Abstract:
PURPOSE:The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia. METHODS:A randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertension and a sitting diastolic blood pressure (SiDBP) of >90 mm Hg and LDL-C levels <250mg/dL were screened. After a 4-week run-in period with therapeutic lifestyle changes and losartan potassium 100mg once daily, patients who met both blood pressure criteria (80 mm Hg ≤ SiDBP < 110 mm Hg) and the LDL-C level criteria (defined in the National Cholesterol Education Program Adult Treatment Panel III cardiovascular risk categories) were randomized to 1 of 3 groups and treated once daily for 8 weeks: losartan potassium 100mg + rosuvastatin 20mg treatment (L/R 100/20) group, amlodipine camsylate 5mg + losartan potassium 100mg treatment (A/L 5/100) group, and amlodipine 5mg+ losartan potassium 100mg + rosuvastatin 20mg (A/L/R 5/100/20) group. The primary efficacy variables were the percent change in LDL-C in the A/L/R 5/100/20 and A/L 5/100 groups and the mean change of SiDBP in the A/L/R 5/100/20 and L/R 100/20 groups after 8 weeks of treatment, relative to baseline values. FINDINGS:A total of 146 patients were enrolled and the demographic characteristics were similar among the 3 treatment groups. After 8 weeks of treatment, the mean (SD) percent change in LDL-C was significantly greater in the A/L/R group than in the A/L group (-48.40% [2.77%] vs -6.70% [3.00%]; P < 0.0001). Moreover, the mean change in SiDBP was significantly greater in the A/L/R group than in the L/R group (-9.75 [0.92] mm Hg vs -1.73 [1.03] mm Hg; P < 0.0001). SiDBP and LDL-C reductions in the A/L/R group were comparable to reductions in the A/L and L/R groups, respectively. Ten adverse events were reported in 7 patients (4.83%), and 1 patient from the A/L group (0.69%) experienced 2 adverse drug reactions (tachycardia and face edema), which were mild and resolved without specific treatment. There were no clinically significant tolerability issues during the treatment period. IMPLICATIONS:Triple combination therapy with amlodipine/losartan/rosuvastatin can be an effective therapeutic strategy in patients with hypertension combined with dyslipidemia. These findings will form the foundation of the future development of a single-pill triple combination. ClinicalTrials.gov identifier: NCT02899455.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Lee HY,Kim SY,Choi KJ,Yoo BS,Cha DH,Jung HO,Ryu DR,Choi JH,Lee KJ,Park TH,Oh JH,Kim SM,Choi JY,Kim KH,Shim J,Kim WS,Choi SW,Park DG,Song PS,Hong TJ,Rhee MY,Rha SW,Park SWdoi
10.1016/j.clinthera.2017.10.013subject
Has Abstractpub_date
2017-12-01 00:00:00pages
2366-2379issue
12eissn
0149-2918issn
1879-114Xpii
S0149-2918(17)31019-6journal_volume
39pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:LX4211 is a first-in-class dual inhibitor of sodium-dependent glucose cotransporters 1 and 2 (SGLT1 and SGLT2). SGLT1 is the primary transporter for glucose absorption from the gastrointestinal tract, and SGLT2 is the primary transporter for glucose reabsorption in the kidney. SGLT1 inhibition reduces postpr...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2013.06.011
更新日期:2013-08-01 00:00:00
abstract:BACKGROUND:Considerable clinical data on the treatment of type 2 diabetes with incretin-based therapies (glucagon-like peptide 1 receptor agonists [GLP-1RAs] and dipeptidyl-peptidase IV [DPP-4] inhibitors) are available. OBJECTIVE:This meta-analysis was performed to support the understanding of the overall evidence by...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.clinthera.2012.04.013
更新日期:2012-06-01 00:00:00
abstract:BACKGROUND:Meclofenoxate hydrochloride is a psychostimulant in the nootropic agent group available in capsule and tablet formulations approved for traumatic cataphora, alcoholic poisoning, anoxia neonatorum, and children's enuresis in China. Although these 2 generic formulations are marketed in China, information regar...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2008.09.013
更新日期:2008-09-01 00:00:00
abstract:BACKGROUND:Besifloxacin is a topical fluoroquinolone with potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. Besifloxacin ophthalmic suspension 0.6% given 3 times daily for 5 days has been reported to be more effective than its vehicle in the treatment of bacterial ...
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.2010.12.004
更新日期:2011-01-01 00:00:00
abstract:PURPOSE:Neuromodulation holds great promise for the treatment of drug-resistant epilepsy. This article reviews the most common types of neuromodulation as well as potential future applications of preclinical techniques such as optogenetics. This review serves as a reference for treating neurologists on the latest scien...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2020.05.017
更新日期:2020-07-01 00:00:00
abstract:BACKGROUND:Antidepressants have been commonly used by women of childbearing age. Recent studies suggest that paroxetine, a selective serotonin reuptake inhibitor (SSRI), might specifically increase teratogenic risk. OBJECTIVES:The purpose of this study was to quantify first-trimester exposure to paroxetine and birth d...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.clinthera.2007.05.003
更新日期:2007-05-01 00:00:00
abstract:BACKGROUND:Terazosin is an alpha1-selective adrenoceptor blocking agent that has been reported in many clinical trials to be an effective choice for the treatment of benign prostatic hyperplasia (BPH). To improve cost-effectiveness, the development of an effective and well-tolerated generic formulation is needed. OBJE...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2007.04.013
更新日期:2007-04-01 00:00:00
abstract:BACKGROUND:Therapeutic drug monitoring (TDM) is essential to maintain the efficacy of many immunosuppressant drugs while minimizing their toxicity. TDM has become more refined with the development of new monitoring techniques and more specific assays. OBJECTIVE:This article summarizes current data on TDM of the follow...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(02)85038-x
更新日期:2002-03-01 00:00:00
abstract::Congestive heart failure (CHF) afflicts more than 4.6 million people in the United States and increases at a rate of 400,000 newly diagnosed patients per year. With more than 1.5 million hospital admissions per year attributed to CHF, it is the number one cause of hospitalization. Hospital length of stay (LOS) is one ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(96)80223-2
更新日期:1996-07-01 00:00:00
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 ...
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.2017.06.014
更新日期:2017-08-01 00:00:00
abstract:BACKGROUND:Emergence agitation (EA) after emergence from sevoflurane anesthesia is a common phenomenon in children. The efficacy of prophylactic midazolam or clonidine in preventing EA is controversial. OBJECTIVE:We performed a meta-analysis of clinical trials of the 2 drugs to evaluate their ability to prevent EA in ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.clinthera.2013.08.016
更新日期:2013-10-01 00:00:00
abstract::In a double-blind study, 59 patients with chronic erosive gastritis received 50 mg of pirenzepine twice daily and 55 patients received 400 mg of cimetidine twice daily for six weeks. In both groups, days of pain, of heartburn, and of nausea per week were significantly reduced during treatment (P less than 0.01). After...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1989-11-01 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::The causes of past accidental viral transmissions associated with blood derivatives are reviewed briefly, as are the safety procedures instituted in Europe on the basis of viral validation studies. A comprehensive five-class classification system for delineating viral risk according to source material and comparative ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(96)80194-9
更新日期:1996-01-01 00:00:00
abstract:BACKGROUND:Although annual per-person health care costs for patients with end-stage renal disease (ESRD) on in-center hemodialysis greatly exceed those for patients on peritoneal dialysis (PD), which is a home dialysis therapy, current use of PD remains low. In April 2008, the Centers for Medicare & Medicaid Services i...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2009.04.004
更新日期:2009-04-01 00:00:00
abstract:BACKGROUND:Pitavastatin, a fully synthetic β-hydroxy-β-methylglutaryl-coenzyme A reductase inhibitor, is potent for the treatment of primary hyperlipidemia and mixed dyslipidemia. Recently, the original product and some generic products of pitavastatin calcium have become available in China. However, the intrasubject v...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.06.021
更新日期:2014-09-01 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:BACKGROUND:New targeted therapeutics for metastatic renal cell carcinoma (mRCC) enable an increment in progression-free survival (PFS) ranging from 2 to 6 months. Compared with best supportive care, everolimus demonstrated an additional PFS of 3 months in patients with mRCC whose disease had progressed on sunitinib and...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.10.004
更新日期:2013-12-01 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:PURPOSE:Methylphenidate hydrochloride extended-release chewable tablet (MPH ERCT) is approved for treatment of attention deficit hyperactivity disorder in patients aged 6 years and older. This article evaluates the pharmacokinetic parameters and relative bioavailability of MPH ERCT when chewed versus swallowed whole. ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2018.03.016
更新日期:2018-05-01 00:00:00
abstract::A single-blind comparison was undertaken to evaluate 250 mg of cinoxacin and 100 mg of nitrofurantoin, both drugs being given four times a day, for the treatment of urinary tract infections. Complete data are available from 58 patients, most of whom were treated for 10 to 15 days. The clinical response was similar in ...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1982-01-01 00:00:00
abstract::The bacteriologic profile in 1081 pediatric patients with culture-positive symptomatic bacteriuria was studied over a 30-month period in a 500-bed acute care hospital in Riyadh, Saudi Arabia. Microbial isolates were considered significant if their numbers equaled or exceeded 10,000 colony-forming units/mL in symptomat...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(96)80010-5
更新日期:1996-03-01 00:00:00
abstract::The subjects were 20 chronic schizophrenic patients with dyslipidemia (total cholesterol levels greater than or equal to 220 mg/dl, triglycerides greater than or equal to 150 mg/dl, or high-density lipoprotein cholesterol less than or equal to 40 mg/dl) who had been receiving neuroleptics for a mean of ten years. Each...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1990-05-01 00:00:00
abstract::Absorption of elemental iron from three single-daily-dose prenatal multivitamin/multimineral supplements was compared in bioavailability studies of subjects under fasting and postprandial conditions. Each of the supplements (Stuartnatal 1 + 1, Stuart Prenatal, and Materna 1.60) contained 60 or 65 mg of iron. The subje...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1988-01-01 00:00:00
abstract::This study sought to compare the efficacy and safety of glyburide and glipizide in elderly patients with well-controlled non-insulin-dependent diabetes mellitus (NIDDM). One hundred forty-five patients aged > or = 65 years with NIDDM that was controlled for at least 3 months with oral sulfonylurea therapy were enrolle...
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:
更新日期:1993-11-01 00:00:00
abstract::Biotechnology represents an opportunity for innovative products, new markets, or capital investments, depending on one's perspective. A primary consideration in regulating this industry is to ensure that innovation is not stifled yet the public is protected from potentially unsafe or ineffective products. We compared ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1993-03-01 00:00:00
abstract:BACKGROUND:Alzheimer's disease (AD) is estimated to affect up to 11% of those aged > or =65 years in the United States, and the number of patients with AD is predicted to increase over the next few decades as the population ages. The substantial social and economic burden associated with AD is well established, with th...
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)80171-6
更新日期:2003-06-01 00:00:00
abstract::This article reviews the drugs used in the treatment of childhood asthma (bronchodilators and anti-inflammatory agents) from the perspective of their safety and clinical tolerability. Adverse events observed in adults are likely to be seen to a greater degree in children and adolescents for many types of antiasthma dr...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1994-07-01 00:00:00
abstract:PURPOSE:The genetic polymorphism was one of the major considerations for adjusting doses of warfarin in Thai individuals. As a result, new oral anticoagulants (NOACs) were introduced to achieve therapeutic goals in stroke prevention in atrial fibrillation (SPAF) patients. However, a cost-utility analysis in a populatio...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.08.016
更新日期:2014-10-01 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