Showing papers in "Annals of Pharmacotherapy in 2017"
TL;DR: Clinicians need to be aware of important differences and distinctions between ritonavir- or cobicistat-based regimens, especially important for patients with multiple comorbidities and concomitant medications.
Abstract: Objective: To describe properties of cobicistat and ritonavir; compare boosting data with atazanavir, darunavir, and elvitegravir; and summarize antiretroviral and comedication interaction studies,...
74 citations
TL;DR: Pharmacy-supported TOC programs were associated with a significant reduction in the odds of 30-day readmissions, and a stratified meta-analysis showed that interventions with patient-centered follow-up reduced 30- day readmissions relative to studies without follow- up.
Abstract: Objective: To describe pharmacy-supported transition-of-care (TOC) interventions and determine their effect on 30-day all-cause readmissions. Data Sources: MEDLINE/PubMed, EMBASE, International Pha...
66 citations
TL;DR: Pharmacists’ interventions as part of the patient’s health care team improved diabetes therapeutic outcomes, substantiating the important role of pharmacists in team-based diabetes management.
Abstract: Objective: To conduct a comprehensive systematic review and meta-analyses examining the impact of pharmacist interventions as part of health care teams on diabetes therapeutic outcomes in ambulatory care settings. Data Sources: PubMed/MEDLINE, EMBASE, Cochrane Library, International Pharmaceutical Abstracts, Web of Science, Scopus, WHO’s Global Health Library, ClinicalTrials.gov, and Google Scholar were searched (1995 to February 2017). Search terms included pharmacist, team, and diabetes. Study Selection: Full-text articles published in English with comparative designs, including randomized controlled trials, nonrandomized controlled trials, and pretest-posttest studies evaluating hemoglobin A1C (A1C), were assessed. Data Extraction and Synthesis: Two reviewers independently screened for study inclusion and extracted data. Quality of the studies was assessed using tools developed based on the framework of the Cochrane Collaboration’s recommendations. Data Synthesis: A total of 1908 studies were identifie...
62 citations
TL;DR: Apixaban may be a cautious consideration in hemodialysis patients until there is further insight into the effect of subsequent, multiple doses on drug accumulation and clinical outcomes.
Abstract: Background: Current guidelines make no specific recommendations on the selection of direct oral anticoagulants for the prevention and treatment of venous thromboembolism in patients with end-stage renal disease (ESRD) receiving hemodialysis. Based on these guidelines, warfarin remains the anticoagulant of choice in these patients. Objective: To compare bleeding rates in patients receiving apixaban or warfarin with ESRD undergoing chronic hemodialysis. Methods: This was a single-center, retrospective, institutional review board–approved cohort analysis. Patients with ESRD undergoing chronic hemodialysis and receiving anticoagulation therapy with either apixaban or warfarin were included in this study. All data were collected from paper charts and electronic medical records and included documentation of bleeding events and related interventions. The primary outcome of this study was clinically relevant major bleeding events. Secondary outcomes included clinically relevant nonmajor bleeding events and minor ...
62 citations
TL;DR: This analysis suggests that the use of vitamin E and C supplements is associated with a reduced risk of cognitive decline, and further investigations are needed to determine their value as a primary prevention strategy.
Abstract: Background: There are few studies of the association between the use of antioxidant vitamin supplements and the risk of Alzheimer’s disease (AD). Cognitive decline is generally viewed as part of the continuum between normal aging and AD. Objective: To evaluate whether the use of vitamin E and C supplements is associated with reduced risks of cognitive impairment, not dementia (CIND), AD, or all-cause dementia in a representative sample of older persons ≥65 years old. Methods: Data from the Canadian Study of Health and Aging (1991-2002), a cohort study of dementia including 3 evaluation waves at 5-yearly intervals, were used. Exposure to vitamins E and C was self-reported at baseline in a risk factor questionnaire and/or in a clinical examination. Results: The data set included 5269 individuals. Compared with those not taking vitamin supplements, the age-, sex-, and education-adjusted hazard ratios of CIND, AD, and all-cause dementia were, respectively, 0.77 (95% CI = 0.60-0.98), 0.60 (95% CI = 0.42-0.86),...
57 citations
TL;DR: Compared with routine care, pharmacist-managed outpatient-based anticoagulation services attained better quality of antICOagulation control, lower bleeding and thromboembolic events, and resulted in lower health care utilization.
Abstract: Objective: To perform a systematic review to evaluate the quality of warfarin anticoagulation control in outpatient pharmacist-managed anticoagulation services (PMAS) compared with routine medical care (RMC). Data Sources: MEDLINE, SCOPUS, EMBASE, IPA, CINAHL, and Cochrane CENTRAL, from inception to May 2017. Search terms employed: (“pharmacist-managed” OR “pharmacist-provided” OR “pharmacist-led” OR “pharmacist-directed”) AND (“anticoagulation services” OR “anticoagulation clinic” OR “anticoagulation management” OR “anticoagulant care”) AND (“quality of care” OR “outcomes” OR “bleeding” OR “thromboembolism” OR “mortality” OR “hospitalization” OR “length of stay” OR “emergency department visit” OR “cost” OR “patient satisfaction”). Study Selection and Data Extraction: Criteria used to identify selected articles: English language; original studies (comments, letters, reviews, systematic reviews, meta-analyses, editorials were excluded); warfarin use; outpatient setting; comparison group present; time in th...
53 citations
TL;DR: Weight-based enoxaparin dosing (0.5 mg/kg/dose BID) is an option in trauma patients considered to be at a lower risk of bleeding complications and may not be optimal for the general trauma patient population.
Abstract: Objective: To review the evidence regarding increased enoxaparin dosing for venous thromboembolism (VTE) prophylaxis in the general trauma patient population. Data Sources: A search of MEDLINE data...
42 citations
TL;DR: An extensive review of case reports, epidemiological data, and the underlying mechanism of antibiotic-induced skin rash in patients with concurrent infectious mononucleosis (IM) suggests a reassessment of the long-held belief of the high incidence (80%-100%) seems prudent.
Abstract: Objective: To provide an extensive review of case reports, epidemiological data, and the underlying mechanism of antibiotic-induced skin rash in patients with concurrent infectious mononucleosis (IM). Data Sources: A MEDLINE literature search inclusive of the dates 1946 to June 2016 was performed using the search terms anti-bacterial agents and infectious mononucleosis. EMBASE (1980 to June 2016) was searched using the terms mononucleosis and antibiotic agent and drug eruption. References of all relevant articles were reviewed for additional citations and information. Study Selection and Data Extraction: We selected English-language, primary literature, review articles, and mechanistic articles that addressed antibiotic-induced skin rash in patients with concurrent IM. We assessed all case reports available for causality utilizing a modified Naranjo nomogram specifically designed for this subject. We assembled the available epidemiological data into tables to identify trends in incidence rates over the ye...
37 citations
TL;DR: Summary of data on cobimetinib, which was approved by the US Food and Drug Administration in November 2015 for use in combination with vemurafenib for unresectable or ...
Abstract: Objective: To review and summarize data on cobimetinib, which was approved by the US Food and Drug Administration (FDA) in November 2015 for use in combination with vemurafenib for unresectable or ...
33 citations
TL;DR: Economic evaluations of hospital and community pharmacy services are becoming increasingly commonplace to enable an understanding of which health care services provide value for money and to inform policy makers as to which services will be cost-effective in light of limited health care resources.
Abstract: Objective: To review the international body of literature from 2010 to 2015 concerning methods of economic evaluations used in hospital- and community-based studies of pharmacy services in publicly funded health systems worldwide, their clinical outcomes, and economic effectiveness. Data Sources: The literature search was undertaken between May 2, 2015, and September 4, 2015. Keywords included “health economics” and “evaluation” “assessment” or “appraisal,” “methods,” “hospital” or “community” or “residential care,” “pharmacy” or “pharmacy services” and “cost minimisation analysis” or “cost utility analysis” or “cost effectiveness analysis” or “cost benefit analysis.” The databases searched included MEDLINE, PubMed, Google Scholar, Science Direct, Springer Links, and Scopus, and journals searched included PLoS One, PLoS Medicine, Nature, Health Policy, Pharmacoeconomics, The European Journal of Health Economics, Expert Review of Pharmacoeconomics and Outcomes Research, and Journal of Health Economics. Stu...
32 citations
TL;DR: In veteran patients hospitalized for HF, pharmacist-managed HF bridge clinic significantly reduced the time to initial follow-up compared with usual care and trend toward improvement of longer-term outcomes in bridge clinic patients was shown.
Abstract: Background: Hospitals that provide early postdischarge follow-up after heart failure (HF) hospitalization tend to have lower rates of readmission. However, HF postdischarge (bridge) clinics have no...
TL;DR: Sofosbuvir/velpatasvir is safe and effective to treat HCV genotypes 1, 2, 3, 4, 5, and 6 in patients with or without compensated cirrhosis and with ribavirin in patients who have decompensated Cirrhosis.
Abstract: Objectives: To review the pharmacology, efficacy, and safety of sofosbuvir/velpatasvir in the treatment of patients with hepatitis C virus (HCV) infection. Data Sources: A literature search through PubMed was conducted (June 2008 to August 2016) using the terms GS-5816, velpatasvir, and sofosbuvir. References from retrieved articles and the prescribing information were reviewed for any additional material. Study Selection/Data Extraction: The literature search was limited to human studies published in English. Phase I, II, and III studies of sofosbuvir/velpatasvir for HCV were identified. Data Synthesis: Sofosbuvir/velpatasvir is indicated for adult patients with chronic HCV genotype 1 through 6. It is given without ribavirin in patients with or without compensated cirrhosis and with ribavirin in patients who have decompensated cirrhosis. The ASTRAL-1 study demonstrated that sofosbuvir 400 mg plus velpatasvir 100 mg for 12 weeks was effective at achieving high sustained virological response (SVR12) rates ...
TL;DR: Venetoclax has demonstrated promising results in relapsed/refractory lymphoid malignancies, with an acceptable adverse effect profile, and may offer benefit to a myriad other patient populations.
Abstract: Objective: To review the pharmacology, efficacy, and safety of venetoclax for treatment of lymphoid malignancies. Data Sources: A literature search was performed of PubMed and MEDLINE databases (20...
TL;DR: Benefits of AMS interventions in the ED primarily included improvement in delivery of care or a decrease in antimicrobial utilization; however, most studies were rated as having unclear or high risk of bias.
Abstract: Background/Objective: To improve antimicrobial utilization, development and implementation of antimicrobial stewardship programs in the emergency department (ED) has been recommended The primary objective of this review was to characterize antimicrobial stewardship (AMS) in the ED and to identify interventions that improve patient outcomes or process of care and/or reduce consequences of antimicrobial use Methods: This study was completed as a systematic review The following databases were searched from inception through November, 2016: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Scopus, and Web of Science Randomized controlled trials, nonrandomized controlled trials, controlled and uncontrolled before-and-after studies, interrupted time series studies, and repeated-measures studies evaluating AMS interventions in the ED were included in the review Studies published in languages other than English were excluded Results: A total of 43 studies meeting inclusion criteria
TL;DR: Obesity and other factors are associated with a higher risk of vancomycin-associated nephrotoxicity in nonobese and obese patients.
Abstract: Background:A consensus statement recommends initial intravenous (IV) vancomycin dosing of 15-20 mg/kg every 8- 24 hours, with an optional 25- to 30-mg/kg loading dose. Although some studies have shown an association between weight and the development of vancomycin-associated nephrotoxicity, results have been inconsistent. Objective: To evaluate the correlation between incidence of nephrotoxicity associated with weight-based IV vancomycin dosing strategies in nonobese and obese patients. Methods: This retrospective cohort study evaluated hospitalized adult patients admitted who received IV vancomycin. Patients were stratified into nonobese (body mass index [BMI] <25 kg/m2), obesity class I and II (BMI 30-39.9kg/m2), and obesity class III (BMI≥40 kg/m2) groups; patients who were overweight but not obese were excluded. Incidence of nephrotoxicity and serum vancomycin trough concentrations were evaluated. Results: Of a total of 62 documented cases of nephrotoxicity (15.1%), 13 (8.7%), 23 (14.3%), and 26 (26.3...
TL;DR: The inclusion of a stroke-competent pharmacist in the bedside response team for acute ischemic stroke patients is supported and reduced door-to-needle (DTN) times are found.
Abstract: Background: Pharmacists are an important member of the stroke team and aid in obtaining medication and medical history, providing education, managing blood pressure, reviewing exclusion criteria fo...
TL;DR: Use of a vasopressor guideline restricting AVP initiation in septic patients to those on at least 50 µg/min of NE appeared to be safe and did not affect the time to reach goal MAP.
Abstract: Background: In septic shock, the dose of norepinephrine (NE) at which vasopressin (AVP) should be added is unknown. Following an increase in AVP price, our medical intensive care unit (MICU) revised its vasopressor guidelines to reserve AVP for patients requiring greater than 50 µg/min of NE. Objective: The purpose of this study is to compare efficacy and safety outcomes for patients admitted before the guideline revision with those for patients admitted after the revision. Methods: This was a single-center, retrospective cohort study of patients admitted to Vanderbilt University Medical Center from November 1, 2014, to November 30, 2015. Before June 1, 2015, the vasopressor guidelines recommended initiation of AVP for patients requiring 10 µg/min of NE or greater. After June 1, 2015, the guidelines recommended initiation of AVP at a NE dose of 50 µg/min or greater. Results: Time to achieve goal mean arterial pressure (MAP) was shorter in the postintervention group (2.0 vs 1.3 hours; P = 0.03) in univaria...
TL;DR: Midodrine and droxidopa possess the most evidence with respect to increasing blood pressure and alleviating symptoms and emerging evidence with low-dose atomoxetine is promising, especially in those with central autonomic failure, and may prove to be a viable alternative treatment option.
Abstract: Objective: To review the efficacy and safety of pharmacological and nonpharmacological strategies used to treat primary orthostatic hypotension (OH). Data Sources: A literature review using PubMed and MEDLINE databases searching hypotension, non-pharmacological therapy, midodrine, droxidopa, pyridostigmine, fludrocortisone, atomoxetine, pseudoephedrine, and octreotide was performed. Study Selection and Data Extraction: Randomized or observational studies, cohorts, case series, or case reports written in English between January 1970 and November 2016 that assessed primary OH treatment in adult patients were evaluated. Data Synthesis: Based on the chosen criteria, it was found that OH patients make up approximately 15% of all syncope patients, predominantly as a result of cardiovascular or neurological insults, or offending medication. Nonpharmacological strategies are the primary treatment, such as discontinuing offending medications, switching medication administration to bedtime, avoiding large carbohydr...
TL;DR: Pimavanserin is a novel 5-HT2A inverse agonist that has shown promising results for managing hallucinations and delusions in patients with PDP without worsening motor effects or orthostasis.
Abstract: Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, and place in therapy of pimavanserin for the treatment of hallucinations and delusions of Parkinson’s disease psychosis (PDP). Data Sources: A comprehensive PubMed search (1966 to January 2017) was conducted using the search terms Parkinson’s disease psychosis, hallucinations, delusions, pimavanserin, and ACP-103. Additional data were obtained from references of identified articles, governmental sources, manufacturer product labeling and website, and Clinicaltrials.gov. Study Selection and Data Extraction: All English-language trials evaluating pimavanserin in PDP were included. Data from review articles were included if relevant to clinical practice. One phase II and 3 phase III trials are discussed. Data Synthesis: Pimavanserin was approved in April 2016 for the treatment of delusions and hallucinations of PDP. One phase II and 2 phase III trials reported no difference for primary outcomes when pimavanserin was compared with plac...
TL;DR: The clinical importance of the interaction between LD-MTX and NSAIDs, penicillins, and PPIs cannot be substantiated and health care providers should assess the benefit and risk of LD- MTX regardless of concomitant drug use, including factors known to predispose patients to MTX toxicity.
Abstract: Objective: To review the potential drug interactions between low-dose methotrexate (LD-MTX) and nonsteroidal anti-inflammatory drugs (NSAIDs), penicillins, and proton-pump inhibitors (PPIs) given the disparity between interactions reported for high-dose and low-dose MTX to help guide clinicians. Data Sources: A literature search was performed in MEDLINE (1946 to September 2016), EMBASE (1974 to September 2016), and International Pharmaceutical Abstracts (1970 to January 2015) to identify reports describing potential drug interactions between LD-MTX and NSAIDS, penicillins, or PPIs. Reference lists of included articles were reviewed to find additional eligible articles. Study Selection and Data Extraction: All English-language observational, randomized, and pharmacokinetic (PK) studies assessing LD-MTX interactions in humans were analyzed to determine clinical relevance in making recommendations to clinicians. Clinical case reports were assigned a Drug Interaction Probability Scale score. Data Synthesis: A...
TL;DR: Understanding the principles of biosimilar development and evolving regulatory guidelines relevant to their use will allow pharmacists to make informed decisions regarding formulary inclusion and educate patients and other health care providers about biosimilars.
Abstract: Objective: To review the scientific and regulatory aspects of biosimilar development and practical considerations for the use of biosimilars that are relevant to pharmacists. Data Sources: Literature searches of PubMed and congress abstracts for publications pertaining to biosimilars were conducted from January 2016 to January 2017. Individual drug company web pages and governmental, regulatory, and other agency websites were also reviewed. Study Selection/Data Extraction: Published articles, regulatory guidelines, and other sources covering biologic/biosimilar development and approval, reporting results of biosimilar studies or survey research, and/or identifying biosimilars in development or approved for use in Europe or the United States were reviewed and included. Data Synthesis: Biologic therapies have revolutionized the treatment of serious diseases, including hematological or autoimmune disorders and cancers. A biosimilar is highly similar to a licensed biologic (ie, reference or originator) and ha...
TL;DR: T-VEC is the first approved oncolytic virus for local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in melanoma recurrent after initial surgery and is well tolerated.
Abstract: Objective: To review the efficacy and safety of talimogene laherparepvec (T-VEC) as well as its pharmacology, pharmacokinetics, drug-drug interactions, handling procedures, cost considerations, and place in therapy. Data Sources: Searches of PubMed (1966 to February 2017) and Cochrane Library (1999 to February 2017) were conducted using the terms talimogene laherparepvec, T-VEC, OncoVEX, immunotherapy, melanoma, and oncolytic virus. Additional information was determined from bibliographies, manufacturer product labeling and website, meeting abstracts, Food and Drug Administration website, and clinicaltrials.gov. Study Selection and Data Extraction: A total of 79 English-language publications were identified. Articles that assessed T-VEC’s pharmacokinetics, pharmacodynamics, mechanism, dosing, safety, and efficacy were included as well as narrative reviews that provided practical information. Data Synthesis: Clinical trials have confirmed the safety and efficacy of T-VEC as monotherapy for the treatment of...
TL;DR: In this paper, the authors summarize and evaluate the existing literature regarding medications to treat Parkinson's disease (PD) psychosis and potential biases assessed using the Cochrane Collaboration's Risk of Bias Assessment Tool.
Abstract: Objective: To summarize and evaluate the existing literature regarding medications to treat Parkinson’s disease (PD) psychosis. Data Sources: MEDLINE (1946 to March 2017), EMBASE (1980 to March 2017), CINAHL (1982 to March 2017), and PsychInfo (1887 to March 2017) were searched using the following terms: Parkinson disease, Parkinson’s disease, psychotic disorders, psychosis, delusions, and hallucinations.Study Selection and Data Extraction: The search was limited to randomized controlled trials (RCTs) reporting human outcomes. Data extracted included the following: study design, population, setting, intervention, control, outcomes related to psychosis and safety, and potential biases assessed using Cochrane Collaboration’s Risk of Bias Assessment Tool. Data Synthesis: After assessment, 16 of 235 studies were included; 11 articles reported comparisons between active drug and placebo, whereas 5 compared clozapine and an active comparator. Placebo-controlled trials demonstrated benefit for clozapine (n = 2) ...
TL;DR: A literature review of assessment and management of iatrogenic opioid withdrawal in critically ill patients and 2 validated assessment tools for pediatric intensive care unit patients are identified; no valid tool for adults is identified.
Abstract: Objective: To (1) provide an overview of the epidemiology, clinical presentation, and risk factors of iatrogenic opioid withdrawal in critically ill patients and (2) conduct a literature review of ...
TL;DR: STRs have significantly advanced HIV management by minimizing pill burden and improving patient compliance and are important to consider the nuances of each STR in regard to renal and hepatic function, drug interactions, and tolerability, to ensure safe and effective use.
Abstract: Objective: To review the pharmacokinetics, safety, drug-drug interactions, and advantages and disadvantages of currently available single-tablet regimens (STRs) for HIV-1 infection. Data Sources: A...
TL;DR: Anticoagulation therapy resumption is recommended, with resumption being considered between 7 and 14 days following GIB regardless of the therapy chosen, and data for warfarin management after GIB should be applied with caution to direct oral anticoagulants (DOACs) because of the quicker onset and experimental nature of reversal agents.
Abstract: Objective: To evaluate current clinical evidence for management of oral anticoagulation therapy after gastrointestinal bleeding (GIB) with an emphasis on whether to, when to, and how to resume an a...
TL;DR: Vaxchora is the only FDA-approved, single-dose oral vaccine for the prevention of cholera caused by V cholerae serogroup O1 in adult travelers from the United States going to cholERA-affected areas.
Abstract: Objective: To review trials evaluating the efficacy and safety of Vaxchora, a reformulated, single-dose, oral, lyophilized Vibrio cholerae CVD 103-HgR vaccine for the prevention of travel-related c...
TL;DR: No significant difference in nephrotoxicity or AKI was detected among patients treated with alternative antimicrobials compared with vancomycin and the use of alternative antimicrobial therapy instead of vancomYcin solely for the purpose of preventing AKI in high-risk patients does not appear to be warranted.
Abstract: Background: Use of alternative antimicrobials to vancomycin is a potential strategy to reduce acute kidney injury (AKI) in high-risk patients, but current data do not support widespread adoption of...
TL;DR: Ferumoxytol was effective in treating IDA in a small study and slow infusion rate and close monitoring allowed early detection of the infrequent ADRs.
Abstract: Iron Deficiency in children is common problem. Its mechanism could be nutritional or due to lack of iron absorption. Several conditions are associated with IDA. Presence of inflammation further complicate attempts to make a definitive diagnoses or accurately quantify reponse to therapy.
TL;DR: The probability of XDDIs varies as a function of ART regimen type, advanced age, and use of multiple non-HIV medications.
Abstract: Background: HIV-infected patients receiving antiretroviral therapy (ART) are at risk for contraindicated drug-drug interactions (XDDIs). Objective: This study compared the frequency of XDDIs betwee...