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337
Abstracts
included. The index date was chosen such that each patient had
at least 6 month’s treatment with either of the products—before
and at least 6 months after that date. Patients receiving other
oral anti-diabetic drugs were excluded. To compensate for lack
of double-blind randomization and to reduce selection bias,
patients in the pioglitazone group were matched 1 : 1 with the
insulin group based on propensity score calculated using demo-
graphic characteristics, co-morbidities, medical therapies, dura-
tion of diabetes, and duration of treatment. The odds ratio for
the microvascular event in the follow-up period was determined
using logistic regression with treatment as a factor and signifi-
cant (p <0.1) baseline characteristics as covariates in the model.
RESULTS: A total of 453 patients in the pioglitazone group were
matched to 453 patients in the insulin group. The crude event
rate in the pioglitazone group was 3.09% compared with
9.49% in the insulin group (p <0.001) and the odds ratio was
0.304 for pioglitazone (95% CI =0.164, 0.564; p <0.001). The
significant risk reduction projected for the pioglitazone group
could not be completely explained by baseline laboratory
measurements of lipids, serum creatinine, blood pressures, or
duration of diabetes. CONCLUSION: In this retrospective,
propensity-matched analysis in patients with type-2 diabetes, the
pioglitazone-treated group was associated with a significantly
lower incidence of microvascular events than the insulin-treated
group.
PDB2
COMPARISON OF PIOGLITAZONE WITH OTHER
ANTIDIABETIC DRUGS FOR ASSOCIATED INCIDENCE OF
LIVER FAILURE: NO EVIDENCE OF INCREASED LIVER
FAILURE WITH PIOGLITAZONE
Rajagopalan R, Iyer S, Perez A
Takeda Pharmaceuticals North America Inc, Lincolnshire, IL, USA
OBJECTIVE: To assess the incidence of liver failure in associa-
tion with anti-diabetic treatment using pioglitazone versus other
oral anti-diabetic medications. METHODS: The study was a ret-
rospective analysis of claims data from the PharMetrics Patient-
Centric Database that had over 1.12 million enrollees with type
2 diabetes. All patients ≥18 years of age with type 2 diabetes
who had initiated treatment with either a thiazolidinedione
(pioglitazone and rosiglitazone), sulfonylurea, or metformin
were identified and matched on the basis of propensity scores,
which served as a proxy for severity of disease. The primary
measure of interest was the incidence of liver failure or hepati-
tis post-index date. In addition to unadjusted comparisons, Cox
proportional hazards models were employed to estimate the risk
of developing liver failure or hepatitis. RESULTS: There was no
significant difference in the 1-year and 2-year incidence rates of
liver failure or hepatitis (primary and secondary diagnosis)
between the pioglitazone monotherapy group and respective
comparator groups (pairs matched with rosiglitazone, n =1847
(p >0.808); with sulfonylurea, n =1474 (p >0.219); and with
metformin, n =1137 (p >0.284)). Cox proportional hazards
models controlling for age, pre-index total health care costs,
charlson comorbidity index, procedures and a hospitalization or
ER visit for pre-index hyperglycemia echoed these results.
Further, no primary or secondary diagnosis of liver failure was
reported in the pioglitazone group during the follow-up period.
CONCLUSION: Results of retrospective data analysis using the
PharMetrics cohort of patients with type 2 diabetes demonstrate
that there is no evidence of increased risk of liver failure or
hepatitis for patients initiating therapy on pioglitazone compared
to other oral anti-diabetic agents. Pioglitazone therapy was not
associated with an increased risk of liver failure at 2 years
relative to other oral anti-diabetic therapies.
PDB3
EVALUATION OF PHARMACIST INTERVENTIONS IN
DIABETIC PATIENTS FROM RURAL COMMUNITY HEALTH
CENTERS
Pinto S, Segal R, Winterstein AG,Annis L, Robinson D,Yates D,
Pederson L,Willis M
University of Florida, Gainesville, FL, USA
OBJECTIVES: The project focuses on improving the drug use
process in the management of patients with chronic diseases,
especially diabetes. This HRSA funded program includes educa-
tion and training of pharmacists in five community health centers
about specific disease state therapies, monitoring, and manage-
ment. The study hypotheses are: 1) patients exposed to the inter-
vention will have improved medical and patient outcomes based
on changes in HbA1c, diabetes symptoms, LDL, blood pressure,
and health related quality-of-life, and 2) process measures con-
sistent with best practices will improve for patients exposed to
the intervention. METHODS: The project uses a prospective
design to determine whether exposure to the intervention over
two years leads to improved outcomes and processes of care.
Patients are the unit-of analysis and serve as their own controls.
Subjects include adults with Type 2 Diabetes Mellitus and
HbA1c >8mg/dL within a 3-month period of enrollment. Sub-
jects meeting the inclusion criteria are consecutively drawn from
a subset of clinic patients. Medical outcome data are collected
from medical and laboratory records, pharmacy records and
patient self-report. Study measures include clinical indicators,
quality-of-life, satisfaction and HEDIS diabetes-related process
measures. Outcomes and process data is collected at baseline and
every six months. RESULTS: Of the 142 patients enrolled in the
study, 137 are at the 6-month level and 104 are at the 12-month
level. The means at baseline for HbA1c, lipids and blood pres-
sure were 9.45, 122.54 (LDL), 136.63 (systolic) and 80.70 (dias-
tolic) while the six-month means were 8.53, 110.74, 135.16,
79.59 respectively. Wilcoxon Sign-Ranked test indicated signifi-
cant differences in HbA1c and LDL mean values (p <= 0.000 &
p <= 0.10 respectively). However, the differences were non-
significant for blood pressure values. CONCLUSIONS: The
baseline and 6 month values of these clinical markers indicate
an improvement in diabetes health outcomes for the patients
included in this initiative. Early findings support a positive
impact of pharmaceutical care on diabetes outcomes.
PDB4
PARTICIPATION IN HOME-BASED A1C TESTING IN
CAREPATTERNS® PROGRAM FOR DIABETES
Berger J, Low D, Hu L, Stine N
Caremark, Nor thbrook, IL, USA
OBJECTIVES: Even though guidelines suggest glycosylated
hemoglobin A1c (HbA1c) testing at least twice a year for dia-
betics and despite the correlation between long term glycemic
control and reductions in overall health care costs and service
utilization, studies have estimated that only 75% of diabetes
patients receive annual HbA1c screening. The purpose of this
study was to examine the relationship between participation in
a free HbA1c home-testing program and several individual-
specific variables, including age level, gender, income range and
disease severity. METHODS: Participants enrolling in the
CarePatterns® Disease Management Program for Diabetes from
January 1, 2003 through June 30, 2003 and who opted to par-
ticipate in the free home-based HbA1c testing program were
included in the study. Allowing sufficient time for test comple-
tion and return, Chi-squared (c2) and Cochran-Mantel-Hanzel
(CMH) statistics were utilized to examine the relationship
between home-testing participation and the independent