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Advances in Therapy

Sanjeevani Arora, Rodion Velichinskii, Randy W Lesh, Usman Ali, Michal Kubiak, Pranshu Bansal, Hossein Borghaei, Martin J Edelman, Yanis Boumber
In the last few years, immunotherapy has transformed the way we treat solid tumors, including melanoma, lung, head neck, breast, renal, and bladder cancers. Durable responses and long-term survival benefit has been experienced by many cancer patients, with favorable toxicity profiles of immunotherapeutic agents relative to chemotherapy. Cures have become possible in some patients with metastatic disease. Additional approvals of immunotherapy drugs and in combination with other agents are anticipated in the near future...
August 13, 2019: Advances in Therapy
Antonio Nicolucci, Riccardo Candido, Domenico Cucinotta, Giusi Graziano, Alberto Rocca, Maria C Rossi, Franco Tuccinardi, Valeria Manicardi
INTRODUCTION: Following the US Food and Drug Administration (FDA) guidance on the evaluation of novel agents for the treatment of type 2 diabetes mellitus (T2DM), a number of cardiovascular outcomes safety trials (CVOTs) on sodium-glucose cotransporter-2 inhibitors (SGLT2i) have been conducted. These trials show similarities in study design and definition of primary endpoints, but differ in their eligibility criteria. The aim of the present study was to investigate the generalizability of CVOTs on SGLT2i to Italian adults with T2DM; we estimated the proportions of this patient population who would be eligible for enrollment in EMPA-REG OUTCOME (empagliflozin), CANVAS (canagliflozin), DECLARE-TIMI 58 (dapagliflozin), and VERTIS-CV (ertugliflozin) studies...
August 13, 2019: Advances in Therapy
Barbara Wójcik, Jerzy Superata, H Bryant Nguyen, Zbigniew Szyguła
INTRODUCTION: This project addresses the important problem of sepsis sequelae resulting in frequent hospital readmissions and higher mortality rate in the post-discharge period. However, neither specific diagnostic methods nor standards for rehabilitation of sepsis patients have been introduced yet. The aim of this study is to evaluate the effectiveness of two different multiparameter-monitored rehabilitation treatments in order to improve the health status and quality of life of sepsis survivors...
August 13, 2019: Advances in Therapy
Peter Zbären, Jatin P Shah, Gregory W Randolph, Carl E Silver, Kerry D Olsen, Ashok R Shaha, Mark Zafereo, Luiz P Kowalski, Carlos Suarez, Alvaro Sanabria, Vincent Vander Poorten, Iain Nixon, Alessandra Rinaldo, Alfio Ferlito
In the United States of America (US), most departments of otorhinolaryngology head and neck surgery have been performing thyroid surgery for many years. In contrast to the US, thyroid surgery is still dominated by general surgeons in most European countries. In numerous university centers, there continues to be friction regarding thyroid surgery. The focus of this editorial is to demonstrate that there is objective data in the literature to suggest that otorhinolaryngologists with appropriate training in head and neck surgery are well suited to perform the entire spectrum of thyroid surgery...
August 10, 2019: Advances in Therapy
Marilyn K Glassberg, Steven D Nathan, Chin-Yu Lin, Elizabeth A Morgenthien, John L Stauffer, Willis Chou, Paul W Noble
INTRODUCTION: This study assessed baseline cardiovascular (CV) risk factors, concomitant CV medication use, risk of major adverse cardiac events-plus (MACE-plus), and bleeding adverse events (AEs) in patients with idiopathic pulmonary fibrosis (IPF) in three randomized, placebo-controlled phase III trials of pirfenidone. METHODS: Patients in the pirfenidone phase III trials were included. Patients with unstable or deteriorating cardiac disease within 6 months before enrollment were ineligible...
August 10, 2019: Advances in Therapy
Koen Demyttenaere, Ellen Frank, David Castle, Elif Cindik-Herbrüggen
A symposium held at the 31st European College of Neuropsychopharmacology congress in October 2018 in Barcelona, Spain discussed patients' expectations of treatment of their depression and how these can be integrated into patient management. Since treatment non-compliance is a major problem in patients suffering from depression, it is important to identify patients' expectations to improve treatment compliance and in turn efficacy. Currently, there is no established protocol for choosing the right antidepressant therapy, and physicians need to tailor the choice based on the type of depression, its predominant symptoms, medical and psychiatric history of patients, and their previous response to, and adverse events with, treatment...
August 9, 2019: Advances in Therapy
Yutaro Maekawa, Setsuo Hasegawa, Tomoko Ishizuka, Kazuhito Shiosakai, Hitoshi Ishizuka
INTRODUCTION: Memantine hydrochloride, an N-methyl-D-aspartate receptor antagonist, is used to treat Alzheimer's disease (AD). A new dry syrup formulation containing memantine hydrochloride has been developed to improve medication adherence in AD patients and to reduce family and caregiver burden. This study was conducted to assess the bioequivalence of this new formulation to the tablet. METHODS: Two single-dose, randomized, open-label, two-period, two-group, crossover studies were conducted to assess the bioequivalence of a test product [dry syrup, 2%, 1 g (containing 20 mg of memantine hydrochloride)] to a reference product (film-coated tablet) under two dosing conditions: administration of the test product as a suspension in water (Study I) and as granules taken with water (Study II)...
August 9, 2019: Advances in Therapy
Charmi Patel, Antoine El Khoury, Ahong Huang, Li Wang, Onur Baser, Kruti Joshi
INTRODUCTION: There is limited literature on treatment patterns, healthcare resource utilization (HRU), and costs among patients who transition from once-monthly paliperidone palmitate (PP1M) to once-every-3-month paliperidone palmitate (PP3M) in a real-world setting. Hence, this study compared treatment patterns, HRU, and costs 12-month pre- and post-PP3M transition among Veteran's Health Administration (VHA) patients with schizophrenia. METHODS: Patients with schizophrenia (aged ≥ 18 years) who initiated PP1M and transitioned per on-label criteria to PP3M (no treatment gap of > 45 days in PP1M during the 4 months prior, same dose strength of the last two PP1M claims, and appropriate dose conversion from last PP1M to first PP3M claim) from January 2015 to March 2017 were included from the VHA database...
August 8, 2019: Advances in Therapy
Kenichi Ishizawa, Tomoko Yanai
Brentuximab vedotin (BV) is an antibody-drug conjugate that has demonstrated effectiveness as a monotherapy for patients with relapsed or refractory Hodgkin lymphoma and systemic anaplastic large-cell lymphoma via several clinical trials. Salvage chemotherapy followed by autologous or allogeneic hematopoietic stem cell transplantation (HSCT) has been performed as a second- or later-line regimen for improving the survival of patients with lymphoma. In particular, the effectiveness of autologous HSCT and the importance of achieving a complete response prior to autologous HSCT are established in Hodgkin lymphoma...
August 7, 2019: Advances in Therapy
Franklin C Lowe, Martin C Michel, Jan M Wruck, Anna E Verbeek
INTRODUCTION: Dipstick urinalysis is a widely used screening tool in the evaluation of men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). As limited data support the use of dipstick urinalysis, we have used data from three recently published studies to assess clinical outcomes in those who had dipstick urinalysis findings for blood, glucose, and/or leukocytes. METHODS: We analyzed data from three observational studies involving men interested in using over-the-counter tamsulosin: a self-selection study (SSS) and two actual-use studies of 8-week (AUS8) and 24-week (AUS24) durations...
August 7, 2019: Advances in Therapy
Emin Özmert, Umut Arslan
INTRODUCTION: To investigate the efficacy of retinal electromagnetic stimulation and sub-tenon autologous platelet-rich plasma in the treatment of deep retinal capillary ischemia. METHODS: The study included 28 eyes of 17 patients aged 15-76 years (mean 37.9 years) who had deep retinal capillary ischemia. Patients who had acute-onset paracentral scotoma in the last 1 month were included in the study between January 2018 and January 2019. The diagnosis of deep retinal capillary ischemia was based on clinical history and typical findings of optical coherence tomography angiography...
August 5, 2019: Advances in Therapy
Greta Lozano-Ortega, Shelagh M Szabo, Antoinette Cheung, Brandon Suehs, Eleanor O Caplan, Adrian Wagg, Noll Campbell, Roger Dmochowski, Basia Rogula, Daniel B Ng
INTRODUCTION: As continuous exposure to anticholinergics has been associated with adverse outcomes, accurately measuring exposure is important. However, no gold standard measure is available, and the performance of existing measures has not been compared. Our objective was to compare the properties of the Cumulative Anticholinergic Burden (CAB) measure against two existing measures of anticholinergic exposure and to assess their compatibility for use in observational studies based on claims data...
August 5, 2019: Advances in Therapy
Kellyn Moran, Kyle Null, Zhongwen Huang, Trevor Lissoos, Sunanda Kane
INTRODUCTION: Patients' adherence to and persistence on treatment for inflammatory bowel disease (IBD) can vary, depending on type and distribution of disease and treatment modality. We aim to identify differences in adherence and persistence with treatments with different administration routes (intravenous vs oral) in IBD. METHODS: A retrospective cohort analysis of a claims database of adult patients diagnosed with IBD or rheumatoid arthritis (RA) who began treatment with vedolizumab, tofacitinib, or infliximab from January 2015 through December 2015...
August 5, 2019: Advances in Therapy
Xin Zhao, Hongyi Wu, Huajie Xu, Li Shen, Bing Fan, Junbo Ge
INTRODUCTION: High on-treatment residual platelet reactivity (HRPR) was associated with greater atherosclerosis burden. We examined whether intrinsic hypercoagulability (IHC) could be attributed to that association in patients treated by drug-eluting stents. METHODS: This retrospective observation enrolled a total of 891 coronary artery disease (CAD) subjects. Platelet and coagulant reactivity was measured by thrombelastography. At least 24 h after a 300-mg dose of clopidogrel, adenosine diphosphate (ADP)-induced maximum amplitude of clot strength (MAadp ) > 47 mm represented HRPR...
August 1, 2019: Advances in Therapy
Young Hee Rho, Anna Rychlewska-Hańczewska, Beata Śliwowska, Tae Hyung Kim
INTRODUCTION: This study aimed to compare the usability of subcutaneous administration of SB4 (an etanercept biosimilar) via prefilled syringe (PFS) and autoinjector (AI) based on injection site pain, patient preference, and safety in patients with rheumatoid arthritis (RA). METHODS: This was an open-label, single-arm, multicenter study to evaluate the usability and safety of the AI and PFS of SB4. Adult patients with RA received two injections of SB4 via the PFS, followed by six injections by the AI every week, up to 8 weeks...
August 1, 2019: Advances in Therapy
Taha Lodhi, Gareth Hughes, Stefan Stanel, Nazia Chaudhuri, Conal Hayton
Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease associated with significant morbidity and mortality. The diagnosis of IPF involves a combination of clinical history, radiological imaging and examination of histopathological samples in appropriate cases. Historically, transbronchial biopsy (TBB) has been used to obtain histological samples; however this lacks diagnostic accuracy. At present, surgical lung biopsy (SLB) is the gold standard technique for obtaining specimen samples; however this carries a significant mortality risk...
July 30, 2019: Advances in Therapy
Eleftherios Loukovitis, Nikolaos Kozeis, Zisis Gatzioufas, Athina Kozei, Eleni Tsotridou, Maria Stoila, Spyros Koronis, Konstantinos Sfakianakis, Paris Tranos, Miltiadis Balidis, Zacharias Zachariadis, Dimitrios G Mikropoulos, George Anogeianakis, Andreas Katsanos, Anastasios G Konstas
INTRODUCTION: Keratoconus (KC) is a complex, genetically heterogeneous multifactorial degenerative disorder characterized by corneal ectasia and thinning. Its incidence is approximately 1/2000-1/50,000 in the general population. KC is associated with moderate to high myopia and irregular astigmatism, resulting in severe visual impairment. KC structural abnormalities primarily relate to the weakening of the corneal collagen. Their understanding is crucial and could contribute to effective management of the disease, such as with the aid of corneal cross-linking (CXL)...
July 30, 2019: Advances in Therapy
Lawrence Blonde, Timothy S Bailey, Jason Chao, Terry A Dex, Juan Pablo Frias, Luigi F Meneghini, Michelle Roberts, Vanita R Aroda
INTRODUCTION: iGlarLixi is a titratable, fixed-ratio combination of insulin glargine (iGlar, 100 units/ml) and the glucagon-like peptide-1 receptor agonist lixisenatide for the treatment of patients with type 2 diabetes. This post hoc analysis of the phase 3 LixiLan-L trial (NCT02058160) investigated baseline characteristics, glycemic control, and safety outcomes in participants who received the study-specified maximum dose (60 units/day) of iGlarLixi or iGlar vs. those who received < 60 units/day...
July 29, 2019: Advances in Therapy
Tereza Lanitis, Irina Proskorovsky, Apoorva Ambavane, Matthias Hunger, Ying Zheng, Murtuza Bharmal, Hemant Phatak
INTRODUCTION: Complex underlying risk functions associated with immuno-oncology treatments have led to exploration of different methods (parametric survival, spline, landmark, and cure-fraction models) to estimate long-term survival outcomes. The objective of this study was to examine differences in estimated short- and long-term survival in previously treated metastatic Merkel cell carcinoma (mMCC) patients receiving avelumab, when using alternative extrapolation approaches. METHODS: Efficacy data from the phase 2 JAVELIN Merkel 200 trial (part A) with at least 12 months of follow-up were analyzed...
July 26, 2019: Advances in Therapy
Yi-Ming Lu, Tian Lin, Yan-Feng Hu, Hao Liu, Ting-Yu Mou, Yu Zhu, Jiang Yu, Guo-Xin Li
INTRODUCTION: Dual-port laparoscopic gastrectomy (DPLG) has been widely performed in recent years for treating gastric cancers. The present study reports our initial experience of dual-port laparoscopic distal gastrectomy (DPLDG). METHODS: From November 2016 to August 2018, 38 consecutive patients underwent DPLDG in our center. The observational outcomes included 30-day morbidity and mortality rates, time to first flatus, time to first oral liquid diet, time to first oral semiliquid diet, time to drainage tube removal, visual analogue scale (VAS) score, postoperative 4-day recovery rate, additional analgesic use, hospital stay and cosmetic benefits...
July 23, 2019: Advances in Therapy
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