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Advances in Therapy

Riccardo Compagnoni, Roberta Gualtierotti, Pietro Randelli
Since its introduction, total joint arthroplasty (TJA) has improved the quality of life of patients with degenerative joint disorders. In the last decades, a number of conventional and biological disease-modifying antirheumatic drugs have become available for the treatment of patients with inflammatory rheumatic diseases (IRD), leading to a reduction in the need to undergo TJA. However, TJA is still frequently performed in IRD patients. Both rheumatologists and orthopedics should be aware that patients with IRD have a peculiar perioperative risk profile due to disease-related, patient-related, and surgery-related risk factors...
July 11, 2018: Advances in Therapy
Simon de Lusignan, Gaël Dos Santos, Rachel Byford, Anne Schuind, Silvia Damaso, Vishvesh Shende, Chris McGee, Ivelina Yonova, Filipa Ferreira
INTRODUCTION: The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced safety surveillance (ESS) of seasonal influenza vaccines including a near real-time evaluation of collected data. The objective was to identify whether the use of passive surveillance or active surveillance provides different results of reported adverse events of interest (AEIs) by specified age strata and AEI type. We report the weekly incidence rates of AEIs within 7 days following seasonal influenza vaccination using passive and active surveillance...
July 11, 2018: Advances in Therapy
Monika Wagner, Dima Samaha, Jesus Cuervo, Harshila Patel, Marta Martinez, William M O'Neil, Paula Jimenez-Fonseca
INTRODUCTION: Unresectable, well-differentiated nonfunctioning gastroenteropancreatic neuroendocrine tumors (GEP-NETs) can be monitored (watchful waiting, WW) or treated with systemic therapy such as somatostatin analogues (SSAs) to delay progression. We applied a reflective multicriteria decision analysis (MCDA) shared-decision framework (previously developed for the USA) to explore what matters to Spanish patients and clinicians considering GEP-NET treatment options. METHODS: The EVIDEM-derived framework was updated and adapted to the Spanish context...
July 9, 2018: Advances in Therapy
Manabu Kato, Hitoshi Ishizuka, Takashi Taguchi, Kazuhito Shiosakai, Emi Kamiyama, Michio Sata, Takafumi Yoshida
INTRODUCTION: The pharmacokinetics, safety, and tolerability of DS-8500a (a G protein receptor 119 agonist) up to 100 mg have been investigated in healthy Japanese adults. The objective of this study was to evaluate the effects of hepatic or renal impairment on the pharmacokinetics of a single 25-mg oral dose of DS-8500a. METHODS: This single-center, open-label study enrolled subjects into eight groups according to hepatic function (normal; mild or moderate impairment) and renal function [normal; mild, moderate, or severe impairment; and end-stage renal disease (ESRD)]...
July 2, 2018: Advances in Therapy
Mehmet Bayrak, Yasemin Altıntas
INTRODUCTION: This study aimed to evaluate the applicability, safety, results, and functional performance of Permacol™ collagen paste injection in patients with an anal fistula. METHODS: Thirty-one patients with anal fistula underwent Permacol™ collagen paste injection between February 2015 and February 2017. The patients were followed up for a total of 12 months with recovery conditions monitored at intervals of 3, 6, and 12 months. Preoperative insertion of seton was performed in 15 patients for a period of 6-8 weeks and 2 patients for a period of 12 weeks...
July 2, 2018: Advances in Therapy
Eamonn M M Quigley, John Horn, Michele Kissous-Hunt, Robert A Crozier, Lucinda A Harris
INTRODUCTION: The BURDEN IBS-C study was conducted to better understand the experiences, attitudes, and unmet needs of sufferers of irritable bowel syndrome with constipation (IBS-C) in comparison to the perceptions and challenges of healthcare providers (HCPs) who treat IBS-C patients. METHODS: This was an author-developed, online questionnaire using KnowledgePanel® to survey individuals with IBS-C (N = 1311). HCPs participated in a complementary online questionnaire and were recruited separately (N = 331)...
June 26, 2018: Advances in Therapy
Jennifer L Beebe-Dimmer, Julie J Ruterbusch, Lauren C Bylsma, Christina Gillezeau, Jon Fryzek, Neil M Schultz, Scott C Flanders, Arie Barlev, Elisabeth Heath, Ruben G W Quek
INTRODUCTION: Bicalutamide (BIC), a non-steroidal anti-androgen, is FDA-indicated for use in combination with a luteinizing hormone-releasing hormone (LHRH) analog for treatment of Stage D2 metastatic carcinoma of the prostate. Lack of consensus exists regarding the clinical benefit of BIC use, either alone or combined use of BIC with an LHRH analog or antagonist (combined androgen blockade or CAB), versus treatment with androgen deprivation therapy (ADT) alone. METHODS: The SEER-Medicare database was used to identify prostate cancer patients aged ≥ 66 years diagnosed between 2007 and 2011 and who filled at least one prescription for BIC...
June 26, 2018: Advances in Therapy
Annie Guérin, Debbie Goldschmidt, Tania Small, Patrick Gagnon-Sanschagrin, Hela Romdhani, Genevieve Gauthier, Sneha Kelkar, Eric Q Wu, Polly Niravath, Anand A Dalal
INTRODUCTION: In the treatment of metastatic breast cancer (mBC), regular monitoring is key in helping physicians to make informed clinical decisions, managing treatment side effects, and maintaining patients' quality of life. Therefore, we investigated the monitoring frequency in post-menopausal women with HR+/HER2- mBC stratified by first-line regimen. METHODS: Treatment monitoring was assessed using two complementary data sources: a medical chart review (chart review analysis) and a commercial claims database (claims analysis)...
June 26, 2018: Advances in Therapy
Nagongbilige He, Wu Lan, Aruna Jiang, Haserden Jia, Shuzhi Bao, Longmei Bao, Altansha Qin, Orgel Bao, Shinjiltu Bao, Nandin Wang, Suyaltu Bao, Shuangfu Dai, Sarula Bao, Sarnai Arlud
INTRODUCTION: Insomnia is a common clinical complaint, and if not addressed it can increase the risk of developing other underlying diseases such as hypertension, depression and anxiety. The use of Mongolian mind-body interactive therapy as a comprehensive psychotherapeutic approach in chronic insomnia has been shown in this retrospective study. METHODS: Subjects who had suffered insomnia for more than 1 month participated in the Mongolian mind-body interactive psychotherapy program between June 2012 and February 2014...
June 19, 2018: Advances in Therapy
Henna Salman, Mohsin Shah, Asif Ali, Asma Aziz, Salvatore Giovanni Vitale
INTRODUCTION: Pre-eclampsia is a pregnancy-induced disorder that complicates approximately 5-7% of pregnancies. It is the leading cause of maternal and foetal morbidity and mortality worldwide. AIM: To determine the role of serum neurokinin-B level in the pathophysiology of pre-eclampsia. METHODS: This was a case-control study. A total of 80 pregnant women in their third trimester of pregnancy were included in the study. They were divided into two groups (40 pre-eclamptic and 40 normotensive) according to the presence or absence of clinical parameters of pre-eclampsia...
June 19, 2018: Advances in Therapy
Anna Cantarutti, Matteo Franchi, Federico Rea, Luca Merlino, Giovanni Corrao
INTRODUCTION: Nimesulide is the most prescribed non-steroidal anti-inflammatory drug in Italy, and it is currently marketed in about 50 countries worldwide. The association between the use of nimesulide in early pregnancy and the risk of birth defects was investigated in a large cohort of pregnant women from Italy. METHODS: Data were from the healthcare utilization databases of the Italian region of Lombardy. The cohort of 353,081 newborns occurring in Lombardy during the period 2005-2010 was investigated...
June 19, 2018: Advances in Therapy
William M Mendenhall, Carlos Suárez, Alena Skálová, Primož Strojan, Asterios Triantafyllou, Kenneth O Devaney, Michelle D Williams, Alessandra Rinaldo, Alfio Ferlito
An endolymphatic sac tumor (ELST) is a rare, indolent but locally aggressive tumor arising in the posterior petrous ridge. Patients present with sensorineural hearing loss and tinnitus. As the tumor progresses, patients may experience vertigo, ataxia, facial nerve paresis, pain and otorrhea. Most patients present in their 4th or 5th decade with a wide age range. Patients with von Hippel-Lindau disease have an increased likelihood of developing ELST. Histologically, ELST is a low-grade adenocarcinoma. As it progresses, it destroys bone and extends into adjacent tissues...
June 19, 2018: Advances in Therapy
Junlong Li, Medha Sasane, Jing Zhao, Viviana Garcia Horton, Pingkuan Zhang, Marie Louise Ricculli, Zheng-Yi Zhou, James Signorovitch
INTRODUCTION: Due to the rarity of BRAF V600E mutation, no randomized study has compared the combination targeted therapy dabrafenib + trametinib with other second-line treatments for advanced or metastatic non-small-cell lung cancer (NSCLC). A network meta-analysis (NMA) was conducted to assess the comparative efficacy of treatments among patients with previously treated advanced or metastatic NSCLC. METHODS: Randomized trials of dabrafenib + trametinib, docetaxel, erlotinib, nintedanib + docetaxel, nivolumab, pemetrexed, pembrolizumab, and best supportive care as second-line or above treatments for advanced or metastatic NSCLC identified in a systematic literature review were included in the NMA...
June 15, 2018: Advances in Therapy
Stefan Gottschlich, Kristina Röschmann, Henning Candler
INTRODUCTION: The objective of this prospective, multicenter, parallel-group, non-interventional clinical trial (NIT) was to characterize the effectiveness of a treatment with the phytomedicines ELOM-080 and BNO 1016 in patients with acute rhinosinusitis (ARS). METHODS: A total of 228 patients suffering from ARS took part in this NIT and were treated for a maximum of 14 days with either BNO 1016 or ELOM-080. Focus was on improvement of rhinosinusitis-associated pain/discomfort and nasal congestion in real-life conditions of primary care setting, as assessed by numeric and verbal rating scale, and five-point Likert scale...
June 15, 2018: Advances in Therapy
Hector Ortega, Andrew Menzies-Gow, Jean-Pierre Llanos, Mark Forshag, Frank Albers, Necdet Gunsoy, Eric S Bradford, Steven W Yancey, Monica Kraft
INTRODUCTION: Previous studies showed that mepolizumab significantly reduces exacerbations and oral corticosteroid use in patients with severe eosinophilic asthma. However, early studies reported inconsistent effects on lung function. This study specifically assessed the onset of clinical effect and the relationship of baseline blood eosinophil count of mepolizumab 100 mg subcutaneous (SC) administration on morning peak expiratory flow (AM PEF). METHODS: Post hoc analysis of data from two randomized, double-blind, placebo-controlled studies (MENSA, NCT01691521; MUSCA, NCT02281318) of 4-weekly mepolizumab 100 mg versus placebo in patients with severe eosinophilic asthma...
June 15, 2018: Advances in Therapy
Mina Nicola, Ahmed Elberry, Ossama Sayed, Raghda Hussein, Haitham Saeed, Mohamed Abdelrahim
INTRODUCTION: We have investigated the effect of adding a pressurized metered dose inhaler (pMDI) training device to verbal counselling on pulmonary function and inhalation technique. METHODS: A total of 304 adult asthmatic subjects (> 18 years old) were enrolled in a 3-month study of assessment and education. They were divided into an investigation group (Trainhaler plus Flo-Tone and verbal counselling, n = 261, mean age 49.2 years) and a control group (verbal counselling only, n = 43, mean age 48...
June 15, 2018: Advances in Therapy
Vadim Y Bogachev, Boris V Boldin, Pavel Y Turkin
INTRODUCTION: Sclerotherapy is a common technique for the removal of intradermal veins. This study examined the rationale for prescribing micronized purified flavonoid fraction (MPFF) in clinical, etiological, anatomic, pathophysiologic (CEAP) class C1 patients with dilated intradermal veins scheduled for sclerotherapy. METHODS: In a national, multicenter, observational program, physicians recruited CEAP C1s patients scheduled for sclerotherapy. The decision to prescribe adjuvant MPFF (1000 mg/day for 6 weeks beginning 2 weeks before sclerotherapy) was made according to usual practice...
June 15, 2018: Advances in Therapy
Hadar Nir-Neuman, Ibrahim Abu-Kishk, Michal Toledano, Eli Heyman, Tomer Ziv-Baran, Matitiahu Berkovitch
INTRODUCTION: Many of the medications prescribed to children are off-label and/or unlicensed because pharmacologic evaluations have not been performed in this age group. METHODS: All drugs prescribed to patients admitted to the neonatal intensive care units (NICU) (n = 134) and pediatric intensive care units (PICU) (n = 56) during a 2-month observation period were recorded and classified according to patient age, drug license status, indicated use, and typical dosing, frequency and way of administration...
June 15, 2018: Advances in Therapy
Ralph A DeFronzo, Christopher Lee, Sven Kohler
INTRODUCTION: Two 52-week Phase III studies evaluated the efficacy and safety of once-daily combinations of empagliflozin/linagliptin as monotherapy or add-on to metformin in patients with type 2 diabetes (T2DM). The aim of this analysis was to further assess the safety and tolerability of empagliflozin/linagliptin compared with their individual components in patients with T2DM, using pooled data from these trials. METHODS: A total of 1363 patients were treated with empagliflozin 25 mg/linagliptin 5 mg (n = 273), empagliflozin 10 mg/linagliptin 5 mg (n = 272), empagliflozin 25 mg (n = 276), empagliflozin 10 mg (n = 275), or linagliptin 5 mg (n = 267)...
June 15, 2018: Advances in Therapy
Maria Del Mar Ropero Rendón, Tatiana Ermakova, Marie-Louise Freymann, Alina Ruschin, Tadeus Nawka, Philipp P Caffier
INTRODUCTION: Functional and organic impairments of the singing voice are common career-threatening problems of singers presenting in phoniatric and laryngological departments. The objective was to evaluate the efficacy of phonosurgery, logopedic voice treatment and vocal pedagogy in common organic and functional voice problems of singers, including investigation of the recently introduced parameter vocal extent measure (VEM). METHODS: In a prospective clinical study, the analysis of treatment outcome in 76 singers [57 female, 19 male; 38 ± 11 years (mean ± SD)] was based on pre- and post-therapeutic voice function diagnostics and videolaryngostroboscopy...
June 15, 2018: Advances in Therapy
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