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1.  The INITIATOR Study: Pilot Data on Real-World Clinical and Economic Outcomes in US Patients with Type 2 Diabetes Initiating Injectable Therapy 
Advances in Therapy  2013;30(12):1128-1140.
Type 2 diabetes mellitus (T2DM) progression often results in treatment intensification with injectable therapy to maintain glycemic control. Using pilot data from the Initiation of New Injectable Treatment Introduced after Anti-diabetic Therapy with Oral-only Regimens study, real-world treatment patterns among T2DM patients initiating injectable therapy with insulin glargine or liraglutide were assessed.
This was a retrospective analysis of claims from the OptumInsight™ (OI; January 1, 2010 to July 30, 2010) and HealthCore® (HC; January 1, 2010 to June 1, 2010) health insurance databases. Baseline characteristics, health care resource utilization, and costs were compared between adults with T2DM initiating injectable therapy with insulin glargine pen versus liraglutide. Follow-up outcomes, including glycated hemoglobin A1c (A1C), hypoglycemia, health care utilization, and costs, were assessed.
At baseline, almost one in three liraglutide patients (OI, n = 363; HC, n = 521) had A1C <7.0%, while insulin glargine patients (OI, n = 498; HC, n = 1,188) had poorer health status, higher A1C (insulin glargine: 9.8% and 9.1% versus liraglutide: 7.9% and 7.7%, OI and HC, respectively, both P < 0.001), and were less likely to be obese (insulin glargine: 10.8% and 9.2% versus liraglutide: 17.4% and 18.8%, OI and HC, respectively, both P < 0.01). The percentage of patients experiencing a hypoglycemic event was numerically higher for insulin pen use for both cohorts (OI 4.4% versus 3.0%; HC 6.2% versus 2.3%). During follow-up, in the insulin glargine cohort, annualized diabetes-related costs remained unchanged ($8,344 versus $7,749 OI, and $7,094 versus $7,731 HC), despite a significant increase in pharmacy costs, due to non-significant decreases in medical costs, while the liraglutide cohort had a significant increase in annualized diabetes-related costs ($4,510 versus $7,731 OI, and $4,136 versus $7,111 HC; both P < 0.001) due to a non-significant increase in medical costs coupled with a significant increase in pharmacy costs.
These descriptive data identified differences in demographic and baseline clinical characteristics among patients initiating injectable therapies. The different health care utilization and cost patterns warrant further cost-effectiveness analysis.
Electronic supplementary material
The online version of this article (doi:10.1007/s12325-013-0074-8) contains supplementary material, which is available to authorized users.
PMCID: PMC3898354  PMID: 24293131
Type 2 diabetes mellitus; Health care costs; Injectable treatment; Treatment initiation
2.  Assessing Medicare Beneficiary Eligibility for Medication Therapy Management Programs Using PINNACLE, a National Cardiovascular Data Registry 
American Health & Drug Benefits  2013;6(7):367-374.
Medication therapy management (MTM) is a mandated component of the 2003 Medicare Modernization Act for Part D prescription drug plans and Medicare Advantage plans, authorizing the pharmacist or other qualified provider to identify, resolve, and prevent medication-related problems for patients with chronic diseases. MTM programs have been shown to improve medication adherence and reduce medication errors while reducing overall costs in patients with cardiovascular (CV) disease; however, MTM has been greatly underutilized for patients with chronic diseases.
To identify the proportion of Medicare beneficiaries who are eligible for, and who could potentially benefit from, participating in MTM among patients enrolled in the National Cardiovascular Data Registry's PINNACLE Registry.
Patient MTM eligibility is based on the presence of multiple chronic diseases and meeting a minimum annual insurance medication costs. We used patient data from 462 academic and private cardiology practices in the United States who participated in the PINNACLE Registry between May 1, 2008, and September 30, 2010, to determine Medicare beneficiaries' eligibility to participate in an MTM program for patients meeting the MTM criteria of (1) a number of chronic diseases (in this case, the number of CV conditions) and (2) an estimated minimum annual medication expenses, using a weighted average cost calculated based on the average wholesale price of the most often prescribed medications, by class, as extracted from the HealthCore Integrated Research Database and weighted according to prescribing frequency within a class.
Among the Medicare beneficiaries in the PINNACLE Registry, 93,089 (58%) had ≥3 chronic CV conditions, and the median annual estimated medication expenditure per patient enrolled in the PINNACLE Registry was $1329. Of the total of 93,089 Medicare beneficiaries, 21.4% were eligible for MTM, based on the 2010 minimum eligibility criterion of an annual insurer medication expenditure of $3000 or more. These costs ranged from $366 for low-cost generics to $3958 for the highest-cost drug in a class. In addition, based on the 2010 minimum eligibility rule, the proportion of patients eligible for MTM ranged from 7.9% for those eligible for MTM for low-cost generics to 64% of patients eligible for MTM for the highest-cost medication in a class.
These data serve to raise awareness regarding patients' potential eligibility to receive the benefits of MTM programs. Providers caring for patients with multiple CV conditions, including specialists such as cardiologists, should explain to eligible patients about MTM programs and encourage these patients to take advantage of such programs.
PMCID: PMC4031728  PMID: 24991369
3.  Amphetamines, Atomoxetine and the Risk of Serious Cardiovascular Events in Adults 
PLoS ONE  2013;8(1):e52991.
Main Objective
To compare the incidence rates of serious cardiovascular events in adult initiators of amphetamines or atomoxetine to rates in non-users.
This was a retrospective cohort study of new amphetamines (n = 38,586) or atomoxetine (n = 20,995) users. Each medication user was matched to up to four non-users on age, gender, data source, and state (n = 238,183). The following events were primary outcomes of interest 1) sudden death or ventricular arrhythmia, 2) stroke, 3) myocardial infarction, 4) a composite endpoint of stroke or myocardial infarction. Cox proportional hazard regression was used to calculate propensity-adjusted hazard ratios for amphetamines versus matched non-users and atomoxetine versus matched non-users, with intracluster dependence within matched sets accounted for using a robust sandwich estimator.
The propensity-score adjusted hazard ratio for amphetamines use versus non-use was 1.18 (95% CI: 0.55–2.54) for sudden death/ventricular arrhythmia, 0.80 (95% CI: 0.44–1.47) for stroke, 0.75 (95% CI: 0.42–1.35) for myocardial infarction, and 0.78 (95% CI: 0.51–1.19) for stroke/myocardial infarction. The propensity-score adjusted hazard ratio for atomoxetine use versus non-use was 0.41 (95% CI: 0.10–1.75) for sudden death/ventricular arrhythmia, 1.30 (95% CI: 0.52–3.29) for stroke, 0.56 (95% CI: 0.16–2.00) for myocardial infarction, and 0.92 (95% CI: 0.44–1.92) for stroke/myocardial infarction.
Initiation of amphetamines or atomoxetine was not associated with an elevated risk of serious cardiovascular events. However, some of the confidence intervals do not exclude modest elevated risks, e.g. for sudden death/ventricular arrhythmia.
PMCID: PMC3559703  PMID: 23382829
4.  The impact of serum lipids on risk for microangiopathy in patients with type 2 diabetes mellitus 
Few large-scale, real-world studies have assessed the relative associations of lipid fractions with diabetic microvascular events. The main objective of this study was to evaluate the association of the lipid profile components, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), and non-high density lipoprotein cholesterol (non-HDL-C) with microvascular complications (MVCs) in type 2 diabetes mellitus (T2DM) patients.
This observational cohort study queried the HealthCore Integrated Research Database (HIRDSM) for newly-diagnosed (Index Date) 18-64-year-old patients with diabetes mellitus between 01/01/2005-06/30/2010. Inclusion required ≥12 months pre-index continuous health plan eligibility and ≥1 pre-index lipid profile result. Patients with polycystic ovary syndrome and prior MVCs were excluded. Incident complications were defined as the earliest occurrence of diabetic retinopathy, peripheral neuropathy, and/or nephropathy post-index. Cox proportional models and Kaplan-Meier (KM) curves were used to evaluate associations among variables.
Of the patients (N = 72,267), 50.05 % achieved HDL-C, 64.28 % LDL-C, 59.82 % TG, and 56.79 % non-HDL-C American Diabetes Association goals at baseline. During follow-up (mean, 21.74 months), there were 5.21 microvascular events per 1,000 patient-months. A 1-mg/dL increase in HDL-C was associated with 1 % decrease in any MVC risk (P < .0001), but for LDL-C, TG, and non-HDL-C, 1-mg/dL increase resulted in increases of 0.2 % (P < .0001), 0.1 % (P < 0.001) and 0.3 % (P < 0.001) in MVC risk. Patients achieving HDL-C goals had a 11 % lower risk of MVC versus non-achievers (RR 0.895, [95 % CI, 0.852-0.941], P < .0001). Similarly, TG goal attainment was associated with a lowered risk for any MVC (RR 0.849, [95 % CI, 0.808-0.892], P < .0001). Evaluation of KM survival curves demonstrated no significant difference in the risk of MVCs between patients achieving vs. not achieving LDL-C goals, but did demonstrate a difference in MVC risk between patients achieving vs. not achieving non-HDL-C goals.
This study demonstrates significant independent associations among lipid fractions and risk for microangiopathy. These findings suggest that attaining established ADA goals for HDL-C, TG, and non-HDL-C may reduce risk for microvascular events among patients with diabetes.
PMCID: PMC3473235  PMID: 22978715
Lipid subfractions; ADA treatment goals; Diabetes; Microvascular complications; Retinopathy; Neuropathy; Nephropathy
5.  Cardiovascular Events and Death in Children Exposed and Unexposed to ADHD Agents 
Pediatrics  2011;127(6):1102-1110.
The objective of this study was to compare the rate of severe cardiovascular events and death in children who use attention-deficit/hyperactivity disorder (ADHD) medications versus nonusers.
We performed a large cohort study using data from 2 administrative databases. All children aged 3 to 17 years with a prescription for an amphetamine, atomoxetine, or methylphenidate were included and matched with up to 4 nonusers on the basis of data source, gender, state, and age. Cardiovascular events were validated using medical records. Proportional hazards regression was used to calculated hazard ratios.
We identified 241 417 incident users (primary cohort). No statistically significant difference between incident users and nonusers was observed in the rate of validated sudden death or ventricular arrhythmia (hazard ratio: 1.60 [95% confidence interval (CI): 0.19–13.60]) or all-cause death (hazard ratio: 0.76 [95% CI: 0.52–1.12]). None of the strokes identified during exposed time to ADHD medications were validated. No myocardial infarctions were identified in ADHD medication users. No statistically significant difference between prevalent users and nonusers (secondary cohort) was observed (hazard ratios for validated sudden death or ventricular arrhythmia: 1.43 [95% CI: 0.31–6.61]; stroke: 0.89 [95% CI: 0.11–7.11]; stroke/myocardial infarction: 0.72 [95% CI: 0.09–5.57]; and all-cause death: 0.77 [95% CI: 0.56–1.07).
The rate of cardiovascular events in exposed children was very low and in general no higher than that in unexposed control subjects. Because of the low number of events, we have limited ability to rule out relative increases in rate.
PMCID: PMC3387871  PMID: 21576311
children; adolescents; amphetamines; atomoxetine; methylphenidate; cardiovascular; death
6.  Association between second-generation antipsychotics and newly diagnosed treated diabetes mellitus: does the effect differ by dose? 
BMC Psychiatry  2011;11:197.
The benefits of some second-generation antipsychotics (SGAs) must be weighed against the increased risk for diabetes mellitus. This study examines whether the association between SGAs and diabetes differs by dose.
Patients were ≥18 years of age from three US healthcare systems and exposed to an SGA for ≥45 days between November 1, 2002 and March 31, 2005. Patients had no evidence of diabetes before index date and no previous antipsychotic prescription filled within 3 months before index date.
49,946 patients were exposed to SGAs during the study period. Person-time exposed to antipsychotic dose (categorized by tertiles for each drug) was calculated. Newly treated diabetes was identified using pharmacy data to determine patients exposed to anti-diabetic therapies. Adjusted hazard ratios for diabetes across dose tertiles of SGA were calculated using the lowest dose tertile as reference.
Olanzapine exhibited a dose-dependent relationship for risk for diabetes, with elevated and progressive risk across intermediate (diabetes rate per 100 person-years = 1.9; adjusted Hazard Ratio (HR), 1.7, 95% confidence interval (CI), 1.0-3.1) and top tertile doses (diabetes rate per 100 person-years = 2.7; adjusted HR, 2.5, 95% CI, 1.4-4.5). Quetiapine and risperidone exhibited elevated risk at top dose tertile with no evidence of increased risk at intermediate dose tertile. Unlike olanzapine, quetiapine, and risperidone, neither aripiprazole nor ziprasidone were associated with risk of diabetes at any dose tertile.
In this large multi-site epidemiologic study, within each drug-specific stratum, the risk of diabetes for persons exposed to olanzapine, risperidone, and quetiapine was dose-dependent and elevated at therapeutic doses. In contrast, in aripiprazole-specific and ziprasidone-specific stratum, these newer agents were not associated with an increased risk of diabetes and dose-dependent relationships were not apparent. Although, these estimates should be interpreted with caution as they are imprecise due to small numbers.
PMCID: PMC3264670  PMID: 22171594

Results 1-6 (6)