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Drug efficacy effectiveness prescription safety

Pin Jiang, Yan Lu, Daofeng Chen
Authentication of species is crucial for ensuring the safety and efficacy of herbal medicines. The fruits of Schisandra chinensis and S. sphenanthera have been used for the same traditional Chinese drug, Wuweizi, but are found to be quite different according to their constituents, pharmacological effects, and qualities. These two fruits have been recorded as Schisandrae Chinensis Fructus (Wuweizi) and Schisandrae Sphenantherae Fructus (Nan-wuweizi), respectively, by Chinese Pharmacopoeia, 2000 edition. However, Nan-wuweizi is often found to be taken as Wuweizi in some Chinese patent drugs intentionally or by mistake because of its lower price and similar characteristics to Wuweizi...
November 30, 2016: Journal of Pharmaceutical and Biomedical Analysis
Ta-Chen Su, Juey-Jen Hwang, Kuo-Chin Huang, Fu-Tien Chiang, Kuo-Liong Chien, Kuo-Yang Wang, Min-Ji Charng, Wei-Chuan Tsai, Lian-Yu Lin, Runar Vige, José Emilio Ruiz Olivar, Chuen-Den Tseng
AIM: Information regarding the effects of omega-3 fatty acid on hypertriglyceridemic patients in Chinese is still limited. This study aimed to investigate the efficacy and safety of Omacor(®), a prescription ethyl-ester omega-3 fatty acid for the treatment of hypertriglyceridemia, administered at doses of 2 g/day and 4 g/day to Taiwanese hypertriglyceridemic patients. METHODS: A multicenter, randomized, double-blind, placebo-controlled, parallel study in adults with hypertriglyceridemia was conducted...
September 6, 2016: Journal of Atherosclerosis and Thrombosis
Jason Grebely, Stefan Mauss, Ashley Brown, Jean-Pierre Bronowicki, Massimo Puoti, David Wyles, Macky Natha, Yanni Zhu, Junming Yang, Bruce Kreter, Diana M Brainard, Chohee Yun, Val Carr, Gregory J Dore
BACKGROUND:  Interferon-based hepatitis C virus (HCV) therapy is safe and effective among people receiving opioid substitution therapy (OST), but treatment uptake remains low. Our aim was to evaluate the impact of OST and drug use during therapy on completion, adherence, sustained virologic response (SVR12), and safety of ledipasvir/sofosbuvir ± ribavirin. METHODS:  The phase 3 ION studies evaluated a fixed-dose combination of ledipasvir/sofosbuvir ± ribavirin administered for 8, 12, or 24 weeks in patients with chronic HCV genotype 1...
August 23, 2016: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Russel J Reiter, Juan C Mayo, Dun-Xian Tan, Rosa M Sainz, Moises Alatorre-Jimenez, Lilian Qin
Melatonin is uncommonly effective in reducing oxidative stress under a remarkably large number of circumstances. It achieves this action via a variety of means: direct detoxification of reactive oxygen and reactive nitrogen species and indirectly by stimulating antioxidant enzymes while suppressing the activity of pro-oxidant enzymes. In addition to these well-described actions, melatonin also reportedly chelates transition metals, which are involved in the Fenton/Haber-Weiss reactions; in doing so, melatonin reduces the formation of the devastatingly toxic hydroxyl radical resulting in the reduction of oxidative stress...
October 2016: Journal of Pineal Research
Lindsey Yeh, Lauren Meshkov Bonati, Nanette B Silverberg
Topical retinoids are currently approved by the US Food and Drug Administration for the treatment of acne vulgaris in nonpregnant, nonlactating patients 12 years of age and older. Their efficacy, safety, and tolerability are well documented for inflammatory and noninflammatory acne with studies repeatedly demonstrating a decrease in the number of lesions, significant improvement in acne severity, improvement in the cosmetic appearance of acne, and the prevention of acne lesions through microcomedone formation...
June 2016: Seminars in Cutaneous Medicine and Surgery
Fabien Calcagno, Sabrina Lenoble, Zaher Lakkis, Thierry Nguyen, Samuel Limat, Christophe Borg, Marine Jary, Stefano Kim, Virginie Nerich
BACKGROUND: Regorafenib is an orally administered multikinase inhibitor that has been approved for patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). Even though regorafenib significantly improved survival in two international phase 3 trials (CORRECT and CONCUR), a high rate of treatment-related toxic effects and dose modifications were observed with a modest benefit. The aim of this study was to provide information concerning the efficacy, safety, and cost of regorafenib in patients with mCRC in clinical practice...
2016: Clinical Medicine Insights. Oncology
Milica Prostran, Katarina Savić Vujović, Sonja Vučković, Branislava Medić, Dragana Srebro, Nevena Divac, Radan Stojanović, Aleksandar Vujović, Lepa Jovanović, Ana Jotić, Nataša Cerovac
Pain is a common symptom in older people. It is possible that pain is underreported in older persons due to an incorrect belief that it is an inevitable part of aging. Opioid analgesics are potent medications, with confirmed efficacy for the treatment of moderate to severe pain. These drugs are commonly used in older persons. However, there is insufficient evidence regarding safety of opioids in older patients. One of the reasons for this is the lack of randomized, controlled clinical trials. People of advanced age often have comorbidites and use other prescription drugs, as well as over-the-counter (OTC) compounds, thus making them more suceptible to the risk of interactions with opioids...
2016: Frontiers in Aging Neuroscience
Pauline De Bruyne, Thierry Christiaens, Koen Boussery, Els Mehuys, Myriam Van Winckel
BACKGROUND AND AIMS: During the last decades, much attention has been paid to off-label and unlicensed prescriptions in paediatrics. However, on-label prescribing can also cause health issues. In this paper, the case of first-generation H1-antihistamines is investigated, notably the range of indications for which products are licensed in different European countries and the evidence base (or lack thereof) for each indication, as well as reported adverse drug reactions. METHODS: Review of the Summary of Product Characteristics of first-generation H1-antihistamines with a focus on paediatric use...
June 22, 2016: Archives of Disease in Childhood
Desiderio Passali, Maria Carla Spinosi, Anna Crisanti, Luisa Maria Bellussi
UNLABELLED: The inflammatory diseases of the nose, rhino-pharynx and paranasal sinuses (allergic and non allergic rhinitis, NARES; rhinosinusitis with/without nasal polyposis, adenoidal hypertrophy with/without middle ear involvement) clinically manifest themselves with symptoms and complications severely affecting quality of life and health care expenditure. Intranasal administration of corticosteroids, being fast, simple, and not requiring cooperation, is the preferred way to treat the patients, to optimize their quality of life, at the same time minimizing the risk of exacerbations and complications...
2016: Multidisciplinary Respiratory Medicine
Mohammad B Nusair, Lisa M Guirguis
BACKGROUND: In Alberta (Canadian province), the Chat Check Chart (CCC) model was developed to help pharmacists understand how patient care standards fit into routine practice. The CCC model outlines a process that covers the following: 1) Chart-asking three prime questions to gather information; 2) Check-perform pharmacotherapy workup by assessing prescription's indication, efficacy, safety and manageability; and 3) Chart-document findings of the pharmacotherapy workup. OBJECTIVES: To characterize how pharmacist collect patient information and apply the pharmacotherapy workup when evaluating routine prescriptions in community pharmacy settings...
March 21, 2016: Research in Social & Administrative Pharmacy: RSAP
Mario Bo, Federica Li Puma, Marco Badinella Martini, Yolanda Falcone, Marina Iacovino, Enrica Grisoglio, Elena Menditto, Gianfranco Fonte, Enrico Brunetti, Giovanni Carlo Isaia, Fabrizio D'Ascenzo, Fiorenzo Gaita
BACKGROUND: Uncertainties about efficacy and safety of oral anticoagulant therapy (OAT) among older and frail medical patients with atrial fibrillation (AF) largely contribute to under-prescription of these drugs. AIMS: In this prospective observational cohort study, we investigated mortality, and ischemic and hemorrhagic events, in hospital-discharged older patients with AF. METHODS: Stroke and bleeding risk were evaluated using CHA2DS2-VASC and HAS-BLED scores...
April 21, 2016: Aging Clinical and Experimental Research
Lisa L Giles, D Richard Martini
Most prescriptions for psychotropic medications are written by primary care physicians, yet pediatricians, many of whom are teaching residents and medical students about pediatric psychopharmacology, often feel inadequately trained to treat mental health concerns. Over the past several decades, the number, size, and quality of psychopharmacologic studies in youth has greatly increased. Here we review the current evidence for efficacy and safety of each of the major pharmacologic drug classes in youth (psychostimulants, antidepressants, mood stabilizers, and antipsychotics)...
August 2016: Academic Pediatrics
Sunyoung Hwang, Geum-Sil Cho, Sangwoo Ryu, Hoon J Kim, Hwa Young Song, Tae Y Yune, Chung Ju, Won-Ki Kim
ETHNOPHARMACOLOGICAL RELEVANCE: Anti-inflammatory therapy has been intensively investigated as a potential strategy for treatment of cerebral stroke. However, despite many positive outcomes reported in animal studies, anti-inflammatory treatments have not proven successful in humans as yet. Although immunomodulatory activity and safety of Cordyceps species (Chinese caterpillar fungi) have been proven in clinical trials and traditional Asian prescriptions for inflammatory diseases, its anti-ischemic effect remains elusive...
June 20, 2016: Journal of Ethnopharmacology
Bo Wang, Jessica M Franklin, Wesley Eddings, Joan Landon, Aaron S Kesselheim
BACKGROUND: Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved ("off-label") uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applications (sNDAs). We evaluated the effect of FDA determinations on pediatric sNDAs for antipsychotic drugs on prescribing of these products in children. METHODS: Retrospective, segmented time-series analysis using new prescription claims during 2003-2012 for three atypical antipsychotics (olanzapine, quetiapine, ziprasidone)...
2016: PloS One
Mascha Nuijten, Peter Blanken, Ben van de Wetering, Bastiaan Nuijen, Wim van den Brink, Vincent M Hendriks
BACKGROUND: Heroin-assisted treatment is effective for methadone treatment-refractory heroin-dependent patients, but continued comorbid cocaine dependence remains problematic. Sustained-release dexamfetamine is a promising agonist pharmacotherapy for cocaine dependence and we aimed to assess its acceptance, efficacy, and safety. METHODS: In this multicentre, randomised, double-blind, placebo-controlled trial, patients who were treatment-refractory, as indicated by at least two earlier failed treatments aimed at reducing or abstaining from cocaine use, and who regularly (≥8 days/month) used crack-cocaine were enrolled from four heroin-assisted treatment centres in the Netherlands...
May 28, 2016: Lancet
Deborah Dowell, Tamara M Haegerich, Roger Chou
IMPORTANCE: Primary care clinicians find managing chronic pain challenging. Evidence of long-term efficacy of opioids for chronic pain is limited. Opioid use is associated with serious risks, including opioid use disorder and overdose. OBJECTIVE: To provide recommendations about opioid prescribing for primary care clinicians treating adult patients with chronic pain outside of active cancer treatment, palliative care, and end-of-life care. PROCESS: The Centers for Disease Control and Prevention (CDC) updated a 2014 systematic review on effectiveness and risks of opioids and conducted a supplemental review on benefits and harms, values and preferences, and costs...
April 19, 2016: JAMA: the Journal of the American Medical Association
Giorgio L Colombo, Enrico Agabiti-Rosei, Alberto Margonato, Claudio Mencacci, Carlo Maurizio Montecucco, Roberto Trevisan, Alberico L Catapano
BACKGROUND: The use of generics, equivalent but less expensive drugs, is an important opportunity to reduce healthcare expenditure. METHODS: The purpose of this study was to investigate the effect of substitution between unbranded generics on persistence and adherence to therapy in two Italian Local Health Units (ASL) in real-world clinical practice in 5 therapeutic areas using tracing drugs. Substitution of generic drugs is any change in the name of the manufacturer of the generic drug...
June 2016: Atherosclerosis. Supplements
Alekhya Mascarenhas, Sobia Khan, Radha Sayal, Sandra Knowles, Tara Gomes, Julia E Moore
OBJECTIVE: To explore and describe the factors that may be influencing the rise of prescribing and use of testosterone replacement therapy (TRT) in adult men. DESIGN: A rapid qualitative research design using semi-structured interviews with providers and patients. SETTING: Ontario, Canada. PARTICIPANTS: Nine men who have used TRT (referred to as "patients"), and six primary care clinicians and seven specialists (collectively referred to as "providers") who prescribed or administered TRT...
June 2016: Aging Male: the Official Journal of the International Society for the Study of the Aging Male
Carl R Thornfeldt, Ronald L Rizer
INTRODUCTION: Research has shown that a disrupted stratum corneum permeability barrier coupled with chronic inflammation induce signs of extrinsic aging (photoaging). An novel herbal-based three product cosmeceutical regimen used to reverse these two anomalies that does not contain retinol, soy, niacinamide, tea, L-ascorbic acid or esters, hydroxy acids, tocopherol, or growth factors was tested in six human clinical trials to determine effectiveness and safety in reversing photoaging...
February 2016: Journal of Drugs in Dermatology: JDD
Daniel Hilleman, Aiman Smer
PURPOSE: To provide an overview of prescription and dietary supplement omega-3 fatty acid (OM3-FA) products and considerations for clinical use. DESIGN: Narrative review. METHODOLOGY: The PubMed database was searched for cardiovascular-related investigations focused on eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA) (limit: English-only articles). Additional regulatory information on prescription and dietary supplements was obtained from United States Food and Drug Administration online sources...
January 2016: Managed Care
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