Lead Investigator: Hyon Choi, Massachusetts General Hospital
Title of Proposal Research: Serum urate reduction, gout flares, and risk of major cardiovascular events during urate-lowering therapy initiation target trial emulation and self-controlled case series analysis
Vivli Data Request: 8593
Funding Source: Planning to apply for NIH funding
Potential Conflicts of Interest: LG-Chem, Protalix, Horizon, Ani, Takeda (previously)
These financial relationships will be disclosed when the research findings are presented and published.
Summary of the Proposed Research:
Gout is the most common type of inflammatory arthritis and now affects 10% of adults aged 65 and older. People with gout often have elevated levels of urate in their blood and experience intensely painful, disabling flares in one or more joints. These can impact the person’s movement, family, social and working life, and self-care and wellbeing. However, recent analyses of a UK healthcare database suggested gout flares may also increase the risk of heart attack or stroke. This finding was important but needs to be confirmed. As well, the impact of lowering blood urate levels on the risk of these cardiovascular events among people with gout is not clear, especially for those first starting medication to control their urate levels (urate-lowering therapy=ULT). As gout flares tend to be worse during this time, it’s important to know whether the risk of cardiovascular events is also higher during this time.
We propose to use data from a large clinical trial of 6,000 people with gout and underlying heart disease to assess whether there is an increased risk of heart attack and stroke after gout flare, especially when first starting urate-lowering therapies, as well as the impact of lowering urate levels on risk of heart attack and stroke. The trial dataset has important information that isn’t available in healthcare databases, including clinical and lab measures. Trial participants reported their flares to study investigators and all cardiovascular events were reviewed by medical experts.
Our findings are expected to tell us more about the cardiovascular risks faced by people with gout, especially after flare, the impact of lowering urate levels on cardiovascular risks, and the potential pathways. These findings may also help gout patients and providers decide on the best treatment approaches for reducing the risks of flare and serious cardiovascular events.
Requested Studies:
A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities
Data Contributor: Takeda
Study ID: NCT01101035
Sponsor ID: TMX-67_301