A Multimodal Pain Management Strategy for Burn Patients.

BACKGROUND: Acute burn pain is difficult to manage, and poorly managed pain can lead to deleterious consequences such as post-traumatic stress disorder, prolonged recovery, chronic pain and long-term dependence on opioids. Understanding the role of nursing in promoting self-efficacy and minimizing opioid use is valuable. It is unknown whether strategic efforts aimed at enhancing patient self-efficacy will improve pain managment and lessen opioid requirements in the adult burn population. AIM: The aim of this study was to examine the effect of a multi-modal, interdisciplinary pain management strategy on coping self-efficacy, pain scores, and opioid use in adult burn patients in the acute care setting. METHOD: A quasi-experimental pre-test/post-test design was employed in an American Burn Association (ABA) verified burn center in the Pacific Northwestern United States. Data were collected prospectively for a 6-month period on 44 burn patients. The comparison group received usual care (n = 28), and the intervention received a pain management protocol (n = 16). Coping self-efficacy was measured on admission and at discharge in both groups using the Coping Self-Efficacy Scale. Numeric pain scores and opioid use in morphine milligram equivalents were averaged for each participant. Burn nurse perceptions were gathered via an anonymous electronic survey post data collection in February 2021. RESULTS: There were no significant differences in measured coping self-efficacy, pain scores, or opioid use between the intervention and comparison groups. A significant positive correlation was found between length of stay, size of burn, and coping self-efficacy and problem focused self-efficacy. Burn nurses reported increased use of nonpharmacologic adjuncts since protocol implementation. CONCLUSION: Nonpharmacologic adjuncts are more likely to be used consistently when protocolized. There is also evidence to support that certain aspects of self-efficacy may be enhanced during acute phase of burn care.

The quantity and quality of cardiovascular fat at mid-life and future cognitive performance among women: The SWAN cardiovascular fat ancillary study.

INTRODUCTION: Cardiovascular fat is a novel risk factor that may link to dementia. Fat volume and radiodensity are measurements of fat quantity and quality, respectively. Importantly, high fat radiodensity could indicate healthy or adverse metabolic processes. METHODS: The associations of cardiovascular fat (including epicardial, paracardial, and thoracic perivascular adipose tissue [PVAT]) quantity and quality assessed at mean age of 51 with subsequent cognitive performance measured repeatedly over 16 years of follow-up were examined using mixed models among 531 women. RESULTS: Higher thoracic PVAT volume was associated with a higher future episodic memory (ß[standard error (SE)] = 0.08 [0.04], P = 0.033), while higher thoracic PVAT radiodensity with lower future episodic (ß[SE] = -0.06 [0.03], P = 0.045) and working (ß[SE] = -0.24 [0.08], P = 0.003) memories. The latter association is prominent at higher volume of thoracic PVAT. DISCUSSION: Mid-life thoracic PVAT may have a distinct contribution to future cognition possibly due to its distinct adipose tissue type (brown fat) and anatomical proximity to the brain circulation. HIGHLIGHTS: Higher mid-life thoracic perivascular adipose tissue (thoracic PVAT) volume is related to a better future episodic memory in women. Higher mid-life thoracic PVAT radiodensity is related to worse future working and episodic memories. Negative association of high thoracic PVAT radiodensity with working memory is prominent at higher thoracic PVAT volume. Mid-life thoracic PVAT is linked to future memory loss, an early sign of Alzheimer's disease. Mid-life women's epicardial and paracardial fat are not related to future cognition.

Cardiovascular disease biomarkers across autoimmune diseases.

Cardiovascular disease is increasingly recognized as a major cause of premature mortality among those with autoimmune disorders. There is an urgent need to identify those patients with autoimmune disease who are at risk for CVD so as to optimize therapeutic intervention and ultimately prevention. Accurate identification, monitoring and stratification of such patients will depend upon a panel of biomarkers of cardiovascular disease. This review will discuss some of the most recent biomarkers of cardiovascular diseases in autoimmune disease, including lipid oxidation, imaging biomarkers to characterize coronary calcium, plaque, and intima media thickness, biomarkers of inflammation and activated complement, genetic markers, endothelial biomarkers, and antiphospholipid antibodies. Clinical implementation of these biomarkers will not only enhance patient care but also likely accelerate the pharmaceutical pipeline for targeted intervention to reduce or eliminate cardiovascular disease in the setting of autoimmunity.

Prevention of Staphylococcus aureus infections by glycoprotein vaccines synthesized in Escherichia coli.

BACKGROUND: Staphylococcus aureus is a leading cause of superficial and invasive human disease that is often refractory to antimicrobial therapy. Vaccines have the potential to reduce the morbidity, mortality, and economic impact associated with staphylococcal infections. However, single-component vaccines targeting S. aureus have failed to show efficacy in clinical trials. METHODS: A novel glycoengineering technology for creation of a multicomponent staphylococcal vaccine is described. Genes encoding S. aureus capsular polysaccharide (CP) biosynthesis, PglB (a Campylobacter oligosaccharyl transferase), and a protein carrier (detoxified Pseudomonas aeruginosa exoprotein A or S. aureus α toxin [Hla]) were coexpressed in Escherichia coli. Recombinant proteins N-glycosylated with S. aureus serotype 5 or 8 CPs were purified from E. coli. RESULTS: Rabbits and mice immunized with the glycoprotein vaccines produced antibodies that were active in vitro in functional assays. Active and passive immunization strategies targeting the CPs protected mice against bacteremia, and vaccines targeting Hla protected against lethal pneumonia. The CP-Hla bioconjugate vaccine protected against both bacteremia and lethal pneumonia, providing broad-spectrum efficacy against staphylococcal invasive disease. CONCLUSIONS: Glycoengineering technology, whereby polysaccharide and protein antigens are enzymatically linked in a simple E. coli production system, has broad applicability for use in vaccine development against encapsulated microbial pathogens.

Complement protein C3 and coronary artery calcium in middle-aged women with polycystic ovary syndrome and controls.

Circulating complement protein C3 (C3) levels have been associated with coronary artery calcification (CAC) in women with systemic lupus erythematosus, but have yet to be evaluated in women with polycystic ovary syndrome (PCOS). We aimed to determine whether C3 levels were elevated in women with PCOS compared to controls and to quantify the association of C3 with cardiovascular disease (CVD) risk factors and CAC and if PCOS modified this association. This cross-sectional analysis included 132 women with PCOS and 155 controls, 35-62 years old, from the third visit of a case-control study. CAC was measured during the study visit, and circulating C3 was measured in stored sera. The presence of CAC and CAC categories (Agatston score 0, 1-9.9 and ≥ 10) were used for logistic and ordinal regression analysis, respectively. C3 levels were not significantly different between women with PCOS and controls. Among all women, C3 was associated with the presence of CAC and increasing CAC groups after adjusting for age, PCOS status and insulin or body mass index (BMI), all p<0.05. In addition, C3 was associated with the presence of CAC after adjusting for age, PCOS status, BMI, insulin and African American race, p=0.049. PCOS status did not modify these associations. In conclusion, circulating C3 levels may prove beneficial in identifying women at risk of CVD in women with PCOS and the general population.

The two-component response regulator LiaR regulates cell wall stress responses, pili expression and virulence in group B Streptococcus.

Group B Streptococcus (GBS) remains the leading cause of early onset sepsis among term infants. Evasion of innate immune defences is critical to neonatal GBS disease pathogenesis. Effectors of innate immunity, as well as numerous antibiotics, frequently target the peptidoglycan layer of the Gram-positive bacterial cell wall. The intramembrane-sensing histidine kinase (IM-HK) class of two-component regulatory systems has been identified as important to the Gram-positive response to cell wall stress. We have characterized the GBS homologue of LiaR, the response regulator component of the Lia system, to determine its role in GBS pathogenesis. LiaR is expressed as part of a three-gene operon (liaFSR) with a promoter located upstream of liaF. A LiaR deletion mutant is more susceptible to cell wall-active antibiotics (vancomycin and bacitracin) as well as antimicrobial peptides (polymixin B, colistin, and nisin) compared to isogenic wild-type GBS. LiaR mutant GBS are significantly attenuated in mouse models of both GBS sepsis and pneumonia. Transcriptional profiling with DNA microarray and Northern blot demonstrated that LiaR regulates expression of genes involved in microbial defence against host antimicrobial systems including genes functioning in cell wall synthesis, pili formation and cell membrane modification. We conclude that the LiaFSR system, the first member of the IM-HK regulatory systems to be studied in GBS, is involved in sensing perturbations in the integrity of the cell wall and activates a transcriptional response that is important to the pathogenesis of GBS infection.

Developing Authentic Mentorship Through Professional Organizations.

Harsh realities in pandemic fatigue, burnout, inequities, and isolation are impacting academic pharmacy. Mentoring programs, especially inter-institutional programs such as those provided within the Sections and Special Interest Groups (SIGs) of the American Association of Colleges of Pharmacy (AACP), may combat some of these issues. Unfortunately, year after year, Academy members continue to request information from these groups on mentoring, whether it be the opportunity to pair up, for advice on how to be better mentors, or for guidance on how to develop a program on mentoring for the Sections and SIGs without an existing program. The need for authentic mentoring is vital to the success and retention of faculty and staff within the Academy. Therefore, it may be appropriate to take a closer look at why, despite ongoing mentoring programs scattered within AACP Sections and SIGs, these programs are unable to fulfill the needs of participants.

Mining for Retention Gems and Unearthing Identity and Belonging.

OBJECTIVE: To determine the relationship between first-year retention and variables related to professional engagement and professional, academic, and personal identities. METHODS: This study evaluated data from 3 cohorts of students at a private 0-6 college of pharmacy. A theoretical and conceptual framework linking professional identity and retention informed the study. Professional engagement scores from the first semester of pharmacy school served as a surrogate of professional identity. Grade point average (GPA) and traditional demographic variables (eg, gender, race/ethnicity, in-state resident) served as surrogates of academic and personal identities, respectively. Logistic regression models were used to determine the relationship between first-year retention and identity variables. RESULTS: Belonging, a domain of professional engagement, was positively related to first-year retention. In multivariable models, belonging and cumulative GPA were associated with increased odds of retention, while in-state status was associated with decreased odds. In separate models for those with GPA ≥3.00, and<3.00, belonging was associated with first-year retention in both. Belonging was also associated with first-semester retention, but not second-semester retention. CONCLUSION: A decision to leave a Doctor of Pharmacy program is complex, but the vast majority of the literature in pharmacy education appears to focus most intently on academic variables, including GPA. This study demonstrates that belonging, an important element in professional identity formation, remains related to first-year retention, even after controlling for grades and other personal variables. This finding unearths several theory-informed gems and strategies that educators may employ to enhance retention.

Mentorship Landscape and Common Practices in an Academic Pharmacy Association.

OBJECTIVES: To explore the landscape of mentorship within professional associations in pharmacy academia, including reviewing available literature and describing currently available programs within the American Association of Colleges of Pharmacy, and recommend key considerations for the development of mentorship programs within professional associations. FINDINGS: A literature review of mentorship programs within professional associations for pharmacy academics was conducted, with a total of 5 articles identified and summarized. Additionally, a survey was conducted to determine the landscape of available mentorship programs within American Association of Colleges of Pharmacy affinity groups to capture unpublished experiences. Information regarding common characteristics and assessment methods was collected for groups that have mentorship programs, while needs and barriers were collected for those who did not. SUMMARY: Literature, while limited, supports positive perceptions of mentorship programs within professional associations. Based on the responses and working group experience, several recommendations are proposed for mentorship program development, including the need for clearly defined goals, relevant program outcomes, association support to reduce redundancies and promote participation, and, in some cases, implementation of an association-wide program to ensure access to mentorship.

Learning Clinical Concepts for Predicting Risk of Progression to Severe COVID-19.

With COVID-19 now pervasive, identification of high-risk individuals is crucial. Using data from a major healthcare provider in Southwestern Pennsylvania, we develop survival models predicting severe COVID-19 progression. In this endeavor, we face a tradeoff between more accurate models relying on many features and less accurate models relying on a few features aligned with clinician intuition. Complicating matters, many EHR features tend to be under-coded degrading the accuracy of smaller models. In this study we develop two sets of high-performance risk scores: (i) an unconstrained model built from all available features; and (ii) a pipeline that learns a small set of clinical concepts before training a risk predictor. Learned concepts boost performance over the corresponding features (C-index 0.858 vs. 0.844) and demonstrate improvements over (i) when evaluated out-of-sample (subsequent time periods). Our models outperform previous works (C-index 0.844-0.872 vs. 0.598-0.810).

A Situational Judgment Test to Assess Students' Achievement of Accreditation Council for Pharmacy Education Standards 3 and 4.

Objective. For pharmacy students to successfully meet competencies related to Accreditation Council for Pharmacy Education Standards 3 and 4, it is essential for pharmacy programs to assess student progression in the affective domain. The purpose of this study was to develop and assess the validity of a situational judgment test (SJT) for evaluating student mastery of Standards 3 and 4.Methods. A multi-institutional faculty team developed an 18-item SJT that consisted of scenarios asking the respondent to rank the effectiveness of four response options mapped to Standards 3 and 4. The research team systematically reviewed the literature, created items, and deliberated until consensus was achieved. Subject matter experts (SMEs) reviewed and provided feedback on the instrument. Students from two institutions were recruited to participate in cognitive interviews about the finalized instrument. Cognitive interview data were analyzed to identify themes.Results. After edits were made to the instrument based on SME feedback, students (n=18) in the cognitive interviews identified item length as a concern and commented on item/response clarity and comprehensiveness. Data from the cognitive interviews were used to modify the SJT to reduce the length and clarify items. The result was two shorter versions of the instrument, both with similar mapping to all elements in Standards 3 and 4.Conclusion. Early steps in validating the SJT suggested that the instrument may be a promising tool to assess student progression in the affective domain. The SJT instrument is intended to provide evidence of student pharmacist development that occurs in the didactic, experiential, and co-curricular portions of pharmacy education. The instrument can serve as one part of a comprehensive assessment plan.

Association of Hydroxychloroquine Use With Decreased Incident Atrial Fibrillation in Systemic Lupus Erythematosus.

OBJECTIVE: To study the relationship between hydroxychloroquine (HCQ) use and new-onset atrial fibrillation in patients with systemic lupus erythematosus (SLE). METHODS: A retrospective cohort of adult patients with SLE was constructed from December 1, 2014 to May 30, 2017. Patients were categorized as either HCQ users or nonusers. The primary outcome was incident atrial fibrillation. Secondary outcomes included incident ventricular arrhythmias (composite of ventricular tachycardia, ventricular fibrillation, or torsades de pointes). Outcomes were adjudicated by review of the electronic health record. Statistical analyses included simple and multivariable logistic regression tests to estimate the association between HCQ use and incident atrial fibrillation after adjusting for relevant confounders. Propensity score matching analysis was completed. RESULTS: Our study included 1,647 patients with SLE, of which 917 were HCQ users and 730 were nonusers. A total of 23 atrial fibrillation events occurred, including 3 in HCQ users and 20 in nonusers. Logistic regression analysis showed an odds ratio (OR) of 0.12 (95% confidence interval [95% CI] 0.034-0.39, P = 0.0005) for incident atrial fibrillation and 2.39 (95% CI 0.25-23.0, P = 0.45) for ventricular arrhythmias. Results remained significant in the fully adjusted and propensity score-matched models. CONCLUSION: In this exploratory study, HCQ use was associated with an 88% decrease in the risk of incident atrial fibrillation in patients with SLE. Considering the increased cardiovascular risk in SLE, incorporation of HCQ into the regimen may be beneficial for both disease manifestations and reducing the risk of atrial fibrillation. Further studies would be needed to confirm the antifibrillatory benefit of this relatively safe and low-cost medication.

Development and assessment of a nationwide, cross-discipline women faculty mentoring program.

INTRODUCTION: Professional health care associations present a unique opportunity for formal mentorship programs, with membership often spanning a variety of experiences, professional ranks, and institutions. However, scarce literature describes the role of professional associations in the development and assessment of mentoring programs. This paper describes development of the American Association of Colleges of Pharmacy Women Faculty Special Interest Group (SIG) mentoring program and characterizes the impact of the program. METHODS: The task force collaboratively developed the mission, vision, and structure of the mentoring program, posted the program description on the SIG's electronic forum, and called for mentors and mentees via an online survey asking for matching preferences. The task force reviewed responses and designated matches. Participants were emailed match information and a guidance document. The program was assessed at three, six, and 12 months via electronic survey. RESULTS: The program matched 43 mentors with 77 mentees, with each mentor assigned one to three mentees. At the three- and six-month assessments, 89% and 87% of respondents, respectively, indicated they had met with their mentor/mentee. At the 12-month assessment, 86% of mentor respondents and 80% of mentee respondents stated the mentoring program met their needs/expectations. Career goal development, work/life integration, and difficult work situations were the most frequently discussed topics. Most participants stated they would continue to serve as a mentor/mentee in a future cycle and recommend other faculty members participate. CONCLUSIONS: Results from three-, six-, and 12-month assessments indicated a positive impact of developing a nationwide, organizational, cross-discipline mentoring program.

Antioxidants and antiinflammatory dietary supplements for osteoarthritis and rheumatoid arthritis.

OBJECTIVE: To review efficacy studies of antioxidant and antiinflammatory dietary supplements used to manage osteoarthritis (OA) and rheumatoid arthritis (RA) and make conclusions about their place in therapy. Glucosamine, chondroitin, and methyl sulfonyl methane were excluded. DATA SOURCES: A literature search was conducted using MEDLINE (1996 through January 2009), EMBASE, Cochrane Library, Natural Medicines Comprehensive Database, and Natural Standard, with bibliographic review of relevant articles. Cited studies from before our search range were included if they represented the only published human data available. Search words included "antioxidant," "antiinflammatory," "cat's claw," "ginger," "fish oil," "omega-3," "turmeric," "vitamin E," "vitamin C," "Baikal skullcap," "barberry," "Chinese goldthread," "green tea," "Indian holy basil," "hu zhang,""oregano," and"rosemary." STUDY SELECTION AND DATA EXTRACTION: Efficacy studies published in English were included provided they evaluated the dietary supplements in patients with OA or RA. DATA SYNTHESIS: Our search strategy yielded 16 clinical studies (11 randomized, placebo-controlled clinical trials, three crossover trials, one case-controlled study, and one open-label study) in addition to one meta-analysis and one review article. CONCLUSIONS: Three studies support cat's claw alone or in combination for OA, and two studies support omega-3 fatty acids for the treatment of RA. We cannot recommend use of vitamin E alone; vitamins A, C, and E in combination; ginger; turmeric; or Zyflamend (New Chapter, Brattleboro, Vermont) for the treatment of OA or RA or omega-3 fatty acids for OA. Whether any of these supplements can be effectively and safely recommended to reduce nonsteroidal antiinflammatory drug or steroid usage is unclear and requires more high-quality research.

Dual plate fixation results in improved union rates in comminuted distal femur fractures compared to single plate fixation.

PURPOSE: The treatment of distal femur fractures with extensive metaphyseal comminution is frequently complicated by high rates of nonunion and varus collapse. Dual plating with lateral and medial locking plates for these types of fractures has shown promising results in the recent literature. We hypothesize that dual plating of comminuted distal femur fractures leads to higher union rates and lower revision rates compared to an isolated lateral locking plate. METHODS: A retrospective medical chart review between January 2015 and December 2017 was conducted. Inclusion criteria included patients 18 years of age and older who sustained a complex distal femur fracture (AO/OTA 33-C2/33-C3 or periprosthetic fracture with significant metaphyseal comminution) and at least 6 months of follow up. Patients with simple fracture patterns, alternative fixation methods, and inadequate follow up were excluded. All patients in the single plating group were treated with a lateral distal femoral locking plate using a lateral approach. In the patients treated with dual plating, an extensile parapatellar approach was utilized for fracture reduction and placement of an adjunctive medial plate. Demographic information, fracture types, injury severity score (ISS), medical comorbidities, type of surgical fixation, union rates, complications, knee range of motion, time to follow up, and need for revision surgery were extrapolated from the medical charts for analysis. RESULTS: Twenty-one patients were included in the study. Thirteen patients underwent single plate fixation and 8 underwent dual plate fixation. There were no significant differences in demographics, number of co-morbidities, fracture classification, or ISS between single and dual plate groups (p > 0.05 for all). There was a statistically significant difference in union rates between the single plate group (6 nonunions, 4 unions, and 3 delayed unions) and the dual plate group, with no nonunions or delayed unions (p = 0.0049). Although not statistically significant, 4 patients treated with single plating underwent revision ORIF, compared to none in the dual plating group (p = 0.13). There were no significant differences in time to follow up, time to full weight bearing, or infection rates (p > 0.1 for all). CONCLUSION: Based on these results, the medial and lateral locked plating technique demonstrates a higher union rate, with possible lower rates of revision surgery, compared to a single lateral plate in highly comminuted distal femur fractures. LEVEL OF EVIDENCE: Level 3. Retrospective Cohort Study.

Risk Factors for Unnecessary Antibiotic Prescribing for Acute Respiratory Tract Infections in Primary Care.

OBJECTIVE: To determine independent risk factors for inappropriate antibiotic prescribing for acute respiratory tract infections (ARIs) in internal medicine (IM) residency-based primary care offices. PATIENTS AND METHODS: A retrospective study was conducted to measure antibiotic prescribing rates, and multivariable analysis was utilized to identify predictors of inappropriate prescribing among patients presenting to IM residency-based primary care office practices. Patients with an office visit at either of 2 IM residency-based primary care office practices from January 1, 2016, through December 31, 2016, with a primary encounter diagnosis of ARI were included. RESULTS: During the study period, 911 unique patient encounters were included with 518 for conditions for which antibiotics were considered always inappropriate. Antibiotics were not indicated in 85.8% (782 of 911) of encounters. However, antibiotics were prescribed in 28.4% (222 of 782) of these encounters. Inappropriate antibiotic prescribing occurred in 111 of 518 (21.4%) encounters for conditions for which antibiotics are always inappropriate. Using multivariable logistic regression analysis to assess for independent risk factors when adjusted for other potential risk factors for office visits at which antibiotics were not indicated, IM resident-associated visits (odds ratio, 0.25; 95% CI, 0.18-0.36) was the only variable independently associated with lower risk of inappropriate antibiotic prescribing. CONCLUSION: For ARI visits at which antibiotics were not indicated, IM resident comanagement was associated with lower rates of inappropriate prescribing.

Greater Periaortic Fat Volume at Midlife Is Associated with Slower Gait Speed Later in Life in Women: The SWAN Cardiovascular Fat Ancillary Study.

BACKGROUND: Higher perivascular adipose tissue (PVAT) contributes to adverse physiologic alterations in the vascular wall, and thus could potentially limit normal physical function later in life. We hypothesize that higher PVAT volume at midlife is prospectively associated with slower gait speed later in life, independent of overall adiposity and other risk factors. METHODS: Participants from the Study of Women's Health Across the Nation (SWAN) cardiovascular fat ancillary study were included. PVAT volume around the descending aorta was quantified using existing computed tomography scans at midlife, while gait speed was measured after an average of 10.4 ± 0.7 years. RESULTS: Two hundred and seventy-six women (aged 51.3 ± 2.8 years at PVAT assessment) were included. Mean gait speed was 0.96 ± 0.21 m/s. Adjusting for study site, race, education level, menopausal status, and length of descending aorta at PVAT assessment, and age, body mass index, difficulty paying for basics, overall health and smoking status at gait speed assessment, a higher midlife PVAT volume was associated with a slower gait speed later in life (p = .03). With further adjustment for presence of any comorbid conditions by the time of gait speed assessment, the association persisted; every 1SD increase in log-PVAT was associated with 3.3% slower gait speed (95% confidence interval: 0.3-6.3%; p = .03). CONCLUSION: Greater PVAT in midlife women may contribute to poorer physical function in older age supporting a potential role of midlife PVAT in multiple domains of healthy aging. Additional research is needed to fully elucidate the physiologic changes associated with PVAT that may underlie the observed associations.

Role of ambrisentan in the management of pulmonary hypertension.

OBJECTIVE: To review the role of ambrisentan in the treatment of pulmonary arterial hypertension (PAH). DATA SOURCES: Literature was accessed through MEDLINE (1950-June 2008), Iowa Drug Information Service (1966-March 2008), EMBASE (1966-June 2008), bibliographies of pertinent articles, and unpublished data provided by the manufacturer and the Food and Drug Administration (FDA). Search terms included ambrisentan, endothelin antagonist, pulmonary hypertension, and pulmonary arterial hypertension. Due to limited literature available, additional criteria to limit searches were not used. STUDY SELECTION AND DATA EXTRACTION: Abstracts and original preclinical and clinical research reports available in the English language were identified for review. All manufacturer-provided data were also evaluated. Literature related to ambrisentan, endothelin antagonists, pulmonary hypertension, and pulmonary arterial hypertension were included. Four clinical trials evaluated the efficacy of ambrisentan in adults with symptomatic PAH. DATA SYNTHESIS: Ambrisentan is the latest endothelin-receptor antagonist (ERA) to obtain FDA approval for the treatment of PAH. It joins the first FDA-approved ERA, bosentan. Like bosentan, ambrisentan is available orally (with once-daily dosing compared with bosentan's twice-daily dosing) and has been shown to improve exercise capacity and delay clinical worsening. As with bosentan, the most significant safety concerns with ambrisentan relate to potential liver injury and a contraindication in pregnancy. Although ambrisentan has higher affinity for the endothelin type A receptor than for the endothelin type B receptor, specific advantages of this selectivity, in terms of efficacy compared with bosentan, a nonselective agent, have not been demonstrated. CONCLUSIONS: Ambrisentan has been shown to be an effective ERA in patients with PAH. A significant advantage of ambrisentan is the lack of any clinically important drug interactions with warfarin and sildenafil, which are frequently used by patients being treated for PAH.

Safety issues associated with commercially available energy drinks.

OBJECTIVE: To describe benefits and adverse effects associated with the consumption of energy drinks. DATA SOURCES: Searches were conducted using Medline, IPA (International Pharmaceutical Abstracts), EMBASE, and MANTIS; databases such as Natural Medicines Comprehensive Database, Natural Standard, ALTMEDEX, and AltHealthWatch; and Google (range 1980 to September 2007). Search terms included energy drink, Red Bull, caffeine, glucose, ginseng, guarana, taurine, and bitter orange. DATA SYNTHESIS: Most energy drinks contain natural products such as guarana, ginseng, and taurine. As much as 80 to 300 mg of caffeine and 35 grams of processed sugar per 8-ounce serving are commonly present in energy drinks such as Cocaine, Pimp Juice, Red Bull, and Spike Shooter. No reports were identified of negative effects associated with taurine, ginseng, and guarana used in the amounts found in most energy drinks. Commonly reported adverse effects seen with caffeine in the quantities present in most energy drinks are insomnia, nervousness, headache, and tachycardia. Four documented case reports of caffeine-associated deaths were found, as well as four separate cases of seizures associated with the consumption of energy drinks. CONCLUSION: The amounts of guarana, taurine, and ginseng found in popular energy drinks are far below the amounts expected to deliver either therapeutic benefits or adverse events. However, caffeine and sugar are present in amounts known to cause a variety of adverse health effects.

Self-reported influence of television-based direct-to-consumer advertising on patient seasonal allergy and asthma medication use: An internet survey.

BACKGROUND: Direct-to-consumer advertising (DDTCA) of medications, a marketing tool used by the pharmaceutical industry to increase patient awareness of products, affects both consumer behavior and, ultimately, physician prescribing practices. Billions of dollars are budgeted each year for DTCA, and its influence is far-reaching. However, little information is available about patient-initiated physician interactions in which television-bbased DTCA has played a role in consumer behavior. OBJECTIVE: The objective of this study was to explore the influence of television-based DTCA on treatment changes in patient-initiated medication use. METHODS: A 68-item survey instrument consisting of dichotomous, multiple-choice, and open-ended questions was constructed and sent to a convenience sample of US residents during 3 consecutive months ending in February 2005. The survey, which was accessed through an Internet link provided in the e-mail, was designed to capture data about patient perceptions and behaviors regarding television-based DTCA of prescription medications used for seasonal allergy and asthma as well as demographic information. Inferential and descriptive analyses were performed. Key tests included Crosstabs analysis and normal approximation to the binomial test with the z score. RESULTS: Surveys were sent to 2500 individuals. A total of 427 valid surveys were returned for a 17.1% response rate. Of the 402 respondents (94.1%) who stated that they had seen DTCA for seasonal allergy medication, 50 (12.4%) said they had discussed the advertised medication with their physician and 22 of those discussions (44.0%) resulted in a change in treatment. Three hundred forty-two respondents (80.1%) stated that they had viewed DTCA for prescription asthma medications, and 23 of those respondents (6.7%) said that they had discussed the brand of asthma medication viewed on television with their physician. Those discussions resulted in a change in treatment for 9 respondents (39.1%). CONCLUSION: Within th his limited, self-reported, survey sample, patient-initiated discussions with physicians regarding television-based DTCA of allergy and asthma medications resulted in a change of treatment in 44.0% and 39.1% of respondents, respectively.