Statin Immune Study (ImmunoStat)

University of Dundee

Status and phase: Completed; Phase 4

Conditions: Drug Intolerance

Treatments: Drug: Atorvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02984293

16/ES/0128 (Other Identifier)

2016CV05

Details and patient eligibility

About

Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe drugs. However, up to one third of statin users can experience muscle symptoms, which are most commonly mild without any conventional laboratory signs of muscle damage. However, these muscle symptoms can often lead to poor compliance to the cholesterol-lowering therapy, reducing its effectiveness. Recent data has highlighted the potential role of immune system in development of statin-induced muscle pain. Variation in the LILRB5 gene has been associated with statin intolerance. We aim to investigate the impact of LILRB5 genetic variability in tolerability and immune response to atorvastatin in healthy volunteers.

The study is being undertaken at the Tayside Institute for Cardiovascular Research (TICR) in Ninewells Hospital, Dundee. We will recruit participants who have donated a sample to GoSHARE study. The participants will be healthy, and recruited according to their genotype of LILRB5 (information available from GoSHARE). The volunteers will then enter a randomised cross-over study with two treatment periods. During treatment period one, all participants will be commenced on atorvastatin or placebo (a dummy drug). Before and at the end of the treatment period, blood and urine samples will be taken and a muscle symptoms questionnaire will be completed to assess the tolerability and immune response to the study drug exposure. After four weeks, the study drug is stopped for a washout period of three weeks before cross-over commences. Thereafter, during treatment period two, the alternate study drug will be started, and tolerability will be assessed similar to that in period one. The study will last approximately 11 weeks. The volunteers have a total of 5 visits to the TICR.

Enrollment: 18 patients

Sex: All

Ages: 40 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 40-69 years
• Statin-naïve
• White European
• Healthy
• Acceptable laboratory test results

Exclusion criteria

• Significant disease
• Regular drug therapy
• Recent involvement (<30 days) in a CTIMP
• Inability/unwillingness to comply with the protocol
• Carry the rare variant of the CKM polymorphism rs11559024
• Unable to consent
• Woman of childbearing potential (i.e. premenopausal female capable of becoming pregnant)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Atorvastatin

Active Comparator group

Description:

The participants will receive atorvastatin (80 mg) orally once daily for 28 days.

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

The participants will receive matched placebo orally once daily for 28 days.

Treatment:

Drug: Placebo