# Prospective Monitoring of Newly Approved Cardiovascular Drugs in Older Adults with Frailty

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2021 · $723,192

## Abstract

PROJECT SUMMARY/ABSTRACT
Cardiovascular disease (CVD) affects 70% of older adults and remains the leading cause of morbidity and mor-
tality in the United States. Several new drugs have recently been approved for CVD, but not enough is known
about their utilization, benefits and risks in frail older patients. Since conducting a clinical trial in frail older adults
can be costly and impractical, there is a pressing need for innovative strategies to generate evidence on new
CVD drugs in a timely manner. The objective of this application is to establish a near-real-time prospective
monitoring program in Medicare data to evaluate the benefit of new CVD drugs for older adults with frailty. A
prospective monitoring program seeks to find early effectiveness and safety signals of new drugs by updating
the analysis at regular intervals as new Medicare data become available. The investigators will incorporate a
novel claims-based frailty index into the monitoring program to generate timely evidence on disease-specific and
patient-centered net benefit of new drugs by frailty status. The central hypothesis is that disease-specific benefit
and net benefit are determined by a patient's degree of frailty. Disease-specific benefit will be evaluated using
clinical trial endpoints of effectiveness (e.g., CVD events) and safety (e.g., bleeding), and net benefit in terms of
the number of days alive and spent at home, or “home time”. To conduct this work, the investigators will analyze
Medicare data on 6 new CVD drugs approved in 2011-2017: 3 anticoagulants vs warfarin for atrial fibrillation, 2
antiplatelets vs clopidogrel for atherosclerotic CVD, and an angiotensin receptor-neprilysin inhibitor vs enalapril
for systolic heart failure. The validity and reproducibility of the results will be enhanced through the linkage of a
subset of Medicare data to electronic health records and a national survey to supplement clinical information,
and external validation of the Medicare data analysis in 2 large commercial databases. In the next 4 years, the
investigators will accomplish 3 specific aims: 1) evaluate the temporal trends and predictors of new CVD drug
use in frail and non-frail older adults with CVD over 2011-2020; 2) determine disease-specific benefit (deaths,
CVD and safety events) and net benefit (home time) of 6 new CVD drugs compared with alternative therapies;
3) identify patient characteristics that can predict net benefit (home time) with new CVD drugs compared with
alternative therapies. This proposal's innovative approach, which combines near-real-time prospective monitor-
ing, a claims-based frailty score, and the patient-centered outcome of home time, offers a readily scalable and
feasible framework for comparative effectiveness and safety studies of newly approved medications. The impact
of the proposed research is significant because timely evidence generated from real-world healthcare data can
enable clinicians to optimize prescribing of new CVD drugs ...

## Key facts

- **NIH application ID:** 10102161
- **Project number:** 5R01AG062713-03
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Dae Hyun Kim
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $723,192
- **Award type:** 5
- **Project period:** 2019-06-01 → 2023-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10102161

## Citation

> US National Institutes of Health, RePORTER application 10102161, Prospective Monitoring of Newly Approved Cardiovascular Drugs in Older Adults with Frailty (5R01AG062713-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10102161. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*