Urso for PSC - CON Christopher L. Bowlus, MD Professor and Chief

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Presentation transcript:

Urso for PSC - CON Christopher L. Bowlus, MD Professor and Chief Division of Gastroenterology and Hepatology University of California Davis

Guilty Until Proven Innocent We should NOT use a treatment until it is proven safe and effective. All treatments have risk/adverse effects Often hard to measure (Celebrex, Omeprazole) Not all treatments have benefits Improving liver tests is not a benefit

New Drug Approval - FDA Substantial evidence from appropriately designed and analyzed trials Demonstrate an improvement in how a patient feels, functions, or survives After > 20 years of study, Urso has still not met these standards

Urso Improves Liver Tests PSC patients with lower liver tests live longer….. ….so doesn’t this mean that Urso will make me live longer? Not necessarily

What we want Urso to do Without Urso With Urso Alkaline Phosphatase

What Urso may actually be doing Alkaline Phosphatase Without Urso Alkaline Phosphatase With Urso

Normal Alkaline Phosphatase Predicts Better Prognosis Regardless of Urso Lindstrom L, et al. Clinic Gastroenterol Hepatol. 2013.

If Urso works, wouldn’t we know by now??? Didn’t work in the US Didn’t work in Scandnavia 12/9/2018

PBC but not PSC Transplants have decreased since Urso was approved http://optn.transplant.hrsa.gov/latestData/rptData.asp Accessed April 2, 2013

High-dose Urso has unintended consequences 12/9/2018

Weighing the risks and benefits? Benefit of Urso Risk of disease progression Risk of Urso Cost of Urso Take Urso Don’t Take Urso