bluuebunny/crossref_metadata_2025_split huggingface dataset:
Ambrisentan for the Treatment of Pulmonary Arterial Hypertension
Authors: Gilchrist Neil A 
Published: September 2013

Objective: To review the pharmacology, pharmacokinetics, efficacy, and safety of ambrisentan, a selective endothelin type A (ETA) receptor antagonist, for the treatment of pulmonary arterial hypertension (PAH). Data Sources: Articles were identified through a search of the MEDLINE (1950–November 2007) database for English-language articles containing the key words ambrisentan, pulmonary arterial hypertension, pulmonary hypertension, endothelin antagonist, and endothelin type A receptor. References from publications identified in this search were reviewed for relevant information. Unpublished data received from the manufacturer were also included in this review. Study Selection and Data Extraction: All articles identified from the data search were reviewed for relevant information. Applicable information was included in this review. Data Synthesis: Ambrisentan is the first oral nonsulfonamide ETA receptor antagonist approved by the FDA for use in patients with PAH who have World Health Organization class II or III symptoms. To date, the use of ambrisentan in the treatment of PAH has been evaluated by only 1 published Phase 2 clinical trial and 3 unpublished Phase 3 clinical trials. Ambrisentan therapy during clinical trials resulted in a significant improvement in exercise capacity and hemodynamic parameters. Metabolism occurs by hepatic glucuronidation, with elimination primarily through nonrenal pathways. A half-life of 15 hours allows for once-daily dosing. The most common adverse effect reported during clinical trials was peripheral edema. Hepatotoxicity occurred very infrequently, with affected patients requiring only a dose reduction to resolve an episode of elevated aminotransferases. Conclusions: Ambrisentan appears to be a promising treatment option for patients affected by PAH, given its improved drug–drug interaction and hepatotoxicity profile compared with other endothelin antagonists. Future studies are needed to determine the role of ambrisentan in the treatment of PAH and the selection of optimal endothelin antagonism.
Oxcarbazepine for Treatment of Posttraumatic Stress Disorder and Alcohol Dependence: A Case Series
Authors: Melvin Kelly E , Martin Peter R 
Published: September 2013

Objective: To report 2 cases that examine the use of oxcarbazepine as treatment for individuals with posttraumatic stress disorder (PTSD) and comorbid alcohol dependence. Case Summaries: A 59-year-old male with a past psychiatric history significant for PTSD and alcohol dependence underwent alcohol detoxification and was subsequently prescribed oxcarbazepine 300 mg twice daily, which was titrated to 600 mg twice daily prior to discharge. He experienced significant reduction in PTSD symptoms including anxiety, nightmares, flashbacks, racing thoughts, and avoidance behaviors. Over time, he also experienced a reduction in alcohol cravings and decreased daily alcohol intake. A 62-year-old male with a past psychiatric history of PTSD and alcohol dependence was treated in the outpatient clinic. He experienced almost complete resolution of PTSD symptoms and any craving for alcohol within 4 months of starting oxcarbazepine treatment, which was initiated at 150 mg twice daily and increased to 600 mg/day during that time. Discussion: Both patients appeared to receive excellent symptomatic relief from their PTSD symptoms. Recurring symptoms, including nightmares and flashbacks, seemed to be particularly responsive to the treatment. Additionally, in both cases, it is possible that oxcarbazepine had a secondary beneficial effect by decreasing alcohol cravings, although this was not formally measured. Conclusions: Our experience with these patients suggests that oxcarbazepine could be an effective treatment for the symptoms of PTSD and may decrease alcohol cravings and consumption in patients with co-occurring alcohol dependence. Controlled studies examining the effectiveness of oxcarbazepine for treatment of patients with PTSD, including those with complicating alcohol dependence, are warranted.
The Role for Anticoagulation with Warfarin in Patients with Systolic Heart Failure and Normal Sinus Rhythm
Authors: Marino Elizabeth A , Perez Mirza E 
Published: September 2013

Objective: To evaluate the role of anticoagulation with warfarin in patients with systolic heart failure (HF) and normal sinus rhythm (NSR). Data Sources: Literature was accessed through MEDLINE (1950–December 2007) and the American College of Cardiology Annual Scientific Session (2004) using the terms heart failure, warfarin, and anticoagulation. Study Selection and Data Extraction: All articles in English identified via the searches were evaluated. We excluded trials that evaluated the use of anticoagulation in patients with atrial fibrillation (AF) or valvular disorders. Data Synthesis: Patients with systolic HF are considered to be in a prothrombotic state. Studies have demonstrated a decreased incidence of thromboembolic events with anticoagulation therapy in patients with HF and concomitant AF, valvular dysfunction, or hypercoagulable disorders, but there are limited data supporting the role of anticoagulation in patients with HF and NSR. There are 3 prospective clinical trials and 1 ongoing trial designed to assess the efficacy of warfarin in patients with HF and NSR. These trials compare warfarin with antiplatelet therapy or no antithrombotic therapy. Warfarin did not show a benefit in the primary clinical composite outcome of death, myocardial infarction, or stroke, but was associated with more adverse events. However, these trials were underpowered to detect a difference between treatment arms. Conclusions: There is no objective evidence to support the need for anticoagulation with warfarin in patients with systolic HF and NSR. Additional large randomized, controlled trials need to be completed to determine the efficacy and safety of anticoagulation with warfarin in such patients.
Documentation of Student Pharmacists' Interventions from Medication Histories in a Primary Care Setting
Authors: Fit Kathy E 
Published: September 2013

Background: Medication safety is a major concern in primary care. Documented interventions by clinical pharmacists have shown positive clinical outcomes. In addition, it has been shown that student pharmacists have positive outcomes when participating in their advanced pharmacy practice experiences (APPEs). Most of this documentation has taken place in hospital settings. No data are available regarding interventions performed when APPE students record medication histories prior to a primary care provider (PCP) appointment. Objective: To describe the number and types of interventions made by APPE students in recording medication histories and to describe PCP acceptance rates. Methods: This prospective study documented the interventions from medication histories by 2 APPE students. With faculty supervision, the students recorded medication histories and vital signs prior to patient appointments with their PCPs. This was done approximately 1.5 days/week. Recommendations to the PCP were made verbally prior to the patient examination. Type of recommendation made, patient demographics, and PCP acceptance were documented. Descriptive statistics were employed. Results: Over 6 weeks, 109 interventions were documented. The mean ± SD patient age was 61.8 ± 14.94 years. The most common interventions documented were laboratory monitoring (22.0%), drug information (17.4%), and patient education (14.7%). Of the applicable interventions, 69% (49/71) were accepted by the PCP. Conclusions: APPE students in this clinic provided a variety of recommendations following completion of medication histories. A majority of the interventions were accepted. Such data demonstrate the benefit of including APPE students in patient care.
Ranirestat: A Selective Aldose Reductase Inhibitor for Diabetic Sensorimotor Polyneuropathy
Authors: Vo Ty , Marcus Kristine B 
Published: September 2013

Objective: To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of ranirestat, an oral aldose reductase inhibitor with a unique chemical structure, as treatment of diabetic sensorimotor polyneuropathy in patients with diabetes mellitus. Data Sources: Primary literature and review articles were identified by searching MEDLINE (1950–June 2008), EMBASE (1991–June 2008), International Pharmaceutical Abstracts (1970–June 2008), and Google Scholar using the key terms ranirestat, AS-3201, SX-3030, aldose reductase inhibitors, diabetes mellitus, and peripheral neuropathy. Additional articles were identified from the bibliographies of the obtained literature. Study Selection and Data Extraction: Reviewed literature was restricted to available English-language articles. Preclinical and clinical trials were reviewed. One Phase 2 clinical trial and its extension study were identified. No data have yet been reported from Phase 3 trials that were conducted between 2004 and 2006. Data Synthesis: Ranirestat is a selective and reversible inhibitor of aldose reductase. Nerve damage is reduced by inhibiting this key enzyme in the polyol pathway, thus preventing the accumulation of sorbitol and fructose. Ranirestat has been compared with placebo in randomized, double-blind, controlled trials. Improvement in nerve function, sensation, and clinical grading scale were noted. Ranirestat was reported to be well tolerated. Conclusions: Ranirestat may offer a clinical advantage over current treatment modalities as the first agent to address one factor in the underlying cause of diabetic sensorimotor polyneuropathy. Further studies should be done on safety, efficacy, tolerability, and quality of life to determine how successful this agent will be in the treatment of diabetic sensorimotor polyneuropathy. ACPE Universal Program Numbers: 407-000-08-056-H01-P (Pharmacists); 407-000-08-056-H01-T (Technicians)
Improvement of Hyperphosphatemia following Patient Education
Authors: Satoh Minori , Koizumi Akiko , Izumi Satoshi , Kugoh Yasuhiro , Kiriyama Eriko , Oguma Emiko , Furukubo Taku , Matsunaga Chiharu , Yamakawa Tomoyuki , Kadowaki Daisuke , Hirata Sumio 
Published: September 2013

Background: Patient adherence to a phosphate binder treatment regimen is crucial in the management of hyperphosphatemia. Nonadherence may be due to a lack of patient knowledge of the nature and treatment of the illness. Objective: To investigate the effectiveness of pharmacist-provided education regarding phosphate binders and hyperphosphatemia on serum phosphate concentration and calcium x phosphorous product in hemodialysis patients. Methods: A total of 398 hemodialysis patients who were prescribed phosphate binders participated in a pharmacist-run, education-based intervention session regarding phosphate binders and hyperphosphatemia. Each session was individualized on the basis of patient knowledge, assessed via a questionnaire. Particular attention was given to correcting patient misconceptions. Patients with elevated serum phosphate received additional education. Mean serum concentrations of phosphate and calcium, averaged from 4 measurements obtained at both baseline and postintervention, were compared to evaluate the efficacy of the intervention. Results: Postintervention, patients with the highest baseline serum phosphate concentrations (≥7.0 mg/dL) showed a significant decrease in mean ± SD serum concentrations of phosphate and calcium-phosphate product (7.4 ± 0.4 mg/dL and 72.6 ± 6.4 mg2/dL2 to 6.5 ± 0.8 mg/dL and 63.1 ± 8.4 mg2/dL2, respectively; p < 0.001). Likewise, patients with serum phosphate concentrations ranging from 6.0–6.9 mg/dL showed a significant decrease in both parameters after educational intervention (p < 0.05 and p < 0.005, respectively). Conclusions: An education session regarding phosphate binders and hyperphosphatemia, provided by pharmacists for hemodialysis patients, appeared effective in reducing serum phosphate concentrations and calcium x phosphorus product, thus contributing to improved patient prognoses.
Pattern of Lisdexamfetamine Ingestions Reported to Texas Poison Centers
Authors: Forrester Mathias B 
Published: September 2013

Background: Little information exists on lisdexamfetamine ingestions reported to poison centers. Objective: To describe the pattern of lisdexamfetamine ingestions reported during the first year of their approved use to Texas poison centers. Methods: The distribution of total cases of lisdexamfetamine ingestions with and without coingestants reported to Texas poison centers from July 2007–June 2008 was determined for the following selected variables: drug formulation, reported total dose ingested, patient sex and age, exposure site, and circumstances of the exposure. Results: Of 187 total ingestions, the total dose ingested was reported for 59% (mean 221.4 mg; range 5–3,080). Fifty-eight percent of the patients were male and 38% were aged 6–12 years. Thirty-eight percent of the ingestions occurred as a result of therapeutic error, 26% were due to general unintentional reasons, and 12% were suspected attempted suicide; 11% of the patients called the poison center due to an adverse reaction to lisdexamfetamine. Of the 133 (71%) cases without coingestants, 53% were managed on site (ie, not a healthcare facility) and 79% resulted in or were expected to result in, at most, minor effects or minimal toxicity. The most frequently reported adverse clinical effects among cases without coingestants were tachycardia (14%), agitation (14%), vomiting (6%), and nausea (5%). Conclusions: The majority of lisdexamfetamine ingestions reported to Texas poison centers did not involve coingestants. Of those without coingestants, most were managed on site and did not result in serious medical outcomes.
Effect of Diabetes Medications on Cardiovascular Risk and Surrogate Markers in Patients with Type 2 Diabetes
Authors: Blake Elizabeth W , Sease Julie M 
Published: September 2013

Objective: To evaluate the effect of diabetes medications on the risk of cardiovascular disease and surrogate markers. Data Sources: Literature was accessed through MEDLINE (1950–July 2008) and PubMed using multiple terms for diabetes, cardiovascular risk, surrogate markers, and diabetes medications. In addition, reference citations from publications were reviewed. Study Selection and Data Extraction: English-language articles that met the above criteria, with clinical relevance, were evaluated. Data Synthesis: Evidence regarding the effect of diabetes medications on cardiovascular risk is sparse, with information on their effects on surrogate markers more widely available. Recent evidence demonstrates that glycemic control alone may not reduce the risk of macrovascular events. Multiple trials were reviewed to determine the effect of diabetes medications on this risk, as well as the effect on surrogate markers (eg, blood pressure, cholesterol, body weight). Metformin and acarbose demonstrated significant reductions in macrovascular events, including myocardial infarction. Data regarding sulfonylureas, thiazolidinediones, and insulin are conflicting. Pioglitazone may reduce cardiovascular events, except heart failure, whereas rosiglitazone may increase these events. Until direct evidence can be obtained, the full effect of diabetes medications on cardiovascular risk is unknown. Conclusions: Current literature provides little support that diabetes medications may lower the risk of cardiovascular events while some agents may increase this risk. Of the drugs available, metformin may be the least detrimental. Current literature regarding other diabetes medications provides conflicting results on their effect on cardiovascular outcomes. In the meantime, practitioners should treat all targets of cardiovascular risk in patients with diabetes. ACPE Universal Program Numbers: 407-000-09-050-H01-P (Pharmacists); 407-000-09-050-H01-T (Technicians)
Lithium Toxicity Secondary to Lithium—Losartan Interaction
Authors: Aruna Augustine S 
Published: September 2013

Objective: To report a case of lithium toxicity following lithium and losartan coadministration in a diabetic patient. Case Summary: A 61-year-old white male with a history significant for bipolar disorder, hypertension, and diabetes was admitted to the Veterans Affairs Medical Center—based Nursing Home Care Unit for long-term intravenous antibiotic therapy for osteomyelitis. He developed lithium toxicity at a dose previously tolerated (1,350 mg/day) following administration of losartan 50 mg on the day before and day of evidence of toxicity. The drugs had been used concurrently prior to admission without evidence of toxicity; however, adherence to treatment could not be confirmed and concurrent dehydration may have been a contributing factor. Lithium toxicity was evidenced by irritability, tremors, confusion, and disorientation. Results of laboratory studies were significant for an elevated lithium concentration, hyponatremia, and slight elevations of serum creatinine and blood urea nitrogen. All other laboratory values were within normal limits. Discussion: Losartan, an angiotensin-receptor blocker (ARB), is commonly used for treatment of hypertension and heart failure as well as for renoprotection in diabetic patients. It has been shown to interact with lithium, resulting in lithium intoxication, most likely as a result of natriuresis leading to hyponatremia. Hyponatremia and a decrease in the glomerular filtration rate through the action of both angiotensin-converting enzyme inhibitors and ARBs enhance the renal tubular reabsorption of lithium, thus leading to potentially toxic serum concentrations of lithium. An objective causality assessment revealed that the interaction was probable. Conclusions: The temporal fashion in which the episode occurred indicated that a lithium—losartan interaction was probably the cause of lithium toxicity in this patient. Clinicians need to be aware of potential lithium—ARB interactions resulting in an increased risk of lithium toxicity associated with concurrent use of these drugs.
Topiramate for Use in Adult Migraine Prophylaxis
Authors: Sinert Molly R , Epstein Benjamin J 
Published: September 2013

Objective: To review studies comparing topiramate with placebo or other migraine prophylaxis agents in order to outline the role of topiramate in the pharmacologic prevention of adult migraine and to provide clinicians with evidence for rationale of its use. Data Sources: Primary studies and review articles were identified via a MEDLINE search (1960–November 2008). Search terms included topiramate, antiepileptic, anticonvulsant, migraine prophylaxis, and migraine prevention. Additional references were obtained from bibliographies of those resources. Study Selection and Data Extraction: All relevant information extracted from randomized, controlled studies and systematic reviews evaluating the efficacy, safety, and pharmacology of topiramate in the prevention of adult migraine were included. Data Synthesis: Topiramate is approved for the prevention of adult migraine. It has historically been used in the treatment of seizure disorders but received approval for migraine prophylaxis in 2004. The exact mechanism of its antimigraine effect remains unknown, but modulation of sodium channels, γ-aminobutyric acid, and glutamate activity seem to be involved, given the proposed shared pathophysiology between seizure and migraine. Two pivotal trials comparing topiramate with placebo led to approval for migraine prophylaxis in the US and a third similar trial that compared topiramate with propranolol secured licensure in Europe. Additional studies evaluated optimal dosing up to 200 mg daily and duration of therapy through 14 months. These trials demonstrated the ability of topiramate 50 mg twice daily, administered for up to 14 months, to safely reduce migraine frequency, duration, and severity. Limited information from comparative studies suggests a similar effect of topiramate and other agents, including divalproex sodium, propranolol, and timolol. The most common adverse effect observed among all trials was mild-to-moderate paresthesias that were transient in nature. Other adverse effects commonly reported include gastrointestinal upset and cognitive impairment. Adverse effects were more likely to occur during titration periods. Topiramate's safety profile appears to be as good as or better than that of other prophylactic agents. Conclusions: Topiramate is an appropriate first-line drug to consider for prevention of adult migraine. The efficacy and safety of topiramate in migraine prophylaxis has been well established in clinical trials and is comparable with other approved agents for this indication. When choosing among these agents, prescribers should consider the adverse effect profile, route of administration, cost, and comorbidities. ACPE Universal Program Number: 407-000-09-052-H01-P (Pharmacists); 407-000-09-052-H01-T (Technicians)
Incidence of Cross-Sensitivity with Carbapenems in Documented Penicillin-Allergic Patients
Authors: Lager Stephanie , White Betsy , Baumann Megan , Mitchem Randall E , Jackson Ronna , Black Nicola 
Published: September 2013

Background: When carbapenems were first introduced, it was recommended to use them cautiously in patients with a penicillin allergy due to an approximately 50% potential risk of cross-sensitivity in these patients. Carbapenems have a broad spectrum of coverage and may be necessary for treatment of acutely ill patients; however, clinicians may avoid the use of carbapenems in patients with a documented penicillin allergy. Objective: To further define the risk of cross-sensitivity to carbapenems in patients with a penicillin allergy that has been documented in the electronic medical record or has been self-reported. Methods: Ninety-five patients with a documented or self-reported penicillin allergy were evaluated for the risk of carbapenem cross-sensitivity. Allergy information was obtained from a patient interview by a pharmacist or from the electronic medical record. Patients were evaluated for the type of allergic reaction, time of onset, and the carbapenem administered. The primary endpoint of the study was to determine the incidence of carbapenem cross-sensitivity in patients with a penicillin allergy. Results: Twenty-eight patients (29%) with a penicillin allergy were interviewed about their allergy, the reaction type, and the date of onset. The other 67 patients were not interviewed due to lack of clinical services or because the patient was unable to communicate. Two (2.1%) of the 95 patients were positive for an allergic reaction to a carbapenem. Conclusions: This research study supports recent findings that the incidence of carbapenem cross-sensitivity is low in patients with a penicillin allergy that is self-reported or documented in the electronic medical record. The benefits of using a carbapenem in penicillin-allergic patients may outweigh the potential risks. Based on these findings, our dispensing algorithm was modified.