Diabetes Mellitus Self-Management Interventions in Latino Adults in the United States - The Role of Pharmacists

VA L U E I N H E A LT H

Objectives: A recent publication exploring real-world treatment patterns between 2000-2015 found HbA1c control in type 2 diabetics has not improved post-2008, one reason being attributable to treatment inertia. This analysis aims to identify the humanistic and economic burden amongst this patient type compared to patients receiving more active management.  Methods: Data were drawn from the 2016 US/EU Adelphi Diabetes Disease Specific Programme. Diabetes specialists and primary care physicians completed physician-reported forms for the next 10 consulting patients including demographics, clinical measures, prescribed drugs, healthcare practitioner (HCP) visits. Patients provided information about the impact of diabetes. Current therapy duration and current HbA1c classified 3 groups: 1) actively managed (dynamic): treatment change within previous 6 months; any HbA1c; 2) non-dynamic/controlled: last treatment change > 6 months; HbA1c < 7.5%; 3) non-dynamic/uncontrolled (treatment inertia): last treatment change > 6 months; HbA1c > 7.5%.  Results: 853 physicians included7487 patients; 32% dynamic, 52% non-dynamic/controlled,16% clinically inert. Compared to dynamic patients, clinically inert patients visit the HCP more often per annum (3.4 vs. 2.9), are co-managed with a cardiologist (22.9% vs. 19.6%), a nephrologist (7.9% vs. 5.9%) or a community specialist diabetes nurse practitioner (20.2% vs. 16.6%),take more products for all conditions (7.6 vs. 6.4). Clinically inert patients report their diabetes ‘sometimes’ or ‘greatly’ affects family/social life (30.6% vs 25.2%), leisure (37.0% vs 28.6%), long distance journeys (36.4% vs 30.9%) and sleep (36.4% vs 21.2%). All results p= < 0.05.  Conclusions: Clinically inert patients represent a group with higher economic burden and suffer a greater impact on lifestyle. Identification and understanding of these patients could help personalise treatment to achieve optimal diabetes control and thus reduce burden of illness.

DIABETES/ENDOCRINE DISORDERS – Health Care Use & Policy Studies PDB61 Diabetes Mellitus Self-Management Interventions in Latino Adults in the United States - The Role of Pharmacists Patel I1, Srivastava J2, Chang J3, Kim S4, Erickson SR5, Balkrishnan R6 1Marshall University, Huntington, VA, USA, 2Ohio University, Athens, VA, USA, 3The University of Texas at El Paso, El Paso, TX, USA, 4Shenandoah Univerity, Winchester, VA, USA, 5University of Michigan, Ann Arbor, VA, USA, 6University of Virginia School of Medicine, Charlottesville, VA, USA

Objectives: To conduct a systematic review of the diabetes mellitus (DM) self-management interventions conducted by non-pharmacy personnel in Latinos with DM and by pharmacists in patients with DM (all races) at the individual, interpersonal and community levels respectively.  Methods: A systematic review was conducted using different computerized databases like Pubmed, Google scholar, Embase and the Cochrane database from inception to March, 2017. Out of the 145 studies whose abstracts or titles were skimmed for this systematic review, 80 studies had theory or non-theory driven DM self-management interventions. Out of those 80 studies, 22 theory based intervention studies were conducted by non-pharmacy personnel (physicians, nurses, diabetes educators, community health workers/promotoras, social workers) in Latinos with DM and 6 theory based intervention studies were conducted by pharmacists in patients (Latinos, non-Latino African Americans, nonLatino Caucasians, non-Latino Native Indians, other races) with DM. Results: Among the DM intervention studies, the constructs there were targeted at the individual level were self-efficacy, motivation, positive reinforcement, knowledge, vicarious experiences and performance mastery, at the interpersonal level were social support, social networks, coping, empowerment and social persuasion and at the community level were community engagement, community integration and social cohesion respectively. The studies conducted in Latinos with DM by the pharmacists were mostly targeted at the individual level whereas the studies conducted by nonpharmacy personnel were mostly targeted at the interpersonal and the community levels respectively. The studies reported improvements in clinical parameters, dietary habits, physical activity, medication management, social support and other social factors.  Conclusions: Overall, studies that were culturally targeted towards Latinos with DM showed an improvement in DM self-management. Robust interventions backed by theory for chronic disease management salient to non-Latino racial/ethnic minorities like African Americans and Native Americans should be translated in practice to improve the overall quality of healthcare delivered to the minorities. PDB62 Burden of Diabetic Foot Ulcers in India: Evidence Landscape from Published Literature Ghosh P, Valia R B|Braun Medical (India) Pvt. Ltd., New Delhi, India

Objectives: The objective of the current review was to summarize burden of diabetic foot ulcers (DFUs) in Indian patients based on findings reported in published literature.  Methods: MEDLINE was queried using key words: foot ulcer; diabetes mellitus; infection; diabetic foot ulcer. Evidence was synthesized from shortlisted articles, presenting epidemiology, microbiology and economic burden of DFUs in Indian patients.  Results: In India, DFUs affect 15% of diabetics during their lifetime. Mono/polymicrobial etiology of diabetic foot infections was widely reported including high prevalence of Pseudomonas, E. coli, and S. aureus infections. Evidence from published literature showed 100,000 leg amputations/ year due to diabetes-related problems and an expense of approximately $1,960 for complete treatment of DFUs. Out of 62 million diabetics in India, 25% develop DFUs, of which 50% become infected, requiring hospitalization while 20% need amputation. DFUs contribute to approximately 80% of all non-traumatic amputations in India, annually. Patients with a history of DFU have 40% higher 10-year death-rate, than those without. Average time required for healing of DFUs is 28 weeks (range 12-62 weeks). Two studies indicated that patients with DFUs spent four times more than those without (Satyavani, 2013: Rs.19,020 (~$295.95) vs. Rs. 4,493(~$69.91)) and (Shobhana, 2001: Rs. 15,450(~$240.40) vs. Rs. 4,373(~$68.04)). Also, India is the most expensive

20 (2017) A399–A811

A485

country for DFU care, as 5.7 years (68.8 months) of an average patient’s income is required to pay for complete DFU therapy. Amongst Indian diabetics, treatment cost of neuropathic ulcers (ambulatory care), infected neuropathic foot (ambulatory care), advanced diabetic foot (salvage, limb amputation, salvage followed by amputation), and neuroischemic foot (bypass) was reported as $56, $165, $1080, $960, $2650 and $1960, respectively. Moreover, 50% of DFU patients who get amputated once, suffer another amputation within next 2 years.  Conclusions: DFU specific clinical guidelines and cost-effective therapies need to be developed urgently to halt this catastrophic pandemic. PDB63 Treatment Patterns Among Newly Diagnosed Diabetes Patients in Dubai Mohamed R1, Pathak P1, Farghaly M2 Emirates, 2Dubai Health Authority, Dubai, United Arab Emirates 1QuintilesIMS, Dubai, United Arab

Objectives: American Diabetes Association’s recommendations related to pharmacologic therapy in type II diabetes mellitus advises metformin monotherapy as the preferred initial therapy, while use of dual and triple therapy is suggested to more expeditiously achieve the target A1C level. The objective of the study is to understand the treatment patterns among newly diagnosed T2DM patients in Dubai and make broad-level comparisons against the ADA’s recommendations.  Methods: A retrospective database analysis was conducted using Dubai Claims Database. All patients with a T2DM diagnosis were identified during July 2014 to March 2016, and their first diagnosis was assigned as the index diagnosis. Patients with a diabetes diagnosis or use of anti-diabetic therapy (ADT) during prior six months were excluded. Patients were continuously enrolled during 6 months before and 12 months after the index diagnosis.  Results: The final study cohort included 25,320 patients, of which 63.1% did not receive any ADT during 12 months follow-up from the index diagnosis. For the remaining 9,349 patients, 54.6% patients received the first ADT on index diagnosis date, while the mean time to ADT for the remaining 45.4% patients was 68.6 days. The most common first ADT was metformin received by 88.9% patients, of which 42.9% received it as a monotherapy while remaining 57.1% received it in combination with another drug. The proportion of patients having their first ADT as combination therapy or insulin was 50.3% and 4.3%, respectively. Mean number of oral prescriptions during follow-up was 2.9. The average most recent HbA1c value before initiating monotherapy, combination therapy and insulin-based therapy was 7.0, 8.4 and 9.1, respectively.  Conclusions: While most patients received metformin as their first ADT, majority received it in combination with another drug. Also, a large proportion of patients did not receive any ADT during follow-up, which needs to be further studied. PDB64 Adequacy of Glycemic Control in Greek Patients with Type 2 Diabetes Mellitus Treated with Metformin Monotherapy at the Maximum Tolerated Dose: The Reload Study Elisaf M1, Pagkalos E2, Manes C3, Pappas A4, Adamidis S5, Boniakos A6, Andreadis V3, Karamousouli E7, Voss B8, Bargiota A9 1Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, Greece, 2Thermi Clinic, Thessaloniki, Greece, 3Diabetes Center, Papageorgiou General Hospital, Thessaloniki, Greece, 4Diabetes Center, Venizelio General Hospital Heraklion, Crete, Greece, 5Department of Internal Medicine, Athens Medical Centre Clinic, Athens, Greece, 6Private Physician, Athens, Greece, 7Merck Sharp & Dohme (MSD), Athens, Greece, 8MSD Sharp & Dohme GmbH, Haar, Germany, 9Department of Endocrinology and Metabolic Diseases, University of Thessaly School of Medicine, Larissa, Greece

Objectives: To assess adequacy of glycaemic control in Greek patients with type 2 diabetes mellitus (T2DM) treated with maximum tolerated doses of metformin.  Methods: RELOAD was a multi-centre, retrospective study in patients with T2DM treated with metformin only. Data were collected from the medical files of patients with T2DM diagnosed at an age ≥ 40 years who received metformin monotherapy at maximum tolerated doses for ≥ 24 months during the 5 years prior to enrolment. Demographic and clinical data were collected at metformin initiation, 9, 17-20 and 24 months. Primary endpoints were the percentage of patients achieving metabolic compensation (MC, reduction of HbA1c values from ≥ 6.5% at baseline to < 6.5%) and the mean HbA1c reduction rate after 9 months of metformin treatment. Secondary endpoints included the average time spent with HbA1c ≥ 6.5% while on metformin monotherapy and the mean time to treatment intensification. In prespecified analysis the relationship of comorbidity to MC was explored.  Results: 316 patients with T2DM were enrolled in the study. Baseline (mean±SD) demographic and clinical characteristics were: age 65.8±10.4 years, T2DM duration 5.8±4.2 years, weight 84.4±15.9kg and HbA1c 7.2%±1.1%. 78% (247/316) of patients had HbA1c ≥ 6.5%. Following 9 months of metformin treatment, 36.4% (90/247) of patients achieved MC, with a mean HbA1c reduction of 1.3% [95% confidence interval [CI]:(-1.57,-0.95)]; mean metformin daily dose was 1,561±532 mg. Mean time of exposure to HbA1c ≥ 6.5% for the overall population was 24.3±15.0 months and time to treatment intensification was 30.6±9.5 months. The percentage of hypertensive patients achieving HbA1c < 6.5% was numerically higher as compared to normotensive patients (40.9% vs 28.4%, respectively; p= 0.051).  Conclusions: In this real-world study, approximately half of Greek T2DM patients treated with maximum tolerated metformin doses had an HbA1c > 6.5% for a substantial period of time, indicating clinical inertia and an increased risk for diabetic complications. PDB65 Costs of Clinical Events in Diabetes Type 2 Patients in the Netherlands: A Systematic Review van Schoonhoven A1, de Vries M1, Gout-Zwart J1, Vemer P1, van Boven J1, Dvortsin E2, Postma MJ1 1University of Groningen, Groningen, The Netherlands, 2University of Groningen / Asc Academics, Groningen, The Netherlands