3,176 results match your criteria Advances In Therapy[Journal]

XaMINA: A Real-World, Prospective, Observational Study of Treatment-Naïve Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation in Asia.

Adv Ther 2022 May 26. Epub 2022 May 26.

Severance Hospital, Yonsei University, 50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, Republic of Korea.

Introduction: The efficacy and safety of rivaroxaban for the prevention of stroke and systemic embolism have been demonstrated in Asian and non-Asian patients with non-valvular atrial fibrillation (NVAF) in multiple studies. However, limited published data exist on its use specifically in treatment-naïve patients from the Asia region. Patients in South Korea and Taiwan can now receive rivaroxaban as first-line therapy, allowing for data generation in this patient group. Read More

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Effectiveness of Neridronate in the Management of Bone Loss in Patients with Duchenne Muscular Dystrophy: Results from a Pilot Study.

Adv Ther 2022 May 25. Epub 2022 May 25.

Department of Medical and Surgical Specialties and Dentistry, University of Campania "Luigi Vanvitelli", via De Crecchio, 4, 80138, Naples, Italy.

Introduction: Bone loss is a major issue in patients affected by Duchenne muscular dystrophy (DMD), a rare musculoskeletal disorder, particularly in those treated with glucocorticoids (GCs). We aimed to assess the effectiveness of neridronate in terms of bone mineral density (BMD) changes in this population.

Methods: We retrospectively reviewed the records of patients affected by DMD receiving GCs referred to our outpatient from 2015 to 2020. Read More

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MANTA and MANTA-RAy: Rationale and Design of Trials Evaluating Effects of Filgotinib on Semen Parameters in Patients with Inflammatory Diseases.

Adv Ther 2022 May 25. Epub 2022 May 25.

Medical University of Vienna, Vienna, Austria.

Introduction: The phase 2 MANTA and MANTA-RAy studies were developed in consultation with global regulatory authorities to investigate potential impacts of filgotinib, a Janus kinase 1 preferential inhibitor, on semen parameters in men with active inflammatory diseases. Here we describe the methods and rationale for these studies.

Methods And Rationale: The MANTA and MANTA-RAy studies included men (aged 21-65 years) with active inflammatory bowel disease (IBD) and rheumatic diseases, respectively. Read More

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Real-world Clinical Outcomes of First-Line Ibrutinib or Chemoimmunotherapy in Patients with Chronic Lymphocytic Leukemia by Risk Status.

Adv Ther 2022 May 24. Epub 2022 May 24.

John Theurer Cancer Center, Hackensack, NJ, USA.

Introduction: Certain genetic features in chronic lymphocytic leukemia (CLL) are associated with inferior outcomes after chemoimmunotherapy (CIT). This retrospective study evaluated treatment patterns and clinical outcomes of patients with CLL, stratified into high-risk and non-high-risk groups, who received first-line ibrutinib or CIT therapy.

Methods: High-risk group included confirmed presence of del(17p), del(11q), unmutated IGHV, TP53 mutations, or complex karyotype. Read More

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A Decreased Absolute Number of T Cells in Patients with Active Rheumatoid Arthritis is Associated with Elevated Serum Osteopontin Levels with Disease Progression.

Adv Ther 2022 May 23. Epub 2022 May 23.

Department of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, 030001, Shanxi, China.

Introduction: Rheumatoid arthritis (RA) is a chronic and refractory autoimmune disease characterized by synovial inflammation with unknown aetiology. Immune system dysfunction mediated by CD4 T lymphocytes, which is regulated by the cytokine osteopontin (OPN), plays an important role in the pathogenesis of RA.

Methods: In this study, the levels of peripheral CD4 T subsets and serum OPN in patients with active RA were measured and analysed to determine the possible pathogenesis of RA and to provide potential therapeutic targets. Read More

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Cost-Effectiveness Analysis of Evolocumab in Adult Patients with Atherosclerotic Cardiovascular Disease in Canada.

Adv Ther 2022 May 23. Epub 2022 May 23.

Health Economics and Market Access, Value Access and Policy, Amgen Canada Inc., 6775 Financial Drive, Suite 100, Mississauga, ON, L5N 0A4, Canada.

Introduction: To evaluate the cost-effectiveness of evolocumab when added to standard of care lipid-lowering treatment (LLT) for patients with atherosclerotic cardiovascular disease (ASCVD) who cannot adequately control their low-density lipoprotein cholesterol (LDL-C) despite optimized LLT in Canada.

Methods: An incremental cost-utility analysis was conducted using a Markov cohort state transition model adapted to the Canadian setting. Analyses were conducted from a public health and societal perspective using a lifetime time horizon for Canada. Read More

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Choroidal Thickness Changes After Intravitreal Aflibercept Injections in Treatment-Naïve Neovascular AMD.

Adv Ther 2022 May 21. Epub 2022 May 21.

Università Cattolica del Sacro Cuore, Rome, Italy.

Introduction: Choroidal thickness (CT) plays an important role in the pathogenesis of various ocular diseases, including neovascular age-related macular degeneration (nAMD). Previous studies evaluated the CT variations after anti-vascular endothelial growth factor (VEGF) injections in patients with nAMD, but the results are still controversial. The present study aimed to evaluate the CT at different times (15, 30, 60, 90, and 365 days) after intravitreal aflibercept injections and its correlation with the baseline CT in treatment-naïve patients with nAMD. Read More

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Using Precision Medicine for the Diagnosis and Treatment of Viral Pneumonia.

Adv Ther 2022 May 21. Epub 2022 May 21.

Department of Medicine, Northeast Ohio Medical University, Rootstown, OH, USA.

The COVID-19 pandemic has drawn considerable attention to viral pneumonia from clinicians, public health authorities, and the general public. With dozens of viruses able to cause pneumonia in humans, differentiating viral from bacterial pneumonia can be very challenging in clinical practice using traditional diagnostic methods. Precision medicine is a medical model in which decisions, practices, interventions, and therapies are adapted to the individual patient on the basis of their predicted response or risk of disease. Read More

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A Computational Platform Integrating a Mechanistic Model of Crohn's Disease for Predicting Temporal Progression of Mucosal Damage and Healing.

Adv Ther 2022 May 17. Epub 2022 May 17.

Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.

Introduction: Physicians are often required to make treatment decisions for patients with Crohn's disease on the basis of limited objective information about the state of the patient's gastrointestinal tissue while aiming to achieve mucosal healing. Tools to predict changes in mucosal health with treatment are needed. We evaluated a computational approach integrating a mechanistic model of Crohn's disease with a responder classifier to predict temporal changes in mucosal health. Read More

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Meta-Analysis of Effect of Nintedanib on Reducing FVC Decline Across Interstitial Lung Diseases.

Adv Ther 2022 May 14. Epub 2022 May 14.

Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

Introduction: The effect of nintedanib on slowing the rate of decline in forced vital capacity (FVC) has been investigated in randomized placebo-controlled trials in subjects with idiopathic pulmonary fibrosis (IPF), other progressive fibrosing interstitial lung diseases (ILDs), and ILD associated with systemic sclerosis (SSc-ILD). We assessed the consistency of the effect of nintedanib on the rate of decline in FVC over 52 weeks across four placebo-controlled phase III trials.

Methods: We used data on FVC decline from the INPULSIS-1 and INPULSIS-2 trials in subjects with IPF, the INBUILD trial in subjects with progressing fibrosing ILDs other than IPF, and the SENSCIS trial in subjects with SSc-ILD. Read More

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Real-World Biologic Adherence, Persistence, and Monotherapy Comparisons in US Patients with Psoriasis: Results from IBM MarketScan Databases.

Adv Ther 2022 May 16. Epub 2022 May 16.

Oregon Medical Research Center, Portland, USA.

Introduction: Limited real-world data are available comparing multiple biologics on their adherence, persistence, and the use of concomitant biologics in the treatment of moderate-to-severe psoriasis in clinical practice. The objective was to compare persistence of and adherence to ixekizumab (IXE) treatment, as monotherapy or with concomitant medication, versus patients receiving other commonly prescribed biologics.

Methods: Patients who newly initiated IXE, adalimumab (ADA), etanercept (ETN), secukinumab (SEC), or ustekinumab (UST) in IBM MarketScan databases with diagnosis of psoriasis were identified. Read More

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Health-Related Quality of Life with Diroximel Fumarate in Patients with Relapsing Forms of Multiple Sclerosis: Findings from Qualitative Research Using Patient Interviews.

Adv Ther 2022 May 13. Epub 2022 May 13.

Biogen, 225 Binney St., Cambridge, MA, USA.

Introduction: Diroximel fumarate (DRF) is an oral fumarate for relapsing multiple sclerosis (MS). Clinical and real-world studies of DRF have demonstrated improved gastrointestinal (GI) tolerability and low (< 1%) GI-related treatment discontinuation versus dimethyl fumarate (DMF) and high rates of treatment adherence. Our aim was to conduct a concept elicitation study to identify treatment-related concepts most meaningful to patients and to evaluate how these concepts shape the patient perspective of DRF. Read More

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The Cost-Effectiveness of Oral Semaglutide in Spain: A Long-Term Health Economic Analysis Based on the PIONEER Clinical Trials.

Adv Ther 2022 May 12. Epub 2022 May 12.

Centro de Investigación Biomédica en Red en Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Barcelona, Spain.

Introduction: Novel glucagon-like peptide-1 (GLP-1) receptor agonist oral semaglutide has demonstrated greater improvements in glycated hemoglobin (HbA1c) and body weight versus oral medications empagliflozin and sitagliptin, and injectable GLP-1 analog liraglutide, in the PIONEER clinical trial program. Based on these data, the present analysis aimed to evaluate the long-term cost-effectiveness of oral semaglutide versus empagliflozin, sitagliptin and liraglutide in Spain.

Methods: Outcomes were projected over patients' lifetimes using the IQVIA CORE Diabetes Model (v9. Read More

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Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study.

Adv Ther 2022 May 11. Epub 2022 May 11.

Navarra Institute for Health Research (IdiSNA), Pamplona, Spain.

Introduction: In clinical trials with hepatitis C virus-infected treatment-naïve (TN) patients with compensated cirrhosis (CC), glecaprevir/pibrentasvir (G/P), a fixed-dose, once-daily, pangenotypic regimen, has demonstrated sustained virologic response at posttreatment Week 12 (SVR12) > 95%. We evaluated the real-world safety and effectiveness of 8-week G/P therapy in TN patients with CC, including certain subgroups of interest.

Methods: The CREST study is a real-world, noninterventional, multicenter study retrospectively assessing data from Canada, Germany, Israel, Italy, and Spain. Read More

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Matching-Adjusted Indirect Comparison (MAIC) of Tepotinib with Other MET Inhibitors for the Treatment of Advanced NSCLC with MET Exon 14 Skipping Mutations.

Adv Ther 2022 May 11. Epub 2022 May 11.

Department of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

Introduction: MET exon 14 skipping in patients with advanced non-small cell lung cancer (aNSCLC), can be targeted with MET inhibitors including tepotinib, capmatinib, savolitinib, and crizotinib. Matching-adjusted indirect comparison (MAIC) methodology was used to compare outcomes data between agents and to address bias from differences in baseline characteristics.

Methods: Patient-level data from the VISION study (tepotinib) were weighted for comparison with aggregate data from the GEOMETRY mono-1 (capmatinib), NCT02897479 (savolitinib) and PROFILE 1001 (crizotinib) studies in patients with aNSCLC, using baseline characteristics prognostic for overall survival (OS) in VISION. Read More

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Treatment Patterns and Clinical Characteristics of Patients with Systemic Lupus Erythematosus and Musculoskeletal Symptoms: A Retrospective, Observational Study.

Adv Ther 2022 May 9. Epub 2022 May 9.

Johns Hopkins University School of Medicine, Baltimore, USA.

Introduction: Musculoskeletal (MSK) symptoms, including arthritis and arthralgia, are common manifestations of systemic lupus erythematosus (SLE); definitions of activity patterns in SLE differ across studies. This study described clinical characteristics and treatment patterns of patients with SLE-MSK over time and by disease activity patterns from a real-world setting.

Methods: This retrospective descriptive analysis includes a subset of patients with SLE from the Hopkins Lupus Cohort with identified MSK involvement by scores on the arthritis domain of the Safety of Estrogens in Systemic Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) or Lupus Activity Index. Read More

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Switching to Preservative-Free Tafluprost/Timolol Fixed-Dose Combination in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: Subanalysis of Data from the VISIONARY Study According to Baseline Monotherapy Treatment.

Adv Ther 2022 May 7. Epub 2022 May 7.

Tutkimusz Ltd, Solymár, Hungary.

Introduction: The VISIONARY study demonstrated statistically significant intraocular pressure (IOP) reductions with the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (PF tafluprost/timolol FC) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients, sub-optimally controlled with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Read More

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Drug Utilization Pattern of Oral Anticoagulants in Patients with Atrial Fibrillation: A Nationwide Population-Based Study in Korea.

Adv Ther 2022 May 7. Epub 2022 May 7.

Division of Cardiology, Department of Internal Medicine, College of Medicine, Korea University Medical Center, Korea University, 73 Inchon-ro, Seongbuk-gu, Seoul, South Korea.

Introduction: Treatment persistence for anticoagulant therapy is important in preventing thromboembolism in nonvalvular atrial fibrillation (NVAF) patients. Understanding drug utilization pattern and treatment changes in oral anticoagulant (OAC) users may facilite better NVAF management. Thus, our study aimed to examine OAC treatment patterns preceding events leading to switch or discontinuation and medication adherence in Korean NVAF patients. Read More

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The Impact of a Prenatal Education Program for Opioid-Dependent Mothers on Breastfeeding Rates of Infants at Risk for Neonatal Abstinence Syndrome.

Adv Ther 2022 May 6. Epub 2022 May 6.

Division of Neonatology, University of South Alabama, Mobile, AL, USA.

Introduction: This study aimed to determine the effect of a prenatal education program for opioid-dependent women on breastfeeding frequency, newborn hospital length of stay, and cost of care for neonates at risk of developing neonatal abstinence syndrome.

Methods: From January 1, 2015 to January 1, 2020, opioid-dependent obstetric patients were educated on non-pharmacological preventative measures for neonatal abstinence syndrome (NAS), with focused counseling on breastfeeding. Data were collected and compared to a control group of opioid-dependent pregnant women who received standard care before initiation of the education program. Read More

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Changes in Refractive Error Under COVID-19: A 3-Year Follow-up Study.

Adv Ther 2022 Jun 4;39(6):2999-3010. Epub 2022 May 4.

Tianjin Key Lab of Ophthalmology and Visual Science, Tianjin Eye Institute, Tianjin Eye Hospital, Nankai University Affiliated Eye Hospital, Tianjin, China.

Introduction: To investigate changes in refractive error in schoolchildren before and during the coronavirus disease 2019 (COVID-19) pandemic.

Methods: This study included 2792 students, who underwent a 3-year follow-up from 2018 to 2020. All participants underwent yearly noncycloplegic refraction and ocular examinations. Read More

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Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in the ALTAIR Study: 96-Week Outcomes in the Polypoidal Choroidal Vasculopathy Subgroup.

Adv Ther 2022 Jun 3;39(6):2984-2998. Epub 2022 May 3.

Department of Medical Affairs and Pharmacovigilance, Bayer Yakuhin Ltd., Osaka, Japan.

Introduction: To explore the efficacy and safety of intravitreal aflibercept (IVT-AFL) proactive, individualized treat-and-extend (T&E) regimens in exudative age-related macular degeneration (AMD) in the subgroup of patients with polypoidal choroidal vasculopathy (PCV) enrolled in the ALTAIR study.

Methods: This was a PCV subgroup analysis of ALTAIR, a 96-week, randomized, open-label, phase 4 study in treatment-naïve patients with exudative AMD in Japan. Following three initial monthly doses, patients received IVT-AFL at week 16 and were randomized 1:1 to T&E regimens with either 2-week (IVT-AFL-2W) or 4-week (IVT-AFL-4W) adjustments. Read More

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Efficacy of GLP-1 RA Approved for Weight Management in Patients With or Without Diabetes: A Narrative Review.

Adv Ther 2022 Jun 3;39(6):2452-2467. Epub 2022 May 3.

Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Centre Ljubljana, Zaloška cesta 7, 1000, Ljubljana, Slovenia.

The approval of once daily liraglutide, 3.0 mg, and once weekly semaglutide, 2.4 mg, for chronic weight management provides a novel effective strategy against obesity. Read More

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Improving Care in Eosinophil-Associated Diseases: A Charter.

Adv Ther 2022 Jun 30;39(6):2323-2341. Epub 2022 Apr 30.

Allergy and Asthma Network, Vienna, VA, USA.

Eosinophil-associated diseases (EADs) are a range of heterogeneous conditions in which eosinophils are believed to play a critical pathological role. EADs include common illnesses such as eosinophilic asthma and chronic rhinosinusitis and rare conditions such as hypereosinophilic syndromes (HES) and eosinophilic gastrointestinal disorders (EGIDs). EADs are associated with substantial burdens for the patient, including chronic, debilitating symptoms, increased financial burden, decreased health-related quality of life, and the need for repeated visits to multiple different healthcare professionals (HCPs), emergency departments, and/or hospitals. Read More

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Cost-Effectiveness of Linaclotide Compared to Osmotic Laxatives in the Treatment of Irritable Bowel Syndrome with Constipation in China.

Adv Ther 2022 Jun 30;39(6):2971-2983. Epub 2022 Apr 30.

School of Public Health, Fudan University, Shanghai, 200032, China.

Introduction: Linaclotide, a selective agonist of guanylate cyclase C, was highly recommended for the treatment of irritable bowel syndrome with constipation (IBS-C). However, the cost-effectiveness of linaclotide in Chinese is not known, and this study aimed to assess the cost-effectiveness of linaclotide for patients with IBS-C.

Methods: An economic evaluation was conducted with a Markov model from a societal perspective. Read More

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Iron Deficiency in Women's Health: New Insights into Diagnosis and Treatment.

Adv Ther 2022 Jun 30;39(6):2438-2451. Epub 2022 Apr 30.

Obstetrics and Gynecology, Division of Clinical Genetics, Feinberg School of Medicine of Northwestern University, Chicago, USA.

Iron deficiency (ID), with or without anemia, is commonly found worldwide and affects the health and wellbeing of pregnant and nonpregnant women. Symptoms of ID- which include fatigue, pica (ice craving), restless legs syndrome, poor concentration and work function, increased susceptibility to infection, and cardiovascular stress- can cause significant morbidity and reduced quality of life. The etiologies of iron deficiency in women are usually specific to each community. Read More

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17-Year Follow-up of Comparing Mastoscopic and Conventional Axillary Dissection in Breast Cancer: A Multicenter, Randomized Controlled Trial.

Adv Ther 2022 Jun 29;39(6):2961-2970. Epub 2022 Apr 29.

Department of Epidemiology and Health Statistics, Capital Medical University, Beijing, China.

Introduction: Longer follow-up was necessary to determine the exact value of mastoscopic axillary lymph node dissection (MALND).

Methods: From January 1, 2003, to December 31, 2005, 1027 patients with breast cancer were randomly assigned to two groups: MALND and CALND (conventional axillary lymph node dissection); 996 eligible patients were enrolled.

Results: The final cohort of 996 patients was followed for an average of 198 months. Read More

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One-Year Sequelae and Quality of Life in Adults with Meningococcal Meningitis: Lessons from the COMBAT Multicentre Prospective Study.

Adv Ther 2022 Jun 28;39(6):3031-3041. Epub 2022 Apr 28.

Institute Pasteur, 25-28 Rue du Dr Roux, 75015, Paris, France.

Introduction: COMBAT is a prospective, multicentre cohort study that enrolled consecutive adults with community-acquired bacterial meningitis (CABM) in 69 participating centres in France between February 2013 and July 2015 and followed them for 1 year.

Methods: Patients aged at least 18 years old, hospitalised with CABM were followed during their hospitalisation and then contacted by phone 12 months after enrolment. Here we present the prevalence of sequelae at 12 months in a subgroup of patients with meningococcal meningitis. Read More

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