Kathy Zaiken

Azilsartan Medoxomil: A New Angiotensin Receptor Blocker

BACKGROUND Azilsartan medoxomil is an angiotensin receptor blocker, approved on February 25, 2011 by the US Food and Drug Administration (FDA) for hypertension management. OBJECTIVE The purpose of this study was to review the pharmacology, pharmacokinetics, efficacy, safety profile, and role of azilsartan for hypertension management. METHODS Peer-reviewed clinical trials, review articles, and relevant treatment guidelines were identified from MEDLINE and Current Contents (both 1966 to August 31, 2011) using the search terms azilsartan, TAK-491, TAK-536, pharmacology, pharmacokinetics, pharmacodynamics, pharmacoeconomics, and cost-effectiveness. The FDA Web site and manufacturer prescribing information were also reviewed to identify other relevant information. RESULTS Compared with olmesartan 40 mg daily, azilsartan 80 mg reduced mean systolic blood pressure (SBP) by an additional 2.1 mm Hg (P = 0.038), whereas azilsartan 40 mg was noninferior to olmesartan 40 mg. Azilsartan 40 mg or 80 mg added to chlorthalidone 25 mg daily significantly reduced SBP to a greater extent than did chlorthalidone alone (P < 0.05), but there was no difference between azilsartan 40 mg and 80 mg (40 mg: -31.72 mm Hg; 80 mg: -31.3 mm Hg [P > 0.05]). When coadministered with amlodipine 5 mg daily, both azilsartan 40 mg and 80 mg + amlodipine decreased SBP significantly more than amlodipine alone (amlodipine: -13.6 mm Hg; with azilsartan 40 mg: -24.79 mm Hg; with azilsartan 80 mg: -24.51 mm Hg [P < 0.05]). Compared with ramipril 10 mg daily, both azilsartan 40 mg and 80 mg resulted in significantly (P < 0.001) greater reductions in mean SBP (-20.63 and -21.24 mm Hg, respectively; ramipril: -12.22 mm Hg). The most common adverse events reported were dizziness (4%), dyslipidemia (3.3%), and diarrhea (2%). CONCLUSIONS At the recommended dose of 80 mg once daily, azilsartan is reported to be an efficacious BP-lowering agent. With once-daily dosing and a favorable side-effect profile, azilsartan is an attractive option for the treatment of hypertension. There is a lack of data supporting the use of azilsartan for improvement in cardiovascular outcomes; therefore, azilsartan is not approved for indications other than the treatment of hypertension.

An update on the pharmacological treatment of obesity

ABSTRACT Objective: To review the commonly utilized pharmacological options for the treatment of overweight and obese patients in the United States. Methods: A MEDLINE and EMBASE search, in English, between January 1995 and November 2005 was conducted using the terms, ‘anti-obesity agents’, ‘orlistat’, ‘sibutramine’, and ‘phentermine’. References cited in relevant studies and reviews were also examined for additional clinical trials to be included in the review. Results: There are several pharmacological options currently available for the treatment of overweight and obese individuals in the United States, including phentermine, sibutramine, and orlistat, with only sibutramine and orlistat being indicated for use in the long term (> 6 months). However, none of these medications have proven to be more effective than another for the indication of weight loss, each with a very similar maximum weight loss potential. Therefore choosing a weight loss medication should be patient specific and based on its pharmacological profile, including mechanism of action and potential adverse effects. Most importantly, it is imperative to realize that these agents are only indicated for use when combined with lifestyle modifications. Most studies have indicated that maximum benefits from any of these medications are only shown when taken in addition to a hypocaloric diet. Conclusion: It has been shown that the combination of lifestyle changes and pharmacological treatment leads to a greater decrease in total body weight loss. Treatment with anti-obesity agents is associated with side effects and an increased cost in health care. These factors must be weighed prior to initiating anti-obesity treatment.

A Review of the Use of Angiotensin Receptor Blockers for the Prevention of Cardiovascular Events in Patients with Essential Hypertension Without Compelling Indications

OBJECTIVE To review the role of angiotensin receptor blockers (ARBs) for the prevention of cardiovascular events in patients with essential hypertension without other compelling indications. DATA SOURCES Peer-reviewed clinical trials, review articles, and relevant treatment guidelines were identified from MEDLINE and Current Content database (both 1966-November 15, 2012) using the search terms angiotensin receptor blockers (ARBs), azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, hypertension, myocardial infarction, stroke, heart failure, and cardiovascular outcomes. Results were limited to human trials published in English. Citations from articles were also reviewed for additional references. STUDY SELECTION AND DATA EXTRACTION The focus was on clinical trials evaluating cardiovascular end points of ARBs used in patients with essential hypertension without compelling indications. DATA SYNTHESIS Data supporting the use of ARBs for reducing cardiovascular events in patients with essential hypertension without compelling indications are inconsistent. To date, only candesartan and losartan have shown a significant reduction in cardiovascular morbidity within this sizable subgroup of patients. In the Study on Cognition and Prognosis in the Elderly (SCOPE) trial, candesartan showed a 27.8% reduction in nonfatal stroke versus placebo (95% CI 1.3–47.2; p = 0.04). Moreover, losartan demonstrated a decrease in all cardiovascular events compared to atenolol in the Cardiovascular Morbidity and Mortality in the Losartan Intervention for Endpoint Reduction in Hypertension (LIFE) study (RR 0.87; 95% CI 0.77–0.98; p = 0.021). CONCLUSIONS Data supporting the use of ARBs for reducing cardiovascular events in patients with essential hypertension without compelling indications are limited and inconclusive. More studies are needed before ARBs can be routinely recommended as first-line therapy for hypertension management in patients without other compelling indications.

Management of chronic obstructive pulmonary disease by pharmacists in an internal medicine department

Pharmacist involvement in the management of chronic diseases has been shown to produce beneficial outcomes, such as cost savings, and it has also been shown to improve therapy and patient outcomes.[1][1] The Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the American Thoracic

Students’ Attitudes, Academic Performance and Preferences for Content Delivery in a Very Large Self-Care Course Redesign

Objective. To evaluate students’ performance/attitudes toward a flipped team-based learning (TBL) format in a “very large” self-care course based on student content delivery preference. Design. Third-year students enrolled in the course were surveyed regarding elements of redesign and homework completion. Additionally, their performance and incoming grade point average were evaluated. Assessment. A survey was completed by 286 of 305 students. Nineteen percent of respondents preferred traditional content delivery, whereas 30% preferred flipped TBL, 48% preferred a mixed format, and 3% had no preference. The grades achieved in the course were: A (49%), B (48%), C (3%) and D (0%). The majority completed “all” or “most” of the homework, appreciated attributes of course redesign, felt home preparation and in-class activities engaged them, and reported improved communication/evaluation skills. Content delivery preference significantly affected attitudes. Conclusion. Students positively received a flipped team-based learning classroom format, especially those who preferred flipped TBL or mixed content delivery. A minority with preference for traditional teaching style did not enjoy the new format; however, their academic performance did not differ significantly from those who did.

Impact of live medication therapy management on cholesterol values in patients with cardiovascular disease

OBJECTIVE To compare the impact of clinical pharmacist (CP) recommendations through a live, primary care-based, medication therapy management (MTM) protocol on low-density-lipoprotein (LDL) cholesterol in patients who have cardiovascular disease (CVD) with standard, chart-review MTM. METHODS Patients with established CVD who were not at their LDL goal were identified and analyzed by either a chart-review MTM service or a live, one-on-one pharmacist-physician MTM service over a 6-month timeframe. For the chart-review MTM service, recommendations were communicated through an electronic medical record (EMR) that the physician and pharmacist had access to. RESULTS Primary outcomes included mean LDL reduction from baseline, number of patients achieving their LDL goal, and percent of implemented CP recommendations. Mean LDL reduction from baseline in the chart-review MTM group and the live MTM group was 36 mg/dL ± 23.2 mg/dL (P = 0.001) and 62 mg/dL ± 28.3 mg/dL (P = 0.001), respectively. The difference between these two groups was statistically significant (P = 0.001). The chart-review MTM group had 30% of patients reach their LDL goal with 66.3% of CP recommendations implemented compared to 51.3% and 86.3% for the same parameters in the live MTM group (P = 0.006 and P = 0.003, respectively). CONCLUSION Although both MTM services provide a significant LDL reduction from baseline in patients with CVD, live MTM provides significantly greater LDL reductions, implemented CP recommendations, and goal attainment than chart-review MTM. Thus, live MTM services are more effective than chart-review MTM services, at least within the clinics that these protocols were assessed for the purposes of this study.

Comparison of long-term knowledge retention in lecture-based versus flipped team-based learning course delivery

OBJECTIVES To determine whether team based learning (TBL) is superior to traditional lecture -based learning in confidence and knowledge retention one year later. DESIGN A survey was administered 17 months after a completion of a required over-the-counter /self-care (OTC) course to two different cohorts of students. The survey assessed confidence and knowledge related to OTC topics. The lecture group had a traditional lecture based classroom experience; the intervention group experienced a TBL format throughout the entire course. ASSESSMENT One hundred forty-seven students of 283 enrolled (51.9%) in the lecture group and 222 of 305 (72.8%) students in the TBL group participated in the knowledge assessment and survey. Demographic data including student grade point averages (GPA) and confidence were similar in both groups. Mean assessment scores (±SD) on OTC knowledge was significantly higher in the traditional lecture based group versus the TBL group; 62.9±19.3 vs. 54.9±15.7 (p=0.001). CONCLUSION Although TBL is thought to improve student engagement and mastery of material, after an initial implementation of TBL, knowledge retention in the long term appears to be lower than lecture based learning.

Outcomes of treatment with direct-acting antivirals for infection with hepatitis C virus genotypes 1–4 in an ambulatory care setting

Purpose. Outcomes with direct‐acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) genotypes 1–4 were determined. Methods. A total of 360 patients at 36 clinical sites in Massachusetts with HCV genotypes 1–4 and a prescription for at least one DAA medication between May 2011 and October 2015 were included. The primary investigator completed a retrospective and concurrent chart review, and data were collected through April 2016. Results. A total of 446 patients were assessed for eligibility into the study, with 86 patients excluded. The majority of patients were white males with genotype 1 infection. About half of the patients were treatment naive (TN), and 40% of patients had documented cirrhosis. TN patients without cirrhosis had the highest overall sustained virologic response (SVR) rate at 107 of 109 (98.2%), followed by treatment‐experienced (TE) patients without cirrhosis at 59 of 63 (93.7%), TN patients with cirrhosis at 40 of 46 (87.0%), and TE patients with cirrhosis at 64 of 79 (81.0%) when boceprevir‐ and telaprevir‐containing regimens were excluded. A total of 7 of 360 (1.9%) patients reported missing at least one dose of medication. Adverse drug reactions reported in the electronic medical record (EMR) were collected for analysis and included patients who received at least one dose of medication and had adequate EMR documentation. Conclusion. In patients treated with DAAs for infection with HCV genotypes 1–4, variables favoring achievement of SVR included an age of <45 years, a body mass index of <25 kg/m2, absence of cirrhosis, a fibrosis score of 0–2, and being TN.

Impact of Medication Onboarding A Clinical Pharmacist–Run “Onboarding” Telephone Service for Patients Entering a Primary Care Practice

Background: Previous studies have demonstrated the role of pharmacists during periods of transition of care. However, there are minimal studies that evaluate the impact that a pharmacist can have when a patient transitions his or her care to a new primary care provider (PCP). Objective: To assess the impact of a pharmacist-run medication “onboarding” service for patients new to a primary care (PC) practice. Methods: This prospective cohort study was approved by an institutional review board. Patients ≥50 years old and new to a PC practice were called by a pharmacist to obtain a medication list and identify any medication issues and recommendations. Recommendations were documented in the electronic medical record (EMR) and provided to the PCP prior to patients’ first appointments. After each appointment, the EMR was reviewed to determine the status of recommendations. As a comparison, the medication list and PCP’s initial appointment notes were reviewed for a similar cohort of patients not receiving a call. Medication-related actions taken at new patients’ first appointments were then compared between the pharmacist-assisted (intervention) and usual care (control) groups. Results: Forty-two percent versus 15% of medication issues were enacted in the intervention and control groups (P = .001), respectively. Seventy-seven percent of PCPs found the service beneficial and time-saving during initial new patient visits; 85% felt the service helped them manage patients’ medication therapy. Conclusion: A pharmacist-provided medication “onboarding” service results in significantly more medication issues addressed by the PCP compared with new patient visits not preceded by this service.

Improving performance of an accountable care organization on a quality measure assessing β-blocker use in systolic heart failure

PURPOSE The implementation and outcomes are described for a clinical pharmacist-generated initiative to improve the performance of a Medicare Pioneer accountable care organization (ACO) quality measure evaluating the percentage of patients at least 18 years of age with heart failure and a left ventricular ejection fraction (LVEF) of less than 40% who are prescribed with an evidence-based β-blocker (carvedilol, metoprolol succinate, or bisoprolol). SUMMARY Atrius Health clinical pharmacists developed several educational documents to facilitate appropriate prescribing of evidence-based therapies in patients with heart failure. After educating clinicians, clinical pharmacists reviewed patient charts to determine eligibility for initiating or switching to evidence-based β-blocker therapy. Medicare Pioneer ACO patients 18-85 years of age with heart failure and a current or prior LVEF of less than 40% were reviewed. Patients had a current prescription for metoprolol tartrate, atenolol, or no β-blocker. Patients were considered ineligible if they had a documented contraindication or intolerance to β-blocker therapy or were clinically unstable. Recommendations to initiate or switch to an appropriate β-blocker were sent electronically by a clinical pharmacist to an eligible patients treating physician before a scheduled office visit. In approximately three months, 48 patients underwent chart review by a clinical pharmacist. Performance improved by 8% after the implementation, with 82% of eligible patients achieving the quality measure in 2014-an increase from 74% in 2013. CONCLUSION The performance on a Medicare Pioneer ACO quality measure evaluating β-blocker use in systolic heart failure improved in a one-year period after a clinical pharmacist-generated initiative was implemented at Atrius Health practice sites.