Short-Term Effectiveness and Reduction in Insulin Requirements in Patients With Type 2 Diabetes Treated With IdegLira in a Real-World Setting.

Background: Type 2 diabetes mellitus (T2DM) is a chronic, highly prevalent disease with a significant impact on health. Appropriate treatment requires effective and timely escalation to achieve metabolic control. To evaluate the effectiveness and safety of IDegLira on adults with T2DM previously treated with oral antidiabetics and/or insulin in a real-life setting. Methods: An observational study in a real-world setting was conducted. Patients were selected from the outpatient clinic of two centers dedicated to specialized diabetes care. Main outcomes were HbA1c, body weight, insulin dose changes, hypoglycemia, and other adverse events. Results: 67 T2DM patients treated with IDegLira were monitored between 3 and 7 months. At the end of foll ow-up, the median change in HbA1c was -1.05% (CI95% -1.45, -0.65), and a decrease in insulin requirement was also observed (mean difference -10 TDD units (CI95% - 17 to -2.5). No treatment discontinuation was reported, hypoglycemia events were reported in 3 patients at the end of follow-up versus 8 patients at baseline. Conclusions: This real-life study shows the effectiveness in glycemic control of IDegLira use in T2DM patients who do not achieve goals with other therapies, with an adequate safety profile. The findings need to be confirmed with evaluation of therapeutic results in larger cohorts.

Long-term impact of pharmacist intervention in patients with bipolar disorder: extended follow-up to the EMDADER-TAB study.

BACKGROUND: Pharmaceutical care (PC) through the Dader method (DMet) vs. the usual care process (UCP) significantly reduced psychiatric hospitalizations and emergency service consultations during one year of follow-up of outpatients with bipolar I disorder (BD-I). To date, the effect of long-term PC on the use of health services by BD-I patients once pharmacist intervention has ended is unknown. OBJECTIVE: To determine whether the effect of PC measured by the decrease in psychiatric hospitalizations and emergency service consultations is maintained one year after pharmacist intervention ceases. METHODS: This was a retrospective analysis of patients who had previously participated in a randomized, controlled, prospective, single-center clinical trial to compare PC (intervention group) vs. UCP (control group) in BD-I patients. Data were collected from November 2012 to March 2014. The primary outcome was the use of health services measured by the number of psychiatric hospitalizations and emergency service consultations. Descriptive statistics, Student's t-test, Kaplan-Meier function, and Log-Rank test were used. RESULTS: The study included 92 patients: 43 in the intervention group and 49 in the control group. Eleven psychiatric hospitalizations occurred for the intervention group and 19 for the control group. One year after pharmacist intervention ceased, there were no significant differences between the groups in psychiatric hospitalizations (p = 0.261). There were 14 emergency service consultations for the intervention group, and 24 for the control group without significant differences (p = 0.212). CONCLUSIONS: PC through the DMet has no long-term effects on psychiatric hospitalizations and emergency department consultations in patients with BD-I following discontinuation of pharmacist intervention; the effect dissipates when the intervention ceases. Future studies should focus efforts on identifying factors associated with PC that explain why the outcomes derived from this intervention are not maintained in the long term.

Effectiveness of the Dader Method for Pharmaceutical Care on Patients with Bipolar I Disorder: Results from the EMDADER-TAB Study.

BACKGROUND: Bipolar I disorder (BD-I) is a chronic illness characterized by relapses alternating with periods of remission. Pharmacists can contribute to improved health outcomes in these patients through pharmaceutical care in association with a multidisciplinary health team; however, more evidence derived from randomized controlled trials (RCTs) is needed to demonstrate the effect of pharmaceutical care on patients with BD-I. OBJECTIVE: To assess the effectiveness of a pharmaceutical intervention using the Dader Method on patients with BD-I, measured by the decrease in the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits from baseline through 1 year of follow-up. METHODS: This study is based on the EMDADER-TAB trial, which was an RCT designed to compare pharmaceutical care with the usual care given to outpatients with BD-I in a psychiatric clinic. The main outcome was the use of health care services, using Kaplan-Meier methods and Cox regression. The trial protocol was registered in ClinicalTrials.gov (Identifier NCT01750255). RESULTS: 92 patients were included in the EMDADER-TAB study: 43 pharmaceutical care patients (intervention group) and 49 usual care patients (control group). At baseline, no significant differences in demographic and clinical characteristics were found across the 2 groups. After 1 year of follow-up, the risk of hospitalizations and emergencies was higher for the control group than for the intervention group (HR = 9.03, P = 0.042; HR = 3.38, P = 0.034, respectively); however, the risk of unscheduled outpatient visits was higher for the intervention group (HR = 4.18, P = 0.028). There was no "placebo" treatment, and patients in the control group might have produced positive outcomes and reduced the magnitude of differences compared with the intervention group. CONCLUSIONS: Compared with usual care, pharmaceutical care significantly reduced hospitalizations and emergency service consultations by outpatients with BD-I. DISCLOSURES: This study received funding from the Universidad de Antioquia, Committee for Development Research and Sustainability Program, CODI, (2013-2014 and 2014-2015). Humax Pharmaceutical provided support for the initial development of the EMDADER-TAB trial without commercial interest in the outcomes derived from the trial. Salazar-Ospina reports grants from Credito Beca Francisco José de Caldas Scholarship for Doctoral Programs (528), which also contributed to the support of this study. González-Avendaño is an employee of Humax Pharmaceutical. The other authors have nothing to disclose. Study concept and design were contributed by Benjumea, Faus, and Rodriguez, along with Salazar-Ospina and Amariles. Salazar-Ospina took the lead in data collection, assisted by González-Avendaño, and data interpretation was performed by Salazar-Ospina, Hincapié-García, and González-Avendaño. The manuscript was written primarily by Salazar-Ospina, with assistance from Amariles and González-Avendaño, and revised by all the authors.