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Interaction between alcohol, statins and cardiovascular disease risk

Award Number: R03AA026099
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2018
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Interaction between alcohol, statins and cardiovascular disease risk - Despite great advances in the prevention and control of cardiovascular diseases (CVD), largely attributable to the widespread use of statins, cardiovascular (CV) risk remains exceptionally high, particularly among the elderly (>65 years) and those with comorbid conditions such as diabetes. Efforts to enhance the therapeutic benefits of statins with combination therapy that includes niacin or fenofibrate have not succeeded. It is thus critical to identify strategies that improve the therapeutic benefits of statins. Alcohol intake, while not recommended as an intervention for disease prevention, serves as an excellent model to study a common dietary factor with high likelihood to impact response to statin therapy in terms of CV benefits. Our preliminary studies show that moderate alcohol use significantly improves statin efficacy with regard to all-cause mortality. Heavy drinking could lower efficacy of statins through biological interactions or poor adherence to statins. The net effect of alcohol use at moderate and heavy levels on the risk of CV events or mortality is not known, despite the growing number of people who are aging and are exposed to both alcohol and statins. In this secondary data analysis we seek to investigate whether alcohol alters the outcomes of statin therapy in the general population so as to determine whether it may be necessary to counsel patients about alcohol when statins are prescribed. If we confirm a strong influence of moderate alcohol intake on enhancing statin efficacy, we will move the field of CVD prevention forward, not by endorsing or encouraging alcohol consumption, but by providing leads for research into specific mechanisms to be translated into pharmaceutical compounds that mimic this specific alcohol effect. Such compounds could be used as adjuncts to statin therapy. Furthermore, if the study confirms the preliminary evidence of reduced statin efficacy with heavy alcohol use, it will provide the basis for updating guidelines on statin use by encouraging health practitioners to aggressively counsel patients to quit alcohol or shift from heavy to moderate alcohol intake. According to CDC (MMWR Jan 7, 2014), only one in six US adults report ever discussing alcohol use with a healthcare provider, an observation that could in part be explained by limited data on effects of alcohol on health, especially in individuals without liver disease. Currently there are no large published studies that have investigated the effect of alcohol on statin efficacy with regard to clinical CVD events. Our specific aims are: (1) to determine whether alcohol consumption modifies the efficacy of statin therapy as measured by mortality and incident CVD events, (2) to determine whether the effect of alcohol consumption on the CV benefits of statins varies by age and gender, variables known to significantly modify alcohol metabolism, and (3) to determine, through mediation analysis, the potential mechanisms or pathways through which alcohol may modify effects of statins. This study, among >120,000 men and women, will bring solid evidence on whether modulation of alcohol intake is relevant to statin therapy, identify modifying effects on specific CVD events, and enable prioritization of areas for mechanistic studies.


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: 2023 ( Subtotal = -$7,684 )
2023	2019	OCHSNER CLINIC FOUNDATION	1514 JEFFERSON HWY	NEW ORLEANS	LA	70121	JEFFERSON	USA	Alcohol Research Programs	000	3	12/7/2022	NON-COMPETING CONTINUATION	-$7,684
														Subtotal = -$7,684

Issue Date FY: 2022 ( Subtotal = -$1,727 )
2022	2019	OCHSNER CLINIC FOUNDATION	1514 JEFFERSON HWY	JEFFERSON	LA	70121	JEFFERSON	USA	Alcohol Research Programs	000	3	3/7/2022	NON-COMPETING CONTINUATION	-$1,727
														Subtotal = -$1,727

Issue Date FY: 2019 ( Subtotal = $72,801 )
2019	2019	OCHSNER CLINIC FOUNDATION	1514 JEFFERSON HWY	NEW ORLEANS	LA	70121	JEFFERSON	USA	Alcohol Research Programs	000	3	8/16/2019	NON-COMPETING CONTINUATION	$72,801
														Subtotal = $72,801

Issue Date FY: 2018 ( Subtotal = $78,419 )
2018	2018	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Alcohol Research Programs	001	1	9/20/2018	NEW	-$79,000
2018	2018	OCHSNER CLINIC FOUNDATION	1514 JEFFERSON HWY	NEW ORLEANS	LA	70121	JEFFERSON	USA	Alcohol Research Programs	002	2	9/21/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$78,419
2018	2018	VANDERBILT UNIVERSITY MEDICAL CENTER	1161 21ST AVE S STE D3300 MCN	NASHVILLE	TN	37232	DAVIDSON	USA	Alcohol Research Programs	000	1	6/15/2018	NEW	$79,000
														Subtotal = $78,419

Grand Total All Awards = $141,809

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Interaction between alcohol, statins and cardiovascular disease risk

Award Number: R03AA026099

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2018

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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