42 Participants Needed

Atorvastatin for Ulcerative Colitis

Recruiting at 4 trial locations
GY
Overseen ByGuang-Yu Yang, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Northwestern University
Must be taking: Mesalamine, Thiopurines, Biologics
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies atorvastatin, a cholesterol-lowering drug, in patients with ulcerative colitis who are at risk of colon cancer. The goal is to see if atorvastatin can reduce cancer risk by lowering cholesterol and affecting certain proteins and genes linked to cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you must not have used statins in the last 12 months or corticosteroids in the past 3 months. You also cannot use certain medications like cyclosporine, fibrates, or strong CYP3A4 inhibitors or inducers.

Is atorvastatin generally safe for humans?

Atorvastatin is generally considered safe for humans, but there is a case report of severe stomach ulcers in a person taking atorvastatin, which resolved after stopping the drug. This suggests that while rare, serious side effects can occur, and any new abdominal pain should be reported to a doctor.12345

How does atorvastatin differ from other drugs for ulcerative colitis?

Atorvastatin is unique for ulcerative colitis because it has anti-inflammatory effects that are not directly related to its cholesterol-lowering activity, and it can enhance anti-inflammatory effects when combined with mesalazine, potentially improving outcomes by targeting specific inflammatory pathways.12467

What data supports the effectiveness of the drug atorvastatin for treating ulcerative colitis?

Research shows that atorvastatin, when combined with another drug called mesalazine, can reduce inflammation and symptoms in a rat model of ulcerative colitis. This combination therapy was more effective than using either drug alone, suggesting atorvastatin may help manage ulcerative colitis by reducing inflammation.12468

Who Is on the Research Team?

GY

Guang-Yu Yang

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

Adults aged 18-70 with longstanding ulcerative colitis and a specific P53 mutation, in clinical remission for at least 8 years. They must not have used statins or had chemotherapy within the last year or two respectively, no recent corticosteroid use, and cannot be pregnant. Participants should have stable cholesterol levels and agree to contraception during the study.

Inclusion Criteria

Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (SGPT) =< 1.5 X institutional upper limit of normal (ULN)
I have had ulcerative colitis for over 8 years and am in remission, confirmed by yearly endoscopy.
My ulcerative colitis is in remission, and any precancerous growths were fully removed.
See 15 more

Exclusion Criteria

Pregnant or lactating participants are excluded
I have used corticosteroids in the last 3 months due to a high risk of my disease returning.
I have not had chemotherapy in the last 2 years.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atorvastatin or placebo orally once daily for 12 months, with colonoscopy and blood collection

12 months
Monthly visits for monitoring and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Atorvastatin Calcium
  • Placebo Administration
Trial Overview The trial is testing if Atorvastatin can lower colon cancer risk in patients with ulcerative colitis who are at increased risk of large intestinal cancer. It involves taking Atorvastatin versus a placebo while monitoring health through biopsies, blood tests, questionnaires, and biospecimen collection.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (atorvastatin, biospecimen collection)Experimental Treatment4 Interventions
Group II: Arm II (placebo, biospecimen collection)Placebo Group4 Interventions

Atorvastatin Calcium is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Lipitor for:
🇺🇸
Approved in United States as Lipitor for:
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Approved in Canada as Lipitor for:
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Approved in Japan as Lipitor for:
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Approved in China as Lipitor for:
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Approved in Switzerland as Lipitor for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

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.
Disease modifying effect of statins in dextran sulfate sodium model of mouse colitis.Kanagarajan, N., Nam, JH., Noah, ZA., et al.[2018]
In a long-term study involving 1124 patients with ulcerative colitis treated with tofacitinib, lipid levels remained stable over time, indicating that the medication does not significantly alter cholesterol or triglyceride levels.
The incidence of major adverse cardiovascular events was very low at 0.26 per 100 patient-years, suggesting that tofacitinib is safe in terms of cardiovascular risk for patients with ulcerative colitis.
Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management.Sands, BE., Colombel, JF., Ha, C., et al.[2022]
Statins and omega-3 polyunsaturated fatty acids were found to positively influence lipid levels and acute phase proteins in patients with ulcerative colitis, suggesting potential benefits for managing this condition.
The study highlights the importance of these interventions in addressing subclinical atherosclerosis, indicating a dual role in both inflammatory bowel disease and cardiovascular health.
[Treatment optimization of subclinical atherosclerosis in patients with ulcerative colitis].Chopeĭ, IV., Ternushchak, TM., Chubirko, KI., et al.[2015]

Citations

Disease modifying effect of statins in dextran sulfate sodium model of mouse colitis. [2018]
Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. [2022]
[Treatment optimization of subclinical atherosclerosis in patients with ulcerative colitis]. [2015]
Dyslipidaemia Is Associated with Severe Disease Activity and Poor Prognosis in Ulcerative Colitis: A Retrospective Cohort Study in China. [2023]
Targeting IL-10, ZO-1 gene expression and IL-6/STAT-3 trans-signaling by a combination of atorvastatin and mesalazine to enhance anti-inflammatory effects and attenuates progression of oxazolone-induced colitis. [2021]
Atorvastatin-induced severe gastric ulceration: a case report. [2019]
Randomized clinical trial: atorvastatin versus placebo in patients with acute exacerbation of mild to moderate ulcerative colitis. [2021]
Protective effect of simvastatin and rosuvastatin on trinitrobenzene sulfonic acid-induced colitis in rats. [2018]
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