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Athens, GA, United States

Hartranft M.E.,Georgia Regents Medical Center | Regal R.E.,University of Michigan
Annals of Pharmacotherapy | Year: 2014

Objective: To describe the treatment of a case of olmesartan-induced enteropathy in a patient with inflammatory areas widely distributed along the gastrointestinal tract. Case Summary: A 75-year-old patient presented with a 5-month history of recurrent severe diarrhea, diagnosed as olmesartan-induced enteropathy. A modified regimen of oral enteric-coated budesonide (EC-BUD), in combination with other antidiarrheal and anti-inflammatory therapies, was prescribed. The patient experienced rapid improvement in symptoms and was able to titrate off all enteropathy medications, including budesonide within 4 months after hospital discharge. Discussion: Olmesartan-induced enteropathy is a recently identified adverse effect of this angiotensin II receptor blocker. Oral budesonide is indicated for use in Crohn's disease to provide topical anti-inflammatory therapy without significant systemic steroid absorption. Budesonide, as enteric-coated oral 3-mg capsules, was chosen as therapy in this patient because of its localized effect and proven efficacy in gastrointestinal inflammatory disorders. The administration technique was modified to target areas of inflammation throughout the gastrointestinal tract. Conclusions: We postulate that this modified administration of EC-BUD may be an effective therapeutic modality for olmesartan-induced enteropathy. It may likewise be an appropriate adjunct to other conditions involving widespread gastrointestinal inflammation, including eosinophilic gastroenteritis and gastrointestinal graft versus host disease. © The Author(s) 2014. Source

Anderegg S.V.,Georgia Regents Medical Center | Anderegg S.V.,University of Kansas | Wilkinson S.T.,Pharmacy | Couldry R.J.,Pharmacy | And 2 more authors.
American Journal of Health-System Pharmacy | Year: 2014

Purpose: The impact of an innovative medication reconciliation and discharge education program on 30-Day readmissions and emergency department (ED) visits was evaluated.Methods: An observational pre-post analysis was conducted at an academic medical center to compare rates of hospital readmissions and return to ED visits during three-Month periods before and after implementation of a restructured pharmacy practice model including (1) medication reconciliation at transitions of care for every patient and discharge education for a high-risk subgroup, (2) new or expanded services in the preanesthesia testing clinic and ED, (3) a medication reconciliation technician team, and (4) pharmacist-topatient ratios of 1:30 on acute care floors and 1:18 on critical care units. The primary outcome was the composite of rates of readmissions and return to ED visits within 30 days of discharge.Results: A total of 3,316 patients were included in the study. Pharmacy teams completed medication reconciliation in 95.8% of cases at admission and 69.7% of cases at discharge. Discharge education was provided to 73.5% of high-risk patients (defined as those receiving anticoagulation therapy or treatment for acute myocardial infarction, chronic obstructive pulmonary disease, congestive heart failure, or pneumonia). No significant difference was observed between the preimplementation and postimplementation groups with regard to the primary outcome. In the high-risk subgroup, there was a significant reduction in the 30-Day rate of hospital readmissions, which declined from 17.8% to 12.3% (p = 0.042); cost projections indicated that this reduction in readmissions could yield annual direct cost savings of more than $780,000.Conclusion: Implementation of a teambased pharmacy practice model resulted in a significant decrease in the rate of 30-Day readmissions for high-risk patients. © 2014, American Society of Health-System Pharmacists, Inc. Source

Karam J.,Washington University in St. Louis | Tsiouris A.,Yale University | Vazquez J.,Georgia Regents Medical Center | Shepard A.,Ford Motor Company
Annals of Vascular Surgery | Year: 2015

We report a case of cryptococcal aortitis in a 59-year-old man presenting as a symptomatic suprarenal abdominal aortic aneurysm (AAA). The patient underwent repair of his aneurysm using a rifampin-soaked graft with omental wrapping. Intraoperative Gram stains showed yeast organisms, the cultures eventually grew Cryptococcus neoformans with results available 43 days postoperatively. He was started on antifungal therapy intraoperatively and will be on lifelong antifungal treatment. Our case is the first report of cryptoccocal aortitis presenting as a symptomatic AAA; the diagnosis of a true mycotic aneurysm was made intraoperatively. © 2015 Elsevier Inc. Source

McCall W.V.,Georgia Regents University | Benca R.M.,University of Wisconsin - Madison | Rosenquist P.B.,Georgia Regents University | Riley M.A.,Georgia Regents University | And 8 more authors.
Clinical Trials | Year: 2015

Background/aims: Suicide is a major public health concern, yet there are very few randomized clinical trials that have been conducted to reduce suicidal ideation in patients at risk of suicide. We describe the rationale and refinements of such a trial that is designed to assess the effect of a hypnotic medication on suicidal ideation in adult outpatients currently experiencing suicidal ideation. Methods: "Reducing Suicidal Ideation Through Insomnia Treatment" is a multi-site randomized clinical trial that includes three recruiting sites and one data management site. This 4-year study is in its second year of recruitment. The purpose of the study is to compare hypnotic medication versus placebo as an add-on treatment to a selective serotonin reuptake inhibitor as a means of reducing suicidal ideation in depressed adult outpatients with insomnia and suicidal ideation. The safety features of the study follow the 2001 National Institutes of Health guidelines for studies that include patients at risk of suicide. Results: In total, 584 potential participants have undergone telephone screening; 67% of these failed the phone screen, most often due to an absence of expressed suicidal ideation (26% of the telephone screen fails). A total of 115 people appeared for a face-to-face baseline assessment, and 40 of these had completed a taper off of their ineffective psychotropic medications before the baseline assessments. In all, 64% of those who completed baseline assessments failed to proceed to randomization, most commonly because of no clinically significant suicidal ideation (51% of those excluded at baseline). One participant was offered and accepted voluntary psychiatric hospitalization in lieu of study participation. Thus far, 40 participants have been randomized into the study and 88.7% of scheduled visits have been attended, with 93.8% adherence to the selective serotonin reuptake inhibitor and 91.6% adherence to the randomized hypnotic versus placebo. None of the randomized participants have required hospitalization or had a suicide attempt. Conclusion: By carefully considering the inclusion and exclusion criteria and other safety features, the safe conduct of randomized clinical trials in suicidal adult patients is possible, including the inclusion of participants who have undergone a prescribed tapering off of psychotropic medications prior to baseline assessment. © The Author(s) 2015. Source

Shah A.,Georgia Regents Medical Center | Mangaonkar A.,Georgia Regents Medical Center
The Annals of pharmacotherapy | Year: 2015

OBJECTIVE: To review and summarize data on idelalisib, which was approved by the Food and Drug Administration (FDA) in July 2014 for use in combination with rituximab for relapsed chronic lymphocytic leukemia (CLL).DATA SOURCES: A literature search using PubMed was conducted from January 2011 through May 2015 using the terms idelalisib, GS-101, CAL-101, PI3Kδ, and CLL. Data were also obtained through the FDA briefing documents, American Society of Clinical Oncology, and American Society of Hematology abstracts.STUDY SELECTION AND DATA EXTRACTION: The literature search was limited to human studies published in English. Priority was placed on trials of idelalisib in CLL.DATA SYNTHESIS: Idelalisib is a potent, first-in-class selective inhibitor of phosphatidylinositol-3-kinaseδ (PI3Kδ) approved by the FDA in July 2014 for the treatment of relapsed CLL, in combination with rituximab, in patients for whom rituximab monotherapy would be considered appropriate due to other comorbidities. PI3Kδ is hyperactivated in B-cell malignancies and plays a vital role in the B-cell receptor pathway, a key oncogenic driver in various B-cell malignancies, including CLL. Several phase I/II studies have demonstrated clinical activity of idelalisib in CLL, particularly in the setting of relapsed/refractory disease, with overall response rate ranging from 70% to 82%. The FDA approval was based on a phase III, randomized trial of rituximab monotherapy (n = 110) or idelalisib in combination with rituximab (n = 110) in heavily, pre-treated patients (median of 3 prior therapies) with relapsed CLL. Idelalisib was administered as 150 mg orally twice daily. Idelalisib plus rituximab was associated with an overall response rate of 81% and overall survival of 91% at 12 months. The median progression-free survival was not reached in the idelalisib arm at the time of the first interim analysis. The incidence of grade 3 or higher adverse events in the idelalisib plus rituximab arm was as follows: neutropenia (34%), thrombocytopenia (10%), anemia (5%), elevation in transaminases (5%), and diarrhea (4%).CONCLUSION: Idelalisib in combination with rituximab is a safe and effective new treatment option for patients with relapsed CLL, including those with poor prognostic factors. As the results from various ongoing studies become available, the role of idelalisib will likely continue to expand. © The Author(s) 2015. Source

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