Lead Investigator: João Pedro Ferreira, Porto University
Title of Proposal Research: Non-steroidal anti-inflammatory drugs (NSAIDs) use and kidney outcomes in Heart Failure
Vivli Data Request: 10411
Funding Source: None
Potential Conflicts of Interest: Dr Ferreira was a member of the Steering Committee for the EMPEROR studies, but I do not have any patents nor receive any payment from Boehringer-Ingelheim. Dr Ferreira will acknowledge/declare any potential conflicts of interest in any subsequent publication.
Summary of the Proposed Research:
Non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen, diclofenac) are compounds commonly used for the treatment of chronic pain (of diverse causes), fever, or infections.
Most NSAIDs do not require medical prescription and can be bought in most drug stores. However, chronic NSAID use may cause kidney failure (ie, impair the capacity of the kidneys to function normally) which can lead to hospitalization and death.
Studying the relationship between NSAID use and kidney outcomes is particularly important in people living with heart failure (HF), a condition in which the heart does not pump the blood normally, because kidney impairment may retain fluids in the body which can aggravate heart function further.
Sodium glucose co-transporter 2 (SGLT2) inhibitors are agents that increase the urinary excretion of sodium (“salt”) and glucose (“sugar”), and improve kidney function in HF. Whether the effect of SGLT2 inhibitors is impacted by the use of NSAIDs is also an important research question.
I will look at three main things using trial data: 1) how patients who use NSAIDs differ from those who don’t; 2) how using NSAIDs affects hospital visits for heart failure, heart-related deaths, kidney problems, and overall death rates; 3) whether taking NSAIDs changes how well empagliflozin works compared to a placebo (in active substance) for heart and kidney health.
Requested Studies:
A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
Data Contributor: Boehringer Ingelheim
Study ID: NCT03057951
Sponsor ID: 1245.110
A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Data Contributor: Boehringer Ingelheim
Study ID: NCT03057977
Sponsor ID: 1245.121