and on antiemetic prophylaxis using palonosetron were found to have significantly lower CINV event rates than those receiving other 5-HT(3) receptor antagonists.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Balu S,Buchner D,Craver C,Gayle Jdoi
10.1016/j.clinthera.2011.04.009subject
Has Abstractpub_date
2011-04-01 00:00:00pages
443-55issue
4eissn
0149-2918issn
1879-114Xpii
S0149-2918(11)00192-5journal_volume
33pub_type
杂志文章abstract:BACKGROUND:Exenatide is an antidiabctic agent currently indicated as adjunctive therapy with oral agents for the treatment of type 2 diabetes mellitus (T2DM). Limited published data exist on the off-label use of exenatide in conjunction with insulin in the treatment of T2DM. OBJECTIVE:The aim of this retrospective stu...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2009.07.021
更新日期:2009-07-01 00:00:00
abstract:PURPOSE:The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefor...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.07.015
更新日期:2015-09-01 00:00:00
abstract:PURPOSE:Megestrol acetate oral suspension is an appetite stimulant indicated for cachexia. It is available in a conventional formulation and as a nanocrystal dispersion. The aim of this study was to compare the tolerability and pharmacokinetics of these formulations under fed conditions in healthy Korean volunteers. M...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2014.09.022
更新日期:2015-02-01 00:00:00
abstract:BACKGROUND:Mexican Americans, the fastest growing ethnic group in the United States, have a 2- to 3-fold higher prevalence of type 2 diabetes mellitus relative to the non-Hispanic white population. It is estimated that 10% of Mexican Americans >or=20 years of age have diabetes. OBJECTIVE:The goal of this study was to ...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(03)90025-7
更新日期:2003-01-01 00:00:00
abstract:PURPOSE:Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This analysis compared the efficacy and safety of tofacitinib with biologic disease-modifying antirheumatic drugs in patients with RA and a prior inadequate response (IR) to tumor necrosis factor inhibitors (TNFi). ME...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析
doi:10.1016/j.clinthera.2016.11.004
更新日期:2016-12-01 00:00:00
abstract:BACKGROUND:Prostaglandin analogues are effective ocular hypotensive agents and are being used increasingly in the treatment of elevated intraocular pressure (IOP). These agents are typically dosed once daily. OBJECTIVES:A pilot study was conducted to evaluate the duration of travoprost's IOP-lowering efficacy up to 84...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(04)90008-2
更新日期:2004-01-01 00:00:00
abstract::Moxifloxacin (BAY 12-8039) is an investigational 8-methoxy-fluoroquinolone with broad-spectrum gram-positive and gram-negative activity. To determine the absolute bioavailability of moxifloxacin, this open-label, randomized, crossover study compared the pharmacokinetic characteristics of a single 100-mg dose administe...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/S0149-2918(00)88306-X
更新日期:1999-03-01 00:00:00
abstract::The in vitro activity of Ro 09-1428, a new parenteral cephalosporin, was compared with that of other beta-lactams and aminoglycosides in 1230 clinical isolates from 1028 consecutive patients. Using an agar dilution method, the drugs were tested against 625 isolates of Enterobacteriaceae, 68 Pseudomonas aeruginosa, 36 ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1992-07-01 00:00:00
abstract:BACKGROUND:Insulin therapy may eventually be required to maintain glycemic control in many patients with type 2 diabetes mellitus. Premixed insulin analogues offer relatively physiologic and predictable time-action profiles and are available in more convenient delivery systems with finer needles than in the past. They ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2005.07.003
更新日期:2005-08-01 00:00:00
abstract:PURPOSE:Saliva is a reliable, noninvasive, and cost-effective alternative to biomarkers measured in other biological fluids. Within certain populations, saliva sampling may be difficult because of insufficient saliva flow, which may compromise disease diagnosis or research integrity. Methods to improve flow rates (eg, ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.02.015
更新日期:2015-03-01 00:00:00
abstract::The antiemetic efficacy and tolerability of four different oral doses of granisetron (0.25, 0.5, 1, and 2 mg twice daily [BID]) were compared in a randomized, double-blind, parallel-group, multicenter study involving 930 patients with malignant disease receiving moderately emetogenic chemotherapy over a 7- or 14-day p...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/0149-2918(95)80005-0
更新日期:1995-01-01 00:00:00
abstract::Macrolide and beta-lactam antimicrobial agents are frequently used for the treatment of upper and lower respiratory tract infections and skin or skin structure infections. To evaluate the relative in vitro activity of these antimicrobial drugs against organisms commonly involved in these infections, we tested clarithr...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1993-01-01 00:00:00
abstract::The effect of leuprorelin acetate depot on the endocrine system and on lipid metabolism was evaluated in a multicentre, noncomparative study. During the first month of treatment, suppression of serum oestradiol levels to below 20 pg/ml was achieved and luteinising hormone and follicle-stimulating hormone levels were r...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:
更新日期:1992-01-01 00:00:00
abstract:BACKGROUND:Danazol is a synthetic androgen derivative frequently used as prophylaxis in patients with hereditary angioedema (HAE) due to complement-1 esterase inhibitor deficiency. However, danazol has been reported to decrease high-density lipoprotein cholesterol (HDL-C) levels and to adversely affect coagulation para...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2008.12.021
更新日期:2008-12-01 00:00:00
abstract::The acid-neutralizing capacity and sodium content of nine antacid products available in Belgium were evaluated and compared with typical values for Mylanta-II. Liquid and tablets of Mylanta-II have a higher acid-neutralizing capacity per unit dose than do all the other Belgian antacids tested. On a unit dose basis, th...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1984-01-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to test the ability of human insulin 70/30, insulin lispro mixture 75/25 (75% neutral protamine lispro [NPL], 25% insulin lispro), and insulin lispro mixture 50/50 (50% NPL, 50% insulin lispro) to control postprandial glucose (PPG) concentrations in patients with type 2 diabetes mell...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2006.10.017
更新日期:2006-10-01 00:00:00
abstract:BACKGROUND:One approach to treating allergic rhinoconjunctivitis is the concomitant use of an intranasal spray such as fluticasone propionate to alleviate nasal symptoms and a topical or systemic agent to relieve ocular symptoms. It has not yet been determined whether a topical or systemic agent is more effective for t...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(02)80027-3
更新日期:2002-07-01 00:00:00
abstract:BACKGROUND:Many patients and physicians interpret episodic headache in the presence or absence of nasal symptoms as "sinus' headache, while ignoring the possible diagnosis of migraine. OBJECTIVE:The purpose of this study was to assess the efficacy and tolerability of sumatriptan succinate 50-mg tablets in patients wit...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2007.01.012
更新日期:2007-01-01 00:00:00
abstract:PURPOSE:This Phase 1 pharmacokinetic (PK) comparability study in healthy subjects was performed to compare the PK properties and tolerability of single-dose golimumab 100 mg delivered subcutaneously by an autoinjector device or by a standard needle and syringe that had been used for the subcutaneous (SC) delivery of go...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2014.09.012
更新日期:2015-02-01 00:00:00
abstract::Eleven patients suffering from WHO stage II essential arterial hypertension were treated with the combination of labetalol plus chlorthalidone in the reciprocal ratio of 10:1 in the form of once-a-day administration in the morning. The dosage was individualized on the basis of hypotensive response and side effects unt...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1981-01-01 00:00:00
abstract:BACKGROUND:Mirodenafil is a phosphodiesterase type 5 (PDE-5) inhibitor developed for the treatment of erectile dysfunction. Mirodenafil has the possibility of being administered with alcohol. OBJECTIVE:This study assessed the hemodynamic effects and pharmacokinetic properties of mirodenafil administered with alcohol. ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2009.06.008
更新日期:2009-06-01 00:00:00
abstract:BACKGROUND:In this era of evidence-based medicine, clinicians require a comprehensive range of well-designed studies to support prescribing decisions and patient management. In recent years, data from observational studies have become an increasingly important source of evidence because of improvements in observational...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2007.07.004
更新日期:2007-06-01 00:00:00
abstract:BACKGROUND:In 2002, fixed-dose combination therapy (FDCT) with rosiglitazone maleate plus metformin hydrochloride became available for the treatment of type 2 diabetes mellitus (DM-2) in subjects whose disease was uncontrolled on monotherapy with metformin or a thiazolidinedione. FDCT allows a reduced pill burden and a...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2004.12.018
更新日期:2004-12-01 00:00:00
abstract:BACKGROUND:The antiepileptic drug ezogabine (EZG; US adopted name for retigabine [the international nonproprietary name]) reduces neuronal excitability by enhancing potassium channel activity. EZG has been approved as adjunctive treatment for adults with partial-onset seizures. OBJECTIVE:The goal of this study was to ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2012.12.003
更新日期:2013-01-01 00:00:00
abstract::Twenty-four patients with pulmonary infections (7 pneumoniae, 17 exacerbations of chronic bronchitis) were treated with a combination of 250 mg of amoxicillin and 125 mg of clavulanic acid supplemented by 500 mg of amoxicillin every eight hours. All patients showed good clinical, roentgenological, and bacteriological ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1982-01-01 00:00:00
abstract::Nicardipine hydrochloride is the first intravenous dihydropyridine calcium antagonist to become available in the United States. Its chemical structure makes it unique among its drug class and confers clinically useful properties for the treatment of acute cardiovascular conditions, such as ischemia, hypertension, cong...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1988-01-01 00:00:00
abstract:OBJECTIVE:This study was conducted to evaluate data on chemotherapy-associated anemia and thrombocytopenia, and cycle delays in patients with cancer in a community oncology practice. METHODS:Data on adult patients (age > or =18 years) with cancer treated in outpatient oncology clinics throughout the United States betw...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1016/j.clinthera.2009.11.020
更新日期:2009-01-01 00:00:00
abstract:PURPOSE:The contribution of intestinal bacterial strains (gut microbiota) in human metabolism and obesity is being increasingly recognized. The goal of this article was to provide a commentary on the clinical usefulness of these data. METHODS:We performed a review of the currently available articles on PubMed. FINDIN...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2015.03.008
更新日期:2015-06-01 00:00:00
abstract::A 1-year, open-label extension of a 12-week, double-blind clinical trial was conducted to evaluate the long-term safety and efficacy of once-daily therapy with triamcinolone acetonide nasal aerosol (110, 220, or 440 micrograms) in 93 patients with perennial allergic rhinitis. All three doses of triamcinolone acetonide...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1994-03-01 00:00:00
abstract::Community-acquired pneumonia (CAP) is responsible for an average of 4.5 million visits annually to physicians' offices, emergency departments, and outpatient clinics. However, there have been few studies using national data on the costs of treating CAP. Without such data, it is difficult to assess whether new therapie...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(98)80144-6
更新日期:1998-07-01 00:00:00