Significant publications in diabetes pharmacotherapy and technology in 2020.

INTRODUCTION: The most significant articles on diabetes pharmacotherapy and technology in the peer-reviewed literature from 2020, as determined by a panel of pharmacists with expertise in diabetes care and education, are summarized. AREAS COVERED: Members of the Association of Diabetes Care and Education Specialists Pharmacy Community of Interest were selected to review articles published in prominent peer-reviewed journals in 2020 that most impacted diabetes pharmacotherapy and technology. A list of 37 nominated articles were compiled (22 in diabetes pharmacotherapy and 15 in diabetes technology). Based on discussion among the authors, the articles were ranked based on significant contribution, impact, and diversity to diabetes pharmacotherapy and technology. The top 10 highest ranked publications (n = 6 for diabetes pharmacotherapy and n = 4 in diabetes technology) are summarized in this article. EXPERT OPINION: With the significant number of publications in diabetes care and education, it can be challenging and overwhelming to remain current with published literature. This review article may be helpful in identifying key articles in diabetes pharmacotherapy and technology from the year 2020.

Evaluating patient knowledge and use of medication disposal in a Chinatown community pharmacy.

BACKGROUND: Drug take-back programs (TBPs) provide the opportunity to safely dispose of unused or expired medications (UEMs), potentially reducing the risk of environmental harm and morbidity. Data on patient perceptions and participation are limited, especially in underserved Asian populations. OBJECTIVE: This study aimed to evaluate medication disposal perceptions and behaviors through a free mail-in medication disposal program among patients in a Chinatown community pharmacy. METHODS: An institutional review board-approved Web-based survey was developed in English and Mandarin. Student pharmacists tabled at a Chinatown community pharmacy in Boston, Massachusetts. The patients were educated about safe medication disposal practices and invited to take the anonymous survey assessing medication disposal needs, practices, and beliefs accessed in person by using a quick response code. On survey completion, the patients were offered a disposal envelope. Envelope tracking numbers were used to evaluate medication disposal over a 9-month follow-up period. RESULTS: Sixty-two patients of Asian descent completed the survey, and 42 (67.7%) accepted an envelope. Forty-seven patients (75.8%) reported having access to UEMs. More than half indicated that TBPs were important to alleviate the risk of medication and environmental consequences despite low previous use (6.5%). Most patients felt more aware of TBPs (72.6%), an increased sense of the importance of TBPs (74.2%), and intent to participate in TBPs (69.4%), including using the envelope (75.8%). Three (4.8%) patients disposed of medications using the study-provided envelope during the 9-month follow-up. CONCLUSION: Patient education about TBPs and their importance may be effective in increasing TBP awareness in a population with low TBP use. Free disposal envelopes did not seem to be highly used within 9 months of receipt despite interest and access to UEMs. Future research should continue offering programs at no charge, evaluating barriers to free TBP use, and implementing follow-up procedures to increase envelope use.

Real-world impact on monthly glucose-lowering medication cost, HbA1c, weight, and polytherapy after initiating a GLP-1 receptor agonist.

OBJECTIVE: Glucagon-like peptide-1 (GLP-1) receptor agonists are preferred injectable therapies for type 2 diabetes, but their high cost is an area of concern. This study evaluated monthly glucose-lowering medication cost and clinical impact after initiating a GLP-1 receptor agonist. DESIGN: A retrospective, pre-post cohort study evaluated monthly glucose-lowering medication cost, glycated hemoglobin (HbA1c), weight, and polytherapy impact (name, dose, and number of daily doses or injections) when a GLP-1 receptor agonist was initiated (baseline) and after 6-12 months (follow-up). The population was analyzed overall and as subgroups, based on baseline medication regimen and demographics. SETTING AND PARTICIPANTS: The study was performed at 8 ambulatory care sites (7 federally qualified health centers and a Program of All-Inclusive Care for the Elderly) in the greater Boston, MA, area. Patients were included in the analyses (n = 120) if they had a documented diagnosis of type 2 diabetes, were 18 years of age or older, had an HbA1c ≥ 7.5% measured within 3 months prior to the initiation of a GLP-1 receptor agonist, and an HbA1c measured 6 to 12 months following the initiation of a GLP-1 receptor agonist. OUTCOME MEASURES: Primary outomes were changes in glucose-lowering medication cost, HbA1c, and weight. Secondary outcome analyses included the impact to the glucose-lowering medication regimen in terms of dose, number of medications, and number of daily doses or injections. RESULTS: The study population was largely female, aged 55.8 ± 11.7 years, obese, 76% non-Caucasian, equally English and non-English speaking, had a high tablet and injection burden, and had an average baseline HbA1c of 10%. After the addition of a GLP-1 receptor agonist, monthly glucose-lowering medication cost increased $586.86 (overall), $741.69 (oral only baseline regimen), and $530.55 (insulin ± oral baseline regimen) (all P < 0.001). Mean decrease in HbA1c was 1.7% (18 mmol/mol) (P < 0.001) and was similar across all subgroups. Weight decreased overall (-1.8 kg, P < 0.001), and there was a significant shift toward taking fewer oral agents and insulin and fewer daily injections. No statistically significant differences in the primary outcomes were noted in terms of age, gender, English-speaking status, or race. CONCLUSION: Although a positive impact was observed in glycemic control, weight, and reduced polytherapy 6-12 months after initiating a GLP-1 receptor agonist, the increase in monthly glucose-lowering medication cost was significant and may serve as a barrier to treatment.

Evaluation of vitamin B12 monitoring in patients on metformin in urban ambulatory care settings.

BACKGROUND: Previous studies linked metformin use to vitamin B12 deficiency and demonstrated that the prevalence of vitamin B12 monitoring remains low. OBJECTIVE: This study aimed to assess the occurrence of monitoring vitamin B12 levels in a diverse population. METHODS: This was a retrospective chart review of adult patients with type 2 diabetes on metformin doses ≥ 1000 mg for ≥ 6 months at five Federally Qualified Health Centers (FQHC) and one Program of All-Inclusive Care for the Elderly (PACE). Charts were reviewed for occurrence of monitoring vitamin B12 levels in the past 5 years. Data collected included patient demographics, laboratory data, other potential vitamin B12 level lowering agents, active prescription for vitamin B12 supplementation, concomitant diabetes medications and metformin total daily dose. RESULTS: Of the 322 patients included, 25% had a vitamin B12 level measured in the previous five years. Among the patients with a vitamin B12 level, 87.7% were within the normal range (>350 pg/mL), 11.1% were low (200-300 pg/mL), and only one patient (1.2%) was deficient (<200 pg/mL). These patients were older (69.2 vs. 56.4, p<0.001); more likely to be white (56.8% vs. 37.8%, p=0.04); and more likely to use proton pump inhibitors (34.6% vs. 20.7%, p=0.02) and vitamin B12 supplementation (27.2% vs. 4.6%, p<0.001). Vitamin B12 monitoring differed between the FQHC (15.2%) and PACE (97.4%) sites (p<0.001). Each greater year of age was associated with a 5% increased odds of vitamin B12 monitoring (a OR: 1.05; 95% CI: 1.02-1.08). CONCLUSIONS: The majority of patients seen at the FQHC sites did not have vitamin B12 levels monitored, however, most of the patients who were monitored had normal vitamin B12 levels, which may warrant extending the monitoring time. This finding may also support monitoring patients who have additional risk factors for vitamin B12 deficiency such as concurrent medication use with other vitamin B12 lowering agents or clinical symptoms of deficiency such as peripheral neuropathy. Future studies are needed to determine appropriate frequency of monitoring.

Evaluation of vitamin B12 monitoring in patients on metformin in urban ambulatory care settings

Background: Previous studies linked metformin use to vitamin B12 deficiency and demonstrated that the prevalence of vitamin B12 monitoring remains low. Objective: This study aimed to assess the occurrence of monitoring vitamin B12 levels in a diverse population. Methods: This was a retrospective chart review of adult patients with type 2 diabetes on metformin doses ≥ 1000 mg for ≥ 6 months at five Federally Qualified Health Centers (FQHC) and one Program of All-Inclusive Care for the Elderly (PACE). Charts were reviewed for occurrence of monitoring vitamin B12 levels in the past 5 years. Data collected included patient demographics, laboratory data, other potential vitamin B12 level lowering agents, active prescription for vitamin B12 supplementation, concomitant diabetes medications and metformin total daily dose. Results: Of the 322 patients included, 25% had a vitamin B12 level measured in the previous five years. Among the patients with a vitamin B12 level, 87.7% were within the normal range (>350 pg/mL), 11.1% were low (200-300 pg/mL), and only one patient (1.2%) was deficient (<200 pg/mL). These patients were older (69.2 vs. 56.4, p<0.001); more likely to be white (56.8% vs. 37.8%, p=0.04); and more likely to use proton pump inhibitors (34.6% vs. 20.7%, p=0.02) and vitamin B12 supplementation (27.2% vs. 4.6%, p<0.001). Vitamin B12 monitoring differed between the FQHC (15.2%) and PACE (97.4%) sites (p<0.001). Each greater year of age was associated with a 5% increased odds of vitamin B12 monitoring (a OR: 1.05; 95% CI: 1.02-1.08). Conclusions: The majority of patients seen at the FQHC sites did not have vitamin B12 levels monitored, however, most of the patients who were monitored had normal vitamin B12 levels, which may warrant extending the monitoring time. This finding may also support monitoring patients who have additional risk factors for vitamin B12 deficiency such as concurrent medication use with other vitamin B12 lowering agents or clinical symptoms of deficiency such as peripheral neuropathy. Future studies are needed to determine appropriate frequency of monitoring

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The stats are in: an update on statin use in COPD.

COPD is a chronic inflammatory disease of the lungs associated with an abnormal inflammatory response to noxious particles, the most prevalent of which is cigarette smoke. Studies have demonstrated that cigarette smoking is associated with activation of the bone marrow, and chronic smoking can lead to the inflammatory changes seen in COPD. Due to the inflammatory nature of the disease, medications affecting the inflammatory pathway may have clinical benefit and are being evaluated. One such class of medications, HMG-CoA reductase inhibitors, have been evaluated in the COPD population. Early studies have suggested that HMG-CoA reductase inhibitors have a variety of benefits in COPD including improvements in inflammatory markers, exacerbation rates, and mortality rates. However, the majority of this data comes from retrospective cohort studies, suggesting the need for randomized controlled trials. Recently, two randomized controlled trials, STATCOPE and RODEO, evaluated the benefit of HMG-CoA reductase inhibitors in the COPD population and found no benefit in exacerbation rates and vascular or pulmonary function, respectively. These results are reflected in practice guidelines, which do not support the use of HMG-CoA reductase inhibitors for the purpose of reducing COPD exacerbations.

Clinical use of aclidinium in patients with COPD.

Chronic obstructive pulmonary disease (COPD) is the sixth-leading cause of death in the US. The Global initiative for Chronic Obstructive Lung Disease (GOLD) guidelines provide evidence-based recommendations for the clinical management of chronic COPD. Long-acting inhaled bronchodilators continue to be the mainstay of current management. Aclidinium bromide (Tudorza™ Pressair™) joins tiotropium as a long-acting inhaled antimuscarinic bronchodilator approved by the US Food and Drug Administration for the maintenance treatment of COPD. Early studies demonstrated aclidinium's significant bronchodilatory effects supporting once-daily dosing; however, two Phase III studies, Aclidinium Clinical Trial Assessing Efficacy and Safety in Moderate to Severe COPD Patients (ACCLAIM/COPD) I and ACCLAIM/COPD II, in which patients were randomized to receive aclidinium 200 µg daily, failed to achieve the minimal clinically important difference in improvement of trough forced expiratory volume in 1 second (FEV1), suggesting the need for higher doses or more frequent dosing. Additional studies - Aclidinium to Treat Airway Obstruction in COPD Patients (ATTAIN) and Aclidinium in Chronic Obstructive Respiratory Disease (ACCORD) I - were undertaken to compare 200 and 400 µg twice-daily dosing. The mean improvements from baseline in trough FEV1 in the 400 µg groups were +129 mL over 24 weeks and +124 mL over 12 weeks in ATTAIN and ACCORD I, respectively. Aclidinium also had beneficial effects on health-related quality of life and other endpoints, such as rescue medication use and rates of exacerbations. Aclidinium bromide inhalation powder is generally well tolerated in patients with COPD, with headache, cough, diarrhea, and rhinosinusitis among the most commonly reported adverse events. Cardiovascular side effects were rarely reported. Patient satisfaction studies found that patients using the aclidinium delivery device had fewer errors affecting drug delivery than those using the tiotropium device and, overall, the aclidinium device was preferred to the tiotropium device. In conclusion, aclidinium bromide is approved for use in the US at a dose of 400 µg twice daily and is a promising alternative to tiotropium.

Emerging Therapeutic Options for the Management of COPD.

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide and is projected to be the third by 2020. COPD is characterized by chronic airflow limitation caused by airway inflammation and parenchymal destruction that is usually progressive. Inhaled bronchodilators continue to be the mainstay of the current management of COPD. Safety and efficacy data of the recently approved medications including aclidinium, glycopyrronium, roflumilast, and indacaterol are reviewed here.

Roflumilast: a novel treatment for chronic obstructive pulmonary disease.

OBJECTIVE: To evaluate the efficacy and safety of roflumilast, approved by the Food and Drug Administration in February 2011 as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. DATA SOURCES: Literature was retrieved through MEDLINE (1977-December 2011), using the terms roflumilast and COPD. In addition, US government Web sites, including clinicaltrials.gov and fda.gov, were reviewed for pertinent information. Lastly, reference citations from publications identified were reviewed. STUDY SELECTION AND DATA EXTRACTION: All articles published in English identified from the data sources were evaluated. For the evaluation of clinical efficacy and safety, only Phase 3 studies were included. DATA SYNTHESIS: Limited treatment options are available for patients with moderate-to-severe COPD and repeated exacerbations. In 6 published Phase 3 trials to date, roflumilast 500 µg daily exhibited modest improvements in lung function, measured by pre- and postbronchodilator forced expiratory volume in 1 second, and reduced rates of moderate and severe exacerbations. Roflumilast was generally well tolerated, with diarrhea, nausea, and headache the most common adverse events seen in clinical trials, although it has also been associated with an increased risk of neuropsychiatric abnormalities and dose-limiting weight loss. The greatest benefit seen with roflumilast was among patients with moderate-to-severe COPD associated with chronic bronchitis along with a recent history of exacerbations. The benefits were demonstrated with monotherapy and in combination with long-acting ß(2)-agonists or anticholinergic agents. CONCLUSIONS: Despite its only modest benefits in improving lung function and reducing exacerbation rates, roflumilast serves as a safe and effective option in the treatment of COPD.

Vegetable and fruit food frequency questionnaire serves as a proxy for quantified intake.

BACKGROUND: Public health practitioners need valid tools to survey trends in dietary intake. The Rapid Risk Factor Surveillance System (RRFSS) includes an optional six-item vegetable and fruit intake food frequency questionnaire (FFQ) module. Our objectives were 1) to compare reported vegetable and fruit consumption from the FFQ to quantified servings (portions) defined by Canada's Food Guide to Healthy Eating and ascertained by a reference method, and 2) to compare the FFQ with the reference method for their classification of the proportion of respondents consuming five or more servings of vegetables and fruit per day. METHODS: Dietitians administered 24-hour recalls to each of 174 adult respondents who had completed the FFQ as part of the RRFSS. Recalls were conducted over the telephone on three separate occasions using an adaptation of the multiple pass method. RESULTS: The mean total intake of vegetables and fruit for the group was 4.6 times/day from the FFQ versus 4.8 servings/day from the recalls (paired t-test; p = 0.92). Thirty-seven percent of respondents were classified as consuming five or more times/day by the FFQ versus 35% by the 24-hour recall servings. CONCLUSION: The FFQ tool can be used as a proxy for quantified intake of vegetable and fruit consumption.