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Drugs in R&D

Bruno Pacciardi, Alfredo Calcedo, Thomas Messer
Agitation is a common and costly phenomenon associated with a number of psychiatric conditions including schizophrenia and bipolar disorder. Early identification and prompt intervention to relieve the symptoms of agitation are essential to avoid symptomatic escalation and emergence of aggressive behaviour. Recent consensus guidelines emphasise the need for non-coercive management strategies to protect the therapeutic alliance between patients and their healthcare providers-an alliance that is critical for the effective management of chronic psychiatric conditions...
February 5, 2019: Drugs in R&D
Israel Rubinstein, Richard van Breemen, Daniel G Nosal, Guy Weinberg, Ronald C Hershow, Douglas L Feinstein
A recent multi-state outbreak of life-threatening bleeding following inhalation of synthetic cannabinoids has been attributed to contamination with the long-acting anticoagulant rodenticide (LAAR) brodifacoum, a second-generation, highly potent, long-acting derivative of the commonly used blood thinner warfarin. While long-term treatment with high-dose vitamin K1 restores coagulation, it does not affect brodifacoum metabolism or clearance, and, consequently, brodifacoum remains in the human body for several months, thereby predisposing to risk of bleeding recurrence and development of coagulation-independent injury in extrahepatic tissues and fetuses...
January 28, 2019: Drugs in R&D
Solange Whegang Youdom, Andreas Chiabi, Leonardo K Basco
INTRODUCTION: Artemisinin-based combination therapies (ACTs) are the first-line antimalarial drugs used to treat uncomplicated Plasmodium falciparum alaria in many endemic countries worldwide. The present work reviewed the therapeutic efficacy of ACT in Cameroon more than 10 years after the initial change in national drug policy in 2004. METHODS: A PubMed literature search was performed to analyse clinical trials conducted in Cameroon from 2001 to May 2017. Clinical studies that evaluated ACT for the treatment of uncomplicated falciparum malaria in children or adults, and reported efficacy and/or safety, were included...
January 17, 2019: Drugs in R&D
Allyson C Marshall, Maureen Damstra, Michael Tuley, Elena L Schifando
OBJECTIVE: This study was conducted to evaluate the taste and grittiness of two formulations of Riomet® ER (metformin hydrochloride for extended release [ER] oral suspension 100 mg/mL) differing only in their flavoring agents (strawberry and grape) in comparison with two commercially available immediate-release (IR) formulations of metformin, Riomet® Cherry (metformin hydrochloride oral solution 500 mg/5 mL) and metformin IR tablets (metformin hydrochloride IR tablets 500 mg), in healthy human subjects aged 10-70 years...
January 16, 2019: Drugs in R&D
Hiroshi Takahashi, Shinichi Kubono, Takehiko Taneyama, Kiyotoshi Kuramoto, Hideki Mizutani, Noriko Tanaka, Masaki Yoshida
OBJECTIVES: Our objective was to investigate the effectiveness and safety of silodosin in patients with benign prostatic hyperplasia (BPH) who switched to silodosin from another α1 blocker because of inadequate response. METHODS: This was a prospective observational study conducted at 715 medical facilities in Japan in patients with BPH who received an α1 blocker other than silodosin for at least 3 months but had experienced unsatisfactory treatment outcomes...
January 3, 2019: Drugs in R&D
Yuko Asai, Hideki Sano, Makoto Miyazaki, Mika Iwakura, Yoshikazu Maeda, Mitsuyoshi Hara
BACKGROUND: We report on the results of a Japanese postmarketing drug-use survey of suvorexant (Belsomra® ) tablets. METHODS: A survey with a ≤ 6-month observation period after the start of administration was conducted, targeting insomnia patients who were treated with suvorexant for the first time in Japan. Information on the safety and efficacy of the drug product was collected. The evaluation period was July 21, 2015-August 12, 2017, and the target number of patients was 3428...
December 14, 2018: Drugs in R&D
John S Sampalis, Eliofotisti Psaradellis, Melissa Stutz, Jenaya Rickard, Emmanouil Rampakakis
BACKGROUND AND OBJECTIVES: Management of hypertension and dyslipidemia is important when considering cardiovascular disease risk; however, achievement of optimal lipid and blood pressure (BP) targets in clinical practice remains inadequate. This analysis sought to estimate the frequency, effectiveness, and safety of co-administrated atorvastatin and perindopril in routine care. METHODS: We conducted a post hoc analysis of four Canadian, prospective, multi-center, observational studies assessing real-life effectiveness and safety of perindopril + atorvastatin in mild-to-moderate hypertensive patients with concomitant dyslipidemia over 16 weeks...
November 17, 2018: Drugs in R&D
Kyle M Gardiner, Susan E Tett, Christine E Staatz
BACKGROUND: Globally, enteric-coated mycophenolate sodium (EC-MPS) is replacing mycophenolate mofetil (MMF) in maintenance immunosuppressant regimens. The predominant reason for conversion is the purported improvement in gastrointestinal (GI) quality of life. This paper considers the level of bias associated with studies comparing EC-MPS and MMF for GI-related improvement and provides insight into whether conversion is supported by evidence. METHODS: Using a pre-determined protocol, a literature search was conducted...
November 13, 2018: Drugs in R&D
Prashanth Rawla, Tagore Sunkara, Krishna Chaitanya Thandra, Vinaya Gaduputi
BACKGROUND AND OBJECTIVE: Eosinophilic esophagitis (EE) is an immune/antigen-driven inflammation that causes esophageal dysfunction. Budesonide has shown promising effect in the management of EE in multiple studies, and we therefore conducted this systematic review/meta-analysis to assess budesonide efficacy and safety in order to provide more updated and robust evidence. METHODS: In April 2018, we conducted a systematic electronic search through four databases: PubMed, Scopus, Web of Science (ISI), and Cochrane Central...
November 2, 2018: Drugs in R&D
Eiji Kutoh, Asuka Wada, Teruma Murayama, Jyunka Hayashi
OBJECTIVES: The aim of this study was to investigate the relations between the changes in body weight and those of glycemic and non-glycemic parameters in drug-naïve subjects with type 2 diabetes mellitus (T2DM) treated with canagliflozin monotherapy. METHODS: Subjects received 50-100 mg/day canagliflozin monotherapy for 3 months (n = 36), and were then divided into two groups: (1) those who lost weight [changes in (Δ)BMI ≤ - 0.45, p < 0.00001: Group L(ost), n = 20); and (2) those who did not lose weight [ΔBMI > - 0...
October 15, 2018: Drugs in R&D
Léa Darnaud, Fabien Lamoureux, Cendrine Godet, Sandrine Pontier, Alexia Debard, Nicolas Venisse, Pauline Martins, Didier Concordet, Peggy Gandia
BACKGROUND: Isavuconazole is a new antifungal prodrug for the treatment of invasive aspergillosis and mucormycosis. As no clear pharmacokinetic-pharmacodynamic relationship has been established for patients, therapeutic drug monitoring is not currently required. However, as isavuconazole is a new drug, clinicians are sometimes sceptical about the exposure achieved in their patients and seek pharmacokinetic exploration. A minimal response consists of determining that the patient's pharmacokinetic profile agrees with profiles reported by Desai et al...
October 10, 2018: Drugs in R&D
André R Durães, Yasmin de Souza Lima Bitar, José Admirço L Filho, Igor S Schonhofen, Edmundo J N Camara, Leonardo Roever, Hugo E D P Cardoso, Kevan M Akrami
INTRODUCTION: Mechanical heart valves (MHV) are extremely durable, but they require permanent use of anticoagulation to prevent thromboembolic events. The only approved therapeutic options are vitamin K antagonists (VKAs), such as warfarin. As a drug class, clinical management is difficult, therefore new alternatives need to be evaluated. METHODS: RIWA is a phase II/III, prospective, open-label, randomized, pilot study designed to investigate oral rivaroxaban 15 mg twice daily compared with dose-adjusted warfarin for the prevention of stroke (ischemic or hemorrhagic) and systemic embolism in patients with MHV, from August 2018 to December 2019...
October 6, 2018: Drugs in R&D
John M Slopis, Octavio Arevalo, Cynthia S Bell, Adelaide A Hebert, Hope Northrup, Roy F Riascos, Joshua A Samuels, Keri C Smith, Patti Tate, Mary Kay Koenig
BACKGROUND: Cutaneous neurofibromas cause disfigurement and discomfort in individuals with neurofibromatosis type 1 (NF-1). METHODS: The primary objective of this phase II, open-label, single-arm trial was to assess whether orally administered everolimus reduced the surface volume of cutaneous neurofibromas in patients with NF-1. RESULTS: Of 22 patients who took the study drug, 17 completed the trial; 5 patients withdrew due to adverse events...
October 3, 2018: Drugs in R&D
Bilal H Lashari, Yazhini Vallatharasu, Lakshmi Kolandra, Mohsin Hamid, Dipesh Uprety
Small cell lung cancer (SCLC) comprises about 15% of all cases of lung cancer. In recent years, owing to a change in the epidemiology of smoking habits, the incidence of the tumor has decreased; however, it remains a significant challenge to global health. While the tumor has a favorable initial response to chemoradiation, relapse is invariable, and second-line regimens may be intolerable given the severity of side effects. For patients with tumors resistant to second-line regimens, no current standard regimens exist...
September 19, 2018: Drugs in R&D
Dongmi Kim, Nicole L Ryba, Julie Kalabalik, Ligia Westrich
Currently, all second-generation antipsychotics are approved for schizophrenia. Many are also approved for bipolar disorder, with some also approved as adjunctive treatment for depression and autism-related irritability. Second-generation antipsychotics are increasingly being prescribed for indications other than those approved by the Food and Drug Administration, such as in dementia, anxiety, and post-traumatic stress disorder to name a few. Obsessive-compulsive and related disorders are a group of disorders characterized by preoccupation and repetitive behaviors...
September 2018: Drugs in R&D
Valeria Tellone, Paola Coppola, Marco Ammendola, Giorgio Di Loreto, Rossella Picollo, Alessandra Del Vecchio, Alessandro Comandini, Fabio Garofolo, Serena Tongiani
BACKGROUND: The antibacterial agent prulifloxacin, a prodrug of ulifloxacin, is indicated in the treatment of acute lower urinary tract infections, acute exacerbation of chronic bronchitis and acute bacterial rhinosinusitis. OBJECTIVE: We aimed to provide new insights on the pharmacokinetics (PK) of ulifloxacin in patients with different degrees of renal impairment. METHODS: A two-site, international, open-label, parallel-group, single- and repeated-dose study was performed...
September 2018: Drugs in R&D
Teruko Nakamura, Taisei Fujisaki, Motoaki Miyazono, Maki Yoshihara, Hiroshi Jinnouchi, Kenichi Fukunari, Yuki Awanami, Yuki Ikeda, Kohei Hashimoto, Masatora Yamasaki, Yasunori Nonaka, Makoto Fukuda, Tomoya Kishi, Yuji Ikeda
BACKGROUND: Concerns about sodium overload when using sodium polystyrene sulfonate (Na-resin) as an ion-exchange resin for the treatment of hyperkalemia led our institution to gradually shift to the use of calcium polystyrene sulfonate (Ca-resin). However, as serum potassium levels were insufficiently controlled and patients experienced constipation, we returned to using Na-resin and observed better results than previously. OBJECTIVE: As few papers have examined the potassium adsorption ability of Ca-resin compared with Na-resin, we investigated this issue within our institution...
September 2018: Drugs in R&D
Magda Opsomer, Dessislava Dimitrova, Johan Verspeelt, Amy Purrington, Abdul Mehbob, Scott Chavers, Helen Pai, Simon Vanveggel, Donghan Luo, Kimberley Brown, Christiane Moecklinghoff, Richard E Nettles, Katia Boven
In the original publication of the article, Table 2 has been published incorrectly.
September 2018: Drugs in R&D
Daniel Gil
No abstract text is available yet for this article.
September 2018: Drugs in R&D
Vance J Bray, Aaron Broadwell, Herbert S B Baraf, Shawn Black, Brenna L Brady, Joseph Tkacz, Lorraine Yarngo, Raphael J DeHoratius
PURPOSE: For patients with rheumatoid arthritis (RA) who do not respond or lose response to anti-tumor necrosis factor (TNF) biologics, switching to a different anti-TNF can be an effective means to manage symptoms and disease progression. This study examined the utilization and effectiveness of intravenous golimumab within a real-world population of patients with RA switching directly from infliximab, a potent anti-TNF. METHODS: Patient charts (n = 113) were collected from five US-based rheumatology practices...
September 2018: Drugs in R&D
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