bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development and Validation of the Medication-Based Disease Burden Index
Authors: George Johnson , Vuong Tam , Bailey Michael J , Kong David CM , Marriott Jennifer L , Stewart Kay 
Published: March 2006

Background: Medication lists offer an alternative source of data on comorbidities and disease burden. Objective: To develop and validate the Medication-Based Disease Burden Index (MDBI). Methods: A list of medications corresponding to the leading causes of global death was pilot tested and finalized by an expert panel. The resulting index was tested on drug regimens of patients at risk of medication misadventure. Criterion validity of the index was established against Charlson's index and Chronic Disease Score (CDS). Sensitivity, specificity, predictive validity, convergent and discriminant validity, and interrater and test–retest reliabilities of the index were also assessed. Results: The MDBI consisting of specific medications for 20 chronic medical conditions and corresponding disability weightings was developed. The MDBI was tested on 317 patients with mean ± SD Charlson's index scores of 2.8 ± 2.2 and CDS scores of 7.3 ± 2.8. Mean MDBI scores (0.33 ± 0.28) demonstrated significant correlations with Charlson's index scores (r = 0.31; p < 0.001) and CDS (r = 0.53; p < 0.001). MDBI had satisfactory sensitivity and high specificity. Age of the patients and number of medications had significant correlation with the MDBI scores, but the MDBI scores were not significantly different in males and females. MDBI scores could successfully predict death and planned or unplanned readmissions (OR = 4.7, 95% CI 1.4 to 15.5; p = 0.01). MDBI demonstrated high inter-rater (intraclass correlation coefficient [ICC] = 0.99) and test–retest reliabilities (ICC = 0.98). Conclusions: Initial testing suggests that MDBI could offer an alternative low-cost and convenient method for quantifying disease burden and predicting health outcomes.
Recent Advances in Neonatal Pharmacotherapy
Authors: Calhoun Darlene A , Murthy S Narasimha , Bryant Bobby G , Luedtke Sherry A , Bhatt-Mehta Varsha 
Published: March 2006

Objective: To provide commentary and reviews and brief discussions in controversial or innovative recent advances in neonatal pharmacotherapy. To discuss cutting edge drug delivery systems that may become useful in neonatal drug delivery in the future. Data Sources: Articles were identified through searches of MEDLINE (1990–October 2005), key articles in the authors' files, and in some cases, through data generated and/or published by the author of a particular topic. Data Selection: Article selection and relevance to the topics under discussion was determined by individual authors. Data Synthesis: Therapeutic strategies addressed in this review include the use of hematopoietic growth factors including a simulated amniotic fluid preparation containing these growth factors for neonates with selected gastrointestinal problems, erythropoietin for neuroprotection following perinatal asphyxia, drug therapy advances in treatment of patent ductus arteriosus (PDA), evaluation of advances in transdermal drug delivery, and its potential application to neonates and advances in the treatment of persistent pulmonary hypertension (PPHN) of the newborn. Conclusions: Despite being over 30 years old, the practice of neonatology is as much of an art as a science. Advances in the basic science research have improved our understanding of use of pharmacologic agents in the premature and full-term neonate including drug disposition pathways. Expanding our knowledge on issues such as physiology of hematopoietic factors, the pharmacologic responses of conditions such as PDA and PPHN, and newer technologies for drug administration, as well as other pharmacologic reponses in the neonate are vital in the development of safe and efficacious treatments for neonates. Many questions remain unanswered, and every clinician must make an effort to contribute to the knowledge and understanding of pharmacotherapy in this patient population.
Safety of Angiotensin-Converting Enzyme Inhibitors in Patients with Insect Venom Allergies
Authors: Stumpf Janice L , Shehab Nadine , Patel Anish C 
Published: March 2006

Objective: To review the literature with respect to the safety of angiotensin-converting enzyme (ACE) inhibitors in patients allergic to insect venom and those undergoing venom immunotherapy (VIT). Data Sources: A MEDLINE search was conducted (1966–March 2006) using the following search terms: bee sting, venom, insect stings, ACE inhibitors, angiotensin II receptor blockers, immunotherapy, and desensitization. The bibliographies of qualifying articles were also searched for relevant references. Data Synthesis: Several case reports have described severe allergic reactions, including anaphylaxis, in patients taking ACE inhibitors subsequent to being stung or receiving VIT. Exacerbation of the allergic response by ACE inhibitors is thought to be related to accumulation of bradykinin and inhibition of the formation of angiotensin II. Similar reactions have not been described with angiotensin-receptor blockers, but are theoretically possible. Conclusions: ACE inhibitors may exacerbate the response to insect venom, resulting in potentially life-threatening allergic reactions to insect stings or VIT. Although this risk is difficult to quantify based only on data from case reports, it seems prudent that patients with documented allergic reactions to insect venom avoid ACE inhibitor therapy, if possible. If, after careful consideration of the risks and benefits, ACE inhibitor therapy is deemed warranted, education regarding measures to minimize exposure to insect stings and training on self-administration of epinephrine should be provided, as with any person with venom allergy. In patients in whom VIT is appropriate, temporary discontinuation of the ACE inhibitor prior to each venom injection may prevent subsequent adverse reactions.
Argatroban Dosing of Patients with Heparin-Induced Thrombocytopenia and an Elevated aPTT Due to Antiphospholipid Antibody Syndrome
Authors: Pendleton Robert , Wheeler Michelle M , Rodgers George M 
Published: March 2006

Objective: To describe the clinical characteristics, management, and outcomes of patients with heparin-induced thrombocytopenia with thrombosis (HITTS) or without thrombosis (HIT) who also had an elevated baseline activated partial thromboplastin time (aPTT) due to antiphospholipid antibody syndrome (APS). Case Summary: Four patients with HIT/HITTS and an elevated baseline aPTT due to APS were identified. Two patients had venous thrombosis, 1 had limb ischemia, and 1 had isolated HIT. All 4 were managed with a weight-based fixed dose of argatroban without laboratory monitoring. None of the patients had thrombotic or bleeding complications once therapy was initiated. Discussion: Management of patients with HIT/HITTS and an abnormal baseline aPTT due to APS is problematic. We review alternative management strategies, such as monitoring direct thrombin inhibitors with the ecarin clotting time or thrombin inhibition time or using an alternative anticoagulant, such as fondaparinux. As of March 13, 2006, none of these management strategies has been evaluated in a clinical trial for this patient population. We report the successful use of weight-based, fixed-dose argatroban without laboratory monitoring in patients with APS. Conclusions: Use of a fixed-dose argatroban regimen without laboratory monitoring is a potential management strategy for patients with HIT/HITTS and an elevated baseline aPTT due to APS.
Acute Dystonia with Low-Dosage Aripiprazole in Tourette's Disorder
Authors: Fountoulakis Konstantinos N , Siamouli Melina , Kantartzis Sotiris , Panagiotidis Panagiotis , lacovides Apostolos , Kaprinis George St 
Published: March 2006

Objective: To report a case of an acute dystonic episode in a patient with Tourette's disorder (TD) treated with the partial dopamine agonist aripiprazole. Case Summary: An 18-year-old male with TD was prescribed aripiprazole 10 mg orally daily, which produced a significant improvement in his symptoms. However, after 3 days of treatment, he experienced an acute episode of dystonia with facial muscle spasm, oculogyric crisis, and torticolis. All symptoms resolved after a single intramuscular injection of Dipendine 5 mg. The Naranjo probability scale indicated that the adverse events were probably caused by aripiprazole. Discussion: To our knowledge, as of this writing, this is the first report concerning an aripiprazole-induced dystonic episode in an adult, and it is especially notable because it occurred at low dosage. Aripiprazole is a dopamine partial agonist and a serotonin2A antagonist with a favorable adverse effect profile. Short-term clinical trials reported a very low incidence of extrapyramidal symptoms, with akathisia being the most common, although there have been reports of severe extrapyramidal symptoms in a 3-year-old child and in an adolescent with a previous history of such symptoms. Conclusions: Acute dystonic phenomena may be caused by aripiprazole, although the drug's suggested mode of action largely precludes them.
Risperidone Treatment of Bipolar Mania
Authors: Nguyen Lisa N , Guthrie Sally K 
Published: March 2006

Objective: To review clinical trial evidence regarding the efficacy and safety of risperidone for the treatment of bipolar mania. Data Sources: Articles were identified through searches of PubMed (1950–August 2005), EMBASE (1988–August 2005 week 37), and International Pharmaceutical Abstracts (1970–August 2005) databases using the key words risperidone, atypical antipsychotics, and bipolar mania. Additional references were found through review of bibliographies of identified articles. PubMed searches for efficacy and safety were limited to clinical trials. Study Selection and Data Extraction: Six randomized trials and 6 observational studies of risperidone monotherapy or combination therapy for bipolar mania in adults were selected. Data Synthesis: Randomized, placebo-controlled and observational trials reported that risperidone monotherapy decreases manic symptoms in patients with a moderate severity of mania, as determined by change in Young Mania Rating Scale (YMRS) scores. Adverse effects observed in monotherapy trials included somnolence, extrapyramidal symptoms (EPS), and weight gain. Clinical trials of risperidone in combination with other mood stabilizers (ie, lithium, valproate, carbamazepine, topiramate) also reported decreases in YMRS scores in patients with moderate and severe manic symptoms. Conclusions: Risperidone monotherapy or adjunctive therapy with other first-line mood stabilizers may be effective for the treatment of acute bipolar mania in adults with moderate severity of mania. The use of risperidone as monotherapy in severe mania or in maintenance treatment remains to be elucidated.
Pantoprazole-lnduced Thrombocytopenia
Authors: Watson Tracy D , Stark Jennifer E , Vesta Kimi S 
Published: March 2006

Objective: To report 2 cases of thrombocytopenia associated with pantoprazole treatment and discuss existing reports on this drug-induced adverse event. Case Summaries: This paper describes the course of thrombocytopenia associated with pantoprazole 40 mg in 2 hospitalized patients. In both cases, thrombocytopenia appeared after the initiation of pantoprazole and rapidly improved after discontinuation of pantoprazole, although complete resolution of thrombocytopenia occurred in only one patient prior to discharge from the hospital. Discussion: The mechanism of drug-induced thrombocytopenia is often poorly understood, and proton-pump inhibitors are generally not strongly suspected as a cause of thrombocytopenia. However, an objective causality assessment using the Naranjo probability scale revealed a probable relationship between thrombocytopenia and pantoprazole in both of the cases. It is unknown whether this is a class effect. Conclusions: Although drug-induced thrombocytopenia with pantoprazole appears to be rare, it represents a potentially severe adverse effect. This supports the judicious prescribing of pantoprazole and possibly other proton-pump inhibitors.
Depressive Symptoms in Coronary Artery Disease Patients After Hypertension Treatment
Authors: Ried L Douglas , Tueth Michael J , Taylor Michael D , Sauer Brian C , Lopez Larry M , Pepine Carl J 
Published: March 2006

Background: Depression is highly prevalent and frequently recurs in patients with coronary artery disease (CAD) and hypertension. Certain medications used to treat hypertension are alleged to be associated with higher risk of depression. Objective: To compare depressive symptoms before and during treatment with 2 equivalent hypertension treatment strategies in patients with CAD stratified according to a self-reported history of physician-diagnosed depression. Methods: Patients enrolled in a randomized hypertension treatment study were mailed baseline and one year follow-up surveys and stratified according to a self-reported history of depression. Patients (N = 1152) were 50 years old or older with hypertension and clinically stable CAD. Depressive symptoms were measured using the Center for Epidemiologic Studies—Depression (CES-D). High risk of depression was defined as a history of physician-diagnosed depression reported by patients on the baseline survey. Depressive symptoms were compared for verapamil sustained-release (SR)– and atenolol-based hypertension treatment. Results: Among patients with a previous history of depression, depressive symptoms improved over the one year follow-up period for patients assigned to both treatment regimens. Depressive symptoms improved for patients with no depression history in the verapamil SR group (p < 0.001) and were unchanged in the atenolol group (p = 0.52). Patients assigned to the atenolol-based strategy without prior history of depression were more likely to worsen 5 or more points on the CES-D. Conclusions: When antihypertensive treatment options are clinically equivalent, prescribers may first consider using a verapamil SR–based strategy, especially in patients with CAD who have no history of depression.
Dutasteride: A Dual 5-α Reductase Inhibitor for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Authors: Dolder Christian R 
Published: March 2006

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, drug interactions, and dosing recommendations of dutasteride, a 5-α reductase inhibitor for benign prostatic hyperplasia (BPH). Data Sources: A MEDLINE search (1966–February 2006) was conducted to extract human research data in the English language on dutasteride. Search terms included benign prostatic hyperplasia, dutasteride, and finasteride. The reference lists of articles identified through this search process, the manufacturer's Web site, and dutasteride prescribing information were also examined. Study Selection and Data Extraction: All published studies and clinical data from the manufacturer were included, with emphasis placed on randomized, controlled trials. Data Synthesis: Dutasteride is approved for the treatment of symptomatic BPH in men with an enlarged prostate to improve urinary symptoms, reduce the risk of acute urinary retention, and reduce the need for BPH-related surgical interventions. Compared with placebo, dutasteride has been shown to significantly improve BPH symptoms, reduce the incidence of acute urinary retention and BPH-related surgery, and improve BPH-related quality of life. Few published data exist comparing dutasteride with finasteride. The most common adverse effects of dutasteride include ear, nose, and throat infection; malaise; headache; dizziness; and musculoskeletal pain. Conclusions: Clinical trials, sponsored primarily by the manufacturer, have shown dutasteride to be an effective treatment of BPH compared with placebo and to likely possess efficacy similar to that of finasteride. Further studies are needed to gain a more clear understanding of any clinically significant differences between dutasteride and finasteride.
Atypical Antipsychotic–Induced Akathisia with Depression: Therapeutic Role of Mirtazapine
Authors: Ranjan Sanjeev , Chandra Prabha S , Chaturvedi Santosh K , Prabhu Santosh C , Gupta Arun 
Published: March 2006

Objective: To investigate the efficacy of mirtazapine in treating akathisia caused by risperidone and olanzapine, as well as its use in alleviating comorbid depressive disorder. Case Summaries: Five patients with diagnoses varying from schizophrenia, delusional disorder, and bipolar disorder developed akathisia while on treatment with olanzapine and risperidone. The likelihood that risperidone and olanzapine had induced akathisia in all patients was rated probable according to the Naranjo probability scale. Four of these patients were also found to be depressed. The akathisia was successfully treated with mirtazapine, and 3 of the 4 depressed patients improved with mirtazapine treatment. Use of mirtazapine did not result in any adverse effect. Discussion: Mirtazapine is a potent antagonist of central α2 auto- and hetero-adrenergic receptors, as well as an antagonist of 5-HT2A/2C, 5-HT3, and histaminergic H1 postsynaptic receptors. The efficacy of mirtazapine in treatment of akathisia may result from its antagonist property at the H1 receptors and its dopaminergic activity in frontal cortex. The use of mirtazapine offers advantages over other antiakathisia drugs in its better adverse effect profile, as well as its ability to treat coexisting depression. Conclusions: Mirtazapine is efficacious in treating atypical antipsychotic–induced akathisia. It may be a good option, particularly in patients with coexisting depression.
Naturalistic Impact of Second-Generation Antipsychotics on Weight Gain
Authors: Brixner Diana I , Said Qayyim , Corey-Lisle Patricia K , Tuomari A Vickie , L'italien Gilbert J , Stockdale William , Oderda Gary M 
Published: March 2006

Background: While second-generation antipsychotics (SGAs) have had benefits over earlier antipsychotic treatments, their use has been associated with reports of weight gain. Body mass index (BMI) has been studied in clinical trials with limited comparison between drugs. Objective: To investigate the impact of each SGA on the risk of weight increase in an adult population. Methods: Using a national electronic medical records database, a naturalistic impact of SGAs on BMI was evaluated. Patients (aged ≥ 18 y) receiving a prescription for an antipsychotic drug between January 1995 and March 2004 were identified. An adverse event was defined as at least a 7% increase in BMI from baseline within one year of antipsychotic prescription and a post-increase BMI of at least 25 kg/m2. Results: A total of 9394 patients were identified, with 1514 cases of increased BMI after initial prescription. Risperidone (OR 1.39; 95% CI 1.16 to 1.66), quetiapine (OR 1.36; 95% CI 1.13 to 1.64), and olanzapine (OR 1.76; 95% CI 1.50 to 2.07)were significantly more likely to cause BMI increase compared with first-generation antipsychotics (FGAs). Aripiprazole (OR 0.72; 95% CI 0.36 to 1.46), ziprasidone (OR 0.68; 95% CI 0.39 to 1.18), and clozapine (OR 1.01; 95% CI 0.56 to 1.81) were less likely to induce weight gain compared with FGAs. Conclusions: This study provides a foundation for understanding how SGAs impact weight gain in a naturalistic, as opposed to a clinical trial, setting and provides evidence that there are differential risks of weight gain between SGAs. Because of negative long-term health effects of weight gain, physicians need to take all factors into consideration when recommending pharmaceutical therapy for patients with severe mental illness.
Critical Care Pharmacy Services in United States Hospitals
Authors: MacLaren Robert , Devlin John W , Martin Steven J , Dasta Joseph F , Rudis Maria I , Bond CA 
Published: March 2006

Background: Critical care pharmacy activities have been described as fundamental, desirable, and optimal, but actual services provided have not been evaluated. Objective: To characterize the type and level of pharmacy services provided to intensive care units (ICUs). Methods: A 38 question survey was sent in 2 consecutive mailings to all US institutions (N = 3238) with an ICU. Questions were categorized according to clinical, educational, administrative, and scholarly activities, with levels of services stratified as fundamental, desirable, or optimal. Results: Completed surveys were received from 382 (11.8%) institutions encompassing 1034 ICUs. Direct clinical pharmacy activities were provided at 62.2% of ICUs. The pharmacists in those programs attended rounds 4.4 ± 1.5 days/wk, mean ± SD, and had a workweek that consisted of patient care (43% of hours worked), drug distribution (26.2%), administration (12.6%), education (10.9%), and scholarly activities (7.3%). Fundamental clinical activities performed during at least 75% of patient ICU days were providing drug information, drug therapy evaluation, drug therapy intervention, and pharmacokinetic monitoring. Conducting inservices (92.8%), a fundamental service, was the only educational activity frequently provided. Most respondents were involved with at least one multidisciplinary committee, and 45.5% conducted scholarly activities. Desirable or optimal activities were not frequently provided across all service categories. Conclusions: Clinical pharmacists are directly involved as caregivers in nearly two-thirds of ICUs in the US. Although they provide a range of clinical and administrative services, involvement in educational and scholarly activities is variable. The level of services provided is consistent with the criteria deemed fundamental for improving patient care. Higher-order services are far less likely to be provided.
Comparative Absorption Profiles of Divalproex Sodium Delayed-Release Versus Extended-Release Tablets—Clinical Implications
Authors: Dutta Sandeep , Reed Ronald C , O'dea Robert F 
Published: March 2006

Background: The distinct absorption characteristics of the conventional enteric-coated, delayed-release (DR) and the novel extended-release (ER) divalproex sodium formulations are not well recognized. Objective: To quantitatively and qualitatively differentiate the absorption characteristics of divalproex-DR and -ER formulations. Methods: Healthy volunteers (N = 28) received single 1000 mg doses of divalproex-DR and divalproex-ER tablets in a crossover fashion. Noncompartmental and compartmental analyses were used to estimate valproic acid (VPA) pharmacokinetics from the plasma concentration–time profiles determined from intensive blood sampling over 48 hours. Results: VPA was not absorbed from divalproex-DR in the first 2 hours (absorption lag-time) after dosing. After VPA release in the intestine, approximately 63% of the dose was absorbed in less than 1 hour, that is, 2.9 hours (mean absorption time) from dosing. Maximum concentration (Cmax) was achieved approximately 4 hours after dosing. VPA absorption was complete (~93% of dose) within 3 absorption half-lives (~4.5 h) post-absorption lag-time, that is, 6–7 hours from dosing. In contrast, VPA absorption from divalproex-ER starts immediately after administration, initially at a modest rate, followed by slow and extended absorption at a constant rate for more than 20 hours; VPA concentrations at 1 and 2 hours were 28% and 40% of Cmax. Approximately 53% of the dose was absorbed within 12 hours (mean absorption time); complete absorption occurred over more than 20 hours without any dose dumping. Conclusions: When antihypertensive treatment options are clinically equivalent, prescribers may first consider using a verapamil SR–based strategy, especially in patients with CAD who have no history of depression. VPA absorption from enteric-coated divalproex-DR is rapid following a lag-time of approximately 2 hours and is complete within 6–7 hours of dosing. In contrast, VPA absorption from divalproex-ER starts immediately after administration, but occurs at a slow, approximately constant rate over more than 20 hours.