6,185 results match your criteria Clinical therapeutics[Journal]


Impact of Optimal Medical Therapy at Discharge on 1-year Direct Medical Costs in Patients with Acute Coronary Syndromes: A Retrospective, Observational Database Analysis in China.

Clin Ther 2019 Feb 12. Epub 2019 Feb 12.

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
February 2019

Outpatient Antimicrobial Stewardship: Targets for Community-Acquired Pneumonia.

Clin Ther 2019 Feb 7. Epub 2019 Feb 7.

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
February 2019
1 Read

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
4 Reads

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

Clin Ther 2019 Jan 31. Epub 2019 Jan 31.

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
January 2019

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 Jan 30. 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
January 2019
1 Read

Clinical Therapeutics in Hong Kong.

Clin Ther 2019 Jan 29. 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
January 2019

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

Clin Ther 2019 Jan 29. Epub 2019 Jan 29.

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

Purpose: Therapy in 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
January 2019
1 Read

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

Clin Ther 2019 Jan 29. Epub 2019 Jan 29.

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
January 2019
2 Reads

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

Clin Ther 2019 Jan 25. 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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http://dx.doi.org/10.1016/j.clinthera.2018.12.017DOI Listing
January 2019

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 Jan 18. 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
January 2019
3 Reads

Relationship Between Exercise-induced Oxidative Stress Changes and Parasympathetic Activity in Chronic Fatigue Syndrome: An Observational Study in Patients and Healthy Subjects.

Clin Ther 2019 Jan 18. Epub 2019 Jan 18.

Pain in Motion International Research Group, Belgium(12); Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussels, Belgium.

Purpose: Oxidative stress has been proposed as a contributor to pain in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). During incremental exercise in patients with ME/CFS, oxidative stress enhances sooner and antioxidant response is delayed. We explored whether oxidative stress is associated with pain symptoms or pain changes following exercise, and the possible relationships between oxidative stress and parasympathetic vagal nerve activity in patients with ME/CFS versus healthy, inactive controls. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.12.012DOI Listing
January 2019
1 Read

A Proof-of-Concept Study Using Quantitative Sensory Threshold Analysis to Compare 2 Intraoral Topical Anesthetics.

Clin Ther 2019 Jan 16. Epub 2019 Jan 16.

Stephen A. Cooper DMD, PhD, LLC, Palm Beach Gardens, FL, USA.

Purpose: CTY-5339A is an investigational topical anesthetic spray containing 14% benzocaine/2% tetracaine in a metered canister. Each spray delivers ∼0.2 mL of solution. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183060
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http://dx.doi.org/10.1016/j.clinthera.2018.12.009DOI Listing
January 2019
3 Reads

Primary Care Management of Patients With Type 2 Diabetes: Overcoming Inertia and Advancing Therapy With the Use of Injectables.

Clin Ther 2019 Jan 14. Epub 2019 Jan 14.

Mercy Diabetes Center, Janesville, WI, United States.

Type 2 diabetes (T2D) is a progressive disease caused by insulin resistance and associated progressive β-cell functional decline, as well as multiple other related metabolic and pathophysiologic changes. Left unchecked, T2D increases the risk of long-term microvascular and cardiovascular complications and is associated with excess morbidity and mortality. Despite multiple effective options for reducing hyperglycemia, patients are not optimally managed, largely due to delays in appropriate and timely advancement of therapy. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183059
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http://dx.doi.org/10.1016/j.clinthera.2018.11.015DOI Listing
January 2019
6 Reads

Policy Change for Deep Vein Thrombosis: Effects on Length of Stay and Hospitalization Costs of Moving From Warfarin to Direct Oral Anticoagulants.

Clin Ther 2019 Jan 11. Epub 2019 Jan 11.

Renown Institute for Heart and Vascular Health, Reno, NV, USA.

Purpose: Renown Health (Reno, Nevada), a large, locally owned, not-for-profit integrated health care network, has developed an institution-wide policy to shift the treatment of deep vein thrombosis (DVT) from a short-acting anticoagulant and vitamin K antagonist to the direct oral anticoagulant rivaroxaban combined with pharmacy-directed follow-up at an outpatient anticoagulation clinic. We examined data on hospitalizations and costs pre-/post-policy change.

Methods: Data were obtained from the electronic health records of adults with newly diagnosed DVT treated at Renown Health. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.12.006DOI Listing
January 2019
2 Reads

Pharmacokinetics and Safety of Enzalutamide in Healthy Chinese Male Volunteers.

Clin Ther 2019 Jan 11. Epub 2019 Jan 11.

Shanghai Xuhui Central Hospital, Shanghai, China. Electronic address:

Purpose: This open-label, single-dose study evaluated the pharmacokinetic profiles of enzalutamide and its major metabolites and the safety of enzalutamide in healthy, Chinese male volunteers.

Methods: Fourteen volunteers (median age, 28.5 years) received a single oral dose of enzalutamide (160 mg) under fasting conditions on day 1 and were followed for 50 days. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183060
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http://dx.doi.org/10.1016/j.clinthera.2018.12.002DOI Listing
January 2019
5 Reads

Cost-effectiveness of Osimertinib as First-line Treatment and Sequential Therapy for EGFR Mutation-Positive Non-Small Cell Lung Cancer in China.

Clin Ther 2019 Jan 10. Epub 2019 Jan 10.

Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China. Electronic address:

Purpose: This study aimed to evaluate the cost-effectiveness of osimertinib with gefitinib or erlotinib as first-line and sequential therapy for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) in China.

Methods: The Markov model was used, and the study included 3 health states over a 10-year period. Transition probabilities and safety data were collected from the FLAURA (AZD9291 versus gefitinib or erlotinib in patients with locally advanced or metastatic Non-small Cell Lung Cancer) trial. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183060
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http://dx.doi.org/10.1016/j.clinthera.2018.12.007DOI Listing
January 2019
5 Reads

Medication Adherence, Health Care Utilization, and Costs in Patients With Major Depressive Disorder Initiating Adjunctive Atypical Antipsychotic Treatment.

Clin Ther 2019 Jan 4. Epub 2019 Jan 4.

Partnership for Health Analytic Research, LLC, Beverly Hills, CA, USA.

Purpose: The purpose of this study was to compare medication adherence, health care utilization, and cost among patients receiving adjunctive treatment for major depressive disorder (MDD) with brexpiprazole, quetiapine, or lurasidone.

Methods: Using Truven Health MarketScan® Commercial, Medicaid, and Medicare Supplemental Databases, we identified adults with MDD initiating adjunctive treatment with brexpiprazole, quetiapine, or lurasidone (index atypical antipsychotic [AAP]). We compared medication adherence and persistence measured by proportion of days covered (PDC) and treatment duration of index AAP, all-cause and psychiatric hospital care (hospitalization or emergency department visit), and medical costs during 6-month follow-up. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183060
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http://dx.doi.org/10.1016/j.clinthera.2018.12.005DOI Listing
January 2019
3 Reads

Humanistic Burden of Refractory and Nonrefractory Chronic Idiopathic Urticaria: A Real-World Study in the United States.

Clin Ther 2018 Dec 31. Epub 2018 Dec 31.

Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address:

Purpose: Chronic idiopathic urticaria (CIU) is a debilitating skin condition that can profoundly affect patients' quality of life. This study explored the impact of refractory and nonrefractory CIU on patients in the real-world setting in the United States.

Methods: Data were collected from the Adelphi Real World 2015 Urticaria Disease-Specific Programme. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.12.004DOI Listing
December 2018
3 Reads

"Inflamma" and Other "Somes".

Authors:
Richard I Shader

Clin Ther 2019 Jan 29;41(1):2-5. Epub 2018 Dec 29.

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http://dx.doi.org/10.1016/j.clinthera.2018.12.011DOI Listing
January 2019
1 Read

Effects of Acute GLP-1 Infusion on Pulmonary and Systemic Hemodynamics in Patients With Heart Failure: A Pilot Study.

Clin Ther 2019 Jan 28;41(1):118-127.e0. Epub 2018 Dec 28.

Department of Interventional Cardiology, Royal Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom. Electronic address:

Purpose: Cardiovascular-safety studies assessing glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase 4 inhibitors have provided inconsistent data on the risk for developing heart failure. Animal studies have shown that GLP-1 is a vasodilator; if confirmed in humans, this may ameliorate heart failure symptoms.

Methods: In a single-center, observational pilot study, we recruited 10 patients with advanced heart failure undergoing right heart catheterization, and we recorded pulmonary hemodynamic measures, including cardiac output calculated by thermodilution and the indirect Fick method before and after a 15-minute continuous infusion of native GLP-1 (7-36) NH. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.11.013DOI Listing
January 2019
1 Read

A Phase I, Randomized, Crossover, Open-Label Study of the Pharmacokinetics of Solriamfetol (JZP-110) in Healthy Adult Subjects With and Without Food.

Clin Ther 2018 Dec 28. Epub 2018 Dec 28.

Jazz Pharmaceuticals, Palo Alto, CA, United States.

Purpose: Solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects, is currently being evaluated for the reduction of sleepiness and improvement of wakefulness in patients with narcolepsy and obstructive sleep apnea. The purpose of this study was to evaluate the effect of food on the pharmacokinetic (PK) parameters and bioavailability of solriamfetol at the highest intended therapeutic dose in healthy adults and to characterize its renal excretion under fasting conditions.

Methods: In this open-label, randomized, crossover study, healthy adult subjects received a single 300-mg dose of solriamfetol in a fasted condition (10 h) and in a fed condition (30 min after the start of a standardized high-fat, high-calorie breakfast), with at least a 7-day washout period between doses. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.12.001DOI Listing
December 2018
2 Reads

Disclosures.

Authors:
Richard I Shader

Clin Ther 2019 Jan 28;41(1). Epub 2018 Dec 28.

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http://dx.doi.org/10.1016/j.clinthera.2018.12.010DOI Listing
January 2019
1 Read

Colchicine in Cardiovascular Disease: Repurposing an Ancient Gout Drug.

Authors:
Peter L Thompson

Clin Ther 2019 Jan 27;41(1):8-10. Epub 2018 Dec 27.

Heart Research Institute, Sir Charles Gairdner Hospital Medical School, University of Western Australia, Crawley, Western Australia, Australia; Harry Perkins Institute of Medical Research, Perth, Western Australia, Australia. Electronic address:

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http://dx.doi.org/10.1016/j.clinthera.2018.11.014DOI Listing
January 2019
2 Reads

Post-myocardial Infarction (MI) Care: Medication Adherence for Secondary Prevention After MI in a Large Real-world Population.

Clin Ther 2019 Jan 24;41(1):107-117. Epub 2018 Dec 24.

Institute of Primary Care, University of Zürich, University Hospital of Zürich, Zürich, Switzerland.

Purpose: Secondary medication prevention after acute myocardial infarction (MI) is strongly recommended in international guidelines, but actual use, adherence, and outcomes in current clinical practice are largely unknown. Therefore, the aims of this study were to determine the current adherence to medications for secondary prevention after MI and to estimate the association between medication adherence and mortality and major adverse cardiovascular events (MACE) in a large real-world population.

Methods: Using a large health care claims database, patients were selected who had been hospitalized with MI between 2012 and 2015 (N = 4349). Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.11.012DOI Listing
January 2019
2 Reads

Why Colchicine Should Be Considered for Secondary Prevention of Atherosclerosis: An Overview.

Clin Ther 2019 Jan 24;41(1):41-48. Epub 2018 Dec 24.

GenesisCare, Perth, Western Australia, Australia; Heart Research Institute, Perth, Western Australia; Harry Perkins Institute of Medical Research, Nedlands, Western Australia, Australia; Sir Charles Gairdner Hospital, University of Western Australia, Nedlands, Western Australia, Australia.

Purpose: Colchicine is a widely available, inexpensive drug with a range of antiinflammatory properties that may make it suitable for the secondary prevention of atherosclerosis. This review examines how past and contemporary approaches to antiinflammatory therapy for atherosclerosis have led to a better understanding of the nature of the disease and sets out the reasons why colchicine has the potential to become a cornerstone therapy in its management.

Methods: We performed a literature search using PubMed, the Cochrane library, and clinical trial registries to identify completed and ongoing clinical studies on colchicine in coronary artery disease, and a PubMed search to identify publications on the mechanism of action of colchicine relevant to atherosclerosis. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.11.016DOI Listing
January 2019
3 Reads

Prevalence of Medication Nonadherence to Co-medication Compared to Immunosuppressants in Heart Transplant Recipients: Findings From the International Cross-sectional BRIGHT Study.

Clin Ther 2019 Jan 24;41(1):130-136. Epub 2018 Dec 24.

Institute of Nursing Science, Department Public Health, Faculty of Medicine, University of Basel, Basel, Switzerland; Academic Centre for Nursing and Midwifery, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium. Electronic address:

Purpose: To assess and compare the prevalence of medication nonadherence (MNA) (implementation and persistence) to immunosuppressants and co-medications in heart transplant recipients.

Methods: MNA prevalence was assessed using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (self-report) and compared using logistic regression in a 4-continent sample of 1397 heart transplant recipients from 36 heart transplant centers in 11 countries.

Findings: MNA was significantly (α = 0. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.11.007DOI Listing
January 2019
1 Read

Letter: Quest for the Best in Relapsed/Refractory Multiple Myeloma: A Mis-placed ENDEAVOR.

Clin Ther 2019 Jan 23;41(1):186-187. Epub 2018 Dec 23.

Amgen Inc, Thousand Oaks, CA, USA.

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http://dx.doi.org/10.1016/j.clinthera.2018.11.010DOI Listing
January 2019
1 Read

In Reply: Network Meta-analyses Are Not About a Single Treatment But About Sets of Regimens.

Clin Ther 2019 Jan 15;41(1):188-190. Epub 2018 Dec 15.

RTI Health Solutions, Manchester, United Kingdom.

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http://dx.doi.org/10.1016/j.clinthera.2018.11.011DOI Listing
January 2019
1 Read

Radiofrequency Catheter Ablation Versus Cryoballoon Ablation in the Treatment of Paroxysmal Atrial Fibrillation: A Cost-effectiveness Analysis in China.

Clin Ther 2019 Jan 14;41(1):78-91. Epub 2018 Dec 14.

Center for Atrial Fibrillation, Heart Center, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. Electronic address:

Purpose: The aim of this study was to evaluate the cost-effectiveness of radiofrequency catheter ablation (RFCA) compared with cryoballoon (CB) ablation in the treatment of patients with paroxysmal atrial fibrillation (PAF) from the payer's perspective in China.

Methods: We constructed a cohort model, combining a 12-month decision-tree model with a lifetime Markov state-transition model, in a hypothetical cohort of patients with drug-refractory PAF managed with either RFCA or CB ablation, to compare the cost-effectiveness of the 2 procedures. Data related to clinical outcomes and costs in this model were obtained from a retrospective 12-month follow-up study in patients in China and from related literature. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183056
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http://dx.doi.org/10.1016/j.clinthera.2018.11.008DOI Listing
January 2019
2 Reads
2.731 Impact Factor

Single-dose Intravenous Safety, Tolerability, and Pharmacokinetics and Absolute Bioavailability of LCB01-0371.

Clin Ther 2019 Jan 15;41(1):92-106. Epub 2018 Dec 15.

Department of Clinical Pharmacology and Therapeutics, ASAN Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address:

Purpose: LCB01-0371 is a novel broad-spectrum oxazolidinone antibacterial agent under investigation for the treatment of infection by gram-positive pathogens, including methicillin-resistant Staphylococcus aureus. This study evaluated the safety, tolerability, and pharmacokinetics of LCB01-0371 after a single intravenous (IV) infusion and determined its absolute oral bioavailability at a therapeutic dose of 800 mg.

Methods: This study was conducted in 2 parts. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.11.009DOI Listing
January 2019
1 Read

Preoperative Low-dose and High-dose Pregabalin and Cardiovascular Response to Endotracheal Intubation: A Prospective, Randomized, Single-blind, Controlled Study in China.

Clin Ther 2019 Jan 13;41(1):68-77. Epub 2018 Dec 13.

Department of Anesthesiology, Qingpu Branch of Zhongshan Hospital affiliated with Fudan University, Shanghai, China.

Purpose: A prospective, randomized, single-blind, controlled clinical study was designed to evaluate the efficacy and tolerability of preoperative pregabalin on cardiovascular response to laryngoscopy and endotracheal intubation.

Methods: Patients aged 18-60 years with an American Society of Anesthesiologists scale score of I or II were recruited and randomly allocated to receive placebo (control), low-dose (150-mg) pregabalin, or high-dose (300-mg) pregabalin. The medications were orally administered 1 hour before general anesthesia. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.11.006DOI Listing
January 2019
4 Reads

Drug Discontinuation in Studies Including a Switch From an Originator to a Biosimilar Monoclonal Antibody: A Systematic Literature Review.

Clin Ther 2019 Jan 11;41(1):155-173.e13. Epub 2018 Dec 11.

Department of Biomathematics, University of Thessaly School of Medicine, Larisa, Greece; Center for Clinical Evidence Synthesis, The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA.

Purpose: In observational studies of patients switched from stable treatment with an originator monoclonal antibody (mAb) to a biosimilar, higher rates of biosimilar discontinuation versus those observed in blinded switching studies have been reported. Because this observation relates to the real-world setting, it has been suggested that switching outside of clinical trials may be associated with nocebo effects. However, real-world data on drug discontinuation and nocebo effects after switching to mAb biosimilars remain limited. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183055
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http://dx.doi.org/10.1016/j.clinthera.2018.11.002DOI Listing
January 2019
2 Reads

Estimating the Cost of Illness of Prostate Cancer in Iran.

Clin Ther 2019 Jan 10;41(1):50-58. Epub 2018 Dec 10.

Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy and Pharmaceutical Management and Economics Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address:

Purpose: Prostate cancer is the second most common cancer among men worldwide. In the past 10 years in Iran, prostate cancer has increased and become more common among hormone-related cancers. As the percentage of seniors in the population increases, the economic burden of this cancer will likely increase significantly. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183055
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http://dx.doi.org/10.1016/j.clinthera.2018.11.001DOI Listing
January 2019
6 Reads

Deconstructing the Pharmacovigilance Hype Cycle.

Clin Ther 2018 Dec;40(12):1981-1990.e3

Pfizer Inc, New York, NY, USA.

Data science is making increasing contributions to pharmacovigilance. Although the technical innovation of these works are indisputable, efficient progress in real-world pharmacovigilance signal detection may be hampered by corresponding technology life cycle effects, with a resulting tendency to conclude that, with large enough datasets and intricate algorithms, "the numbers speak for themselves," discounting the importance of clinical and scientific judgment. A practical consequence is overzealous declarations regarding the safety or lack of safety of drugs. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.10.021DOI Listing
December 2018
1 Read

Pharmacovigilance and Some Thoughts About What We Eat.

Authors:
Richard I Shader

Clin Ther 2018 Dec;40(12):1957-1961

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http://dx.doi.org/10.1016/j.clinthera.2018.11.005DOI Listing
December 2018
1 Read

Effects of Perioperative Dexmedetomidine on Postoperative Mortality and Morbidity: A Systematic Review and Meta-analysis.

Clin Ther 2019 Jan 7;41(1):138-154.e4. Epub 2018 Dec 7.

Departments of Anesthesiology, Intensive Care Medicine, and Pain Medicine, First Affiliated Hospital of Soochow University, Suzhou, China.

Purpose: Major postoperative complications translate into increased health care resource utilization, prolonged hospital stays, and increased mortality. We aimed to assess the effects of perioperative dexmedetomidine use on postoperative mortality and the prevalence of major complications after cardiac and noncardiac surgery.

Methods: We searched the PubMed, EMBASE, and Cochrane databases to analyze all published evidence from randomized controlled trials (RCTs) and cohort studies comparing perioperative dexmedetomidine use versus no dexmedetomidine use in adult patients undergoing cardiac and noncardiac surgery. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.10.022DOI Listing
January 2019
4 Reads

Current Trends in Clinical Development of Gene and Cellular Therapeutic Products for Cancer in Japan.

Clin Ther 2019 Jan 7;41(1):174-184.e3. Epub 2018 Dec 7.

Department of Translational Research Promotion Incubation Center for Advanced Medical Science, Kyushu University, Fukuoka, Japan.

Purpose: In Japan, gene therapy and cellular therapy are categorized as regenerative medicine products based on the Pharmaceuticals and Medical Devices Law that was implemented in 2014. In this new law, regenerative medicine products were newly defined, and a conditional and term-limited approval system for regenerative medicine products was instituted. In addition, the Ministry of Health, Labour and Welfare instituted the SAKIGAKE (meaning pioneer or forerunner in Japanese) designation system in 2015. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183055
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http://dx.doi.org/10.1016/j.clinthera.2018.11.003DOI Listing
January 2019
9 Reads

Association Between Immune-Related Adverse Events and Clinical Efficacy in Patients with Melanoma Treated With Nivolumab: A Multicenter Retrospective Study.

Clin Ther 2019 Jan 7;41(1):59-67. Epub 2018 Dec 7.

Department of Pharmacy, Tokushima University Hospital, Kuramoto, Tokushima, Japan; Department of Clinical Pharmacology and Therapeutics, Tokushima University Graduate School of Biomedical Sciences, Kuramoto, Tokushima, Japan. Electronic address:

Purpose: Nivolumab, an anti-programmed death 1 antibody, produces antitumor effects by activating host immunity, which also causes immune-related adverse events (irAEs). The aim of this study was to analyze the association between antitumor effect and irAEs induced by nivolumab in patients with melanoma.

Methods: Fifteen patients with melanoma who had received nivolumab at Tokushima University Hospital or Ehime University Hospital between January 2015 and December 2016 were enrolled in this study. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.11.004DOI Listing
January 2019
1 Read

Rituximab Serum Concentrations and Anti-Rituximab Antibodies During B-Cell Depletion Therapy for Myalgic Encephalopathy/Chronic Fatigue Syndrome.

Clin Ther 2018 Nov 28. Epub 2018 Nov 28.

Section of Clinical Pharmacology, Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Science, University of Bergen, Norway.

Purpose: Previous Phase II trials indicated clinical benefit from B-cell depletion using the monoclonal anti-CD20 antibody rituximab in patients with myalgic encephalopathy/chronic fatigue syndrome (ME/CFS). The association between rituximab serum concentrations and the effect and clinical relevance of antidrug antibodies (ADAs) against rituximab in ME/CFS is unknown. We retrospectively measured rituximab concentrations and ADAs in serum samples from patients included in an open-label Phase II trial with maintenance rituximab treatment (KTS-2-2010) to investigate possible associations with clinical improvement and clinical and biochemical data. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.10.019DOI Listing
November 2018
1 Read

Comparative Pharmacokinetics of a Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and an Immediate-release Pregabalin Capsule in Healthy Male Volunteers.

Clin Ther 2018 Dec 27;40(12):2112-2124. Epub 2018 Nov 27.

Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea; Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju, Republic of Korea. Electronic address:

Purpose: Pregabalin is a widely used drug for the management of neuropathic pain. This study compared the pharmacokinetics of the GLA5PR GLARS-NF1 tablet, a 150-mg controlled-release formulation of pregabalin taken once daily, with those of a 75-mg immediate-release (IR) capsule formulation of pregabalin taken twice daily with a 12-h interval between doses.

Methods: Two separate studies, single dose and multiple dose, were conducted with a sequence-randomized, open-label crossover design. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S01492918183051
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http://dx.doi.org/10.1016/j.clinthera.2018.10.017DOI Listing
December 2018
3 Reads

Relationship Between Symptoms and Health-related Quality-of-life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR.

Clin Ther 2018 Dec 24;40(12):2006-2020.e2. Epub 2018 Nov 24.

Dana-Farber Cancer Institute, Boston, MA, USA.

Purpose: Patients with metastatic neuroendocrine tumors and carcinoid syndrome (CS) may experience chronic, recurring symptoms despite somatostatin analogue therapy. Little is known about the relationship between bowel movement (BM) frequency, patient-reported symptoms and health-related quality of life (QoL). Data from the TELESTAR study were used in exploratory, post hoc analyses to understand the relationship between durable reductions in BM frequency, symptom relief, and health-related QoL. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.10.008DOI Listing
December 2018
4 Reads

Pharmacovigilance: Challenges in Getting From Here to There.

Authors:
Paul Beninger

Clin Ther 2018 Dec 23;40(12):1964-1966. Epub 2018 Nov 23.

Public Health & Community Medicine, Tufts University School of Medicine, Boston, MA USA.

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http://dx.doi.org/10.1016/j.clinthera.2018.10.020DOI Listing
December 2018
1 Read

Effects of the Intravenous Calcimimetic Etelcalcetide on Bone Turnover and Serum Fibroblast Growth Factor 23: Post Hoc Analysis of an Open-label Study.

Clin Ther 2018 Dec 23;40(12):2099-2111. Epub 2018 Nov 23.

Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.

Purpose: Secondary hyperparathyroidism (SHPT) is a serious complication that increases the risk of bone disorders in patients with chronic kidney disease (CKD) undergoing hemodialysis. Etelcalcetide is the first injectable calcimimetic approved for treatment of SHPT, which reduces bone turnover markers and suppresses intact fibroblast growth factor 23 (iFGF-23). This study aimed to explore the associations between etelcalcetide-induced changes in circulating factors and serum iFGF-23 levels. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.10.016DOI Listing
December 2018
7 Reads

Effectiveness of Delayed-release Dimethyl Fumarate on Clinical and Patient-reported Outcomes in Patients With Relapsing Multiple Sclerosis Switching From Glatiramer Acetate: RESPOND, a Prospective Observational Study.

Clin Ther 2018 Dec 22;40(12):2077-2087. Epub 2018 Nov 22.

Biogen, Cambridge, MA, USA. Electronic address:

Purpose: The goal of this study was to evaluate clinical outcomes and patient-reported outcomes (PROs) over 12 months in patients with relapsing multiple sclerosis (RMS) who switched from glatiramer acetate (GA) to delayed-release dimethyl fumarate (DMF) 240 mg BID after suboptimal response to GA in real-world clinical practice.

Methods: The RESPOND (Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS) study was a Phase IV, prospective, multicenter, open-label, single-arm, 12-month observational trial. The study was conducted in the United States at 63 sites between August 2013 and February 2016. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.10.011DOI Listing
December 2018
10 Reads

Clopidogrel Versus Aspirin for the Treatment of Acute Coronary Syndrome After a 12-Month Dual Antiplatelet Therapy: A Cost-effectiveness Analysis From China Payer's Perspective.

Clin Ther 2018 Dec 22;40(12):2125-2137. Epub 2018 Nov 22.

Health Economic Research Institute, Sun Yat-sen University, Guangzhou, China. Electronic address:

Purpose: Monotherapy with either aspirin or clopidogrel is recommended for long-term use after discontinuation of dual-antiplatelet therapy (DAPT) for acute coronary syndrome (ACS) management after percutaneous coronary intervention (PCI). The present study is to evaluate the cost-effectiveness of clopidogrel versus aspirin after 12-month DAPT for patients with ACS who underwent PCI in China.

Methods: A 2-part model was developed to estimate the cost-effectiveness of clopidogrel compared with aspirin. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.10.018DOI Listing
December 2018
6 Reads
2.731 Impact Factor

Tacrolimus Concentrations Measured in Excreted Bile in Liver Transplant Recipients: The STABILE Study.

Clin Ther 2018 Dec 19;40(12):2088-2098. Epub 2018 Nov 19.

Inserm, CIC 1414 (Centre d'Investigation Clinique de Rennes), Rennes, France; Faculté de Médecine, Université Rennes, Rennes, France; Department of Clinical and Biological Pharmacology and Pharmacovigilance, CHU Rennes, Rennes, France.

Purpose: Tacrolimus (TAC) is the main immunosuppressive drug in liver transplantation. Despite intensive therapeutic drug monitoring (TDM) that relies on whole blood trough concentration (TAC), patients still present with acute cellular rejection or TAC-related toxic effects with concentrations within the therapeutic range. TAC concentration in peripheral blood mononuclear cells (TAC) is considered as an efficient surrogate marker of TAC efficacy. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.10.015DOI Listing
December 2018
16 Reads

Pharmacovigilance is Everyone's Concern: Let's Work It Out Together.

Authors:
Bruce A Donzanti

Clin Ther 2018 Dec 26;40(12):1967-1972. Epub 2018 Oct 26.

Genentech Inc, A Member of the Roche Group, South San Francisco, CA, USA. Electronic address:

In recent decades, the field of drug safety/pharmacovigilance (PV) has advanced dramatically in some ways and yet has remained stagnant or progressed slowly in others. One way to assess the PV landscape is to view it through both a regulatory lens and a science and technology lens. This commentary highlights some of the current PV issues that can be resolved by sustained collaboration among all relevant stakeholders. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.09.016DOI Listing
December 2018
2 Reads

On the Policy of the Italian Government in the Discovery, Development, and Access to Medicines.

Clin Ther 2018 Nov 27;40(11):1931-1940. Epub 2018 Oct 27.

Department of Experimental Medicine - Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", Napoli, Italy.

This commentary outlines how discovery, development, and access to medicines are regulated and promoted in Italy by the government through the Ministry of University and Research, the Ministry of Health, and the Italian Medicines Agency. We describe and comment on the existing research programs stimulating preclinical, translational, and clinical research and how access to medicines and their pricing is regulated by Italy's National Health Service both at the national and regional levels. Finally, we describe the current scenario of industrial research and medicines manufacturing. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.09.015DOI Listing
November 2018
13 Reads

Identifying Myocardial Ischemia due to Coronary Microvascular Dysfunction in the Emergency Department: Introducing a New Paradigm in Acute Chest Pain Evaluation.

Clin Ther 2018 Nov 27;40(11):1920-1930. Epub 2018 Oct 27.

Vita Salute University and San Raffaele Hospital, Milan, Italy.

Chest pain stands as one of the most frequent patient presentations in the emergency department (ED). Despite established diagnostic algorithms for identifying several important causes of chest pain, such as acute myocardial infarction (AMI), aortic dissection, and pulmonary embolism, guidance on managing patients with recurrent chest pain, one of the top 3 reasons for repeated hospitalization in the United States, is less defined. The assessment of symptoms, serial ECG, and necrosis biomarkers plays a major role in patient management. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.09.010DOI Listing
November 2018
14 Reads

The Role of Double and Triple Therapy with Direct Oral Anticoagulants in Coronary Artery Disease, Peripheral Artery Disease, and Stroke.

Clin Ther 2018 Nov 24;40(11):1907-1917.e3. Epub 2018 Oct 24.

Brigham and Women's Hospital, Boston, MA, USA.

Purpose: Combining antiplatelet and anticoagulant therapy is often necessary in clinical practice. However, there is limited literature on tolerability and efficacy for triple therapy with the newer direct oral anticoagulants (DOACs). The objective of this study is to characterize the discharge prescribing practice of double versus triple antithrombotic therapy with a DOAC at a large, tertiary academic medical center. Read More

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http://dx.doi.org/10.1016/j.clinthera.2018.09.014DOI Listing
November 2018
14 Reads