Treatment adherence in newly diagnosed type 2 diabetes: patient characteristics and long-term impact of adherence on inpatient care utilization.

OBJECTIVES: The purpose of this study was to evaluate the impact of antidiabetic medication adherence on hospital utilization in patients with newly diagnosed type 2 diabetes mellitus (T2D). This study specifically analyzed patients with newly diagnosed T2D with the intent of lessening intragroup disease severity differences, and adjusting for a range of other clinical and demographic characteristics. METHODS: This retrospective US claims database study evaluated adults with newly diagnosed T2D who started antidiabetic medications in 2005-2009, had ≥ 2 antidiabetic medication claims after their first (baseline). Medication adherence was evaluated using the medication possession ratio (MPR) of any or all antidiabetic medication(s) during the 3-year post-baseline period. Repeated-measures analyses examined changes in inpatient utilization from the pre- to post-baseline period. The impact of adherence on hospital utilization during the post-baseline period was evaluated with a logistic regression model to adjust for confounding factors. RESULTS: The study included 192,717 patients (mean age, 55.0 years). Mean MPR for antidiabetic therapy was 0.74. MPR was highest in elderly patients and Medicare beneficiaries. Mean annualized inpatient admissions during the 3-year post-baseline period were significantly lower in patients with MPR ≥ 0.80 (1.4) than in those with MPR < 0.80 (2.2; P < 0.05). Logistic regression analysis, adjusting for patient characteristics and prior inpatient utilization, showed 39% lower odds of hospitalization (OR = 0.61; 95% CI = 0.534-0.693) for patients with MPR ≥ 0.80. People with T2D-related complications or hospitalization had approximately 2- to 3-fold higher risk of subsequent hospitalization. CONCLUSIONS: In newly diagnosed T2D patients with antidiabetic therapy in the first three ensuing years, higher antidiabetic medication adherence was significantly associated with lower hospital inpatient utilization before and after adjusting for patient characteristics.

Historical cohort analysis of treatment patterns for patients with type 2 diabetes initiating metformin monotherapy.

OBJECTIVE: To describe treatment regimen changes of patients with type 2 diabetes mellitus (T2DM) initiating metformin monotherapy, and assess factors associated with those changes 12 months post-initiation. METHODS: Retrospective cohort analysis of medical, pharmacy and laboratory claims of 17,527 Medicare Advantage (MAPD) Humana members aged 18-89, who had ≥1 medical claim with primary diagnosis or ≥2 medical claims with secondary diagnosis of T2DM (ICD-9-CM code 250.x0 or 250.x2) who filled an initial prescription for metformin (GPI code 2725) between 1 January 2008 and 30 September 2011. The main outcome measure was change in metformin monotherapy during the 12 months following initiation. Factors associated with treatment changes during follow-up were examined using Cox proportional hazards regression models. RESULTS: Fifty-nine percent of patients (mean age 69.6 years) remained on metformin monotherapy with no changes. Discontinuation was the most common treatment change (33%), followed by addition (5%), and switching (2%) to other antidiabetics. Of patients who discontinued treatment (median time to discontinuation = 90 days), 61% did not reinitiate any diabetic treatment during the follow-up period. Among patients who added or switched to other antidiabetics, sulfonylureas were the most common addition or replacement agent. Predictors of discontinuation were being female, Black or Hispanic, low-income subsidy eligible, having higher initial out-of-pocket metformin costs, or a diagnosis of depression. Discontinuation was less likely during follow-up if patients had higher pre-index pill burdens or records of a pre-index A1C screening test. A higher risk of discontinuation was observed for patients with low baseline A1C. One study limitation was that exact discontinuation dates could not be determined using claims. CONCLUSIONS: The findings suggest that gender, race, ethnicity, depression, and low income status were contributory factors to metformin discontinuation. More intensive monitoring and treatment adjustments may be warranted for patients newly initiated on metformin. This could ultimately improve morbidity, mortality, and costs associated with poor glycemic control.

Antidiabetic treatment patterns in a medicare advantage population in the United States.

BACKGROUND: Published guidelines for treatment of type 2 diabetes mellitus (T2DM) agree on initial pharmacotherapy. However, few specific recommendations on second-line agents are provided. OBJECTIVE: The objective of this study was to describe antidiabetic treatment patterns in Medicare Advantage patients with T2DM within 6 months of measurement of the glycosylated hemoglobin (HbA1c) level. RESEARCH DESIGN: This retrospective cross-sectional study utilized medical, pharmacy, and laboratory claims from a large Medicare Advantage with Prescription Drug (MAPD) coverage payer. MAPD members between 65 and 89 years old identified as having T2DM between 2009 and 2011 were eligible for inclusion. A 12-month baseline period before the first HbA1c value (index date) was evaluated for demographic and clinical differences. Antidiabetic therapy was evaluated for 6 months post-index. The study population was stratified into three cohorts based on index HbA1c value: controlled (<8%, 64 mmoL/mol), uncontrolled (≥ 8%, 64 mmoL/mol and <10%, 86 mmoL/mol), and severely uncontrolled (≥ 10%, 86 mmoL/mol). RESULTS: Despite elevated HbA1c values (≥ 8%, 64 mmoL/mol), 7-8% of patients did not receive antidiabetic therapy during the post-index period. Metformin and sulfonylureas were the oral antidiabetics (OADs) most frequently used as monotherapy. The majority of patients on combination therapy were on two or more OADs and higher injectable use was observed in the severely uncontrolled cohort. Metformin was included in >60% of the combination regimens with metformin + sulfonylurea being the most common. CONCLUSION: This study suggests suboptimal treatment of those not in glycemic control (HbA1c ≥ 8%, 64 mmoL/mol). Many patients classified as severely uncontrolled based on HbA1c received only monotherapy. Opportunities exist for treatment modification within this population to achieve tighter glycemic control.

The cost-effectiveness and budget impact of stepwise addition of bolus insulin in the treatment of type 2 diabetes: evaluation of the FullSTEP trial.

UNLABELLED: Abstract Background and aims: Intensification of basal insulin-only therapy in type 2 diabetes is often achieved through addition of bolus insulin 3-times daily. The FullSTEP trial demonstrated that stepwise addition (SWA) of bolus insulin aspart was non-inferior to full basal-bolus (FBB) therapy and reduced the rate of hypoglycemia. Here the cost-effectiveness and budget impact of SWA is evaluated. METHODS: Cost-effectiveness and budget impact models were developed to assess the cost and quality-of-life (QoL) implications of intensification using SWA compared with FBB in the US setting. At assessment, SWA patients added one bolus dose to their current regimen if the HbA1c target was not met. SWA patients reaching three bolus doses used FBB event rates. Outcomes were evaluated at trial end and projected annually up to 5 years. Models captured hypoglycemic events, the proportion meeting HbA1c target, and self-measured blood glucose. Event rates and QoL utilities were taken from trial data and published literature. Costs were evaluated from a healthcare-payer perspective, reported in 2013 USD, and discounted (like clinical outcomes) at 3.5% annually. This analysis applies to patients with HbA1c 7.0-9.0% and body mass index <40 kg/m(2). RESULTS: SWA was associated with improved QoL and reduced costs compared with FBB. Improvement in QoL and cost reduction were driven by lower rates of hypoglycemia. Sensitivity analyses showed that outcomes were most influenced by the cost of bolus insulin and QoL impact of symptomatic hypoglycemia. Budget impact analysis estimated that, by moving from FBB to SWA, a health plan with 77,000 patients with type 2 diabetes, of whom 7.8% annually intensified to basal-bolus therapy, would save USD 1304 per intensifying patient over the trial period. CONCLUSIONS: SWA of bolus insulin should be considered a beneficial and cost-saving alternative to FBB therapy for the intensification of treatment in type 2 diabetes.

Diabetes management in the real world and the impact of adherence to guideline recommendations.

OBJECTIVE: To evaluate diabetes management in the real world, examining adherence to the American Diabetic Association (ADA) guidelines on frequency of glycated hemoglobin A1c (A1C) testing and antidiabetic treatment modifications in patients with type 2 diabetes and measuring the impact of adherence to the guidelines for achieving an A1C target <7%. RESEARCH DESIGN AND METHODS: Retrospective analyses of claims data were conducted in three groups of patients aged ≥18 years with at least two diagnoses of type 2 diabetes in a large US health insurance claims database between January 2009 and December 2011 and with A1C ≥7% (≥53 mmol/mol). Descriptive analyses were performed on adherence to A1C testing frequency and adherence to antidiabetic treatment modification. Pearson's chi-square test and logistic regression were conducted to estimate the odds ratios. RESULTS: Of 42,837 patients evaluated for adherence to the ADA guideline for A1C testing frequency, only 7% were fully adherent for 1 year. Analysis of 95,330 patients for adherence to antidiabetic treatment modification revealed that drug therapy was modified in accordance with ADA guidelines for 39% of patients. Among 1337 treatment-naive patients meeting the selection criteria, only 3% met both testing frequency and treatment modification guidelines; the odds of achieving the A1C target of <7% were approximately five-fold higher in patients who met both guidelines versus those who did not (odds ratio 5.29; P < 0.0001). CONCLUSIONS: This study, based on real-world data from a large type 2 diabetes patient population, demonstrated that adherence to ADA guidelines for A1C testing frequency and drug treatment modifications was extremely low. Achievement of glycemic control (A1C <7%) was significantly associated with adherence to both A1C testing frequency and antidiabetic treatment modification guidelines. Limitations of this study include the retrospective nature, lack of important patient clinical information, and issues with incomplete source data.

Clinical outcomes, health resource use, and cost in patients with early versus late dual or triple anti-platelet treatment for acute coronary syndrome.

BACKGROUND: Acute coronary syndrome (ACS) guidelines recommend early dual anti-platelet therapy (thienopyridines + acetylsalicylic acid [aspirin]). However, triple therapy (thienopyridines + aspirin + glycoprotein IIb/IIIa receptor inhibitors [GRIs]) has shown benefit in clinical trials. OBJECTIVE: This study assessed real-world ACS treatment patterns and outcomes in the acute care setting. STUDY DESIGN: A retrospective analysis of patients admitted to hospital with ACS (index event) from January 2007 to December 2009 was conducted (Thomson's MarketScan Hospital Drug Database). PATIENTS: Eligible patients were ≥18 years of age, of either sex, and had primary admission and discharge diagnoses of ACS. OUTCOME MEASURES: Cohorts were defined by anti-platelet treatment and then by the timing of treatment initiation (early initiation: within ≤2 days of admission; late initiation: ≥2 days post-admission). Patient characteristics, clinical outcomes, resource utilization, and costs were assessed using descriptive statistics. RESULTS: A total of 249,907 eligible patients were placed into four treatment cohorts (aspirin assumed for all patients): aspirin only; clopidogrel only (dual therapy); GRI only (dual therapy); and clopidogrel + GRI (triple therapy). Patients in the 'clopidogrel-only' cohort were more likely to be older, female, and have more co-morbidities than those in other cohorts; stroke (6.2 %) and re-hospitalization (15.4 %) rates were higher than in the 'GRI-only' and 'triple therapy' cohorts. The GRI-only cohort had higher major bleeding rates (3.3 %), mortality (7.6 %), and costs ($US21,975 [year 2010 values]) than the clopidogrel-only and triple-therapy cohorts. Late initiation cohorts were more likely to be older, female, and have more co-morbidities than early initiation cohorts. Major bleeding was more likely with GRI-only patients (regardless of initiation timing) than with other cohorts. Late-treated clopidogrel-only patients had higher rates of stroke (6.9 %), ACS-related re-admissions (6.1 %), and all-cause re-admissions (15.9 %) than other cohorts. Late treatment was associated with longer length of stay and significantly higher costs. CONCLUSIONS: Real-world anti-platelet treatment patterns are consistent with ACS guidelines recommending early initiation and selective GRI use. In contrast to recommendations, some outcomes were improved with triple therapy compared with dual therapy.

A cost-effectiveness evaluation of two continuous-combined hormone therapies for the management of moderate-to-severe vasomotor symptoms.

OBJECTIVES: After the release of the results of the Women's Health Initiative, an emerging consensus suggests that continuous-combined hormone therapy (CCHT) should be limited to short-term management of moderate-to-severe vasomotor symptoms. This, in turn, raises the important question of the economic value, if any, of short-term CCHT for this indication. We conducted a cost-effectiveness analysis comparing a 1-year treatment course with 1 mg of norethindrone acetate/5 microg of ethinyl estradiol (1/5 NA/EE) or 0.625 mg/day of conjugated estrogens plus 2.5 mg of medroxyprogesterone (0.625/2.5 CEE/MPA) compared with no therapy for the management of moderate-to-severe vasomotor symptoms. DESIGN: A literature-based Markov model was developed to compare these three options' cost and quality-of-life (QOL) benefits. The impact of therapy on vasomotor symptoms and breakthrough bleeding/spotting on the direct costs of care and QOL were considered. RESULTS: Compared with no therapy, CCHTs resulted in net increases in quality-adjusted life-years (QALYs) gained (0.110 for 1/5 NA/NE v 0.104 for 0.625/2.5 CEE/MPA). Net costs (v no therapy) were $167 lower for 1/5 NA/NE compared with 0.625/2.5 CEE/MPA. Cost per QALY gained (compared with no therapy) were $6,200 and $8,200, respectively. Cost-effectiveness was most favorable for individuals with more severe symptoms who were less bothered by breakthrough bleeding/spotting. CONCLUSIONS: A short-term course of CCHT for the sole purpose of managing moderate-to-severe vasomotor symptoms is cost-effective. However, 1/5 NA/NE seemed to be more cost-effective than 0.625/2.5 CEE/MPA. These findings can be used to further refine the role of CCHT and to improve formulary decisions.

High rates of co-occurrence of hypertension, elevated low-density lipoprotein cholesterol, and diabetes mellitus in a large managed care population.

OBJECTIVE: To examine prevalence and co-occurrence of diabetes mellitus (DM), hypertension (HT), and elevated low-density lipoprotein cholesterol (dyslipidemia, or DL) in a managed care population. STUDY DESIGN: Period prevalence study. PATIENTS AND METHODS: The study population included all adults (age > 20 years) who had been members of Kaiser Permanente, Northern California, for at least 4 months on December 31, 2001 (n = 2.1 million). Criteria from the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of Hypertension, the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, and the Northern California Kaiser Permanente Diabetes Registry were applied to computerized databases for an 18-month period to identify HT, DL, and DM, respectively. Because screening for these conditions is incomplete, we applied age- and sex-specific prevalence estimates from the Third National Health and Nutrition Examination Survey to simulate full ascertainment. RESULTS: Unadjusted prevalence rates of HT, DL, and DM were 23.8%, 17.6%, and 6.6%, respectively. More than 50% of persons with either HT or DL also had at least 1 other condition. Of all persons with DM, 74% had HT, 73% had DL, and 56% had both. Under full ascertainment, prevalence increased to 27.6%, 35.6%, and 8.7% for HT, DL, and DM, respectively, and co-occurrence increased further. CONCLUSION: HT, DL, and DM co-occur in most affected individuals. To avoid fragmentation of care, disease management strategies should aim to manage these conditions within the same programs.