# Determining medications associated with drug-induced pancreatic injury through novel pharmacoepidemiology techniques that assess causation

> **NIH NIH R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2024 · $348,813

## Abstract

PROJECT SUMMARY
Acute pancreatitis causes nearly 300,000 hospitalizations per year in the United States, and its rates are rising.
One-third of cases are classified as having unknown cause, leaving patients vulnerable to repeated episodes
because they do not know how to alter their lifestyles. Unexpected side effects of prescription medications may
be responsible for acute pancreatitis cases with unknown cause. This situation is called drug-induced
pancreatic injury (DIPI). Unfortunately, healthcare providers and medical researchers do not know which
medications cause DIPI. This is because the majority of research about DIPI comes from descriptions of the
experience of individual patients. While these are valuable for providing clues about medications that might
cause DIPI, they do not account for other factors that could contribute to acute pancreatitis. Therefore,
conclusions from this type of study may falsely label particular medications as dangerous. This may lead to
reduced use of medications that are effective for the conditions that they treat, resulting in worse outcomes for
patients. There is a critical need to determine which medications do and do not cause DIPI in order to prevent
cases of acute pancreatitis and to continue patients on safe essential medications. The recent availability of
electronic databases with health information and powerful computer processing has made it possible to study
the effects of thousands of medications. Additionally, a new data analysis technique called pharmacopeia-wide
association studies (PWAS) has improved the efficiency of these studies. Furthermore, PWAS can be
combined with fundamental epidemiology principles to determine whether a study finding demonstrating a
medication side effect is true or false. The overall objective of this proposal is to identify medications that cause
DIPI by applying PWAS to two large databases of patient health information. Additionally, this proposal will
combine PWAS with a research framework called the Bradford Hill criteria to distinguish medications that
cause DIPI from false results. The specific aims of this proposal are (1) To identify medications that are
strongly associated with DIPI, demonstrate dose response, and exhibit biologic plausibility by applying the
PWAS framework to case-control studies; (2) To identify medications that demonstrate consistent temporality
and specificity with DIPI through novel applications of the PWAS framework; (3) To identify replicable
medication-DIPI associations by repeating Aims 1 and 2 using a second database; and (4) To develop and
disseminate an interactive database to integrate the study findings for clinicians and investigators. This
research is significant because it will improve patient outcomes by resolving clinical uncertainty about which
medications should be stopped after acute pancreatitis and which essential medications are safe to continue.
This research is innovative because it combines cutting-edge data anal...

## Key facts

- **NIH application ID:** 10851963
- **Project number:** 5R01DK135876-02
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Ravy Kuppalapalle Vajravelu
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $348,813
- **Award type:** 5
- **Project period:** 2023-07-01 → 2027-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10851963

## Citation

> US National Institutes of Health, RePORTER application 10851963, Determining medications associated with drug-induced pancreatic injury through novel pharmacoepidemiology techniques that assess causation (5R01DK135876-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10851963. Licensed CC0.

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