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Evaluating the role of multimorbidity in modulation medication effects in older adults

Award Number: R01HL163163
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2023
PERIOD OF PERFORMANCE END DATE: 01/31/2028

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Evaluating the role of multimorbidity in modulation medication effects in older adults - Multimorbidity, defined as the co-occurrence of two or more medical conditions, impacts two-thirds of older individuals over 65 – corresponding to 36 million U.S. adults, and is a major driver of healthcare spending, polypharmacy, and mortality. However, the routine exclusion of older and more multimorbid patients from clinical trials has resulted in the paucity of data regarding the risks and benefits of medications in this population, or an understanding of how multimorbidity alters treatment effects. To address this unmet need, this proposal will evaluate the role of multimorbidity in modulating medication effects and identify the optimal approach that best quantifies its impact on medication outcomes. Our central hypothesis is that (a) by attenuating drug-related benefits and amplifying drug-related harms, multimorbidity should be a key consideration when making treatment decisions, and that (b) approaches that incorporate the cumulative burden of illness – especially the multi- morbidity weighted index [MWI] – can better characterize these alterations in medication effects (preliminary analysis). The proposal will use Medicare fee-for-service data from >23 million patients and replicate findings in two large external databases. We will focus on cardiometabolic therapies as: older adults have the highest burden of these conditions, and since 2010, more than 20 new cardiometabolic therapies have been approved, highlighting the immense need to study these medications. We will identify patients with: (a) type 2 diabetes initiating sodium glucose co-transporter 2 inhibitors vs established antidiabetic therapies; (b) atrial fibrillation initiating direct oral anticoagulants vs warfarin; and (c) atherosclerotic cardiovascular disease [CVD] initiating newer antiplatelet drugs (e.g. ticagrelor) vs clopidogrel. Aim 1 will evaluate how clinical (e.g. cognitive impairment) and non-clinical (e.g. social deprivation) factors interact with multimorbidity to influence medication prescribing of cardiometabolic therapies in the real world. Aim 2 will elucidate the role of multimorbidity in modulating the risks and benefits for newer compared to established cardiometabolic medications by estimating the adjusted rates of disease specific benefits (i.e. reduction in CVD events), harms (e.g. major bleeding) and universal outcome measures (e.g. home-time, loss of functional independence) by levels of multimorbidity. We will also validate multimorbidity measures (e.g. MWI, Elixhauser index) and frameworks (e.g. disease dyads) against medication outcomes. The impact of this proposal is significant as it will establish a rigorous and readily scalable framework to study the effects of multimorbidity on drug outcomes in older adults. It will also represent the first effort to systematically evaluate and validate multimorbidity indices and approaches against medication outcomes, beginning a new and exciting line of research that has potential to expand to other populations (e.g. middle-aged adults) and clinical areas. Given the paucity of data from clinical trials, study findings will serve as the primary source of information for patients, caregivers, and clinicians to make individualized evidence-based decisions.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $672,139 )
2026	2026	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Cardiovascular Diseases Research	000	4	2/9/2026	NON-COMPETING CONTINUATION	$651,562
2026	2026	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Cardiovascular Diseases Research	001	4	3/24/2026	NON-COMPETING CONTINUATION	$20,577
														Subtotal = $672,139

Issue Date FY: 2025 ( Subtotal = $687,339 )
2025	2025	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Cardiovascular Diseases Research	000	3	2/19/2025	NON-COMPETING CONTINUATION	$618,605
2025	2025	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Cardiovascular Diseases Research	001	3	7/23/2025	NON-COMPETING CONTINUATION	$68,734
														Subtotal = $687,339

Issue Date FY: 2024 ( Subtotal = $668,085 )
2024	2024	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Cardiovascular Diseases Research	000	2	1/23/2024	NON-COMPETING CONTINUATION	$613,548
2024	2024	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Cardiovascular Diseases Research	001	2	6/19/2024	NON-COMPETING CONTINUATION	$54,537
														Subtotal = $668,085

Issue Date FY: 2023 ( Subtotal = $700,279 )
2023	2023	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Cardiovascular Diseases Research	000	1	1/20/2023	NEW	$700,279
														Subtotal = $700,279

Grand Total All Awards = $2,727,842

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Evaluating the role of multimorbidity in modulation medication effects in older adults

Award Number: R01HL163163

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2023

PERIOD OF PERFORMANCE END DATE: 01/31/2028

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