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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
compliance; proportion of days covered; PDC; MPR; T2DM; treatment; medication
2.  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
3.  Physician Reasons for Nonpharmacologic Treatment of Hyperglycemia in Older Patients Newly Diagnosed with Type 2 Diabetes Mellitus 
Diabetes Therapy  2012;3(1):5.
To identify reasons why primary care physicians (PCPs) do not treat older patients newly diagnosed with type 2 diabetes mellitus (T2DM) with antihyperglycemic agents following diagnosis.
US PCPs were surveyed via the internet regarding their reasons for not treating patients aged >65 years diagnosed with T2DM and had not yet initiated antihyperglycemic therapy for ≥6 months after diagnosis. PCPs were requested to provide relevant clinical information for untreated older patients and select applicable reasons for not initiating treatment from a list of 35 possibilities, grouped into five categories.
A total of 508 PCPs completed the online survey and provided complete clinical data for 770 patients. The reasons provided by the first-ranked physician for not initiating antihyperglycemic therapy were related to diet and exercise (57.5%); mild hyperglycemia (23.8%); patient’s concerns (13.4%); concerns about antihyperglycemic agents (3.0%); and comorbidities and polypharmacy (2.3%). The “diet and exercise” category was the most common first-ranked non-treatment reason, regardless of recent hemoglobin A1c (HbA1c) stratum. Reasons within the “patient’s concerns,” “concerns related to antihyperglycemic agents,” and “comorbidities and polypharmacy” categories tended to be selected more often as first-ranked reasons by physicians for patients with higher HbA1c values. Of the 158 patients whose physicians planned to initiate antihyperglycemic therapy within the next month, 54.4% already had a most recent HbA1c value above their physician-stated threshold for treatment initiation.
In the PCPs studied, there was a tendency to select appropriate reasons for non-treatment with antihyperglycemic agents given their patients’ glycemic status. However, there was inertia related to the initiation of pharmacological therapy in some older patients with newly diagnosed T2DM. Important factors included physicians’ perceptions of “mild” hyperglycemia and the HbA1c threshold for using antihyperglycemic agents.
PMCID: PMC3508110  PMID: 22700283
Antihyperglycemic agents; Clinical inertia; Elderly; Non-treatment; Type 2 diabetes mellitus
4.  Reasons given by general practitioners for non-treatment decisions in younger and older patients with newly diagnosed type 2 diabetes mellitus in the United Kingdom: a survey study 
Older patients with newly diagnosed type 2 diabetes mellitus are less likely to receive antihyperglycaemic therapy compared to their younger counterparts. The purpose of this study was to assess the reasons of general practitioners (GPs) for not treating younger and older patients with newly diagnosed type 2 diabetes mellitus with antihyperglycaemic agents.
In a survey conducted between November 2009 and January 2010, 358 GPs from the United Kingdom selected reasons for not initiating antihyperglycaemic therapy in younger (< 65 years) and older (≥65 years) patients with newly diagnosed type 2 diabetes mellitus and untreated with any antihyperglycaemic agent for at least six months following diagnosis. Thirty-six potential reasons were classified into four major categories: Mild hyperglycaemia, Factors related to antihyperglycaemic agents, Comorbidities and polypharmacy, and Patient-related reasons. Reasons for non-treatment were compared between younger (n = 1, 023) and older (n = 1, 005) patients.
Non-treatment reasons related to Mild hyperglycaemia were selected more often by GPs for both younger (88%) and older (86%) patients than those in other categories. For older patients, Factors related to antihyperglycaemic agents (46% vs. 38%) and Comorbidities and polypharmacy (33% vs. 19%), both including safety-related issues, were selected significantly (p < 0.001) more often by GPs. No between-group difference was observed for the Patient-related reasons category. The GP-reported HbA1c threshold for initiating antihyperglycaemic therapy was significantly (p < 0.001) lower for younger patients (mean ± standard deviation: 7.3% ± 0.7) compared to older patients (7.5% ± 0.9).
GPs selected reasons related to Mild hyperglycaemia for non-treatment of their untreated patients with newly diagnosed type 2 diabetes mellitus, despite nearly one-third of these patients having their most recent HbA1c value ≥7%. The findings further suggest that safety-related issues may influence the non-treatment of older patients with type 2 diabetes mellitus.
PMCID: PMC3219572  PMID: 22035104
5.  Assessment of severity and frequency of self-reported hypoglycemia on quality of life in patients with type 2 diabetes treated with oral antihyperglycemic agents: A survey study 
BMC Research Notes  2011;4:251.
Some oral antihyperglycemic agents may increase risk of hypoglycemia and thereby reduce patient quality of life. Our objective was to assess the impact of the severity and frequency of self-reported hypoglycemia on health-related quality of life (HRQoL) among patients with type 2 diabetes treated with oral antihyperglycemic agents.
A follow-up survey was conducted in participants with self-reported type 2 diabetes treated with oral antihyperglycemic agents from the US National Health and Wellness Survey 2007. Data were collected on the severity and frequency of hypoglycemic episodes in the 6 months prior to the survey, with severity defined as mild (no interruption of activities), moderate (some interruption of activities), severe (needed assistance of others), or very severe (needed medical attention). HRQoL was assessed using the EuroQol-5D Questionnaire (EQ-5D) US weighted summary score (utility) and Worry subscale of the Hypoglycemia Fear Survey (HFS). Of the participants who completed the survey (N = 1,984), mean age was 58 years, 57% were male, 72% reported an HbA1c <7.0%, and 50% reported treatment with a sulfonylurea-containing regimen. Hypoglycemic episodes were reported by 63% of patients (46% mild, 37% moderate, 13% severe and 4% very severe). For patients reporting hypoglycemia, mean utility score was significantly lower (0.78 versus 0.86, p < 0.0001) and mean HFS score was significantly higher (17.5 versus 6.2, p < 0.0001) compared to patients not reporting hypoglycemia. Differences in mean scores between those with and without hypoglycemia increased with the level of severity (mild, moderate, severe, very severe) for utility (0.03, 0.09, 0.18, 0.23) and HFS (6.1, 13.9, 20.1, 25.6), respectively. After adjusting for age, gender, weight gain, HbA1c, microvascular complications, and selected cardiovascular conditions, the utility decrement was 0.045 (by level of severity: 0.009, 0.055, 0.131, 0.208), and the HFS increase was 9.6 (by severity: 5.3, 12.4, 17.6, 23.2). HRQoL further decreased with greater frequency of hypoglycemic episodes.
Self-reported hypoglycemia is independently associated with lower HRQoL, and the magnitude of this reduction increases with both severity and frequency of episodes in patients with type 2 diabetes treated with oral antihyperglycemic agents.
PMCID: PMC3148563  PMID: 21777428
6.  Health Care and Productivity Costs Associated With Diabetic Patients With Macrovascular Comorbid Conditions 
Diabetes Care  2009;32(12):2187-2192.
To examine and quantify from the societal perspective the impact of macrovascular comorbid conditions (MVCCs) on health care and productivity costs in diabetic patients in the U.S.
With use of the pooled Medical Expenditure Panel Survey (MEPS) 2004 and 2006 data, a nationally representative adult sample (aged ≥18 years) was included in the study. Health care cost was measured by the annual health care expenditure. Productivity cost was calculated from the lost productivity from missed work days and additional bed days due to illness/injury based on the 2006 average national hourly wage. Both 2004 and 2006 cost data were adjusted to 2006 dollars. Given the heavily right-skewed distribution of the cost data, the generalized linear model with log-link function and γ variance was used to identify the relationship between MVCCs and costs after controlling for age, sex, race, ethnicity, education, income, employment status, smoking status, health insurance, diabetes severity, and comorbidities. Negative binomial models were applied to analyze the outcomes of missed work days and bed days. All statistics were adjusted using the proper sampling weight from MEPS.
Compared with diabetic patients without MVCCs (n = 3,320), those with MVCCs (n = 913) had statistically significant higher annual health care costs (5,120 USD, P < 0.001), more missed work days (13.03 days, P < 0.001), and more bed days (7.60 days, P = 0.025) per patient after controlling for differences in sociodemographics, smoking, diabetes severity, and comorbidities. The marginal lost productivity cost was 2,388 USD annually per patient.
From the U.S. societal perspective, MVCCs in diabetic patients are associated with increased health care and lost productivity costs.
PMCID: PMC2782975  PMID: 19729528
7.  Multinational Internet-based survey of patient preference for newer oral or injectable Type 2 diabetes medication 
The prevalence of Type 2 diabetes mellitus continues to rise. Although glucagon-like peptide-1 (GLP-1) analog and dipeptidyl peptidase-4 (DPP-4) inhibitor medications are effective, there are differences between these products, including method of administration (injectable versus oral). The objective of this study was to examine patient preferences (and predictors of preferences) for two different medication profiles, one similar to a GLP-1 analog (liraglutide) and another similar to a DPP-4 inhibitor (sitagliptin).
Internet survey data were collected in two waves (wave 1, n = 2402; wave 2, n = 1340) using patients from the US and Europe. Patients were presented with two hypothetical medication profiles (“drug A” and “drug B”, resembling sitagliptin and liraglutide, respectively) and asked to report their preferences.
Most patients in wave 1 and wave 2 reported that overall they would prefer a drug with the sitagliptin-like profile (81.9% and 84.4%, respectively) over a drug with the liraglutide-like profile (18.1% and 15.6%, respectively), and >80% of patients reported that they would be able to take a drug with the sitagliptin-like profile as directed by their physician for a longer period. The likelihood of preferring the sitagliptin-like profile significantly increased as age (odds ratio [OR] = 1.02) and importance placed on method of administration (OR = 1.32) increased (P < 0.05). Although the sitagliptin-like profile was preferred by the majority of patients in all subgroups, a lower proportion of patients with obesity, with weight gain, with A1C values above target, and who exercised preferred the sitagliptin-like profile compared with those without obesity (77.0% versus 87.9%), without weight gain (77.8% versus 86.7%), with A1C values at or below target (79.0% versus 86.5%), and who did not exercise (81.6% versus 86.4%), respectively (P < 0.05).
This research suggests that patients (across geographies) prefer an oral medication with a profile resembling sitagliptin to an injectable medication with a profile resembling liraglutide.
PMCID: PMC3003606  PMID: 21206515
Type 2 diabetes; medication preference; sitagliptin; liraglutide
8.  Pre-existing cardiovascular diseases and glycemic control in patients with type 2 diabetes mellitus in Europe: a matched cohort study 
Although there is a growing body of evidence showing that patients with type 2 diabetes mellitus (T2DM) have poor glycemic control in general, it is not clear whether T2DM patients with pre-existing cardiovascular diseases (CVD) are more or less likely to have good glycemic control than patients without pre-existing CVD. Our aim was to examine the degree of glycemic control among T2DM patients in Europe with and without pre-existing CVD.
This is a matched cohort study based on a multi-center, observational study with retrospective medical chart reviews of T2DM patients in Spain, France, United Kingdom, Norway, Finland, Germany, and Poland. Included patients were aged >= 30 years at time of diagnosis of T2DM, had added a SU or a PPARγ agonist to failing metformin monotherapy (index date) and had pre-existing CVD (cases). A control cohort with T2DM without pre-existing CVD was identified using 1:1 propensity score matching. With difference-in-difference approach, logistic and linear regression analyses were applied to identify differences in glycemic control by CVD during the follow up period, after controlling for baseline demographics, clinical information, and concurrent anti-hyperglycemic medication use.
The percentage of case patients with adequate glycemic control relative to control patients during the 1st, 2nd, 3rd, and 4th years after the index date was 19.9 vs. 26.5, 16.8 vs. 26.5, 18.8 vs. 28.3, and 16.8 vs. 23.5 respectively. Cases were significantly less likely to have adequate glycemic control (odds ratio: 0.62; 95% confidence interval: 0.46-0.82) than controls after adjusting for baseline differences, secular trend, and other potential confounding covariates.
T2DM patients with pre-existing CVD tended to have poorer glycemic control than those without pre-existing CVD, all other factors being equal. It suggests that clinicians may need to pay more attention to glycemic control among T2DM patients with CVD.
PMCID: PMC2876102  PMID: 20409333
9.  Assessing different perspectives on the value of a pharmaceutical innovation 
Southern Med Review  2010;3(1):24-28.
Numerous pharmaceutical products are launched each year for the treatment of various medical conditions. The prescriber is in a difficult position to determine which the optimal product is for a specific patient, when he has available immediate release as well as sustained action capsules and tablets, chewable tablets and liquid dosage forms. Some have activity within 15 minutes while others take longer. Some are more costly but have never been implicated with gastric distress; some are very widely prescribed and others are not well known. Some are promoted as enhancing compliance and others for schedule simplicity.In order to make sense of the array of diverse product attributes and to determine the value associated with different dosage form features, separate panels of practicing physicians, practicing pharmacists and patients were asked to ascribe value to a list of 10 drug product features that were mentioned in drug product advertisements in medical journals, by indicating what percentage price increase that feature might merit over a basic product without that feature. In addition, the respondents were asked to rank order the mentioned product features.In all three panels, efficacy and safety were accorded the highest status. Pharmacists and patients appeared to be most welcoming of some of the listed features. This pilot study demonstrates that there appears to be a recognized value assigned to some product features and it may differ by audience.
PMCID: PMC3471174  PMID: 23093880
10.  Mortality of aircraft maintenance workers exposed to trichloroethylene and other hydrocarbons and chemicals: extended follow up 
To extend follow-up of 14,455 workers from 1990 to 2000, and evaluate mortality risk from exposure to trichloroethylene (TCE) and other chemicals.
Multivariable Cox models were used to estimate relative risk for exposed vs. unexposed workers based on previously developed exposure surrogates.
Among TCE exposed workers, there was no statistically significant increased risk of all-cause mortality (RR=1.04) or death from all cancers (RR=1.03). Exposure-response gradients for TCE were relatively flat and did not materially change since 1990. Statistically significant excesses were found for several chemical exposure subgroups and causes, and were generally consistent with the previous follow up.
Patterns of mortality have not changed substantially since 1990. While positive associations with several cancers were observed, and are consistent with the published literature, interpretation is limited due to the small numbers of events for specific exposures.
PMCID: PMC2763375  PMID: 19001957
trichloroethylene; TCE; hydrocarbons; solvents; cancer; mortality
11.  A Retrospective Occupational Cohort Study of End-Stage Renal Disease in Aircraft Workers Exposed to Trichloroethylene and Other Hydrocarbons 
Case–control studies suggest hydrocarbons increase end-stage renal disease (ESRD) risk. No cohort studies have been conducted.
An occupational database was matched to the U.S. Renal Data System, and the outcome of all-cause ESRD was examined using multivariable Cox regression. Sixteen individual hydrocarbons were studied, although exposures were not mutually exclusive.
For the 1973–2000 period, there was an approximate twofold increased risk of ESRD among workers exposed to trichloroethylene, 1,1,1-trichloroethane, and JP4 gasoline compared with unexposed subjects (all P < 0.05). Relative risk was greater than unity (P > 0.05) for several other hydrocarbons. Associations attenuated (all P > 0.05) when 2001–2002 data were included in the analyses.
Certain hydrocarbons may increase all-cause ESRD risk. Uncertainty regarding the mechanism for increased risk and the observed attenuation in risk in 2001–2002, as well as the overlap of exposures, complicates interpretation. Additional research is needed.
PMCID: PMC1351384  PMID: 16404204

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