Search our Database of Scientific Publications and Authors

I’m looking for a

    1682 results match your criteria Advances in therapy[Journal]

    1 OF 34

    Systematic Literature Review of the Impact of Endocrine Monotherapy and in Combination with Targeted Therapy on Quality of Life of Postmenopausal Women with HR+/HER2- Advanced Breast Cancer.
    Adv Ther 2017 Nov 16. Epub 2017 Nov 16.
    Methodist Hospital, Houston, TX, USA.
    Introduction: A major treatment goal for advanced breast cancer (ABC) is to maintain or ideally improve patient quality of life (QoL). Given the changing disease landscape, this systematic literature review (SLR) aims to assess the impact of endocrine therapies (ET), including ET monotherapy (ET mono) and ET combined with targeted therapy (ET + TT), on QoL of women with HR+/HER2- ABC.

    Methods: A SLR was conducted to identify randomized controlled trials (RCTs) meeting the following criteria: (1) included ET mono or ET + TT, (2) reported QoL outcomes, (3) focused on women with HR+/HER2- ABC, and (4) published after 2007 (when standardized HER2 testing became available). Read More

    Update on the Treatment of Uveitis in Patients with Juvenile Idiopathic Arthritis: A Review.
    Adv Ther 2017 Nov 16. Epub 2017 Nov 16.
    1st and 3rd University Departments of Ophthalmology, Aristotle University of Thessaloniki, Thessaloniki, Greece.
    Chronic uveitis is a common extra-articular manifestation of juvenile idiopathic arthritis. The classic clinical picture is one of chronic anterior uveitis, which usually remains asymptomatic until ocular complications arise. The risk of uveitis is increased in girls with an early onset of oligoarthritis and positive antinuclear antibodies. Read More

    Prolonging Time to Flare in Pediatric Atopic Dermatitis: A Randomized, Investigator-Blinded, Controlled, Multicenter Clinical Study of a Ceramide-Containing Moisturizer.
    Adv Ther 2017 Nov 16. Epub 2017 Nov 16.
    Galderma R&D, Sophia Antipolis, France.
    Introduction: Delaying or preventing flares is important in atopic dermatitis (AD) management. The objective of the study was to evaluate whether using a ceramide-containing moisturizer in addition to a body wash during latent AD can delay flares.

    Methods: This was a randomized, investigator-blinded, parallel-group, controlled study among Chinese children with a history of mild to moderate AD, within 1 week of successful treatment with a topical corticosteroid. Read More

    The Influence of Hepatic and Renal Impairment on the Pharmacokinetics of a Treatment for Herpes Zoster, Amenamevir (ASP2151): Phase 1, Open-Label, Single-Dose, Parallel-Group Studies.
    Adv Ther 2017 Nov 13. Epub 2017 Nov 13.
    Division of Clinical Pharmacology, University of Miami, Miami, FL, USA.
    Introduction: Amenamevir (ASP2151) is a nonnucleoside human herpesvirus helicase-primase inhibitor that was approved in Japan for the treatment of herpes zoster (shingles) in 2017. This article reports the results of two clinical trials that investigated the effects of renal and hepatic impairment on the pharmacokinetics of amenamevir.

    Methods: These studies were phase 1, open-label, single-dose (oral 400 mg), parallel-group studies evaluating the pharmacokinetics, safety, and tolerability of amenamevir in healthy participants and participants with moderate hepatic impairment and mild, moderate, and severe renal impairment. Read More

    Overall Survival of Patients with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma Treated with Nimotuzumab in the Real World.
    Adv Ther 2017 Nov 13. Epub 2017 Nov 13.
    Center of Molecular Immunology, Calle 216 esq 15, 11600, Atabey, Havana, Cuba.
    Introduction: Despite improvements in surgical techniques and treatments introduced into clinical practice, the overall survival of patients with esophageal squamous cell carcinoma remains low. Several epidermal growth factor receptor inhibitors are being evaluated in the context of clinical trials, but there is little evidence of effectiveness in real-world conditions. This study aimed at assessing the effectiveness of nimotuzumab combined with onco-specific treatment in Cuban real-life patients with locally advanced or metastatic esophageal squamous cell carcinoma. Read More

    Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies.
    Adv Ther 2017 Nov 13. Epub 2017 Nov 13.
    Astellas Pharma Inc., Tokyo, Japan.
    Introduction: Amenamevir (ASP2151) is a nonnucleoside antiherpesvirus compound available for the treatment of varicella-zoster virus infections. In this article we summarize the findings of four phase 1 studies in healthy participants.

    Methods: Four randomized phase 1 studies investigated the safety and pharmacokinetics of single and multiple doses of amenamevir, including the assessment of age group effect (nonelderly vs elderly), food effect, and the relative bioavailability of two formulations. Read More

    Evaluation of the Efficiency of Single-Inhaler Combination Therapy with Budesonide/Formoterol Fumarate in Patients with Bronchial Asthma in Daily Clinical Practice.
    Adv Ther 2017 Nov 8. Epub 2017 Nov 8.
    Department of Internal Medicine and Oncological Chemotherapy, Medical Faculty in Katowice, Medical University of Silesia, Katowice, Poland.
    Introduction: The effectiveness of single-inhaler budesonide/formoterol fumarate combination therapy for asthma has been previously shown for the original product. The aim of this nonrandomized, open-label, postauthorization efficacy study (PAES) real-life clinical assessment was to evaluate the clinical effectiveness of a second product (Bufomix Easyhaler(®)) in the daily clinical practice of asthma therapy.

    Methods: This multicenter PAES was conducted by 220 unselected allergologists and pulmonologists who enrolled 2200 adult outpatients (age 49. Read More

    The Concomitant Use of Diuretics, Non-Steroidal Anti-Inflammatory Drugs, and Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Blockers (Triple Whammy), Extreme Heat, and In-Hospital Acute Kidney Injury in Older Medical Patients.
    Adv Ther 2017 Nov 7. Epub 2017 Nov 7.
    College of Medicine and Public Health, Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, Australia.
    Introduction: We investigated whether the concomitant use of diuretics, non-steroidal anti-inflammatory drugs, and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (triple whammy, TW) predicts in-hospital acute kidney injury (AKI) and whether admission during recorded periods of extreme heat influences this association.

    Methods: We retrospectively collected data on patient characteristics and use of TW/non-TW drugs on admission, AKI (increase in serum creatinine ≥ 27 µmol/l either within the first 48 h of admission or throughout hospitalization, primary outcome), length of stay (LOS), and mortality (secondary outcomes) in medical patients ≥65 years admitted (1) during five consecutive heat waves (HWs) between 2007 and 2009 (n = 382) or (2) either before or after each HW, matched for HW period, age, and admission day of the week (non-HW, controls, n = 1339).

    Results: Number of TW and non-TW drugs, co-morbidities, number of daily admissions, incidence of in-hospital AKI, LOS, and mortality were similar in the HW and non-HW groups. Read More

    The Better Understanding and Recognition of the Disconnects, Experiences, and Needs of Patients with Chronic Idiopathic Constipation (BURDEN-CIC) Study: Results of an Online Questionnaire.
    Adv Ther 2017 Nov 6. Epub 2017 Nov 6.
    Houston Methodist Hospital, Houston, TX, USA.
    Introduction: There is limited literature comparing the experiences and attitudes of patients with chronic idiopathic constipation (CIC) to those of healthcare professionals (HCPs) treating CIC patients. The BURDEN-CIC study was conducted to better understand the experiences and ongoing needs of CIC patients and to assess their alignment versus disconnection with the perceptions and needs of HCPs who treat CIC patients.

    Methods: The BURDEN-CIC study was an author-developed, online questionnaire that used KnowledgePanel(®) to survey individuals with CIC (n = 1223). Read More

    Paliperidone Palmitate Improves and Maintains Functioning in Asia-Pacific Patients with Schizophrenia.
    Adv Ther 2017 Nov 3. Epub 2017 Nov 3.
    Janssen Pharmaceutical Companies of Johnson & Johnson, Singapore, Singapore.
    Introduction: Post hoc analyses (two single-arm studies) were conducted to determine the impact of once-monthly injection of paliperidone palmitate on functioning in adult patients with schizophrenia in the Asia-Pacific region.

    Methods: Study 1 enrolled hospitalized patients with acute exacerbation of schizophrenia, and study 2 enrolled patients with recently diagnosed schizophrenia unsatisfactorily treated with oral antipsychotics. Patients received paliperidone palmitate, 150 mg eq. Read More

    Changes in Healthcare Spending After Diagnosis of Comorbidities Among Endometriosis Patients: A Difference-in-Differences Analysis.
    Adv Ther 2017 Nov 3. Epub 2017 Nov 3.
    Colorado Center for Reproductive Medicine, Lone Tree, CO, USA.
    Introduction: We sought to characterize changes in healthcare spending associated with the onset of 22 endometriosis-related comorbidities.

    Methods: Women aged 18-49 years with endometriosis (N = 180,278) were extracted from 2006-2015 de-identified Clinformatics(®) DataMart claims data. For 22 comorbidities, comorbidity patients were identified on the basis of having a first comorbidity diagnosis after their initial endometriosis diagnosis. Read More

    Muscle Relaxants as a Risk Factor for Vis-à-tergo During Penetrating Keratoplasty: A Prospective Interventional Study.
    Adv Ther 2017 Nov 3. Epub 2017 Nov 3.
    Department of Ophthalmology, University Hospital Halle (Saale), Martin-Luther University Halle-Wittenberg, Halle (Saale), Germany.
    Introduction: This study aimed to investigate the influence of three muscle relaxants on intraocular pressure (IOP), ocular pulse amplitude (OPA), and vis-à-tergo (VAT) in patients undergoing penetrating keratoplasty (PKP) under general anesthesia.

    Methods: Ninety-five patients undergoing PKP were included in this prospective single-center interventional study. IOP and OPA were measured with a dynamic contour tonometer before and 5 min after onset of general anesthesia. Read More

    Comparative Efficacy of Once-Daily Umeclidinium/Vilanterol and Tiotropium/Olodaterol Therapy in Symptomatic Chronic Obstructive Pulmonary Disease: A Randomized Study.
    Adv Ther 2017 Nov 1. Epub 2017 Nov 1.
    Neumología, Hospital de Alta Resolución de Loja, Granada, Spain.
    Introduction: We report the results of the first direct comparison of the once-daily fixed-dose long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) combinations umeclidinium/vilanterol (UMEC/VI) and tiotropium/olodaterol (TIO/OLO) in patients with COPD.

    Methods: This was a randomized, two-period crossover open-label study in symptomatic patients with COPD [age 40 years or older, postbronchodilator forced expiratory volume in 1 s (FEV1) of 70% or less and 50% or more of predicted normal values, and modified Medical Research Council Dyspnoea Scale score of 2 or greater] not receiving inhaled corticosteroid therapy. Patients were randomized to receive UMEC/VI (62. Read More

    Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews.
    Adv Ther 2017 Oct 27. Epub 2017 Oct 27.
    RTI Health Solutions, Research Triangle Park, NC, USA.
    Introduction: To improve understanding of the diabetic gastroparesis (DGP) patient experience and inform the patient-reported outcome measurement strategy for future trials in DGP, qualitative interviews were conducted with participants in a phase 2 clinical trial of a novel DGP treatment.

    Methods: Trial participants were invited to participate in interviews at both the pretreatment visit (PTV) and the end-of-treatment visit (EOTV). The interviews were conducted by experienced qualitative researchers and followed a semistructured interview guide. Read More

    Clinical and Economic Outcomes in Elderly Advanced Renal Cell Carcinoma Patients Starting Pazopanib or Sunitinib Treatment: A Retrospective Medicare Claims Analysis.
    Adv Ther 2017 Oct 26. Epub 2017 Oct 26.
    Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, USA.
    Introduction: Studies indicate similar survival and toxicity between pazopanib and sunitinib, but few have examined real-world outcomes among elderly patients with advanced renal cell carcinoma (RCC). The purpose of this retrospective claims analysis was to assess real-world overall survival (OS), healthcare resource utilization (HRU), and healthcare costs (both all-cause and associated with RCC diagnosis) among elderly advanced RCC patients starting pazopanib or sunitinib treatment.

    Methods: Advanced RCC patients aged 65 years or older who started first-line treatment with pazopanib or sunitinib (index drug; the initiation date was the index date) were identified from the 100% Medicare database plus Part D linkage (January 1, 2006 to December 31, 2014). Read More

    Pharmacokinetic Evaluation of the Interactions of Amenamevir (ASP2151) with Ketoconazole, Rifampicin, Midazolam, and Warfarin in Healthy Adults.
    Adv Ther 2017 Oct 26. Epub 2017 Oct 26.
    Astellas Pharma Inc., Tokyo, Japan.
    Introduction: Amenamevir is a nonnucleoside antiherpes virus compound available for treating herpes zoster infections. Four studies aimed to determine any potential interactions between amenamevir and ketoconazole, rifampicin, midazolam, or warfarin in healthy male participants.

    Methods: Two studies were open-label studies that evaluated the effects of multiple doses of ketoconazole (400 mg) and rifampicin (600 mg) on the pharmacokinetics of a single oral dose of amenamevir. Read More

    Prevalence of Co-existing Autoimmune Disease in Rheumatoid Arthritis: A Cross-Sectional Study.
    Adv Ther 2017 Oct 24. Epub 2017 Oct 24.
    University of British Columbia, Vancouver, BC, Canada.
    Introduction: Many autoimmune diseases, including rheumatoid arthritis (RA), share common mechanisms; however, population-based studies of the magnitude of multiple autoimmune diseases in patients with RA have not been performed.

    Methods: We conducted a cross-sectional study using a US administrative healthcare thcare claims database to screen for prevalence of multiple autoimmune diseases in patients with RA and osteoarthritis (OA). Each patient diagnosed with RA between January 1, 2006 and September 30, 2014 was age- and sex-matched with five patients with OA. Read More

    Treatment Patterns, Complications, and Health Care Utilization Among Endometriosis Patients Undergoing a Laparoscopy or a Hysterectomy: A Retrospective Claims Analysis.
    Adv Ther 2017 Oct 16. Epub 2017 Oct 16.
    AbbVie, Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
    Introduction: Hysterectomy and laparoscopy are common surgical procedures used for the treatment of endometriosis. This study compares outcomes for women who received either procedure within the first year post initial surgery.

    Methods: The study used data from the Truven Health MarketScan claims databases from 2004 to 2013 to identify women aged 18-49 years who received an endometriosis-related laparoscopy or hysterectomy. Read More

    Treatment Persistence and Healthcare Costs Among Patients with Rheumatoid Arthritis Changing Biologics in the USA.
    Adv Ther 2017 Oct 16. Epub 2017 Oct 16.
    Formerly of Sanofi, Bridgewater, NJ, USA.
    Introduction: After a patient with rheumatoid arthritis (RA) fails tumor necrosis factor inhibitor (TNFi) treatment, clinical guidelines support either cycling to another TNFi or switching to a different mechanism of action (MOA), but payers often require TNFi cycling before they reimburse switching MOA. This study examined treatment persistence, cost, and cost per persistent patient among MOA switchers versus TNFi cyclers.

    Methods: This study of Commercial and Medicare Advantage claims data from the Optum Research Database included patients with RA and at least one claim for a TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) between January 2012 and September 2015 who changed to another TNFi or a different MOA therapy (abatacept, tocilizumab, or tofacitinib) within 1 year. Read More

    Sepsis: A Review of Advances in Management.
    Adv Ther 2017 Oct 11. Epub 2017 Oct 11.
    CIBERES, Vall d'Hebron Institut of Research, Barcelona, Spain.
    Infections represent a common health problem in people of all ages. Usually, the response given to them is appropriate and so little treatment is needed. Sometimes, however, the response to the infection is inadequate and may lead to organ dysfunction; this is the condition known as sepsis. Read More

    Assessing the Role of Reversible Contraceptives in the Health Care of Women as it Pertains to Cancer Prevention.
    Adv Ther 2017 Oct 11. Epub 2017 Oct 11.
    The Division of Clinical Genetics, Department of Obstetrics and Gynecology, Feinberg School of Medicine of Northwestern University, Chicago, IL, USA.
    The use of effective and reversible contraception is characterized by many non-contraceptive benefits distinct from its ability to prevent pregnancy. Notably, the use of hormonal and non-hormonal birth control methods is known to impact the risk for developing certain female genital cancers as well as breast and colon cancers. We present here the current understanding of the role of effective and reversible contraceptives in the prevention and development of female genital cancers along with breast and colon cancers. Read More

    Effects of Ketoconazole on the Pharmacokinetics of Mifepristone, a Competitive Glucocorticoid Receptor Antagonist, in Healthy Men.
    Adv Ther 2017 Oct 11;34(10):2371-2385. Epub 2017 Oct 11.
    MedVal Scientific Information Services, LLC, Princeton, NJ, USA.
    Introduction: Mifepristone, a competitive glucocorticoid receptor antagonist approved for Cushing syndrome, and ketoconazole, an antifungal and steroidogenesis inhibitor, are both inhibitors of and substrates for cytochrome P450 (CYP3A4). This study evaluated the pharmacokinetic effects of concomitant ketoconazole, a strong CYP3A4 inhibitor, on mifepristone.

    Methods: In an open-label, two-period, single-center study, healthy adult men received mifepristone 600 mg orally daily for 12 days (period 1) followed by mifepristone 600 mg daily plus ketoconazole 200 mg orally twice daily for 5 days (period 2). Read More

    Pharmacotherapy Choice Is Associated with 2-Year Mortality for Patients with Heart Failure and Reduced Ejection Fraction.
    Adv Ther 2017 Oct 10;34(10):2345-2359. Epub 2017 Oct 10.
    Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
    Introduction: Factors associated with mortality for patients with heart failure and reduced ejection fraction (HFrEF) are known; however, the association between initial pharmacotherapy (IPT) and mortality is unclear in real-world settings.

    Methods: Using a retrospective design and claims database, 14,359 Medicare patients with HFrEF from August 2010 to July 2015 were identified. Index date was first HF claim. Read More

    Challenges Associated with Estimating Utility in Wet Age-Related Macular Degeneration: A Novel Regression Analysis to Capture the Bilateral Nature of the Disease.
    Adv Ther 2017 Oct 10;34(10):2360-2370. Epub 2017 Oct 10.
    Novartis Pharmaceuticals UK Limited, Surrey, UK.
    Introduction: The estimation of utility values for the economic evaluation of therapies for wet age-related macular degeneration (AMD) is a particular challenge. Previous economic models in wet AMD have been criticized for failing to capture the bilateral nature of wet AMD by modelling visual acuity (VA) and utility values associated with the better-seeing eye only.

    Methods: Here we present a de novo regression analysis using generalized estimating equations (GEE) applied to a previous dataset of time trade-off (TTO)-derived utility values from a sample of the UK population that wore contact lenses to simulate visual deterioration in wet AMD. Read More

    Mechanical Ventilation During Resuscitation: How Manual Chest Compressions Affect a Ventilator's Function.
    Adv Ther 2017 Oct 5;34(10):2333-2344. Epub 2017 Oct 5.
    Department of Emergency Medicine, Faculty of Medicine, Philipps University, Marburg, Germany.
    Introduction: Guidelines for resuscitation recommend positive-pressure ventilation with a fixed ventilation rate as provided by an automated transport ventilator during cardiopulmonary resuscitation (CPR) with a secured airway. We investigated the influence of manual chest compressions (CC) on the accuracy of ventilator presets and the quality of CC with intermittent positive-pressure ventilation (IPPV), bilevel ventilation (BiLevel), and the novel ventilation mode chest compression synchronized ventilation (CCSV) in a simulation model.

    Methods: Ninety paramedics performed continuous CC for 2 min on a modified advanced life support mannequin with a realistic lung model. Read More

    Subcutaneous Rituximab for the Treatment of B-Cell Hematologic Malignancies: A Review of the Scientific Rationale and Clinical Development.
    Adv Ther 2017 Oct 5;34(10):2210-2231. Epub 2017 Oct 5.
    Department of Haematology, St. George Hospital, Kogarah, Australia.
    Rituximab (MabThera(®)/Rituxan(®)), a chimeric murine/human monoclonal antibody that binds specifically to the transmembrane antigen CD20, was the first therapeutic antibody to enter clinical practice for the treatment of cancer. As monotherapy and in combination with chemotherapy, rituximab has been shown to prolong progression-free survival and, in some indications overall survival, in patients with various B-cell malignancies, while having a well-established and manageable safety profile and a wide therapeutic window. As a result, rituximab is considered to have revolutionized treatment practices for patients with B-cell malignancies. Read More

    Rituximab in B-Cell Hematologic Malignancies: A Review of 20 Years of Clinical Experience.
    Adv Ther 2017 Oct 5;34(10):2232-2273. Epub 2017 Oct 5.
    Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
    Rituximab is a human/murine, chimeric anti-CD20 monoclonal antibody with established efficacy, and a favorable and well-defined safety profile in patients with various CD20-expressing lymphoid malignancies, including indolent and aggressive forms of B-cell non-Hodgkin lymphoma. Since its first approval 20 years ago, intravenously administered rituximab has revolutionized the treatment of B-cell malignancies and has become a standard component of care for follicular lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukemia, and mantle cell lymphoma. For all of these diseases, clinical trials have demonstrated that rituximab not only prolongs the time to disease progression but also extends overall survival. Read More

    Modeled Health Economic Impact of a Hypothetical Certolizumab Pegol Risk-Sharing Scheme for Patients with Moderate-to-Severe Rheumatoid Arthritis in Finland.
    Adv Ther 2017 Oct 3;34(10):2316-2332. Epub 2017 Oct 3.
    Department of Rheumatology, Helsinki University Hospital, Helsinki, Finland.
    Purpose: To model the American College of Rheumatology (ACR) outcomes, cost-effectiveness, and budget impact of certolizumab pegol (CZP) (with and without a hypothetical risk-sharing scheme at treatment initiation for biologic-naïve patients) versus the current mix of reimbursed biologics for treatment of moderate-to-severe rheumatoid arthritis (RA) in Finland.

    Methods: A probabilistic model with 12-week cycles and a societal approach was developed for the years 2015-2019, accounting for differences in ACR responses (meta-analysis), mortality, and persistence. The risk-sharing scheme included a treatment switch and refund of the costs associated with CZP acquisition if patients failed to achieve ACR20 response at week 12. Read More

    Pharmacological and Non-pharmacological Treatments for Stroke Prevention in Patients with Atrial Fibrillation.
    Adv Ther 2017 Oct 27;34(10):2274-2294. Epub 2017 Sep 27.
    Department of Electrophysiology, HELIOS Heart Center Leipzig, Leipzig, Germany.
    Atrial fibrillation (AF) is associated with significant risk of stroke and other thromboembolic events, which can be effectively prevented using oral anticoagulation (OAC) with either vitamin K antagonists (VKAs) or non-VKA oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban, or edoxaban. Until recently, VKAs were the only available means for OAC treatment. NOACs had similar efficacy and were safer than or as safe as warfarin with respect to reduced rates of hemorrhagic stroke or other intracranial bleeding in the respective pivotal randomized clinical trials (RCTs) of stroke prevention in non-valvular AF patients. Read More

    Content Validity of a Willingness to Quit Tool for Use with Current Smokers in Clinical Practice.
    Adv Ther 2017 Oct 22;34(10):2295-2306. Epub 2017 Sep 22.
    Statistical Research and Data Science Center, Global Product Development, Pfizer Inc., New York, NY, USA.
    Introduction: Despite reductions in rates of smoking in the past decade, smoking remains one of the most significant public health concerns. Quitting smoking can result in reductions in a number of serious health conditions. The brief Willingness to Quit (WTQ) tool can be used in routine clinical practice to assess current willingness to quit and engage a patient-physician dialogue regarding smoking cessation. Read More

    Concurrent Improvement in Both Binge Eating and Depressive Symptoms with Naltrexone/Bupropion Therapy in Overweight or Obese Subjects with Major Depressive Disorder in an Open-Label, Uncontrolled Study.
    Adv Ther 2017 Oct 16;34(10):2307-2315. Epub 2017 Sep 16.
    Lindner Center of HOPE, Research Institute, Mason, OH, USA.
    Introduction: Binge eating disorder (BED) is associated with obesity and major depressive disorder (MDD). Naltrexone extended-release (ER)/bupropion ER (NB) is approved as an adjunct to diet and physical activity for chronic weight management. In a prospectively designed 24-week open-label, single-arm, single-site trial of 25 women with MDD and overweight/obesity, NB reduced weight and depressive symptoms. Read More

    Methodological Aspects in Studies Based on Clinical Routine Data.
    Adv Ther 2017 Oct 12;34(10):2199-2209. Epub 2017 Sep 12.
    Department of Economics and Business Administration, University of Applied Sciences Stralsund, Stralsund, Germany.
    Randomized controlled clinical trials are regarded as the gold standard for comparing different clinical interventions, but generally their conduct is operationally cumbersome, time-consuming, and expensive. Studies and investigations based on clinical routine data on the contrary utilize existing data acquired under real-life conditions and are increasingly popular among practitioners. In this paper, methodological aspects of studies based on clinical routine data are discussed. Read More

    Insulin Resistance and Hunger in Childhood Obesity: A Patient and Physician's Perspective.
    Adv Ther 2017 Oct 7;34(10):2386-2391. Epub 2017 Sep 7.
    , New York, USA.
    This article is co-authored by the mother of a child with obesity and insulin resistance, who gives her perspective. It is also co-authored by the treating Obesity Medicine clinician and an investigator in obesity clinical research (both certified in Obesity Medicine), who give their perspectives. The discussion focuses upon the potential clinical use of metformin in managing young patients with obesity and insulin resistance. Read More

    Once-Daily Triple Therapy in Patients with Advanced COPD: Healthcare Resource Utilization Data and Associated Costs from the FULFIL Trial.
    Adv Ther 2017 Sep 5;34(9):2163-2172. Epub 2017 Sep 5.
    Respiratory Research and Development, GSK, King of Prussia, PA, USA.
    Introduction: Chronic obstructive pulmonary disease is associated with a high healthcare resource and cost burden. Healthcare resource utilization was analyzed in patients with symptomatic chronic obstructive pulmonary disease at risk of exacerbations in the FULFIL study. Patients received either once-daily, single inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol) 100 µg/62. Read More

    The Impact of Histologic Phenotype in the Treatment of Sinonasal Cancer.
    Adv Ther 2017 Oct 4;34(10):2181-2198. Epub 2017 Sep 4.
    Coordinator of the International Head and Neck Scientific Group, Padua, Italy.
    The management of sinonasal cancer is a challenge due to its low occurrence and anatomical and significant diversity of histological types. The therapeutic modality used should be tailored individually according to the histology, tumour stage, molecular profile and previous treatments. The clinical management of sinonasal cancer has improved greatly owing to developments in endoscopic surgery and precision radiotherapy. Read More

    Efficacy and Safety of Linagliptin in 2681 Asian Patients Stratified by Age, Obesity, and Renal Function: A Pooled Analysis of Randomized Clinical Trials.
    Adv Ther 2017 Sep 17;34(9):2150-2162. Epub 2017 Aug 17.
    Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, Hong Kong, China.
    Introduction: Asian patients with type 2 diabetes (T2D) are younger, leaner, and more likely to develop renal dysfunction than White populations. In this multiethnic analysis of data from phase 3 trials, we investigated the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in Asians stratified by these subphenotypes.

    Methods: Data from randomized, double-blind, placebo-controlled trials evaluating linagliptin (as monotherapy, add-on therapy to metformin ± sulfonylurea, combined with pioglitazone or added to insulin) were pooled with efficacy data from 11 randomized trials of at least 24 weeks and safety data from 15 trials of various durations. Read More

    Foveal Microstructure Analysis in Eyes with Diabetic Macular Edema Treated with Vitrectomy.
    Adv Ther 2017 Sep 14;34(9):2139-2149. Epub 2017 Aug 14.
    Department of Ophthalmology, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan.
    Introduction: The purpose of this study was to evaluate baseline and postoperative factors affecting outcomes after vitrectomy for diabetic macular edema (DME) using optical coherence tomography (OCT).

    Methods: Vitrectomy combined with inner limiting membrane (ILM) peeling and additional laser photocoagulation therapy was performed on 36 eyes of 30 DME patients. Evaluations included the logarithm of the minimal angle of resolution (logMAR), best-corrected visual acuity (BCVA) and OCT parameters at baseline and 1, 3, 6, and 12 months postoperatively. Read More

    Cost-Effectiveness of Posaconazole Tablets for Invasive Fungal Infections Prevention in Acute Myelogenous Leukemia or Myelodysplastic Syndrome Patients in Spain.
    Adv Ther 2017 Sep 14;34(9):2104-2119. Epub 2017 Aug 14.
    Pharmacy Department, Del Mar Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.
    Introduction: Posaconazole is superior to fluconazole (FLU) and itraconazole (ITRA) in the prevention of invasive fungal diseases (IFDs) in neutropenic patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). A new tablet formulation of posaconazole with improved pharmacokinetic and pharmacodynamic properties compared to posaconazole oral solution has recently been approved. The objective of this study is to estimate the cost-effectiveness of the newly developed posaconazole tablets versus FLU oral suspension or ITRA oral solution for preventing IFDs in high-risk neutropenic patients with AML or MDS and from the perspective of the Spanish National Health System (NHS). Read More

    A Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers.
    Adv Ther 2017 Sep 14;34(9):2071-2082. Epub 2017 Aug 14.
    Genentech Inc., 1 DNA way, South San Francisco, CA, 94080-4990, USA.
    Introduction: Pirfenidone film-coated tablets were developed to offer an alternative to the marketed capsule formulation. This study assessed the bioequivalence of the tablet and capsule formulations under fed and fasted states.

    Methods: A Phase I, open-label, randomized, four-treatment-period, four-sequence, crossover pharmacokinetics study (NCT02525484) was conducted. Read More

    Assessment of Pharmacokinetic Interactions Between Obeticholic Acid and Caffeine, Midazolam, Warfarin, Dextromethorphan, Omeprazole, Rosuvastatin, and Digoxin in Phase 1 Studies in Healthy Subjects.
    Adv Ther 2017 Sep 14;34(9):2120-2138. Epub 2017 Aug 14.
    Intercept Pharmaceuticals Inc., San Diego, CA, USA.
    Introduction: Obeticholic acid (OCA), a potent and selective farnesoid X receptor agonist, is indicated for the treatment of primary biliary cholangitis (PBC). We investigated the potential drug-drug interaction effect of OCA on metabolic CYP450 enzymes and drug transporters.

    Methods: Five phase 1 single-center, open-label, fixed-sequence, inpatient studies were conducted in healthy adult subjects to evaluate the effect of oral daily doses of 10 or 25 mg OCA on single-dose plasma pharmacokinetics of specific probe substrates for enzymes CYP1A2 (caffeine, R-warfarin), CYP3A (midazolam, R-warfarin), CYP2C9 (S-warfarin), CYP2D6 (dextromethorphan), CYP2C19 (omeprazole), and drug transporters, BCRP/OATP1B1/OATP1B3 (rosuvastatin), and P-gp (digoxin). Read More

    Health-Related Quality of Life in Individuals with Down Syndrome: Results from a Non-Interventional Longitudinal Multi-National Study.
    Adv Ther 2017 Aug 9;34(8):2058-2069. Epub 2017 Aug 9.
    Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
    Introduction: To date, there is little research on health-related quality of life (HRQoL) in Down syndrome (DS), and existing research is variable with regard to reported HRQoL in DS. There are also no HRQoL measures developed specifically to be used with individuals with Down syndrome.

    Methods: A multi-national, longitudinal, 24-week non-interventional study was conducted in adolescents and adults with DS. Read More

    The Patterns of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Use in Patients with Atrial Fibrillation in Seven Balkan Countries: a Report from the BALKAN-AF Survey.
    Adv Ther 2017 Aug 9;34(8):2043-2057. Epub 2017 Aug 9.
    School of Medicine, Belgrade University, Belgrade, Serbia.
    Introduction: Data on management of atrial fibrillation (AF) in the Balkan Region are scarce. To capture the patterns in AF management in contemporary clinical practice in the Balkan countries a prospective survey was conducted between December 2014 and February 2015, and we report results pertinent to the use of non-vitamin K antagonist oral anticoagulants (NOACs).

    Methods: A 14-week prospective, multicenter survey of consecutive AF patients seen by cardiologists or internal medicine specialists was conducted in Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Montenegro, Romania, and Serbia (a total of about 50 million inhabitants). Read More

    Hypoglycemia After Initiation of Basal Insulin in Patients with Type 2 Diabetes in the United States: Implications for Treatment Discontinuation and Healthcare Costs and Utilization.
    Adv Ther 2017 Sep 4;34(9):2083-2092. Epub 2017 Aug 4.
    STATinMED Research, Ann Arbor, MI, USA.
    Introduction: Hypoglycemia and fear of hypoglycemia may contribute to basal insulin discontinuation, poor glycemic control, and increased healthcare burden in patients with type 2 diabetes (T2D). This study aimed to determine the impact of hypoglycemia soon after basal insulin initiation on treatment discontinuation and economic outcomes in patients with T2D.

    Methods: Hypoglycemic events within 6 months of basal insulin initiation were identified using retrospective cohort data from patients with T2D, at least 18 years of age, initiated on basal insulin therapy in the Clinformatics™ Data Mart for Multiplan claims database from January 1, 2008, through August 31, 2012. Read More

    Changes in Healthcare Utilization After Etanercept Initiation in Patients with Rheumatoid Arthritis: A Retrospective Claims Analysis.
    Adv Ther 2017 Sep 2;34(9):2093-2103. Epub 2017 Aug 2.
    Partnership for Health Analytic Research, Beverly Hills, CA, USA.
    Introduction: Effective treatment for rheumatoid arthritis (RA) may lead to lower overall and RA-related healthcare utilization. We evaluated healthcare utilization before and after initiation of the tumor necrosis factor inhibitor etanercept in patients with moderate to severe RA.

    Methods: This retrospective cohort study used data from the MarketScan(®) claims database. Read More

    Catheter Ablation of Atrial Fibrillation: An Overview for Clinicians.
    Adv Ther 2017 Aug 21;34(8):1897-1917. Epub 2017 Jul 21.
    Cardiology Clinic, Clinical Center of Serbia, Višegradska 26, Belgrade, Serbia.
    Catheter ablation (CA) of atrial fibrillation (AF) is currently one of the most commonly performed electrophysiology procedures. Ablation of paroxysmal AF is based on the elimination of triggers by pulmonary vein isolation (PVI), while different strategies for additional AF substrate modification on top of PVI have been proposed for ablation of persistent AF. Nowadays, various technologies for AF ablation are available. Read More

    Prescribing Trends in a Glaucoma Clinic and Adherence to EGS Guidelines: A Retrospective, Non-Interventional, Single-Center UK Study.
    Adv Ther 2017 Aug 19;34(8):2033-2042. Epub 2017 Jul 19.
    Maidstone and Tunbridge Wells NHS Trust, Maidstone, UK.
    Introduction: The purpose of this study was to determine prescribing trends in a specialist glaucoma clinic in the UK. Specifically, the aims were to determine which drugs were prescribed as first-, second-, and third-line treatment, the persistence of first-, second-, and third-line treatment regimens, and the proportion of treatment decisions conforming to the European Glaucoma Society (EGS) guidelines.

    Methods: A retrospective, non-interventional, single-center, case-note review was performed on a cohort of consecutive patients presenting to a specialist glaucoma clinic for follow-up. Read More

    1 OF 34