Statins for Crohn's Disease

Overseen By Touran Fardeen

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stanford University

Must not be taking: Cyclosporine, Antifungals, Fibrates, others

Disqualifiers: Pregnancy, Severe renal dysfunction, others

Compensation: Varies

Number of Visits: 2

Duration: 6-12 months

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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.

What data supports the effectiveness of the drug Rosuvastatin for Crohn's Disease?

Research shows that statins, including Rosuvastatin, can reduce inflammation, which is a key issue in Crohn's Disease. In a study with mice, Rosuvastatin was found to lower inflammation in the colon, suggesting it might help manage similar symptoms in humans with Crohn's Disease. ^{1 2 3 4 5}

Is rosuvastatin generally safe for humans?

Rosuvastatin is generally considered safe for humans, with most side effects being acceptable. However, rare but serious side effects, like ischaemic colitis (inflammation of the colon due to reduced blood flow), have been reported. In large studies, its safety profile was similar to other statins, with uncommon significant liver enzyme or muscle enzyme elevations. ^{1 3 4 6 7}

How does the drug rosuvastatin differ from other treatments for Crohn's disease?

Rosuvastatin is unique because it not only lowers cholesterol but also reduces inflammation in the gut, which may help manage Crohn's disease. This anti-inflammatory effect is achieved by preserving certain proteins that protect the gut lining, making it different from standard treatments that primarily focus on immune suppression. ^{1 2 3 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to learn if statins work to prevent strictures in adults with Crohn's disease. The main question it aims to answer is: * Can statins reduce the formation of strictures in participants with stricturing Crohn's disease? Researchers will compare statins to a placebo (a look-a-like substance that contains no drug) to see if statins work to prevent strictures from forming. Participants will: * Take statins or a placebo every day for 6-12 months * Visit the clinic for lab tests twice after starting either statins or placebo * Complete questionnaires about symptoms and medications * Respond to monthly check-ins (via phone call) during participation

Research Team

Sidhartha R Sinha, MD

Principal Investigator

Stanford University

Eligibility Criteria

Adults with a confirmed diagnosis of stricturing Crohn's disease, who are scheduled for surgical resection of terminal ileum strictures at Stanford University or Dr. Phillip Fleshner's practice in Los Angeles.

Inclusion Criteria

I have been diagnosed with stricturing Crohn's disease.

I am scheduled for surgery on my intestine at Stanford or Dr. Fleshner's in LA.

Exclusion Criteria

Pregnant, nursing, or planning to become pregnant in the next 6-12 months

Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)

I am not taking specific medications like antifungals or antibiotics without my doctor's approval to join the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take statins or placebo daily for 6-12 months, with dose adjustments based on tolerance

6-12 months

2 visits (in-person), monthly check-ins (phone call)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-surgery surveillance colonoscopy

6-12 months post surgery

Treatment Details

Interventions

• Rosuvastatin

Trial Overview The trial is testing if statins can prevent the formation of strictures in Crohn's disease patients compared to a placebo. Participants will take either statins or placebo daily for 6-12 months and have regular clinic visits, complete symptom questionnaires, and monthly phone check-ins.

Participant Groups

Group I: Statin Experimental Treatment 1 Intervention

Rosuvastatin tablet(s) once daily for 6-12 months. Dose will start at 10 mg daily (5 mg daily for Asians), then increase to 20 mg for those tolerating and without contraindication.

Group II: Control Placebo Group 1 Intervention

Placebo tablet(s) taken once daily for 6-12 months.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

In a study involving 30 female mice with colitis induced by DSS, both simvastatin and atorvastatin significantly reduced disease activity, with reductions of 64% and 76% respectively, compared to a 41% reduction in the control group.

The effectiveness of statins in modifying disease activity in this colitis model was found to be comparable to that of an anti-TNFalpha treatment, suggesting a potential therapeutic role for statins in inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease modifying effect of statins in dextran sulfate sodium model of mouse colitis. Kanagarajan, N., Nam, JH., Noah, ZA., et al.[2018]

Rosuvastatin, a commonly prescribed medication for high cholesterol, is generally safe but can lead to rare and serious side effects, such as ischaemic colitis.

In a case study of a 64-year-old woman, ischaemic colitis was diagnosed after starting rosuvastatin, and her symptoms resolved completely after discontinuing the drug, highlighting the need for awareness of this potential adverse reaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reaction: rosuvastatin as a cause for ischaemic colitis in a 64-year-old woman. Tan, J., Pretorius, CF., Flanagan, PV., et al.[2021]

In a study involving 12,400 patients over 12,212 patient-years, rosuvastatin was found to have a safety profile similar to other statins, with adverse events occurring in 57.4% of patients, comparable to 56.8% in the placebo group.

Serious side effects like myopathy and significant liver or muscle enzyme elevations were very rare (less than 0.03% for myopathy), indicating that rosuvastatin is well tolerated among patients with dyslipidemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of rosuvastatin. Shepherd, J., Hunninghake, DB., Stein, EA., et al.[2015]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Rosuvastatin, a new HMG-CoA reductase inhibitor, reduces the colonic inflammatory response in dextran sulfate sodium-induced colitis in mice. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Editorial: Statins for Inflammatory Bowel Disease: Expanding the Scope of Prevention. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Use of atorvastatin as an anti-inflammatory treatment in Crohn's disease. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Statins are associated with reduced use of steroids in inflammatory bowel disease: a retrospective cohort study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Disease modifying effect of statins in dextran sulfate sodium model of mouse colitis. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Adverse drug reaction: rosuvastatin as a cause for ischaemic colitis in a 64-year-old woman. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of rosuvastatin. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Atorvastatin reduces plasma levels of chemokine (CXCL10) in patients with Crohn's disease. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Anti-inflammatory and anti-apoptotic effects of rosuvastatin by regulation of oxidative stress in a dextran sulfate sodium-induced colitis model. [2018]