Applying RE-AIM to examine the impact of an implementation facilitation package to scale up a program for Veterans with chronic obstructive pulmonary disease.

BACKGROUND: US Veterans are four times more likely to be diagnosed with chronic obstructive pulmonary disease (COPD) compared to the civilian population with no care model that consistently improves Veteran outcomes when scaled. COPD Coordinated Access to Reduce Exacerbations (CARE) is a care bundle intended to improve the delivery of evidence-based practices to Veterans. To address challenges to scaling this program in the Veterans' Health Administration (VA), the COPD CARE Academy (Academy), an implementation facilitation package comprised of five implementation strategies was designed and implemented. METHODS: This evaluation utilized a mixed-methods approach to assess the impact of the Academy's implementation strategies on the RE-AIM framework implementation outcomes and the extent to which they were effective at increasing clinicians' perceived capability to implement COPD CARE. A survey was administered one week after Academy participation and a semi-structured interview conducted 8 to 12 months later. Descriptive statistics were calculated for quantitative items and thematic analysis was used to analyze open-ended items. RESULTS: Thirty-six clinicians from 13 VA medical centers (VAMCs) participated in the Academy in 2020 and 2021 and 264 front-line clinicians completed COPD CARE training. Adoption of the Academy was indicated by high rates of Academy session attendance (90%) and high utilization of Academy resources. Clinicians reported the Academy to be acceptable and appropriate as an implementation package and clinicians from 92% of VAMCs reported long-term utilization of Academy resources. Effectiveness of the Academy was represented by clinicians' significant increases (p < 0.05) in their capability to complete ten implementation tasks after Academy participation. CONCLUSIONS: This evaluation found that the use of implementation facilitation paired with additional strategies enhanced the capacity of clinicians to implement COPD CARE. Future assessments are needed to explore post-academy resources that would help VAMCs to strategize localized approaches to overcome barriers.

Applying RE-AIM to examine the impact of an implementation facilitation package to scale up a program for Veterans with Chronic Obstructive Pulmonary Disease.

Background: U.S. Veterans are four-times more likely to be diagnosed with Chronic Obstructive Pulmonary Disease (COPD) compared to the civilian population with no care model that consistently improves Veteran outcomes when scaled. COPD Coordinated Access to Reduce Exacerbations (CARE) is a care bundle intended to improve the delivery of evidence-based practices to Veterans. To address challenges to scaling this program in the Veterans' Health Administration (VA), the COPD CARE Academy (Academy), an implementation facilitation package comprised of four implementation strategies was designed and implemented. Methods: This evaluation utilized a mixed-methods approach to assess the impact of the Academy's implementation strategies on the RE-AIM framework implementation outcomes and the extent to which they were effective at increasing clinicians' perceived capability to implement COPD CARE. A survey was administered one week after Academy participation and a semi-structured interview conducted eight to 12 months later. Descriptive statistics were calculated for quantitative items and thematic analysis was used to analyze open-ended items. Results: Thirty-six clinicians from 13 VA medical centers (VAMCs) participated in the Academy in 2020 and 2021 and 264 front-line clinicians completed COPD CARE training. Adoption of the Academy was indicated by high rates of Academy completion (97%), session attendance (90%), and high utilization of Academy resources. Clinicians reported the Academy to be acceptable and appropriate as an implementation package and clinicians from 92% of VAMCs reported long-term utilization of Academy resources. Effectiveness of the Academy was represented by clinicians' significant increases (p < 0.05) in their capability to complete ten implementation tasks after Academy participation. Conclusions: This evaluation found that the use of implementation facilitation paired with additional strategies seemed to demonstrate positive implementation outcomes across all RE-AIM domains and identified areas for potential improvement. Future assessments are needed to explore post-academy resources that would help VAMCs to strategize localized approaches to overcome barriers.

Evaluation of an implementation package to deliver the COPD CARE service.

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide and is estimated to be the leading cause of death in the next 15 years. Patients with COPD suffer from persistent chronic cough, sputum production and exacerbations leading to deteriorating lung function, worsening quality of life and loss of independence. While evidence-based interventions exist to improve the well-being of patients with COPD, incorporation of these interventions into routine clinical care is challenging. Chronic Obstructive Pulmonary Disease Coordinated Access to Reduce Exacerbations (COPD CARE) is a team-based, coordinated care transitions service integrating evidence-based interventions for COPD management within the patient care delivery model to reduce readmissions. This evaluation considers the process of scaling the COPD CARE service across medical facilities using an implementation package designed for service expansion. The implementation package was developed at the United States Veterans Health Administration and implemented at two medical centres. Core dissemination and implementation science methods were applied to guide design and delivery of the implementation package.The aims of this evaluation were to (1) evaluate the impact of the implementation package on use of evidence-based interventions for COPD management and (2) explore clinician perceptions of the implementation package. This prospective mixed-methods quality improvement project included two Plan Do Check Act (PDCA) cycles conducted over a 24-month period. Electronic health record data demonstrated significant improvements in the count of evidence-based interventions incorporated into routine clinical care after training completion (p<0.001), offering preliminary effectiveness of the package to improve uptake of best practices for COPD management. Clinician perceptions of the implementation package, measured by questionnaire at multiple time points, demonstrated significant improvements for all scales at the end of the final PDCA cycle. Clinicians described the implementation package as positively impacting clinician confidence, interprofessional collaboration and patient care delivery.

Assessing the Impact of Comprehensive Medication Management on Achievement of the Quadruple Aim.

Nonoptimized medication regimens cost patients and payors in the United States more than $528 billion in additional health care expenses each year. Comprehensive medication management is a patient-centered approach to medication optimization delivered by a clinical pharmacist working with the patient, physicians, and other members of the health care team. Comprehensive medication management ensures medications are assessed for appropriateness, effectiveness, and safety given the patient's clinical status, comorbidities, and other medications, as well as the patient's ability to take the medications as intended and adhere to the regimen. This article reviews the growing body of literature demonstrating the value of comprehensive medication management in achieving the quadruple aim of health care: better care, reduced health care costs, an improved patient experience, and provider well-being.

Implementation and Effect of a Pharmacist-to-Pharmacist Transitions of Care Initiative on Ambulatory Care Sensitive Conditions.

BACKGROUND: One of the most vulnerable times in a patient's encounter with a health care system is during transitions of care (TOC), defined by the Joint Commission as the movement of a patient from one health care provider or setting to another. The use of a clinical pharmacist as a member of the care transitions team has received focused attention and shown improved benefit. OBJECTIVE: To determine the effect of a large-scale pharmacist-to-pharmacist TOC model where inpatient clinical pharmacists identify patients during a hospital stay, provide evidence-based care and education, and then coordinate follow-up with an outpatient clinical pharmacist who provided comprehensive medication management (CMM) under a scope of practice. METHODS: This was a multisite, single health care system, quasi-experimental, matched interrupted time series design study conducted at an integrated Veterans Affairs (VA) health care system. Patients admitted with a primary or secondary diagnosis of diabetes, hypertension, chronic obstructive pulmonary disease (COPD) and heart failure (HF) were included for enrollment. Clinical pharmacists rounding on inpatient medical teams provided evidence-based recommendations to optimize medications while coordinating follow-up by an outpatient clinical pharmacy specialist within 10 days of discharge for CMM. The primary endpoint of this study was to determine the effect on the composite all-cause 30-day acute care utilization rate (emergency department [ED] visit or hospital readmission) for patients discharged with a primary or secondary diagnosis of diabetes, hypertension, COPD, and HF compared with a comparator group of patients with similar discharge diagnosis before implementation of the TOC program. RESULTS: 484 patients (242 in each group, with 366 heart failure, 66 COPD, 10 hypertension, and 42 diabetes) were included for analysis. For the primary outcome of composite 30-day, all-cause acute care utilization rates, no statistically significant difference was identified, with 26.9% of patients in the intervention group and 28.9% in the historical group readmitted or seen in the ED within 30 days of discharge (P = 0.6852). Outcomes for the HF index acute care utilization rate (i.e., admission for the same disease state discharged with), including 30-day index readmissions (P = 0.0014), 30-day index ED visits (P = 0.0047), and 90-day index readmissions for HF (P < 0.0001) were significantly reduced. CONCLUSIONS: Our study is one of the first to identify at-risk patients using rounding clinical pharmacists in the acute care arena and coordination of care systematically with a clinical pharmacy specialist practicing under a scope of practice targeted for CMM. Although the overall primary endpoint was not met, a reduction in acute care utilization rates for HF at 30 and 90 days can be achieved. DISCLOSURES: No outside funding supported this research. The authors report no conflicts of interest.

Perceptions of Integration of the Clinical Pharmacist into the Patient Care Medical Home Model.

INTRODUCTION: The patient-centered medical home (PCMH) model is a multidisciplinary, team-based approach to healthcare that focuses on actively involving the patient in clinical decision making. The Veterans Health Administration (VA), while desiring to be a national leader in the delivery of primary care services, used the principles of the PCMH model to design the patient-aligned care team (PACT). The purpose of this study, was to explore the perception of the PACT members after integration of a clinical pharmacist to the PACT. METHODS: This was a single-center cross-sectional study conducted at an integrated Veterans Health Administration system. We electronically surveyed PACT staff practicing within VA-Tennessee Valley Health Care System as of October 1, 2016 using a modified version of the Medicine Medication Use Processes Matrix (MUPM) containing 19 items on five theoretical grouping of processes (evaluation and management, monitoring, medication review, documentation, and education) and two groupings(clinician satisfaction and access). RESULTS: Ninety-one complete responses were received. Perceptions were positive, with 79% rated as either 4 ("moderate contribution") or 5 ("major contribution"). Individual responses based on discipline, with the exception of the medical support assistant were rated positive, specifically job satisfaction. CONCLUSIONS: This study evaluated the perceptions of clinical pharmacist integration into the PACT model. Respondents perceived clinical pharmacist beneficial.

An Innovative Approach to Addressing the HIV Care Continuum: Implementation of a Clinical Pharmacy Resident in a Veterans Affairs HIV Specialty Clinic.

PURPOSE: Engagement of patients in the HIV care continuum and adherence to antiretroviral therapy (ART) continue to limit successful viral suppression. Innovative practices to improve this continuum and ameliorate potential physician shortages are needed. The objective of this evaluation was to determine the clinical benefits of incorporating pharmacy resident involvement on a multidisciplinary team in caring for patients with HIV. METHODS: A single-center pre-post cohort pilot evaluation was conducted at the Tennessee Valley Healthcare Systems VA Medical Center. Patients were enrolled in an HIV pharmacotherapy clinic implemented by an ambulatory care pharmacy resident. The primary end point of the evaluation was the percentage of patients achieving an undetectable plasma HIV viral load after enrollment. Secondary end points included change from baseline in CD4 T-cell count and self-reported adherence. RESULTS: A total of 55 patients were seen in the HIV pharmacotherapy clinic over a 28-week evaluation period. Of those patients with detectable viral load at enrollment, 70% reached viral suppression during follow-up, with a significant 0.75 log10 decrease in the median viral load ( P < .0001 for both). The median CD4 T-cell count increased from 464 to 525 cells/mm3 ( P = .01). Reported adherence, assessed using the Visual Analogue adherence Scale (VAS) increased significantly ( P = .0001). CONCLUSION: After enrollment in an HIV pharmacotherapy clinic, a significant decrease in viral load was seen, as were improvements in secondary end points of CD4 T cells and adherence. These data demonstrate the clinical benefits of pharmacy resident involvement on a multidisciplinary team in caring for patients with HIV.

Oral Acyclovir in the Treatment of Verruca.

OBJECTIVE: To describe a case in which persistent plantar warts resolved after a ten-day treatment course of oral acyclovir prescribed for herpes zoster. CASE SUMMARY: A 49 year-old Caucasian female with non-significant past medical history presented to the podiatry clinic for treatment of verrucae. Debridement was performed and monochloroacetic acid was applied to affected areas seven times over seven months. The patient was diagnosed and treated for herpes zoster with acyclovir for ten days. Following acyclovir completion, only one verruca remained with complete resolution at the next follow-up podiatry visit. DISCUSSION AND CONCLUSION: Few previous trials have supported the use of acyclovir cream in treatment-resistant plantar warts. However, no case reports to date describe the efficacy of oral acyclovir in the treatment of verruca. While a causal relationship has not been solidified between verrucous lesion resolution and treatment with acyclovir, it can be inferred and warrants additional attention.

Limitations of A1c Interpretation.

Hemoglobin A1c is the measurement of glycated hemoglobin and can aid in both the diagnosis and continued management of diabetes mellitus. Accurate glycosylated hemoglobin A1c (A1c) measurements are an essential part of decision making in the diagnosis and treatment of type 2 diabetes mellitus. Although national standards exist to eliminate technical error with A1c testing, multiple patient conditions can falsely decrease or elevate the A1c. In this review, we discuss the methods to measure A1c and the corresponding conditions that can affect the clinical utility of the test. Conditions that affect the A1c can be either those that impair erythrocyte production or alter the normal process of glycation. Some variation also has been associated with patient ethnicity and even with normal aging. We describe alternatives to A1c testing for the above clinical scenarios in an effort to make the practicing clinician aware of alternatives for glucose evaluation.

Implementation of a pharmacotherapy clinic into the patient centered medical home model by a second year pharmacy resident.

OBJECTIVE: Evaluate the impact a post graduate year 2 (PGY-2) pharmacy resident run clinic incorporated into the patient centered medical home (PCMH) model may have on achieving reduction in glycosylated hemoglobin (A1c), low density lipoprotein (LDL), and systolic and diastolic blood pressures (SBP and DBP) over six months in type 2 diabetics within the Veterans Health Administration (VHA). METHODS: This was a prospective, quasi-experimental study enrolling type 2 diabetics referred to the pharmacist-run clinic not meeting American Diabetes Association (ADA) treatment goals for A1c less than 7%, and/or LDL less than 100 mg/dL, and/or blood pressure (BP) less than 130/80 mmHg. Once signed informed consent was obtained, veterans were followed according to usual standards of care for six months with visits and lab follow-up at baseline, three, and six months (±45 days). The primary endpoint was the change in HbA1c, LDL, and BP from baseline to six months. Secondary endpoints included the change from baseline to three months in A1c, LDL, and BP and the percentage of patients who achieved ADA treatment goals for A1c, LDL, and BP at six months. RESULTS: Among the 24 patients included in the data analysis (100% male, 92% Caucasian), A1c decreased significantly from 7.56% to 7.19% (p = 0.0122) as well as LDL from 92.9 to 68.5 mg/dL (p = 0.0023), SBP from 131 to 124 mmHg (p = 0.0302), and DBP from 71.5 to 64.8 mmHg (p = 0.0012). The proportion of patients at recommended goal A1c <7% rose from 17% to 38%, as did the percentage of patients meeting ADA goals for LDL (75% to 96%), SBP (46% to 71%), and DBP (79% to 92%). CONCLUSION: Patients followed in a resident run pharmacotherapy clinic in the PCMH model with interventions over six months showed significant improvements in clinical endpoints including A1c, LDL, SBP, and DBP.

Designing a resident research program.

PURPOSE: The development of a resident research program and the role of the residency research advisory board (RRAB) in the program are described. SUMMARY: Over the past decade, there have been numerous barriers to successfully implementing a residency research program. An RRAB was subsequently developed to assist with research mentoring to help prepare residents to incorporate research into future positions. Within this board, one clinical pharmacy practitioner or preceptor serves as the research coordinator and acts as chair and liaison to the institutional review board (IRB) and research and development (R&D) committee. All members of the RRAB function as research experts in various aspects of the research process. The RRAB comprises three members to navigate IRB and R&D paperwork, generate and develop research ideas, create relationships with institutional research committees, educate pharmacy residents in a consistent manner on research methods in a longitudinal fashion, provide mentorship to preceptors, and facilitate service-related communication on our research timelines, plans, local and distant presentations, and other related efforts. The development of the resident research program and the RRAB have resulted in an improvement in the level of research conducted by our residents and preceptors. Due to the support of the RRAB, residents are submitting and presenting posters at local, state, and national meetings as well as submitting manuscripts to and publishing manuscripts in health care journals. CONCLUSION: Development of an RRAB increased residents' manuscript publication and poster presentation rates and facilitated the research process.

Comparing dosing of basal insulin analogues detemir and glargine: is it really unit-per-unit and dose-per-dose?

OBJECTIVE: To review the available evidence regarding dosing conversion between glargine and detemir in an effort to assist clinicians in performing dosing conversion. DATA SOURCES: A MEDLINE literature search was performed using the search terms glargine and detemir for articles published through August 2013. STUDY SELECTION AND DATA EXTRACTION: All English-language clinical trials were reviewed for inclusion of dosing and/or pharmacokinetic data. DATA SYNTHESIS: A total of 7 large (n ≥ 258) randomized controlled trials (RCTs) comparing glargine and detemir in patients with type 1 and 2 diabetes had dosing equivalency data available. In these 7 RCTs, on average, a 38% higher detemir dose was required (range = 8.0%-77.2%) to achieve glucose control comparable to that achieved with glargine. A 24-hour isoglycemic clamp study conducted in 11 patients with type 1 diabetes demonstrated that the duration of action of detemir is dose dependent, with increasing doses of detemir resulting in increased duration of action of detemir. Pharmacokinetic studies conducted in patients with type 2 diabetes are conflicting, although the majority of evidence suggests that glargine provides a longer duration of glycemic control as compared with detemir. CONCLUSIONS: When performing conversion between glargine and detemir, prescribers should be aware that higher doses of detemir as compared with glargine may be necessary to achieve the same glycemic control. Additionally, twice-daily injections of detemir should be considered in clinical situations in which glucose control appears to decline after 12 hours, especially with doses ≤0.4 units/kg/d in patients with type 1 diabetes.

Pharmacoeconomic analysis of the diabetes initiative program: a pharmacist-physician collaborative care model.

BACKGROUND: Diabetes treatment cost increased 41% from 2007 to 2011. Pharmacists have provided collaborative diabetes management for decades with improvement in disease-related end points. Few have reported economic benefits of pharmacist management of type 2 diabetes. OBJECTIVE: The purpose was to determine if cost savings associated with hemoglobin A1c (A1C) and systolic blood pressure (SBP) change outweighed programmatic pharmacist-physician collaborative care model costs. METHODS: This cost analysis of a 12 month, prospective, multicenter, observational study included English-speaking adults, 18 years or older, with type 2 diabetes mellitus, a life expectancy >1 year, and either a A1C >7%, SBP >130 mm Hg, diastolic blood pressure >80 mm Hg, or low-density lipoprotein concentration >100 mg/dL. Pregnant patients were excluded. Primary analysis outcome was average cost per outcome, ratio of net cost (numerator) and percentage achieving outcomes (denominator). Assessment outcomes included A1C reduction by at least 1% and SBP reduction by at least 5.6 mm Hg. RESULTS: 206 patients were seen by pharmacists during 1612 encounters (mean = 7.8 encounters/patient). Pharmacists spent 983 hours caring for type 2 diabetes patients (mean 3.8 hours/patient). Base case net labor and program costs per patient were -$66.77 and $106.81, respectively. Improvement in A1C and SBP yielded $421.01 in cost savings per patient. Labor and program average costs per patient for each outcome achieved were -$100.40 and $160.61, respectively. CONCLUSIONS: This multisite pharmacist-physician collaboration in diabetes management showed cost savings when assessing pharmacist labor costs alone. Total program costs, including overhead, slightly increased cost of care.

Pharmacist-physician collaboration for diabetes care: the diabetes initiative program.

BACKGROUND: Multiple complications can arise secondary to poor control of glucose, blood pressure, and cholesterol in a patient with diabetes. OBJECTIVE: To evaluate the effect of a pharmacist-physician collaboration on attainment of diabetes-related measures of control. METHODS: This was a prospective, multicenter, cohort study. Patients were enrolled from 7 practice sites throughout Tennessee if they had been diagnosed with type 2 diabetes, were aged 18 years or older with a life expectancy greater than 1 year, and were English speaking. Pregnant women were excluded. Patients were followed for 12 months following enrollment by informed consent. The pharmacist-physician collaboration method was established prior to study initiation. Primary outcomes included hemoglobin A1c (A1C), number of patients with A1C less than 7%, and percentage of patients with A1C greater than 9%. RESULTS: Of the 206 patients enrolled, the mean age was 59.73 years, and most were male (59.71%) and white (66.02%). The A1C was reduced by an average of 1.16% (p < 0.0001). The proportion of patients with A1C less than 7% increased from 12.75% at baseline to 36.76% at study conclusion (p = 0.0002). The proportion of patients with A1C greater than 9% decreased from 34.15% to 16.50%, (p < 0.0001). CONCLUSIONS: Pharmacist-physician collaborative management at multiple practice locations and types of setting (eg, private, academic, Veterans Affairs medical center) has a positive impact on glycemic control and diabetes-related health maintenance. This was accomplished without increasing the total number of antihyperglycemic agents prescribed and without an increase in patient-reported episodes of hypoglycemia.

Clinical utility and tolerability of linagliptin in diabetic patients.

BACKGROUND: The purpose of this paper is to review the efficacy, safety, and tolerability of linagliptin in the management of hyperglycemia in adults with type 2 diabetes mellitus. METHODS: A Medline search was performed using the keywords "linagliptin" and "type 2 diabetes" for articles published September 2010 through July 2012. The literature search was limited by the following criteria: articles' publication in the English language, clinical trials, randomized controlled trials, and research conducted in humans. RESULTS: A review of the data for linagliptin in the treatment of type 2 diabetes as monotherapy or in combination with other antidiabetic therapies suggests clinical efficacy in terms of reductions in glycosylated hemoglobin, fasting plasma glucose, and postprandial glucose. Most adverse events with linagliptin are considered to be mild to moderate in nature. Although linagliptin therapy may offer a low risk of hypoglycemia, the risk increases when it is used in combination with insulin secretagogues. Linagliptin can generally be considered weight neutral, but a weight increase was observed when linagliptin was used in combination with a thiazolidinedione. CONCLUSION: Linagliptin is a once-daily oral medication used for the treatment of type 2 diabetes. The use of linagliptin as monotherapy or in combination with metformin, sulfonylureas, or pioglitazone led to improvement in glycemic control and was well tolerated by most patients.

Evaluation of Modification of Diet in Renal Disease Study and Cockcroft-Gault equations for sitagliptin dosing.

BACKGROUND: Assessment of kidney function is necessary to determine appropriate dosing regimens. While the Cockcroft-Gault (CG) equation is used to calculate the estimated creatinine clearance (eCLCr) for drug dosing, the Modification of Diet in Renal Disease (MDRD) Study equation has recently been advocated. Sitagliptin is a dipeptidyl-peptidase IV inhibitor with dose adjustments based on eCLCr. We assessed discordance in sitagliptin doses recommended using MDRD and CG equations. METHODS: Adult patients with type 2 diabetes mellitus were included. Estimated glomerular filtration rate (eGFR) individualized for body surface area (eGFR-BSA) and eCLCr were calculated by the MDRD and CG equations, respectively, and sitagliptin dose was determined. Discordance in doses recommended by method were compared overall and by subgroup based on eCLCr category. RESULTS: A total of 121 patients were included: 52% male, 90% white, mean age 61 ± 12 years, weight 93 ± 19 kg, BSA 2.0 ± 0.22 m2 and body mass index (BMI; calculated as kg/m2) 33 ± 7. Mean eGFR-BSA was 76 ± 19 ml/min and eCLCr was 68 ± 17 ml/min. Discordance in sitagliptin dose was observed in 11 patients (9%) with MDRD compared with CG. All patients with eCLCr =50 would have received a higher dose using MDRD, while patients with eCLCr >50 would have received a lower dose. CONCLUSIONS: Overall there was agreement in sitagliptin dose using MDRD and CG equations. Discrepancies resulted in underestimation of sitagliptin dose at eCLCr above 50 ml/min and overestimation at lower eCLCr. Clinical implications are the potential for excessive dosing of sitagliptin and other agents with similar dose stratification by eCLCr in individuals with kidney dysfunction.

Comparison of hemoglobin A1c goal achievement with the addition of pioglitazone to maximal/highest tolerated doses of sulfonylurea and metformin combination therapy.

OBJECTIVES: It has been proposed that the combination of thiazolidinedione (TZD) therapy to metformin and sulfonylurea is beneficial due to each medication having a unique mechanism of action. Within the Veterans Affairs Hospital, specific criteria of use define when TZD therapy can be initiated. Most patients who receive TZD therapy have failed other medications prior to use. The primary objective of this study was to determine the percentage of patients achieving the American Diabetes Association (ADA) goal hemoglobin A1c (A1c) of less than 7% with the addition of pioglitazone to the maximal/highest tolerated doses of sulfonylurea and metformin combination therapy. METHODS: This was a six healthcare system retrospective, descriptive, analysis of type 2 diabetic patients (DM-2). Patients must have received the maximal/highest tolerated doses of sulfonylurea and metformin combination therapy and have been TZD naïve or off TZD therapy for a minimum of 6 months, a baseline A1c greater than 7%, a repeat A1c at 3 and 6 months available, and deemed medication compliant. RESULTS: We evaluated 98 total patients. The percentage of veteran patients achieving ADA goal A1c of less than 7% after the addition of pioglitazone reached statistical significance at both 3 and 6 months post TZD initiation. The mean reduction in A1c post-pioglitazone initiation was 0.67% (SD ± 0.92) and 0.78% (SD ± 0.94) at 3 and 6 months, respectively. CONCLUSION: The addition of pioglitazone to veteran patients who were already receiving maximal/highest tolerated doses of sulfonylurea was able to achieve a higher percentage in with the ADA goal A1c of less than 7%. Initiating pioglitazone in patients with an A1c of 9% or greater did not reach statistical significance in achieving an A1c less than 7%. The initial starting dose of pioglitazone 30 mg can be considered as compared to 15 mg daily if contraindications do not exist.

Place in therapy for liraglutide and saxagliptin for type 2 diabetes.

BACKGROUND: The release of incretin based therapeutic entities has brought the possibility to offer control of the disease by augmenting a natural process in the body that has become deficient with type 2 diabetes. Liraglutide, an incretin mimetic, and saxagliptin, a dipeptidyl peptidase-4 inhibitor, have been approved and introduced to the market. OBJECTIVES: To (a) review the efficacy and safety data of for the treatment of type 2 diabetes, and (b) recommend their place in therapy. METHODS: A MEDLINE search was performed using key words "liraglutide" and "saxagliptin" for articles published and available through July 2010. RESULTS: The Liraglutide Effect and Action in Diabetes (LEAD) trials encompassed six published phase 3 trials that evaluated the efficacy and safety of liraglutide either as monotherapy or in addition to oral hypoglycemic medications. Saxagliptin has been studied as monotherapy and in combination to oral hypoglycemic medications. CONCLUSIONS: Liraglutide has been shown to improve glucose control and weight loss compared to other pharmacologic treatments with diabetes and may offer improved control with a decrease in daily dosing compared to exenatide. Saxagliptin improved glucose control as monotherapy or in combination with medications other than sulfonylurea. Saxagliptin has not been evaluated head to head with sitagliptin other than in combination with metformin where saxagliptin was deemed noninferior. Given the lack of long-term safety and clinical data compared to current treatment modalities, and more importantly the overall cost of the therapies to the health care system, a global recommendation for their use cannot be issued.