Healthy Subjects (Treated With no Diabetes Therapies) Clinical Trial
Official title:
A Retrospective Cohort Study of Acute Pancreatitis in Relation to Use of Byetta (Exenatide) and Other Antidiabetic Agents
The purpose of this research was to assess the absolute and relative incidence of acute pancreatitis in persons initiating exenatide compared with persons initiating a different antidiabetic agent, and secondarily, persons without diabetes. This protocol summarizes a retrospective cohort study using eligibility, pharmacy claims, and medical claims data from a large US health plan affiliated with i3 Drug Safety.
Limitations of the study: The results provided below should be interpreted in light of the
following limitations:
- Misclassification of acute pancreatitis may have distorted our estimates of absolute
and relative IRs. In cases where the degree of misclassification is non-differential
with respect to the exposure cohort, as is likely the case in administrative data, the
RR would be biased toward the null value, although the magnitude of bias will depend on
the amount of misclassification.
- Lack of information on important potential confounders, like obesity and alcohol use,
is another limitation of the present analysis. Although we adjusted for propensity
scores of exenatide initiation, which included a large number of factors derived from
the claims data, it is likely that the present estimates are somewhat inaccurate due to
residual confounding.
- Our definition of current use in the time-on-drug analysis, which extended 31 days past
the nominal end of the last dispensing of the cohort-defining drug, may be too long in
duration and thus misclassify exposure during the relevant etiologic period.
- Additionally, these analyses assume that when pharmacies submit a claim for a
medication that patients receive and consume the medication. While it is possible that
misclassification of exposure by non-adherence to the medications dispensed occurred,
prior work showed that pharmacy claims are valid for ascertaining medication exposure.
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Observational Model: Cohort, Time Perspective: Retrospective