Statins for Crohn's Disease

This trial explores whether statins, typically used to lower cholesterol, can prevent strictures (narrowing of the intestines) in individuals with Crohn's disease. Researchers aim to determine if statins reduce the formation of these strictures compared to a placebo, which contains no active ingredient. Participants will take either the statin rosuvastatin or a placebo daily for 6-12 months, with clinic visits and regular check-ins. Individuals with stricturing Crohn's disease scheduled for specific surgeries in California may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how rosuvastatin affects people with Crohn's disease, offering participants the opportunity to contribute to groundbreaking medical insights.

The trial requires you to stop taking certain medications unless you have explicit clearance from your doctor. These include antifungals, fibrate drugs, macrolide antibiotics, protease inhibitors, calcium channel blockers, amiodarone, warfarin, and colchicine. If you are currently using cyclosporine or statins, you cannot participate in the trial.

Research has shown that statins, such as rosuvastatin, are usually well-tolerated for various health issues. Studies have found that statins are linked to fewer surgeries and hospital visits in individuals with inflammatory bowel diseases (IBD), including Crohn's disease, suggesting they might be safe for these patients.

However, research on rosuvastatin specifically for Crohn's disease remains in the early stages, so detailed safety information for this use is limited. While statins can sometimes cause side effects like muscle pain, liver problems, or digestive issues, these are uncommon.

Unlike the standard treatments for Crohn's Disease, which often include anti-inflammatory drugs, immune system suppressors, and biologics, rosuvastatin offers a unique approach by leveraging its cholesterol-lowering properties. This statin is known for its ability to reduce inflammation and improve endothelial function, which could be beneficial for managing Crohn's Disease symptoms. Additionally, rosuvastatin's well-established safety profile for treating high cholesterol makes it an intriguing candidate for repurposing in this new context. Researchers are excited about its potential to provide an alternative treatment option with a different mechanism of action compared to current therapies.

Research suggests that statins, such as rosuvastatin, might benefit people with Crohn's disease. Some studies have found that statin use links to a lower risk of developing Crohn's disease and fewer hospital visits for this condition. Specifically, rosuvastatin has been associated with lower death rates in patients with inflammatory bowel diseases, including Crohn's disease. However, earlier studies did not show significant changes in disease activity after short-term use. In this trial, participants will receive either rosuvastatin or a placebo to evaluate its potential benefits. Researchers hope that statins might help prevent the narrowing of the intestines, known as strictures, by reducing inflammation.¹²³⁵⁶