6,225 results match your criteria Clinical therapeutics[Journal]


Pharmacokinetics of Single Doses of BI 425809 in Healthy Chinese and Japanese Subjects: A Randomized Study.

Clin Ther 2019 Apr 17. Epub 2019 Apr 17.

Inje University Busan Paik Hospital, Busan, South Korea.

Purpose: This study's primary goal was to evaluate the safety profile, tolerability, pharmacokinetics, and dose proportionality of BI 425809, a potent and selective inhibitor of glycine transporter 1, in healthy Chinese and Japanese subjects.

Methods: This single center, double-blind, single-rising dose study conducted in Korea randomly assigned (3:1) subjects within each ethnic subgroup (Chinese and Japanese) to receive a single dose of BI 425809 (10, 25, or 50 mg) or placebo. The primary end point was number (%) of subjects with drug-related adverse events (AEs). Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.03.014DOI Listing

Pharmacokinetics and Pharmacodynamics of Once-daily Prolonged-release Tacrolimus in Liver Transplant Recipients.

Clin Ther 2019 Apr 16. Epub 2019 Apr 16.

Département de Pharmacocinétique et Pharmacochimie, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France; UMR8638 CNRS, UFR Pharmacie, Université Paris Descartes, PRES Sorbonne Paris Cité, Paris, France. Electronic address:

Purpose: Limited published data are available regarding the pharmacokinetic (PK) and pharmacodynamic (PD) variables of prolonged-release tacrolimus (PRT) after liver transplantations. The goal of this study was to compare the PK and PD profiles of PRT in early and stable liver transplant recipients by developing a population PK model of PRT and investigating the profile of calcineurin activity (CNA) in the peripheral blood mononuclear cells.

Methods: A conversion from BID immediate-release tacrolimus (IRT) to once-daily PRT based on a one-to-one daily dose was performed at day 7 (D7) and D90 posttransplantation in groups A (n = 12) and B (n = 12), respectively. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.03.006DOI Listing

Letter to the Editor: Myalgic Encephalomyelitis and Chronic Fatigue Syndrome: Definitions, Similarities, and Differences.

Authors:
Frank N M Twisk

Clin Ther 2019 Apr 16. Epub 2019 Apr 16.

ME-de-patiënten Foundation, Limmen, the Netherlands. Electronic address:

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http://dx.doi.org/10.1016/j.clinthera.2019.03.010DOI Listing

Insulin Autoimmune Syndrome Diagnosis and Therapy in a Single Chinese Center.

Clin Ther 2019 Apr 13. Epub 2019 Apr 13.

Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China. Electronic address:

Purpose: Insulin autoimmune syndrome (IAS) is a relatively rare cause of hypoglycemia characterized by endogenous hyperinsulinism and autoantibodies against endogenous insulin despite no prior exposure to exogenous insulin. We present a series of IAS cases and describe the clinical characteristics of these cases.

Methods: The medical records of inpatients with the final diagnosis of IAS were collected from August 2007 to August 2017 in Peking Union Medical College Hospital. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918193012
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http://dx.doi.org/10.1016/j.clinthera.2019.03.009DOI Listing
April 2019
3 Reads

An Analysis of Time to Improvement in Oxygenation in Japanese Preterm and Late Preterm or Term Neonates With Hypoxic Respiratory Failure and Pulmonary Hypertension.

Clin Ther 2019 Apr 12. Epub 2019 Apr 12.

Nagoya City West Medical Center, Nagoya, Japan.

Purpose: We analyzed data from an ongoing registry to determine time to improvement in oxygenation in preterm and late preterm or term neonates with hypoxic respiratory failure and pulmonary hypertension receiving inhaled nitric oxide (iNO) in Japan.

Methods: Registry neonates received iNO ≤7 days after birth (February 26, 2010, to October 9, 2012). Efficacy and safety profile data were collected up to 96 h after iNO initiation and, if necessary, every 24 h thereafter and before iNO discontinuation. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.03.008DOI Listing

Pharmacokinetics and Tolerability of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate and Glycopyrronium/Formoterol Fumarate Dihydrate Metered Dose Inhalers in Healthy Chinese Adults: A Randomized, Double-Blind, Parallel-Group Study.

Clin Ther 2019 Apr 11. Epub 2019 Apr 11.

AstraZeneca, Durham, NC, USA. Electronic address:

Purpose: The objective of this study was to assess pharmacokinetic (PK) and safety profiles of 2 fixed-dose combinations in development for the treatment of chronic obstructive pulmonary disease (COPD): budesonide/glycopyrronium/formoterol fumarate dihydrate metered-dose inhaler (BGF MDI; triple combination) and glycopyrronium/formoterol fumarate dihydrate (GFF MDI; dual combination). The PK and safety profiles of BGF MDI and GFF MDI were assessed for the first time in healthy Chinese adults after single and repeated (7-day) dosing.

Methods: This Phase I, randomized, double-blind, parallel-group study was conducted at a single site in Shanghai, China. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.03.007DOI Listing

Varied Presentation of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and the Needs for Classification and Clinician Education: A Case Series.

Clin Ther 2019 Apr 1;41(4):619-624. Epub 2019 Apr 1.

Instituto de Química Médica (CSIC), Madrid, Spain.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a complex, heterogeneous and serious disease. In this article, we analyze the cases of 3 patients with ME/CFS. Due to the disbeliefs, misconceptions, and stigmas that are attached to ME/CFS, patient diagnosis is made after years of disease progression. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.014DOI Listing
April 2019
1 Read

A Timely Multidisciplinary Update on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

Clin Ther 2019 Apr 30;41(4):610-611. Epub 2019 Mar 30.

Laboratory of Molecular Immunopharmacology and Drug Discovery, Department of Immunology, Tufts University School of Medicine, Boston, MA, USA; Department of Internal Medicine, Tufts University School of Medicine, Tufts Medical Center, Boston, MA, USA; Department of Psychiatry, Tufts University School of Medicine, Tufts Medical Center, Boston, MA, USA. Electronic address:

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http://dx.doi.org/10.1016/j.clinthera.2019.03.004DOI Listing

Derivation and Evaluation of the Ischemic Risk Model in High-Risk Chinese Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndrome.

Clin Ther 2019 Apr 29;41(4):754-765. Epub 2019 Mar 29.

Department of Cardiology, The First Affiliated Hospital, China Medical University, Shenyang, China. Electronic address:

Purpose: Coronary artery disease is the top cause of death among the Chinese population. With the establishment of a Chinese prediction model, it is urgent to assess factors related to the prognosis of patients with acute coronary syndrome at extremely high risk.

Methods: In this retrospective study, we enrolled 601 patients assessed as being of extremely high risk, according to specific criteria from the China-PAR (Prediction for Atherosclerotic Cardiovascular Disease Risk) project, and investigated various clinical parameters using Cox multivariate analysis to establish a risk nomogram. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.03.001DOI Listing
April 2019
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Leveraging Prior Knowledge of Endocrine Immune Regulation in the Therapeutically Relevant Phenotyping of Women With Chronic Fatigue Syndrome.

Clin Ther 2019 Apr 28;41(4):656-674.e4. Epub 2019 Mar 28.

Institute for Neuro Immune Medicine, Nova Southeastern University, Fort Lauderdale, FL, USA; Miami Veterans Affairs Medical Center, Miami, FL, USA.

Purpose: The complex and varied presentation of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has made it difficult to diagnose, study, and treat. Its symptoms and likely etiology involve multiple components of endocrine and immune regulation, including the hypothalamic-pituitary-adrenal axis, the hypothalamic-pituitary-gonadal axis, and their interactive oversight of immune function. We propose that the persistence of ME/CFS may involve changes in the regulatory interactions across these physiological axes. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.03.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478538PMC
April 2019
3 Reads

Pharmacokinetics of Ketamine at Dissociative Doses in an Adult Patient With Refractory Status Asthmaticus Receiving Extracorporeal Membrane Oxygenation Therapy.

Clin Ther 2019 Mar 28. Epub 2019 Mar 28.

Department of Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.

Purpose: First-line management of severe asthma exacerbations include the use of inhaled short-acting β-agonists, anticholinergics, and systemic corticosteroids. Continuous intravenous ketamine given at dissociative doses may be a pharmacologic option in patients who are intubated with life-threatening severe bronchospasm unresponsive to standard therapy. We describe the case of a 44-year-old man admitted to the intensive care unit for status asthmaticus requiring intubation and mechanical ventilation. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918193011
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http://dx.doi.org/10.1016/j.clinthera.2019.03.005DOI Listing
March 2019
7 Reads

A New Sustained-release, 3-Month Leuprolide Acetate Formulation Achieves and Maintains Castrate Concentrations of Testosterone in Patients With Prostate Cancer.

Clin Ther 2019 Mar 8;41(3):412-425. Epub 2019 Feb 8.

GP-Pharm S.A., Pol. Industrial Els Vinyets-Els Fogars, St. Quintí de Mediona, Barcelona, Spain.

Purpose: This clinical trial investigated the effectiveness, pharmacokinetic properties, and safety profile of leuprolide acetate 22.5-mg depot, a new 3-month leuprolide depot formulation, as androgen deprivation therapy for patients with prostate cancer.

Methods: A Phase III, open-label, multicenter study design for patients with prostate cancer, with patient inclusion assessed by the investigative site as patient's appropriate for androgen deprivation therapy. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.004DOI Listing
March 2019
1 Read

Comments on Chronic Fatigue Syndrome.

Authors:
Richard I Shader

Clin Ther 2019 Apr 27;41(4):605-607. Epub 2019 Mar 27.

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http://dx.doi.org/10.1016/j.clinthera.2019.03.003DOI Listing

Epigenetic Components of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Uncover Potential Transposable Element Activation.

Clin Ther 2019 Apr 23;41(4):675-698. Epub 2019 Mar 23.

School of Medicine, Universidad Católica de Valencia San Vicente Mártir, Valencia, Spain; Unidad Mixta CIPF-UCV, Centro de Investigación Príncipe Felipe, Valencia, Spain. Electronic address:

Purpose: Studies to determine epigenetic changes associated with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) remain scarce; however, current evidence clearly shows that methylation patterns of genomic DNA and noncoding RNA profiles of immune cells differ between patients and healthy subjects, suggesting an active role of these epigenetic mechanisms in the disease. The present study compares and contrasts the available ME/CFS epigenetic data in an effort to evidence overlapping pathways capable of explaining at least some of the dysfunctional immune parameters linked to this disease.

Methods: A systematic search of the literature evaluating the ME/CFS epigenome landscape was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.012DOI Listing

Total Versus Subtotal Hysterectomy: Systematic Review and Meta-analysis of Intraoperative Outcomes and Postoperative Short-term Events.

Clin Ther 2019 Apr 23;41(4):768-789. Epub 2019 Mar 23.

Sector of Urogynecology, Department of Gynecology, Federal University of São Paulo, UNIFESP, São Paulo, Brazil.

Purpose: The benefits and disadvantages of cervical extraction during hysterectomy are unclear in the literature. We intended to compare total (TH) with subtotal or supracervical (SH) hysterectomy regarding intraoperative and postoperative outcomes (quality of life, sexual function, pain and cyclical bleeding).

Methods: A systematic literature search for randomized controlled trials was conducted on MEDLINE, LILACS, Cochrane CENTRAL, SCOPUS, EMBASE, Clinicaltrials. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.006DOI Listing
April 2019
1 Read

Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study.

Clin Ther 2019 Apr 21;41(4):728-741. Epub 2019 Mar 21.

Daejeon St. Mary's Hospital, Daejeon, Korea; Seoul St. Mary's Hospital of the Catholic University, Seoul, Korea. Electronic address:

Purpose: Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine + rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.013DOI Listing
April 2019
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The Importance of Tablet Formulation on Allergen Release Kinetics and Efficiency: Comparison of Freeze-dried and Compressed Grass Pollen Sublingual Allergy Immunotherapy Tablet Formulations.

Clin Ther 2019 Apr 16;41(4):742-753. Epub 2019 Mar 16.

ALK Abelló A/S, Hørsholm, Denmark. Electronic address:

Purpose: Efficient delivery of allergens to the sublingual mucosa is a prerequisite for successful sublingual immunotherapy (SLIT) for allergy, and in order to become available to immune-competent cells embedded in the sublingual mucosa, allergens need to be delivered in a soluble form. Delivery of solubilized allergens poses a particular challenge for tablet-based allergy immunotherapy, in which allergens are administered under the tongue in the form of dry tablets and need to be dissolved rapidly in a small volume of saliva, with little or no agitation. The purposes of this article were to compare the properties of 2 different pharmaceutical SLIT-tablet formulations, freeze-dried and compressed, and to examine how the tablet formulation affects the efficiency with which allergen is delivered from the dry state of the tablet into soluble form. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.008DOI Listing
April 2019
1 Read

Associations Between Autonomic and Orthostatic Self-report and Physician Ratings of Orthostatic Intolerance in Youth.

Clin Ther 2019 Apr 12;41(4):633-640. Epub 2019 Mar 12.

Center for Community Research, DePaul University, Chicago, IL, USA. Electronic address:

Purpose: There is no known biological marker or physical assessment to diagnose chronic fatigue syndrome (CFS), leaving physicians to heavily rely on self-report measures regarding the symptoms associated with CFS. Common symptoms of CFS include difficulty sleeping, joint pain, headaches, sore throat, cognitive dysfunction, physical exhaustion, dizziness, and nausea. Because of the overlap among CFS symptoms and autonomic functioning, we examined the association between 2 self-report measures of orthostatic and autonomic symptoms and a physician's report of autonomic functioning (measures of changes in blood pressure and pulse) to further understand the association among autonomic functioning within individuals with symptoms of CFS. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478562PMC

Pharmaceutical Interventions in Chronic Fatigue Syndrome: A Literature-based Commentary.

Clin Ther 2019 Mar 11. Epub 2019 Mar 11.

Institute for Neuro Immune Medicine, Nova Southeastern University, Fort Lauderdale, FL, USA; Department of Clinical Immunology, Nova Southeastern University, Fort Lauderdale, FL, USA.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating disorder characterized by prolonged periods of fatigue, chronic pain, depression, and a complex constellation of other symptoms. Currently, ME/CFS has no known cause, nor are the mechanisms of illness well understood. Therefore, with few exceptions, attempts to treat ME/CFS have been directed mainly toward symptom management. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.011DOI Listing
March 2019
1 Read

Treatment Avenues in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Split-gender Pharmacogenomic Study of Gene-expression Modules.

Clin Ther 2019 Mar 6. Epub 2019 Mar 6.

Institute for Neuro-Immune Medicine, Nova Southeastern University, Ft. Lauderdale, FL, USA; College of Psychology, Nova Southeastern University, Ft. Lauderdale, FL, USA; Department of Clinical Immunology, Nova Southeastern University, Ft. Lauderdale, FL, USA; Department of Computer Science, Nova Southeastern University, Ft. Lauderdale, FL, USA. Electronic address:

Purpose: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating multisymptom illness impacting up to 1 million people in the United States. As the pathogenesis and etiology of this complex condition are unclear, prospective treatments are limited. Identifying US Food and Drug Administration-approved drugs that may be repositioned as treatments for ME/CFS may offer a rapid and cost-effective solution. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918193004
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http://dx.doi.org/10.1016/j.clinthera.2019.01.011DOI Listing
March 2019
8 Reads
2.731 Impact Factor

Review of Interventions for the Frailty Syndrome and the Role of Metformin as a Potential Pharmacologic Agent for Frailty Prevention.

Clin Ther 2019 Mar 7;41(3):376-386. Epub 2019 Mar 7.

Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA; Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.

Purpose: Frailty is a syndrome of vulnerability and physical decline with aging that increases risk for disability, hospitalizations, and death. To date, interventions for frailty have primarily focused on exercise and/or nutritional interventions, many of which show improvement in frailty-related characteristics, such as gait speed and lower extremity strength and function. The goal of this article was to review prior research studies investigating interventions for frailty and review the literature with regard to the role of insulin resistance and inflammation in the development of frailty. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.006DOI Listing
March 2019
2 Reads

Clinical and Economic Analysis of Morphine Versus Fentanyl in Managing Ventilated Neonates With Respiratory Distress Syndrome in the Intensive Care Setting.

Clin Ther 2019 Apr 4;41(4):714-727.e8. Epub 2019 Mar 4.

College of Pharmacy, Qatar University, Doha, Qatar. Electronic address:

Purpose: Morphine and fentanyl opioids are common analgesic agents for consideration in the neonatal intensive care unit (NICU) for neonates with respiratory distress syndrome (RDS) and undergoing mechanical ventilation (MV). The aim of this study was to evaluate the clinical and economic impact of morphine versus fentanyl in neonates with RDS undergoing MV.

Methods: Retrospective cost-effectiveness analysis of critically ill neonates with RDS receiving standard doses of morphine versus fentanyl at Women's Wellness and Research Center, Qatar. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.009DOI Listing
April 2019
5 Reads

Comparative Effectiveness of Pemetrexed-platinum Doublet Chemotherapy With or Without Bevacizumab as First-line Therapy for Treatment-naive Patients With Advanced Nonsquamous Non-small-cell Lung Cancer in China.

Clin Ther 2019 Mar 4;41(3):518-529. Epub 2019 Mar 4.

Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China. Electronic address:

Purpose: Bevacizumab plus platinum-based doublet chemotherapy is recommended by the National Comprehensive Cancer Network as a category 1 regimen and is widely used in patients with advanced nonsquamous non-small-cell lung cancer (NS-NSCLC). In China, a common first-line chemotherapy for NS-NSCLC is the pemetrexed-platinum doublet regimen (Pem-Pt). However, limited evaluation exists to show the effectiveness of the Pem-Pt + bevacizumab (Bev) regimen in advanced NS-NSCLC. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.004DOI Listing
March 2019
1 Read
2.731 Impact Factor

Benefit-risk Assessment of Cladribine Using Multi-criteria Decision Analysis (MCDA) for Patients With Relapsing-remitting Multiple Sclerosis.

Clin Ther 2019 Feb;41(2):249-260.e18

Department of Management, London School of Economics and Political Science, London, United Kingdom. Electronic address:

Purpose: We applied Multi-Criteria Decision Analysis (MCDA) methods in a structured benefit-risk assessment of cladribine and newer approved disease-modifying drugs (DMDs) for patients with relapsing-remitting multiple sclerosis (RRMS).

Methods: Decision conferencing with clinical neurologists as decision makers was used to create an MCDA model that incorporated available evidence on DMDs for RRMS and clinical judgments about the relevance of the evidence. Benefit-risk assessments were conducted for DMDs in both patients with RRMS and patients with RRMS with high disease activity (HDA; defined as ≥2 relapses in the previous year). Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.12.015DOI Listing
February 2019
1 Read

Women and Heart Disease.

Authors:
Richard I Shader

Clin Ther 2019 Feb;41(2):191-194

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http://dx.doi.org/10.1016/j.clinthera.2019.01.008DOI Listing
February 2019

Chronic Low-grade Inflammatory Phenotype (CLIP) and Senescent Immune Dysregulation.

Clin Ther 2019 Mar 1;41(3):400-409. Epub 2019 Mar 1.

Division of Geriatric Medicine and Gerontology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address:

Purpose: The aim was to provide an overview of chronic low-grade inflammatory phenotype (CLIP) and evidence for its role in the pathogenesis of frailty and other chronic conditions as well as potential causative factors and interventions.

Methods: We reviewed evidence from published clinical and laboratory studies and summarized the opinions of experts from published reviews.

Findings: CLIP is a low-grade, systemic, unresolved, and smoldering chronic inflammatory state clearly indicated by a 2- to 4-fold increase in serum levels of inflammatory mediators, such as interleukin-6 and C-reactive protein. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.001DOI Listing
March 2019
4 Reads
2.731 Impact Factor

Estimation of Health Utilities Based on the Response to Treatment in Atopic Dermatitis: a Population-based Study.

Clin Ther 2019 Apr 28;41(4):700-713. Epub 2019 Feb 28.

NDnex, Uiwang, South Korea. Electronic address:

Purpose: This study estimated utility weights based on the response to treatment for atopic dermatitis in the general population.

Methods: The Korean general population aged 20-60 years was stratified by using a random sampling method based on age and sex. Two hypothetical health states of atopic dermatitis were developed: response to treatment and no response to treatment. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.007DOI Listing

Falls, Frailty, Vision, and Aging.

Authors:
Richard I Shader

Clin Ther 2019 Mar 1;41(3):369-372. Epub 2019 Mar 1.

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http://dx.doi.org/10.1016/j.clinthera.2019.02.002DOI Listing

Colchicine for Stroke Prevention: A Systematic Review and Meta-analysis.

Clin Ther 2019 Mar 1;41(3):582-590.e3. Epub 2019 Mar 1.

Department of Cardiology, Royal Prince Alfred Hospital, New South Wales, Australia; The University of Sydney, New South Wales, Australia.

Purpose: There has been recent interest in the role of colchicine in cardiovascular diseases, given the implication of inflammation in the pathogenesis of atherothrombosis. This systematic review assessed the role of colchicine in preventing primary or secondary stroke/transient ischemic attack (TIA) in an adult population.

Methods: Four databases were electronically searched: MEDLINE, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), and OpenGrey. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.02.003DOI Listing

Computerized Clinical Decision Support Systems and Antibiotic Prescribing: A Systematic Review and Meta-analysis.

Clin Ther 2019 Mar 28;41(3):552-581. Epub 2019 Feb 28.

Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBER en Epidemiología y Salud Pública-CIBERESP), Santiago de Compostela, Spain; Institute of Health Research of Santiago de Compsotela (IDIS), Spain.

Purpose: The aim of this study was to perform a systematic review and meta-analysis of studies performed in primary care centers and hospital facilities that evaluated the effectiveness of computerized clinical decision support systems (CDSSs) in decision making on the prescription of any given antibiotic.

Methods: We conducted a search of the MEDLINE and EMBASE databases. A meta-analysis was then conducted of all variables with results reported in >2 studies. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.018DOI Listing

Clinical Approaches and Emerging Therapeutics for Frailty Syndrome.

Authors:
William W Hung

Clin Ther 2019 Mar 26;41(3):374-375. Epub 2019 Feb 26.

Geriatric Research, Education and Clinical Center, James J Peters VA Medical Center, Bronx, NY, USA; Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address:

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http://dx.doi.org/10.1016/j.clinthera.2019.02.005DOI Listing
March 2019
1 Read

Population Pharmacokinetics Study of Nemonoxacin Among Chinese Patients With Moderate Hepatic Impairment.

Clin Ther 2019 Mar 26;41(3):505-517.e0. Epub 2019 Feb 26.

Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.

Purpose: Nemonoxacin is a novel C-8-methoxy nonfluorinated quinolone that has been approved for the treatment of community-acquired pneumonia (CAP) in adults. The goals of this study were to evaluate the pharmacokinetic (PK) and population PK parameters of nemonoxacin and to provide the appropriate dose adjustment recommendations for patients with hepatic impairment.

Methods: An open-label, single-dose, parallel group (moderate hepatic impairment group and healthy control group) PK study of nemonoxacin was conducted. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.015DOI Listing
March 2019
4 Reads
2.731 Impact Factor

Preoperative Frailty Evaluation: A Promising Risk-stratification Tool in Older Adults Undergoing General Surgery.

Authors:
Fred C Ko

Clin Ther 2019 Mar 22;41(3):387-399. Epub 2019 Feb 22.

Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Geriatric Research Education and Clinical Center (GRECC), James J. Peters VA Medical Center, Bronx, NY, USA. Electronic address:

Purpose: General surgical procedures are among the most commonly performed operations in the United States. Despite advances in surgical and anesthetic techniques and perioperative care, complications after general surgery in older adults remain a significant cause of increased morbidity, mortality, and health care costs. Frailty, a geriatric syndrome characterized by multisystem physiologic decline and increased vulnerability to stressors and adverse clinical outcomes, has emerged as a plausible predictor of adverse outcomes after surgery in older patients. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.014DOI Listing
March 2019
1 Read

A Single-dose, Comparative Bioavailability Study of a Formulation containing OM3 as Phospholipid and Free Fatty Acid to an Ethyl Ester Formulation in the Fasting and Fed States.

Clin Ther 2019 Mar 22;41(3):426-444. Epub 2019 Feb 22.

Acasti Pharma Inc, Laval, Quebec, Canada.

Purpose: Formulations of ω (OM)-3 with adequate bioavailability in the low-fat fed state are advantageous in patients with severe hypertriglyceridemia (HTG), as these patients are advised to adhere to a low-fat diet. The OM3-containing prescription drugs approved by the US Food and Drug administration (FDA) provide OM3 in either ethyl ester (EE) or free fatty acid (FFA) forms. The OM3 FFA form and formulations with micelle-forming ability have shown improved bioavailability versus the EE form. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.017DOI Listing
March 2019
1 Read

Fatigue in Mastocytosis: A Case Series.

Clin Ther 2019 Apr 21;41(4):625-632. Epub 2019 Feb 21.

Clinical Immunology Unit, Department of Internal Medicine, Stavanger University Hospital, Stavanger, Norway; Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, Norway. Electronic address:

Purpose: Accumulating evidence suggests that fatigue in chronic inflammatory diseases is generated in the brain by mechanisms involving proinflammatory cytokines. We recently reported a high prevalence of fatigue in patients with mastocytosis, a condition with a constant activation of mast cells and release of a variety of bioactive substances. This observation indicates that mast cells somehow could be involved in the biological mechanisms that generate fatigue. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.016DOI Listing
April 2019
1 Read

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Fibromyalgia: Definitions, Similarities, and Differences.

Clin Ther 2019 Apr 20;41(4):612-618. Epub 2019 Feb 20.

Department of Neurology, Pain & Fatigue Study Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address:

This commentary presents a simplified way of making the diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) using the 1994 Centers for Disease Control and Prevention case definition. The format used can easily be modified for other case definitions. The commentary then discusses whether ME/CFS is the same or a different illness from fibromyalgia. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918193000
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http://dx.doi.org/10.1016/j.clinthera.2018.12.016DOI Listing
April 2019
5 Reads

Harmonization of Pharmacovigilance Regulation in Brazil: Opportunities to Improve Risk Communication.

Clin Ther 2019 Mar 18;41(3):598-603. Epub 2019 Feb 18.

Department of Drugs and Medicines, School of Pharmaceutical Sciences, São Paulo State University, Araraquara, Brazil. Electronic address:

Brazilian pharmacovigilance regulations involve 3 spheres: health services, Marketing Authorization Holders (MAHs), and sanitary agency. Drug tolerability began to be effectively assessed in Brazil after the founding of the National Agency of Sanitary Surveillance, which developed the Sentinel Network Project. The objective of the Sentinel Network Project is to increase the adverse drug reaction (ADR) reporting rate by health care professionals in the hospital setting. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.013DOI Listing

Risk Factors of QTc Prolongation in Women With Hormone Receptor‒positive/Human Epidermal Growth Factor Receptor 2‒negative Metastatic Breast Cancer: A Retrospective Analysis of Health Care Claims Data.

Clin Ther 2019 Mar 18;41(3):494-504.e1. Epub 2019 Feb 18.

Pfizer Inc, New York, NY, USA.

Purpose: In addition to biomarker status, treatment selection for metastatic breast cancer (mBC) includes individual patient and clinical characteristics such as tumor burden, timing of disease recurrence, and comorbidities. Women with mBC may take medications that can increase the risk of drug-induced toxicities, including prolongation of cardiac repolarization (prolongation of QT interval). Corrected QT (QTc) prolongation, a toxicity associated with many cancer treatments, can lead to potentially life-threatening ventricular arrhythmias. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.012DOI Listing
March 2019
3 Reads

Common Community-acquired Bacterial Skin and Soft-tissue Infections in Children: an Intersociety Consensus on Impetigo, Abscess, and Cellulitis Treatment.

Clin Ther 2019 Mar 15;41(3):532-551.e17. Epub 2019 Feb 15.

Division of Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.

Purpose: The main objective of this article was to offer practical suggestions, given the existing evidence, for identifying and managing bacterial impetigo, abscess, and cellulitis in ambulatory and hospital settings.

Methods: Five Italian pediatric societies appointed a core working group. In selected conditions, specially trained personnel evaluated quality assessment of treatment strategies according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.010DOI Listing
March 2019
8 Reads
2.731 Impact Factor

Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma.

Clin Ther 2019 Mar 14;41(3):477-493.e7. Epub 2019 Feb 14.

US Oncology Research/Rocky Mountain Cancer Centers, Denver, CO, USA.

Purpose: Multiple new regimens are available for the treatment of relapsed/refractory multiple myeloma (RRMM). In this context, it is increasingly important to understand the differential costs of regimens used to treat RRMM.

Methods: A treatment journey for RRMM during a 12-month period of therapy was developed to reflect real-world clinical practice based on current treatment guidelines and input from hematologists/oncologists. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.009DOI Listing
March 2019
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Impact of Optimal Medical Therapy at Discharge on One-year Direct Medical Costs in Patients with Acute Coronary Syndromes: A Retrospective, Observational Database Analysis in China.

Clin Ther 2019 Mar 13;41(3):456-465.e2. Epub 2019 Feb 13.

School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China. Electronic address:

Purpose: This study was conducted to examine the use of optimal medical therapy (OMT), consisting of an antiplatelet, a β-blocker, an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB), and a statin combined, after hospital discharge and its relationship with direct medical costs in patients with acute coronary syndromes (ACS) in Tianjin, China.

Methods: Data were obtained from the Tianjin Urban Employee Basic Medical Insurance database (2011-2015). Data from adult patients with ≥1 hospitalization for ACS between January 2012 and December 2014 were included. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.005DOI Listing
March 2019
1 Read
2.731 Impact Factor

Outpatient Antimicrobial Stewardship: Targets for Community-acquired Pneumonia.

Clin Ther 2019 Mar 8;41(3):466-476. Epub 2019 Feb 8.

Department of Pharmacy, Veteran Affairs Western New York Healthcare System, Buffalo, NY, USA. Electronic address:

Purpose: Community-acquired pneumonia (CAP) is one of the leading causes of death in the United States. The primary objective of this study was to determine the prevalence of appropriate diagnosis and treatment of outpatients treated for CAP. Knowledge of problems with CAP treatment can be helpful in developing stewardship initiatives to improve care of outpatients with CAP. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.007DOI Listing
March 2019
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Cyclophosphamide + Thalidomide + Dexamethasone Versus Melphalan + Dexamethasone for the Treatment of Amyloid Light-chain Amyloidosis With Kidney Involvement: A Retrospective Study in Chinese Patients.

Clin Ther 2019 Feb 1. Epub 2019 Feb 1.

Department of Nephrology, Xijing Hospital, Air Force Medical University, Xi'an, China. Electronic address:

Purpose: At present, a diverse array of treatment regimens are available for systemic amyloid light-chain (AL) amyloidosis. Both cyclophosphamide + thalidomide + dexamethasone (CTD) and melphalan + dexamethasone (MD) regimens have been recommended as first-line therapies, but no detailed comparative studies of the two have been performed. This study is the first to compare the efficacy and tolerability of the CTD and MD regimens in the treatment of AL amyloidosis. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.12.003DOI Listing
February 2019
11 Reads

Cost-effectiveness of Insulin Degludec Versus Insulin Glargine in Insulin-naive Chinese Patients With Type 2 Diabetes.

Clin Ther 2019 Mar 1;41(3):445-455.e4. Epub 2019 Feb 1.

Medical Decision and Economic Group, Department of Pharmacy, Ren Ji Hospital, South Campus, School of Medicine, Shanghai Jiaotong University, Shanghai, China. Electronic address:

Purpose: The goal of this study was to investigate the long-term economic outcomes of insulin degludec versus insulin glargine use in Chinese patients with type 2 diabetes mellitus (T2DM) whose oral antidiabetic drugs did not provide sufficient glycemic control.

Methods: A published and validated Chinese diabetes health policy model, which reflects Chinese T2DM epidemiologic profiles, was used to assess the lifetime economic outcomes of microvascular and macrovascular complications and mortality. Efficacy and safety, medical expenditure, and utility data were derived from the literature, which were assigned to model variables for estimating the quality-adjusted life-years (QALYs) and costs, as well as incremental cost-effectiveness ratios. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.003DOI Listing
March 2019
7 Reads

Effects of Sodium-glucose Cotransporter 2 Inhibitor Monotherapy on Weight Changes in Patients With Type 2 Diabetes Mellitus: a Bayesian Network Meta-analysis.

Clin Ther 2019 Feb 30;41(2):322-334.e11. Epub 2019 Jan 30.

Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

Purpose: The aim of this study was to systematically evaluate the effect of sodium-glucose cotransporter 2 (SGLT2) inhibitor monotherapy on the weight of patients with type 2 diabetes mellitus (T2DM) and to compare different SGLT2 inhibitors with other oral glucose-lowering medications.

Methods: PubMed, EMBASE, Cochrane Library, and the ClinicalTrials.gov Web site were searched for relevant randomized controlled trials. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.001DOI Listing
February 2019
4 Reads

Clinical Therapeutics in Hong Kong.

Clin Ther 2019 Mar 29;41(3):592-597. Epub 2019 Jan 29.

Clinical Trials Centre, University of Hong Kong, Hong Kong.

Hong Kong is a compact territory in Southern China that enjoys a high degree of autonomy. Despite its dense population and uneven wealth distribution, infant mortality is low and life expectancy is long. The health service is more hospital and clinic based than community based. Read More

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http://dx.doi.org/10.1016/j.clinthera.2019.01.002DOI Listing
March 2019
3 Reads

Clinical and Economic Outcomes of Patients with Type 2 Diabetes on Multiple Daily Injections of Basal-bolus Insulin (MDI) Therapy: A Retrospective Cohort Study.

Clin Ther 2019 Feb 30;41(2):303-313.e1. Epub 2019 Jan 30.

Health Economics and Outcomes Research, Becton Dickinson, Franklin Lakes, NJ, USA. Electronic address:

Purpose: Therapy for patients with type 2 diabetes (T2DM) not achieving hemoglobin (Hb) A targets may progress from an oral antidiabetic drug (OAD) to added basal insulin and then to multiple daily injections of basal-bolus insulin (MDI); however, the relative clinical and economic burden experienced by patients prescribed MDI for T2DM is not well quantified. The intent of this work was to describe direct medical costs, health care resource utilization, and glycemic control in patients with T2DM exposed to MDI in a clinical practice setting.

Methods: This retrospective cohort study used administrative claims data (2012-2015, United States) from patients aged 18 to 64 years with T2DM prescribed OAD, basal insulin, or MDI therapy. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.12.014DOI Listing
February 2019
1 Read

The Case for Real-world Evidence in the Future of Clinical Research on Chronic Myeloid Leukemia.

Clin Ther 2019 Feb 30;41(2):336-349. Epub 2019 Jan 30.

Sidney Kimmel Comprehensive Cancer Center, Division of Hematologic Malignancies, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address:

Purpose: In light of recently published guidelines from the US Food and Drug Administration (FDA) on the communication of real-world data (RWD) and real-world evidence (RWE) to support regulatory decision making, it is important to understand how such data are developed, the limitations of these data, and how to best use RWD to improve patient care. Historically, the use of RWE has been approached with skepticism because of its often-retrospective nature compared with data from conventional randomized controlled trials (RCTs). This review discusses the role and function of RWE and RWD in clinical research. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183061
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http://dx.doi.org/10.1016/j.clinthera.2018.12.013DOI Listing
February 2019
8 Reads

Assessing Changes in Statin Prescribing Patterns Surrounding the 2013 American College of Cardiology/American Heart Association Lipid Guidelines.

Clin Ther 2019 Feb 25;41(2):314-321. Epub 2019 Jan 25.

Campbell University College of Pharmacy & Health Sciences, Buies Creek, NC, USA; Cape Fear Valley Health System, Fayetteville, NC, USA.

Purpose: The American College of Cardiology (ACC) and the American Heart Association (AHA) introduced new lipid guidelines in late 2013 that were a vast departure from older guidelines. Concerns were raised regarding the likely increase in the number of adults who would be eligible for lipid-lowering therapy, namely moderate to high intensity statins. We sought to determine whether, in the first year after the ACC/AHA guideline release, more patients were prescribed statins, prescribed moderate- to high-intensity statins, and eligible for statins compared with the previous year. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918193000
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http://dx.doi.org/10.1016/j.clinthera.2018.12.017DOI Listing
February 2019
6 Reads

Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial.

Clin Ther 2019 Feb 18;41(2):233-248.e9. Epub 2019 Jan 18.

Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address:

Purpose: Fixed-dose combination therapy with telmisartan, amlodipine, and rosuvastatin is needed in patients with hypertension and dyslipidemia for better adherence and cost-effectiveness than free-equivalent combination therapies. This study aimed to compare the efficacy and safety of combination therapy with telmisartan, amlodipine, and rosuvastatin versus telmisartan plus amlodipine or telmisartan plus rosuvastatin in patients with hypertension and dyslipidemia.

Methods: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial (J-TAROS-RCT) was an 8-week, multicenter, randomized, double-blind, parallel, Phase III clinical trial conducted at 9 hospitals in Korea. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.12.008DOI Listing
February 2019
8 Reads