Abstract:
:Clinical outcomes that measure how patients feel, function, or survive are the most important and relevant outcomes of therapy in clinical trials and in clinical practice. Surrogate end points, which do not directly measure clinical benefit to the patient, may function as substitutes for clinical end points in clinical trials. Such surrogates are attractive as they may allow measurement of outcomes earlier in time or with a smaller sample size than with clinical outcomes. Microbiologic biomarkers, such as culture results at a specific time after start of therapy, or pharmacodynamic analyses of the effect of drugs on organisms often are proposed as surrogate end points in clinical trials of therapies for infectious diseases. However, evaluation of biomarkers as surrogate end points poses distinct challenges, and only a few biomarkers have been useful replacements for clinical end points. Evaluation of biomarkers as potential surrogate end points first requires an understanding of the differences among measurements of the cause of a disease, risk factors for outcome, and measurements of treatment effects. We will discuss the definitions of clinical and surrogate end points and the reasons why surrogate end points may not predict the true clinical benefit of therapies. We will use the example of the biomarker of microbiologic outcomes from tympanocenteses performed during therapy as the sole measure of clinical effectiveness in clinical trials of acute otitis media to illustrate the challenges in evaluating biomarkers as surrogate end points.
journal_name
Pharmacotherapyjournal_title
Pharmacotherapyauthors
Powers JHdoi
10.1592/phco.2005.25.12part2.109Ssubject
Has Abstractpub_date
2005-12-01 00:00:00pages
109S-123Sissue
12 Pt 2eissn
0277-0008issn
1875-9114journal_volume
25pub_type
杂志文章,评审相关文献
PHARMACOTHERAPY文献大全abstract::Methotrexate, administered for treatment of pediatric and adult malignancies, is a direct renal toxin, which can lead to renal dysfunction, decreased methotrexate clearance, elevated methotrexate concentrations, and systemic toxicity. Although plasma methotrexate concentrations have been shown to decline precipitously...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.30.1.111
更新日期:2010-01-01 00:00:00
abstract:STUDY OBJECTIVE:To evaluate the effect of acarbose on glycemic control and glycemic variability, using a continuous glucose-monitoring system, in patients with type 2 diabetes mellitus who were not well controlled on metformin and vildagliptin therapy. DESIGN:Multicenter, randomized, double-blind, placebo-controlled s...
journal_title:Pharmacotherapy
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1002/phar.1648
更新日期:2015-11-01 00:00:00
abstract:STUDY OBJECTIVE:To evaluate claims-related treatment adherence, health care resource utilization, and associated costs of therapy conversion from an insulin vial and syringe to a premixed biphasic insulin analog pen device among privately insured patients with type 2 diabetes mellitus. DESIGN:Retrospective, longitudin...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.27.7.948
更新日期:2007-07-01 00:00:00
abstract::A pharmacist consult service was developed to evaluate the appropriateness of enteral feeding through a permanent ostomy in 24 nonambulatory patients with severe developmental disabilities. Several problems with enteral nutrition were identified. Policies to improve them were instituted, and several educational presen...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:
更新日期:1997-07-01 00:00:00
abstract:STUDY OBJECTIVES:To assess the use and safety of concurrent administration of voriconazole and sirolimus-which is contraindicated-and to determine approaches for appropriately managing patients who receive both drugs. DESIGN:Retrospective medical record review. SETTING:University-affiliated medical center. PATIENTS:...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.28.6.719
更新日期:2008-06-01 00:00:00
abstract::Patients who experienced pain after surgery were administered a single dose of 1 of 3 treatments: acetaminophen 1000 mg, codeine phosphate 60 mg, or a combination of these. Patients rated their pain intensity on ordinal and visual analog scales just prior to medication and at intervals thereafter for up to 5 hours. Th...
journal_title:Pharmacotherapy
pub_type: 临床试验,杂志文章
doi:10.1002/j.1875-9114.1986.tb03462.x
更新日期:1986-05-01 00:00:00
abstract:STUDY OBJECTIVE:To compare clinical and safety outcomes of warfarin therapy before and after implementation of a novel patient self-management (PSM) program in which patients received their venipuncture-derived international normalized ratio (INR) results through a secure online messaging system and adjusted their warf...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1002/phar.1139
更新日期:2012-12-01 00:00:00
abstract::Aspirin has been used for the prevention and treatment of cardiovascular disease (CVD) for several decades. The efficacy of aspirin for secondary prevention of cardiovascular disease is well established, but the clinical benefit of aspirin for primary prevention of CVD is less clear. The primary literature suggests th...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1002/phar.1127
更新日期:2012-11-01 00:00:00
abstract::Telavancin is a once-daily lipoglycopeptide antibiotic structurally derived from vancomycin. It has broad-spectrum activity against gram-positive bacteria, including strains with reduced susceptibility to vancomycin. Telavancin's multifunctional mechanism of action, including inhibition of peptidoglycan synthesis and ...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.28.4.458
更新日期:2008-04-01 00:00:00
abstract::Aortic stenosis (AS) is the most common form of valvular heart disease. A detailed diagnostic workup is necessary to promptly stage and classify disease severity to determine optimal management. Medical therapy and valvuloplasty are options that fail to delay or reverse disease progression. Surgical aortic valve repla...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1002/phar.2056
更新日期:2018-01-01 00:00:00
abstract::Dabigatran, a direct thrombin inhibitor, is an oral anticoagulant indicated for the prevention of stroke in patients with atrial fibrillation (AF) and for the treatment and prevention of deep vein thrombosis and pulmonary embolism. Dabigatran, as well as the other new anticoagulants-rivaroxaban, apixaban, and edoxaban...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1002/phar.1698
更新日期:2016-02-01 00:00:00
abstract::Combination antiretroviral therapy including protease inhibitors such as ritonavir has added significant potency to therapy for human immunodeficiency viral (HIV) infection as well as substantial drug-drug interactions. Methadone metabolism is affected by cytochrome P450 (CYP) 3A4 inhibitors or inducers. Because riton...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.20.1.93.34654
更新日期:2000-01-01 00:00:00
abstract::The primary objective of this study was to determine if a pharmacist-managed anticoagulation monitoring service (AMS) improved the outcomes of patients receiving warfarin in a family practice setting and was cost effective in treating and preventing thromboembolic disorders. A retrospective chart review was performed ...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:
更新日期:1995-11-01 00:00:00
abstract:STUDY OBJECTIVE:To evaluate the safety and efficacy of valganciclovir 450 mg/day for 6 months for cytomegalovirus (CMV) prophylaxis in renal transplant recipients. DESIGN:Single-center, retrospective analysis. SETTING:Urban, academic medical center. PATIENTS:Fifty-eight patients who received de novo renal transplant...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.24.14.1323.43152
更新日期:2004-10-01 00:00:00
abstract:STUDY OBJECTIVES:To determine the incidence of Clostridium difficile infection (CDI) at one community hospital by identifying patients with stool samples positive for C. difficile toxin A or B, and to compare the incidence with a 2008 national estimate; and to determine which patient characteristics and concomitant ant...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.31.7.642
更新日期:2011-07-01 00:00:00
abstract:STUDY OBJECTIVE:To investigate the adverse drug reactions (ADRs) from peginterferon alfa-2b plus ribavirin in patients infected with the hepatitis C virus (HCV). DESIGN:Prospective, observational, pharmacovigilance study. SETTING:Gastroenterology department of a French university hospital. PATIENTS:A cohort of conse...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.24.16.1546.50947
更新日期:2004-11-01 00:00:00
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 noninfer...
journal_title:Pharmacotherapy
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1002/phar.1729
更新日期:2016-04-01 00:00:00
abstract::Opioid-related adverse drug events (ORADEs) can have a significant impact on patient recovery after surgery. This review investigates the impact of two ORADEs, respiratory depression and postoperative ileus (POI), on clinical and economic outcomes. Opioid-induced ventilatory impairment is a potentially serious ORADE t...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1002/j.1875-9114.2012.01178.x
更新日期:2012-09-01 00:00:00
abstract::The U.S. population continues to experience an alarmingly high rate of unintended pregnancies that have an impact on individual families and society alike. Lack of effective contraception accounts for most unintended pregnancies, along with incorrect use of contraceptives. The most common reversible contraceptive meth...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1002/phar.1457
更新日期:2014-09-01 00:00:00
abstract::Fifteen percent of premenopausal women, 10-40% of postmenopausal women, and 10-25% of women receiving systemic hormone therapy experience urogenital atrophy. The most common symptoms are dryness, burning, pruritus, irritation, and dyspareunia. Estrogen loss, drugs, and chemical sensitivities are causes. Estrogen or ho...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.21.5.464.34486
更新日期:2001-04-01 00:00:00
abstract::Highly active antiretroviral therapy (HAART) for human immunodeficiency virus (HIV) has resulted in significant morbidity and mortality reductions. Lifelong antiretroviral therapy must be incorporated into each patient's medical regimen. Patients with HIV may also have simultaneous chronic medical conditions, resultin...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.28.7.945
更新日期:2008-07-01 00:00:00
abstract::Posttransplantation hypertension has been identified as an independent risk factor for chronic allograft dysfunction and loss. Based on available morbidity and mortality data, posttransplantation hypertension must be identified and managed appropriately. During the past decade, calcium channel blockers have been recom...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.23.6.788.32180
更新日期:2003-06-01 00:00:00
abstract::Children warrant access to care from clinical pharmacists trained in pediatrics. The American College of Clinical Pharmacy Pediatrics Practice and Research Network (ACCP Pediatrics PRN) released an opinion paper in 2005 with recommendations for improving the quality and quantity of pediatric pharmacy education in coll...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1002/phar.1246
更新日期:2013-02-01 00:00:00
abstract::Cefepime is a new extended-spectrum cephalosporin with gram-positive and gram-negative coverage including Staphylococcus aureus and Pseudomonas aeruginosa. We evaluated the drug's plasma, peritoneal fluid, and appendix tissue concentrations in patients with a postoperative diagnosis of perforated or gangrenous appendi...
journal_title:Pharmacotherapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1991-01-01 00:00:00
abstract:STUDY OBJECTIVE:To evaluate the pharmacokinetics and use of intravenous human cytomegalovirus immune globulin (CytoGam) in allogeneic bone marrow transplantation (BMT). DESIGN:Prospective, nonrandomized, nonblinded, single-center study. SETTING:University teaching hospital. PATIENTS:Five consecutive patients with he...
journal_title:Pharmacotherapy
pub_type: 杂志文章
doi:10.1592/phco.20.15.1175.34592
更新日期:2000-10-01 00:00:00
abstract::Intravenous unfractionated heparin (UFH) remains an important therapeutic agent, particularly in the inpatient setting, for anticoagulation. Historically, the activated partial thromboplastin time (aPTT) has been the primary laboratory test used to monitor and adjust UFH. The aPTT test has evolved since the 1950s, and...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1002/j.1875-9114.2011.01049.x
更新日期:2012-06-01 00:00:00
abstract::The complexities of oral anticoagulation with warfarin have led to the search for more practical alternative agents. Novel direct factor IIa inhibitors and direct factor Xa inhibitors currently in development can be administered at a fixed dose and do not require routine coagulation monitoring and ongoing dosage adjus...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.31.12.1175
更新日期:2011-12-01 00:00:00
abstract::Mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes (MELAS) syndrome is a rare neurodegenerative disease caused by the decreased ability of cells to produce sufficient energy in the form of adenosine 5'-triphosphate. Although it is one of the most common maternally inherited mitochondrial...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.30.11.1179
更新日期:2010-11-01 00:00:00
abstract::The newer quinolone antibiotics, including levofloxacin, moxifloxacin, and gatifloxacin, offer coverage of the likely pathogens in community-acquired pneumonia (CAP) and have been shown to be safe and effective treatments for CAP. Two of these agents, levofloxacin and gatifloxacin, have pharmacokinetic and antibacteri...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1592/phco.21.10.100s.34534
更新日期:2001-07-01 00:00:00
abstract::Skilled nursing facilities and nursing homes are care settings that offer increasing opportunities for pharmacists to take the lead when addressing the new updated Centers for Medicare and Medicaid Services (CMS) requirements coupled with enhanced quality measures reporting. In addition, the complexity of the medicati...
journal_title:Pharmacotherapy
pub_type: 杂志文章,评审
doi:10.1002/phar.2155
更新日期:2018-08-01 00:00:00