bluuebunny/crossref_metadata_2025_split huggingface dataset:
Acute Cholestatic Hepatitis Associated with Celecoxib
Authors: Grieco Antonio , Miele Luca , Giorgi Andrea , Civello Ignazio M , Gasbarrini Giovanni 
Published: June 2003

OBJECTIVE: To report a case of acute cholestatic hepatitis associated with the selective cyclooxygenase-2 inhibitor celecoxib. CASE SUMMARY: A 41-year-old white man was hospitalized for jaundice after 2 doses of celecoxib 200 mg for pain associated with right-knee trauma. Laboratory workup showed hyperbilirubinemia, mildly elevated serum transaminase concentrations, and cholestasis. Abdominal imaging showed no dilation of the biliary tree. Histology showed cholestasis, with bile plugs in dilated bile canaliculi and a mild portal infiltrate that are highly suggestive of drug-induced cholestasis. DISCUSSION: This is the fourth report in the English-language literature describing cholestatic hepatitis temporally related to celecoxib use, the second supported by histologic findings typical of drug-induced cholestasis, and the first in a patient who denied use of alcoholic beverages and was taking no other drugs or herbal products at the time of the reaction. The Naranjo probability scale indicated that celecoxib was a probable cause of acute cholestatic hepatitis in this patient. CONCLUSIONS: Cholestatic hepatitis is a well-recognized adverse effect of several drugs. Although celecoxib is considered to have a very low potential for hepatic toxicity, well-documented reports of adverse reactions can contribute significantly to the definition of more accurate safety profiles for new drugs introduced into clinical practice.
International Survey of Self-Reported Medicine Use Among Adolescents
Authors: Hansen Ebba H , Holstein Bjørn E , Due Pernille , Currie Candace E 
Published: June 2003

OBJECTIVE: To examine gender, age, and country variations in adolescents' self-reported medicine use. DESIGN: Cross-sectional school surveys of representative samples of 11- to 15-year-old girls and boys were used. The 1997-1998 Health Behaviour in School-aged Children study was referenced. A standardized questionnaire was completed during school hours. SETTING: Canada, US, Greenland, Israel, and 24 European countries. PARTICIPANTS: 123 227 participants equally distributed by gender and by 3 age groups (mean 11.7, 13.6, 15.6 y). MAIN OUTCOME MEASURES: Self-reported medicine use for headache, stomachache, difficulties in getting to sleep, and nervousness during the past month. RESULTS: The magnitude of the adolescents' medicine use for headache, stomachache, difficulties in getting to sleep, and nervousness varied substantially across countries. In each of the 28 countries, more girls than boys used medicine for pain. Use of medicine for headache increased by age; use of medicine for stomachache increased by age among girls, but decreased among boys; and use of medicine for difficulties in getting to sleep and nervousness decreased from the age of 11 to 15 years. There was an increase in the crude girl versus boy ratios for medicine use by age for all 4 symptoms. Multivariate logistic regression analyses, adjusting for age group and country, revealed the following odds ratios (95% CI) for girls' versus boys' medicine use: headache 1.56 (1.53 to 1.60), stomachache 2.16 (2.10 to 2.22), difficulties in getting to sleep 0.96 (0.91 to 1.00), and nervousness 1.04 (0.99 to 1.08). CONCLUSIONS: Substantial proportions of adolescents used medicine for common health problems. The prevalence of use differed between type of symptom for which the medicine was used, between countries, and between gender and age groups. We suggest that young people's medicine use should be addressed in public health policy.
Fluvoxamine Interaction with Warfarin
Authors: Limke Kristi K , Shelton Angela R , Elliott Ellie S 
Published: June 2003

OBJECTIVE: To report a case of an elevated international normalized ratio (INR) in a patient receiving fluvoxamine and warfarin. CASE SUMMARY: A 79-year-old white woman was admitted for suicidal thoughts. Her medical history included depression, chronic obstructive pulmonary disorder, asthma, hypertension, atrial fibrillation with pacemaker placement, and breast cancer with lumpectomy and subsequent left mastectomy. Her medication list prior to admission was extensive, including warfarin 5 mg on Sunday, Monday, Wednesday, and Friday; warfarin 2.5 mg on Tuesday, Thursday, and Saturday, and citalopram 10 mg/d. Citalopram was changed to fluvoxamine during her hospital stay. This resulted in an elevated INR that persisted for approximately 7 days. DISCUSSION: The metabolism of warfarin involves several cytochrome P450 isoenzymes, including CYP1A2, CYP2C9, CYP2C19, and CYP3A4. Fluvoxamine has the potential to inhibit CYP1A2, CYP2C9, CYP2C19, and CYP3A4 to a significant degree. It also has 11 inactive metabolites that may contribute to enzyme inhibition. Fluvoxamine has an extensive elimination half-life of 17–22 hours after a single dose, which increases with multiple dosing by 30–50%. It can take approximately 10 days to reach a steady-state concentration. In the elderly, the half-life is increased by 50%. CONCLUSIONS: The coadministration of warfarin and fluvoxamine can result in an increase in the anticoagulant effect of warfarin. This anticoagulant effect can be seen for several days after the discontinuation of fluvoxamine. Our case emphasizes the need to closely monitor potential drug interactions in the elderly, especially those concerning fluvoxamine and warfarin.
Caspofungin Acetate for Treatment of Invasive Fungal Infections
Authors: Pacetti Staci A , Gelone Steven P 
Published: June 2003

OBJECTIVE To briefly discuss the changing epidemiology of fungal infections and review currently available agents; provide a review of caspofungin; and discuss its pharmacology, pharmacokinetics, dosing guidelines, safety and efficacy, and role in the treatment of invasive fungal infections as it relates to current antifungal therapy. DATA SOURCES A MEDLINE (1966 to August 2002) database search using key words caspofungin, echino candins, fungal infections, and invasive aspergillosis, was completed to identify relevant articles including reviews, recent studies, treatment guidelines, and data from Merck and Company. STUDY SELECTION In vitro studies and all clinical trials were evaluated to summarize the clinical efficacy and safety of caspofungin. DATA SYNTHESIS The incidence of fungal infections is increasing as the population at risk expands. Cost, resistance, and morbidity and mortality are key issues. Adding to the antifungal armamentarium is necessary to address these therapeutic dilemmas. Caspofungin is the first member of a new class of antifungal agents, the echinocandins, to be approved for clinical use. Caspofungin is classified as a glucan synthase inhibitor and represents a class of agents with a novel mechanism of action. Unlike currently available agents (polyenes, pyrimidines, azoles) that exert their effect on the fungal cell membrane, the echinocandins are the first agents to inhibit fungal cell wall synthesis. Caspofungin exhibits activity against Aspergillus spp. and Candida spp., including non-albicans species. Data from clinical trials demonstrate that caspofungin is effective in patients with invasive aspergillosis as well as candida esophagitis. Its Food and Drug Administration–approved indication is limited to invasive aspergillosis refractory to or intolerant of current therapy. CONCLUSIONS Caspofungin has activity against Aspergillus spp. as well as a variety of Candida spp. Clinical data support its usefulness in the treatment of invasive aspergillosis and select candida infections. As additional clinical data become available, it seems likely that the therapeutic role of caspofungin will expand. THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT ACPE UNIVERSAL PROGRAM NUMBER: 407-000-03-001-H01
Therapeutic Controversies; Lack of Therapeutic Interchangeability of HMG-CoA Reductase Inhibitors
Authors: Chong Pang H 
Published: June 2003

OBJECTIVE: To review relevant literature and provide an opinion on the class effect of hydroxymethylglutaryl coenzyme A reductase inhibitors (statins). DATA SOURCES: Primary and review articles were identified by MEDLINE search (1990–July 2002). STUDY SELECTION AND DATA EXTRACTION: Editorials, studies, and review articles related to the class effect or therapeutic interchangeability of statins were reviewed. Also included was information that is relevant to this topic. DATA SYNTHESIS: Although statins share common main actions, they may have clinically important differences in terms of efficacy and safety. At fixed or allowable dosages, rosuvastatin, atorvastatin, and simvastatin produced greater low-density lipoprotein cholesterol—lowering effects compared with other statins. Some statins have shown reduction in either cardiovascular and/or total mortality. Statins also differ in their structure, pharmacokinetics, potency, and rate of metabolism, any or all of which may have clinical significance. Although inconclusive, subtle differences in nonlipid effects of some statins may have contributed to positive benefits observed in clinical studies. As a result of drug-related deaths, cerivastatin was withdrawn voluntarily from the market, which may raise the question whether there is therapeutic interchangeability (due to class effect) among statins. CONCLUSIONS: Despite the competition for market share and strategies attempting to identify differences in therapeutic value, few head-to-head comparisons between statins have been performed. The limited, available data suggest that statins are not therapeutically interchangeable.
Chronic Metoclopramide Therapy for Diabetic Gastroparesis
Authors: Lata Paul F , Pigarelli Denise L Walbrandt 
Published: June 2003

OBJECTIVE To review the safety and efficacy of chronic metoclopramide for diabetic gastroparesis. DATA SOURCES Medical literature was accessed through MEDLINE (1965 to October 2002) and PubMed (1965 to October 2002). Key search terms included metoclopramide; diabetic gastroparesis; and dyskinesia, drug induced. DATA SYNTHESIS Metoclopramide is often used for diabetic gastroparesis, despite the risk of tardive dyskinesia. Published information is limited regarding long-term efficacy and toxicity of metoclopramide. The literature was assessed concerning these topics. CONCLUSIONS Limited data do not provide sufficient evidence to conclude whether metoclopramide is efficacious for chronic use. Routine monitoring may mitigate the risk associated with metoclopramide therapy.
Concurrent Administration of Interferon Alfa-2b and Beta-1a
Authors: Tanvetyanon Tawee , Stadtmauer Edward A , Kerson Lawrence A 
Published: June 2003

OBJECTIVE To describe the concurrent use of interferon (IFN) alfa and beta in a patient with multiple sclerosis (MS) and chronic myeloid leukemia (CML). CASE SUMMARY A 60-year-old white man developed CML while receiving IFN beta-1a treatment for MS. The patient was started on IFN alfa-2b 1 million units 3 times weekly with IFN beta-1a 30 μg weekly. The dosage of IFN alfa was increased to 3 million units/d 1 month later. He achieved complete hematologic remission in 3 months. The observed adverse effects were mild and included fatigue, somnolence, weight loss, and difficulty with memory. At 19 months after treatment, the patient remained in hematologic remission and his expanded disability status scale score remained unchanged. DISCUSSION Concomitant treatment with interferon alfa and beta by a gradual increase in the dosage of IFN alfa was well tolerated. Although imatinib mesylate may be a preferred treatment for patients with CML and MS at this time, our experience with safe concurrent use of IFN alfa and beta may benefit other patients who require this combined treatment. CONCLUSIONS Concurrent administration of interferon alfa-2b and beta-1a was well tolerated by our patient with CML and MS.
Goiter in a Newborn Exposed to Lithium in Utero
Authors: Frassetto Florence , Martel Florence Tourneur , Barjhoux Claude-Elisabeth , Villier Céline , Le Bot Brigitte , Vincent Françoise 
Published: June 2003

OBJECTIVE: To report a case of neonatal goiter and biological hypothyroidism in a newborn exposed to lithium in utero resulting from therapy given to the mother before and during her pregnancy. CASE SUMMARY: A male neonate, born at 37 weeks' gestation, presented with a goiter without other signs of hypothyroidism. His serum thyroid-stimulating hormone concentration was high and unbound tetrathyroxine concentration was low, indicating that chronic exposure to lithium was present. Oral thyroxine treatment was initiated when the infant was 3 days old and continued for 11 weeks. Treatment was effective in reducing the goiter and hormone concentrations, and allowing normal growth and psychomotor development during the following 3.5 months. Other drugs taken by the mother during pregnancy are not known to induce thyroid abnormalities. DISCUSSION: Lithium is used for prophylaxis and treatment of bipolar disorder. Goiter and hypothyroidism in adults have been described in patients treated with lithium; thyroid disorders are reversible if lithium is discontinued. Few cases of goiter and hypothyroidism have been reported in newborns exposed to lithium in utero. In our patient, congenital hypothyroidism required longer thyroxine treatment than lithium-induced thyroid disorders. The delay before improvement seems to be similar to that observed in adults. The Naranjo probability scale indicated that lithium was the probable cause of hypothyroidism resulting from in utero exposure. CONCLUSIONS: Lithium is a well-known goitrogenic agent. Thus, if lithium treatment needs to be continued during pregnancy in women with bipolar disorder, adequate screening for morphology by ultrasonography and systematic hormonal biological control in newborns are recommended.
Combined Budesonide/Formoterol Turbuhaler Treatment of Asthma
Authors: Remington Tami L , Heaberlin Andrea M , DiGiovine Bruno 
Published: June 2003

OBJECTIVE: To provide product information; review and analyze the clinical literature studying combination therapy, budesonide, and formoterol in asthmatics; and to define the role for this therapy in asthma treatment. DATA SOURCES: A MEDLINE search (1990–September 2001) was conducted to identify the primary literature. Bibliographies were reviewed for further relevant citations. STUDY SELECTION/DATA EXTRACTION: All randomized, blinded, controlled studies at least 3 months in duration exploring the efficacy of the combination of budesonide and formoterol (in 1 or separate formulations) compared with other treatments were selected to be included in the review of clinical studies. DATA SYNTHESIS: The combination of budesonide and formoterol was more effective than increasing the dose of budesonide in patients with moderate or severe persistent asthma and in patients with mild asthma not previously controlled with inhaled corticosteroids. Milder corticosteroid-naïve asthmatics did not derive benefit compared with inhaled corticosteroids alone. CONCLUSIONS: Combination therapy in 1 device is a preferred treatment option in patients with moderate to severe persistent asthma and in those with milder asthma not controlled with inhaled corticosteroids. Advantages of this product include rapid onset of action, long duration of action, and a wide dosing range to assist with titration. Further research is required to evaluate this therapy in asthmatic children <5 years old and in patients with oral corticosteroid—dependent asthma. Investigations into the effect of this combination product on other disease outcomes, such as quality of life and productivity, will further define the role for this drug therapy.
Economic Impact of Ramipril on Hospitalization of High-Risk Cardiovascular Patients
Authors: Carroll Cathryn A , Coen Michael M , Piepho Robert W 
Published: June 2003

OBJECTIVE: To estimate differences in direct costs attributable to avoided hospitalizations and procedures during the years of the HOPE (Heart Outcomes Prevention Evaluation) study after the cost of treatment with ramipril or alternative angiotensin-converting enzyme inhibitor therapy was taken into account. METHODS: A decision analytical model was developed to estimate the economic impact of reductions in hospitalizations and/or procedures both at annual increments and over the first 4 years of the HOPE study. The analysis compared the number of cardiovascular events per endpoint per year in the intervention and placebo group with hospitalization and procedural costs. Cost data were derived from the literature and inflated to the appropriate index year using the consumer price index. RESULTS: For approximately 9000 patients studied, the gross estimated savings in direct costs for 297 events avoided were more than $5 million over 4 years. After the cost of treatment was deducted for both groups, the net estimated savings were $871 000 over 4 years. CONCLUSIONS: The results demonstrate that the use of ramipril provides cost-effective treatment for high-risk cardiovascular patients with an ejection fraction >40%.
Economic Impact of Pharmacists' Interventions with Nonsteroidal Antiinflammatory Drugs
Authors: Guignard Adrienne P , Couray-Targe Sandrine , Colin Cyrille , Chamba Geneviève 
Published: June 2003

Objective: To estimate the economic impact of community pharmacists' interventions following the detection of problems related to nonsteroidal antiinflammatory drugs (NSAIDs), whether in a prescription or self-medication format. The evaluation focused on the gastroduodenal adverse events that could be avoided and the subsequent savings of healthcare resources spent on treating these adverse effects. Methods: A previous study conducted during a 12-week period in 924 French community pharmacies provided the number of interventions for drug-related problems concerning NSAIDs. A simulation model was constructed to compare 2 strategies: a systematic pharmacist's intervention and the absence of intervention. The base-case patient was assumed to have been taking an NSAID for 3 months. The model's inputs were extracted from medical literature and from an institutional medical database. Results: In this study, 608 interventions were the results of NSAID-related problems. All of these interventions reduced the risk of gastrointestinal adverse events and avoided a total cost of €37 300. Conclusions: This model indicates that the dispensing of NSAIDs by pharmacists and related pharmaceutical care activities have a positive impact by reducing the number of gastrointestinal complications. The model quantifies the costs thus avoided. It also underlines the necessity of effective collaboration between the prescriber and the pharmacist if optimal patient management is to be achieved.
Venous Thromboembolism Prevention with LMWHs in Medical and Orthopedic Surgery Patients
Authors: Deitelzweig Steven B , Vanscoy Gordon J , Niccolai Cynthia S , Rihn Thomas L 
Published: June 2003

OBJECTIVE: To discuss the role of low-molecular-weight heparins (LMWHs) in the prevention of venous thromboembolism (VTE) in medical and orthopedic surgery patients. VTE prophylaxis trials in these practice settings establishing the current use of LMWHs marketed in the US are included. An overview is also provided of VTE incidence, risk factors, and prophylaxis consensus guidelines. DATA SOURCES AND STUDY SELECTION: Clinical trials, review articles, and meta-analyses for Food and Drug Administration–approved LMWHs were identified from a MEDLINE search (1980–March 2002). Search terms included dalteparin, enoxaparin, internal medicine, low-molecular-weight heparin, orthopedic surgery, risk factors, tinzaparin, and venous thromboembolism. DATA SYNTHESIS: Consensus guidelines are useful as an initial guide to appropriate VTE prophylaxis; however, a review of the primary literature is needed to identify optimal agents, regimens, or interventions. LMWHs have demonstrated sound efficacy in VTE prevention; however, the quantity and quality of literature are not always comparable for the available agents. CONCLUSIONS: Enoxaparin has demonstrated efficacy and safety in VTE prevention in medical patients, whereas information is limited or lacking for dalteparin and tinzaparin. Total hip replacement (THR) trials have been conducted with all US-marketed LMWHs and have demonstrated the efficacy and safety of each agent. Trials specifically establishing the efficacy of an LMWH in total knee replacement surgery (TKR) have been published for enoxaparin. One combination THR and TKR trial has been published for tinzaparin. These trial outcomes have positioned the LMWHs as key alternatives to adjusted-dose warfarin for VTE prophylaxis in orthopedic surgery. Inherent differences between LMWHs prevent the extrapolation of clinical outcomes from 1 trial to another.
Quality-of-Life Assessment in an Outpatient Parenteral Antibiotic Program
Authors: Goodfellow Alan F , Wai Amy O , Frighetto Luciana , Marra Carlo A , Ferreira Barbara M , Chase M Lynn , Nicol Ruth E , Leong Carole A , Tomlinson Sally , Jewesson Peter J 
Published: June 2003

OBJECTIVE: To measure changes and to identify predictors of change of health-related quality of life (HRQoL) for enrollees into an outpatient parenteral antibiotic therapy (OPAT) program. METHODS: A multidisciplinary, single-center, prospective investigation was conducted at a 1000-bed Canadian adult tertiary-care teaching hospital. Over a 15-month study period, consenting patients who were enrolled in the OPAT program completed paired Short Form-36 (SF-36) questionnaires within 48 hours prior to discharge from the hospital and again 26–30 days after discharge. Sociodemographic data and clinical variables were also collected for the purpose of determining potential predictors of change in quality of life. RESULTS: During the study period, 134 patients were enrolled in the OPAT program and 82 completed the paired SF-36 questionnaires. Study participants experienced a significant improvement in 3 SF-36 domains (physical functioning, bodily pain, role emotional) and the mental component summary scale (MCS) scores when they were transferred from the hospital to home setting. The SF-36 scores for all domains and summary scales were lower than the Canadian population average (all p < 0.001). Multiple linear-regression analysis revealed that infectious disease diagnosis and baseline physical component summary scale (PCS) scores were predictors of the change in the PCS score when patients transferred from the hospital to the home setting. Length of hospital stay and baseline MCS scores were predictors of the change in MCS scores when patients transferred from the hospital to the home setting. CONCLUSIONS: This study reveals that some domains in HRQoL appear to improve 4 weeks after discharge for adults enrolled in an OPAT program and that there are different predictors for changes in physical and mental health.