Correction of Warfarin Coagulopathy for Non-bleeding Patients in the Outpatient Setting at an Ambulatory Care Organization: Application of Vitamin K Guidance.

BACKGROUND: Warfarin is an effective anticoagulant but requires close International Normalized Ratio (INR) monitoring and may occasionally require correction of excessive anticoagulation. Current guidelines provide limited practical guidance on the administration of vitamin K for the management of supratherapeutic INR levels ≥ 5.0 in non-bleeding outpatients. OBJECTIVE: Based on expert consensus and guidelines, the Atrius Health Anticoagulation Management Services (AMS) has developed internal guidance for oral vitamin K use in highly selected populations. This study will describe the internal guidance for oral vitamin K use and present associated results and clinical outcomes. METHODS: Episodes with INR > 5.0 were included, with vitamin K considered for episodes with INR ≥ 6. Moreover, compelling indications and exclusions to select ideal patients for vitamin K intervention were also defined. RESULTS: Overall, episodes were managed conservatively; of the 246 collected episodes of excessive anticoagulation, in 18 episodes (7%), patients received vitamin K, and in 228 (93%) episodes, patients did not receive vitamin K. The mean index INR was 6.0 (range 5.0 - 10.5, SD 1.07), with nearly 57% of episodes achieving INR correction and 15% of episodes developing INR overcorrection. High thrombotic risk patients, regardless of hemorrhagic risk, were less likely to receive vitamin K. Three episodes (1.2%) resulted in bleeding complications. No thrombotic complications occurred during the 30-day follow-up of the index INR value ≥ 5.0. CONCLUSION: Our internal guidance is a novel, standardized approach that serves as a decision support tool for the management of warfarin-associated coagulopathy and vitamin K intervention using patient-specific characteristics and index INR values. This guidance may assist other anticoagulation management services with practical applications and require validation in a prospective clinical trial.

Impact of American Diabetes Association 2022 Guidelines on Prescribing Rates of Sodium-Glucose Cotransporter-2 Inhibitors in Ambulatory Care Organization Patients With Type 2 Diabetes.

Background: Recent clinical trials and guideline updates have highlighted the efficacy and safety of sodium-glucose cotransporter-2 inhibitor (SGLT2i) use in patients with type 2 diabetes (T2D) and comorbidities including atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or heart failure (HF). Objective: This study assesses the rates of guideline-based prescribing of SGLT2i in patients with T2D and one or more of the following comorbidities: ASCVD, CKD, or HF, prior to and after the 2022 American Diabetes Association (ADA) guideline publication within the Atrius Health clinical pharmacy, internal medicine, and specialty medicine departments. Methods: This is a retrospective chart review of data from the electronic medical record. Patients with the aforementioned criteria were included if they were managed by either the clinical pharmacy department, internal medicine, or specialty medicine departments. Patients were excluded if they did not have any of the comorbidities listed or a form of diabetes other than T2D. Results: Of the 10,631 patients enrolled, 354 (3.3%) were initiated on an SGLT2i during the study. The average number of SGLT2i initiations prior to the 2022 ADA guideline publication was five prescription starts per week. After the guideline publication initiation increased to seven prescription starts per week. Secondary outcomes showed the majority of SGLT2i prescriptions were started in the internal medicine department, followed by cardiology and nephrology. Conclusion: Overall utilization rates of SGLT2i are low but increased after the 2022 ADA guidelines were published. These results suggest opportunities to optimize the use of SGLT2i in this patient population.

Optimization of Medication Point-Of-Prescribing Alerts at a Multi-Site, Ambulatory Care Organization to Aid Clinical Care and Reduce HealthCare Cost.

BackgroundLiterature has shown the integration of electronic alerts into patient care has the potential to improve clinicians' workflow by saving time, increasing efficiency, and improving patient safety. However, despite these possible benefits of alerts, studies have shown that alerts are often overridden by clinicians. Objective: The purpose of this study was to optimize the acceptance rates of medication point-of-prescribing alerts within the electronic medical record (EMR) of an ambulatory care organization. Methods: The study design evaluated the actions taken by clinicians when they were presented with medication point-of-prescribing alerts. These alerts were created by the clinical pharmacy informatics team to help promote cost-effective and safe prescribing. Alerts determined to be high value alerts were optimized to increase clinicians' likelihood of accepting each alert's recommended alternative. The primary objective was to increase acceptance rates of high value alerts. The exploratory objective was to identify the estimated annualized cost-savings when high value alerts were accepted, and a lower cost alternative prescription resulted. Results: The acceptance rate of the optimized point-of-prescribing alerts increased to 8.7%, compared to a 3.2% acceptance in the pre-modification period (P <.001). The lower cost alternative prescriptions that resulted from the accepted alerts translated into an estimated annualized cost-savings of over 2 million dollars. Conclusion: The use of point-of-prescribing alerts with optimized information and specific cost comparisons in an ambulatory setting led to an increase in the acceptance rates of the alerts and more cost-conscious prescribing.

Clinical Response and Cost-Savings Associated With Generic Fluticasone Propionate/Salmeterol Multidose, Dry-Powder Inhaler in Asthma Patients Managed in an Ambulatory Care Practice Setting.

BACKGROUND: Fluticasone propionate/salmeterol multidose, dry powder inhaler (MDPI) was the first and only authorized generic inhaled corticosteroid/long-acting beta agonist (ICS/LABA) combination inhaler at the time of this study. This offers the potential for significant prescription cost-savings for both patients and accountable care organizations. The objective of the study was to demonstrate patients' clinical response to generic fluticasone propionate/salmeterol MDPI when switched from one of its brand name competitors. METHODS: The study was approved by the Institutional Review Board at MCPHS University. This was a prospective chart review of a large, multi-center ambulatory care organization in the Greater Boston area. Patients 12 years of age or older who were switched from a brand-name ICS/LABA inhaler to the generic fluticasone/salmeterol MDPI were included in the study. The primary endpoint was worsened asthma control requiring a change in therapy, oral corticosteroid therapy, or hospitalization at or before 12 weeks after the inhaler was switched. RESULTS: In total, 203 patients met inclusion criteria. Of those 203 patients, 35 had a change in therapy due to worsened asthma control (17.2% of patients, 95% CI 12.0% to 22.4%) within 12 weeks. Total projected yearly prescription cost-savings for patients who were switched and remained on the generic inhaler was $581,628. CONCLUSION: Eighty-three percent of patients maintained appropriate asthma control after switching from a brand ICS/LABA inhaler to the generic fluticasone/salmeterol MDPI for 12 weeks. Switching to the generic inhaler resulted in significant prescription cost-savings for the accountable care organization.

Evaluation of Patient Factors Associated With Achieving Goal Hemoglobin A1c in Collaborative Drug Therapy Management Ambulatory Care Clinics by Clinical Pharmacists: A Retrospective Chart Review.

Background: Literature has shown the positive impact pharmacists have on diabetic outcome measures through collaborative drug therapy management (CDTM). There is minimal literature evaluating characteristics and clinical factors of patients who benefit from CDTM diabetes clinics by pharmacists. Objective: Identify patient characteristics and clinical factors that may be associated with patients who reach goal hemoglobin A1c (HbA1c) of <7% at discharge by pharmacists practicing under CDTM agreements. Methods: This retrospective chart review included patients referred to pharmacist CDTM clinics for type 2 diabetes with an HbA1c goal of <7%. Data were extracted from the electronic medical record at enrollment and discharge. Results: Of the 228 patients included, 84 achieved a goal HbA1c of <7%. Factors predictive of patient success were Asian ethnicity (odds ratio [OR] = 19.32), baseline HbA1c of 7% to 7.9% (OR = 2.34), enrolled in clinic for 5 to 6 months (OR = 2.06), in-person visit every 4 to <8 weeks (OR = 3.06), not on insulin initially or at discharge (OR = 1.79, OR = 2.02), or discharged on a glucagon-like peptide-1 receptor agonist (OR = 1.83). Factors predictive of not reaching goal were Black or African American ethnicity (OR = 0.42), <5 encounters of any type (OR = 0.44), an encounter of any type every 8 weeks or more (OR = 0.08), or discharged on a sodium-glucose cotransporter-2 inhibitor (OR = 0.27). Conclusion: Several clinical and demographic factors were identified that influenced a patient's ability to reach a goal HbA1c of <7%. The results of this study may be applied to further advance pharmacist-run clinics in optimizing diabetes care for patients.

A Case Report of Serotonin Syndrome in a Patient on Selective Serotonin Reuptake Inhibitor (SSRI) Monotherapy.

INTRODUCTION: Paroxetine is a selective serotonin reuptake inhibitor (SSRI) with several indications, one of which is for depression. We present a case of probable paroxetine-induced serotonin syndrome. CASE SUMMARY: A 21-year-old female with a history of generalized anxiety disorder and major depression presented with increased depressive symptoms over several months while taking fluoxetine 20 mg daily. Fluoxetine was discontinued without taper and replaced with paroxetine 10 mg daily, along with hydroxyzine 50 mg twice daily as needed for anxiety. Within a week of starting the paroxetine, the patient reported increased anxiety, insomnia, and constant shaking. The paroxetine continued to be uptitrated over a 3-week period to a dose 30 mg due to unremitting depressive symptoms. One month later, the patient presented with tachycardia, generalized body aches, extreme fatigue, weakness, uncontrollable twitching, tremor, and hyperreflexia. A widespread burning sensation accompanied by random hot flashes without diaphoresis was also noted. Serotonin syndrome was diagnosed using the Hunters criteria. Paroxetine was discontinued, and the patient's physical symptoms resolved within a week. DISCUSSION: To date, only 5 cases of serotonin syndrome have been reported in patients receiving SSRI monotherapy at recommended therapeutic doses.

Opioid Prescribing: A Retrospective Analysis of Opioid Prescription Requests in a Large, Multicenter Ambulatory Care Organization.

Background: To date, Atrius Health has not assessed how often patients request additional pain medication after receiving an initial opioid for acute pain management. This assessment was requested to help justify prescribing patterns for opioids in the primary care setting. Objective: To assess the amount of requests for additional opioid prescriptions in patients who received a short-acting opioid for acute pain management. Methods: This was a retrospective chart review of a multicenter large ambulatory care organization in the Greater Boston Area. Atrius Health patients who received an initial prescription for a short-acting oral opioid indicated for acute pain management between May 1, 2016, and October 1, 2016, were included in the study. Results: The overall percentage of patients requesting additional medication for acute pain management was 13% (46/350). Of the 46 patients who requested additional medication, 15 patients received a second opioid prescription (33%, 15/46). For those patients who requested additional pain medication, there were no trends between the day supply that was prescribed and a patient receiving a second opioid prescription from a health care provider. Patients who received a 4- to 5-day supply of opioids were not more likely to call back requesting additional pain medication than patients who received a 1- to 3-day supply of opioids (odd ratio = 0.41; 95% confidence interval = 0.17-1.00). Conclusion: At Atrius Health, roughly 13% of patients are requesting additional pain medications after being prescribed a short-acting opioid for acute pain management. Other primary care and urgent care health systems may consider reducing the day supply of opioids prescribed for acute pain management.

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.

Real-World Drug Costs of Treating Hepatitis C Genotypes 1-4 with Direct-Acting Antivirals: Initiating Treatment at Fibrosis 0-2 and 3-4.

BACKGROUND: Direct-acting antivirals (DAA) for the treatment of hepatitis C virus (HCV) have drastically improved outcomes but are also very costly. For this reason, priority for treatment is often given to patients with a higher fibrosis score at baseline by payers and providers rather than treating all eligible patients. Simulation studies have suggested that waiting to treat patients until fibrosis 3-4 may be more costly and result in worse outcomes; however, real-world implications are unknown. OBJECTIVE: To determine drug costs and outcomes for treating hepatitis C in patients with fibrosis scores of 0-2 and 3-4 at baseline in a real-world ambulatory care setting. METHODS: A total of 322 patients at 36 clinical sites in Massachusetts with HCV genotype 1-4 and a prescription for at least 1 DAA medication between May 2011 and October 2015 were included. Retrospective and prospective chart reviews were completed by the primary investigator. Data were collected through April 2016. The primary outcome for the study was to determine the mean drug cost per sustained virologic response (SVR) achieved for patients with fibrosis scores of 0-2 and 3-4. Drug costs were calculated using average wholesale price and only included the cost of HCV medications, not for adjunctive medications, blood work, hospitalizations, anticipated complications, or any other projected medical costs. RESULTS: The mean ± SD (median) drug cost per patient was $130,391 ± 46,787 (113,400) and completed treatment duration was 15.0 ± 8.9 (12) weeks. The mean drug cost per SVR was $155,662 for all patients with a mean drug cost per SVR of $122,452 and $178,401 for patients with fibrosis scores of 0-2 and 3-4, respectively. SVR rates were 83.5% (269/322) for all patients and 92.2% (107/116) and 78.6% (162/206) for patients with fibrosis scores of 0-2 and 3-4, respectively. Ledipasvir/ sofosbuvir; sofosbuvir + ribavirin; ledipasvir/sofosbuvir + ribavirin; sofos-buvir + interferon + ribavirin; boceprevir + interferon + ribavirin; sofosbu-vir + simeprevir; and telaprevir + interferon + ribavirin had a mean drug cost per SVR of $123,559; $153,347; $157,969; $184,800; $248,640; $251,550; and $373,333; respectively. CONCLUSIONS: Real-world knowledge about outcomes and drug costs may influence future decisions. Further studies are needed to evaluate emerging treatment options and to reflect changes in treatment guidelines. DISCLOSURES: No outside funding supported this study. The authors report no conflicts of interest. Data in this study were presented as a poster at the ASHP Midyear Clinical Meeting; New Orleans, Louisiana; December 9, 2015; at the Massachusetts Society of Health-System Pharmacists Annual Meeting; Newton, Massachusetts; April 12, 2016; and at Eastern States Conference for Pharmacy Residents and Preceptors; Hershey, Pennsylvania; May 2, 2016. Study concept and design was primarily contributed by Bach, along with Zaiken. Bach took the lead in data collection, data interpretation, and preparation of the manuscript, along with Zaiken.

Improving performance of an accountable care organization on a quality measure assessing ß-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 ß-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 ß-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 ß-blocker. Patients were considered ineligible if they had a documented contraindication or intolerance to ß-blocker therapy or were clinically unstable. Recommendations to initiate or switch to an appropriate ß-blocker were sent electronically by a clinical pharmacist to an eligible patient's 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 ß-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.

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 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.

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 equations for dosing of medications requiring renal adjustment.

OBJECTIVE: To compare the Cockcroft-Gault (CG) and Modification of Diet in Renal Disease (MDRD) equations for renal dosing of medications in primary care patients. METHODS: Patients with stages 3, 4, or 5 chronic kidney disease who had been prescribed one of the renally cleared study medications during a 16-month time period were identified. The appropriate dose of patients' study medications, based on their most recent creatinine clearance (CrCl) and estimated glomerular filtration rate (eGFR), was determined. The primary outcome was the rate in which the CG and MDRD equations provided the same dosing recommendation. RESULTS: The rate at which the CG ideal body weight and MDRD equations recommended the same dose was 59.6% (P = 0.001). The rate at which the CG actual body weight and MDRD equations recommended the same dose was 71.1% ( P = 0.001). CONCLUSION: A significant difference exists in the doses derived from the CG and MDRD equations in the primary care setting. CG should continue to be used for renal dosing until further recommendations are available.

Impact of clinical pharmacists' recommendations on a proton pump inhibitor taper protocol in an ambulatory care practice.

BACKGROUND: Previous studies have demonstrated an association between chronic proton pump inhibitor (PPI) utilization and adverse events such as fractures, infections, hypomagnesemia, and vitamin B12 deficiency. Because patients taking PPIs for an extended period of time are more susceptible to these adverse events, an approach to tapering patients off PPIs is clinically warranted. OBJECTIVE: To evaluate the impact of clinical pharmacists' recommendations to clinicians to decrease PPI use in patients when chronic therapy is not indicated. METHODS: Clinical pharmacists electronically sent PPI taper recommendations for qualifying patients to primary care providers the day before each patient's appointment. Using insurance claims data, an average pills per month (PPM) count was calculated for the 5-month period prior to initiating the PPI taper as well as for the 5-month period after the date of taper initiation. The PPM count was calculated by dividing the total number of pills a patient received by the total number of days in that period, multiplied by 30. The primary outcome for the study was the change in average PPM count from baseline (pretaper period) to follow-up (posttaper period) and was assessed using a paired t-test. Secondary outcomes included change in total annualized PPI costs to the organization, proportion of patients who began the taper protocol after primary care provider recommendation, and whether baseline characteristics were predictors of successful response. Change in annualized PPI costs to the organization was calculated by multiplying the average unit cost per pill (determined using a weighted average of the average wholesale price of the individual drugs) by the PPM change seen with the primary outcome and by the number of patients included in the study and expressed over the period of a full year. Logistic regression analysis was used to determine whether baseline variables including alcohol and tobacco use, diagnosis related to PPI use, PPI dose, dosing frequency, gender, and length of prior PPI use significantly impacted successful tapering. RESULTS: Average PPM count decreased by 8.7 pills (95% CI: 6.4, 11.1), from 25.6 at baseline (95% CI: 23.1, 28.1) to 16.9 at follow-up (95% CI: 14.3, 19.5; P less than 0.001). For the 117 evaluable patients in the study, there was an annualized PPI cost reduction of $18,151. 37.6% (44/117) of pharmacist-recommended tapers were enacted upon by primary care providers at the patient visit. Baseline patient characteristics were not found to be predictors of a successful taper response. CONCLUSION: Clinical pharmacist intervention may decrease overutilization of PPIs and associated costs in the primary care setting. While a decrease in PPI use was observed in this study, these findings do not imply improvement in clinically meaningful patient outcomes.

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.

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.