# Statin Therapy for patients with compensated Cirrhosis

> **NIH NIH U01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2021 · $366,344

## Abstract

Project Abstract
Cirrhosis is a highly morbid and resource intensive condition that afflicts an increasing number of individuals in
the US. The epidemiology of cirrhosis, however is changing, with demographic shifts and increasing
prevalence of metabolic and alcohol associated liver disease. We lack sufficient tools for risk stratification of
the changing population of patients with cirrhosis, as our current prognostic models for compensated cirrhosis
lack adequate discrimination. Furthermore, patients with cirrhosis have symptoms and quality of life deficits
that are not routinely addressed in clinical practice. Patient reported outcomes (PROs) can be incorporated into
risk models with excellent prognostic discrimination. Patients with cirrhosis have a risk of deadly complications
such as hepatic decompensation or hepatocellular carcinoma, however we lack disease modifying agents that
can forestall the development of these complication. Several epidemiological studies suggest statins may be
associated with a decreased risk of cirrhosis related decompensation, however we lack prospective data to
support its use for this indication. In Aim 1 of this proposal, as part of a multicenter consortium, we aim to
recruit a large contemporary longitudinal cohort of patients with compensated cirrhosis from our Hepatology
practice at the University of Michigan, which follows over 1,900 patients with cirrhosis longitudinally. We will
perform serial measurements of clinical, liver fibrosis, PRO, functional, and laboratory parameters over the
study period. As part of the PRO measurement, will develop automated alerts with care pathways within the
electronic medical record to alert providers for alcohol use disorder in patients enrolled in the cohort. In Aim 2,
we will develop and validate multidimensional risk models, incorporating the longitudinal parameters measured
in Aim 1, in order to predict outcomes, including survival, hepatic decompensation, cardiovascular events, and
disability. In Aim 3 we will perform a randomized placebo control trial of statins in patients with compensated
cirrhosis. The primary outcome will be overall survival, with secondary outcomes of hepatic
decompensation/hepatocellular carcinoma development and cardiovascular events. We will perform additional
exploratory analyses to determine the impact of statins on fibrosis progression. This proposal will provide
critical information that will have profound clinical impact on the management of patients with cirrhosis. We are
well positioned to conduct this study given our Hepatology and clinical research infrastructure.

## Key facts

- **NIH application ID:** 10307664
- **Project number:** 1U01DK130113-01
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Neehar Dilip Parikh
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $366,344
- **Award type:** 1
- **Project period:** 2021-09-22 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10307664

## Citation

> US National Institutes of Health, RePORTER application 10307664, Statin Therapy for patients with compensated Cirrhosis (1U01DK130113-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10307664. Licensed CC0.

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