bluuebunny/crossref_metadata_2025_split huggingface dataset:
Encephalopathy and Hyperammonemia Associated with Valproic Acid
Authors: Yee Jennie L , Wong David , Ormiston Thomas M 
Published: September 2013

Objective: To discuss the case of a patient who experienced an altered level of consciousness secondary to hyperammonemia associated with valproic acid who had normal drug concentrations and liver function tests. Case Summary: A 48-year-old man with a history of seizure disorder treated with valproic acid presented with an altered level of consciousness. An extensive workup revealed only an increased ammonia level. His medications were withheld. Within 24 hours, the ammonia level returned to normal and he was able to be aroused. His antiseizure medication was changed to gabapentin. All of his chronic medications, other than valproic acid, were restarted. The patient has had no further increases in ammonia levels or episodes of altered mental status. Discussion: Encephalopathy due to hyperammonemia is generally due to severe liver dysfunction. In our case, however, hyperammonemia occurred in a patient with normal liver function who was also taking valproic acid. An objective causality assessment revealed that the adverse drug event was probably related to valproic acid. A review of the literature indicates that the increased ammonia levels were probably secondary to the effect of valproic acid on the kidneys or the liver. Withdrawal of the offending agent resulted in normalization of ammonia levels and resolution of encephalopathy. Conclusions: With a widening of its clinical indications, the use of valproic acid has been increasing. Even though valproic acid concentrations may be therapeutic/nontoxic and liver function tests normal, practitioners are encouraged to check the ammonia level. Hyperammonemia, once recognized, is easily treated.
Cytochrome P450 Enzymes and Drug—Drug Interactions: An Update on the Superfamily
Authors: Lewis Jeffrey D , Bachmann Kenneth A 
Published: September 2013

Objective: To provide an update of the biological characteristics of cytochrome P450 (CYP) enzymes and appreciate the implications of such in the prediction and assessment of drug–drug interactions (DDIs). Data Sources: Searches of MEDLINE (1966–July 2005) and Web sites plus manual review of journals, conference proceedings, and reference textbooks were performed using the key search terms cytochrome P450 and drug–drug interaction. Study Selection/Data Extraction: All articles identified from the data sources were evaluated, and information deemed relevant was included for this review. Data Synthesis: During the past few years, significant strides have been made in our understanding of the biology of CYP enzymes and our ability to accurately assess and predict the occurrence of CYP enzyme–related pharmacokinetic DDIs. Once considered a single enzyme, the enzymes of the CYP superfamily are now recognized to exhibit highly variable substrate specificity and intriguing cooperativity with other enzymes and transporter proteins (eg, P-glycoprotein). Mechanisms of enzyme induction and inhibition have been further characterized, and the clinical implications of this knowledge require a more thorough understanding of the topic by healthcare practitioners. Conclusions: We offer a contemporary survey of the biology of CYP enzymes, including mechanisms of enzyme induction and inhibition, and encourage the incorporation of this knowledge into the assessment and prediction of DDIs in the clinical setting.
Keeping Score on Psychiatric Drug Effects: Is Mefloquine Safe for Malaria Chemoprophylaxis?
Authors: Willmore Catherine B , Ayesu Linda W 
Published: September 2013

Background: Armed servicemen or tourists visiting Asian and African continents bear the risk of contracting falciparum malaria. Chemoprophylaxis, for certain individuals, is recommended. All drugs marketed for prophylaxis of malarial infection have adverse effects. Notably, antimalarial drugs can impose neuropsychiatric harm. Mefloquine is a widely used malaria chemoprophylactic despite its association with neuropsychiatric symptoms including panic attacks, seizures, headaches, visual and auditory hallucinations, sleeplessness, paranoia, and psychosis. Objective: To emphasize caregiver counseling and ensure patient follow-up for nonimmune travelers to malaria indigenous regions when mefloquine chemoprophylaxis is scheduled. Data Sources and Selection: A literature search was conducted through May 1, 2004, for reports of psychologic or neurologic adverse effects following mefloquine therapy. After review of MEDLINE, EMBASE, and EMBR citations, pertinent articles were selected if they were thought to be of special interest to physicians and pharmacists handling mefloquine. Data Synthesis: Literature to date indicates a higher rate of drug-provoked neuropsychiatric adverse effects than that acknowledged by mefloquine's manufacturer, Hoffman LaRoche. There is also evidence supporting a greater incidence of adverse effects for specific groups. Neuropsychiatric adverse effects are more often reported by females, particularly low body-weight females. Individuals who ingest mefloquine while under stress appear more at risk for neuropsychiatric adverse effects. Conclusions: Professional consult and therapeutic follow-up for all patients receiving mefloquine chemoprophylaxis is warranted.
Compliance with the JNC 7 Guidelines and Blood Pressure Attainment in an Inner-City Tertiary Care Hospital
Authors: Plakogiannis Roda , Sakalis Elias G 
Published: September 2013

Background: Blood pressure control has demonstrated significant reductions in strokes and coronary events. Using an evidence-based approach, the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guidelines recommend health-promoting lifestyle modifications, antihypertensive agents, and target blood pressure for different patient care groups. Objective: To assess medication selection(s) and blood pressure goal attainment in a large inner-city, hospital-based, primary care clinic. Methods: A 6 month retrospective, randomized, observational study was conducted to evaluate hypertension management in Bellevue Hospital's adult primary care clinic. Age, sex, ethnicity, comorbidities, blood pressure measurement, and antihypertensive treatment were obtained from computerized medical records. Antihypertensive medication selection was compared with recommendations given by the JNC 7 guidelines. Blood pressure goal attainment sorted by ethnicity, comorbidities, and age was assessed and compared with the National Health and Nutrition Examination Survey (NHANES) data. Results: A total of 210 patients were evaluated for antihypertensive agent(s) selection. Overall, 72% of patients received antihypertensive agents recommended by the JNC 7 guidelines. More patients in our primary care clinic achieved their systolic blood pressure goal compared with NHANES data. However, hypertensive management at our clinic was below the national average in goal diastolic blood pressure achievement. Patients with frequent follow-up visits were more likely to achieve their goal blood pressure. The most common antihypertensive agents prescribed were β-blockers (40%), followed by angiotensin-converting enzyme inhibitors (35%) and diuretics (33%). Conclusions: Hypertensive management in the outpatient primary care clinic of our institution warrants improvement in blood pressure goal attainment. Frequent follow-up clinic visits were associated with higher attainment rates of JNC 7 blood pressure goals.
Lanthanum Carbonate Treatment of Hyperphosphatemia in End-Stage Renal Disease
Authors: Cheng Christine M 
Published: September 2013

Objective: To review the literature on the safety and efficacy of lanthanum carbonate for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD). Data Sources: Primary literature was obtained through a PubMed search (1966–September 2005) using the key terms Fosrenol and lanthanum carbonate. The FDA review, manufacturer-provided data, and published abstracts on lanthanum carbonate were also reviewed and evaluated. Study Selection and Data Extraction: Human studies in which lanthanum carbonate was compared with placebo or active control for the treatment of hyperphosphatemia secondary to renal disease were included. Dose-titration studies were excluded. Data Synthesis: Phosphate-lowering agents and dietary phosphate restriction are currently the first-line therapies for initial treatment of hyperphosphatemia associated with ESRD. Lanthanum carbonate is a highly effective non–aluminum, non–calcium-containing phosphate binder. It is the only FDA-approved phosphate binder that is available as an unflavored chewable tablet that may be taken without water. Conclusions: Clinical studies demonstrate that lanthanum carbonate is more effective than placebo but as or less effective than standard therapies in lowering serum phosphate to target levels. When compared with calcium salts, lanthanum carbonate had a lower incidence of hypercalcemia and a lower risk of patients developing bone disease. However, in clinical trials, patients receiving lanthanum carbonate had greater discontinuation rates, some due to adverse events. The long-term safety data (>5 y), including the potential for lanthanum accumulation in the bone with subsequent development of osteodystrophy, remain unknown.
Vildagliptin (LAF 237): A Dipeptidyl Peptidase IV Inhibitor for the Treatment of Type 2 Diabetes Mellitus
Authors: Cornell Susan 
Published: September 2013

Objective: To review the pharmacology, pharmacokinetics, clinical efficacy and safety studies, adverse effects, drug interactions, dosage, and administration of vildagliptin (LAF 237), a dipeptidyl peptidase IV (DPP-4) inhibitor in Phase III development for the treatment of type 2 diabetes mellitus. Data Sources: Information was obtained from MEDLINE searches of the English-language literature (1990–September 2005). Search terms included vildagliptin, LAF 237, DPP-IV inhibitor, DPP-4 inhibitor, and GLP-1 agonist. Study Selection and Data Extraction: Available literature reviewed included abstracts, clinical trials with human and animal data, and review articles. Data Synthesis: Vildagliptin is a potent and highly selective DPP-4 inhibitor. This novel treatment modality enhances the activity of incretin hormones through inhibition of the enzyme responsible for their degradation. Conclusions: Vildagliptin demonstrates good tolerability with minimal adverse effects and can effectively improve metabolic control of glucose through an array of mechanisms.
Combination of Methylphenidate, Venlafaxine, and Escitalopram Resulting in Serotonin Syndrome
Authors: Lizer Mitsi H , Masters Kelly P 
Published: September 2013

Objective: To report a case of possible serotonin syndrome resulting from the addition of methylphenidate and/or escitalopram to venlafaxine. Case Summary: A 23-year-old woman being treated for bipolar depression experienced suspected serotonin syndrome. During the course of hospitalization, several medication changes were implemented. Despite these treatment interventions, depressive symptoms persisted during combination therapy with venlafaxine, lamotrigine, and gabapentin. Clinical problems developed when escitalopram and methylphenidate were later added to the regimen within a 2 day period. Several hours after receiving the second dose of methylphenidate, the patient developed a fever, exhibited hallucinations, and began hyperventilating. She was managed with supportive measures with some response, but continued to be lethargic and dizzy. Physical examination revealed increased rigidity of the upper extremities and labile blood pressure. Serotonin syndrome was suspected and all medications were withheld; the patient was then transferred to the intensive care unit. Discussion: Prompt and accurate diagnosis of serotonin syndrome is difficult but requires the presence of serotonergic agents in addition to core symptoms that have been identified through years of clinical antidepressant use. Additionally, serotonin syndrome is often complicated by other drug-related disorders with overlapping symptoms. Separately and together, escitalopram, venlafaxine, and methylphenidate have the ability to increase serotonin levels. Utilizing the Naranjo probability scale, we determined the likelihood of both methylphenidate and escitalopram contributing to serotonin syndrome as possible. Review of the established criteria for diagnosing serotonin syndrome, the clinical presentation of the patient, and the time frame of symptom development in correlation with drug therapy changes suggests that this is a case of serotonin syndrome. Conclusions: We believe that this was most likely a case of serotonin syndrome, precipitated by the addition of methylphenidate and/or escitalopram to venlafaxine.
Smoking Cessation Therapy in Pregnancy
Authors: Smith Curtis L , Rivard Erin K , Edick Cathleen M 
Published: September 2013

Objective: To determine the safety and efficacy of pharmacologic therapy for smoking cessation in pregnancy by conducting a review of current literature, focusing on controlled clinical trials. Data Sources: A MEDLINE search (1966–May 2006) of English-language, human clinical trials was conducted. Key search terms included nicotine, nicotine replacement therapy, bupropion, smoking cessation, and pregnancy. In addition, relevant articles were cross-referenced to screen for additional information. Study Selection/Data Extraction: Studies were chosen for further review if they were randomized, controlled, long-term evaluations of the safety and/or efficacy of pharmacologic therapy for smoking cessation in pregnancy. A total of 5 trials met the criteria for review. Data Synthesis: Controlled clinical trials of smoking cessation therapy in pregnant women are limited. Three trials have examined the long-term use of nicotine replacement products. Neither of the 2 placebo-controlled trials found a statistically significant difference in abstinence rates between women receiving transdermal nicotine replacement therapy (NRT) and placebo. However, transdermal nicotine products appeared to be safe in this population. No long-term studies have evaluated use of other nicotine replacement products in pregnant women. Bupropion has demonstrated efficacy in smoking cessation in pregnancy, but the data are limited. Conclusions: Transdermal NRT appears to be safe in pregnant women, although its efficacy is unclear. Information on other NRT formulations in pregnancy is unavailable. Bupropion may be a nonnicotine alternative for smoking cessation in pregnancy, but data are currently incomplete. Further studies are needed to determine the ideal population for treatment, the timing of initiation, appropriate monitoring, and the optimal length of therapy.
Potential Contribution of Long-Term Rofecoxib in a Patient with Cardiogenic Syncope and Ischemic Stroke
Authors: Colucci Vincent J , Rivey Michael P 
Published: September 2013

Objective: To report a case of syncope followed by a cerebrovascular event in a patient receiving long-term therapy with rofecoxib. Case Summary: A 62-year-old man presented to a local rural hospital emergency department with loss of motor control in his left extremities. Neurologic workup confirmed a right hemispheric cerebrovascular accident. Carotid arteries were noncontributory, and cardiac workup was unrevealing except for thoracic aorta atherosclerosis. There was no history of hypertension, coronary artery disease, diabetes mellitus, left ventricular systolic dysfunction, or valvular stenotic disease. Cardiovascular risk factors included smoking and dyslipidemia with low high-density lipoprotein cholesterol and hypertriglyceridemia. Of importance was the patient's 4 year history of rofecoxib use, 25 mg daily for a chronic back injury. Discussion: Recently published reports suggest that rofecoxib can contribute significantly to increased cerebrovascular events by an approximately twofold elevation in relative risk. An adverse drug reaction assessment, using the Naranjo probability scale, indicated a possible relationship of rofecoxib to the events. Rofecoxib was discontinued. Conclusions: Recent evidence of additive cardiovascular risk conveyed by cyclooxygenase-2 inhibitors and the temporal relationship between rofecoxib use and cerebrovascular events suggests that rofecoxib may be a potentially contributing factor to the unfavorable outcomes in our patient.
Combining Bisphosphonates with Raloxifene to Treat Osteoporosis: A Review of the Evidence
Authors: Miller Brian M , Patel Sheel M , Sokos Denise R 
Published: September 2013

Objective: To evaluate published studies regarding the combination of a bisphosphonate and raloxifene in the treatment of osteoporosis. Data Sources: A MEDLINE search (1966–February 2006) was conducted using the search terms osteoporosis, alendronate, risedronate, ibandronate, raloxifene, bisphosphonate, treatment, and selective estrogen-receptor modulators. Study Selection and Data Extraction: Clinical trials examining the efficacy of bisphosphonate and raloxifene in the treatment of osteoporosis were reviewed. Two trials evaluated alendronate or clodronate plus raloxifene for the treatment of osteoporosis in postmenopausal women. Data Synthesis: The results demonstrated a significant increase in lumbar bone mineral density (BMD) and conflicting results in the femoral BMD. Fracture risk was not assessed in either study. Conclusions: Published trials assessed BMD rather than fracture risk and were limited by methodologic flaws. Due to insufficient clinical outcomes data, combining these antiresorptive treatments cannot be recommended.
Anaphylactic Shock to Oxaliplatin in the Adjuvant Context
Authors: Tze Christina Ng Van 
Published: September 2013

Objective: To report a case of anaphylactic shock in a patient receiving oxaliplatin treatment. Case Summary: A 60-year-old Chinese woman received adjuvant oxaliplatin in combination with fluorouracil and folinic acid for treatment of stage 3 colon cancer. Shortly after initiation of her 12th infusion, she developed anaphylactic shock. She has since fully recovered from the adverse drug event. She was not rechallenged with oxaliplatin. Discussion: Severe hypersensitivity reactions to oxaliplatin are rare. An objective causality assessment using the Naranjo probability scale revealed that an adverse drug reaction to oxaliplatin was highly probable. Based on the Common Terminology Criteria for Adverse Events version 3 for defining reaction severity, our patient had experienced a grade 4 reaction, or anaphylaxis. Conclusions: With more widespread use of oxaliplatin in the treatment of early stage as well as advanced disease, the potential for more instances of severe hypersensitivity reactions exists, although the percentage of grade 4 reactions will likely remain rare. The role of intradermal skin testing to predict oxaliplatin sensitivity and the implementation of oxaliplatin desensitization protocols in cases of severe hypersensitivity reactions to this drug in the adjuvant setting may be useful.
Sorafenib for the Treatment of Renal Cell Carcinoma
Authors: Hughes Caren L , Tan Winston W , Ferrone Marcus 
Published: September 2013

Objective: To summarize the pharmacology, development, and clinical application of sorafenib, a specific tyrosine kinase and vascular growth factor inhibitor, for the treatment of renal cell carcinoma (RCC). Data Sources: Clinical literature, including both primary studies and review articles, was obtained by searching MEDLINE (1966–May 2006), using the search terms BAY 43-9006, sorafenib, renal cell carcinoma, and tyrosine kinase inhibitor. Additional information was supplied by the manufacturer, Bayer HealthCare Pharmaceuticals. Study Selection and Data Extraction: Review articles, abstracts, and clinical studies related to sorafenib were analyzed. An evaluation of the research exploring sorafenib as a potential therapy for RCC was conducted. Relevant information was then selected and is reviewed in this article. Data Synthesis: Knowledge of the cellular abnormalities that can cause solid tumors has led to the development of medications that block these pathways. Sorafenib is an oral tyrosine kinase inhibitor that both blocks the Raf kinase pathway and inhibits vascular growth factors. Phase I and II trials have demonstrated that sorafenib has activity against RCC. Dermatologic reactions (rash, desquamation), fatigue, and hypertension have been the most commonly seen treatment-related adverse events. Sorafenib received FDA approval in December 2005 for treatment of advanced RCC. Conclusions: Sorafenib is a novel oral tyrosine kinase inhibitor effective in the treatment of RCC.
Educational Intervention to Reduce Frequency of Use of Restricted Abbreviations in a Community Health Center
Authors: Burkiewicz Jill S , Hassenplug Karen L 
Published: September 2013

Background: Joint Commission on Accreditation of Healthcare Organizations' (JCAHO) patient safety goals recognize that misuse of many common medical abbreviations correlates directly with medication errors. An institution-specific educational intervention may facilitate appropriate use of abbreviations to improve communication. Objective: To estimate the frequency of use of JCAHO-restricted abbreviations in prescriptions received at an outpatient pharmacy and determine whether an educational intervention on proper abbreviations decreases the rate of use of restricted abbreviations. Methods: Prescription records from an outpatient pharmacy of an urban community health center were reviewed during a 3 week interval to determine the baseline rate of inappropriate abbreviation use. Following an educational intervention, prescription records were prospectively reviewed for a 3 week interval to compare the frequency of inappropriate abbreviation use. Results: Inappropriate abbreviation use occurred at a rate of 25.8% (214/829) in the preintervention group and 18.3% (169/922) in the postintervention group (p < 0.001). The most commonly misused abbreviation was QD, representing 98.5% and 98.2% of the misused abbreviations before and after the intervention, respectively. Compared with the preintervention period, the frequency of overall abbreviation misuse (25.8% vs 18.3%; p < 0.001) and use of QD (62.4% vs 50.9%; p = 0.001) were decreased after the educational intervention. Conclusions: There is a high frequency of use of the abbreviation QD within this institution. While a brief educational intervention decreased the frequency of inappropriate abbreviation use, the rate of abbreviation misuse remained unacceptably high. A system-wide educational effort and/or enforcement approach may be needed to target inappropriate abbreviation use.
Abatacept: A Novel Agent for Rheumatoid Arthritis
Authors: Sheth Neha U , Hilas Olga , Charneski Lisa 
Published: September 2013

Objective: To evaluate the role of abatacept in the treatment of rheumatoid arthritis (RA) with respect to its pharmacology, pharmacokinetics, clinical efficacy, and adverse effect profile. Data Sources: A MEDLINE search (1966–November 2006) was conducted for primary and secondary literature. Search terms included BL125118, CTLA4-Ig, abatacept, and rheumatoid arthritis. Study Selection and Data Extraction: All articles retrieved from the data sources were evaluated. The most relevant studies were selected and included in this review. Data Synthesis: Abatacept is the first in a new class of RA agents with a unique mechanism of action. It is a selective costimulation modulator that inhibits T cell activation and other inflammatory mediators. This agent has been studied as an adjunct in patients who are receiving disease-modifying antirheumatic drug therapy and in those who have failed tumor necrosis factor-alfa antagonist therapy. Clinical trials were evaluated for information on abatacept's indication, dosing, safety, and efficacy profile. Conclusions: Abatacept has been shown to reduce signs and symptoms of RA and improve the condition of patients with moderately to severely active RA.