Impact on patients' compliance with medication using prepacked blisters for multidrug medical therapy: I-COMPLY Study.

PURPOSE: Studies have supported the use of packaging interventions such as pillboxes or blister packs to improve medication adherence but have not evaluated the efficacy of these interventions in a population of low socioeconomic status. The aim of this study was to assess the effect of home-delivered pill packs on medication adherence in a low-income Black American population with Medicaid insurance. METHODS: This study was an open-label, randomized, controlled trial. The patient population studied included 80 patients followed by primary care physicians at the Cleveland Clinic. Patients were randomized to a study group who received delivery of their multidrug medical therapy, defined as a minimum of 4 medications daily, in prepackaged blisters or a control group who obtained their prescriptions from their routine pharmacy. RESULTS: The primary analysis compared the mean percentage of missed pills between the 2 groups using t-test analysis. The percentage of missed pills in the study group was significantly lower than in the control group (mean [SD]: 3.7% [6.0%] vs 17.4% [16.6%] missed daily pills; P < 0.001). The number of daily missed doses was also significantly lower in the study group (0.3 [0.5] vs 0.7 [0.6]; P = 0.002). Patients were on a mean of 8.1 (SD, 2.3) and 8.1 (SD, 2.6) medications in the study and control groups, respectively (P = 0.96). CONCLUSION: Delivery of prepackaged medications in a low-income Black American community was demonstrated to improve medication adherence. The use of prepackaged blisters for medication home delivery is a model that can be utilized on a larger scale for patients on multidrug medical therapy.

Evaluation of multidisciplinary weight loss shared medical appointments.

OBJECTIVES: A multidisciplinary weight loss shared medical appointment (SMA) was created to help patients with weight management. The study objective was to evaluate the change in weight in patients participating in weight loss SMAs. The secondary objective was to evaluate the change in patients' cardiometabolic risk factors. SETTING: The study took place in Beachwood, OH, at a family medicine clinic associated with an academic medical center. PRACTICE DESCRIPTION AND INNOVATION: Groups of 10 to 15 overweight and obese patients participated in weight loss SMAs in a family medicine clinic. The provider team included a family practice physician, a pharmacist, and a registered dietician. The pharmacist assisted with medication optimization to assist with weight management. EVALUATION: This retrospective observational study evaluated weight loss in patients who attended at least 1 weight loss SMA over a 9-month period. Weight loss and other cardiometabolic risk factors were compared from the time of the first SMA, 3 months after the first SMA, and at the end of the study period. RESULTS: A total of 222 patients attended at least 1 weight loss SMA. The mean weight loss was 4.0 ± 5.1 kg (3.8%) at 3 months and 4.4 ± 5.9 kg (4.1%) at the end of the study period. At 3 months, 38.7% of patients achieved 5% weight loss, and 41% of patients achieved 5% weight loss at the end of the study period. Patients also had a significant reduction in body mass index, blood pressure, and glycated hemoglobin. There was a significant correlation between the number of SMA visits attended and the amount of weight lost. CONCLUSION: Patients who attended a weight loss SMA lost weight and had modest improvements in cardiometabolic risk factors. Weight loss SMAs are a promising weight loss option to assist patients seen in the primary care setting.

Adjunct Antihyperglycemic Agents in Overweight and Obese Adults With Type 1 Diabetes.

OBJECTIVE: People with type 1 diabetes often have suboptimal glycemic control. The gold standard of treatment is basal-bolus insulin or subcutaneous insulin infusion via insulin pump. Although insulin therapy improves glycemic control, weight gain and hypoglycemia often limit achievement of hemoglobin A1C (A1C) goals. The number of people with type 1 diabetes who are overweight or obese is increasing, and there are many similarities between what was historically called type 1 and type 2 diabetes. Therefore, there is rationale for using antihyperglycemic agents that target other pathophysiological abnormalities to facilitate weight loss and improve glycemic control. DATA SOURCES: We performed a MEDLINE search from 1975 through October 2018 to identify articles that studied noninsulin agents in adults with type 1 diabetes and body mass index (BMI) ≥25 kg/m2. STUDY SELECTION AND DATA EXTRACTION: Identified articles were included if the study duration was ≥4 weeks, included ≥20 patients, and set mean baseline BMI ⩾25kg/m2. DATA SYNTHESIS: This review summarizes 32 clinical trials. Amylin mimetics, sodium-glucose-like transporter-2 inhibitors, and glucagon-like-peptide-1 receptor agonists demonstrate the greatest improvements in body weight and A1C. The most common adverse effects are hypoglycemia and ketosis. Relevance to Patient Care and Clinical Practice: Patients with type 1 diabetes may have interest in starting noninsulin agents. Clinicians need to be knowledgeable in the efficacy and adverse effect profile of these agents, specifically in people with type 1 diabetes. CONCLUSIONS: Adding noninsulin antihyperglycemic agents may benefit select overweight or obese adults with type 1 diabetes. These agents are off-label, and if used, close monitoring is essential.

Thromboembolic and Major Bleeding Events With Rivaroxaban Versus Warfarin Use in a Real-World Setting.

BACKGROUND: Although randomized trials demonstrate the noninferiority of rivaroxaban compared with warfarin in the context of nonvalvular atrial fibrillation (AF), little is known about how these drugs compare in practice. OBJECTIVE: To assess the relative effectiveness and safety of rivaroxaban versus warfarin in a large health system and to evaluate this association by time in therapeutic range (TTR). METHODS: We conducted a retrospective cohort study with propensity matching in the Cleveland Clinic Health System. The study included patients initiated on warfarin or rivaroxaban for thromboembolic prevention in nonvalvular AF between January 2012 and July 2016. The main outcomes were thromboembolic events and major bleeds. Analyses were stratified by warfarin patients' TTR. RESULTS: The cohort consisted of 472 propensity-matched pairs. The mean age was 73.6 years (SD = 11.7), and the mean CHADS2 score was 1.8. The median TTR for warfarin patients was 64%. In the propensity-matched analysis, there was no significant difference in thromboembolic or major bleeding events between groups. Among warfarin patients with a TTR <64% and their matched rivaroxaban pairs, there was also no significant difference in thromboembolic or major bleeding events. CONCLUSIONS: Under real-world conditions, warfarin and rivaroxaban were associated with similar safety and effectiveness, even among those with suboptimal therapeutic control. Individualized decision making, taking into account the nontherapeutic tradeoffs associated with these medications (eg, monitoring, half-life, cost) is warranted.