Abstract:
PURPOSE:Intensive blood pressure (BP) lowering is important for the treatment of hypertension; however, it has been a challenge to achieve target BP in many patients. The purpose of this study was to explore the optimal dosage of a fixed-dose combination of candesartan cilexetil (CAN) and amlodipine besylate (AML), by examining the tolerability and efficacy of CAN/AML combination therapy compared with those of monotherapy with either drug in patients with essential hypertension. METHODS:This Phase II multicenter, randomized, double-blind clinical trial enrolled patients aged 19 years or older with essential hypertension, defined as a mean sitting diastolic BP (msDBP) between 95 and 115 mm Hg, and a mean sitting systolic BP (msSBP) of <200 mm Hg after a 2-week placebo run-in period. A total of 635 patients were screened, of whom 439 were randomized to receive treatment; 425 patients were included in the full analysis set (combination therapy, 212; monotherapy, 213). Participants were randomly assigned to receive 1 of 8 treatments: CAN (8 or 16 mg), AML (5 or 10 mg), CAN/AML (8 mg/5 mg, 8 mg/10 mg, 16 mg/5 mg, or 16 mg/10 mg), once daily for 8 weeks. FINDINGS:After 8 weeks of treatment, changes in msDBP were significantly greater in the groups receiving CAN/AML combination therapies compared with monotherapies at matched doses, with the exception of CAN 8 mg/AML 10 mg versus AML 10 mg. The response to treatment and the achievement of target BP (both msSBP and msDBP) at week 8 were significantly greater overall in the groups that received combination therapy versus monotherapy. All medications were relatively well tolerated in each group. IMPLICATIONS:Eight-week administration of CAN/AML (8 mg/5 mg, 16 mg/5 mg, and 16 mg/10 mg) resulted in a significantly greater BP reduction than that with CAN or AML monotherapy, and was determined to be well tolerated. ClinicalTrials.gov identifier: NCT02944734.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Sohn IS,Kim CJ,Ahn T,Youn HJ,Jeon HK,Ihm SH,Cho EJ,Chung WB,Chae SC,Kim WS,Nam CW,Park SM,Choi JY,Kim YK,Hong TJ,Lee HY,Cho JH,Shin ES,Yoon JH,Yang TH,Jeong MH,Lee JH,Park JIdoi
10.1016/j.clinthera.2017.06.014subject
Has Abstractpub_date
2017-08-01 00:00:00pages
1628-1638issue
8eissn
0149-2918issn
1879-114Xpii
S0149-2918(17)30767-1journal_volume
39pub_type
杂志文章,多中心研究,随机对照试验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:BACKGROUND:Oral bisphosphonates are well established for the treatment and prevention of postmenopausal osteoporosis; however, they are poorly absorbed from the gastrointestinal (GI) tract and have been associated with GI adverse events. Thus, current dosing guidelines recommend that the patient not eat or lie down for...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(03)90005-1
更新日期:2003-01-01 00:00:00
abstract::Outcomes research in oncology is a relatively young field, but its potential for expanding our understanding of patients' experiences with cancer gives it increasing relevance to clinical oncology research. We provide a brief overview of the growing prevalence of oncology outcomes research, and we discuss some of the ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(03)80103-0
更新日期:2003-02-01 00:00:00
abstract::Twenty-six women (aged 26 to 60) with stress incontinence underwent urodynamic investigation before and after oral administration of 5 mg of midodrine, a new adrenergic agent with alpha-stimulant activity. A significant increase in maximum urethral closing pressure combined with a nonsignificant increase in flow time ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1986-01-01 00:00:00
abstract::The Southern California region Kaiser Permanente Medical Care Program, which serves 2.2 million patients, and the University of Southern California School of Pharmacy have designed and implemented a patient consultation study to determine the cost-effectiveness of three different approaches to providing pharmacist con...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:10.1016/0149-2918(95)80077-8
更新日期:1995-09-01 00:00:00
abstract:BACKGROUND:Therapeutic proteins have revolutionized the treatment of many diseases. In the near future, many more therapeutic proteins are likely to become available for an increasingly wide range of indications. OBJECTIVES:This article reviews the incidence, causes, and consequences of formation of antibodies to ther...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(02)80075-3
更新日期:2002-11-01 00:00:00
abstract::Cefoperazone was evaluated as the therapeutic agent in 64 adults with serious infections. Included were pneumonias, urinary tract infections, septicemia, osteomyelitis, joint infections, and superficial infections. A total of 84 organisms, including many multiantibiotic-resistant strains, were designated as the etiolo...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1982-01-01 00:00:00
abstract:BACKGROUND:Several studies have reported increased health care resource use among hypertensive patients with uncontrolled blood pressure (BP). OBJECTIVE:The purpose of this study was to investigate the relationship between BP control and health care resource use. METHODS:Data were obtained from the Caring for Hyperte...
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(01)80143-0
更新日期:2001-10-01 00:00:00
abstract:BACKGROUND:Prophylaxis with granulocyte colony-stimulating factor reduces the risk for febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy. OBJECTIVE:We estimated the incremental cost-effectiveness of primary prophylaxis (starting in cycle 1 of chemotherapy) with pegfilgrastim versus filgrasti...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2009.05.003
更新日期:2009-05-01 00:00:00
abstract:BACKGROUND:Endotracheal intubation and mechanical ventilation are major components of routine intensive care for very low birth weight newborns and sick full-term newborns. These procedures are associated with physiologic, biochemical, and clinical responses indicating pain and stress in the newborn. Most neonates rece...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.clinthera.2005.06.019
更新日期:2005-06-01 00:00:00
abstract:BACKGROUND:Dipeptidyl peptidase-IV (DPP-IV) inhibitors represent a new class of oral antihyperglycemic agents. Sitagliptin is an orally active and selective DPP-IV inhibitor currently in Phase III development for the treatment of type 2 diabetes mellitus. OBJECTIVE:The aim of this study was to assess the pharmacokinet...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2006.01.015
更新日期:2006-01-01 00:00:00
abstract:PURPOSE:Hypertension occurs in >50% of US nursing home (NH) residents, but it is unclear which antihypertensive classes offer the best balance of benefits and risks in this population. The objectives of this study were to describe the patterns of antihypertensive medication treatment in this population, focusing on thi...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2020.02.016
更新日期:2020-04-01 00:00:00
abstract:BACKGROUND:Patients and physicians consider rapid onset of pain relief and pain freedom among the most important attributes of migraine therapy. OBJECTIVE:This study compared the effectiveness of rizatriptan 10 mg and usual-care oral migraine medications in everyday clinical practice settings. METHODS:This was a mult...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/j.clinthera.2006.06.006
更新日期:2006-06-01 00:00:00
abstract:PURPOSE:Samidorphan (3-carboxamido-4-hydroxy naltrexone) is a novel opioid receptor antagonist that is currently in clinical development. The oral dose pharmacokinetics, safety, and tolerability of samidorphan were evaluated in 2 double-blind, placebo-controlled, randomized studies in healthy adults. METHODS:The first...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2014.10.001
更新日期:2015-02-01 00:00:00
abstract::Recently published guidelines for the treatment of dyspepsia have emphasized the importance of age, Helicobacter pylori infection, and alarm symptoms such as weight loss, anemia, and dysphagia in patient assessment. However, the currently available guidelines were not designed specifically for regions in which the inc...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(98)70002-5
更新日期:1998-01-01 00:00:00
abstract::The long-term tolerability and efficacy of indomethacin were evaluated in a retrospective study of 67 patients with moderate to severe rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis who took the drug daily for periods ranging from three to 20 years. Only patients who had not experienced side effects d...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1986-01-01 00:00:00
abstract:BACKGROUND:Patients' adherence to antiosteoporotic drug therapy is essential to prevent fracture and complications of osteoporosis over the long term. The guidance given in treating osteoporosis can potentially enhance adherence. OBJECTIVE:This study was conducted to compare adherence to osteoporosis regimens by patie...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.05.019
更新日期:2013-07-01 00:00:00
abstract:PURPOSE:Despite significant advances in optimizing drug therapy, heart failure-related mortality and morbidity remain high. There has been great progression with regard to device therapy in heart failure, and device use continues to increase. The aims of this review were to critically re-examine the evidence base and t...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2015.08.012
更新日期:2015-10-01 00:00:00
abstract::It is generally understood that pain experience and opioid abuse have relied on male-dominated models. However, sex and gender play a role in both pain experience and opioid use disorder. Using the previously validated Texas Tech University Health Sciences Center Sex and Gender Specific Health PubMed Advanced Search T...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.12.016
更新日期:2018-02-01 00:00:00
abstract::The objective of this study was to compare the cost of intravenous adenosine and intravenous dipyridamole in positron emission tomography (PET) in patients with coronary artery disease. A retrospective, open-label, case-control, cost-effectiveness analysis was performed in the out-patient nuclear medicine department o...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:10.1016/s0149-2918(97)80141-5
更新日期:1997-05-01 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:Most marketed artificial tears are substitutes for the aqueous layers of the tear film; therefore, frequent instillation of artificial tears is necessary. Newer gel-, cellulose-, and mineral oil-based formulations have been designed to overcome the disadvantages of current aqueous tear substitutes by offerin...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2010.01.024
更新日期:2010-01-01 00:00:00
abstract::This commentary reviews the difficulties in formulating oral products for children. The significance of the fragmentation of the pediatric population in terms of development and ability to ingest different dosage formulations is examined. It is postulated that a flexible formulation, acceptable by all patient groups, ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2014.01.010
更新日期:2014-02-01 00:00:00
abstract::Fourteen patients with serious infections caused by Staphylococcus aureus and other gram-positive bacteria were prospectively treated with chromatographically purified vancomycin in an open-label, nonrandomized study, between December 1986 and June 1987. Five patients were excluded from the evaluation of efficacy. Amo...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1988-01-01 00:00:00
abstract:BACKGROUND:Cytochrome P450-related drug interactions can lead to adverse effects that may affect health care resource utilization. OBJECTIVE:The purpose of this study was to quantify the impact of drug interactions involving hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) on health care resource utiliz...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(02)80102-3
更新日期:2002-12-01 00:00:00
abstract:BACKGROUND:Hypertension usually clusters with other cardiovascular risk factors; however, it has not been reported whether hypertension treatment has an impact on the awareness and treatment of other cardiovascular risk factors such as diabetes mellitus and hypercholesterolemia. OBJECTIVE:To analyze the effect of hype...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2012.05.006
更新日期:2012-07-01 00:00:00
abstract:OBJECTIVES:This study was conducted to estimate the prevalence of antipsychotic polypharmacy among fee-for service state Medicaid beneficiaries initiating antipsychotic drug therapy and to investigate psychiatric and demographic predictors of such polypharmacy. METHODS:This was a retrospective cohort study employing M...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2007.01.002
更新日期:2007-01-01 00:00:00
abstract::The pharmacodynamic parameter that appears to correlate best with a successful therapeutic outcome with beta-lactam antibiotics is the length of time the serum antibiotic concentration remains above the minimum inhibitory concentration (MIC) for the infecting pathogen. By maximizing this parameter, continuous administ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/S0149-2918(00)86736-3
更新日期:1999-11-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to assess obese patients with hypercholesterolemia whom were prescribed a standardized diet, comparing the action of orlistat, fluvastatin, orlistat with fluvastatin, and placebo on anthropometric measurements, blood pressure (BP), and lipid profile. METHODS:This was a 1-year, rando...
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(03)80070-x
更新日期:2003-04-01 00:00:00
abstract:PURPOSE:The aim of this study was to assess the pharmacokinetic (PK) and pharmacodynamic (PD) properties and safety of single and multiple doses of cinacalcet in Chinese healthy volunteers (HVs) for the purposes of a New Drug Application package for the Chinese Food and Drug Administration. METHODS:In this randomized,...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2015.12.015
更新日期:2016-02-01 00:00:00