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    Real-World Evaluation of Direct and Indirect Economic Burden Among Endometriosis Patients in the United States.
    Adv Ther 2018 Feb 15. Epub 2018 Feb 15.
    Abbvie, Inc, North Chicago, IL, USA.
    Introduction: The prevalence of endometriosis and the need for treatment in the USA has led to the need to explore the contemporary cost burden associated with the disease. This retrospective cohort study compared direct and indirect healthcare costs in patients with endometriosis to a control group without endometriosis.

    Methods: Women aged 18-49 years with endometriosis (date of initial diagnosis = index date) were identified in the Truven Health MarketScanCommercial database between 2010 and 2014 and female control patients without endometriosis were matched by age and index year. Read More

    Using Self-Reported Patient Experiences to Understand Patient Burden: Learnings from Digital Patient Communities in Ankylosing Spondylitis.
    Adv Ther 2018 Feb 15. Epub 2018 Feb 15.
    Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
    Introduction: Online communities contain a wealth of information containing unsolicited patient experiences that may go beyond what is captured by guided surveys or patient-reported outcome (PRO) instruments used in clinical settings. This study described patient experiences reported online to better understand the day-to-day disease burden of ankylosing spondylitis (AS).

    Methods: Unguided, English-language patient narratives reported between January 2010 and May 2016 were collected from 52 online sources (e. Read More

    A Review of Photodynamic Therapy for Neoplasms of the Head and Neck.
    Adv Ther 2018 Feb 7. Epub 2018 Feb 7.
    International Head and Neck Scientific Group, Padua, Italy.
    Photodynamic therapy (PDT) involves the use of a phototoxic drug which is activated by low powered laser light to destroy neoplastic cells. Multiple photosensitizers have been studied and tumors have been treated in a variety of head and neck sites over the last 30 years. PDT can effectively treat head and neck tumors, particularly those of the superficial spreading type, and the classic application of this technology has been in the patient with a wide field of dysplastic change and superficial carcinomatosis. Read More

    Haptoglobin Genotype and Vitamin E Versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis in China: A Multicenter, Randomized, Placebo-Controlled Trial Design.
    Adv Ther 2018 Feb 6;35(2):218-231. Epub 2018 Feb 6.
    Department of Hepatology, Hangzhou Normal University Affiliated Hospital, Hangzhou, Zhejiang, China.
    Introduction: Vitamin E is one of the most promising agents for nonalcoholic steatohepatitis (NASH) treatment, and its drug responsiveness may be closely associated with haptoglobin (Hp) genotype. However, its efficacy and safety remain unknown in China. This clinical trial of vitamin E versus placebo for the treatment of nondiabetic patients with nonalcoholic steatohepatitis (VENS) is conducted to evaluate (a) the efficacy and safety of treatment with vitamin E softgel (300 mg/day) determined from standardized histologic scoring of liver biopsies, (b) whether treatment with vitamin E improves biochemical parameters, cytokines, anthropometric parameters, controlled attenuation parameter (CAP), and transient elastography (TE) values determined by Fibroscan and health-related quality of life (SF-36), (c) whether the efficacy of vitamin E treatment is associated with the Hp genotype in nondiabetic adults with NASH. Read More

    Single-Dose Comparative Pharmacokinetics of Two Formulations of Lenalidomide 25 mg in Healthy Subjects: A Randomized Crossover Study.
    Adv Ther 2018 Feb 6;35(2):210-217. Epub 2018 Feb 6.
    Department of Pharmacology, Chungnam National University College of Medicine and Hospital, Daejeon, Republic of Korea.
    Background: Lenalidomide is used for the treatment of multiple myeloma in combination with dexamethasone. The purpose of this study was to compare the pharmacokinetics (PKs) and assess the bioequivalence of two formulations of lenalidomide 25 mg: Lenalid25 mg tablet (test formulation) and Revlimid25 mg capsule (reference formulation).

    Methods: A randomized, single-dose, two-treatment, two-period, two-sequence crossover study was conducted in 42 healthy subjects. Read More

    A Phase 1 Pharmacokinetic Study of Cysteamine Bitartrate Delayed-Release Capsules Following Oral Administration with Orange Juice, Water, or Omeprazole in Cystinosis.
    Adv Ther 2018 Feb 6;35(2):199-209. Epub 2018 Feb 6.
    Celerion Inc., Lincoln, NE, USA.
    Introduction: Cystinosis is a rare, metabolic, autosomal recessive, genetic lysosomal storage disorder characterized by an accumulation of cystine in various organs and tissues. Cysteamine bitartrate (CB) is a cystine-depleting aminothiol agent approved in the United States and Europe in immediate-release and delayed-release (DR) formulations for the treatment of nephropathic cystinosis in children and adults. It is recommended that CBDR be administered with fruit juice (except grapefruit juice) for maximum absorption. Read More

    A Review of New Findings in Adult T-cell Leukemia-Lymphoma: A Focus on Current and Emerging Treatment Strategies.
    Adv Ther 2018 Feb 6;35(2):135-152. Epub 2018 Feb 6.
    Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
    Adult T-cell leukemia-lymphoma (ATL), a rare and aggressive T-cell malignancy caused by human T-cell lymphotropic virus type 1 (HTLV-1), is associated with a poor prognosis. Evidence-based standard treatment options are lacking and outcomes are generally unsatisfactory, particularly for patients with relapsed or refractory disease. Continued research is contributing to changing treatment landscape as a number of existing and investigational agents are evaluated. Read More

    Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria.
    Adv Ther 2018 Feb 2;35(2):173-190. Epub 2018 Feb 2.
    GlaxoSmithKline R&D, Research Triangle Park Durham, North Carolina, USA.
    Causality assessment is crucial to post-marketing pharmacovigilance and helps optimize safe and appropriate use of medicines by patients in the real world. Self-reported olfactory and gustatory dysfunction are common in the general population as well as in patients with allergic rhinitis and nasal polyposis. Intranasal corticosteroids, including intranasal fluticasone propionate (INFP), are amongst the most effective drugs indicated in the treatment of allergic rhinitis and nasal polyposis. Read More

    Head and Neck Cancer: A Review of the Impact of Treatment Delay on Outcome.
    Adv Ther 2018 Feb 2;35(2):153-160. Epub 2018 Feb 2.
    Coordinator of the International Head and Neck Scientific Group, Padua, Italy.
    Delay between the initial symptoms, diagnosis, and the definitive treatment of head and neck cancers is associated with tumor progression and upstaging. These delays may lead to poor outcomes and may mandate more aggressive treatments with unnecessary morbidity and even mortality. The multidisciplinary team approach for the treatment of patients with head and neck cancers has improved organization of standard clinical guidelines, but this development has yet to translate into a demonstrable impact on survival. Read More

    Detection of Distant Metastases in Head and Neck Cancer: Changing Landscape.
    Adv Ther 2018 Feb 2;35(2):161-172. Epub 2018 Feb 2.
    Coordinator of the International Head and Neck Scientific Group, Padua, Italy.
    As head and neck squamous cell carcinoma (HNSCC) patients with distant metastases (DM) were generally treated only palliatively, the value of screening for DM was usually limited to attempts to avoid extensive locoregional treatment when DM were present pretreatment. Recently, the concept of treating oligometastases, e.g. Read More

    Association of Low Bone Mineral Density with Anti-Citrullinated Protein Antibody Positivity and Disease Activity in Established Rheumatoid Arthritis: Findings from a US Observational Cohort.
    Adv Ther 2018 Feb 25;35(2):232-242. Epub 2018 Jan 25.
    Brigham and Women's Hospital, Boston, MA, USA.
    Introduction: To assess the relationship between low bone mineral density (BMD), anti-cyclic citrullinated peptide-2 (anti-CCP2) antibodies, and disease activity in patients with established rheumatoid arthritis (RA).

    Methods: Patients enrolled in a single-center, observational cohort registry of patients with RA. Eligible patients had known BMD, as measured by digital X-ray radiogrammetry (DXR-BMD), and anti-CCP2 antibody measurements at the same time point or within 6 months. Read More

    Managing Obesity in Primary Care: Breaking Down the Barriers.
    Adv Ther 2018 Feb 18;35(2):191-198. Epub 2018 Jan 18.
    Upper GI Surgery, Kogarah, Australia.
    Several Australian obesity management guidelines have been developed for general practice but, to date, implementation of these guidelines has been shown to be inadequate. In this review, we explore the barriers to obesity treatment and propose a four-stage plan to manage individuals with obesity in general practice using a framework of a multidisciplinary team.

    Funding: Novo Nordisk. Read More

    Once-Daily Triple Therapy in Patients with COPD: Patient-Reported Symptoms and Quality of Life.
    Adv Ther 2018 Jan 8;35(1):56-71. Epub 2018 Jan 8.
    Respiratory Research and Development, GSK, King of Prussia, PA, USA.
    Introduction: Directly recorded patient experience of symptoms and health-related quality of life (HRQoL) can complement lung function and exacerbation rate data in chronic obstructive pulmonary disease (COPD) clinical studies. The FULFIL study recorded daily symptoms and activity limitation together with additional patient-reported outcomes of dyspnea and HRQoL, as part of the prespecified analyses. FULFIL co-primary endpoint data have been previously reported. Read More

    Treatment Dosing Patterns and Clinical Outcomes for Patients with Type 2 Diabetes Starting or Switching to Treatment with Insulin Glargine (300 Units per Milliliter) in a Real-World Setting: A Retrospective Observational Study.
    Adv Ther 2018 Jan 8;35(1):43-55. Epub 2018 Jan 8.
    Sanofi US, Inc., Bridgewater, NJ, USA.
    Introduction: Usage patterns and effectiveness of a longer-acting formulation of insulin glargine at a strength of 300 units per milliliter (Gla-300) have not been studied in real-world clinical practice. This study evaluated differences in dosing and clinical outcomes before and after Gla-300 treatment initiation in patients with type 2 diabetes starting or switching to treatment with Gla-300 to assess whether the benefits observed in clinical trials translate into real-world settings.

    Methods: This was a retrospective observational study using medical record data obtained by physician survey for patients starting treatment with insulin glargine at a strength of 100 units per milliliter (Gla-100) or Gla-300, or switching to treatment with Gla-300 from treatment with another basal insulin (BI). Read More

    Intragastric Balloon Treatment for Obesity: FDA Safety Updates.
    Adv Ther 2018 Jan 28;35(1):1-4. Epub 2017 Dec 28.
    Department of Psychiatry, Mt. Sinai St. Luke's, Icahn School of Medicine at Mt. Sinai, New York, NY, USA.
    Over the past year, the FDA has issued two letters to healthcare providers alerting them to adverse events associated with ORBERA and ReShape intragastric balloons (IGBs), including several deaths. Both IGB devices were FDA-approved for use in the US in the summer of 2015. Although the adverse events cited in the two letters occurred following FDA approval, there was already evidence prior to FDA approval that the safety and efficacy of ReShape and ORBERA were highly questionable. Read More

    An Emerging Treatment Alternative for Anemia in Chronic Kidney Disease Patients: A Review of Daprodustat.
    Adv Ther 2018 Jan 28;35(1):5-11. Epub 2017 Dec 28.
    St. John's University, Jamaica, NY, USA.
    This article reviews an emerging therapeutic agent, which is currently in phase III development for the treatment of anemia secondary to chronic kidney disease, covering promising phase II results, drug characteristics, and the current phase III trials, which, if approved, may significantly impact the management of anemia in this patient population. Read More

    The Effect of Novel Glucose Monitoring System (Flash Glucose Monitoring) on Mental Well-being and Treatment Satisfaction in Japanese People with Diabetes.
    Adv Ther 2018 Jan 22;35(1):72-80. Epub 2017 Dec 22.
    Diabetes Center, Eiju General Hospital, Tokyo, Japan.
    Introduction: FreeStyle Libre (Abbot Diabetes Care Ltd) has been launched as a novel glucose monitoring system called flash glucose monitoring (FGM) in Europe. Several reports are becoming available on its usefulness and safety. To date, however, reports from Asian countries have not been made available. Read More

    Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study.
    Adv Ther 2018 Feb 21;35(2):243-253. Epub 2017 Dec 21.
    CORESEARCH-Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.
    Introduction: The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice.

    Methods: ReaL was a multicenter, non-interventional, observational, retrospective, longitudinal study on the effectiveness of liraglutide, a human glucagon-like peptide-1 analog, in individuals with T2D treated in daily practice in Italy. Between 26 March and 16 November 2015, data were taken from clinical records of patients aged ≥ 18 years with treatment follow-up data of up to 24 months and who received their first prescription of liraglutide in 2011. Read More

    Development of a Framework Based on Reflective MCDA to Support Patient-Clinician Shared Decision-Making: The Case of the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) in the United States.
    Adv Ther 2018 Jan 21;35(1):81-99. Epub 2017 Dec 21.
    Analytica Laser, Montreal, Canada.
    Introduction: Well- or moderately differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are often slow-growing, and some patients with unresectable, asymptomatic, non-functioning tumors may face the choice between watchful waiting (WW), or somatostatin analogues (SSA) to delay progression. We developed a comprehensive multi-criteria decision analysis (MCDA) framework to help patients and physicians clarify their values and preferences, consider each decision criterion, and support communication and shared decision-making.

    Methods: The framework was adapted from a generic MCDA framework (EVIDEM) with patient and clinician input. Read More

    Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.
    Adv Ther 2018 Jan 21;35(1):12-30. Epub 2017 Dec 21.
    Grünenthal GmbH, Aachen, Germany.
    Introduction: Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009.

    Methods: This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. Read More

    The Effect of Phacoemulsification on Intraocular Pressure in Eyes with Hyperfiltration Following Trabeculectomy: A Prospective Study.
    Adv Ther 2018 Jan 8;35(1):116-123. Epub 2017 Dec 8.
    Department of Medical and Surgical Specialties, University of Brescia, Brescia, Italy.
    Introduction: The aim of this study was to evaluate the effect of visually non-significant cataract extraction in patients with hypotony maculopathy and reduced visual acuity due to over-filtering blebs after trabeculectomy.

    Methods: Patients with intraocular pressure (IOP) < 6 mmHg and documented hypotony maculopathy due to over-filtering blebs after trabeculectomy were prospectively recruited. Eligible patients underwent visually non-significant cataract phacoemulsification, no earlier than 12 weeks from the diagnosis of hypotony maculopathy. Read More

    Using Patient Feedback to Optimize the Design of a Certolizumab Pegol Electromechanical Self-Injection Device: Insights from Human Factors Studies.
    Adv Ther 2018 Jan 8;35(1):100-115. Epub 2017 Dec 8.
    UCB Pharma, Bulle, Switzerland.
    Introduction: We incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava, an electromechanical device (e-Device) for self-injecting the anti-tumor necrosis factor certolizumab pegol (CZP).

    Methods: Healthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn's disease participated in 11 formative HFS to optimize the e-Device design through intended user feedback; nine studies involved simulated injections. Formative participant questionnaire feedback was collected following e-Device prototype handling. Read More

    The Role of Trypsin:Chymotrypsin in Tissue Repair.
    Adv Ther 2018 Jan 5;35(1):31-42. Epub 2017 Dec 5.
    Medicare Hospital, Mumbai, India.
    Tissue damage of all types, such as surgical or accidental injuries, fractures, and burns, stimulates a well-orchestrated, physiological process of healing, which ultimately leads to structural and functional restoration of the damaged tissues. The tissue repair process can be broadly divided into four continuous and overlapping phases-hemostasis and coagulation, inflammation, proliferation, and remodeling. If the process is interrupted or halted during any stage, it leads to impaired healing and formation of a chronic wound. Read More

    Predictors for the Treatment Effect of Sodium Glucose Co-transporter 2 Inhibitors in Patients with Type 2 Diabetes Mellitus.
    Adv Ther 2018 Jan 28;35(1):124-134. Epub 2017 Nov 28.
    Department of Cardiovascular Medicine, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.
    Introduction: Predictors for the effect of sodium glucose co-transporter 2 (SGLT2) inhibitors at lowering hemoglobin A1c (HbA1c) levels in type 2 diabetes mellitus patients remain unclear. We therefore aimed to elucidate these predictors in type 2 diabetes patients after 3 months of SGLT2 treatment.

    Methods: A total of 302 consecutive type 2 diabetes patients who had been treated with SGLT2 inhibitors as monotherapy or add-on therapy to existing antidiabetic treatments were enrolled retrospectively. Read More

    A Review of Chronic Granulomatous Disease.
    Adv Ther 2017 Dec 22;34(12):2543-2557. Epub 2017 Nov 22.
    Children's Hospital of Philadelphia, Wood Center, Rm 3301, 3401 Civic Center Blvd, Philadelphia, PA, 19104, USA.
    Chronic granulomatous disease (CGD) is a primary immunodeficiency caused by defects in any of the five subunits of the NADPH oxidase complex responsible for the respiratory burst in phagocytic leukocytes. Patients with CGD are at increased risk of life-threatening infections with catalase-positive bacteria and fungi and inflammatory complications such as CGD colitis. The implementation of routine antimicrobial prophylaxis and the advent of azole antifungals has considerably improved overall survival. Read More

    Dispensing Patterns of Ranibizumab and Aflibercept for the Treatment of Neovascular Age-Related Macular Degeneration: A Retrospective Cohort Study in Australia.
    Adv Ther 2017 Dec 21;34(12):2585-2600. Epub 2017 Nov 21.
    Centre for Ophthalmology and Visual Science (Incorporating Lions Eye Institute), The University of Western Australia, Perth, WA, Australia.
    Introduction: Anti-vascular endothelial growth factor therapy is the standard of care for neovascular age-related macular degeneration (nAMD). The dosage of two licensed agents, ranibizumab and aflibercept, was established through clinical trials; however, it is unclear if either agent is administered as recommended in routine clinical practice. Using pharmacy claims data, we investigated if the dispensing patterns of ranibizumab differ from those of aflibercept 6 and 12 months after treatment initiation. Read More

    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 Dec 16;34(12):2566-2584. 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 Dec 16;34(12):2558-2565. 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 Dec 16;34(12):2601-2611. 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 Dec 13;34(12):2612-2624. 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 Dec 13;34(12):2638-2647. 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 Dec 13;34(12):2625-2637. 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 Dec 8;34(12):2648-2660. 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;34(11):2534-2541. 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 Dec 6;34(12):2661-2673. 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 KnowledgePanelto 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;34(11):2503-2517. 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;34(11):2491-2502. 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 ClinformaticsDataMart 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 Dec 3;34(12):2674-2679. 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;34(11):2518-2533. 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 β-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 (FEV) 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 Dec 27;34(12):2680-2692. 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 Nov 26;34(11):2452-2465. 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 Nov 26;34(11):2466-2480. 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 Nov 24;34(11):2481-2490. 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 Nov 16;34(11):2436-2451. 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 Nov 16;34(11):2422-2435. 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 Nov 11;34(11):2393-2411. 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 Nov 11;34(11):2412-2421. 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

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