Simvastatin for Chronic Pancreatitis

(SMV in CP Trial)

Recruiting at 1 trial location

Overseen By Marissa Maiman

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Antifungals, Antibiotics, HIV drugs, others

Disqualifiers: Pregnancy, Pancreatic tumors, Transplant, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 6 months

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pilot study to examine the feasibility and acceptability of simvastatin in adults with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking certain drugs like itraconazole, ketoconazole, or simvastatin within the past 6 months. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug Simvastatin for chronic pancreatitis?

Research suggests that statins, like Simvastatin, may help prevent recurrent episodes of pancreatitis, which can improve quality of life for patients with chronic pancreatitis. Additionally, statins have anti-inflammatory properties that might be beneficial in managing chronic pancreatitis. ^{1 2 3 4 5}

Is Simvastatin generally safe for humans?

In adults, the safety profile of statins, including Simvastatin, is well known. However, in children and adolescents, there have been reports of rare but serious side effects like muscle damage and liver injury, which can affect quality of life or lead to life-threatening complications. ^{6 7 8 9 10}

How does the drug Simvastatin differ from other treatments for chronic pancreatitis?

Simvastatin is unique for chronic pancreatitis as it is primarily a cholesterol-lowering drug, but it is being studied for its potential to prevent recurrent episodes of pancreatitis, which is not a standard use for this condition. Unlike other treatments, it may offer a novel approach by potentially altering the disease's natural course. ^{1 3 4 5 11}

Research Team

Stephen Pandol, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

Adults aged 18-75 with Recurrent Acute Pancreatitis or Chronic Pancreatitis not caused by gallstones, medications, trauma, or autoimmune issues. Participants must be able to take oral meds and commit to the study's duration. Women of childbearing age and men must use effective contraception.

Inclusion Criteria

Provision of signed and dated informed consent form

For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

History of solid organ transplant, HIV/AIDS

Pregnancy or lactation

Known Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Simvastatin or placebo for 6 months to assess its impact on pain and quality of life in chronic pancreatitis

6 months

Visits at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome measures collected 6 months post-treatment

6 months

Final visit at 12 months

Treatment Details

Interventions

• Placebo
• Simvastatin

Trial Overview The trial is testing simvastatin's effectiveness for improving patient-reported outcomes in those with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP). It compares simvastatin against a placebo to see if it can help manage pancreatitis symptoms.

Participant Groups

Group I: Simvastatin Experimental Treatment 1 Intervention

Participants receive Simvastatin 40mg capsule once daily for 6 months.

Group II: Placebo Placebo Group 1 Intervention

Participants receive Placebo capsule matching Simvastatin once daily for 6 months.

Simvastatin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Zocor for:

• Hypercholesterolemia
• Cardiovascular disease

Approved in United States as Zocor for:

• Hypercholesterolemia
• Cardiovascular disease

Approved in Canada as Zocor for:

• Hypercholesterolemia
• Cardiovascular disease

Approved in Japan as Zocor for:

• Hypercholesterolemia
• Cardiovascular disease

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

In a study involving 2845 patients and 8954 treatment cycles, ustekinumab and secukinumab were found to have the lowest rates of adverse events compared to other systemic drugs for psoriasis, indicating a safer profile for these treatments.

Conversely, cyclosporine and infliximab were associated with the highest rates of adverse events, suggesting that these medications may carry more risks for patients with moderate to severe psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. Daudén, E., Carretero, G., Rivera, R., et al.[2021]

A review of 311 individual case safety reports (ICSRs) from the WHO database revealed that musculoskeletal disorders were the most common adverse drug reactions (ADRs) in children and adolescents taking statins, accounting for 27.3% of reported cases.

The study highlighted serious safety concerns, including 42.8% of reports being classified as 'serious' with 11 deaths primarily due to intentional overdoses in adolescents, indicating a need for increased monitoring and reporting of statin ADRs in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of statins in children and adolescents: a descriptive analysis from VigiBase, the WHO global database of individual case safety reports. Conte, C., Rousseau, V., Vert, C., et al.[2021]

Brodalumab, an IL-17 antagonist approved for moderate-to-severe plaque psoriasis, has a safety profile similar to other IL-17 treatments, based on data from phase II and III clinical trials.

While common adverse events include nasopharyngitis and upper respiratory infections, a significant concern arose from six reported suicides among patients, leading to a black box warning, although no direct causal link was established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brodalumab: A Review of Safety. Rusta-Sallehy, S., Gooderham, M., Papp, K.[2019]

References

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

A case of simvastatin-associated pancreatitis and review of statin-associated pancreatitis. [2013]

2. England pubmed.ncbi.nlm.nih.gov

The relationship between the use of statins and mortality, severity, and pancreatic cancer in Danish patients with chronic pancreatitis. [2018]

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

Simvastatin is associated with reduced risk of acute pancreatitis: findings from a regional integrated healthcare system. [2022]

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

Use of Simvastatin and Risk of Acute Pancreatitis: A Nationwide Case-Control Study in Taiwan. [2022]

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

Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial. [2021]

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

Risk of Serious Infection in Patients Receiving Systemic Medications for the Treatment of Psoriasis. [2022]

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

To test or not to test? An updated evidence-based assessment of the value of screening and monitoring tests when using systemic biologic agents to treat psoriasis and psoriatic arthritis. [2022]

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

Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of statins in children and adolescents: a descriptive analysis from VigiBase, the WHO global database of individual case safety reports. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Brodalumab: A Review of Safety. [2019]

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

Pancreatitis associated with simvastatin plus fenofibrate. [2017]