bluuebunny/crossref_metadata_2025_split huggingface dataset:
Blind Comparison of Patient Preference for Flavored Colestid Granules and Questran Light
Authors: Jungnickel Paul W. , Shaefer Mark S. , Maloley Pierre A. , Campbell James R. , Shawaryn Gregory G. , Goris George B. , Oliphant Thomas H. 
Published: January 2017

OBJECTIVE: To compare the sensory and mixability characteristics of Flavored Colestid Granules (a new colestipol formulation) with Questran Light (the most recent cholestyramine formulation). METHODOLOGY: Seventy-two nonsmoking adults between the ages of 25 and 64 years were enrolled in the study. Subjects assessed the sensory and mixability characteristics of each product in chilled bottled water and orange juice after at least a one-hour fast. Products were administered in a double-blind, randomized fashion. The sensory characteristics that were rated included overall rating, aftertaste, appearance, aroma, color, consistency, flavor, sweetness, mouthfeel, and thickness. Each characteristic was rated with a nine-point hedonic scale. Mixability of the products was assessed on a five-point scale. Subjects also were asked to choose which product they preferred as to sensory and mixability characteristics in each vehicle. RESULTS: Fifty-three of the 72 subjects preferred the sensory characteristics of Flavored Colestid Granules in water (p<0.001). Questran Light was preferred by 61 subjects when mixed in orange juice (p<0.001). The sensory characteristic rating scores also supported subject preferences for Flavored Colestid Granules in water and Questran Light in orange juice. Mixability of Flavored Colestid Granules was rated significantly better (p<0.001) than Questran Light in water. There was no significant difference for mixability between the products in orange juice. CONCLUSIONS: Questran Light was significantly preferred on a sensory basis when mixed in orange juice. Flavored Colestid Granules was significantly preferred over Questran Light for both sensory and mixability characteristics with water as the vehicle.
Amphotericin B Overdose in Pediatric Patients with Associated Cardiac Arrest
Authors: Cleary John D. , Hayman Jimmy , Sherwood Julia , Lasala Gabriel Perez , Piazza-Hepp Toni 
Published: January 2017

OBJECTIVE: To report the first five cases of amphotericin B overdose with secondary cardiac complications in a pediatric population. Treatment is also presented. SETTING: Hospital. PATIENTS: Two infants and three children inpatients receiving amphotericin B. INTERVENTIONS AND RESULTS: Cardiac complications were observed in five pediatric patients who received between 4.6 and 40.8 mg/kg/d of amphotericin B. Cardiac arrest occurred in all patients, and four patients died. A detailed description of the cardiac event is provided for one patient who was on a cardiac monitor during the adverse reaction. Hydrocortisone prophylaxis and verapamil therapy were the primary therapies used in patient 1 (the only survivor). Evaluation of the literature provides substantial evidence for the use of hydrocortisone in prevention of cardiac arrhythmias. CONCLUSIONS: Amphotericin B overdose can be fatal in children and infants. The presentation in humans appears similar to that in dogs where cardiac arrhythmias occurred at doses of 5–15 mg/kg. Hydrocortisone may decrease the incidence of mortality associated with cardiac arrhythmias in children receiving amphotericin B overdoses. Animal studies are necessary to evaluate this observation and potential disadvantages of hydrocortisone usage.
Fluoxetine and Tics in an Adolescent
Authors: Eisenhauer Gail , Jermain Donna M. 
Published: January 2017

OBJECTIVE: To describe a case of tics associated with fluoxetine. CASE SUMMARY: A depressed adolescent was treated with fluoxetine. The patient had not been exposed to any other pharmacologic agents prior to this treatment. Following eight months of fluoxetine therapy the patient developed numerous tics. The movements subsided six months after discontinuation of fluoxetine. DISCUSSION: Antidopaminergic effects have been reported in patients treated with fluoxetine. Because fluoxetine is a specific serotonin reuptake inhibitor, one plausible explanation for the extrapyramidal symptoms observed in these patients is that serotonin modulates dopaminergic neurons. CONCLUSIONS: Extrapyramidal symptoms have been reported in patients receiving fluoxetine, although never previously in an adolescent. This case report provides further evidence that fluoxetine may be associated with severe extrapyramidal adverse reactions.
Lorazepam Toxicity in a Premature Infant
Authors: Reiter Pamela D. , Stiles Alan D. 
Published: January 2017

OBJECTIVE: To report a case of lorazepam toxicity in a premature infant and discuss the importance of altered pharmacodynamics and pharmacokinetics in the neonatal population. CASE SUMMARY: A 2025-g, 33-weeks' gestation infant was born with respiratory distress syndrome that required mechanical ventilation. Lorazepam was used to establish sedation and prevent asynchronous breathing while the infant was on the ventilator. Shortly after the first dose of lorazepam, the infant experienced a seizure and was subsequently given a loading dose of phenobarbital. Lorazepam therapy was continued for sedation. The patient was transferred to our tertiary care center on day 2 of life for evaluation of possible cardiac disease. Upon arrival, the infant was extremely hypotonic and unresponsive; therefore, all sedative medications were discontinued. Two days after admission, the infant continued to exhibit very little spontaneous activity and a lorazepam serum concentration was obtained (63 h after the last dose). Analysis revealed a toxic lorazepam serum concentration of 4453 nmol/L. The patient eventually was weaned to room air and was transported back to the referring hospital. DISCUSSION: Lorazepam is commonly prescribed in the pediatric population for sedative, anticonvulsant, anxiolytic, antiemetic, and amnestic activity. Few data exist regarding the safety of long-term lorazepam therapy in the neonatal subpopulation. There have been some reports of neurologic toxicity secondary to lorazepam in preterm infants. Its metabolism depends on glucuronidation, an enzymatic process that is very depressed in the premature infant. Accumulation of the drug in the neonate accompanied by clinical toxicity is highly likely. CONCLUSIONS: The inability to establish a clear pharmacokinetic-pharmacodynamic relationship, along with the increased incidence of reported adverse events of lorazepam in neonates, is concerning. Clinicians should be aware of the altered metabolism and elimination of lorazepam in the premature infant.
Oral Agents in the Management of Urticaria: Patient Perception of Effectiveness and Level of Satisfaction with Treatment
Authors: Pontasch Martin J. , White Lynn J. , Bradford John C. 
Published: January 2017

OBJECTIVE: Orally administered diphenhydramine, famotidine, and cromolyn sodium were compared for their abilities to alleviate symptoms of acute urticaria. DESIGN AND SETTING: This was a prospective, randomized, blind study, implemented in the emergency departments (EDs) of two teaching hospitals, each with an annual average of 40000 ED patient visits. Patient perception of the effectiveness of treatment was assessed using a visual analog scale. PATIENTS: 33 adult patients presenting to the EDs were entered into the study over a one-year period. Of these, 8 were lost to follow-up and 5 were noncompliant with medications and not included in data analysis. Twenty adult patients, aged 19–78 years, completed the five-day study: 7 received diphenhydramine, 6 received famotidine, and 7 received cromolyn sodium. RESULTS: Patients receiving diphenhydramine reported the greatest satisfaction with treatment: 86 percent (6/7) indicated they would use the medication again. Fifty percent (3/6) in the famotidine group and 43 percent (3/7) in the cromolyn sodium group rated the treatment as worth using again. Patients receiving famotidine reported the greatest occurrence of adverse effects (50 percent, 3/6); the lowest incidence of such effects was seen in the cromolyn sodium group (14 percent, 1/7). Patients receiving diphenhydramine reported adverse effects at a rate of 43 percent (3/7). CONCLUSIONS: Our results suggest that patients receiving diphenhydramine are more satisfied with their treatment than are patients receiving famotidine or cromolyn sodium.
Concomitant Amiodarone and the Implantable Cardioverter-Defibrillator: Is There a Place?
Authors: Thompson Dennis F. , Raebel Marsha A. , McCollam Patrick L. , Nappi Jean M. 
Published: January 2017

OBJECTIVE: To discuss the controversy surrounding concomitant therapy with amiodarone and the implantable cardioverter-defibrillator (ICD). DATA SOURCES: A MEDLINE search identified English-language literature sources, including nonhuman studies. STUDY SELECTION: Studies included those that specifically addressed the use of amiodarone plus the ICD as well as reviews of the ICD. DATA EXTRACTION: Studies were evaluated for design, type of defibrillation electrode or defibrillator, method of defibrillation, amiodarone loading and maintenance dosages, duration of amiodarone therapy, and study endpoints. DATA SYNTHESIS: Because the ICD functions by delivering energy to depolarize a mass of myocardium, concomitant use of antiarrhythmic agents that elevate the defibrillation threshold (DFT) beyond an ICD's energy capability may adversely effect patient outcome. Amiodarone has been shown to both increase and decrease the DFT. Trials examining the use of amiodarone plus the ICD have not provided strong evidence that amiodarone will decrease the number of ICD discharges or favorably affect the mortality rate. Amiodarone is also expensive and toxic. Although the cost of the ICD is relatively high, continuing improvements in battery life will decrease long-term costs. CONCLUSIONS: Controlled trials are required to substantiate the improved survival rate with the ICD and to determine the role of antiarrhythmic agents in conjunction with the device. At present, there are no data to support the combination of amiodarone and an ICD in terms of improved quality or duration of life.
Aldose Reductase Inhibitors: An Update
Authors: Tsai Sandra C. , Burnakis Thomas G. 
Published: January 2017

OBJECTIVE: To update readers on research being conducted with the aldose reductase inhibitor (ARI) tolrestat in treating complications of diabetes mellitus. The article briefly describes early investigations with other ARIs and reviews the more recent studies of tolrestat. In addition, the article gives readers a simplified overview of the biochemical background pertinent to the use of these agents. DATA SOURCES: A MEDLINE search was performed to identify articles relating to the clinical use of, and research involving, the following ARIs: sorbinil, alrestatin, ponalrestat, and tolrestat. In addition, pharmaceutical manufacturers were contacted in an attempt to obtain data relating to ongoing investigations. STUDY SELECTION: Review articles and clinical trials of sorbinil, alrestatin, and ponalrestat were included. Articles dealing with clinical trials of tolrestat were selected from the MEDLINE search. As there were only a few trials, all studies identified were included. No additional written data were available from the manufacturers. DATA SYNTHESIS: ARIs, which when first introduced were proclaimed to be major advances in treating diabetic complications, have never produced the expected results. Problems with efficacy and toxicity relegated most of this class of agents to historical interest. One compound, tolrestat, has continued to be tested and has potential clinical application. To date, the extent of benefit that has been realized in tolrestat-treated patients is small to moderate. Improvements have occurred in paresthesia and neuropathy, but unfortunately, not in pain symptoms. Adverse effects have been minor and are primarily confined to elevations of hepatic alanine aminotransferase. Additional clinical trials are being conducted with this agent. CONCLUSIONS: Tolrestat is the only one of the original ARIs still undergoing clinical trials. Results so far have been encouraging, but by no means definitive, for improvement in some aspects of diabetic neuropathy. Information from ongoing investigations is necessary before the true usefulness of tolrestat therapy can be determined.
Magnesium and Diabetes: A Review
Authors: White John R. , Campbell R. Keith 
Published: January 2017

OBJECTIVE: To discuss the potential link between diabetes mellitus (DM) and Hypomagnesemia, the methods used to assess magnesium status, and the potential benefits of magnesium repletion in hypomagnesemic patients with DM. DATA SOURCES: A MEDLINE search (key terms: magnesium and diabetes) was conducted to identify pertinent literature. STUDY SELECTION: All major clinical trials and most published case reports were reviewed. SYNTHESIS: Several studies have demonstrated a higher than expected frequency of magnesium deficiency in patients with DM. Hypomagnesemia may play a role in the development of retinopathy, altered glucose disposition, hypertension, abnormal platelet function, and other problems frequently observed in patients with DM. The lack of a widely available, accurate screening methodology is one of the main problems in assessing total body magnesium status. One study has suggested that hypomagnesemia in patients with DM may be related to enhanced urinary loss of magnesium. Several studies evaluating hypomagnesemia and glucose disposal have suggested a direct correlation between magnesium concentration and glucose disposal, with an improvement in glucose disposal with magnesium supplementation. It has been suggested that there is a relationship between hypomagnesemia and diabetic retinopathy; however, the effect of magnesium supplementation on the development of diabetic retinopathy has not been evaluated. Researchers evaluating the effect of magnesium on platelet aggregation have suggested that magnesium supplementation may reduce the incidence of vascular disease in hypomagnesemic patients with DM. Several studies have demonstrated a correlation between hypomagnesemia and hypertension. CONCLUSIONS: Studies have suggested a link between hypomagnesemia and hyperglycemia, as well as an association between hypomagnesemia and the complications of DM. The American Diabetes Association has published a consensus statement suggesting that patients who have documented hypomagnesemia and DM receive magnesium supplementation.
Effect of Multiple Staggered Doses of Calcium on the Bioavailability of Ciprofloxacin
Authors: Lomaestro Ben M. , Bailie George R. 
Published: January 2017

OBJECTIVE: To determine the effect on the relative bioavailability (Fr) of a staggered single dose of ciprofloxacin given two hours after a morning dose of calcium carbonate given three times daily over the three previous days. DESIGN: Thirteen male volunteers participated in this randomized, nonblinded, crossover investigation; 12 subjects were included in the final analysis. SETTING: Data collection and ciprofloxacin administration occurred at Albany Medical Center, a tertiary-care teaching institution. Calcium carbonate administration was on an outpatient basis. RESULTS: For 12 volunteers, the mean ± SD Fr of ciprofloxacin staggered with calcium was 0.87 ± 0.23 (noncompartmental model) and 0.98 ± 0.27 (compartmental model). Other statistically significant findings were a decrease in the time to maximum concentration of ciprofloxacin staggered with calcium in serum compared with ciprofloxacin alone (from 1.76 ± 0.54 to 1.23 ± 0.52 h in the noncompartmental model; p<0.05), and a decrease in the same parameter (from 1.92 ± 0.96 to 0.77 ± 0.53 in the compartmental model; p<0.005). Maximum concentration of ciprofloxacin staggered with calcium was decreased in the noncompartmental model compared with ciprofloxacin alone (from 2.11 ± 0.72 to 1.60 ± 0.33, respectively; p<0.05). The elimination half-life and area under the concentration-time curve of ciprofloxacin were not significantly altered. CONCLUSIONS: Repeated doses of calcium carbonate, administered two hours before ciprofloxacin, did not significantly alter the Fr of this fluoroquinolone.
Effect of Frequently Prescribed Cardiovascular Medications on Sexual Function: A Pilot Study
Authors: Kroner Beverly A. , Mulligan Thomas , Briggs Geneva C. 
Published: January 2017

OBJECTIVE: To determine the effect on male sexual function of initiating any one of the cardiovascular medications most frequently prescribed at our institution. DESIGN: Men were surveyed via telephone when they received a new prescription for hydrochlorothiazide, furosemide, lisinopril, verapamil, nifedipine, or diltiazem, and after 30 days of daily medication ingestion. To assess Hawthorne effect, men who had no change to their medication regimen also were surveyed at the time of medication refill for maintenance therapy and 30 days later. PARTICIPANTS: Community-dwelling male veterans who received a single new prescription between January 1 and April 1, 1992 (n=134). MAIN OUTCOME MEASURES: Responses to questions about sexual interest, erectile function, orgasmic ability, and sexual satisfaction. RESULTS: Men who had no change to their medication regimen showed no change in sexual interest, erectile function, orgasmic ability, or satisfaction. Hydrochlorothiazide was associated with decreased orgasmic ability (p=0.008). Although none of the other changes were statistically significant (p<0.05), both nifedipine and diltiazem showed a trend toward improved sexual function. CONCLUSIONS: Hydrochlorothiazide may be associated with anorgasmia. More study is needed to determine if nifedipine and diltiazem improve erectile function. Furosemide, lisinopril, and verapamil likely have no effect on sexual function.
Correlation of Aminoglycoside and Vancomycin Pharmacokinetic Parameters
Authors: Wragge Todd M. , Cooper Brad E. 
Published: January 2017

OBJECTIVE: To investigate a correlation between the elimination rate constants (Ke) of aminoglycosides (AG) and vancomycin; to investigate the correlation between actual Ke and creatinine clearance (Clcr) for AG versus vancomycin; to investigate the calculated versus actual Ke for AG and vancomycin; and to investigate a correlation between volumes of distribution (Vd) between AG and vancomycin. DESIGN: Retrospective data collection. METHODS: Patients in our institution who received AGs or vancomycin concomitantly or within six weeks of each other were identified retrospectively. Patient subpopulations were identified and analyzed collectively as well as individually. Steady-state serum concentrations of AG and vancomycin (more than four half-lives) were obtained and kinetic parameters (Ke‘ Vd) were calculated using first-order pharmacokinetic equations. Linear regression was used to determine correlation coefficients. RESULTS: In the total population and all subpopulations, the correlation between Ke of AG and vancomycin was superior to the correlation between Ke and Clcr. The correlations (r2) between Ke for AG and vancomycin in the total, general medicine, oncology, and intensive care units (ICU) populations were 0.572, 0.878, 0.349, and 0.561, respectively. The correlations (r2) between Ke and Clcr for AG in the total, general medicine, oncology, and ICU populations were 0.235, 0.430, 0.005, and 0.238, respectively. The correlations (r2) between Ke and Clcr for vancomycin in the total, general medicine, oncology, and ICU populations were 0.300, 0.407, 0.055, and 0.309, respectively. CONCLUSIONS: The correlation between Ke of AG and vancomycin may be beneficial for predicting Ke of vancomycin when AG concentrations have already been obtained or vice versa, and may give more accurate estimations of dosing intervals and require less time adjusting, ordering, and interpreting concentrations and dosages.
Cefpodoxime Proxetil: A New, Broad-Spectrum, Oral Cephalosporin
Authors: Chocas Elaine C. , Paap Christopher M. , Godley Paul J. 
Published: January 2017

OBJECTIVE: To discuss the chemistry, pharmacokinetics, spectrum of activity, clinical trials, adverse effects, drug interactions, and dosage guidelines of cefpodoxime proxetil. DATA SOURCES: Literature was identified through a MEDLINE search from 1988 to the present and from review of bibliographies in that literature. STUDY SELECTION: Data were limited to comparative trials published in the English literature. Although many studies were conducted in Japan, the results often were available only in Japanese or partly in English. As these studies could not be completely evaluated, they are not included in this review. DATA SYNTHESIS: Cefpodoxime exhibits good activity against many gram-positive and gram-negative organisms. In clinical trials, cefpodoxime was similar in both clinical and bacteriologic efficacy to amoxicillin, cefaclor, amoxicillin/clavulanate, and penicillin in the treatment of respiratory and urinary tract infections. It also appeared effective in the treatment of skin and soft tissue infections, although no comparative trials have been performed. Cefpodoxime is well tolerated by children and is effective in the treatment of otitis media and pharyngitis. It has a similar adverse effect profile to that of other penicillins and cephalosporins, with gastrointestinal effects being most common. CONCLUSIONS: Cefpodoxime demonstrates good in vitro activity against pathogens frequently associated with respiratory tract, urinary tract, and skin and tissue infections. It has not demonstrated greater efficacy than the other antibiotics to which it has been compared. The available published clinical trials are fraught with methodologic, statistical, and evaluative flaws. Thus, further trials comparing cefpodoxime with established treatments, as well as the newer cephalosporins, are needed before its place in therapy can be established.
Bioequivalence of Two Methotrexate Formulations in Psoriatic and Cancer Patients
Authors: Teresi Mary E. , Riggs Charles E. , Webster Paul M. , Adams Michael J. , Noonan Patrick K. , O'Donnell John P. 
Published: January 2017

OBJECTIVE: To compare the bioequivalence of a generic methotrexate (MTX) tablet (Mylan) with that of a brand-name (Lederle) product. DESIGN: A single-dose, randomized, crossover study. SETTING: Clinical Research Center (CRC) at a university hospital. PATIENTS: Men and women who had a diagnosis of malignancy or psoriasis who were at least 21 years old. METHODOLOGY: Two overnight study periods were scheduled at the CRC at least one week, but not more than two weeks apart. Each period consisted of a 10-hour fast prior to and 4 hours following oral MTX 15 mg administered as six 2.5-mg tablets. Blood samples were collected over 48 hours. Plasma MTX concentrations were determined using an HPLC assay. Area under the curve from zero to infinity (AUC0-∞) was calculated by the log-trapezoidal method. RESULTS: Twenty-two patients (21 psoriasis, 1 colon cancer) aged 23–61 years completed both study periods. Mean values for peak concentration, time to peak concentration, and AUC0-∞ were 0.80 μmol/L, 1.2 hours, and 3.0 μmol•h/L, respectively, for Mylan's MTX tablets and 0.81 μmol/L, 1.4 hours, 3.0 μmol•h/L, respectively, for Lederle's MTX. Normalization for weight or body surface area did not affect interpatient variability. Relative bioavailability of generic MTX was 99.2 percent Rate and extent of absorption were not significantly different and the confidence intervals were within the range of 80–120 percent required by the Food and Drug Administration. CONCLUSIONS: Mylan's MTX tablet is bioequivalent to Lederle's product.