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OBJECTIVEPostoperative surgical site infections (SSIs) in neurosurgical patients carry a significant risk of increased morbidity and mortality. With SSIs accounting for approximately 20% of nosocomial infections and costing approximately $1.6 billion USD annually, there is a need for additional prophylaxis to improve current standards of care. Topical vancomycin is increasingly utilized in instrumented spinal and cardiothoracic procedures, where it has been shown to reduce the risk of SSIs. A randomized controlled trial assessing its efficacy in the general neurosurgical population is currently underway...
December 14, 2018: Journal of Neurosurgery
Haley V Solomon, Kevin W Cates, Kevin J Li
Treatment non-response and adverse reactions are common in patients receiving antidepressants. Personalizing psychiatric treatment based on pharmacogenetic testing has been proposed to help clinicians guide antidepressant selection and dosing. This systematic literature review assesses the two most robustly studied drug-metabolizing enzymes, CYP2D6 and CYP2C19, and examines whether obtaining CYP2D6 and CYP2C19 testing can be used to predict antidepressant response or adverse drug reactions in order to improve clinical outcomes...
December 8, 2018: Psychiatry Research
Andrew Rotando, Lindsey Picard, Samantha Delibert, Karin Chase, Courtney M C Jones, Nicole M Acquisto
PURPOSE: Evaluate push dose vasopressor (PDP) practice patterns, efficacy, and safety in critically ill patients. METHODS: Critically ill patients receiving phenylephrine or ephedrine PDP from November 2015-March 2017 were included. Patient demographics, medication administration details, vital signs pre- and post-administration, adverse effects, and medications errors were collected. Descriptive data are presented and comparisons were made with paired samples t-test, Wilcoxon Rank Sum and Chi-squared analysis or Fisher's Exact Test as appropriate...
December 3, 2018: American Journal of Emergency Medicine
Simone Pinto Carneiro, Karen Vitor Carvalho, Rodrigo Dian de Oliveira Aguiar Soares, Cláudia Martins Carneiro, Milton Hércules Guerra de Andrade, Rafael Silva Duarte, Orlando David Henrique Dos Santos
Tuberculosis is an infectious bacterial disease that causes millions of deaths worldwide. Current treatment recommended by WHO is effective, however it is an extensive and arduous process associated to severe adverse effects, which induces a low patient compliance and the emerging of multidrug resistant tuberculosis. Thus, as a main goal of this study, rifampicin nanoparticles were surface functionalized with a tuftsin-modifed peptide to selectively recognize receptors located on infected alveolar macrophages, enhancing nanoparticles uptake by these cells and improving antimycobacterial activity...
December 4, 2018: Colloids and Surfaces. B, Biointerfaces
Ashok Chockalingam, Lin Xu, Sharron Stewart, Maxime LeMerdy, Eleftheria Tsakalozou, Jianghong Fan, Vikram Patel, Rodney Rouse
Topical ophthalmic drugs are the most commonly used dosage form to treat diseases of the anterior segment of the eye. Although this dosage form has the advantages of ease of application, small volume dose, and rapid action and is largely devoid of systemic adverse effects, the bioavailability is low due to pre-corneal anatomical barriers and the nature of the drug formulation itself. Some complex generic formulations (suspensions, ointments, gels) for topical ophthalmic products face impediments to rapid regulatory approval because of the complex nature of the formulations and difficulties in determining bioequivalence with the innovator product...
December 12, 2018: Journal of Pharmacological and Toxicological Methods
Hamideh Bayrampour, Mike Zahradnik, Sarka Lisonkova, Patti Janssen
Cannabis is the most commonly used illicit drug among general and pregnant populations. Despite recommendations to abstain from cannabis use, its use is increasing during the perinatal period. In this integrative review, we aim to understand women's perspectives about the health aspects of perinatal cannabis use. The following databases were searched: MEDLINE, PsycInfo, EMBASE, and CINAHL. We included quantitative and qualitative studies with a primary focus on perinatal cannabis use. The methodological quality of the included studies was appraised using appropriate checklists...
December 12, 2018: Preventive Medicine
Hyun Young Lee, Seung Whan Doo, Won Jae Yang, Yun Seob Song, Hwa Yeon Sun, Eli Jongchan Nho, Bora Lee, Jae Heon Kim
OBJECTIVE: To investigate the efficacy and safety of non-invasive intravesical instillation of OBTX-A through systematic review and meta-analysis. Recently, several studies of non-invasive intravesical instillation of Onabotulinum Toxin-A (OBTX-A) have been published. However, its efficacy is not well validated yet compared to well-known efficacy of minimally invasive intravesical injection of OBTX-A. METHOD: Systematic review and meta-analysis were performed to evaluate the efficacy of non-invasive intravesical instillation of OBTX-A in patients with overactive bladder (OAB) and interstitial cystitis/bladder pain syndrome (IC/BPS) by measuring outcomes such as urgency episode per 72 hours, frequency per 72 hours, urgency urinary incontinence (UUI), voided volume (VV), post-voided residual volume (PVR), maximum flow rate (Qmax), and patient perception of bladder condition (PPBC)...
December 12, 2018: Urology
Saravanan Vijayakumar, Vishnu Kant, Pradeep Das
Despite the availability of drugs to treat Leishmaniasis, various other factors including drug resistance and adverse side effects encourage the researchers to search for new strategies and alternatives for treating Leishmaniasis. Repurposing and devising combination therapy with the existing small molecules would serve as an alternative strategy to address the issue, especially the drug resistance. Hence, here we report LeishInDB, a web-accessible resource of small molecule inhibitors having a varying degree of activity towards Leishmania sp...
December 12, 2018: Acta Tropica
Ryosuke Araki, Takayuki Keira, Yutaka Masuda, Tsuneaki Tanaka, Hideki Yamada, Tomoyuki Hamamoto
WHAT IS KNOWN AND OBJECTIVE: Pemetrexed/carboplatin combination chemotherapy has shown efficacy as a first-line treatment for advanced non-small-cell lung cancer. However, severe haematotoxicity is often observed during this combination chemotherapy. Some studies have suggested that concomitant drugs may be the risk factors for severe adverse events. However, those studies identified the predictive risk factors without paying attention to the relative dose intensities (RDIs) of the anticancer drugs...
December 15, 2018: Journal of Clinical Pharmacy and Therapeutics
Tyler Gallo, Steven C Curry, Angela Padilla-Jones, C William Heise, Kenneth S Ramos, Raymond L Woosley, Robert A Raschke
BACKGROUND: Heparin induced thrombocytopenia (HIT) is an immune-mediated adverse drug event associated with life-threatening thrombotic complications. The four T's (4Ts) score is widely used to estimate the risk for HIT and guide diagnostic testing, but it is not easily amenable to computerized clinical decision support (CDS) implementation. OBJECTIVES: Our main objective was to develop a HIT computerized risk (HIT-CR) scoring system that provides platelet count surveillance for timing and degree of thrombocytopenia to identify those for whom diagnostic testing should be considered...
December 14, 2018: Journal of Thrombosis and Haemostasis: JTH
Narissa J Nonzee, Thanh Ha Luu
Drug shortages pose a significant public health concern in the United States, and cancer drugs are among those most affected. Shortages present serious safety risks for patients and substantial burden on providers and the healthcare system. Multifaceted drivers of this complex problem include manufacturing disruptions, raw material shortages, regulatory issues, market dynamics, and limited financial incentives that reward quality and production of off-patent drugs. Oncology drugs in short supply have resulted in substitution of less effective or more toxic alternatives, medication errors, and treatment delays, and are especially concerning for medications with no adequate substitute...
2019: Cancer Treatment and Research
Brian Chen, John Restaino, Elizabeth Tippett
Adverse drug reactions, or unintended and harmful outcomes related to the administration of a pharmaceutical product, are a major public health concern, particularly for cancer patients. If counted as a separate cause of death, adverse drug reactions would represent the fourth leading cause of death in the United States. Several legal strategies are available to help mitigate their occurrences and to compensate victims for the harm that results from adverse events. Prior to FDA approval of a drug, the limited size and duration of clinical trials often fail to detect adverse drug reactions...
2019: Cancer Treatment and Research
Dustin B Liebling, Emmanuel Cordova, Gary Deng, June M McKoy
With the increase in utilization of alternative medications to manage cancer treatment-related side effects, pharmacovigilance of alternative drug therapies, specifically herbal supplements, has become of increasing importance in the oncologic setting. This chapter focuses on the pharmacovigilance of herbal supplements in the setting of cancer drug therapy and explores national and international drug policies that have been employed to mitigate adverse herbal supplement events (AHEs). This chapter examines common drug-herbal supplement interactions, discusses the mechanisms behind these interactions, and investigates several common pharmacovigilance reporting methods clinicians can use to report adverse events...
2019: Cancer Treatment and Research
Renato Rocha Martins, Lunara Teles Silva, Flavio Marques Lopes
Background Drug-related problems are mostly preventable or predictable circumstances that may impact on health outcomes. Clinical pharmacy activities such as medication therapy management can identify and solve these problems, with potential to improve medication safety and effectiveness. Objective To evaluate ability of medication therapy management service to detect drug-related problems and prevent adverse drug events. This study also aimed to assess the risk factors for drugrelated problem occurrence. Setting Medical intensive care unit of a public tertiary hospital in Brazil...
December 15, 2018: International Journal of Clinical Pharmacy
Signe Harder, Mogens Groenvold, Jesper Isaksen, Jarl Sigaard, Karin Bruun Frandsen, Mette Asbjoern Neergaard, Lise Mondrup, Jørn Herrstedt
INTRODUCTION: The antipsychotic drug olanzapine is effective against chemotherapy-induced nausea and targets multiple receptors known to be involved in the emetic reflex arch. The drug has a mean half-life of 30 h, which allows for a single daily administration and is therefore of interest in patients with advanced cancer suffering from nausea. OBJECTIVES: To investigate the antiemetic effect and tolerability of olanzapine in patients with advanced cancer not receiving chemotherapy or irradiation...
December 14, 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
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
Margreet Kloppenburg, Charles Peterfy, Ida K Haugen, Féline Kroon, Su Chen, Li Wang, Wei Liu, Gwen Levy, Roy M Fleischmann, Francis Berenbaum, Désirée van der Heijde, Prashant Bansal, Ruth Wittoek, Sheng Feng, Yuni Fang, Mary Saltarelli, Jeroen K Medema, Marc C Levesque
OBJECTIVE: To assess the efficacy, safety, pharmacokinetics and pharmacodynamics of the anti-interleukin (IL)-1α/β dual variable domain immunoglobulin lutikizumab (ABT-981) in erosive hand osteoarthritis (HOA). METHODS: Patients with ≥1 erosive and ≥3 tender and/or swollen hand joints were randomised to placebo or lutikizumab 200 mg subcutaneously every 2 weeks for 24 weeks. The primary endpoint was change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain subdomain score from baseline to 16 weeks...
December 14, 2018: Annals of the Rheumatic Diseases
Lynn J Howie, Nancy S Scher, Laleh Amiri-Kordestani, Lijun Zhang, Bellinda L King-Kallimanis, Yasmin Choudhry, Jason Schroeder, Kirsten B Goldberg, Paul G Kluetz, Amna Ibrahim, Rajeshwari Sridhara, Gideon M Blumenthal, Richard Pazdur, Julia A Beaver
On December 20, 2017, the Food and Drug Administration granted regular approval to pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) at high risk of recurrence. Approval was based on data from the APHINITY trial, which randomized patients to receive pertuzumab or placebo in combination with trastuzumab and chemotherapy. After 45.4 months median follow-up, the proportion of invasive disease-free survival (IDFS) events in the intent-to-treat population was 7...
December 14, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Neil Gupta, Aimable Mbituyumuremyi, Jules Kabahizi, Fabien Ntaganda, Claude Mambo Muvunyi, Fabienne Shumbusho, Emmanuel Musabeyezu, Constance Mukabatsinda, Cyprien Ntirenganya, Jennifer Ilo Van Nuil, Fredrick Kateera, Gregory Camus, Makuza Jean Damascene, Sabin Nsanzimana, Joia Mukherjee, Philip M Grant
BACKGROUND: Limited treatment data are available for hepatitis C virus (HCV) in sub-Saharan Africa, especially for genotype 4. Our objective was to establish the safety and efficacy of ledipasvir-sofosbuvir for chronic HCV genotype 1 or 4 infection in adults in Rwanda. METHODS: We did a single-arm trial to evaluate the safety and efficacy of ledipasvir-sofosbuvir in Rwandan adults with chronic HCV infection at a single study site (Rwanda Military Hospital, Kigali, Rwanda)...
December 10, 2018: Lancet. Gastroenterology & Hepatology
Georgios Bakalos, Elias Zintzaras
PURPOSE: In observational studies of patients switched from stable treatment with an originator monoclonal antibody (mAb) to a biosimilar, higher rates of biosimilar discontinuation versus those observed in blinded switching studies have been reported. Because this observation relates to the real-world setting, it has been suggested that switching outside of clinical trials may be associated with nocebo effects. However, real-world data on drug discontinuation and nocebo effects after switching to mAb biosimilars remain limited...
December 11, 2018: Clinical Therapeutics
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