Anticoagulants, Multiple Sclerosis Fatigue Studies Receive $5.5M in PCORI Funding

Two researchers at UC San Francisco have received funding awards from the Patient-Centered Outcomes Research Institute (PCORI) that total $5.5 million.

Margaret Fang, MD, MPH, associate professor of Medicine, was awarded $3.5 million to compare the effectiveness of blood thinners for the long-term treatment of venous thromboembolism. Collecting data from electronic health records and patient surveys, her team will compare the risks and benefits of warfarin and four newer oral anticoagulants in preventing recurrence of blood clots.

Bardia Nourbakhsh, MD, clinical fellow in Neurology, received $2 million to conduct a clinical trial of several drugs for reducing fatigue in multiple sclerosis (MS). In a randomized, double-blind,and placebo-controlled study, Nourbakhsh’s team will evaluate the ability of these drugs to improve quality of life in a diverse group of patients with MS.

Comparing Old and New Anticoagulants

Venous thromboembolism (VTE) occurs when a blood clot formed in a deep vein breaks loose and travels to lungs. The condition is responsible for more than half a million hospitalizations and 100,000 deaths each year in the U.S. Patients with VTE are treated with anticoagulant medication for at least three months, and often longer to prevent recurrence. But long-term anticoagulant therapy can lead to serious bleeding complications and the choice between available medications is unclear.

Portrait of Margaret Fang
Margaret Fang, MD, MPH

“Choosing the best anticoagulant strategy is particularly difficult when treating people of older age, people who have kidney disease, or people who have high bleeding risk, due to the scant evidence available on the relative benefits and harms in these populations,” Fang said.

Fang’s team will review patient records from Kaiser Permanente Northern California and Kaiser Permanente Southern California to identify adults treated for VTE. They will compare clinical outcomes for warfarin, the old standby anticoagulant, with four newer drugs ­– apixaban, dabigatran, edoxaban, and rivaroxaban. They will also survey patients to measure self-reported health, well-being, and treatment satisfaction.

“The long-term objective of our project is to compare the benefits and harms of different anticoagulant options for the extended treatment of VTE, information that will be critical in helping clinicians and patients personalize their treatment decisions,” Fang said.

Relief for Multiple Sclerosis Fatigue

Many patients with MS have disabling fatigue that leaves them exhausted after minimal physical or mental exertion. Three drugs ­– amantadine, modafinil, and methylphenidate – are commonly used to treat MS fatigue, although none is FDA-approved for this condition.

Portrait of Bardia Nourbakhsh
Bardia Nourbakhsh, MD

“We propose to perform a clinical trial to find out if any of the commonly used drugs is truly effective in reducing fatigue in diverse group of patients with MS, mirroring the real-world setting,” Nourbakhsh said. In their proposed trial, each patient will receive all the study medications at different points in time. Researchers will assess fatigue levels through online or phone questionnaires to minimize the burden on patients.

The study will also evaluate how well patients tolerate different doses of the drugs, whether reducing fatigue improves quality of life, and which type of patient may benefit more from a specific treatment.

“Successful execution of our project will increase the attention of clinicians, patients, and policy maker to this common, disabling, undertreated, and under-researched MS symptom,” Nourbakhsh said.

The PCORI board approved the research awards pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed health care decisions.

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