bluuebunny/crossref_metadata_2025_split huggingface dataset:
Febuxostat: A Novel, Non-Purine Xanthine Oxidase Inhibitor
Authors: Kim Karissa Y , Wigle Patricia R 
Published: September 2013

Objective: To review the pharmacology and clinical data for febuxostat in the treatment of gout and hyperuricemia. Data Sources: Articles on febuxostat published in English between 1966 and November 2006 were identified through a MEDLINE search using the key words febuxostat, TEI-6720, TMX-67, gout, and hyperuricemia. Additional articles were identified through search of the publications' reference lists. Abstracts from the 2005 proceedings of the American College of Rheumatology, American College of Clinical Pharmacology, and American Society for Clinical Pharmacology and Therapeutics were also searched for febuxostat studies. Study Selection and Data Extraction: All published febuxostat trials in humans were selected for this review. Clinical, pharmacokinetic, and pharmacodynamic data were evaluated. Data Synthesis: Febuxostat is a non-purine, selective inhibitor of xanthine oxidase that has demonstrated efficacy in lowering serum uric acid levels in patients with hyperuricemia associated with gout. Compared with allopurinol 300 mg/day, febuxostat 80 or 120 mg/day was more effective in lowering serum uric acid levels to less than 6 mg/dL. Febuxostat appears to be safe, with the majority of treatment-related adverse events reported being transient and mild-to-moderate in severity. However, abnormal elevation of liver enzyme levels has been reported with its use. There have been no documented major drug interactions with febuxostat. Conclusions: Febuxostat is a novel, non-purine xanthine oxidase inhibitor undergoing review by the FDA. It represents a potential advancement in the treatment of hyperuricemia associated with gout.
A Comparison of Event Rates for Patients Receiving Sirolimus Drug-Eluting vs. Bare Metal Stents
Authors: Mullin Molly A , Brouse Sara D 
Published: September 2013

Background: Two types of stents are used to revascularize occluded coronary arteries. Bare metal stents prevent elastic recoil and negative remodeling of the vessel wall following balloon catheter stretch. Drug-eluting stents release medications that prevent the development of neointimal hyperplasia. Drug-eluting stents, however, have been purported to increase the risk of acute stent thrombosis, potentially placing patients at higher risk for major adverse cardiac events in the 12 months following stent implementation. Objective: To determine whether patients receiving a drug-eluting stent experienced a higher rate of major adverse cardiac events at one year after stent placement than did patients who received a bare metal stent, and to determine the impact of antiplatelet therapy on major adverse cardiac event rates. Methods: We conducted a retrospective chart review of patients receiving either a sirolimus-eluting or bare metal stent at the Veterans Affairs North Texas Health Care System between July and December 2003. Results: Sixty-eight patients were included in the study. There was one episode of acute stent thrombosis and no statistically significant difference in major adverse cardiac event rates at 1 year after stent placement between the groups. Clopidogrel therapy was originally prescribed for an average of 3.9 months in the drug-eluting stent group and 1 month in the bare metal stent group. The actual duration of clopidogrel therapy differed significantly from the original prescribed duration for both groups, mainly due to renewal of clopidogrel prescriptions by noncardiology practitioners. Conclusions: Patients who received a sirolimus-eluting stent did not experience an increase in major adverse cardiac events compared with patients receiving a bare metal stent.
PDA-Based Documentation of Medication Interventions in an Ambulatory Care Setting
Authors: Fit Kathy E , Burkiewicz Jill S , Sweeney Brooke L 
Published: September 2013

Background: Although personal digital assistant (PDA)-based documentation systems are available for documentation of clinical pharmacy services, none is specific to documentation of drug-related problems (DRPs) in the ambulatory care setting. Objective: To describe types of medication interventions performed by pharmacists in an urban ambulatory care clinic within a teaching hospital, determine predictors of preselected DRPs, and describe physician acceptance rates. Methods: Following development of a PDA-based documentation system, this 6 month prospective study documented interventions performed by a clinical pharmacy team. Descriptive statistics were employed to describe the type and frequency of interventions and physician acceptance rates. Multivariate logistic regression analysis was used to determine significant predictors for preselected DRPs. Results: Over a 6 month period, 965 interventions were documented. The patients' mean ± SD age was 61.8 ± 15.51 years, 72.3% of patients were female, and the mean number of medications was 7.1 ± 3.95 per intervention. The most common interventions were laboratory monitoring (56.2%), patient education (14.5%), and changes in drug therapy (12.4%). The use of antihypertensive agents was a predictor for the DRPs “dose too high” and “dose too low” (p = 0.001 and p = 0.003, respectively). Of the applicable interventions, 89.8% (246/274) were accepted by the physician. Conclusions: Pharmacists in this urban ambulatory care clinic offered a variety of recommendations that were well received by physicians.
Investigation of Consumer Choice of Community, Mail Order, or Internet Pharmacies
Authors: Holiday-Goodman Monica , Darley William K , Lively Buford T , Siganga Walter , Deshmukh-Estoll Harsha C 
Published: September 2013

Background: The 3 major options for purchase of medications by consumers are community pharmacy, mail order pharmacy, and Internet pharmacy. Certain consumer characteristics and motivating factors may be related to the type of pharmacy a person chooses to patronize. Objective: To describe and compare consumers who use Internet pharmacy versus those who choose community or mail order pharmacy and identify and compare the motivating factors for the use or lack of use of Internet versus community or mail order pharmacies. Methods: Two hundred seventy-eight residents of a major Midwest city were surveyed by mail questionnaire. A total of 91 responses were received, yielding a response rate of 32.7%. Descriptive statistics and Kendall's W coefficient of concordance were performed to analyze the respondents' answers. Results: Internet pharmacy patrons, compared with community pharmacy and mail order pharmacy patrons, were more likely to be male, younger, white, married, wealthier, and more educated. Respondents using Internet pharmacy listed quality and convenience as highly ranked factors in choosing a pharmacy, while respondents using community pharmacy listed quality and reliability and those using mail order pharmacy ranked reliability and convenience most highly. Conclusions: This study suggests that characteristics and motivating factors may differ for customers who choose Internet pharmacy instead of community or mail order pharmacy. As this study was exploratory in nature, additional studies are needed to draw more definitive conclusions.
Varenicline: A Novel Nicotinic Receptor Partial Agonist for Smoking Cessation
Authors: Kerr Jessica L , Timpe Erin M , Karpinski Julie P 
Published: September 2013

Objective: To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of varenicline, a selective partial nicotinic receptor agonist for smoking cessation. Data Sources: Primary literature and review articles were obtained via a MEDLINE search (1966–January 2007) using the key terms smoking cessation, nicotinic receptor, tobacco, and varenicline. Additional studies and abstracts were identified from the bibliographies of reviewed literature. Study Selection and Data Extraction: Available English-language literature, including abstracts, preclinical and clinical trials, and review articles were identified. Six randomized, placebo-controlled trials were evaluated to determine varenicline's efficacy for smoking cessation. Data Synthesis: Varenicline is a partial agonist selective for the α4β2 nicotinic receptor. Varenicline has been compared with placebo and sustained-release (SR) bupropion in randomized, double-blind, controlled trials. These trials found varenicline to have more successful 4 week continuous quit rates compared with both placebo and bupropion SR. One study reported a significantly increased continuous abstinence rate with varenicline versus bupropion SR; however, 2 other studies found no difference between varenicline and bupropion SR. To date, dose-dependent nausea is the most frequent adverse effect associated with varenicline; this may be limited with proper dosage titration. Conclusions: Increased cessation rates in comparison with placebo and, possibly, bupropion SR, as well as limited safety concerns, suggest that varenicline may have a role as another first-line therapy for smoking cessation.
Should Gabapentin Be Dose Adjusted: What are the Clinical Consequences?
Authors: Gonyeau Michael J , Rooney Christina A 
Published: September 2013

Objective: To review the clinical necessity of renal dose adjustment of gabapentin. Data Sources: Medical literature (1966–February 2006, week 2) was accessed through MEDLINE, EMBASE, Pre-MEDLINE, International Pharmaceutical Abstracts, and the manufacturer's package insert. Search terms included gabapentin, side effects/adverse effects, overdose, toxicity, and renal impairment. Literature references were consulted for relevant information. Study Selection and Data Extraction: All studies from the data sources that were published in English were evaluated. Case reports, case series, and clinical trials with primarily adult populations were included in the review to determine the clinical necessity of dosage adjustment, including morbidity and mortality associated with dose adjustment failure. Case reports of gabapentin overdose were evaluated for clinically significant outcomes. All reports were examined for clinical relevance and adequate information to address the issue of major clinical consequences of failure to dose adjust gabapentin in specific patient populations, including renally impaired and elderly patients. Data Synthesis: The package insert suggests dose adjustment of gabapentin in patients with decreased renal function, yet published information regarding clinical consequences of gabapentin in patients is limited. Although gabapentin possesses a favorable safety profile and is generally well tolerated, there have been cases reporting serious adverse effects. While clinical studies and the majority of case reports demonstrate minimal adverse effects, there is some concern that select patients may experience serious outcomes if the drug is not dose adjusted. Conclusions: The recommendation for dosage adjustment is suitably based upon the pharmacokinetic properties of gabapentin, yet healthcare practitioners should determine the need for gabapentin dosage adjustment in specific patients. There should be continued emphasis on recommending renal dose adjustments, with the most concern applied to the elderly and patients with significant renal impairment/end-stage renal disease.
A Qualitative Review of Recent Economic Evaluations of Escitalopram
Authors: Sadri Hamid , Mittmann Nicole 
Published: September 2013

Objective: To review published pharmacoeconomic evaluations of escitalopram. Data Sources: MEDLINE, EMBASE, Health Star, and Ovid Journals databases were searched using escitalopram, cost, cost-effectiveness, and economics as search terms. All articles and abstracts published from January 2003 to April 2006 were reviewed and cross-referenced for possible exclusions or duplications. Searches were not limited to English-language publications. Study Selection and Data Extraction: One prospective economic study and 10 studies using decision analytical models assessing the cost-effectiveness of escitalopram compared with citalopram and/or venlafaxine were identified and reviewed. Data Synthesis: Pharmacoeconomic studies using country-specific currency economic analysis from Europe and Canada have been conducted assessing the cost-effectiveness of escitalopram in major depression. Several studies have shown escitalopram to be more cost-effective compared with citalopram, with cost savings identified in societal and healthcare system perspectives. However, the cost-effectiveness of escitalopram was less significant when compared with venlafaxine. Conclusions: Economic studies suggest that escitalopram is cost-effective compared with citalopram in treatment of major depression, but has marginal advantage compared with venlafaxine.
Interleukin-1 in Rheumatoid Arthritis: Its Inhibition by IL-1Ra and Anakinra
Authors: Ghivizzani Steven C , Gouze Elvire , Watson Rachael S , Saran Jeetpaul , Kay Jesse D , Bush Marsha L , Levings Padraic P , Gouze Jean-Noel 
Published: September 2013

Objective: To review the biology of interleukin-1 (IL-1) in the pathogenesis of rheumatoid arthritis (RA), as well as the biology of its natural inhibitor, IL receptor antagonist (IL-1Ra), and the clinical efficacy and safety of the recombinant form, anakinra. Data Sources: A MEDLINE search (1966–January 2007) of English-language articles was conducted using the key words anakinra, arthritis, clinical trial, interleukin-1 receptor antagonist, and Kineret. Study Selection and Data Extraction: Over 79 research articles and literature reviews were used to compile a discussion of the biology of IL-1 and IL-1Ra. Ten of these articles were selected to discuss the clinical safety and efficacy of anakinra. Data Synthesis: In RA, IL-1 primarily acts locally to mediate erosion of cartilage and bone. IL-1Ra serves to modulate its activity through competitive inhibition of cellular receptors. Administration of anakinra to animals with experimental arthritis reduced inflammation and joint damage. In clinical trials, anakinra was reasonably well tolerated; however, injection site reactions were frequent and there was a slight increased risk of serious infection. Alone or in combination with methotrexate, anakinra significantly reduced the symptoms and clinical signs of RA at the American College of Rheumatology 20% response level. However, no additive benefit was observed following coadministration with etanercept, a soluble tumor necrosis factor antagonist, and anakinra had no beneficial effect in patients that failed treatment with etanercept. Conclusions: Laboratory studies have indicated that IL-1 is primarily responsible for cartilage destruction and bone erosion in RA. The selective inhibition of IL-1 through administration of anakinra may offer symptomatic relief of RA in some patients.
Retrospective Evaluation of Prescription Frequency in Heart Failure
Authors: Ryzner Kristi L , Burkiewicz Jill S 
Published: September 2013

Background: Current clinical guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) recommend that all patients with heart failure, in the absence of absolute contraindications, be treated with both a β-blocker and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB). Despite guideline recommendations and strong evidence of mortality benefit, studies of practice patterns show suboptimal use of such drugs. Objective: To determine the frequency of ACE inhibitor or ARB and β-blocker combination therapy in patients diagnosed with heart failure. Methods: Medical records of patients diagnosed with heart failure through ICD-9 codes at an urban community health center were reviewed over a one year period to determine the frequency of use of β-blockers, ACE inhibitors, and ARBs. Data were classified according to patient characteristics and comorbid conditions. Results: Combination therapy with both a β-blocker and ACE inhibitor or ARB was used in 61.1% (107/175) of patients. Overall, 65.7% (115/175) of patients had no relative contraindications to therapy and were more likely to be prescribed combination therapy than those with contraindications (72.2% vs 40.0%; p < 0.001). Patients with relative contraindications to β-blocker therapy (chronic obstructive pulmonary disease, asthma) were less likely to be on combination therapy than patients without such contraindications (51.0% vs 81.0%; p < 0.001). Conclusions: Although a majority of patients were taking both a β-blocker and either an ACE inhibitor or ARB, a large number of patients were not prescribed appropriate ACC/AHA–recommended therapy. Interventions within health systems should be explored as a means to bridge this gap to improve patient outcomes and ensure quality of care.
Time Required by Pharmacy Technicians to Reconstitute New versus Old Piperacillin/Tazobactam Formulations
Authors: Sahni Jasmine K , Kuti Joseph L , Nicolau David P 
Published: September 2013

Background: Piperacillin/tazobactam, an intravenous broad-spectrum antibiotic commonly used in the hospital setting, has recently been reformulated with edetate disodium dehydrate (EDTA) and sodium citrate due to new guidelines on particulate standards. This reformulation is now compatible with lactated Ringer's solution and certain aminoglycosides. Objective: To determine the time required for pharmacy technicians to reconstitute the reformulated piperacillin/tazobactam solution compared with the original and European (Vial X) formulations. Methods: This study was conducted in an intravenous preparation room using a time–motion design. Each of 5 pharmacy technicians, who were blinded to the formulation, repeated the reconstitution process 6 times for a total of 30 observations of each strength within each formulation. Each piperacillin/tazobactam vial was reconstituted individually. Labor costs were calculated using the 2005 US hourly wage for pharmacy technicians. Results: Reconstitution times did not differ between formulations for the 3.375 g vial (mean ± SE, 4.15 ± 0.26 min for original vs 4.92 ± 0.58 min for EDTA formulations; p = 0.112). However, formulations containing EDTA went into solution more rapidly at the 4.5 g strength (4.41 ± 0.33 min vs 6.79 ± 0.61 min; p < 0.001) and did not differ from the Vial X formulation (4.12 ± 0.23 min; p = 0.781). The large 40.5 g pharmacy bulk vial was tested only with the EDTA formulation, which required 5.58 ± 0.41 minutes to reconstitute. Conclusions: Based on these timings, the labor costs associated with reconstituting a single vial of each strength is approximately $1 per vial, regardless of which formulation is used. Reformulated piperacillin/tazobactam containing EDTA and sodium citrate will go into solution at least as quickly as the original formulation.
Consumer Comprehension of OTC Medication Labels and the Scope for Improvement in Font Size
Authors: Murty Sharanya , Sansgiry Sujit S 
Published: September 2013

Background: On March 17, 1999, the FDA mandated a new standardized format called “Drug Facts” and a minimum font size of 6 points for the labeling of over-the-counter (OTC) medications. Yet, some text legibility studies report consumer preference for font sizes of at least 10 points. The possibility therefore exists that the minimum font size mandated by the FDA might be too small for certain consumers to read. Objective: To compare the effectiveness of 3 labeling formats—old, new, and simulated labels (SLs)—using the OTC medication Label Evaluation Process Model (LEPM). Methods: A within-subjects experimental design was used. SLs designed for this study contained similar information as the new labels plus a larger font size. English-speaking consumers viewed these label formats and completed a questionnaire that requested consumer demographic information and measured their responses on 5 domains of the LEPM: ease of use, product knowledge, attitude toward product label, product evaluation, and purchase intention. These 5 domains were the dependent variables for this study. The independent variable was the label format. Data were analyzed using the SAS 9.1 software. A multivariate analysis of variance (ANOVA) followed by a univariate ANOVA determined the effect of label format on the dependent variables. Results: Each label format differed significantly from the others in terms of ease of use, attitude, product evaluation, and purchase intention, with the highest mean scores reported for SLs. SLs were the only label format that significantly improved consumers' product knowledge. Conclusions: Although the new standardized OTC labels are an improvement from the old unstandardized label format, there is a need for further improvement in OTC medication labeling, especially regarding the font size on these labels.
What Women Want to Know: An Assessment of Online Questions Asked by Women Using an Ask-the-Pharmacist Service
Authors: Jariangprasert Chad S , El-Ibiary Shareen Y , Tsourounis Candy , Assemi Mitra 
Published: September 2013

Background: Almost three-quarters of American adults use the Internet. Eighty percent of these adults use online health information resources. Ask-the-Pharmacist (ATP) services provide individualized clinical information to online consumers. Objective: To characterize the content of online queries submitted by or on behalf of women to an ATP service. Methods: A retrospective review was conducted of online queries submitted to the Blue Shield of California ATP service between 2003 and 2004. Questions were characterized and analyzed using Analysis ToolPak package and SPSS software (version 12). Results: A total of 1,056 submitted queries were analyzed. The mean age of female consumers was 45.6 years (range 18–88). Thirty-three percent inquired about drug adverse effects; of these, 19% reported experiencing acute adverse reactions. Drug efficacy or indications were the subject of 26% of queries. The most common drug-related queries were about antidepressants (8.6%) and contraceptives (8.2%), with a majority interested in the adverse effects of these drug classes. Over-the-counter products accounted for 4.9% of the queries. Contraception and dermatology were the most frequent indications listed for women aged 18–35 years; for women over the age of 50 years, menopause was the most frequent indication. Conclusions: The questions asked regarding the health of female consumers reflect the fact that consumers need more information to make treatment decisions. Women want to know the differences in drug efficacy and adverse effects among different medications. Healthcare providers should be aware of these issues to better anticipate women's healthcare needs. In addition, this information may help health plans to develop specific materials targeted toward these issues.