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Hayes D.,Mayo Medical School | Freedman R.,University of Utah | Curtis A.B.,State University of New York at Buffalo | Niebauer M.,Cleveland Clinic | And 3 more authors.
Heart Rhythm | Year: 2013

Background/Objective Following a class I recall of St. Jude Medical Riata/Riata ST silicone implantable cardioverter-defibrillator leads, we report on the phase I results of the Riata Lead Evaluation Study, a prospective, multicenter investigation to assess the prevalence of externalized conductors (ECs) and the electrical dysfunction in these leads. Methods We enrolled patients previously implanted with Riata/Riata ST leads and performed cinefluoroscopy using multiple views. A physician panel adjudicated the images for the presence of EC. The prevalence of EC was stratified and compared by lead model and patient characteristics. Upon occurrence of a lead revision, another physician panel determined whether electrical dysfunction had occurred based on predefined criteria. Results Seven hundred seventy six patients with Riata/Riata ST silicone leads (8Fr/7Fr = 66.6%/33.4%; single-/dual-coil = 12.9%/87.1%) across 23 centers were analyzed. Implant duration was 4.8 ± 0.9 years for 7Fr and 6.5 ± 1.6 years for 8Fr leads (P <.001). The prevalence of EC was significantly lower in 7Fr compared with 8Fr leads for the entire study population (9.3% vs 24.2%, P <.001) and for leads implanted ≤6 years (9.4% vs 18.8%, P =.006). Other than lead size, there were no significant differences in lead, patient, or electrical characteristics between leads with and without EC. Over a period of 9.8 ± 2.0 months, the overall prevalence of electrical dysfunction was 1.3% (confidence interval 0.49%-2.1%), with only 3 of 10 cases occurring in leads with EC. Conclusion Larger-diameter Riata leads were more prone to EC than smaller-diameter Riata ST leads. The prevalence of electrical dysfunction was not associated with EC. © 2013 Heart Rhythm Society. Source


Dixon K.S.,Huntsville Hospital | Hassoun A.,Alabama Infectious Diseases Center
Journal of the American Pharmacists Association | Year: 2010

Objective: To report an interaction between all-trans retinoic acid (ATRA) and voriconazole resulting in pseudotumor cerebri. Setting: Hospital in Huntsville, AL, in November 2007. Patient description: 21-year-old black woman admitted to the hospital for fever in the setting of pancytopenia. Case summary: The patient had been diagnosed with acute promyelocytic leukemia 5 months before admission and continued on ATRA throughout induction and two consolidation therapies. Voriconazole was started in view of persistent fever and pancytopenia despite adequate broad-spectrum antimicrobial therapy. On day 15 of voriconazole therapy, the patient complained of blurred vision, farsightedness, and dry skin with pruritus and was subsequently diagnosed with pseudotumor cerebri secondary to ATRA toxicity. All symptoms of pseudotumor cerebri resolved after discontinuation of ATRA. Main outcome measures: Not applicable. Results: The development of pseudotumor cerebri after initiation of voriconazole may have been secondary to the inhibition of the cytochrome P450 (CYP) enzymes. The interaction may have led to changes in ATRA serum concentrations, thus contributing to the observed adverse drug reaction. Conclusion: To our knowledge, this is the first case report of pseudotumor cerebri in an adult patient secondary to metabolic inhibition of ATRA by voriconazole. This case illustrates the importance of monitoring for drug interactions when using medications metabolized via the CYP enzyme pathway. Source


Rasmussen C.B.,Huntsville Hospital | Glisson J.K.,University of Mississippi Medical Center | Minor D.S.,University of Mississippi Medical Center
Journal of Clinical Hypertension | Year: 2012

Dietary supplements (DSs) are used extensively in the general population and many are promoted for the natural treatment and management of hypertension. Patients with hypertension often choose to use these products either in addition to or instead of pharmacologic antihypertensive agents. Because of the frequent use of DS, both consumers and health care providers should be aware of the considerable issues surrounding these products and factors influencing both efficacy and safety. In this review of the many DSs promoted for the management of hypertension, 4 products with evidence of possible benefits (coenzyme Q10, fish oil, garlic, vitamin C) and 4 that were consistently associated with increasing blood pressure were found (ephedra, Siberian ginseng, bitter orange, licorice). The goals and objectives of this review are to discuss the regulation of DS, evaluate the efficacy of particular DS in the treatment of hypertension, and highlight DS that may potentially increase blood pressure. © 2012 Wiley Periodicals, Inc. Source


Eiland L.S.,Auburn University | Hunt M.O.,Huntsville Hospital
Pediatric Drugs | Year: 2010

Migraine headaches frequently occur in the pediatric population, with a prevalence of 3 in children 27 years of age, 411 in children 711 years of age, and 823 in children 11 years of age and older. Migraine without aura is more than twice as common as migraine with aura in children. Headaches are the third leading cause of emergency room referrals and rank in the top five health problems of children. The 2004 American Academy of Neurologys treatment parameter for migraine in children and adolescents recommended that nasal sumatriptan be considered for acute treatment; however, data were lacking to make a decision regarding the available oral triptans at that time. The more recently released European guidelines discuss three different triptans for use in children but no specific triptan was recommended.Currently, six of the seven available triptans have been studied for efficacy and safety in the pediatric population; however, only a few well controlled clinical studies have been conducted. Sumatriptan has the most available data on outcomes in general, with nasal sumatriptan showing the most positive results. Nasal sumatriptan is approved in children older than 12 years of age in Europe. Oral sumatriptan does not show any clinical benefit versus placebo in children. Rizatriptan and zolmitriptan have conflicting efficacy and safety data, with most studies favoring the use of oral rizatriptan and nasal zolmitriptan. Almotriptan is the first triptan to obtain a US FDA indication in adolescents with migraines lasting 4 or more hours. This approval was based upon two studies, one large clinical trial and one very small, open-label, pilot study. At this time, there are insufficient data to recommend naratriptan and eletriptan for first-or second-line use in pediatric patients with migraines. There are currently no efficacy data for frovatriptan in pediatric patients, which limits its use in this population. Adverse effects of triptans and pharmacokinetic data in children and adolescents are similar to those in adults.The triptan class should be considered as an acute treatment option for children and adolescents with migraines, although their use is mostly 'off-label'. Of the available triptans, there are more positive efficacy data for sumatriptan and zolmitriptan nasal sprays, and rizatriptan and almotriptan tablets than for the other triptans. © 2010 Adis Data Information BV. All rights reserved. Source


Brown T.M.,University of Alabama at Birmingham | Voeks J.H.,Medical University of South Carolina | Bittner V.,University of Alabama at Birmingham | Brenner D.A.,University of Alabama at Birmingham | And 5 more authors.
Journal of the American College of Cardiology | Year: 2014

Objectives In a nonclinical trial setting, we sought to determine the proportion of individuals with coronary artery disease (CAD) with optimal risk factor levels based on the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation) trial. Background In the COURAGE trial, the addition of percutaneous coronary intervention (PCI) to optimal medical therapy did not reduce the risk of death or myocardial infarction in stable CAD patients but resulted in more revascularization procedures. Methods The REGARDS (REasons for Geographic And Racial Differences in Stroke) study is a national prospective cohort study of 30,239 African-American and white community-dwelling individuals older than 45 years of age who enrolled in 2003 through 2007. We calculated the proportion of 3,167 participants with self-reported CAD meeting 7 risk factor goals based on the COURAGE trial: 1) aspirin use; 2) systolic blood pressure <130 mm Hg and diastolic blood pressure <85 mm Hg (<80 mm Hg if diabetic); 3) low-density lipoprotein cholesterol <85 mg/dl, high-density lipoprotein cholesterol >40 mg/dl, and triglycerides <150 mg/dl; 4) fasting glucose <126 mg/dl; 5) nonsmoking status; 6) body mass index <25 kg/m2; and 7) exercise ≥4 days per week. Results The mean age of participants was 69 ± 9 years; 33% were African American and 35% were female. Overall, the median number of goals met was 4. Less than one-fourth met ≥5 of the 7 goals, and 16% met all 3 goals for aspirin, blood pressure, and low-density lipoprotein cholesterol. Older age, white race, higher income, more education, and higher physical functioning were independently associated with meeting more goals. Conclusions There is substantial room for improvement in risk factor reduction among U.S. individuals with CAD. © 2014 by the American College of Cardiology Foundation. Source

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