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1.  Factors associated with adherence to oral antihyperglycemic monotherapy in patients with type 2 diabetes 
To estimate the rate of adherence to oral antihyperglycemic monotherapy for patients with type 2 diabetes in the US and describe factors associated with adherence in these patients.
Materials and methods
In this retrospective cohort analysis, patients aged 18 years or older with a type 2 diabetes diagnosis received between 1 January 2007 and 31 March 2010 were identified using a large US-based health care claims database. The index date was defined as the date of the first prescription for oral antihyperglycemic monotherapy during this period. Patients had to have continuous enrollment in the claims database for 12 months before and after the index date. Adherence was assessed using proportion of days covered (PDC) and an adjusted logistic regression analysis was performed to evaluate factors associated with adherence (PDC ≥80%).
Of the 133,449 eligible patients, the mean age was 61 years and 51% were men. Mean PDC was 75% and the proportion of patients adherent to oral antihyperglycemic monotherapy was 59%. Both mean PDC and PDC ≥80% increased with increasing age and the number of concomitant medications, and were slightly higher in men compared to women. Results from the logistic regression demonstrate an increased likelihood of non-adherence for patients who were younger, new to therapy, on a twice-daily dose, female, or on fewer than three concomitant medications compared to their reference groups. Higher average daily out-of-pocket pharmacy expense was also associated with an increased likelihood of non-adherence. All results were statistically significant (P<0.05).
Patient characteristics, treatment regimens, and out-of-pocket expenses were associated with adherence to oral antihyperglycemic monotherapy in our study.
PMCID: PMC4315552  PMID: 25670888
compliance; proportion of days covered; PDC; MPR; T2DM; treatment; medication
2.  A Survey of Patient Preferences for Oral Antihyperglycemic Therapy in Patients with Type 2 Diabetes Mellitus 
Diabetes Therapy  2015;6(1):75-84.
Previous research has demonstrated a correlation among patient preferences, dosing burden, and medication nonadherence, a well-recognized challenge in type 2 diabetes mellitus (T2DM). The objective of this study was to elicit preferences for alternative dosing regimens for oral antihyperglycemic therapies among patients with T2DM and to quantify differences in dosing preferences among patients with different characteristics.
Preferences for dosing of oral antihyperglycemic drugs (OAD) were evaluated by surveying patients with T2DM in the United States (US). Survey participants were adult US patients with T2DM who were taking no or only 1 OAD and no injectable therapies. Each patient completed a web-enabled discrete-choice experiment (DCE) including a series of 8 pairs of hypothetical OAD profiles. Each profile was defined by reductions in average glucose, dosing schedule (e.g., once-weekly, once-daily, or twice-daily dosing), chance of mild-to-moderate gastrointestinal side effects, frequency of hypoglycemia, weight change, incremental risk of congestive heart failure, and cost. Each participant also answered a direct question about dosing preference. Random-parameters logit was used to analyze the DCE data. Prespecified subgroups were analyzed.
Of 2,262 patients invited to participate, 923 were included in the analysis (mean age 63 years, 45% male, 79% white). Reducing dosing frequency was statistically significantly important to patients; however, it was relatively less important than medication cost or clinical outcomes. On average, patients preferred once-weekly to once-daily dosing. Patients not currently taking an OAD had a stronger preference for once-weekly dosing than patients on treatment (P = 0.012). Patients younger than 45 years had a stronger preference for weekly dosing than older patients (P < 0.075).
For younger patients and patients not currently on treatment, once-weekly dosing may provide additional incentive to initiate and adhere to antihyperglycemic treatment; however, additional research will be required to confirm this hypothesis.
Electronic supplementary material
The online version of this article (doi:10.1007/s13300-015-0094-2) contains supplementary material, which is available to authorized users.
PMCID: PMC4374080  PMID: 25586555
Conjoint analysis; Discrete-choice experiment; Patient preferences; Treatment adherence; Type 2 diabetes mellitus
3.  Effect of pill burden on dosing preferences, willingness to pay, and likely adherence among patients with type 2 diabetes 
To quantify willingness-to-pay (WTP) for reducing pill burden and dosing frequency among patients with type 2 diabetes mellitus (T2DM), and to examine the effect of dosing frequency and pill burden on likely medication adherence.
Patients and methods
Participants were US adults with T2DM on oral antihyperglycemic therapy. Each patient completed an online discrete-choice experiment (DCE) with eight choice questions, each including a pair of hypothetical medication profiles. Each profile was defined by reduction in average glucose (AG), daily dosing, chance of mild-to-moderate stomach problems, frequency of hypoglycemia, weight change, incremental risk of congestive heart failure (CHF), and cost. Patients were asked to rate their likely adherence to the profiles presented in each question. Choice questions were based on a predetermined experimental design. Choice data were analyzed using random-parameters logit. Likely treatment adherence was analyzed using a Heckman two-stage model.
Of the 1,114 patients who completed the survey, 90 had lower dosing burden (<5 pills/day taken once/day or as needed) for all medications, and 1,024 had higher dosing burden (≥5 pills/day or more than once/day). Reduction in AG was valued most highly by patients. Hypoglycemia, chance of mild-to-moderate stomach problems, weight change, incremental risk of CHF, and daily dosing were less valued. Patients with higher current dosing burden had lower WTP for more convenient dosing schedules than patients with lower current dosing burden. Changes in dosing and cost impacted likely adherence. The magnitude of the impact of dosing on likely adherence was higher for patients with lower current dosing burden than for patients with higher current dosing burden.
Patients with T2DM were willing to pay for improvements in efficacy, side effects, and dosing. Patients’ WTP for more convenient dosing depended on current dosing burden, as did the effect of these attributes on likely adherence.
PMCID: PMC3786815  PMID: 24086104
discrete-choice experiment; conjoint analysis; willingness to pay; adherence; type 2 diabetes mellitus; oral antihyperglycemic therapy
4.  Factors associated with initiation of antihyperglycaemic medication in UK patients with newly diagnosed type 2 diabetes 
To assess the factors associated with antihyperglycaemic medication initiation in UK patients with newly diagnosed type 2 diabetes.
In a retrospective cohort study, patients with newly diagnosed type 2 diabetes were identified during the index period of 2003-2005. Eligible patients were ≥ 30 years old at the date of the first observed diabetes diagnosis (referred to as index date) and had at least 2 years of follow-up medical history (N = 9,158). Initiation of antihyperglycaemic medication (i.e., treatment) was assessed in the 2-year period following the index date. Adjusted Cox regression models were used to examine the association between time to medication initiation and patient age and other factors.
Mean (SD) HbA1c at diagnosis was 8.1% (2.3). Overall, 51% of patients initiated antihyperglycaemic medication within 2 years (65%, 55%, 46% and 40% for patients in the 30- < 45, 45- < 65, 65- < 75, 75+ age groups, respectively). Among the treated patients, median (25th, 75th percentile) time to treatment initiation was 63 (8, 257) days. Of the patients with HbA1c ≥ 7.5% at diagnosis, 87% initiated treatment within 2 years. These patients with a higher HbA1c also had shorter time to treatment initiation (adjusted hazard ratio (HR) = 2.44 [95% confidence interval (CI): 1.61, 3.70]; p < 0.0001). Increasing age (in years) was negatively associated with time to treatment initiation (HR = 0.98 [95% CI: 0.97, 0.99]; p < 0.001). Factors significantly associated with shorter time to treatment initiation included female gender and use of cardiovascular medications at baseline or initiated during follow up.
In this UK cohort of patients with newly diagnosed type 2 diabetes, only 51% had antihyperglycaemic medication initiated over a 2-year period following diagnosis. Older patients were significantly less likely to have been prescribed antihyperglycaemic medications. Elevated HbA1c was the strongest factor associated with initiating antihyperglycaemic medication in these patients.
PMCID: PMC3353844  PMID: 22397700
Clinical inertia; Age; Type 2 diabetes mellitus; Antihyperglycaemic medication
5.  Treatment with Sitagliptin or Metformin Does Not Increase Body Weight Despite Predicted Reductions in Urinary Glucose Excretion 
We used a mathematical model to estimate the contribution of urinary glucose excretion (UGE) to reported changes in body weight (BW) following oral antihyperglycemic agent (AHA) therapy. This modeling approach was used to gain novel insight into the mechanisms by which oral AHA affects BW.
Twenty-four hour glucose profiles were used to predict UGE before and after treatment with oral AHA. Modelpredicted changes in BW due to reduced UGE were compared with reported changes in BW to quantify non-UGEdependent effects (fluid retention, food intake, and energy expenditure).
In type 2 diabetes patients [hemoglobin A1c (HbA1c) >7.3%], the energy lost to UGE is predicted to decrease an average of 100 kcal/day for each 1% decrease in HbA1c. This effect, alone, is predicted to increase BW 1.4 kg after 6 months. Differences from this value reported for changes in BW with oral AHA therapy (+1.4 kg for pioglitazone and rosiglitazone; –0.4 kg for glyburide; –0.9 kg for sitagliptin and vildagliptin; –2.3 kg for metformin) are therefore predicted to be due to additional, non-UGE-dependent mechanisms.
Weight gain following thiazolidinedione therapy is predicted to result from both reduced UGE and non-UGE-dependent mechanisms. Reduced UGE alone is predicted to account for most of the weight gain reported following sulfonylurea therapy. Weight loss observed in response to metformin and weight maintenance observed in response to dipeptidyl peptidase-4 inhibitors may result from an increase in satiety, energy expenditure, or both.
PMCID: PMC2769847  PMID: 20046651
body weight; diabetes; glyburide; HbA1c; mathematical modeling; metformin; pioglitazone; rosiglitazone; sitagliptin; urinary glucose excretion
6.  Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes 
To explore the concept of the Minimum Clinically Important Difference (MID) of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II) and to quantify the clinical importance of different types of patient-reported hypoglycaemia.
An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM), and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia.
112 patients (28.6%) reported hypoglycaemic episodes, with 15 patients (3.8%) reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6) and without (12.1) need for assistance scored higher on the HFS-II (range 0 to 72) than patients who did not report hypoglycaemia (6.0).
We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents.
PMCID: PMC2770562  PMID: 19849828
7.  Employer-Paid Nonmedical Costs for Patients With Diabetes and End-Stage Renal Disease 
Preventing Chronic Disease  2006;3(3):A83.
Disease conditions such as end-stage renal disease (ESRD), which have severe consequences of disability and mortality, can generate substantial costs for large employers providing life insurance and disability insurance benefits. This study is the first to examine such disease-related nonmedical costs for employers and models the following employer-paid costs for ESRD in patients with diabetes: 1) life insurance benefits, 2) disability benefits, and 3) cost of replacing a worker.
We simulated a hypothetical cohort of 10,000 individuals with the age and sex distribution of a typical employee population in the United States. Data sources for the model parameters included the United States Renal Data System and proprietary life insurance and disability insurance claims databases. In addition, we used published information to identify the structures of typical employee benefits programs and annual salary information and to estimate the cost of replacing lost workers.
The study estimated that employers may incur life insurance costs of $55,055 per ESRD-related death, disability insurance costs of $31,671 per ESRD-related disability, and worker replacement costs of $27,869 per ESRD-related lost worker. Overall, the total monthly cost per employee with ESRD and diabetes was $5439.
Our study finds that, other than the large direct medical costs documented in literature, ESRD onset also results in substantial nonmedical costs for employers. As employers continue to debate changes in the structure of future health plan benefits to reduce health care costs, they should consider potential indirect cost savings of providing affordable access to medical care that prevents or delays disability and mortality in their workers.
PMCID: PMC1636708  PMID: 16776884
8.  Cholesterol Levels and Statin Use in Patients With Coronary Heart Disease Treated in Primary Care Settings 
Preventing Chronic Disease  2005;2(3):A05.
Therapy with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins, has proven to be effective in the treatment of lipid disorders. However, statin therapy continues to be underused, even though statins are a relatively safe and well-tolerated class of agents. In this study, we assessed trends in lipid control in patients with heart disease who receive most of their health care in primary care clinics. The objective was to determine whether systems of care implemented within a large medical group are associated with improved treatment and control of dyslipidemia in a high-risk group of coronary heart disease patients.
All adults with heart disease in a Minnesota medical group (N = 2947) were identified using diagnosis and procedure codes related to coronary heart disease (sensitivity = 0.85; positive predictive value = 0.89) in 1996. Study subjects were observed from 1995 to 1998. Subjects had a baseline and follow-up test for low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Changes between baseline and follow-up measurements and trends in the use of statins and other lipid-active agents among the study subjects were analyzed.
Among 1388 subjects with two or more eligible lipid measurements, mean low-density lipoprotein cholesterol improved from 137.6 mg/dL to 111.0 mg/dL (P < .001), and mean high-density lipoprotein cholesterol improved from 42.3 mg/dL to 46.3 mg/dL (P < .001). The percentage of patients with low-density lipoprotein cholesterol ≤100 mg/dL rose from 12.5% to 39.8% (P < .001), and the percentage with high-density lipoprotein cholesterol ≥40 mg/dL rose from 52.5% to 67.6% (P < .001). In multivariate models, statin use was identified as the main factor that contributed to the improvement in low-density lipoprotein cholesterol (P < .001). Men had greater decreases in low-density lipoprotein cholesterol than women after adjusting for other variables (P < .001). Statin use rose from 24.3% at baseline to 69.6% at follow-up. The statin discontinuation rate was 8.3% for baseline statin users and 12.2% for subjects who used statins at any time during the study period.
Investment in better heart disease care for patients in primary care clinics led to major improvement in lipid control over 30 months, primarily due to increased statin use. Improvements in low-density lipoprotein cholesterol and high-density lipoprotein cholesterol were sufficient to substantially reduce risk of subsequent major cardiovascular events.
PMCID: PMC1364514  PMID: 15963307
9.  Development and Validation of the Hyperlipidemia 
Many patients treated with lipid-lowering medications in clinical practice do not achieve targeted National Cholesterol Education Program (NCEP) goals for low-density lipoprotein cholesterol (LDL-C), despite the proven efficacy of these medications. Understanding physician attitudes and beliefs about treating patients to goal may be useful in improving patient care and ensuring that all patients receive the benefits of treatments shown to be optimal in clinical trials.
To develop a theoretically based, and statistically reliable and valid survey instrument for measuring the attitudes and beliefs of physicians toward hyperlipidemia and its treatment, including treatment of patients to goal. To determine whether the attitudes measured were associated with physician intentions to treat patients to LDL-C goal.
We assessed the reliability of the instrument through an examination of the internal consistency and factor structure of the constructs. Validity was assessed through zero-order correlations among the constructs and the relationship between the constructs and an intent to treat to goal case study.
Internal consistency scores for the 8 constructs ranged from 0.48 to 0.75. Factor loadings indicated that the individual items belonged to their respective constructs, as hypothesized. The predictive validity of the instrument was demonstrated by significant relationships between 5 of the 8 attitudinal constructs and an intent to treat to goal case study.
The HABIT physician survey is the first validated instrument covering a broad set of attitudes about the treatment of hyperlipidemia that are both theoretically and empirically linked to physician intent to treat to NCEP LDL-C goal.
PMCID: PMC1494952  PMID: 14687256
physician behavior; education; attitudes; cholesterol
10.  Disparities in lipid management for African Americans and Caucasians with coronary artery disease: A national cross-sectional study 
Individuals with coronary artery disease are at high risk for adverse health outcomes. This risk can be diminished by aggressive lipid management, but adherence to lipid management guidelines is far from ideal and substantial racial disparities in care have been reported. Lipid treatment and goal attainment information is not readily available for large patient populations seen in the fee-for-service setting. As a result, national programs to improve lipid management in this setting may focus on lipid testing as an indicator of lipid management. We describe the detection, treatment, and control of dyslipdemia for African Americans and Caucasians with coronary artery disease to evaluate whether public health programs focusing on lipid testing can eliminate racial disparities in lipid management.
Physicians and medical practices with high numbers of prescriptions for coronary artery disease medications were invited to participate in the Quality Assurance Program. Medical records were reviewed from a random sample of patients with coronary artery disease seen from 1995 through 1998. Data related to the detection, treatment, and control of dyslipidemia were abstracted from the medical record and evaluated in cross-sectional stratified and logistic regression analyses using generalized estimation equations.
Data from the medical records of 1,046 African Americans and 22,077 Caucasians seen in outpatient medical practices in 23 states were analyzed. African-American patients were younger, more likely to be women and to have diabetes, heart failure, and hypertension. The low density lipoprotein cholesterol (LDL-C) testing rate for Caucasian men was over 1.4 times higher than that for African-American women and about 1.3 times higher than that for African-American men. Almost 60% of tested Caucasian men and less than half of tested African Americans were prescribed lipid-lowering drugs. Tested and treated Caucasian men had the highest LDL-C goal attainment (35%) and African-American men the lowest (21%).
Although increased lipid testing is clearly needed for African Americans, improvements in treatment and control are also necessary to eliminate racial disparities in lipid management. Disparities in treatment and goal attainment must be better understood and reflected in policy to improve the health of underserved populations.
PMCID: PMC516441  PMID: 15317654

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