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    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 Sep 16. 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 Sep 12. 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 Sep 7. 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. 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 Sep 4. 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 Aug 17. 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 Aug 14. 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 Aug 14. 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 Aug 14. 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 Aug 14. 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. 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. 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 Aug 4. 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 Aug 2. 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 Jul 21. 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 Jul 19. 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

    Comparison of the Systemic and Local Pharmacokinetics of Clonidine Mucoadhesive Buccal Tablets with Reference Clonidine Oral Tablets in Healthy Volunteers: An Open-Label Randomised Cross-Over Trial.
    Adv Ther 2017 Jul 19. Epub 2017 Jul 19.
    Simbec Research Limited, Merthyr Tydfil, CF48 4DR, UK.
    Introduction: The clonidine mucoadhesive buccal tablet (MBT) is a novel delivery system resulting in high and sustained concentrations of clonidine in the oral cavity. In a phase II clinical trial, clonidine MBT reduced the incidence of severe oral mucositis (OM) compared to placebo in head and neck cancer patients undergoing chemoradiation. This study compared the pharmacokinetics (PK), safety and tolerability of clonidine MBT with a reference oral tablet (OT). Read More

    Practical Considerations for the Use of Subcutaneous Treatment in the Management of Dyslipidaemia.
    Adv Ther 2017 Jul 17. Epub 2017 Jul 17.
    Department of Endocrinology-Diabetology-Nutrition, Jean Verdier Hospital, APHP, CRNH-IdF, CINFO, Paris Nord University, Bondy, France.
    Suboptimal drug adherence represents a major challenge to effective primary and secondary prevention of cardiovascular disease. While adherence is influenced by multiple considerations, polypharmacy and dosing frequency appear to be rate-limiting factors in patient satisfaction and subsequent adherence. The cardiovascular and metabolic therapeutic areas have recently benefited from a number of advances in drug therapy, in particular protease proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and incretin-based therapies, respectively. Read More

    Patient Perspectives on Gene Transfer Therapy for Sickle Cell Disease.
    Adv Ther 2017 Jul 17. Epub 2017 Jul 17.
    Department of Psychology, University of Cincinnati, Cincinnati, OH, USA.
    Introduction: Sickle cell disease (SCD) is a chronic genetic disease with high morbidity and early mortality; it affects nearly 100,000 individuals in the USA. Bone marrow transplantation, the only curative treatment, is available to less than 20% of patients because of a number of access barriers. Gene transfer therapy (GTT) has been shown to be curative in animal models and is approved for use in humans for early-phase studies at a few centers. Read More

    Intragastric Balloon Treatment for Obesity: Review of Recent Studies.
    Adv Ther 2017 Jul 13. Epub 2017 Jul 13.
    Department of Psychiatry, Mt. Sinai St. Luke's, Icahn School of Medicine at Mt. Sinai, New York, NY, USA.
    Introduction: The FDA recently approved three intragastric balloon (IGB) devices, ReShape, ORBERA™, and Obalon for treatment of obesity. Given the high cost, complication risk, and invasiveness of bariatric surgery, IGB treatment may present a safer and lower cost option for weight reduction. IGBs are generally placed in the stomach endoscopically for up to 6 months to reduce gastric capacity, enhance feelings of fullness, and induce weight loss. Read More

    Burden of Atopic Dermatitis in the United States: Analysis of Healthcare Claims Data in the Commercial, Medicare, and Medi-Cal Databases.
    Adv Ther 2017 Jul 13. Epub 2017 Jul 13.
    Regeneron Pharmaceuticals, Inc., Tarrytown, NJ, USA.
    Introduction: Comparative data on the burden of atopic dermatitis (AD) in adults relative to the general population are limited. We performed a large-scale evaluation of the burden of disease among US adults with AD relative to matched non-AD controls, encompassing comorbidities, healthcare resource utilization (HCRU), and costs, using healthcare claims data. The impact of AD disease severity on these outcomes was also evaluated. Read More

    Fixed-Dose Versus Off-Label Combination of Isosorbide Dinitrate Plus Hydralazine Hydrochloride: Retrospective Propensity-Matched Analysis in Black Medicare Patients with Heart Failure.
    Adv Ther 2017 Jul 13. Epub 2017 Jul 13.
    National Minority Quality Forum, Washington, DC, USA.
    Introduction: Based upon the findings of the African-American Heart Failure Trial, the US Food and Drug Administration approved the fixed-dose combination of isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD) (FDC-ISDN/HYD) as a new drug for treatment of heart failure (HF) in self-identified African Americans. According to the FDA, FDC-ISDN/HYD has no therapeutic equivalent. However, off-label combinations of the separate generic drugs ISDN and HYD (OLC-ISDN+HYD) or isosorbide mononitrate (ISMN) and HYD (OLC-ISMN+HYD) are routinely substituted without any supporting outcome data. Read More

    Dexpanthenol: An Overview of its Contribution to Symptom Relief in Acute Rhinitis Treated with Decongestant Nasal Sprays.
    Adv Ther 2017 Jul 10. Epub 2017 Jul 10.
    Faculty of Medicine, Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany.
    Nasal blockage is the most bothersome symptom of acute rhinitis. Nasal decongestant sprays containing alpha-sympathomimetics, such as oxymetazoline and xylometazoline, have a rapid onset of action. However, this effect decreases with repeated application and, furthermore, the ciliary function of the nasal mucosa is practically paralyzed. Read More

    Short-Term Effects of a Combined Nutraceutical on Lipid Level, Fatty Liver Biomarkers, Hemodynamic Parameters, and Estimated Cardiovascular Disease Risk: A Double-Blind, Placebo-Controlled Randomized Clinical Trial.
    Adv Ther 2017 Jul 7. Epub 2017 Jul 7.
    Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy.
    Introduction: There is a growing interest in nutraceuticals improving cardiovascular risk factor levels and related organ damage.

    Methods: This double-blind, placebo-controlled randomized clinical trial aims to compare the effect of a combined nutraceutical containing red yeast rice (10 mg), phytosterols (800 mg), and L-tyrosol (5 mg) on lipid profile, blood pressure, endothelial function, and arterial stiffness in a group of 60 patients with polygenic hypercholesterolemia resistant to Mediterranean diet.

    Results: After 8 weeks of treatment, when compared to the placebo group, the active treated patients experienced a more favorable percentage change in total cholesterol (-16. Read More

    Prevalence of Lower Urinary Tract Symptoms in China, Taiwan, and South Korea: Results from a Cross-Sectional, Population-Based Study.
    Adv Ther 2017 Jul 7. Epub 2017 Jul 7.
    Astellas Pharma Singapore Pte. Ltd, Singapore, Singapore.
    Introduction: Few population-based data are available evaluating the prevalence of lower urinary tract symptoms (LUTS) in Asia. The objective of our study was to determine LUTS prevalence in China, Taiwan, and South Korea using International Continence Society (ICS) 2002 criteria.

    Methods: An Internet-based self-administered survey among individuals aged at least 40 years with the ability to use a computer and to read the local language. Read More

    Update of Ablative Fractionated Lasers to Enhance Cutaneous Topical Drug Delivery.
    Adv Ther 2017 Jul 7. Epub 2017 Jul 7.
    Dermatology, Larkin Hospital/NSU-COM, South Miami, FL, USA.
    Ablative fractional lasers (AFXL) enhance uptake of therapeutics and this newly emerging field is called laser-assisted drug delivery (LAD). This new science has emerged over the past decade and is finding its way into clinical practice. LAD is poised to change how medicine delivers drugs. Read More

    Treatment Persistence and Clinical Outcomes of Tumor Necrosis Factor Inhibitor Cycling or Switching to a New Mechanism of Action Therapy: Real-world Observational Study of Rheumatoid Arthritis Patients in the United States with Prior Tumor Necrosis Factor Inhibitor Therapy.
    Adv Ther 2017 Jul 3. Epub 2017 Jul 3.
    The Hospital for Special Surgery, New York, NY, USA.
    Introduction: To examine treatment persistence and clinical outcomes associated with switching from a tumor necrosis factor inhibitor (TNFi) to a medication with a new mechanism of action (MOA) (abatacept, anakinra, rituximab, tocilizumab, or tofacitinib) versus cycling to another TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) among patients with rheumatoid arthritis.

    Methods: This retrospective, longitudinal study included patients with rheumatoid arthritis in the JointMan(®) US clinical database who received a TNFi in April 2010 or later and either cycled to a TNFi or switched to a new MOA therapy by March 2015. Cox proportional hazards models were used for time to non-persistence (switching or discontinuing). Read More

    Monovision Versus Multifocality for Presbyopia: Systematic Review and Meta-Analysis of Randomized Controlled Trials.
    Adv Ther 2017 Jul 3. Epub 2017 Jul 3.
    Department of Pharmacology, Zagreb University School of Medicine, Zagreb, Croatia.
    Introduction: Refractive surgery in presbyopia tends to achieve spectacle independence with minimal optical disturbances. We compared monovision to multifocality procedures regarding these outcomes.

    Methods: We conducted a systematic review of published (till November 21, 2016) randomized controlled trials (RCTs) comparing any monovision to any multifocality method or comparing different monovision/multifocality methods to each other that enabled direct or indirect comparisons between particular monovision and particular multifocality procedures in presbyopic patients undergoing cataract-related or unrelated surgery in respect to spectacle independence, unaided binocular visual acuity (VA), contrast sensitivity (CS), and adverse events. Read More

    A Review of the Long-Term Efficacy, Tolerability, and Safety of Exenatide Once Weekly for Type 2 Diabetes.
    Adv Ther 2017 Jul 3. Epub 2017 Jul 3.
    Diabetes Endocrine and Metabolic Diseases Unit, IRCCS MultiMedica, Sesto San Giovanni (MI), Italy.
    Introduction: Exenatide once weekly (ExeOW, Bydureon(®), Astra Zeneca), a drug belonging to the class of glucagon-like peptide-1 (GLP-1) receptor agonists, is the first agent approved for treatment of type 2 diabetes (T2D) that can be administered on a weekly basis.

    Methods: Data concerning treatment of T2D with ExeOW are reviewed with special reference to its long-term efficacy, tolerability, and safety. Relevant literature was identified through the PubMed database from inception to January 2015. Read More

    Intracameral Dexamethasone Injection as Adjuvant Therapy in Endothelial Immune Reaction After Penetrating and Posterior Lamellar Keratoplasty: A Retrospective Clinical Observation.
    Adv Ther 2017 Jun 30. Epub 2017 Jun 30.
    Department of Ophthalmology, Saarland University Medical Center, Homburg/Saar, Germany.
    Introduction: The aim of this observational study is to evaluate the effectiveness of an adjuvant intracameral corticosteroid injection (ICI) in cases of severe endothelial immune reaction (SEIR) (anterior chamber cells and flare, retrocorneal precipitates, Descemet's folds, and corneal edema) after penetrating keratoplasty and posterior lamellar keratoplasty.

    Methods: In this retrospective study, 24 subjects treated between November 2011 and September 2014 were divided into two groups. The control group received topical and systemic steroid therapy while the study group received additionally ICI (400 µg dexamethasone). Read More

    Assessing the Therapeutic Utility of Professional Continuous Glucose Monitoring in Type 2 Diabetes Across Various Therapies: A Retrospective Evaluation.
    Adv Ther 2017 Jun 30. Epub 2017 Jun 30.
    Jothydev's Diabetes Research Centre, Konkalam Road, Mudavanmugal, Trivandrum, Kerala, 695032, India.
    Background: There have been few large studies that have analyzed the effect of professional (masked) continuous glucose monitoring (P-CGM) on glycemic control in patients with type 2 diabetes (T2DM) who were on a broad spectrum of baseline therapies.

    Methods: We performed a retrospective, blinded evaluation of glycemic control in 296 T2DM adults for 6 months following a 6- to 7-day study of their glycemic profile using masked P-CGM. At baseline, 91% of the patients were on some form of insulin treatment with oral hypoglycemic agents (OHA), while 7% were on one or more OHAs without insulin, and the remaining 2% were on GLP-1RAs. Read More

    Clinical and Economic Evaluation of Repository Corticotropin Injection: A Narrative Literature Review of Treatment Efficacy and Healthcare Resource Utilization for Seven Key Indications.
    Adv Ther 2017 Jun 28. Epub 2017 Jun 28.
    Mallinckrodt Pharmaceuticals Inc., Hampton, NJ, USA.
    Introduction: Repository corticotropin injection (RCI; H.P. Acthar(®) Gel; Mallinckrodt Pharmaceuticals Inc. Read More

    Gluten and Aluminum Content in Synthroid(®) (Levothyroxine Sodium Tablets).
    Adv Ther 2017 Jul 26;34(7):1764-1769. Epub 2017 Jun 26.
    AbbVie Inc., North Chicago, IL, USA.
    Introduction: Inquiries from healthcare providers and patients about the gluten and aluminum content of Synthroid(®) (levothyroxine sodium tablets) have increased. The objective of this study was to measure and evaluate the gluten content of the raw materials used in the manufacturing of Synthroid. Additionally, this study determined the aluminum content in different strengths of Synthroid tablets by estimating the amount of aluminum in the raw materials used in the manufacturing of Synthroid. Read More

    The Antihypertensive Efficacy of the Triple Fixed Combination of Perindopril, Indapamide, and Amlodipine: The Results of the PETRA Study.
    Adv Ther 2017 Jul 23;34(7):1753-1763. Epub 2017 Jun 23.
    Department of Cardiology, Petz Aladár County Teaching Hospital, Gyor, Hungary.
    Introduction: The etiology of essential hypertension is multifactorial. Therefore, treatment with combinations of antihypertensive agents acting on multiple targets is necessary for successful therapy in the majority of patients. According to the experience and clinical data accumulated so far, combination therapy with three agents from different pharmacological classes is required in approx. Read More

    The Changing Landscape of Alopecia Areata: The Therapeutic Paradigm.
    Adv Ther 2017 Jul 23;34(7):1594-1609. Epub 2017 Jun 23.
    Department of Dermatology and the Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
    Alopecia areata (AA), a prevalent inflammatory cause of hair loss, lacks FDA-approved therapeutics for extensive cases, which are associated with very poor rates of spontaneous hair regrowth and major psychological distress. Current treatments for severe cases include broad immune-suppressants, which are associated with significant adverse effects, precluding long-term use, with rapid hair loss following treatment termination. As a result of the extent of the disease in severe cases, topical contact sensitizers and intralesional treatments are of limited use. Read More

    The Changing Landscape of Alopecia Areata: The Translational Landscape.
    Adv Ther 2017 Jul 23;34(7):1586-1593. Epub 2017 Jun 23.
    Columbia University Medical Centre, Russ Berrie Medical Pavilion, New York City, NY, USA.
    Recent genetic and preclinical studies have increased our understanding of the immunopathogenesis of alopecia areata (AA). This has allowed expedited development of targeted therapies for the treatment of AA, and a paradigm shift in our approach and understanding of autoimmunity and the hair follicle. The synergy between preclinical studies, animal models, and translational studies has led to unprecedented advances in the treatment options for AA, ultimately benefiting patients who have had little recourse. Read More

    The Changing Landscape of Alopecia Areata: An Introduction.
    Adv Ther 2017 Jul;34(7):1584-1585
    Icahn School of Medicine at Mount Sinai, New York, NY, USA.
    Alopecia areata is an extremely common autoimmune condition affecting hair. Severe forms of alopecia areata exist, with existing treatments consisting of systemic immunosuppressants with numerous side effects. Recently, breakthroughs have been made in both understanding the pathogenesis of alopecia areata and the treatment thereof, which hold the promise of being able to target severe cases of alopecia areata with more efficacy and better tolerability. Read More

    An Observational Study of the Effect of Levodopa-Carbidopa Intestinal Gel on Activities of Daily Living and Quality of Life in Advanced Parkinson's Disease Patients.
    Adv Ther 2017 Jul 19;34(7):1741-1752. Epub 2017 Jun 19.
    Parkinson and Movement Disorders Unit, Department of Neuroscience, University of Padua, Padua, IRCCS Hospital San Camillo, Venice, Italy.
    Introduction: Continuous delivery of levodopa-carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson's disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations ("on" and "off" states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients.

    Methods: This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2-4 h of "off" time or 2 h of dyskinesia daily. Read More

    24-Month Open-Label Teriparatide Once-Weekly Efficacy Research Trial Examining Bone Mineral Density in Subjects with Primary Osteoporosis and High Fracture Risk.
    Adv Ther 2017 Jul 19;34(7):1727-1740. Epub 2017 Jun 19.
    Touto Sangenjaya Rehabilitation Hospital, Setagaya-ku, Tokyo, Japan.
    Introduction: To clarify the additional efficacy and safety benefits of 24 months' treatment with the once-weekly formulation of teriparatide, which is currently used for 72 weeks.

    Methods: This was a multicenter, open-label, single-arm study conducted in Japan. Subjects who were 65 years or older with prevalent vertebral fractures received once-weekly subcutaneous injection of 56. Read More

    Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes: Pooled Analysis of Phase I-III Clinical Trials.
    Adv Ther 2017 Jul 19;34(7):1707-1726. Epub 2017 Jun 19.
    Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173, 55216, Ingelheim, Germany.
    Introduction: We characterized the safety and tolerability of empagliflozin in patients with type 2 diabetes (T2DM) randomized 1:1:1 to placebo, empagliflozin 10 mg, or empagliflozin 25 mg in clinical trials.

    Methods: Pooled data were analyzed from patients with T2DM treated with placebo (N = 4203), empagliflozin 10 mg (N = 4221), or empagliflozin 25 mg (N = 4196) in 15 randomized phase I-III trials plus four extension studies. Adverse events (AEs) were assessed descriptively in participants who took at least one dose of study drug. Read More

    When Science is Not Enough: A Framework Towards More Customer-Focused Drug Development.
    Adv Ther 2017 Jul 17;34(7):1572-1583. Epub 2017 Jun 17.
    Mundipharma International, Cambridge, UK.
    Introduction: The purpose of this study was to identify the key barriers to a customer-focused drug development process and develop a comprehensive framework to overcome them.

    Methods: The paper draws on existing literature, both academic and practitioner, across a range of disciplines (innovation management, marketing, organizational behavior, behavioral economics, health economics, industry reports). On the basis of this extensive review, a conceptual framework is developed that offers concrete suggestions on how organizations can overcome the barriers and enable a more customer-focused development process. Read More

    Resource Utilization Among Glaucoma Patients in the UK Treated with Beta-Blocker and Non-Beta-Blocker Adjunctive Therapy: A Retrospective Cohort Analysis.
    Adv Ther 2017 Jul 30;34(7):1695-1706. Epub 2017 May 30.
    Novartis Pharma AG, Basel, Switzerland.
    Introduction: Few studies have examined outcomes and potential complications among glaucoma patients who are prescribed topical beta-blockers. This study examined resource usage (number of GP visits and hospitalizations) and diagnoses of respiratory or cardiovascular conditions among glaucoma patients prescribed beta-blockers compared to patients not prescribed beta-blockers.

    Methods: A retrospective cohort analysis was conducted using data from the UK Clinical Practice Research Datalink (CPRD) database over the period January 1, 2006 to March 31, 2014. Read More

    Minimal Device Encrustation on Vesair Intravesical Balloons in the Treatment of Stress Urinary Incontinence: Analysis of Balloons Removed from Women in the SOLECT Trial.
    Adv Ther 2017 Jul 9;34(7):1686-1694. Epub 2017 Jun 9.
    University Hospital Antwerpen, University of Antwerp-Urology, Antwerp, Belgium.
    Introduction: Encrustation of urinary biomaterials is common; however, the incidence of surface deposition on the Vesair(®) intravesical pressure-attenuation balloon has not been previously reported. The purpose of this analysis is to determine the incidence and potential risk factors for encrustation of the Vesair intravesical balloon.

    Methods: The SOLECT trial is a prospective randomized controlled trial conducted at several European centers to evaluate the safety and efficacy of the Vesair balloon for the treatment of female stress urinary incontinence (SUI). Read More

    Monitoring for and Characterizing Crizotinib Progression: A Chart Review of ALK-Positive Non-Small Cell Lung Cancer Patients.
    Adv Ther 2017 Jul 3;34(7):1673-1685. Epub 2017 Jun 3.
    Analysis Group, Inc., 111 Huntington Ave, Boston, MA, USA.
    Introduction: Crizotinib is recommended as first-line therapy for ALK-positive non-small cell lung cancer (NSCLC), but within a year of treatment initiation many patients develop resistance. With the recent approval of second-generation ALK inhibitors, this study assessed how physicians monitor for and diagnose progression and how they alter treatment following progression on crizotinib.

    Methods: A panel of oncologists from the United States were surveyed regarding their monitoring practices and criteria for diagnosing progression on crizotinib. Read More

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