2,411 results match your criteria Adv Ther[Journal]


Diagnosis and Management of Hypothyroidism in Gulf Cooperation Council (GCC) Countries.

Adv Ther 2020 Jun 1. Epub 2020 Jun 1.

Merck Serono Middle East FZ LLC, Dubai, United Arab Emirates.

Hypothyroidism is one of the most common chronic endocrine conditions. However, as symptoms of hypothyroidism are non-specific, up to 60% of those with thyroid dysfunction are unaware of their condition. Left untreated, hypothyroidism may contribute to other chronic health conditions. Read More

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http://dx.doi.org/10.1007/s12325-020-01382-2DOI Listing

Papillary Thyroid Cancer-Aggressive Variants and Impact on Management: A Narrative Review.

Adv Ther 2020 Jun 1. Epub 2020 Jun 1.

Coordinator of the International Head and Neck Scientific Group, Padua, Italy.

Introduction: Aggressive variants of papillary thyroid cancer (PTC) have been described with increasing frequency. These variants include diffuse sclerosing variant, tall cell variant, columnar cell variant, solid variant, and hobnail variant.

Methods: We have performed a review of the more aggressive variants of PTC with respect to main characteristics, histological and molecular features, and the consequences that the knowledge of these variants should have in the treatment of the patients. Read More

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http://dx.doi.org/10.1007/s12325-020-01391-1DOI Listing

Treatment Sequencing in Patients with Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer in Japan: A Real-World Observational Study.

Adv Ther 2020 May 29. Epub 2020 May 29.

Department of Thoracic Oncology, National Cancer Center Hospital, 5 Chome-1-1 Tsukiji, Chūō City, Tokyo, 104-0045, Japan.

Introduction: The anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) alectinib was approved in Japan in 2014 for the treatment of ALK fusion gene-positive advanced non-small cell lung cancer (NSCLC). With the approvals of crizotinib in 2012 and ceritinib in 2017, Japan became the first country with multiple ALK TKIs available for first-line or later use in patients with ALK-positive advanced NSCLC. Here, we collected and evaluated real-world data on ALK TKI clinical usage patterns and sequencing in patients with ALK-positive NSCLC in Japan. Read More

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http://dx.doi.org/10.1007/s12325-020-01392-0DOI Listing

Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO and OTEMTO Studies.

Adv Ther 2020 May 27. Epub 2020 May 27.

Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.

Introduction: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy report recommends long-acting muscarinic antagonists (LAMA) or long-acting β-agonists (LABA) as first-line treatment for chronic obstructive pulmonary disease (COPD), but many patients remain symptomatic on monotherapy and escalation to dual-bronchodilator therapy may be warranted.

Methods: TONADO 1&2 and OTEMTO 1&2 assessed lung function and patient-reported outcomes in patients with moderate-to-severe (OTEMTO) or moderate-to-very-severe (TONADO) COPD. This pooled post hoc analysis included patients treated with LAMA monotherapy at baseline who were randomised to receive either 5 µg tiotropium (LAMA) or 5/5 µg tiotropium/olodaterol (LAMA/LABA). Read More

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http://dx.doi.org/10.1007/s12325-020-01373-3DOI Listing

Antimicrobial De-Escalation in the ICU: From Recommendations to Level of Evidence.

Adv Ther 2020 May 27. Epub 2020 May 27.

MEPHI, IHU Méditerranée Infection, Aix Marseille Université, Marseille, France.

Antimicrobial de-escalation (ADE) is a component of antimicrobial stewardship (AMS) aimed to reduce exposure to broad-spectrum antimicrobials. In the intensive care unit, ADE is a strong recommendation that is moderately applied in clinical practice. Following a systematic review of the literature, we assessed the studies identified on the topic which included one randomized controlled trial and 20 observational studies. Read More

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http://dx.doi.org/10.1007/s12325-020-01390-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7252418PMC

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Mini-Tabs Plus Ribavirin for Children Aged 3-11 Years with Hepatitis C Genotype 1a.

Adv Ther 2020 May 25. Epub 2020 May 25.

Baylor College of Medicine, Gastroenterology, Hepatology, and Nutrition, Texas Children's Liver Center, Houston, TX, USA.

Introduction: To assess the safety, efficacy, and pharmacokinetics of mini-tablet formulations of ombitasvir (OBV), paritaprevir (PTV), ritonavir, and dasabuvir (DSV) with or without ribavirin for 12 weeks in children infected with chronic hepatitis C virus (HCV) genotype (GT) 1.

Methods: This is an ongoing, open-label, Phase 2/3 study in children 3-11 years old infected with HCV GT1 who were HCV treatment-naïve and non-cirrhotic. Pediatric mini-tablet formulations of OBV, PTV, ritonavir, and DSV plus ribavirin oral solution were administered for 12 weeks based on body weight. Read More

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http://dx.doi.org/10.1007/s12325-020-01389-9DOI Listing

Prevalence and Management Challenges in Central Post-Stroke Neuropathic Pain: A Systematic Review and Meta-analysis.

Adv Ther 2020 May 23. Epub 2020 May 23.

Medical School, University of Cyprus, Nicosia, Cyprus.

Introduction: Central post-stroke pain (CPSP) is defined as the neuropathic pain that arises either acutely or in the chronic phase of a cerebrovascular event and is a result of central lesions of the somatosensory tract. The aim of this systematic review and meta-analysis was to establish the prevalence of CPSP, to describe its characteristics, and to discuss the associated management challenges.

Methods: After a systematic Medline search, we identified 69 papers eligible to be included. Read More

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http://dx.doi.org/10.1007/s12325-020-01388-wDOI Listing

Healthcare Resources Utilization and Costs of Patients with Non-IPF Progressive Fibrosing Interstitial Lung Disease Based on Insurance Claims in the USA.

Adv Ther 2020 May 21. Epub 2020 May 21.

Decision Resources Group, Burlington, USA.

Introduction: Idiopathic pulmonary fibrosis (IPF) is the classic progressive fibrosing interstitial lung disease (ILD), but some patients with ILDs other than IPF also develop a progressive fibrosing phenotype (PF-ILD). Information on use and cost of healthcare resources in patients with PF-ILD is limited.

Methods: We used USA-based medical insurance claims (2014-2016) to assess use and cost of healthcare resources in PF-ILD. Read More

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http://dx.doi.org/10.1007/s12325-020-01380-4DOI Listing

Correction to: Panel Discussion: Some Aspects of the Management of Patients with X-Linked Hypophosphataemic Rickets.

Adv Ther 2020 May 23. Epub 2020 May 23.

Departamento de Medicina, Universidad de Granada, UGC Endocrinología y Nutrición, Hospital Universitario San Cecilio, CIBERFES, Instituto de Salud Carlos III, Instituto de Investigación Biosanitaria de Granada, Granada, Spain.

In the original article, third author name has been published incorrectly. Read More

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http://dx.doi.org/10.1007/s12325-020-01370-6DOI Listing

Best Practice Approach to Successful Conversion of Fosaprepitant to Aprepitant IV in a Large Multisite Community Oncology Infusion Center: A Retrospective Analysis.

Adv Ther 2020 May 23. Epub 2020 May 23.

Department of Pharmacy, Rocky Mountain Cancer Centers, Greenwood Village, CO, USA.

Purpose: To evaluate the impact on cost, time, resource use, and clinic workflow of converting the route of drug administration from a neurokinin-1 receptor antagonist (NK-1 RA) 30-min intravenous (IV) infusion to aprepitant IV, and more specifically to IV push, within a multicenter community oncology practice.

Methods: This was a retrospective, multicenter time, motion, and resource/cost evaluation study. Conversion to aprepitant IV was determined by calculating number of doses of aprepitant IV versus fosaprepitant administered in patients receiving moderately or highly emetogenic chemotherapy regimens. Read More

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http://dx.doi.org/10.1007/s12325-020-01377-zDOI Listing

The Burden of Progressive Fibrosing Interstitial Lung Disease: A DELPHI Approach.

Adv Ther 2020 May 22. Epub 2020 May 22.

Boehringer Ingelheim, Amsterdam, The Netherlands.

Introduction: The term progressive fibrosing interstitial lung disease (ILD) describes patients with fibrotic ILDs who, irrespective of the aetiology of the disease, show a progressive course of their disease despite current available (and non-licensed) treatment. Besides in idiopathic pulmonary fibrosis, little is known about management and the burden of patients with fibrotic ILD, particularly those with a progressive behaviour.

Methods: Using the Delphi method, 40 European experts in ILD management delivered information on management of (progressive) fibrosing ILD and on the impact of the disease on patients' quality of life (QoL) and healthcare resource utilisation (HCRU). Read More

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http://dx.doi.org/10.1007/s12325-020-01384-0DOI Listing

The Promise for Histone Methyltransferase Inhibitors for Epigenetic Therapy in Clinical Oncology: A Narrative Review.

Adv Ther 2020 May 22. Epub 2020 May 22.

Institut de Cancérologie de Strasbourg, Strasbourg, France.

Epigenetic processes are essential for normal development and the maintenance of tissue-specific gene expression in mammals. Changes in gene expression and malignant cellular transformation can result from disruption of epigenetic mechanisms, and global disruption in the epigenetic landscape is a key feature of cancer. The study of epigenetics in cancer has revealed that human cancer cells harbor both genetic alterations and epigenetic abnormalities that interplay at all stages of cancer development. Read More

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http://dx.doi.org/10.1007/s12325-020-01379-xDOI Listing
May 2020
2.438 Impact Factor

Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program.

Adv Ther 2020 May 22. Epub 2020 May 22.

F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.

Introduction: Etrolizumab is a next-generation anti-integrin with dual action that targets two pathways of inflammation in the gut. A robust phase 3 clinical program in ulcerative colitis (UC) and Crohn's disease is ongoing and will evaluate the efficacy and safety of etrolizumab in well-defined patient populations in rigorous trials that include direct head-to-head comparisons against approved anti-tumor necrosis factor alpha agents (anti-TNF). The etrolizumab phase 3 clinical program consists of six randomized controlled trials (RCTs; UC: HIBISCUS I and II, GARDENIA, LAUREL, HICKORY; Crohn's disease: BERGAMOT) and two open-label extension trials (OLEs; UC: COTTONWOOD; Crohn's disease: JUNIPER) evaluating patients with moderately to severely active UC or Crohn's disease. Read More

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http://dx.doi.org/10.1007/s12325-020-01366-2DOI Listing

Persistence of Inflammation After Uncomplicated Cataract Surgery: A 6-Month Laser Flare Photometry Analysis.

Adv Ther 2020 May 21. Epub 2020 May 21.

Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Purpose: To evaluate, by laser photometry, the persistency of anterior chamber flare after uneventful phacoemulsification in asymptomatic patients with no signs of inflammation on slit lamp examination.

Method: Seventy-five patients previously enrolled in a randomized clinical trial that evaluated inflammation after uneventful phacoemulsification in eyes treated with dexamethasone 0.1% ophthalmic suspension (group 1) or bromfenac 0. Read More

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http://dx.doi.org/10.1007/s12325-020-01383-1DOI Listing

Pharmacokinetics and Dialyzability of a Single Oral Dose of Amenamevir, an Anti-Herpes Drug, in Hemodialysis Patients.

Adv Ther 2020 May 21. Epub 2020 May 21.

Drug Development Research Laboratory, Maruho Co., Ltd., Kyoto, Japan.

Introduction: Amenamevir (ASP2151), a herpesvirus helicase-primase inhibitor, is currently used for the treatment of herpes zoster in Japan. Amenamevir is mainly metabolized in the liver, and urinary excretion of amenamevir is approximately 10% in healthy adults. The increase of systemic exposure in non-dialysis patients with severe renal impairment was much less than that associated with nucleoside antiviral agents. Read More

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http://dx.doi.org/10.1007/s12325-020-01375-1DOI Listing

Treatment Patterns Among Patients with Multiple Sclerosis Initiating Second-Line Disease-Modifying Therapy.

Adv Ther 2020 May 20. Epub 2020 May 20.

IBM Watson Health, Cambridge, MA, USA.

Objective: Disease-modifying therapies (DMTs) can reduce multiple sclerosis (MS) relapse rates; however, effectiveness of treatments may vary. It is important to understand real-world treatment patterns in the context of MS relapses. We describe MS relapses related to treatment patterns among patients who switch treatment after their first DMT. Read More

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http://dx.doi.org/10.1007/s12325-020-01367-1DOI Listing

Incidence of Pericardial Effusion in Patients with Advanced Non-Small Cell Lung Cancer Receiving Immunotherapy.

Adv Ther 2020 May 20. Epub 2020 May 20.

S.C. Cardiologia, Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale, Napoli, Italy.

Introduction: Cardiovascular toxicity of immunotherapy represents an underreported but potentially fatal side effect. A relatively high incidence of pericardial disease has been noticed in patients with non-small cell lung cancer (NSCLC).

Methods: We retrospectively analyzed a population of patients with advanced NSCLC receiving immune checkpoint inhibitors (ICIs) looking for the presence of pericardial effusion at baseline or during treatment. Read More

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http://dx.doi.org/10.1007/s12325-020-01386-yDOI Listing
May 2020
2.438 Impact Factor

Development and Validation of a Nomogram-Based Prognostic Evaluation Model for Sarcomatoid Hepatocellular Carcinoma.

Adv Ther 2020 May 20. Epub 2020 May 20.

Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.

Introduction: Sarcomatoid hepatocellular carcinoma (SHC) is a rare subtype of liver cancer with extremely poor prognosis. This study aimed to identify the prognostic factors and develop an exclusive and efficient nomogram to predict cancer-specific survival (CSS) for SHC.

Methods: The data on patients diagnosed with SHC from January 1973 to December 2015 were retrieved from the Surveillance, Epidemiology, and End Results (SEER) database, and these patients were included as the training cohort. Read More

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http://dx.doi.org/10.1007/s12325-020-01357-3DOI Listing

Treatment of Oculoplastic and Ocular Surface Disease in Eyes Implanted with a Type I Boston Keratoprosthesis in Southern China: A Retrospective Study.

Adv Ther 2020 May 20. Epub 2020 May 20.

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, 510060, China.

Introduction: This study aimed to describe the clinical features, surgical management of the eyelid and ocular surface, and outcomes of 16 patients implanted with a Boston type I keratoprosthesis (KPro).

Methods: A retrospective, single-center, consecutive case series of 16 patients with Stevens-Johnson syndrome (1), ocular chemical burns (12), and ocular thermal burns (3) implanted with KPro was studied. All subjects were men aged 27-51 years. Read More

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http://dx.doi.org/10.1007/s12325-020-01381-3DOI Listing

Correction to: Sulodexide in the Treatment of Chronic Venous Insufficiency: Results of the All-Russian Multicenter ACVEDUCT Program.

Adv Ther 2020 Jun;37(6):3031-3032

Krasnoyarsk Interregional Polyclinic No 1, Krasnoyarsk, Russia.

In the original article, there is some error in the Table 2. The correct Table 2 is given below. Read More

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http://dx.doi.org/10.1007/s12325-020-01315-zDOI Listing

Comparative Efficacy of Cabozantinib and Regorafenib for Advanced Hepatocellular Carcinoma.

Adv Ther 2020 Jun 18;37(6):2678-2695. Epub 2020 May 18.

Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Background: No trials have compared cabozantinib and regorafenib for the second-line treatment of advanced hepatocellular carcinoma (HCC).

Objectives: Conduct a matching-adjusted indirect comparison (MAIC) of the efficacy and safety of second-line cabozantinib and regorafenib in patients with advanced HCC and disease progression after prior sorafenib.

Methods: The CELESTIAL and RESORCE trials were used for indirect comparison of second-line cabozantinib and regorafenib in advanced HCC. Read More

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http://dx.doi.org/10.1007/s12325-020-01378-yDOI Listing

Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Acetylsalicylic Acid in Fixed-Dose Combination with Clopidogrel Versus Enteric Aspirin in Chinese Subjects Under Fasting Conditions: A Phase 1, Open-Label, Randomized, Crossover Study.

Adv Ther 2020 Jun 16;37(6):2696-2709. Epub 2020 May 16.

Phase I Center, Luzhong Hospital, Shandong, China.

Introduction: Dual antiplatelet therapy, aspirin and a P2Y inhibitor, is recommended to prevent thrombotic complications of acute coronary syndrome. Clopidogrel plus acetylsalicylic acid combination is the most commonly used dual antiplatelet therapy recommended by international guidelines and in Chinese clinical practice. Poor adherence to dual antiplatelet therapy or premature interruption of dual antiplatelet therapy is an important contributor to cardiovascular mortality and lethal cardiovascular events. Read More

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http://dx.doi.org/10.1007/s12325-020-01369-zDOI Listing

Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study.

Adv Ther 2020 May 16. Epub 2020 May 16.

The Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China.

Introduction: Optimal dual antiplatelet therapy (DAPT) duration for medically managed acute coronary syndrome (ACS) (MMACS) patients is still unknown. We explored the efficacy and safety of ≥ 12-month DAPT among MMACS patients.

Methods: In this sub-analysis of the optimal antiplatelet therapy for Chinese Patients with Coronary Artery Disease study (NCT01735305), clinical outcomes among MMACS patients were compared between the < 12-month and ≥ 12-month DAPT groups. Read More

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http://dx.doi.org/10.1007/s12325-020-01376-0DOI Listing

Preoperative Versus Extended Postoperative Antimicrobial Prophylaxis of Surgical Site Infection During Spinal Surgery: A Comprehensive Systematic Review and Meta-Analysis.

Adv Ther 2020 Jun 15;37(6):2710-2733. Epub 2020 May 15.

Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA, USA.

Introduction: Surgical site infection (SSI) following spinal surgery is a major source of postoperative morbidity. Although studies have demonstrated perioperative antimicrobial prophylaxis (AMP) to be beneficial in the prevention of SSI among spinal surgery patients, consensus is lacking over whether preoperative or extended postoperative AMP is most efficacious. To date, no meta-analysis has investigated the comparative efficacy of these two temporally variable AMP protocols in spinal surgery. Read More

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http://dx.doi.org/10.1007/s12325-020-01371-5DOI Listing

The Relationship Between White Adipose Tissue Inflammation and Overweight/Obesity in Chinese Female Breast Cancer: A Retrospective Study.

Adv Ther 2020 Jun 15;37(6):2734-2747. Epub 2020 May 15.

Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, China.

Introduction: This study aims to investigate the relationship between breast white adipose tissue (WAT) inflammation and being overweight or obese, menopausal status, and metabolic syndrome-related indicators in breast cancer patients as well as the association between adipocyte size and the severity of WAT inflammation and body mass index (BMI).

Methods: The crown-like structures (CLS-B) formed by macrophages surrounding dying or dead adipocytes can be used to identify breast WAT inflammation. In this study, breast WAT and fasting blood from 136 Chinese women with breast cancer were collected for analysis. Read More

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http://dx.doi.org/10.1007/s12325-020-01368-0DOI Listing

Comparing Physician and Patient Perspectives on Prophylactic Treatment with BAY 94-9027 for Severe Haemophilia A: A Post Hoc Analysis.

Adv Ther 2020 Jun 14;37(6):2763-2776. Epub 2020 May 14.

Rush Hemophilia and Thrombophilia Center, Rush University Medical Center, Chicago, IL, USA.

Introduction: BAY 94-9027 is a newly developed extended half-life product to treat haemophilia, allowing for fewer injections than with standard products. This post hoc analysis aimed to compare physicians' and patients' opinions on BAY 94-9027 prophylaxis, and explore how qualitative interview data is aligned with the data from the Haemophilia-specific Quality of Life questionnaire for Adults (Haemo-QoL-A).

Methods: Exploratory qualitative interviews were conducted with physicians and patients by phone upon the exit of patients from the PROTECT VIII extension phase following a semi-directed guide. Read More

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http://dx.doi.org/10.1007/s12325-020-01374-2DOI Listing

Pattern of Laboratory Parameters and Management of Secondary Hyperparathyroidism in Countries of Europe, Asia, the Middle East, and North America.

Adv Ther 2020 Jun 14;37(6):2748-2762. Epub 2020 May 14.

AbbVie Inc., North Chicago, IL, USA.

Introduction: This analysis explored laboratory mineral and bone disorder parameters and management of secondary hyperparathyroidism in patients undergoing hemodialysis in Belgium, Canada, China, France, Germany, Italy, Japan, Russia, Saudi Arabia, Spain, Sweden, the UK, and the USA.

Methods: Analyses used demographic, medication, and laboratory data collected in the prospective Dialysis Outcomes and Practice Patterns Study (2012-2015). The analysis included 20,612 patients in 543 facilities. Read More

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http://dx.doi.org/10.1007/s12325-020-01359-1DOI Listing

Healthcare Resource Use and Costs Associated with Opioid Initiation Among Patients with Newly Diagnosed Endometriosis with Commercial Insurance in the USA.

Adv Ther 2020 Jun 12;37(6):2777-2791. Epub 2020 May 12.

Genesis Research, Hoboken, NJ, USA.

Introduction: To compare all-cause and endometriosis-related healthcare resource utilization (HCRU) and healthcare costs by service categories (outpatient, inpatient, emergency room [ER], pharmacy) among patients with newly diagnosed endometriosis using opioids compared to patients with endometriosis not using opioids.

Methods: A retrospective analysis of IBM® MarketScan® Commercial Claims data from 2009 to 2018 was performed for women aged 18-49 with newly diagnosed endometriosis (International Classification of Diseases (ICD)-9 code 617.xx; ICD-10 code N80. Read More

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http://dx.doi.org/10.1007/s12325-020-01361-7DOI Listing
June 2020
2.438 Impact Factor

Real-World Treatment Patterns, Adverse Events, Resource Use, and Costs Among Commercially Insured, Younger Patients with Chronic Lymphocytic Leukemia in the USA: A Retrospective Cohort Study.

Adv Ther 2020 May 12. Epub 2020 May 12.

IQVIA, Falls Church, VA, USA.

Introduction: Amidst a changing treatment landscape, real-world evidence on the burden of chronic lymphocytic leukemia (CLL) is limited. The purpose of this study was to describe treatment patterns, adverse events (AEs), and economic burden among treated patients with CCL.

Methods: A retrospective cohort study was conducted with IQVIA PharMetrics Plus. Read More

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http://dx.doi.org/10.1007/s12325-020-01350-wDOI Listing

Micronized Purified Flavonoid Fraction in Hemorrhoid Disease: A Systematic Review and Meta-Analysis.

Adv Ther 2020 Jun 12;37(6):2792-2812. Epub 2020 May 12.

State Scientific Center of Coloproctology, Ministry of Health of Russian Federation, Moscow, Russia.

Introduction: Hemorrhoidal disease (HD) is a common and recurrent problem for many adults worldwide. Venoactive drugs, such as micronized purified flavonoid fraction (MPFF; Daflon), have been used to treat HD and their clinical benefits have been demonstrated in previous meta-analyses of clinical trials. The aim of this study was to evaluate the efficacy of MPFF across the broader spectrum of signs and symptoms following treatment of patients with HD. Read More

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http://dx.doi.org/10.1007/s12325-020-01353-7DOI Listing

Consensus Recommendations for Management and Counseling of Adverse Events Associated With Lorlatinib: A Guide for Healthcare Practitioners.

Adv Ther 2020 Jun 12;37(6):3019-3030. Epub 2020 May 12.

University of Missouri Health Care, Columbia, MO, USA.

Resistance to first- and second-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) and development and progression of central nervous system metastases remain significant issues in the treatment of ALK-positive non-small-cell lung cancer. Lorlatinib is a novel third-generation ALK TKI that is able to penetrate the blood-brain barrier and has broad-spectrum potency against most known resistance mutations that can develop during treatment with crizotinib and second-generation ALK TKIs. The safety profile of lorlatinib is distinct from those of other ALK TKIs. Read More

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http://dx.doi.org/10.1007/s12325-020-01365-3DOI Listing

Identification of Patient Needs and Preferences in Pigmented Villonodular Synovitis (PVNS) Using a Qualitative Online Bulletin Board Study.

Adv Ther 2020 Jun 11;37(6):2813-2828. Epub 2020 May 11.

Novartis Healthcare Pvt. Ltd., Hyderabad, India.

Introduction: Pigmented villonodular synovitis (PVNS), also known as giant-cell tumour of the tendon sheath (GCTT), is a rare, benign proliferative tumour affecting the inner lining of synovial joints and tendon sheets. Information on treatment needs of PVNS patients to inform drug development is currently scarce. We conducted an exploratory qualitative study with PVNS patients to generate insights into the objective and emotional aspects related to their medical journey and experiences of living with this disease. Read More

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http://dx.doi.org/10.1007/s12325-020-01364-4DOI Listing

Malignant Transformation and Associated Biomarkers of Ovarian Endometriosis: A Narrative Review.

Adv Ther 2020 Jun 8;37(6):2580-2603. Epub 2020 May 8.

Department of Clinical Pathology, Federal State Budgetary Institution "Research Institute of Human Morphology", 3, Tsyurupy Str, Moscow, 117418, Russian Federation.

This review focuses on pathogenesis of endometriosis, its possible biomarkers and role in endometriosis-associated ovarian cancer. We analyzed various databases to obtain new insights, theories, and biomarkers associated with endometriosis. There are several theories of endometriosis development and biomarker changes including atypical forms. Read More

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http://dx.doi.org/10.1007/s12325-020-01363-5DOI Listing

Lenvatinib and Subsequent Therapy for Radioactive Iodine-Refractory Differentiated Thyroid Cancer: A Real-World Study of Clinical Effectiveness in the United States.

Adv Ther 2020 Jun 7;37(6):2841-2852. Epub 2020 May 7.

Real-World Evidence and Insights, Cardinal Health Specialty Solutions, Dublin, OH, USA.

Introduction: Lenvatinib has become the most commonly prescribed first-line (1L) agent for the treatment of radioactive iodine-refractory differentiated thyroid cancer (RAI-r DTC) since its approval in 2015. With no real-world studies describing clinical outcomes of 1L lenvatinib and subsequent therapy, the current study aimed to assess treatment sequencing and related clinical outcomes in patients treated with 1L lenvatinib in the USA METHODS: We conducted a multisite, retrospective chart review of US patients with a diagnosis of RAI-r DTC who had initiated 1L therapy with lenvatinib from January 1, 2016 through May 31, 2017 with follow-up through October 17, 2018. Physicians completed electronic case report forms for two patient cohorts: patients still receiving 1L lenvatinib (cohort 1) and those who had initiated second-line (2L) therapy prior to data cutoff (cohort 2). Read More

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http://dx.doi.org/10.1007/s12325-020-01362-6DOI Listing

Cetuximab Maintenance Therapy in Patients with Unresectable Wild-Type RAS and BRAF Metastatic Colorectal Cancer: A Single-Institute Prospective Study.

Adv Ther 2020 Jun 7;37(6):2829-2840. Epub 2020 May 7.

Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, People's Republic of China.

Introduction: Cetuximab plus FOLFIRI (leucovorin, fluorouracil, and irinotecan) is the preferred first-line therapy for RAS and BRAF wild-type (RBWT) metastatic colorectal cancer (mCRC). To counter chemotherapy-induced side effects, use of maintenance therapy is suggested. Therefore, we evaluated the efficacy and safety of cetuximab maintenance therapy in patients after effective completion of first-line induction therapy. Read More

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http://dx.doi.org/10.1007/s12325-020-01360-8DOI Listing
June 2020
2.438 Impact Factor

A Phase II Study of Modified FOLFOX6 for Advanced Gastric Cancer Refractory to Standard Therapies.

Adv Ther 2020 Jun 7;37(6):2853-2864. Epub 2020 May 7.

Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.

Introduction: In patients with advanced gastric cancer refractory to chemotherapy, the treatment options are limited. Via this phase II study, we aimed to assess the efficacy and safety of oxaliplatin in combination with 5-fluorouracil and l-leucovorin (modified FOLFOX6).

Methods: Patients who had histologically confirmed metastatic gastric cancer refractory to ≥ two previous chemotherapy regimens were included. Read More

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http://dx.doi.org/10.1007/s12325-020-01358-2DOI Listing

Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study.

Adv Ther 2020 Jun 6;37(6):2865-2883. Epub 2020 May 6.

Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg, Hamburg, Germany.

Introduction: Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications.

Methods: SERENA is an ongoing, longitudinal, observational study conducted at 438 sites across Europe in patients with moderate to severe plaque PsO, active PsA or active AS. Read More

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http://dx.doi.org/10.1007/s12325-020-01352-8DOI Listing

Limited Utility for Benzodiazepines in Chronic Pain Management: A Narrative Review.

Authors:
Steven L Wright

Adv Ther 2020 Jun 6;37(6):2604-2619. Epub 2020 May 6.

Alliance for Benzodiazepine Best Practices, Littleton, CO, USA.

Introduction: Controversy and uncertainty exist about the use of benzodiazepine receptor agonists (BZRAs) in pain management. This article curates available research to determine the appropriate role of BZRAs in the course of pain management, and how prescribers might address these challenges.

Methods: A narrative review was performed to determine the appropriate role of BZRAs in pain management and to develop practice recommendations. Read More

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http://dx.doi.org/10.1007/s12325-020-01354-6DOI Listing

Pooled Safety and Tolerability Analysis of Empagliflozin in Patients with Type 2 Diabetes Mellitus.

Adv Ther 2020 May 5. Epub 2020 May 5.

Boehringer Ingelheim International GmbH, Ingelheim, Germany.

Introduction: The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials.

Methods: Pooled data from 20 trials were analyzed for patients with T2DM treated with empagliflozin 10 mg (n = 4858), empagliflozin 25 mg (n = 5057), or placebo (n = 4904). The dataset comprised 15 randomized phase I-III trials, an extension trial and dose escalation studies. Read More

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http://dx.doi.org/10.1007/s12325-020-01329-7DOI Listing

Qualitative Interviews to Better Understand the Patient Experience and Evaluate Patient-Reported Outcomes (PRO) in RLBP1 Retinitis Pigmentosa (RLBP1 RP).

Adv Ther 2020 Jun 5;37(6):2884-2901. Epub 2020 May 5.

Novartis Pharma AG, Basel, Switzerland.

Introduction: RLBP1 RP is an autosomal recessive form of retinitis pigmentosa (RP), characterized by night blindness, prolonged dark adaptation, constricted visual fields and impaired macular function. This study aimed to better understand the patient experience of RLBP1 RP and evaluate the content validity of existing patient reported outcome (PRO) instruments in this condition.

Methods: Semi-structured concept elicitation and cognitive debriefing interviews were conducted with RLBP1 RP patients in Canada and Sweden. Read More

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http://dx.doi.org/10.1007/s12325-020-01275-4DOI Listing

A Novel Nomogram Integrated with Inflammation-Based Factors to Predict the Prognosis of Gastric Cancer Patients.

Adv Ther 2020 Jun 3;37(6):2902-2915. Epub 2020 May 3.

Department of Laboratory Medicine, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.

Introduction: Gastric cancer (GC) is the fifth most common cancer worldwide, and every year approximately 950,000 individuals are diagnosed worldwide. Our study aimed to establish an effective nomogram to predict the prognosis of GC based on inflammation biomarkers.

Methods: We retrospectively analysed GC patients from the Sun Yat-sen University Cancer Center. Read More

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http://dx.doi.org/10.1007/s12325-020-01356-4DOI Listing

Advances in Clinical Cardiology 2019: A Summary of Key Clinical Trials.

Adv Ther 2020 Jun 2;37(6):2620-2645. Epub 2020 May 2.

Southern Health and Social Care Trust, Craigavon Area Hospital, Craigavon, Northern Ireland, UK.

Introduction: A large number of important clinical trials in cardiology were published or presented at major international conferences during 2019. This paper aims to offer a concise overview of these significant advances and to put them into clinical context.

Methods: Trials presented at the major international cardiology meetings during 2019 were reviewed including The American College of Cardiology (ACC), Euro PCR, The European Society of Cardiology (ESC), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). Read More

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http://dx.doi.org/10.1007/s12325-020-01355-5DOI Listing

Persistence and Adherence to ICS/LABA Drugs in UK Patients with Asthma: A Retrospective New-User Cohort Study.

Adv Ther 2020 Jun 2;37(6):2916-2931. Epub 2020 May 2.

Real World Solutions, IQVIA, London, UK.

Introduction: Asthma is associated with significant economic burden. Inhaled corticosteroid and long-acting beta-agonist (ICS/LABA) combination therapies are considered mainstays of treatment. We describe real-world use of ICS/LABAs by comparing treatment persistence and adherence among patients with asthma in the United Kingdom initiating fluticasone furoate/vilanterol (FF/VI) versus budesonide/formoterol (BUD/FM) or beclometasone dipropionate/formoterol (BDP/FM). Read More

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http://dx.doi.org/10.1007/s12325-020-01344-8DOI Listing

Anti COVID-19 Drugs: Need for More Clinical Evidence and Global Action.

Adv Ther 2020 06 29;37(6):2575-2579. Epub 2020 Apr 29.

Department of Microbiology, Faculty of Chemical and Life Sciences, Abdul Wali Khan University Mardan (AWKUM), Mardan, KPK, Pakistan.

The World Health Organization (WHO) called the outbreak of coronavirus infectious disease-2019 (COVID-19) a "Public Health Emergency of International Concern" (PHEIC). According to the WHO, Centers for Disease Control and Prevention (CDC), and the US Food and Drug Administration (FDA), currently there are no medicines or vaccines that have been claimed to be useful in the prevention or treatment of COVID-19. Several existing antiviral drugs, previously developed or used as treatments for severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), human immunodeficiency virus (HIV), and malaria, are being investigated as COVID-19 treatments and some of them are being used in clinical trials. Read More

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http://dx.doi.org/10.1007/s12325-020-01351-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7189176PMC

Alternative Regimens of Neuraminidase Inhibitors for Therapy of Hospitalized Adults with Influenza: A Systematic Review of Randomized Controlled Trials.

Adv Ther 2020 Jun 28;37(6):2646-2666. Epub 2020 Apr 28.

Clinical Research/Epidemiology in Pneumonia and Sepsis (CRIPS), Vall d'Hebron Institut of Research (VHIR), Barcelona, Spain.

Introduction: Influenza in hospitalized intensive care unit (ICU) patients with respiratory failure is associated with 25% mortality, despite timely oseltamivir treatment. A systematic review of randomized controlled trials (RCTs) was conducted to evaluate the efficacy and safety of alternative neuraminidase inhibitor (NAI) regimens compared to standard of care in patients hospitalized for H1N1, H3N2, or B influenza.

Methods: The Cochrane collaboration searching methods were followed in Cochrane Library, PubMed, and Web of Science databases (2009-2019). Read More

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http://dx.doi.org/10.1007/s12325-020-01347-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7187665PMC
June 2020
2.438 Impact Factor

Relevant Patient Benefit of Sublingual Immunotherapy with Birch Pollen Allergen Extract in Allergic Rhinitis: An Open, Prospective, Non-Interventional Study.

Adv Ther 2020 Jun 28;37(6):2932-2945. Epub 2020 Apr 28.

Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Martinistr. 52, 20246, Hamburg, Germany.

Introduction: Sublingual immunotherapy (SLIT) with birch pollen extract has been shown to be an efficacious treatment of allergic rhinitis (AR). An as-yet unanswered question is whether and how clinical benefit translates into patient benefit, i.e. Read More

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http://dx.doi.org/10.1007/s12325-020-01345-7DOI Listing

Prognostic Potential of Electrocardiographic Parameters in Patients with Multiple Myeloma: A Retrospective Analysis of the Multiple Myeloma Population.

Adv Ther 2020 Jun 26;37(6):2946-2955. Epub 2020 Apr 26.

Department of Cardiovascular Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, 277 Yanta West Road, Xi'an, 710061, Shaanxi, China.

Introduction: Patients with multiple myeloma (MM) can develop cardiac abnormalities, predisposing them to the development of heart failure, arrhythmias, or infarction with poor prognosis. The purpose of this study is to evaluate the prognostic potential of electrocardiographic (ECG) parameters in patients with MM.

Methods: This study retrospectively included patients with MM from January 2010 to December 2018 in the First Affiliated Hospital of Xi'an Jiao Tong University. Read More

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http://dx.doi.org/10.1007/s12325-020-01343-9DOI Listing

Efficacy of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Versus Other Inhaled Corticosteroid/Long-Acting Muscarinic Antagonist/Long-Acting β-Agonist (ICS/LAMA/LABA) Triple Combinations in COPD: A Systematic Literature Review and Network Meta-analysis.

Adv Ther 2020 Jun 25;37(6):2956-2975. Epub 2020 Apr 25.

AstraZeneca, Cambridge, UK.

Introduction: Triple inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β-agonist (ICS/LAMA/LABA) combination therapy is recommended for patients with chronic obstructive pulmonary disease (COPD) who experience further exacerbations/symptoms on dual LAMA/LABA or ICS/LABA therapy. The relative efficacy of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler 320/18/9.6 µg (BGF MDI) in COPD was compared with other ICS/LAMA/LABA fixed-dose and open combination therapies in a network meta-analysis (NMA). Read More

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http://dx.doi.org/10.1007/s12325-020-01311-3DOI Listing

The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial.

Adv Ther 2020 Jun 24;37(6):2976-2987. Epub 2020 Apr 24.

Medical Consumer Health Care, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.

Introduction: A fixed dose combination (FDC) of ibuprofen 400 mg and caffeine 100 mg has been shown to be more effective than ibuprofen 400 mg alone for the treatment of acute postoperative dental pain in a phase III randomised controlled trial. A post hoc subgroup analysis of the primary data from an active-/placebo-controlled, double-blind, single-centre, parallel-group study was conducted in patients with moderate or severe baseline pain.

Methods: After dental surgery, patients with moderate or severe pain, which was determined on a 4-point verbal rating scale ('no pain' to 'severe pain'), received a single dose of ibuprofen 400 mg/caffeine 100 mg FDC, ibuprofen 400 mg, caffeine 100 mg or placebo. Read More

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http://dx.doi.org/10.1007/s12325-020-01297-yDOI Listing

Real-World Utilisation and Bleed Rates in Patients with Haemophilia B Who Switched to Recombinant Factor IX Fusion Protein (rIX-FP): A Retrospective International Analysis.

Adv Ther 2020 Jun 24;37(6):2988-2998. Epub 2020 Apr 24.

Hemophilia and Thrombosis Center, University Hospital of Bari, Bari, Italy.

Introduction: Despite the well-documented benefits of prophylaxis, treatment burden is still a barrier to adherence in patients with haemophilia. An extended half-life fusion protein linking recombinant FIX (rFIX) with human albumin (rIX-FP) has been developed for the treatment of patients with haemophilia B and is indicated for dosing up to every 14 days. This analysis evaluated real-world outcomes in patients switching to rIX-FP from the previous FIX product in Italy, Belgium and the UK. Read More

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http://dx.doi.org/10.1007/s12325-020-01300-6DOI Listing